(35 days)
Not Found
Not Found
No
The device description and other sections do not mention any AI or ML components or functionalities. The device is a simple tubing set for delivering air and fluid.
No
The device delivers humidified air or fluid during ophthalmic surgery, which is a supportive function rather than a direct therapeutic intervention to treat a disease or condition.
No
The device description indicates its function is "delivery of forced humidified air or fluid during ophthalmic surgery." There is no mention of analysis, measurement, or diagnosis of a condition.
No
The device description clearly outlines physical components like tubing, spikes, and a stopcock, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For the delivery of forced humidified air or fluid during ophthalmic surgery." This describes a device used during a surgical procedure on a patient, not a device used to examine specimens in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a tubing set for delivering air and fluid into the eye. This is a surgical instrument, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, the Peregrine Wet Set is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For the delivery of forced humidified air or fluid during ophthalmic surgery.
Product codes
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
ophthalmic surgery
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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: (215) 348-0456 (215) 348-5526 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
GLOBAL
CONTROL | ALCON
VGFI TUBING SET | PEREGRINE
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 (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 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. 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:
------------------------------------------------------io+==========================================================================================================================================================================
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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