(14 days)
Not Found
No
The summary describes a laser system for photocoagulation and does not mention any AI or ML components or functionalities.
Yes
The device is described as being used for "photocoagulating ocular tissues for the treatment of diseases of the eye," which directly implies a therapeutic (treatment) purpose.
No
The device is described as a photocoagulating laser system for treating eye diseases, not for diagnosing them.
No
The device description clearly outlines hardware components such as a laser console, operating control panel, fiber ports, foot switch, and application devices (laser slit lamp, indirect ophthalmoscope, endoprobes). This indicates it is a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are 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").
- VISULAS Trion Function: The VISULAS Trion is a laser system used for photocoagulating ocular tissues. This is a therapeutic procedure performed directly on the patient's eye ("in vivo") to treat diseases. It does not involve analyzing samples taken from the body.
The description clearly states its purpose is to deliver laser energy to ocular tissues for treatment, not to perform diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The VISULAS Trion is intended for use in photocoagulating ocular tissues for the treatment of diseases of the eye, such as:
- Photocoagulation of the retina .
- Trabeculoplasty for treatment of glaucoma .
- . Iridotomy for treatment of glaucoma.
The laser energy is delivered via either transpupillary delivery or intraocular endoprobe delivery.
Product codes
GEX
Device Description
The VISULAS Trion is a diode-pumped, solid state, three-color laser system for green, yellow and red wavelengths, based upon the predicate VISULAS 532s (K013402). The VISULAS Trion laser system consists of the following components: Laser console as the source of laser radiation with detachable operating control panel, two fiber ports for application devices and a foot switch. Application devices for laser radiation delivery are offered via either transpupillary or intraocular delivery, laser slit lamp, laser indirect ophthalmoscope and endoprobes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ocular tissues (eye, retina)
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)
Evaluation performed on the VISULAS Trion supports the indications for use statement and demonstrates the device is substantially equivalent to the predicate devices and does not raise new questions regarding safety and effectiveness.
As described in this 510(k) Summary, all testing deemed necessary was conducted on the VISULAS Trion to ensure that the device is safe and effective for its intended use when used in accordance with its Instructions for Use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(K) SUMMARY
5. 510 (K) SUMMARY
Image /page/0/Picture/3 description: The image shows a handwritten number "1072514" on the top line. Below the number, the date "SEP 2 1 2007" is printed. The date is likely the date the number was written or recorded. The image appears to be a scan or photograph of a document.
510 (k) SUMMARY (per 21 CFR §807.92)
VISULAS Trion
GENERAL INFORMATION
| Name and Address of the
Applicant: | Carl Zeiss Meditec AG
Goeschwitzer Strasse 51-52
07745 Jena, Germany
Est. Reg. No. 9615030 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Kent W. Jones
Vice President, RA/CA/QA/Compliance
Carl Zeiss Meditec Inc.
5160 Hacienda Drive
Dublin, California 94568
(925) 557-4353 (phone)
(925) 557-4481 (fax) |
| Classification name: | Laser Instrument, Surgical, Powered |
| Classification: | Class II (acc. 21 CFR 878.4810) |
| Product Code: | GEX |
| Trade/Proprietary name: | VISULAS Trion |
| PREDICATE DEVICE | |
| Company:
Device: | Carl Zeiss Meditec AG
VISULAS 532s (K013402) |
| Company:
Device: | Lumenis
Novus® Varia™ Ophthalmic Laser and Delivery Devices
(K022181) |
| Company:
Device: | Nidek
Multi Color Laser Photocoagulator Model MC-300
(K042785) |
1
INTENDED USE
The VISULAS Trion is intended for use in photocoagulating ocular tissues for the treatment of diseases of the eye, such as:
- Photocoagulation of the retina .
- Trabeculoplasty for treatment of glaucoma .
- . Iridotomy for treatment of glaucoma.
The laser energy is delivered via either transpupillary delivery or intraocular endoprobe delivery.
DEVICE DESCRIPTION
The VISULAS Trion is a diode-pumped, solid state, three-color laser system for green, yellow and red wavelengths, based upon the predicate VISULAS 532s (K013402). The VISULAS Trion laser system consists of the following components: Laser console as the source of laser radiation with detachable operating control panel, two fiber ports for application devices and a foot switch. Application devices for laser radiation delivery are offered via either transpupillary or intraocular delivery, laser slit lamp, laser indirect ophthalmoscope and endoprobes.
SUBSTANTIAL EQUIVALENCE
The VISULAS Trion is substantially equivalent to the predicate devices identified previously. The VISULAS Trion is substantially equivalent to the predicate devices with regard to intended use, operating principle, function, and materials.
Evaluation performed on the VISULAS Trion supports the indications for use statement and demonstrates the device is substantially equivalent to the predicate devices and does not raise new questions regarding safety and effectiveness.
SUMMARY
As described in this 510(k) Summary, all testing deemed necessary was conducted on the VISULAS Trion to ensure that the device is safe and effective for its intended use when used in accordance with its Instructions for Use.
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Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 1 2007
Carl Zeiss Meditec AG % Regulatory Technology Services, LLC Mr. Mark Job 1394 25th Street Buffalo, MN 55313
Re: K072514 Trade/Device Name: VISULAS Trion 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: September 6, 2007 Received: September 7, 2007
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
3
Page 2 - Mr. Mark Job
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
PdOL
Mark N. Melkerson
Dr.
12-11-2
Mark N. Melkers Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: VISULAS Trion
The VISULAS Trion is intended for use in photocoagulating Indications for Use: ocular tissues for the treatment of diseases of the eye, such as:
- Photocoagulation of the retina .
- Trabeculoplasty for treatment of glaucoma .
- Iridotomy for treatment of glaucoma. .
The laser energy is delivered via either transpupillary delivery or intraocular endoprobe delivery.
Prescription Use x (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) المستقل التي تعاون القرار المستوى التي تعاون المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General, Restorative, and Neurological Devices | |
| 510(k) Number | L072514 |
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