(85 days)
Not Found
Not Found
No
The device description focuses on physical components and light diffusion, with no mention of AI/ML terms or functionalities.
No
Explanation: The device is described as a light guide for illumination during ophthalmic surgery, not a device used for treating a disease or condition.
No
The device is described as a light guide for wide angle illumination during ophthalmic surgery, not for diagnosing conditions.
No
The device description clearly outlines physical components such as a light guide, connector, jacket, fiber, handpiece, and needle, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For wide angle illumination of the posterior segment during ophthalmic surgery." This describes a device used during a surgical procedure to provide light, not a device used to examine specimens in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a light guide used for illumination during surgery. It does not mention any components or processes related to testing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples, reagents, diagnostic tests, or any other elements typically associated with IVD devices.
Therefore, the Peregrine Shielded Diffusion Probe is a surgical illumination device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For Illumination, coagulation, irrigation/aspiration, and tissue manipulation during ophthalmic surgery.
For wide angle illumination of the posterior segment during ophthalmic surgery
Product codes
MPA
Device Description
The Peregrine Shielded Diffusion Probe is a single use light guide approximately 6' in length consisting of the following: A Universal Aluminum connector at the proximal end to fit into a surgical light source. A polyethylene jacket through which an Acrylic fiber runs. A Delrin Handpiece with a 20 GA Stainless Steel Needle at the distal end. The acrylic fiber, which is polished and affixed at both ends, is tapered and extends past the tip to achieve the diffusion of light. The Stainless Steel Needle is ground at an angle so as to "shield" a portion of the exposed fiber in order to reduce light emitted in the surgeon's eyes. (glare)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior segment
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAR 3 1 1998
March 23, 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 Shielded Diffusion Probe
Common Name: Fiber Optic Light Pipe with wide angle dispersion of illuminated field
Registration Number: 2529392
Classification: Class II
Class Name: Not Known
Panel: Ophthalmic
Product Code: MPA
Device Description: The Peregrine Shielded Diffusion Probe is a single use light guide approximately 6' in length consisting of the following: A Universal Aluminum connector at the proximal end to fit into a surgical light source. A polyethylene jacket through which an Acrylic fiber runs. A Delrin Handpiece with a 20 GA Stainless Steel Needle at the distal end. The acrylic fiber, which is polished and affixed at both ends, is tapered and extends past the tip to achieve the diffusion of light. The Stainless Steel Needle is ground at an angle so as to "shield" a portion of the exposed fiber in order to reduce light emitted in the surgeon's eyes. (glare)
Statement of Indications for use. - For Illumination, coagulation, irrigation/aspiration, and tissue manipulation during ophthalmic surgery.
1
Substantial Equivalence Comparison
| Peregrine
Peregrine Shielded
Diffusion Probe | Peregrine
Peregrine Diffusion Light Pipe | Peregrine
Peregrine Wide Angle
Light Pipe |
|----------------------------------------------------|---------------------------------------------|-------------------------------------------------|
| Application for 510(K) | Manufactured for Grieshaber | Manufactured for Storz |
| Wide Angle Light Diffusion | Wide Angle Light Diffusion | Wide Angle Light Diffusion |
| Delrin Handpiece | Delrin Handpiece | Delrin Handpiece |
| 20 GA Stainless Steel Needle | 20 GA Stainless Steel Needle | 20 GA Stainless Steel Needle |
| Polyethylene Jacket | Polyethylene Jacket | Teflon Jacket |
| Acrylic Fiber w/Tapered End | Acrylic Fiber w/ Prism Wafer | Acrylic Fiber w/ Sapphire Ball |
| Aluminum Connector | Aluminum Connector | Acetal Connector |
| Single Use | Single Use | Single Use |
| | | |
.
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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 | 1998
Mr. Todd Richmond Peregrine Surgical Ltd. Contract Manufacturer 4050D Skyron Drive Doylestown, PA 18901
Re: K980027
Trade Name: Peregrine Shielded Diffusion Probe Regulatory Class: II Product Code: 86 MPA Dated: December 30, 1997 Received: January 5, 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.
3
Page 2- 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 marked 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. Roepi 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 Shielded Diffusion Probe
Indications for Use:
For wide angle illumination of the posterior segment 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 ✓ xx_
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
Marsha L. Burke hi Stokes
OR
Division Sign-Off)
Division of Ophthalmic Devices
(k) Number K980627