(181 days)
Not Found
No
The summary describes a laser photocoagulator with different delivery systems and a tactile LCD screen for control. There is no mention of AI, ML, image processing, or any features that would suggest the use of such technologies. The performance studies focus on laboratory testing to meet design specifications and substantial equivalence, not on the performance of an AI/ML algorithm.
Yes
The device is indicated for use in the treatment of various ocular pathologies, which constitutes a therapeutic application.
No
Explanation: The device is described as a "laser photocoagulator" used for "treatment of ocular pathology," directly indicating a therapeutic function rather than a diagnostic one.
No
The device description explicitly states it is a "laser photocoagulator emitting a treatment beam of green (532nm) laser radiation" and includes physical components like a control box and delivery systems. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The VITRA MULTISPOT Laser photocoagulator is a therapeutic device that uses laser energy to treat ocular pathology. It directly interacts with the patient's eye to perform a medical procedure (photocoagulation).
- Lack of Specimen Analysis: The device description and intended use do not mention the analysis of any biological specimens.
Therefore, the VITRA MULTISPOT Laser photocoagulator falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VITRA MULTISPOT Laser is indicated for use in the treatment of ocular pathology of anterior and posterior segments including, retinal photocoagulation and pan retinal photocoagulation for vascular and structural abnormalities of the retina and choroids including:
· Proliferative and nonproliferative diabetic retinopathy;
● Choroidal neovascularization;
· Branch retinal vein occlusion;
· Treatment of choroidal neovascularization associated with wet Age-related macular degeneration:
· Retinal tears and detachments
- · Macular edema
- · Retinopathy of prematurity
- · Iridotomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
VITRA MULTISPOT is a laser photocoagulator emitting a treatment beam of green (532nm) laser radiation. The treatment beam is delivered through a delivery system and is aimed using a Red Laser diode (635-650nm).
The Quantel Medical VITRA MULTISPOT Laser can be connected with the following delivery systems:
-
- Scanning Laser Delivery System adaptor
-
- Slit Lamp adaptor
-
- Indirect ophthalmoscope adaptor
Output power from all these delivery systems are calibrated to deliver a maximum of 1.5 watts. The control box is a tactile LCD screen which is part of the main housing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ocular (anterior and posterior segments), retina, choroids
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Laboratory testing was conducted to validate and verify that the VITRA MULTISPOT Laser met all design specifications and was substantially equivalent to the predicate devices.
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.
K043486, K081744, K043236, K100678
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
§ 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.
0
K 122.251
JAN 2 4 2013
510(k) Summary for the Quantel Medical VITRA MULTISPOT
This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
1. General Information
Submitter:
Quantel Medical 11 Rue du Bois Joli - CS 40015 63808 Cournon D'Auvergne Cedex FRANCE 33-473 745 745 33-473 745 700 (Fax)
Contact Person:
Maureen O'Connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864 Telephone: 978-207-1245 Fax: 978-824-2541
Summary Preparation Date:
January 23, 2013
-
- Names
Device Name:
- Names
VITRA MULTISPOT
Classification Name:
Laser Instrument, Surgical, Powered Product Code: GEX Panel: General & Plastic Surgery
3. Predicate Device
- Quantel Medical SUPRA SCAN™ Delivery System coupled to a SUPRA 532 . -(K100678)
- Quantel Medical VITRA (K043236) -
- OPTIMEDICA CORPORATION PASCAL Photocoagulator (K043486) -
- OPTIMEDICA CORPORATION PASCAL Synthesis Delivery System -(K081744)
1
4. Device Description
VITRA MULTISPOT is a laser photocoagulator emitting a treatment beam of green (532nm) laser radiation. The treatment beam is delivered through a delivery system and is aimed using a Red Laser diode (635-650nm).
The Quantel Medical VITRA MULTISPOT Laser can be connected with the following delivery systems:
-
- Scanning Laser Delivery System adaptor
-
- Slit Lamp adaptor
-
- Indirect ophthalmoscope adaptor
Output power from all these delivery systems are calibrated to deliver a maximum of 1.5 watts. The control box is a tactile LCD screen which is part of the main housing.
5. Indications for Use
The VITRA MULTISPOT Laser is indicated for use in the treatment of ocular pathology of anterior and posterior segments including, retinal photocoagulation and pan retinal photocoagulation for vascular and structural abnormalities of the retina and choroids including:
· Proliferative and nonproliferative diabetic retinopathy;
● Choroidal neovascularization;
· Branch retinal vein occlusion;
· Treatment of choroidal neovascularization associated with wet Age-related macular degeneration:
· Retinal tears and detachments
- · Macular edema
- · Retinopathy of prematurity
- · Iridotomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma.
6. Substantial Equivalence
The VITRA MULTISPOT Laser shares the same intended use and safety compliance, similar design features, functional features, and therefore is substantially equivalent to the predicate devices, the PASCAL Photocoagulator (K043486) and Synthesis Delivery System (K081744), VITRA (K043236) and the Quantel Medical SUPRA SCAN™ Delivery System coupled to the SUPRA 532 (K100678). In addition, a review of the predicate devices demonstrates that the VITRA MULTISPOT Laser is substantially equivalent to the predicate
2
devices as they share equivalent specifications / characteristics and are used to perform the same indicated surgical procedures.
7. Performance Data
Laboratory testing was conducted to validate and verify that the VITRA MULTISPOT Laser met all design specifications and was substantially equivalent to the predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Quantel Medical % O'Connell Regulatory Consultants, Incorporated Ms. Maureen O'Connell Regulatory Counsultant 5 Timber Lane North Reading, Massachusetts 01864
January 24. 2013
Re: K122251
Trade/Device Name: VITRA MULTISPOT Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: December 12, 2012
Received: December 13, 2012
Dear Ms. O'Connell:
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
4
Page 2 - Ms. Maureen O'Connell
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. 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K122251
Device Name: YITRA MULTISPOT
Indications for Use:
The VITRA MULTISPOT Laser photocoagulator is indicated for use in the treatment of ocular pathology of anterior and posterior segments including, retinal photocoagulation and pan retinal photocoagulation of vascular and structural abnormalities of the retina and choroids including:
- Proliferative and nonproliferative diabetic retinopathy;
- · Choroidal neovascularization;
- · Branch retinal vein occlusion;
- · Treatment of choroidal neovascularization associated with wet Age-related macular degeneration;
- · Retinal tears and detachments
- · Macular edema
- · Retinopathy of Prematurity
- · Iridotomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over The Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1
Neil R Ogden 2013.01.23 14:36:51 -05'00'
mkm (Division Sign-Off) tor Division of Surgical Devices 510(k) Number K122251