(57 days)
For use in removing smoke from laser and/or electrosurgical procedures.
Edge Systems Sterile Tubing (Accessory Device Name:
This document is a 510(k) clearance letter from the FDA to Edge Systems Corporation for their "Edge Systems Sterile Tubing" device. It does not contain any information regarding acceptance criteria, device performance studies, or clinical trial data.
Therefore, I cannot fulfill your request for the detailed information outlined (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, or training set size/ground truth establishment).
The document merely states that the device is substantially equivalent to legally marketed predicate devices for its intended use: "For use in removing smoke from laser and/or electrosurgical procedures." This clearance is based on the device meeting general controls provisions and compliance with Good Manufacturing Practice for Medical Devices.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with three curved lines above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 4 1999
Edge Systems Corporation C/O Mr. Gary Mocnik Gary S. Mocnik and Associates 30001 Golden Lantern #334 Laquna Niquel, California 92677
K990748 Re : Edge Systems Sterile Tubing Trade Name: Regulatory Class: II Product Code: GEX Dated: February 23, 1999 March 8, 1999 Received:
Dear Mr. Mocnik:
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 The general controls provisions of the Act 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. ਸੈ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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. Mocnik
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 ene regaracion Chercross, "Missananany as a worker 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,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K990748 510(k) Number (if known):
Edge Systems Sterile Tubing (Acressory Device Name:
Indication For Use: For use in removing smoke from laser and/or electrosurgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| (Division Sign-Off) |
| Division of Dental, Infection Control, and General Hospital Devices |
| 510(k) Number | K990748 |
|---|---|
| --------------- | --------- |
| Prescription UsePer 21 CFR 801.109 | OR | Over-The-Counter Use X |
|---|---|---|
| ---------------------------------------- | ---- | ------------------------ |
§ 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.