(90 days)
Not Found
Not Found
No
The device description focuses on the physical components and functions (illumination, coagulation, tissue manipulation) and does not mention any computational or data-driven capabilities indicative of AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
Yes
The device is used for illumination, coagulation, and tissue manipulation during ophthalmic surgery, which are direct interventions aimed at treating a medical condition or altering body function.
No
This device is used for illumination, coagulation, and tissue manipulation during ophthalmic surgery, which are therapeutic and procedural functions, not diagnostic ones.
No
The device description clearly outlines physical components such as a connector, polyethylene jacket, acrylic fiber, electrical wires, Delrin handpiece, stainless steel needle, and insulated inner blunt needle. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "illumination, coagulation, and tissue manipulation during ophthalmic surgery." This describes a surgical tool used directly on the patient's body during a procedure.
- Device Description: The description details a fiberoptic illuminator with capabilities for tissue manipulation and coagulation. This aligns with a surgical instrument, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely within the realm of surgical intervention.
N/A
Intended Use / Indications for Use
For Illumination, coagulation, and tissue manipulation during ophthalmic surgery
Product codes (comma separated list FDA assigned to the subject device)
86 MPA
Device Description
The Peregrine Fiber Optic Bipolar Straight and Angled Picks are fiberoptic illuminators with capabilities to manipulate tissue and coagulate blood. They consist of the following: A connector at the proximal end to fit into a surgical light source. A polyethylene jacket through which an Acrylic Fiber and fine insulated electrical wires run. A Delrin handpiece with a 20 GA stainless steel needle at the distal end. An insulated inner blunt needle running parallel to the outer blunt needle with a gap of approximately one to two millimeters between the respective ends. Electrical connection is made via fine insulated wires from the inner and outer needles to the connectors which attach to the coagulator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ophthalmic
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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
falcon
Peregrine Surgical Ltd 40500 Skyron Drive Doylestown, PA 18901
MAY 1 2 1998
May 11, 1998
Premarket Notification [510(k)] Summary
Submitter: Peregrine Surgical Ltd. 4050D Skyron Drive Doylestown, PA 18901 Phone: (215) 348-0456 Fax: (215) 348-5526
Official Correspondent: Amy Hessenthaler
Trade Name: Peregrine Fiber Optic Bipolar Straight Pick Peregrine Fiber Optic Bipolar Angled Pick
Common Name: Fiber Optic Light Pipe with Pick and Coagulation
Registration Number: 2529392
Classification: Class II
Class Name: Not Known
Panel: Ophthalmic
Product Code: 86 MPA, 21 CFR 876.1500
Device Description: The Peregrine Fiber Optic Bipolar Straight and Angled Picks are fiberoptic illuminators with capabilities to manipulate tissue and coagulate blood. They consist of the following: A connector at the proximal end to fit into a surgical light source. A polyethylene jacket through which an Acrylic Fiber and fine insulated electrical wires run. A Delrin handpiece with a 20 GA stainless steel needle at the distal end. An insulated inner blunt needle running parallel to the outer blunt needle with a gap of approximately one to two millimeters between the respective ends. Electrical connection is made via fine insulated wires from the inner and outer needles to the connectors which attach to the coagulator.
Statement of indications for use. - For Illumination, coagulation, and tissue manipulation during ophthalmic surgery
Tel: 215-348-0450 Fax: 215-348-5520
1
Substantial Equivalence Comparison
. . . .
| | Peregrine F.O.
Straight Bipolar
Pick #100.12 | Peregrine F.O.
Angled Bipolar
Pick #100.13 | Grieshaber
Straight Pic
#630.06 | Storz
Straight Pick
DP9605 | Storz
45deg Angled Pick
DP 9606 | Grieshaber
3-Function Manip.
#149.89 |
|----------------|----------------------------------------------------|--------------------------------------------------|---------------------------------------|----------------------------------|---------------------------------------|--------------------------------------------|
| Design | 510K Application | 510K Application | | | | |
| Gauge | 20 | 20 | 20 | 20 | 20 | 20 |
| Pick | 4mm | 4mm | 4mm | 4mm | 4mm | 3mm |
| Pick Formation | Outer Needle | Outer Needle | Outer Needle | Outer Needle | Outer Needle | Inner Needle |
| | Straight | Angled | Straight | Straight | Angled | Straight |
| Features | ||||||
|---|---|---|---|---|---|---|
| Illumination | XXX | XXX | XXX | XXX | XXX | XXX |
| Tissue | ||||||
| Manipulation | XXX | XXX | XXX | XXX | XXX | XXX |
| Irrigation/ | ||||||
| Aspiration | XXX | |||||
| Coagulation | XXX | XXX | XXX |
| Materials | ||||||
|---|---|---|---|---|---|---|
| Handpiece | Delrin | Delrin | Delrin | Delrin | Delrin | Delrin |
| Jacket | Polyethylene | Polyethylene | Polyethylene | Teflon | Teflon | Polyethylene |
| Connector | Aluminum | Aluminum | Aluminum | Acetal | Acetal | Acetal |
| Needle | 20 ga Stainless | 20 ga Stainless | 20 ga Stainless | 20 ga Stainless | 20 ga Stainless | 20 ga Stainless |
| Insulating Coating | Paralene | Paralene | none | none | none | polyamide |
The proposed Peregrine Fiber Optic Bipolar Picks are a combination of identical features and designs from the two types of instruments referenced above and marketed today. The materials used are the same for the features provided except for the Paralene insulating coating used on the Bipolar Picks.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 2 1998
Mr. Todd Richmond Peregrine Surgical Ltd. Contract Manufacturer 4050D Skyron Drive Doylestown,PA 18901
K980530 Re:
Trade Names: Peregrine Fiber Optic Bipolar Straight Pick and Peregrine Fiber Optic Bipolar Angled Pick Regulatory Class: II Product Code: 86 MPA Dated: February 6, 1998 Received: February 11, 1998
Dear Mr. Richmond
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the device are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 OS 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 devices 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.
3
Page 2 - Mr. Todd Richmond
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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 devices, 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 tollfree number (800) 638-2041 or at (301) 443-6597.
Sincerely yours.
Afrez L. Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
STATEMENT OF INDICATIONS FOR USE
510K Number (if known):
- Device Name: Peregrine Fiber Optic Bipolar Straight Pick Peregrine Fiber Optic Bipolar Angled Pick
Indications for Use:
For illumination, coagulation, and tissue manipulation during 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 Jxx
OR
Over-The-Counter Use
Marsha L. Buck Nichols
*** - ﺍﻟﻤﻴﺮ:
Division of Ophthalmic Devices X 4x AS 510(k) Number _
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