(510 days)
The Laparo-Tenser is intended for use as a laparoscopic retractor in gasless laparoscopic procedures. the Laparo-Tenser creates a gasless cavity to permit direct viewing of the organs within the peritoneal cavity for the purpose of performing diagnostic and surgical procedures.
Laparo-Tenser Laparoscopic Abdominal Retractor
This document is a 510(k) clearance letter from the FDA for a medical device called the "Laparo-Tenser Laparoscopic Abdominal Retractor." It is a regulatory approval document, not a study report or clinical trial summary.
Therefore, the input document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria. The document only confirms that the device is substantially equivalent to a predicate device already on the market, allowing it to be marketed.
Specifically, it lacks:
- A table of acceptance criteria and reported device performance.
- Details about a study, sample sizes, data provenance, expert qualifications, or adjudication methods.
- Information on MRMC comparative effectiveness studies or standalone algorithm performance.
- Details about ground truth establishment or training set sample sizes.
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Rockville MD 20850
Food and Drug Administration 9200 Corporate Boulevard
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JUL 21
L & T S.N.C. DI E. LUCINI & C. c/o Mr. Terry O'Brien Project Marketing 112 Caviston Way Cary, NC 27560
Re: K970712
Laparo-Tenser Laparoscopic Abdominal Retractor Dated: Mav 6, 1998 Received: May 8, 1998 Regulatory Class: II 21 CFR 884.1720/Procode: 85 HET
Dear Mr. O'Brien:
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 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 requirements, as set forth in the Quality System Regulation (OS) 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 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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) 594-4613. 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/dsmaldsmamain.html".
Sincerely yours
Lillian Yin, Ph.D.
Director, Division of Reproducti ve Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | K970712and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the commenwas and the company of the comments of the comments of the consisted to the control of the control of |
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Laparo-Tenser ice Name:
Indications For Use:
The Laparo-Tenser is intended for use as a laparoscopic retractor in gasless laparoscopic procedures. the Laparo-Tenser creates a gasless cavity to permit direct viewing of the organs within the peritoneal cavity for the purpose of performing diagnostic and surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert R. Satting/
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 1970712 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use__
(Optional Format 1-2-96)
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. 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 § 884.9.