(90 days)
The Fiber Optic Endoillumination Probe is indicated for intraocular illumination in vitreoretinal surgery.
The Fiber Optic Endoillumination Probe provides intraocular illumination. The light is transmitted from the source to the inside of the eye through a flexible optical fiber, which has been threaded through an illumination probe.
This 510(k) summary (K980636) for the Fiber Optic Endoillumination Probe does not describe a study with acceptance criteria and reported device performance. Instead, it demonstrates substantial equivalence to a predicate device (Infinitech, Inc. Fiber Optic Probe, K870942) based on operational and technological characteristics.
Therefore, most of the requested information regarding acceptance criteria, study details, and performance metrics is not available in the provided text.
Here's a breakdown of what can be extracted and what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly provided.
The submission relies on a comparison table to establish substantial equivalence, not to report performance against specific acceptance criteria. The "Comparison Criteria" act as attributes that are matched for equivalence rather than performance metrics with thresholds.
| Comparison Criteria | Acceptance Criteria (Implied for Equivalence) | Reported Device Performance (Dutch Ophthalmic, USA Fiber Optic Endoillumination Probe) |
|---|---|---|
| Device Type: Fiber Optic Probe | Must be "Yes" (a Fiber Optic Probe) | Yes |
| Indication: Intraocular illumination in vitreoretinal surgery | Must be "Yes" (for intraocular illumination in vitreoretinal surgery) | Yes |
| Patient Contact Materials: PMMA and fluoropolymer fiber and medical grade Surgical stainless steel | Must be "Yes" (matching materials) | Yes |
| Sterilization Method: Validated ETO | Must be "Validated ETO" (or equivalent, typically requiring validation data) | Validated ETO |
| Packaging: Validated Heat Sealed Tyvek | Must be "Validated Heat Sealed Tyvek" (or equivalent, typically requiring validation data) | Validated Heat Sealed Tyvek |
Note: The predicate device details for "Sterilization Method" and "Packaging" are "Not Known," indicating that Dutch Ophthalmic's methods were assessed for safety and effectiveness on their own merits and found acceptable, rather than directly comparing to a known predicate value.
2. Sample size used for the test set and the data provenance
Not applicable/Not provided. This submission does not detail an experimental test set with sample sizes. It's a regulatory submission for substantial equivalence based on descriptive and technological characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. No test set or ground truth established by experts is described.
4. Adjudication method for the test set
Not applicable/Not provided. No test set or adjudication method is described.
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. This is not an AI-enabled device. It's a fiber optic endoillumination probe. Therefore, no MRMC study or AI-related effectiveness is discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable/Not provided. No ground truth is described as the device is for illumination, not diagnosis or measurement requiring ground truthful comparison.
8. The sample size for the training set
Not applicable/Not provided. This is not an AI/machine learning device, so there is no training set mentioned.
9. How the ground truth for the training set was established
Not applicable/Not provided. As there's no training set, there's no ground truth established for one.
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510(k) Summary Fiber Optic Endoillumination Probe (per 21 CFR 807.92)
MAY 20 1998
SUBMITTER NAME AND ADDRESS 1.
DUTCH OPHTHALMIC, USA One Little River Road P.O. Box 9866 6 Kingston, NH 03848 USA
Mark W. Furlong, President Contact Person: Telephone: 603-642-8468
February 9, 1998 Date Prepared:
2. DEVICE NAME
Fiber Probe Trade Name: Fiber Optic Endoillumination Probe Proprietary Name: Light, Surgical, Fiberoptic Classification name:
PREDICATE DEVICE 3.
Infinitech, Inc. Fiber Optic Probe (K870942)
DEVICE DESCRIPTION 4.
The Fiber Optic Endoillumination Probe provides intraocular illumination. The light is transmitted from the source to the inside of the eye through a flexible optical fiber, which has been threaded through an illumination probe.
INTENDED USE ട.
The Fiber Optic Endoillumination Probe is indicated for intraocular illumination in vitreoretinal surgery.
BASIS FOR SUBSTANTIAL EQUIVALENCE 6.
Operational and technological characteristics form the basis for the determination of substantial equivalence of the Fiber Optic Endoillumination Probe with legally marketed predicate devices. Information supplied in this premarket notification includes descriptive information about the intended use, operation, and technological characteristics.
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COMPARISON TABLE
.
-้
| Comparison Criteria | Dutch Ophthalmic, USAFiber OpticEndoillumination Probe | Infinitech, Inc.Fiber OpticProbe |
|---|---|---|
| Device Type: Fiber Optic Probe | Yes | Yes |
| Indication: Intraocular illumination in vitreoretinal surgery | Yes | Yes |
| Patient Contact Materials:PMMA and fluoropolymer fiber and medical gradeSurgical stainless steel | Yes | Yes |
| Sterilization Method | Validated ETO | Not Known |
| Packaging | Validated Heat SealedTyvek | Not Known |
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 20 1998
Mr. Mark W. Furlong ·President Dutch Ophthalmic, USA One Little River Road P.O. Box 968 Kingston, New Hampshire 03848
K980636 Re: Fiber Optic Endoillumination Probe Trade Name: Regulatory Class: II Product Code: FFS February 9, 1998 Dated: February 19, 1998 Received:
Dear Mr. Furlong:
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 The general controls provisions of the Act 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. ਸੈ substantially equivalent determination assumes compliance with --the current Good Manufacturing Practice requirement, 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 "od and Drug Administration (FDA) will verify such assamptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. 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 requlations.
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Page 2 - Mr. Furlong
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) 594-4595. 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,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: Fiber Optic Endoillumination Probe
Indication For Use:
Fiber Optic Endoillumination Probe is indicated for intraocular illumination in vitreoretinal surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) 0,0636 Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109)
§ 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.