(70 days)
Not Found
No
The summary describes a laser system for photocoagulation and mentions a multispot treatment cascade option, but there is no mention of AI, ML, image processing, or any data-driven decision-making processes.
Yes
The device is used for photocoagulation of ocular tissues in the treatment of various eye diseases, which is a therapeutic intervention.
No
The device is described as an ophthalmic surgical laser intended for photocoagulating ocular tissues in the treatment of eye diseases, not for diagnosis.
No
The device description clearly states it is a "Laser System" and includes hardware components like a laser slit lamp. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "photocoagulation of ocular tissues in the treatment of diseases of the eye". This is a therapeutic procedure performed directly on the patient's body (in vivo).
- Device Description: The description reinforces this by stating it's an "ophthalmic surgical laser intended for use in photocoagulating ocular tissues".
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for treatment.
N/A
Intended Use / Indications for Use
The VISULAS 532s Laser System with the VITE option is intended for use in retinal, panretinal, focal and grid photocoagulation of ocular tissues in the treatment of diseases of the eye including:
- Proliferative and non-proliferative diabetic retinopathy .
- Macular edema ◆
- Branch and central retinal vein occlusion .
- Lattice degeneration .
- Retinal tears and detachments .
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The VISULAS 532s Laser System with the VITE option is an ophthalmic surgical laser intended for use in photocoagulating ocular tissues in treatment of diseases of the eye. As with the predicate device, laser energy for the proposed device is delivered via transpupillary delivery or intraocular endoprobe delivery. The VISULAS 532s Laser System with the VITE option includes an optional new laser slit lamp (the LSL 532s VITE) that features a multispot treatment cascade delivery option.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ocular tissues
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)
The VISULAS 532s Laser System with the VITE option has been designed and tested to applicable safety standards. The determination of substantial equivalence is based on the comparison between the results of performance data conducted using the VISULAS 532s with the VITE option and the predicate device. These results demonstrate the ability of the proposed device to produce photocoagulation of ocular tissues that is comparable to the photocoagulation produced by the predicate device.
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.
K013402, K043486, K081744, K091966, K092621
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
(6603)
510(K) SUMMARY
a.
b.
c.
MAR 1 7 2010
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92(a).
SUBMITTER'S NAME, ADDRESS, TELEPHONE NUMBER, CONTACT PERSON, AND DATE PREPARED
- Carl Zeiss Meditec AG Applicant: a. Goeschwitzer Strasse 51-52 7740 Jena Germany
- Judith A. Brimacombe Contact Person: b. Carl Zeiss Meditec, Inc. 5160 Hacienda Drive Dublin, CA 94568 USA j.brimacombe(@meditec.zeiss.com Tel: (925) 557-4616 Fax: (925) 557-4259
- November 20, 2009 c. Date Prepared:
NAME OF DEVICE, INCLUDING TRADE NAME & CLASSIFICATION NAME
- VISULAS 532s Laser System with the VITE option Trade/Proprietary Name:
- Common/Usual Name: Ophthalmic surgical laser
- Laser Instrument, Surgical, Powered
- Classification Code: d.
Classification Name:
- 21 CFR §878.4810; 79 GEX
1
100035
PREDICATE DEVICES
| PREDICATE DEVICE | MANUFACTURER | 510(K)
CLEARANCE
NUMBER | CLEARANCE DATE |
|--------------------------------------|------------------------|-------------------------------|--------------------|
| VISULAS 532s | Carl Zeiss Meditec AG | K013402 | November 14, 2001 |
| PASCAL
Photocoagulator | OptiMedica Corporation | K043486 | March 3, 2005 |
| PASCAL Synthesis
Delivery System | OptiMedica Corporation | K081744 | September 9, 2008 |
| PASCAL
Photocoagulator | OptiMedica Corporation | K091966 | July 15, 2009 |
| PASCAL Streamline
Photocoagulator | OptiMedica Corporation | K092621 | September 25, 2009 |
DEVICE DESCRIPTION
The VISULAS 532s Laser System with the VITE option is an ophthalmic surgical laser intended for use in photocoagulating ocular tissues in treatment of diseases of the eye. As with the predicate device, laser energy for the proposed device is delivered via transpupillary delivery or intraocular endoprobe delivery. The VISULAS 532s Laser System with the VITE option includes an optional new laser slit lamp (the LSL 532s VITE) that features a multispot treatment cascade delivery option.
STATEMENT OF INTENDED USE
The VISULAS 532s Laser System with the VITE option is intended for use in retinal, panretinal, focal and grid photocoagulation of ocular tissues in the treatment of diseases of the eye including:
- Proliferative and non-proliferative diabetic retinopathy .
- Macular edema ◆
- Branch and central retinal vein occlusion .
- Lattice degeneration .
- Retinal tears and detachments .
TECHNOLOGICAL CHARACTERISTICS COMPARISON
The VISULAS 532s Laser System with the VITE option has the same operating characteristics and is substantially equivalent to the predicate VISULAS 532s Laser System, also by Carl Zeiss Meditec (K013402). Both the predicate and proposed devices deliver laser energy via the Laser Slit Lamp (LSL), the Laser Indirect Ophthalmoscope LIO 532 (for transpupillary delivery) or the endoprobe (for intraocular delivery). The primary
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106035
modification incorporated in the VISULAS 532s Laser System is the addition of an alternative laser slit lamp that is equipped with the VITE functionality, which allows the option of delivering a multi-spot treatment.
BRIEF SUMMARY OF NONCLINICAL TESTS & RESULTS
The VISULAS 532s Laser System with the VITE option has been designed and tested to applicable safety standards. The determination of substantial equivalence is based on the comparison between the results of performance data conducted using the VISULAS 532s with the VITE option and the predicate device. These results demonstrate the ability of the proposed device to produce photocoagulation of ocular tissues that is comparable to the photocoagulation produced by the predicate device.
CONCLUSION
The VISULAS 532s Laser System with the VITE option is substantially equivalent to the predicate device, the VISULAS 532s Laser System (K013402).
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with its wings spread, rendered in a simple, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
MAR 1 7 2010
Carl Zeiss Meditec, Inc. % Regulatory Technology Services, LLC Mr. Mark Job 1394 25th Street, NW Buffalo, Minnesota 55313
Re: K100035
Trade/Device Name: VISULAS 532s Laser System with the VITE option Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology. Regulatory Class: Class II Product Code: GEX Dated: March 08, 2010 Received: March 09, 2010
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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Page 2 - Mr. Mark Job
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fdaggv/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcestorYou/Industry/default.htm
Sincerely yours,
cerely yours,
for Peter Thum
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): _ | |
Device Name(s): VISULAS 532s Laser System with the VITE option
Indications for Use:
The VISULAS 532s Laser System with the VITE option is intended for use in retinal, panretinal, focal and grid photocoagulation of ocular tissues in the treatment of diseases of the eye including:
- Proliferative and nonproliferative diabetic retinopathy .
- . Macular edema
- . Branch and central retinal vein occlusion
- Lattice degeneration .
- Retinal tears and detachments .
Prescription Use X AND/OR (Part 21 CFR §801 Subpart D)
Over-The-Counter Use (21 CFR§ 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
l of 1 Page
Neil Rodda for mkm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100035