MICRORUPTER V

K023045 · Meridian AG · LXS · Sep 26, 2002 · Ophthalmic

Device Facts

• Record ID: K023045
• Device Name: MICRORUPTER V
• Applicant: Meridian AG
• Product Code: LXS · Ophthalmic
• Decision Date: Sep 26, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4392
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

This device will be used in ophthalmic applications, including: Posterior Capsulotomy Peripheral Iridotomy . Pupillary Membranectomy . This device is intended for use by skilled Physicians and Healthcare Workers and may only be used under the supervision of a Physician. " Federal law restricts this device to sale by or on the order of a licenced practioner "

Device Story

Microruptor V is a Q-switched Nd:YAG laser system for ophthalmic surgery. System includes table, control electronics, headrest, and movable housing with joystick-controlled biomicroscope/slit-lamp. Device emits 1064 nm laser pulses focused via ophthalmic microscope to cause optical breakdown for noninvasive tissue disruption. Red 635 nm diode laser provides aiming beam. Operated by physicians or supervised healthcare workers in clinical settings. Physician visualizes target tissue through microscope, adjusts energy, and positions focus to perform precise dissection. Benefits include noninvasive treatment of ocular membranes.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Q-switched Nd:YAG laser; 1064 nm wavelength; 635 nm red diode aiming beam. System includes power module, control module, Haag-Streit slit-lamp biomicroscope, headrest, and delivery optics. Table-mounted form factor. Non-software based control system.

Indications for Use

Indicated for ophthalmic tissue/membrane dissection (photodisruption) including posterior capsulotomy, peripheral iridotomy, and pupillary membranectomy in patients requiring these procedures.

Regulatory Classification

Identification

The Nd:YAG laser for posterior capsulotomy and peripheral iridotomy consists of a mode-locked or Q-switched solid state Nd:YAG laser intended for disruption of the posterior capsule or the iris via optical breakdown. The Nd:YAG laser generates short pulse, low energy, high power, coherent optical radiation. When the laser output is combined with focusing optics, the high irradiance at the target causes tissue disruption via optical breakdown. A visible aiming system is utilized to target the invisible Nd:YAG laser radiation on or in close proximity to the target tissue.

Special Controls

*Classification.* Class II (special controls). Design Parameters: Device must emit a laser beam with the following parameters: wavelength = 1064 nanometers; spot size = 50 to 100 micros; pulse width = 3 to 30 nanoseconds; output energy per pulse = 0.5 to 15 millijoules (mJ); repetition rate = 1 to 10 pulses; and total energy = 20 to 120 mJ.

Predicate Devices

• A.R.C. Q-las 10 (k001511)

Submission Summary (Full Text)

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# SEP 2 6 2002

#### E 510(k) Summary

| Trade Name: | MICRORUPTOR V |
|----------------------|-------------------------------------------------------------------------------------------|
| Common Name: | Q-switched Nd:YAG laser |
| Classification Name: | Nd:YAG laser for posterior Capsulotomy Peripheral Iridotomy and<br>Pupillary Membranotomy |
| Predicate Device: | A.R.C. Q-las 10 (k001511) |

## Description:

The MICRORUPTOR V is a Q-switched Nd:YAG laser system designed for use in ophthalmologic procedures. It has the form of a table containing supply and control electronics and supporting a headrest where the head of the patient is placed, as well as a movable housing that is controlled by a joystick. The housing comprises a biomicroscope with a slit-lamp illumination (Haag-Streit), a Qswitched Nd:YAG laser, a laser diode producing a red (635 nm) aiming beam and optical, mechanical and electronics elements necessary to control the parameters and geometry of the laser beams.

The integrated Q-switched Nd:YAG laser emits short pulses of light at wavelength of 1064 nm. This light is focused in the plane of observation of the ophthalmic microscope. The irradiance at the focal point is high enough to cause optical breakdown, thus permitting the disruption of tissues.

The MICRORUPTOR V allows the physician to adjust the energy delivered to the target tissue and to precisely control and visualize the position of the beam focus, thus allowing a precise and noninvasive dissection of tissues inside the eye of the patient.

### Intended Use:

The intended use for the MICRORUPTOR V is for noninvasive tissue/membrane dissection (photodisruption) in the eye. Indications for use include posterior capsulotomy, peripheral indotomy. and pupillary membranotomy

### Technological Characteristics:

The "new" device and the predicate both target the same applications of noninvasive tissue disruption in the eye, including posterior capsulotomy, peripheral iridotomy and pupillary membranotomy . The controls, materials, method of manufacture, indications and labeling of both systems are identical or equivalent.

The "new" device and the predicate consist of a power module, a control module, an ophthalmic microscope with headrest and slit lamp, a laser module and delivery optics.

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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 consists of a stylized eagle or bird symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 6 2002

Meridan AG c/o Mr. Mark Job TÜV Product Service 1775 Old Highway 8 NW, Suite 104 New Brighton, MN 55112-1891

Re: K023045

Trade/Device Name: Microruptor V Regulation Number: 886.4392 Regulation Name: Nd: YAG laser for posterior capsulotomy and peripheral iridotomy Regulatory Class: II Product Code: LXS Dated: September 6, 2002 Received: September 12. 2002

Dear Mr. Job:

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. Mark Job

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Aupk Charles

Azalia M. Witte, Ph.D., M.D.

elia 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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D Indications for Use

Applicant:

MERIDIAN Inc. Bierigutstrasse 7 CH-3608 Thun Switzerland Phone [phone] Fax [phone]

510(k) Number (if known):

K023045

Device Name:

MICRORUPTOR V

#### Indications for Use:

This device will be used in ophthalmic applications, including:

...

- . Posterior Capsulotomy
- Peripheral Iridotomy .
- Pupillary Membranectomy .

This device is intended for use by skilled Physicians and Healthcare Workers and may only be used under the supervision of a Physician.

" Federal law restricts this device to sale by or on the order of a licenced practioner "

Hypt. Church

Division of General, Restorative and Neurological Devices

510(k) Number K023045