PEREGRINE WET SET, MODEL PD400.00

K990518 · Peregrine Surgical , Ltd. · FRN · Mar 25, 1999 · General Hospital

Device Facts

• Record ID: K990518
• Device Name: PEREGRINE WET SET, MODEL PD400.00
• Applicant: Peregrine Surgical , Ltd.
• Product Code: FRN · General Hospital
• Decision Date: Mar 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Peregrine Wet Set is an 8-foot PVC tubing set used during ophthalmic surgery. Device connects an external air supply unit to a bottle of Balanced Salt Solution via a three-channel IV spike. The spike injects air into the solution to humidify it; a dual PVC tube then transports the humidified air and saline to a three-way stopcock. Operated by ophthalmic surgeons or clinical staff in an OR setting. Output is controlled delivery of humidified air or fluid to the eye, facilitating surgical maneuvers. Benefits include maintaining ocular environment during procedures.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

8-foot PVC tubing set; three-channel IV spike; three-way stopcock. Sterilized via ETO using AAMI Overkill Method. Operates via external air supply system and gravity-fed/pressurized fluid bottle.

Indications for Use

Indicated for patients undergoing ophthalmic surgery requiring the delivery of forced humidified air or fluid.

Regulatory Classification

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.

Predicate Devices

• GRIESHABER GLOBAL CONTROL
• ALCON VGFI TUBING SET

Submission Summary (Full Text)

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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

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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 | GRIESHABER<br>GLOBAL<br>CONTROL | ALCON<br>VGFI TUBING SET | PEREGRINE<br>WET 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

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