(14 days)
Not Found
No
The description focuses on the laser technology and mechanical controls, with no mention of AI or ML capabilities.
Yes
The device is described as a Q-switched Nd:YAG laser system designed for ophthalmic procedures to disrupt tissues, allowing for "precise and noninvasive dissection of tissues inside the eye of the patient," which aligns with the definition of a therapeutic device.
No
Explanation: The device description states its purpose is for "disruption of tissues" and "noninvasive dissection of tissues inside the eye," which are therapeutic actions, not diagnostic ones.
No
The device description clearly outlines a physical laser system with hardware components like a table, headrest, movable housing, biomicroscope, laser diode, and optical/mechanical/electronic elements. It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The MICRORUPTOR V is a surgical laser system used to perform procedures directly on the eye of a patient. It uses light energy to disrupt tissues inside the body (in vivo).
- Intended Use: The intended uses listed (Posterior Capsulotomy, Peripheral Iridotomy, Pupillary Membranectomy) are all surgical procedures performed on the eye.
The device description clearly indicates it's a laser system for ophthalmic surgery, not for testing biological samples.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
LXS
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
skilled Physicians and Healthcare Workers and may only be used under the supervision of a Physician.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 886.4392 Nd:YAG laser for posterior capsulotomy and peripheral iridotomy.
(a)
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.(b)
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.
0
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 |
| 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 (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,
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
3
D Indications for Use
Applicant:
MERIDIAN Inc. Bierigutstrasse 7 CH-3608 Thun Switzerland Phone +41 33 334 11 11 Fax +41 33 334 11 19
510(k) Number (if known):
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