(30 days)
The VISULAS 532s laser is intended for use in photocoagulating ocular tissues in the treatment of diseases of the eye. The laser energy is delivered via either transpupillary, delivery or intraocular endoprobe delivery.
The VISULAS 532s laser represents an improved version of the predicate Zeiss-Diode Pumped Solid State Laser (K925642). The improvement includes the following 2 modifications: In addition to the known laser slit lamp, the slit lamp adapter VISULINK 532/U or the Laser Indirect Ophthalmoscope LIO 532 may be used now as a laser application system. Laser console and user interface were improved to allow operation, setting, and monitoring of the different laser treatment procedures.
The provided text does not contain information about acceptance criteria or a study proving device performance as typically understood in the context of medical device validation for AI-powered diagnostic tools. Instead, the document describes a special 510(k) premarket notification for a modification to an existing ophthalmic surgical laser, the VISULAS 532s.
The key points from the document are:
- Device: VISULAS 532s, an ophthalmic surgical laser.
- Modification: Improvements to the predicate device (Zeiss-Diode Pumped Solid State Laser (K925642)) include:
- Addition of new laser application systems: VISULINK 532/U (slit lamp adapter) or LIO 532 (Laser Indirect Ophthalmoscope).
- Improved laser console and user interface for operation, setting, and monitoring.
- Conclusion: The FDA determined the modified device (VISULAS 532s) is substantially equivalent to the predicate device based on side-by-side comparisons. The modifications do not raise new questions for safety and efficacy.
Therefore, the specific questions regarding acceptance criteria, reported device performance, sample sizes, experts, adjudication, MRMC studies, standalone performance, and ground truth for a diagnostic or AI-powered device are not applicable to the content provided for this surgical laser modification.
The FDA's substantial equivalence determination for this device modification primarily relies on the comparison to the predicate device, demonstrating that the changes do not alter the fundamental safety or effectiveness of the product for its intended use. There is no mention of analytical or clinical performance studies with acceptance criteria in the context of AI or diagnostic accuracy.
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NOV 1 4 2001
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Carl Zeiss Jena GmbH, Ophthalmic Instruments Division
VISULAS 532s - Special 510(k) - Device Modification Summary
| Name of Unmodified Device: | ZEISS-DIODE PUMPED SOLID STATE LASER |
|---|---|
| Name of Modified Device: | VISULAS 532s |
| Common or Usual Name: | OPHTHALMIC SURGICAL LASER |
| Classification Name: | LASER INSTRUMENT, SURGICAL, POWERED |
| Product Code: | GEX |
| Submitter: | Carl Zeiss Inc.One Zeiss DriveThornwood, NY 10594, USA |
| Tel.: | (914) 681 7761 |
| Fax: | (914) 681 7418 |
| Contact Person: | Kenneth M. Nicoll |
| Date Prepared: | October 05, 2001 |
Intended Use
The Zeiss-Diode Pumped Solid State Laser (DPSSL) as well as now the modified device renamed as VISULAS 532s is intended for use in photocoagulating ocular tissues in the treatment of diseases of the eye.
The laser energy is delivered via either transpupillary delivery or intraocular ENDO probe delivery.
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Device Modification
The VISULAS 532s laser represents an improved version of the predicate Zeiss-Diode Pumped Solid State Laser (K925642).
JOP .
The improvement includes the following 2 modifications, which are detailed introduced in the Special 510(k) - Device Modification description:
- · In addition to the known laser slit lamp, the slit lamp adapter VISULINK 532/U or the Laser Indirect Ophthalmoscope LIO 532 may be used now as a laser application system.
- · Laser console and user interface were improved to allow operation, setting, and monitoring of the different laser treatment procedures.
Conclusion
The introduced side by side comparisons of the VISULAS 532s laser system versus the predicate Zeiss-Diode Pumped Solid State Laser as approved with the notification K925642 indicate that both devices are virtually identical with exception of minor variations which are detailed introduced.
Also the additional applied delivery systems VISULINK 532/U and the LIO 532 are very similar to the already used previously cleared devices/accessories. In addition the delivery systems do not refer to any other claims compared with the approved indications for use.
Thus the described device modification do not raise any new questions for safety and efficacy and in the summary of the reviewed similarities and differences between the compared devices/accessories has to be concluded that the VISULAS 532s may be applied by the surgeon after the modification in a more state of the art way.
Finally the renaming of the Zeiss-Diode Pumped Solid State Laser to VISULAS 532s does not affect any question for safety and efficacy. The new name is caused by the marketing strategy of the Carl Zeiss Jena GmbH, Ophthalmic Instruments Division to use a concerted recognizable device name which distinguishes the laser treatment devices by the applied laser wavelength.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 스 2001
Mr. Kenneth M. Nicoll Carl Zeiss, Inc. One Zeiss Drive Thornwood, New York 10594
Re: K013402
Trade Name: Visulas 532S Regulation Number: 878.4810 Regulation Name: Laser Instrument, Surgical, Powered Regulatory Class: Class II Product Code: GEX Dated: October 5, 2001 Received: October 15, 2001
Dear Mr. Nicoll:
We have reviewed your Section 510(k) premarket 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) 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. Kenneth Nicoll
This letter will allow you to begin marketing your device as described in your Section 510(k) remarket notification. The FDA finding of substantial equivalence of your device to a legally presided 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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» (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
bo. Mark N. Mellemson
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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NOV 1 스 2001
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Page 1 of 1
KO13402
510(k) Number (if known):
Device Name: VISULAS 532s
Indication for Use: The VISULAS 532s laser is intended for use in photocoagulating ocular tissues in the treatment of diseases of the eye.
The laser energy is delivered via either transpupillary, delivery or intraocular endoprobe delivery.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurence of CDRH, Office of Device Evaluation (ODE) (Optional Format 3-10-98)
la Mark M. Millerson
Restorative and Neurological Devices
510(k) Number -
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.