(90 days)
For Illumination, coagulation, and tissue manipulation during ophthalmic surgery
The Peregrine Fiber Optic Bipolar Straight and Angled Picks are fiberoptic illuminators with capabilities to manipulate tissue and coagulate blood. They consist of the following: A connector at the proximal end to fit into a surgical light source. A polyethylene jacket through which an Acrylic Fiber and fine insulated electrical wires run. A Delrin handpiece with a 20 GA stainless steel needle at the distal end. An insulated inner blunt needle running parallel to the outer blunt needle with a gap of approximately one to two millimeters between the respective ends. Electrical connection is made via fine insulated wires from the inner and outer needles to the connectors which attach to the coagulator.
This looks like a 510(k) premarket notification for a medical device, which typically compares a new device to a predicate device to establish substantial equivalence, rather than a study with acceptance criteria and device performance as you'd find in a clinical trial or performance study for a novel device.
Therefore, many of the requested elements (like acceptance criteria, sample size for test sets/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and how ground truth was established) are not applicable to this type of submission.
Here's a breakdown of what can be extracted and what is not present:
1. A table of acceptance criteria and the reported device performance:
- Not Applicable. This document is a 510(k) premarket notification. The primary "acceptance criteria" for a 510(k) is demonstrating substantial equivalence to a legally marketed predicate device, not meeting specific performance metrics against pre-defined acceptance criteria in a clinical study. The tables provided are for comparison of features, design, and materials to predicate devices, not for reporting performance against acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. No test set or clinical study data is presented in this 510(k) summary. The submission relies on a comparison to predicate devices, not new performance data from a specific test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. As no test set data is presented, there is no mention of experts or ground truth establishment in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set data or adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This device is a surgical tool (fiber optic bipolar pick), not an AI diagnostic imaging device. Therefore, MRMC studies and AI assistance comparisons are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a manual surgical instrument. Standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. No ground truth data is used or established in this 510(k) submission.
8. The sample size for the training set:
- Not Applicable. This is a physical device, not an AI model, so there is no concept of a "training set."
9. How the ground truth for the training set was established:
- Not Applicable. There is no training set for this type of device.
Summary of what is provided in the document related to substantial equivalence:
The document focuses on demonstrating substantial equivalence to predicate devices already on the market.
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Predicate Devices Used for Comparison:
- Grieshaber Straight Pick #630.06
- Storz Straight Pick DP9605
- Storz 45deg Angled Pick DP 9606
- Grieshaber 3-Function Manip. #149.89
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Comparison Points (from the table):
- Design: The Peregrine devices are presented as a combination of features and designs from the referenced predicate instruments.
- Gauge: All devices (new and predicates) are 20 gauge.
- Pick: Most picks are 4mm, with one predicate at 3mm.
- Pick Formation: Outer Needle for Peregrine and several predicates, Inner Needle for one predicate. Describes "Straight" or "Angled" configuration.
- Features:
- Illumination: All (Peregrine and predicates) have this feature.
- Tissue Manipulation: All (Peregrine and predicates) have this feature.
- Coagulation: Peregrine devices and one predicate (Grieshaber 3-Function Manip.) have this feature. Some predicates do not.
- Irrigation/Aspiration: Only one predicate (Grieshaber 3-Function Manip.) has this feature; Peregrine devices do not.
- Materials: Similar materials are used across devices for Handpiece (Delrin), Jacket (Polyethylene for Peregrine, some predicates), Connector (Aluminum for Peregrine, some predicates), Needle (20 ga Stainless for all).
- Distinguishing Material: The Peregrine Fiber Optic Bipolar Picks use a Paralene insulating coating, which is noted as different from some predicates that have "none" or "polyamide." The submission states the materials used are "the same for the features provided except for the Paralene insulating coating".
The 510(k) is an assertion that the new device is as safe and effective as the predicate devices based on these comparisons. The FDA's letter (K980530) grants market clearance based on this determination of substantial equivalence.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.