OPMI TWINER SURGICAL MICROSCOPE by CARL ZEISS, INC.

This device will be used in the same manner as all: (a) surgical microscopes are used and (b) as all lasers are used in ENT and general surgery not requiring photocoagulation. The device is primarily intended to allow surgeons to perform tissue ablation with minimal peripheral thermal effects. More specifically, the device can be used for: general surgery which does not require photocoagulation; and in ENT applications, including microsurgery in the middle ear, stapedoplasty, for preparation of sites for osteosynthesis, microsurgery on ossicles, tympanic membrane, ablative surgery on soft tissues (for example: ligament severance of the stapes muscle), and removal of exostosis.

Device Description

The OPMI® TwinER Surgical Microscope is a surgical microscope with an integrated solid-state Er: YAG (Erbium Yttrium aluminum garnet) laser. The Er:YAG laser is used for the ablation of biological tissue. The OPMI® TwinER is designed for use in general surgery where coagulation is not required, and otology, rhinology, and laryngology ("ENT") applications. Because the Er: YAG laser operates in the 2,940 nm wavelength and is absorbed very well by water, it causes minimal damage to the peripheral tissues from thermal absorption. This makes the Er: YAG particularly effective in traditional and microsurgery in the ear.

The therapy beam is a Class IV laser with adjustable power output between 10 mJ and 100 mJ. The OPMT® TwinER also uses an aiming beam to position the therapy beam, which operates in the 660-680 nm wavelength. The aiming beam is a Class IIIA laser with adjustable power output between 0.2 mW and 3 mW.

The therapy and aiming beams are delivered to the surgical field via a micromanipulator. A mirror, which can be finely adjusted using a joystick, allows the exact positioning of the laser beam.

AI/ML Overview

The provided text describes the OPMI® TwinER Surgical Microscope, a device combining a surgical microscope with an integrated solid-state Er:YAG laser. It discusses the device's intended use, its substantial equivalence to predicate devices, and the underlying technology. However, the text does not contain information about acceptance criteria or a specific study proving the device meets acceptance criteria.

The document is a 510(k) summary and the subsequent FDA clearance letter, which focuses on demonstrating substantial equivalence to pre-market cleared devices rather than providing detailed performance studies against specific acceptance criteria.

Therefore, most of the requested information cannot be extracted from the given text.

Here's a breakdown of what can be inferred or stated based on the provided text, and what cannot:

Information that CANNOT be extracted from the provided text:

A table of acceptance criteria and the reported device performance: This level of detail about specific performance metrics and their acceptance thresholds is not present.
Sample size used for the test set and the data provenance: There is no mention of a specific "test set" or a study performed with a defined sample size.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment for a specific test set is not discussed.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: No information is available regarding adjudication.
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: This is irrelevant as the device is a surgical microscope with a laser, not an AI-assisted diagnostic tool for "human readers."
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not discussed in the context of a specific study for this device.
The sample size for the training set: Not applicable as it's not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable.

Information that CAN be inferred or stated from the provided text:

While a formal "study" proving acceptance criteria isn't detailed, the document makes a claim based on existing literature:

"Numerous studies have proven that the Er: YAG laser, such as that used by the OPM10 TwinER, is safe and effective. Studies indicate that the Er. YAG laser is in fact safer and more effective than CO2 lasers for certain ENT applications."

This statement serves as the general "proof" for the underlying technology's safety and effectiveness. The acceptance criteria, therefore, are implicitly tied to the general understanding and regulatory acceptance of Er:YAG lasers for the stated applications.

In summary, the provided document focuses on regulatory approval through substantial equivalence to predicate devices, rather than presenting a detailed study with specific acceptance criteria for the OPMI® TwinER Surgical Microscope itself. The safety and effectiveness are established by referencing existing knowledge and studies on Er:YAG lasers in general.

Summary

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JAN 29 1999

Image /page/0/Picture/1 description: The image shows the logo for Zeiss, a German manufacturer of optical systems and optoelectronics. The logo consists of the word "ZEISS" in a bold, sans-serif font, set against a black square. The bottom edge of the square is curved, giving it a slightly rounded appearance. The logo is simple, modern, and easily recognizable.

983868

510(k) Summary

Pursuant to 21 CFR 807.92 the following summary is submitted.

1. Submitter's Name: Carl Zeiss, Inc. 1 Zeiss Drive Thornwood, NY 10594 (914) 681 7880 Contact Person: Scott A. Margolin October 27, 1998
Trade Name: OPMI® TwinER Surgical Microscope 2. Classification Name: Surgical Microscope: § 878.4700 Instrument, Surgical Powered, Laser: § 878.4810
1. We are claiming substantial equivalence to the Sharplan Laser, Inc.'s 1041s (K900077) and the Premier Centauri Laser System (K933841) predicate devices, which already have pre-market clearance.
1. The OPMI® TwinER Surgical Microscope is a surgical microscope with an integrated solid-state Er: YAG (Erbium Yttrium aluminum garnet) laser. The Er:YAG laser is used for the ablation of biological tissue. The OPMI® TwinER is designed for use in general surgery where coagulation is not required, and otology, rhinology, and laryngology ("ENT") applications. Because the Er: YAG laser operates in the 2,940 nm wavelength and is absorbed very well by water, it causes minimal damage to the peripheral tissues from thermal absorption. This makes the Er: YAG particularly effective in traditional and microsurgery in the ear.

The therapy and aiming beams are delivered to the surgical field via a micromanipulator. A mirror, which can be finely adjusted using a joystick, allows the exact positioning of the laser beam.

1. This device will be used in general surgical applications where coagulation is not required and in surgical ENT applications, in particular as a surgical otology laser, in the same manner as the Sharplan 1041s predicate device (with the exception that the Sharplan device may be used where coagulation is required).

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OPMI® TwinER Surgical Microscope
510(k) Summary
Page 2

The OPMI® TwinER is intended for use in the following applications: general surgery which does not require coagulation; general surgical ENT, microsurgery on the middle car: stepedoplasty; for preparation of sites for osteosynthesis; microsurgery on ossicles, tympanic membrane, ablative surgery on soft tissues (for example: ligament severance of the stapes muscle); and for the removal of exostosis.

The Zeiss OPMI® TwinER and the predicate devices are substantially equivalent because ર. they all utilize a laser to perform tissue ablation. The OPMI® TwinER and the Sharplan 1041s (K900077) both achieve the surgical effect of tissue ablation in ENT/ otology applications by laser energy. Although the type of laser employed by the OPMIN TwinER differs from that used by the Sharplan 1041s, their basic functionality and intended use are virtually the same. These devices present the same questions regarding safety and effectiveness. Any differences between the two devices do not affect the safety or effectiveness of the device.
Similarly, the OPMI® TwinER and the Premier Centauri Laser (K933841) both achieve the effect of hard tissue ablation through the application of Er: Y AG lasers. Although the Centauri laser is intended for dental applications rather than surgical otology, both devices utilize the Er. YAG laser on similar tissue types. The basic functionality of these two devices is virtually the same. The technological characteristics of the two devices pose the same types of questions regarding safety and effectiveness. Any differences between the two devices do not affect the safety or effectiveness of the device.

Numerous studies have proven that the Er: YAG laser, such as that used by the OPM10 TwinER, is safe and effective. Studies indicate that the Er. YAG laser is in fact safer and more effective than CO2 lasers for certain ENT applications. The CO2 laser operates at a wavelength of 10,600 nm (10.6 um), achieving tissue ablation through a thermal effect, which may result in thermal damage to the delicate surrounding tissues. The Er:YAG, however, operates at a wavelength of 2,940 mm (2.94 um), which is nearly the maximum absorption rate for light in water. The laser energy is entirely absorbed by the water in the tissue and converted to thermal energy. This leads to a rapid increase in water temperature and then to evaporation, followed immediately by a microexplosion. Thus, tissue ablation is achieved in a more mechanical fashion, rather than through the thermal effect of the CO2 lasers. By this mechanism, the Er: YAG laser ablates without inducing significant thermal effects to the surrounding tissues and fluids.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other, with a flowing, wave-like design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 29 1999

Mr. Scott A. Margolin Regulatory Affairs Specialist Carl Zeiss, Inc. One Zeiss Drive Thornwood. New York 10594

K983868 Trade Name: OPMI® TwinER Surgical Microscope Regulatory Class II: Product Code: GEX Dated: October 27, 1998 Received: November 2, 1998

Dear Mr. Margolin:

Re:

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 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 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 - Mr. Scott A. Margolin

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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JAN 29 1999

INDICATIONS

Carl Zeiss, Inc. OPMI® TwinER 510(K) Submission

510(K) Number	: K983868
Device Name	: OPMI® TwinER Surgical Microscope
Indications for Use	:

This device is intended for use primarily by physicians and health care workers and may only be used under the supervision of a physician. This device will not be sold to the general public.

Signature

cila with

Prescription Use PrescripCFR 801.109)

r Use (Per 21 Crk 801.109)

Carl Zeiss, Inc. One Zeiss Drive Thornwood, NY 10594

(914) 747-1800 Fax (914) 682-8296 www.zeiss com

Regulation Number and Section

§ 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.