(85 days)
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Not Found
No
The 510(k) summary describes laser surgery accessories and does not mention any AI or ML capabilities, image processing, or performance studies related to algorithmic analysis.
Yes
The device is used for surgical procedures like incision/excision, ablation, and coagulation, which are direct treatments of medical conditions.
No
Explanation: The device is described as "Laser Surgery Accessories" used for incision, excision, ablation, and coagulation, which are surgical procedures, not diagnostic ones.
No
The device is described as "Laser Surgery Accessories" and is intended to be "attached to cleared laser systems". This strongly suggests a hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as "Laser Surgery Accessories" used for surgical procedures (incision/excision, ablation, and coagulation) when attached to laser systems. This is a description of a surgical tool used on the body, not a device used to test samples from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The OptiLITE IX Laser Surgery Accessories are clearly described as surgical instruments used during procedures.
N/A
Intended Use / Indications for Use
The OptiLITE IX Laser Surgery Accessories are indicated for incision/excision, ablation, and coagulation (homeostasis) when attached to cleared laser systems such as KTP, Nd: YAG, Argon, Diode, Ho:YAG, and Er:YAG wavelengths for the indications for which the lasers have becn cleared.
Product codes
GEX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 8 1999
Marilyn Chou. Ph.D. Executive Vice President Convergent Laser Technologies 900 Alice Street Oakland, California 94607
Re: K992866
Trade Name: OptiLITE IX Laser Surgery Accessories Regulatory Class: II Product Code: GEX Dated: August 24, 1999 Received: August 25, 1999
Dear Dr. Chou:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Marilyn M. Chou. Ph.D.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Russell L. Raynor
James E. Dillard III Sur Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number : K 992866
Devicc Name: OptiLITE IX Laser Surgery Accessories
Indications For Use:
The OptiLITE IX Laser Surgery Accessories are indicated for incision/excision, ablation, and coagulation (homeostasis) when attached to cleared laser systems such as KTP, Nd: YAG, Argon, Diode, Ho:YAG, and Er:YAG wavelengths for the indications for which the lasers have becn cleared.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Remell/Roza 80520
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K992866
| Prescription Use | X |
|---|---|
| ------------------ | ----------------- |
OR
Over-The-Counter Use _
i
(21 CFR 801.109)