(85 days)
For wide angle illumination of the posterior segment during ophthalmic surgery
The Peregrine Tapered 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 provided text is a 510(k) Premarket Notification summary for the Peregrine Tapered Diffusion Probe. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria through clinical studies in the way a new, high-risk device might.
Therefore, the document does not contain the information requested regarding:
- A table of acceptance criteria and reported device performance: The submission focuses on comparing physical characteristics and indications for use with predicate devices.
- Sample size and data provenance for a test set: No test set for performance evaluation is described.
- Number and qualifications of experts for ground truth, adjudication methods: These are relevant for studies establishing clinical performance, which this document does not detail.
- Multi-reader multi-case (MRMC) comparative effectiveness study: This is not mentioned as part of the 510(k) submission process for this device.
- Standalone algorithm performance: This is a manual device, not an algorithm.
- Type of ground truth used: Not applicable in this context.
- Sample size for the training set, how training set ground truth was established: Not applicable, as this is not an AI/ML device or a study involving training data.
The relevant information from the document is related to sterilization validation, which is the only aspect where "acceptance criteria" and a "study" (validation method) are explicitly mentioned:
1. A table of acceptance criteria and the reported device performance
| Aspect | Acceptance Criteria (Implied) | Reported Device Performance / Method |
|---|---|---|
| Sterility | Sterilized product | ETO sterilized, validated using AAMI Overkill Method |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document states a "method used to validate the sterilization cycle is AAMI Overkill Method", but does not provide details on sample size for this validation or its provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not a study requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC study was not done. This is a medical device, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a manual surgical instrument.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For sterility, the 'ground truth' is successful sterilization as defined by the AAMI Overkill Method, which is a recognized standard for sterilization validation.
8. The sample size for the training set
Not applicable. This is not an AI/ML device or a study involving a training set.
9. How the ground truth for the training set was established
Not applicable.
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Premarket Notification [510(k)] Summary
MAR 3 1 1998
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 Tapered 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 Tapered 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.
Statement of indications for use. - For Illumination, coagulation, irrigation/aspiration, and tissue manipulation during ophthalmic surgery.
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| PeregrinePeregrine TaperedDiffusion Probe | PeregrinePeregrine Diffusion Light Pipe | PeregrinePeregrine Wide AngleLight 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
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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Todd Richmond Peregrine Surgical Ltd. Contract Manufacturer 4050D Skyron Drive Doylestown, PA 18901
MAR 3 1 1998
K980025/S1 Re:
Trade Name: Peregrine Tapered 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 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 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- 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 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 Tapered Diffusion Probe
Indications for Use:
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For wide angle illumination of the posterior segment during ophthalmic surgery
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use______________________________________________________________________________________________________________________________________________________________
Over-The-Counter Use_
Thassha L. Burke kicholors
(Division Sign-Off)
Division of Ophthalmic Devices 510(k) Number. 49,0075
§ 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.