(64 days)
Not Found
Not Found
No
The device description and intended use are purely mechanical, describing a tubing set for pneumatic infusion. There is no mention of any computational or analytical capabilities, let alone AI/ML.
Yes
The device is used for the pneumatic infusion of silicone oil into the posterior segment of the eye, which is a treatment procedure.
No
The device is described as a tubing set for pneumatic infusion of silicone oil, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly details physical components like tubing, connectors, a syringe head with a filter, and a syringe assembly, 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 pneumatic infusion of silicone oil into the posterior segment." This describes a surgical procedure performed directly on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The device description details tubing, connectors, a filter, and a syringe assembly used for delivering a substance into the eye. This is consistent with a surgical or therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to deliver a substance into the body, which is a therapeutic or surgical action.
N/A
Intended Use / Indications for Use
For pneumatic infusion of silcone oil into the posterior segment.
Product codes (comma separated list FDA assigned to the subject device)
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
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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
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
liaska L. Duske kicholas
Division of Ophthalmic Devices 510(k) Number
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