In December 2021, RQM+ acquired AcKnowledge Regulatory Strategies (AcKnowledge RS), a San Diego-based firm specializing in regulatory affairs consulting for the medical device and IVD industry. The integration of this impressive team enhances the extensive RQM+ network of current and former FDA reviewers, scientists, engineers and regulatory and quality experts, and adds additional expertise with FDA submissions. The author of this post is a member of this team, which has done significant work with novel and/or high-risk devices focusing on pre-submissions, 510(k)s, IDEs, PMAs, De Novos, Breakthrough Designation Requests and Safer Technology Program Requests.
In this week’s Medical Device Monday blog, we are discussing two devices that provide real-time identification of the parathyroid tissue during surgery. The devices— Fluobeam 800 Clinic Imaging Device (Fluobeam®) marketed by Fluoptics, and Parathyroid Detection PTeye System marketed by AiBiomed— were granted by the FDA recently under the De Novo review pathway.
Everyone has (or at least is supposed to be born with) four parathyroid glands. These pea-sized glands are located on the back of the thyroid gland at the base of the neck. Parathyroid glands produce the parathyroid hormone which, along with calcitonin (secreted by the thyroid gland), regulates the amount of calcium in the blood and within the bones. As you can imagine, this calcium regulation is essential for proper functioning of both our muscular system and our nervous system. The overproduction of the parathyroid hormone results in primary hyperparathyroidism, whereas an underactive parathyroid gland results in hypothyroidism.
Hyperparathyroidism can lead to hypercalcemia, or high levels of calcium in the blood. In turn, hypercalcemia can lead to a variety of problems in the body, such as fragile bones, abdominal pain, kidney stones, and excessive urination. In the United States, about 100,000 people are diagnosed with primary hyperparathyroidism annually1. People between age 50 and 60 are most commonly affected, with women being three times more affected than men2. Hypothyroidism, on the other hand, can cause health problems like joint pain, heart disease, and obesity, and can be characterized by dry skin, muscle weakness, sensitivity to the cold, along with other symptoms.
Surgery to remove the parathyroid tissue is the most common treatment for hyperparathyroidism. Parathyroid tissue can be visually difficult to locate as they can sometimes be indistinguishable from neighboring tissues. According to Binita Ashar, M.D., director of the Division of Surgical Devices in the FDA’s Center for Devices and Radiological Health, “Real-time identification of parathyroid tissue during surgery can provide surgeons with valuable information to help preserve healthy tissue or to remove diseased tissue.”
The Fluobeam 800 Clinic Imaging Device
Fluobeam® is an integrated fluorescence imaging device with a Class 1 laser as the excitation light source, and a near-infrared-sensitive camera. When exposed to the laser light, the parathyroid glands emit auto fluorescence in the near infrared without a need for any dye injection.
Parathyroid Detection PTeye System
The Parathyroid Detection PTeye System uses a probe that emits fluorescent light. Tissue detection is based on how the parathyroid tissue reacts to the fluorescent light. When parathyroid tissue is detected, the system provides an audio and visual display to indicate its presence.
Both of these devices are intended to assist (not replace) visual assessment by the surgeons in identifying the parathyroid tissue. FDA reviewed both of these devices and concluded that they should be classified as Class II devices, which, along with general controls, are subject to the following special controls:
- In vivo testing to show that the device can detect auto fluorescent signals from tissues
- Biocompatibility testing of the patient-contacting components of the device
- Testing to demonstrate the electromagnetic compatibility and electrical, mechanical and thermal safety of the device
- Software verification, validation, and hazard analysis
- Sterility testing of patient-contacting components of the device
- Performance testing to demonstrate laser and light safety for eye, tissue and skin
- Appropriate Labeling
Both of these de novo devices have undergone clinical testing to demonstrate their accuracy in locating parathyroid tissue during surgery. Removing the parathyroid and not surrounding tissue, or preserving the parathyroid when it’s meant to remain where it belongs, is important for doctors and their patients undergoing surgery. Using these tools to improve patient outcome during surgeries is a win-win in our opinion. We’re excited to see what other interesting technology comes to the US market in 2019! Happy New Year!
- FDA Press Release
- Fluobeam Classification Order
- Parathyroid Detection PTeye System Classification Order
- Bilezikian JP. Primary hyperparathyroidism. In: DeGroot LJ, ed.; Arnold A, section editor. Diseases of Bone and Mineral Metabolism. www.endotext.org website. South Dartmouth, MA: MDTEXT.COM, Inc. Accessed February 22, 2012
- Silverberg SJ and Bilezikian JP. Primary hyperparathyroidism. In: Jameson JL and DeGroot LJ, senior eds. Endocrinology: Adult and Pediatric. 6th ed. (online version). Philadelphia: Saunders; 2010.