(87 days)
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Not Found
No
The description focuses on the mechanical and pneumatic operation of a surgical tool and does not mention any AI/ML components or functions.
No
The device is described as a surgical tool for removing vitreous and vitreal membranes during ophthalmic surgery, which is an interventional procedure, not a therapeutic treatment.
No
Explanation: The device is described as a surgical tool ("guillotine style cutter") for removing vitreous and vitreal membranes during ophthalmic surgery. Its function is to perform a physical action (cutting/removal) rather than to diagnose or detect a condition.
No
The device description clearly outlines physical components like tubing, a handpiece, a stainless steel needle, and pneumatic mechanics, 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 removal of vitreous and vitreal membranes during ophthalmic surgery." This describes a surgical procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a surgical instrument (a vitrectomy probe) used for cutting and removing tissue during surgery. It does not describe a device used to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment based on sample analysis.
In summary, the Peregrine OptiPort Vitrectomy Probe is a surgical device used in vivo (within the living body) during ophthalmic surgery, not an in vitro diagnostic device used to test samples outside the body.
N/A
Intended Use / Indications for Use
For removal of vitreous and vitreal membranes during opthalmic surgery.
Product codes (comma separated list FDA assigned to the subject device)
86 HQE
Device Description
The Peregrine OptiPort Vitrectomy Probe is a single use, 20 GA guillotine style cutter for use during ophthalmic surgery. Approximately 6' in length and provided sterile, it consists of the following. At the proximal end, a female and male luer connector attached to the resective ends of dual PVC tubing. A colored stripe is added to one of the tubes to establish it as the half used for aspiration. A Delrin Handpiece with a 20 GA stainless steel needle at the distal end. The mechanics to operate the vitrectomy probe extend through the inner lumen of the stainless shaft and may be activated pneumatically.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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.
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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.
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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).
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§ 886.4150 Vitreous aspiration and cutting instrument.
(a)
Identification. A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.(b)
Classification. Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
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APR 3 0 1998
January 30, 1998
K9803999
Premarket Notification [510(k)] Summary
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 OptiPort Vitrectomy Probe
Common Name: Vitrectomy Guillotine Cutter
Registration Number: 2529392
Classification: Class II
Class Name: Not Known
Panel: Ophthalmic
Product Code: 86 HQE
Device Description: The Peregrine OptiPort Vitrectomy Probe is a single use, 20 GA guillotine style cutter for use during ophthalmic surgery. Approximately 6' in length and provided sterile, it consists of the following. At the proximal end, a female and male luer connector attached to the resective ends of dual PVC tubing. A colored stripe is added to one of the tubes to establish it as the half used for aspiration. A Delrin Handpiece with a 20 GA stainless steel needle at the distal end. The mechanics to operate the vitrectomy probe extend through the inner lumen of the stainless shaft and may be activated pneumatically. (see Appendix B)
Statement of indications for use. - For removal of vitreous and vitreal membranes during opthalmic surgery.
1
Substantial Equivalence Comparison
| Peregrine
OptiPort Vitrectomy Probe | H.S. International
Shapiro Cutter Vitrectomy
Probe |
|-------------------------------------------|----------------------------------------------------------|
| Application for 510(K)
Product# 505.10 | Manufactured by H.S. International
Product# HS32-803 |
| Vitreous Removal | Vitreous Removal |
| pneumatic driver | pneumatic driver |
| guillotine cutting action | guillotine cutting action |
| 20 GA stainless steel shaft | 20 GA stainless steel shaft |
| .035mm port at distal tip | .034mm port at distal tip |
| insertion through 1mm incision | insertion through 1mm incision |
| single use | single use |
| ergonomic handle | ergonomic handle |
| | |
| | |
| | |
The Peregrine OptiPort Vitrectomy Probe is identical in principle to the ophthalmic guillotine cutters marketed today. The materials used in its manufacture are similar, if not in most comparisons identical.
, 1
Sterility
The Device will be ETO Sterilized.
The method used to validate the sterilization cycle is AAMI Overkill Method
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular in shape, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles an eagle or other bird, with three stylized human profiles incorporated into the design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 3 0 1998
Mr. Todd Richmond Peregrine Surgical Ltd. 4050D Skyron Drive Doylestown, PA 18901
Re: K980399
Trade Name: Peregrine OptiPort Vitrectomy Probe Regulatory Class: II Product Code: 86 HQE Dated: January 30, 1998 Received: February 2, 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 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 forentthal
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): K980399
Device Name: Peregrine OptiPort Vitrectorny Probe
Indications for Use:
For removal of vitreous and vitreal membranes dering ophthalmic surgery.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED:
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _______xx
ાર
Over-The-Counter Use
Everett T. Boom
(Division Sign-Off) Division of Ophthalmic D 510(k) Number
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