PEREGRINE WET SET, MODEL PD400.00

• K Number: K990518
• Device Name: PEREGRINE WET SET, MODEL PD400.00
• Manufacturer: PEREGRINE SURGICAL LTD.
• Date Cleared: 1999-03-25 ( 35 days)
• Product Code: FRN
• Regulation Number: 880.5725
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: K091441

Intended Use

For the delivery of forced humidified air or fluid during ophthalmic surgery.

Device Description

The Peregrine Wet Set is an 8' tubing set designed to deliver humidified air or fluid into the eye during ophthalmic surgery. It consists of the following: An 8' PVC tube running from an air supply unit to a three channel IV spike for insertion into a bottle of Balanced Salt Solution. The three way spike is designed to inject the air from the air supply unit through the solution, while at the same time deliver humidified air and saline through a dual PVC tube. The dual PVC tube is designed to transport the humidified air in one side and the saline in the other. The dual PVC tube attaches at the other end to a three way stopcock.

AI/ML Overview

The provided text is a 510(k) Premarket Notification Summary for the Peregrine Wet Set, an air/fluid tubing set for ophthalmic surgery. This document primarily focuses on establishing substantial equivalence to predicate devices and does not contain information about specific acceptance criteria, performance studies, or clinical trial data as would typically be found for a device requiring such evidence for approval.

Therefore, many of the requested details about acceptance criteria, study design, ground truth, and reader performance cannot be extracted from this document.

However, based on the provided text, here is what can be inferred or stated:

1. A table of acceptance criteria and the reported device performance:
   The document does not explicitly list acceptance criteria as quantitative thresholds for performance. Instead, it relies on a "Substantial Equivalence Comparison" table to show that the Peregrine Wet Set has similar features to two predicate devices (GRIESHABER GLOBAL CONTROL and ALCON VGFI TUBING SET). The "reported device performance" is implicitly that the device functions comparably to these predicate devices based on its design features.

   FEATURES	GRIESHABER GLOBAL CONTROL (Predicate)	ALCON VGFI TUBING SET (Predicate)	PEREGRINE WET SET (Device)
   Number of channels in drip chamber spike	2	2	3
   Pressurized air enters bottle	/INTO FLUID	/INTO AIR SPACE	/INTO FLUID
   Pressurized air to stopcock delivered from	AIR SYSTEM	AIR SYSTEM	BOTTLE
   Fluid Source	BOTTLE	BOTTLE	BOTTLE
   Air system required	YES	YES	YES
   Bottle hung at eye level	YES	YES	YES
   Bottle pressurized by air system	YES	YES	YES
   Delivery line for fluid to stopcock	YES	YES	YES
   Delivery line for air to stopcock	YES	YES	YES
   3-way stopcock for air/fluid selection	YES	YES	YES
   Filter at air line attachment to system	YES	YES	YES
   Extension tube into bottle air space	NO	YES	YES

   The key "acceptance criteria" here appear to be demonstrating that the Peregrine Wet Set possesses the functional characteristics necessary for its intended use, a fact supported by its design being largely analogous to legally marketed predicate devices, with some minor differences noted (e.g., 3 channels vs. 2, and the source of pressurized air to the stopcock). For sterility, the acceptance criterion is that it is ETO sterilized, with validation using the AAMI Overkill Method.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
   The document does not describe a clinical performance study with a test set. This device is a tubing set, and its approval appears to be based on substantial equivalence to existing devices and verification of sterility, rather than performance in a patient cohort.

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 clinical performance test set or ground truth establishment by experts is described for this type of device submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   Not applicable, as no clinical performance test set or adjudication process 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 simple tubing set used for delivering air or fluid, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   Not applicable. This device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   Not applicable, as no clinical performance study requiring ground truth is described. The relevant "truths" for this submission are the device's physical features, materials, and sterilization efficacy, which are evaluated against established standards and predicate devices.

8. The sample size for the training set:
   Not applicable. There is no training set mentioned for this device, as it is not an AI/machine learning device.

9. How the ground truth for the training set was established:
   Not applicable, as there is no training set.

Summary

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3/25/99

Peregrine

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

Image /page/0/Picture/3 description: The image shows a black silhouette of a bird, possibly a falcon or hawk, in flight. The bird is depicted in a stylized manner, with sharp angles and streamlined features. The wings are spread out, and the head is turned to the side, giving the impression of speed and agility. The image is simple yet striking, conveying a sense of power and freedom.

March 18, 1999

Premarket Notification [510(k)] Summary

100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

Submitter: Peregrine Surgical Ltd. 4050D Skyron Drive Dovlestown, PA 18901 Phone: [phone] [phone] Fax:

Official Correspondent: Amy Hessenthaler

Trade Name: Peregrine Wet Set

Common Name: Air/Fluid Tubing Set

Registration Number: 2529392

Classification: Class II

Class Name: We were unable to find the device listed in the Disposable classification regulations, 21 CFR Parts 862-892 [807.87 (c)]

Panel: Ophthalmic

Product Code: 80 FRN

Device Description: The Peregrine Wet Set is an 8' tubing set designed to deliver humidified air or fluid into the eye during ophthalmic surgery. It consists of the following: An 8' PVC tube running from an air supply unit to a three channel IV spike for insertion into a bottle of Balanced Salt Solution. The three way spike is designed to inject the air from the air supply unit through the solution, while at the same time deliver humidified air and saline through a dual PVC tube. The dual PVC tube is designed to transport the humidified air in one side and the saline in the other. The dual PVC tube attaches at the other end to a three way stopcock.

Statement of indications for use. - For the delivery of forced humidified air or fluid during ophthalmic surgery.

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Substantial Equivalence Comparison:

FEATURES	GRIESHABERGLOBALCONTROL	ALCONVGFI TUBING SET	PEREGRINEWET SET
Number of channels in drip chamber spike:	2	2	3
Pressurized air enters bottle	/INTO FLUID	/INTO AIR SPACE	/INTO FLUID
Pressurized air to stopcock delivered from	AIR SYSTEM	AIR SYSTEM	BOTTLE
Fluid Source	BOTTLE	BOTTLE	BOTTLE
Air system required	YES	YES	YES
Bottle hung at eye level	YES	YES	YES
Bottle pressurized by air system	YES	YES	YES
Delivery line for fluid to stopcock	YES	YES	YES
Delivery line for air to stopcock	YES	YES	YES
3 way stop cock for air/fluid selection	YES	YES	YES
Filter at air line attachment to system	YES	YES	YES
Extension tube into bottle air space	NO	YES	YES

Sterility

:

The Device will be ETO Sterilized.

The method used to validate the sterilization cycle is AAMI Overkill Method

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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 the department's name arranged in a circular fashion around a symbol. The symbol features three stylized human profiles facing to the right, stacked on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 5 1999

Mr. John E. Richmond President Peregrine Surgical Limited 4050 D Skyron Drive Doylestown, PA 18901

Re: K990518 Trade Name: Peregrine Wet Set Regulatory Class: II Product Code: 80 FRN Dated: February 15, 1999 Received: February 18, 1999

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. John E. Richmond, President

· 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 [phone]. Additionally, for questions on.the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Ralph 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 Wet Set

Indications for Use:

For the delivery of forced humidified air or fluid during ophthalmic surgery.

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use xx

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Sta Calloway

OR

Division of Ophthalmic Devices 1990518 510(k) Number

Page 5

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).