(80 days)
The Synergetics Inc., Mode Scrambled LindoOto Laser Probe provides a means of delivering photocoagulation during otologic surgery. Indications include, but are not limited to treatment of stapes related disorders to be treated with stapedectorny by means of photocoagulation. This device transmits laser energy to target tissuc, thereby causing photocoagulation. Spot size can be varied by altering the distance between the tissuc and the probe tip.
Mode Scrambled EndoOto Laser Probe
The provided document is a 510(k) clearance letter from the FDA for a medical device (Mode Scrambled EndoOto Laser Probe) from 1999. It states that the device is substantially equivalent to legally marketed predicate devices.
However, the document does not contain any information regarding specific acceptance criteria for device performance, nor does it describe a study proving the device meets such criteria.
The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive new performance studies with pre-defined acceptance criteria and statistical analyses as might be seen for novel devices or in the de novo pathway today.
Therefore, I cannot provide the requested information based on the given text.
To be explicit about the missing information:
- Table of acceptance criteria and reported device performance: Not present.
- Sample size used for the test set and data provenance: Not present. The document refers to "indications for use stated in the enclosure" and implicitly relies on the safety and effectiveness of the predicate device.
- Number of experts used to establish ground truth and qualifications: Not present.
- Adjudication method for the test set: Not present.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: Not present. This type of study is more common for diagnostic imaging devices and AI/ML-enabled devices, which is not the case for this laser probe.
- Standalone performance study (algorithm only): Not applicable as this is a physical medical device, not an algorithm.
- Type of ground truth used: Not present.
- Sample size for the training set: Not applicable and not present.
- How ground truth for the training set was established: Not applicable and not present.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 4 1999
Mr. Kurt Gampp Vice President Synergetics, Inc. 88 Hubble Drive St. Charles, Missouri 63304-8694
K990568 Re: Trade Name: Mode Scrambled EndoOto Laser Probe Regulatory Class: II Product Code: GEX Dated: February 19, 1999 Received: February 23, 1999
Dear Mr. Gampp:
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 - Mr. Kurt Gampp
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,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section XII - Indications for Use Statement
Intended Use: A.
The Synergetics Inc., Mode Scrambled LindoOto Laser Probe provides a means of delivering photocoagulation during otologic surgery. Indications include, but are not limited to treatment of stapes related disorders to be treated with stapedectorny by means of photocoagulation. This device transmits laser energy to target tissuc, thereby causing photocoagulation. Spot size can be varied by altering the distance between the tissuc and the probe tip.
Prescription Use
(Per 21 CFR 801.109) X
Oeeeto
(Division Sign-Off)
Division of General Restorative Devices K990568
510(k) Number
§ 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.