(77 days)
Not Found
No
The summary describes a laser photocoagulator and its intended uses, focusing on the physical properties of the laser and delivery systems. There is no mention of AI, ML, image processing, or any data-driven algorithms typically associated with AI/ML in medical devices.
Yes
The device is a photocoagulator used for retinal treatment in various medical conditions, indicating its therapeutic purpose.
No
Explanation: The device is described as a "Photocoagulator" used for "retinal photocoagulation" to treat various eye conditions. This indicates a therapeutic function (treatment), not a diagnostic one (identifying or assessing a condition).
No
The device description explicitly states it is a "Nd:YAG frequency doubled laser with a KTP crystal," which are hardware components.
Based on the provided information, the Vitra Ophthalmic Laser Photocoagulator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The Vitra Ophthalmic Laser Photocoagulator is a therapeutic device. Its intended use is to deliver laser energy directly to the retina for the treatment of various eye conditions. It does not analyze or process biological samples.
The description clearly outlines a device used for treatment (photocoagulation) of the retina, not for diagnostic testing of biological specimens.
N/A
Intended Use / Indications for Use
The Vitra Ophthalmic Laser Photocoagulator is indicated for retinal photocoagulation in the following conditions:
With an indirect ophthalmoscope - for peripheral photocoagulation for the treatment of proliferative diabetic retinopathy and retinal detachments.
With an endocular probe – for intraocular retinal photocoagulation as an adjunct to vitrectomy surgery (and not the sole indication for vitrectomy) in the management of complicated rhegmatogenous and tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy.
With a slit Lamp - for the treatment of proliferative diabetic retinopathy, choroidal neovascularization secondary to age-related macular degeneration, and retinal detachments.
Product codes
HQF
Device Description
The Quantel Vitra Ophthalmic Laser Photocoagulator is a Nd:YAG frequency doubled laser with a KTP crystal which emits a beam of coherent light at 532 nm. The energy is delivered to the treatment site(s) via delivery systems/devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
retinal, intraocular retinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
None required.
Key Metrics
Not Found
Predicate Device(s)
K960867, K991258, K013402, K023464
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.
0
FEB - 7 2005
510(k) SUMMAR Y
KO 43236
This 510(k) summary of safety and effectiveness for the modification in the Indications for Use for the Vitra Ophthalmic Laser Photocoagulator is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.
| Applicant: | Quantel Medical |
|---|---|
| Address: | QUANTEL MEDICAL |
| 21 rue Newton | |
| Z.I. du Br 'zet | |
| 63039 Clermont-Ferrand | |
| Cedex 2 | |
| FRANCE | |
| +33 (0)473 745 745 | |
| +33 (0)473 745 700 (Fax) | |
| Contact Person: | Mr. Jean Abascal |
| Regulatory Affairs Manager |
(+33) 169 29 17 25
(+33) 169 29 17 29 |
Preparation Date: November 2004 (of the Summary)
Device Name: Quantel Vitra Ophthalmic Laser Photocoagulator
- Common Name: Ophthalmic Laser, frequency doubled Nd: YAG (532 nm) laser Laser Surgical Instrument, frequency doubled Nd: Y AG (532 nm) laser
Ophthalmic laser (see 21 CFR 886.4390) Classification
Product Code: HQF; Panel: 86
Name:
- Predicate devices: B.V.I. Viridis Laser (K960867); Novus Verdi Laser and Delivery Systems (K991258), Carl Zeiss Visulas 532s (K013402), and the 532 nm laser of the Quantel Viridis Twin Laser (K023464).
- Device description: The Quantel Vitra Ophthalmic Laser Photocoagulator is a Nd:YAG frequency doubled laser with a KTP crystal which emits a beam of coherent light at 532 nm. The energy is delivered to the treatment site(s) via delivery systems/devices.
1
- Indications: The Vitra Ophthalmic Laser Photocoagulator is indicated for retinal photocoagulation in the following conditions:
With an indirect ophthalmoscope - for peripheral photocoagulation for the treatment of proliferative diabetic retinopathy and retinal detachments.
With an endocular probe – for intraocular retinal photocoagulation as an adjunct to vitrectomy surgery (and not the sole indication for vitrectomy) in the management of complicated rhegmatogenous and tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy.
With a slit Lamp - for the treatment of proliferative diabetic retinopathy, choroidal neovascularization secondary to age-related macular degeneration, and retinal detachments.
Performance Data: None required.
- CONCLUSION: Based on the information in this notification Quantel Medical concludes that the Vitra Ophthalmic Laser Photocoagulator is substantially equivalent to the cited legally marketed predicates. Information regarding delivery systems which may be used with the laser is supplied by Quantel Medical; the individual devices or systems are marketed by their respective manufacturers who have the responsibility for complying with applicable regulations and marketing requirements.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 7 2005
Quantel Medical c/o Mr Roger Barnes 342 Sunset Bay Road Hot Springs, Arkansas 71913
Re: K043236
Ko+5230
Trade/Device Name: Quantel Vitra Ophthalmic Laser Photocoagulator Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: II Product Code: HQF Dated: November 19, 2004 Received: November 22, 2004
Dear Mr. Barnes:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosale) to regary the enactment date of the Medical Device Amendments, or to comments provided in accordance with the provisions of the Federal Food. Drug. devices may been receissined in assee approval of a premarket approval application (PMA). alla Cosment Act (Act) that do not require approvisions of the general controls provisions of the Act. The I ou may, dicierore, market the act include requirements for annual registration, listing of general controls provisions of tax tice, 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 If your device is elassinod (600 as controls. Existing major regulations affecting your device can may oc subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may be fourther announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease of advised that I Dr o locan that your device complies with other requirements of the Act that I DA has made a determissions administered by other Federal agencies. You must of any I cacal statutes and regaraments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR in the quality systems (21 CFR Part 820); and if applicable, the electronic forth in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 – Mr Roger Barnes
This letter will allow you to begin marketing your device as described in your Section 510(k)
10 1legal This letter will allow you to begin maketing your active of your device of your device to a legally premarket notification. The FDA midnig of substantal equive 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
rs the results of the may of 10, 276 0115. All as a loca note the requilati If you desire specific advice for your ac vice on our nooming the regulation entitled,
contact the Office of Compliance at (240) 276-0115. Also, please note the regulation o contact the Office of Colliphalice at (240) 270 - 131 (21CFR Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Part 807.97). "Misbranding by reference to premarket nonfication" (1733 Act from the Division of Small
other general information on your responsibilities under the Act from the (800) 638-2 other general information on your responsionner Assistance at is toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at is toll-free which Manufacturers, Internet address http://www.fda.cov/cdrb/industry/support/index.html.
Sincerely yours,
Mark A. Milliken
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
4
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): _ K043236
Device Name: Quantel Vitra Ophthalmic Laser Photocoagulator
Indications for Use Statement:
The Vitra Ophthalmic Laser Photocoagulator is indicated for retinal photocoagulation in the following conditions:
With an indirect ophthalmoscope -- for peripheral photocoagulation for the treatment of proliferative diabetic retinopathy and retinal detachments.
With an endocular probe – for intraocular retinal photocoagulation as an adjunct to vitrectomy surgery (and not the sole indication for vitrectomy) in the management of complicated rhegmatogenous and tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy.
With a slit Lamp - for the treatment of proliferative diabetic retinopathy, choroidal neovascularization secondary to age-related macular degeneration, and retinal detachments.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Prescription Use X
(Per 21 CFR 801.109) OR
Over-The Counter Use
(Division Sign-Off)
Division of General, Restorative,
and Necrological Devices
036
510(k) Number K04