(85 days)
For Illumination, coagulation, irrigation/aspiration, and tissue manipulation during ophthalmic surgery.
For wide angle illumination of the posterior segment during ophthalmic surgery
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)
The provided text is a 510(k) summary for the Peregrine Shielded Diffusion Probe, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive de novo clinical study data to define acceptance criteria and prove device performance in the way a new drug or novel high-risk device might.
Therefore, the document does not contain the detailed information requested regarding acceptance criteria and a specific study proving the device meets those criteria in terms of performance metrics like sensitivity, specificity, or reader improvement.
Here's a breakdown of why the information isn't present and what is available:
1. A table of acceptance criteria and the reported device performance:
- Information not available: The document does not define specific "acceptance criteria" for performance metrics in terms of clinical outcomes or diagnostic accuracy. It focuses on demonstrating equivalence to predicate devices (Peregrine Diffusion Light Pipe and Peregrine Wide Angle Light Pipe) in terms of design and intended use.
- Available in document: The "Substantial Equivalence Comparison" table lists design features of the proposed device against two predicate devices. This implies that the 'acceptance criteria' for this type of submission are essentially that the device's characteristics and intended use are similar enough to existing, legally marketed devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Information not available: No test set sample size or data provenance is mentioned because a clinical performance study with such a test set was not presented in this 510(k) summary.
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):
- Information not available: Not applicable, as there is no mention of a test set requiring ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Information not available: 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:
- Information not available: This device is a fiber optic light pipe for surgical illumination, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is not relevant or included.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Information not available: Not applicable, as this is a surgical illumination device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Information not available: Not applicable, as no clinical performance study requiring ground truth is presented.
8. The sample size for the training set:
- Information not available: Not applicable, as there is no machine learning or AI component to this device that would involve a training set.
9. How the ground truth for the training set was established:
- Information not available: Not applicable.
What the document does address regarding "acceptance criteria" and "proof":
For a 510(k) submission like this, "acceptance criteria" primarily relate to:
- Substantial Equivalence: The primary "acceptance criterion" is whether the device is substantially equivalent to a predicate device already legally marketed. This is "proven" by providing a comparison of features, materials, and intended use as seen in the "Substantial Equivalence Comparison" table.
- Sterility: The document explicitly states:
- Acceptance Criteria (Implied): The device must be sterile.
- Study/Method of Proof: "The method used to validate the sterilization cycle is AAMI Overkill Method." This is the standard method for validating sterilization.
- Intended Use Compatibility: The device's "Indications for Use" (For wide angle illumination of the posterior segment during ophthalmic surgery) are reviewed and deemed acceptable by the FDA (indicated by the FDA's concurrence signature on the "STATEMENT OF INDICATIONS FOR USE" form).
In summary, this 510(k) document demonstrates the device meets the regulatory requirements for market clearance by showing substantial equivalence and addressing basic safety aspects like sterilization, but it does not present a clinical performance study with quantifiable acceptance criteria for typical performance metrics (e.g., sensitivity, specificity) as would be the case for a diagnostic device.
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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.
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Substantial Equivalence Comparison
| PeregrinePeregrine ShieldedDiffusion 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 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.
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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 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
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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)
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Prescription Use ✓ xx_
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
Marsha L. Burke hi Stokes
OR
Division Sign-Off)
Division of Ophthalmic Devices
(k) Number K980627
§ 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.