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.

AI/ML Overview

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.

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
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.

Summary

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falcon

K980530

Peregrine Surgical Ltd 40500 Skyron Drive Doylestown, PA 18901

MAY 1 2 1998

May 11, 1998

Premarket Notification [510(k)] Summary

Submitter: Peregrine Surgical Ltd. 4050D Skyron Drive Doylestown, PA 18901 Phone: (215) 348-0456 Fax: (215) 348-5526

Official Correspondent: Amy Hessenthaler

Trade Name: Peregrine Fiber Optic Bipolar Straight Pick Peregrine Fiber Optic Bipolar Angled Pick

Common Name: Fiber Optic Light Pipe with Pick and Coagulation

Registration Number: 2529392

Classification: Class II

Class Name: Not Known

Panel: Ophthalmic

Product Code: 86 MPA, 21 CFR 876.1500

Device Description: 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.

Statement of indications for use. - For Illumination, coagulation, and tissue manipulation during ophthalmic surgery

Tel: 215-348-0450 Fax: 215-348-5520

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Substantial Equivalence Comparison

K980530

. . . .

	Peregrine F.O.Straight BipolarPick #100.12	Peregrine F.O.Angled BipolarPick #100.13	GrieshaberStraight Pic#630.06	StorzStraight PickDP9605	Storz45deg Angled PickDP 9606	Grieshaber3-Function Manip.#149.89
Design	510K Application	510K Application
Gauge	20	20	20	20	20	20
Pick	4mm	4mm	4mm	4mm	4mm	3mm
Pick Formation	Outer Needle	Outer Needle	Outer Needle	Outer Needle	Outer Needle	Inner Needle
	Straight	Angled	Straight	Straight	Angled	Straight

Features
Illumination	XXX	XXX	XXX	XXX	XXX	XXX
TissueManipulation	XXX	XXX	XXX	XXX	XXX	XXX
Irrigation/Aspiration						XXX
Coagulation	XXX	XXX				XXX

Materials
Handpiece	Delrin	Delrin	Delrin	Delrin	Delrin	Delrin
Jacket	Polyethylene	Polyethylene	Polyethylene	Teflon	Teflon	Polyethylene
Connector	Aluminum	Aluminum	Aluminum	Acetal	Acetal	Acetal
Needle	20 ga Stainless	20 ga Stainless	20 ga Stainless	20 ga Stainless	20 ga Stainless	20 ga Stainless
Insulating Coating	Paralene	Paralene	none	none	none	polyamide

The proposed Peregrine Fiber Optic Bipolar Picks are a combination of identical features and designs from the two types of instruments referenced above and marketed today. The materials used are the same for the features provided except for the Paralene insulating coating used on the Bipolar Picks.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 2 1998

Mr. Todd Richmond Peregrine Surgical Ltd. Contract Manufacturer 4050D Skyron Drive Doylestown,PA 18901

K980530 Re:

Trade Names: Peregrine Fiber Optic Bipolar Straight Pick and Peregrine Fiber Optic Bipolar Angled Pick Regulatory Class: II Product Code: 86 MPA Dated: February 6, 1998 Received: February 11, 1998

Dear Mr. Richmond

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the device are substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the devices, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Todd Richmond

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its tollfree number (800) 638-2041 or at (301) 443-6597.

Sincerely yours.

Afrez L. Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INDICATIONS FOR USE

510K Number (if known):

Device Name: Peregrine Fiber Optic Bipolar Straight Pick Peregrine Fiber Optic Bipolar Angled Pick

Indications for Use:

For illumination, coagulation, and tissue manipulation during ophthalmic surgery.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Jxx

Over-The-Counter Use

Marsha L. Buck Nichols

*** - ﺍﻟﻤﻴﺮ:

Division of Ophthalmic Devices X 4x AS 510(k) Number _

Page 6

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Regulation Number and Section

§ 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.