The Peregrine V.F.I. Tubing Set is 8' in length and designed to infuse silicone oil into the posterior segment of the eye. It consists of the following: A connector at the proximal end to fit into a pneumatic injection system, 8' PVC tubing running from the connector and attaching to a Delrin Syringe Head which incorporates a .2um filter, and a syringe assembly (Terumo) which is attaches to the syringe head.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a medical device called the "V.F.I. (Viscous Fluid Injection) Tubing Set." It seeks to establish substantial equivalence to a predicate device, rather than demonstrate performance against specific acceptance criteria through a study.

Therefore, many of the requested elements (acceptance criteria, device performance table, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types and establishment for training sets) are not applicable to this type of regulatory submission.

The document primarily focuses on:

Device Description: What the Peregrine V.F.I. Tubing Set is and what it's used for.
Substantial Equivalence Comparison: Directly comparing its features to a legally marketed predicate device (Grieshaber & Co. V.I.S. Pack Tubing Set).
Sterility: Mentioning that the device will be ETO sterilized and the validation method (AAMI Overkill Method).
Intended Use: For pneumatic infusion of silicone oil into the posterior segment.

Key points from the document regarding the "study" for regulatory approval:

Acceptance Criteria: The primary "acceptance criterion" for this 510(k) submission is that the device is substantially equivalent to a legally marketed predicate device. This is determined by comparing its design, materials, indications for use, and technological characteristics.
Study Proving Equivalence: The "study" is a comparative textual analysis presented in Section {1} "Substantial Equivalence Comparison." It lists features of the Peregrine V.F.I. Tubing Set alongside the predicate Grieshaber & Co. V.I.S. Pack Tubing Set.
Reported Device Performance: The document states: "The Peregrine V.F.I. Tubing Set, product #PD300.01, is identical to the Grieshaber V.I.S. Pack with the exception of the labeling specifications." This implies that its performance is expected to be identical to the predicate.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (for 510(k) Equivalence)	Reported Device Performance/Comparison
Substantial Equivalence to Predicate Device	Peregrine V.F.I. Tubing Set is "identical" to the Grieshaber V.I.S. Pack (predicate device) with the exception of labeling specifications.
Intended Use	For pneumatic infusion of silicone oil into the posterior segment. (Matches predicate)
Design/Materials	Nylon connectors, PVC Tubing 8', Delrin Syringe Head, Terumo Syringe 35cc, Gelman .2um filter. (Matches predicate)
Sterility	ETO Sterilized, validated by AAMI Overkill Method. (Implied to be equivalent/acceptable for this type of device)
Single Use	Single Use (Matches predicate)

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable. This was a comparative analysis of device specifications, not a clinical trial or performance study requiring a "test set" of patient data or device units to be run.
Data Provenance: Not applicable in the context of a clinical or performance study. The data provenance is the design specifications of the Peregrine device and the known specifications of the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There was no "test set" requiring expert ground truth establishment in this type of submission. The "ground truth" for substantial equivalence is the set of specifications of the predicate device and the new device.

4. Adjudication method for the test set

Not applicable. No "test set" or adjudication process for performance data was 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 medical tubing set, not an AI-powered diagnostic or assistive technology.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical tubing set, not an algorithm.

7. The type of ground truth used

The "ground truth" for this 510(k) submission is the documented specifications and indications for use of the predicate device (Grieshaber V.I.S. Pack Tubing Set). The new device is then compared against this "truth" to establish equivalence.

8. The sample size for the training set

Not applicable. There is no "training set" for this type of device submission.

9. How the ground truth for the training set was established

Not applicable. There is no "training set" for this type of device submission.

Summary

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Peregrine

Peregrine Surgical Ltd. 4050D Skyron Drive Doylestown, PA 18901

May 28, 1998

AUG 4 1998

Premarket Notification [510(k)] Summary

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

Official Correspondent: Amy Hessenthaler

Trade Name: V.F.I. (Viscous Fluid Injection) Tubing Set

Common Name: Viscoelastic Infusion Tubing Set

Registration Number: 2529392

Classification: Class II

Class Name: Not Known

Panel: Ophthalmic

Product Code: MRH

Device Description: The Peregrine V.F.I. Tubing Set is 8' in length and designed to infuse silicone oil into the posterior segment of the eye. It consists of the following: A connector at the proximal end to fit into a pneumatic injection system, 8' PVC tubing running from the connector and attaching to a Delrin Syringe Head which incorporates a .2um filter, and a syringe assembly (Terumo) which is attaches to the syringe head.

Statement of indications for use. - For pneumatic infusion of silcone oil into the posterior segment.

Tel: 215-348-0456 Fax: 215-348-5526

{1}------------------------------------------------

Substantial Equivalence Comparison:

Peregrine V.F.I.Tubing Set	Grieshaber & Co.V.I.S. Pack Tubing Set
Application for 510(K)Product# 300.01	Manufactured by Grieshaber & Co.Product# 629.30
Silicone Oil Infusion	Silicone Oil Infusion
nylon connectors	nylon connectors
PVC Tubing 8'	PVC Tubing 8'
Delrin Syringe Head	Delrin Syringe Head
Terumo Syringe 35cc	Terumo Syringe 35cc
Gelman . 2um filter	Gelman .2um filter
Single Use	Single Use

The Peregrine V.F.I. Tubing Set, product #PD300.01, is identical to the Grieshaber V.I.S. Pack with the exception of the labeling specifications.

Sterility

The Device will be ETO Sterilized.

The method used to validate the sterilization cycle is AAMI Overkil! Method

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 4 1998

Mr. Todd Richmond Director of Product Development Peregrine Surgical LTD. 4050 D Skyron Drive Doylestown, PA 18901

Re: K981907

Trade Name: V.F.I.-Viscous Fluid Infusion Tubing Set Regulatory Class: II Product Code: 86 MRH Dated: May 28, 1998 Received: June 1, 1998

Dear Mr. Richmond:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is 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 device, 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 device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device 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 QS 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 device 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 device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device 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 device, 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 i obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A Roerl forenthal

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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510K Number (if known):

Device Name: V.F.I. (Viscous Fluid Injection) Tubing Set

Indications for Use:

For pneumatic infusion of silicone oil into the posterior segment.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

liaska L. Duske kicholas

Division of Ophthalmic Devices 510(k) Number

Page 4

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).