(91 days)
The intended use of the device is to illuminate the eye during anterior and posterior vitreoretinal surgery and to provide photocoagulation when used with the appropriate commercially available laser light source and probe.
The intended use of the device is to illuminate the eye during anterior and posterior vitreoretinal surgery and to provide photocoagulation when used with the appropriate commercially available laser light source and probe.
Acceptance Criteria and Study Details for Synergetics Synerlight FiberOptic Lightsource
The provided document describes the 510(k) summary and FDA clearance letter for the Synergetics Synerlight FiberOptic Lightsource. This submission is for substantial equivalence to a predicate device, K964005.
Based on the provided information, there are no explicit acceptance criteria or detailed study results demonstrating device performance against such criteria in the manner typically expected for AI/ML-based medical devices.
Instead, the submission relies on the concept of substantial equivalence to a predicate device already on the market. This means the device is considered safe and effective because it is as safe and effective as a legally marketed device, and does not raise different questions of safety and effectiveness.
Here’s a breakdown of the information that is available and what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicitly stated in document) | Reported Device Performance (Explicitly stated in document) |
|---|---|
| Not explicitly stated as quantifiable performance metrics (e.g., sensitivity, specificity, accuracy, illumination intensity targets). | "Testing demonstrated that the subject device is substantially equivalent to the predicate device." |
Explanation: The document does not provide specific, measurable acceptance criteria in terms of clinical or technical performance parameters for the device itself (e.g., minimum lumen output, color temperature range, specific photocoagulation effectiveness). The primary "acceptance criterion" from an FDA 510(k) perspective is demonstrated substantial equivalence to a legally marketed predicate device. The "reported device performance" is a general statement of meeting this substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable/not provided. This type of information is typically associated with studies involving data analysis, such as image analysis for AI devices. The submission for a fiberoptic light source would not involve a "test set" of patient data in this manner.
- Data Provenance: Not applicable/not provided. The submission focuses on the performance characteristics of the hardware device itself, likely through engineering and functional testing, rather than analysis of patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable/not provided. Ground truth establishment with experts is relevant for diagnostic devices that interpret clinical data. For a fiberoptic light source, the "ground truth" would be objective measurement of its physical properties and functionality.
4. Adjudication Method for the Test Set
- Not applicable/not provided. This typically refers to resolving discrepancies in expert interpretations, which is not relevant for a hardware device like a light source.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. MRMC studies are used to assess the impact of a diagnostic tool (often AI-assisted) on human reader performance, usually in interpreting medical images or data. This is not relevant for a light source.
- Effect Size of Human Readers with vs. without AI assistance: Not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a hardware component and does not operate as a standalone algorithm. Its function is to illuminate, and potentially provide photocoagulation when used with a laser.
7. The Type of Ground Truth Used
- Implicit Ground Truth: For a fiberoptic light source, the "ground truth" would implicitly be based on established engineering standards for light output, spectral characteristics, safety (e.g., heat generation, electrical safety), and compatibility with other surgical equipment. These would be objectively measured and compared to the predicate device.
- The document does not specify the exact technical parameters or standards used for comparison, but states unequivocally that "Testing demonstrated that the subject device is substantially equivalent to the predicate device."
8. The Sample Size for the Training Set
- Not applicable. This device is a hardware product, not an AI/ML algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set, there is no ground truth for it to be established.
Summary of Approach for This Device:
The Synergetics Synerlight FiberOptic Lightsource gained FDA clearance through the 510(k) pathway by demonstrating substantial equivalence to an existing predicate device (K964005). The "study" mentioned, "Testing demonstrated that the subject device is substantially equivalent to the predicate device," refers to internal engineering and functional testing. This testing would have assessed that the new device has similar technological characteristics (e.g., light output, spectral range, safety features, intended use, materials) or, if different, that those differences do not raise new questions of safety and effectiveness.
The documentation does not contain the detailed performance metrics, clinical study designs, or expert review processes that would be typical for more complex diagnostic or AI-driven devices.
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NOV 2 4 2003
Attachment 2
510(k) Summary
| Company: | Synergetics, Inc.3845 Corporate Centre DriveSt. Charles, MO 63304 |
|---|---|
| Contact Person: | Dan Regan |
| Date: | October 21, 2003 |
| Trade Name: | Synergetics Synerlight FiberOptic Lightsource |
| Common Name: | Ophthalmic Fiberoptic Lightsource |
| Predicate Device: | K964005 |
| Description/Intended Use: | The intended use of the device is to illuminate the eyeduring anterior and posterior vitreoretinal surgery andto provide photocoagulation when used with theappropriate commercially available laser light sourceand probe. |
| Testing Summary: | Testing demonstrated that the subject device issubstantially equivalent to the predicate device. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 4 2003
Mr. Dan Regan Quality Assurance/Regulatory Affairs Director Synergetics, Inc. 3845 Corporate Centre Drive St. Charles, Missouri 63304
Re: K032598
Trade/Device Name: Synergetics Synerlight FiberOptic Lightsource Regulation Number: 21 CFR 876.1500, 878.4810 Regulation Name: Endoscope and accessories, Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: MPA, GEX Dated: August 22, 2003 Received: August 26, 2003
Dear Mr. Regan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Dan Regan
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment 2
Indications for Use Statement
| 510(k) Number(if known) | K032598 |
|---|---|
| Device Name | Synergetics Synerlight FiberOptic Lightsource |
| Indications for Use | The intended use of the device is to illuminate the eye duringanterior and posterior vitreoretinal surgery and to providephotocoagulation when used with the appropriate commerciallyavailable laser light source and probe. |
PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(per 21 CFR 801.109)
OR
Over-The Counter Use _________________________________________________________________________________________________________________________________________________________
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K032598
§ 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.