(510 days)
Not Found
Not Found
No
The summary describes a mechanical retractor and explicitly states that AI, DNN, or ML were not found in the description.
No
The Laparo-Tenser is a retractor, a surgical tool used to hold tissue or organs, and does not provide therapy or treatment.
No
The device is described as a laparoscopic retractor used to create a gasless cavity for direct viewing of organs during diagnostic and surgical procedures. Its function is to facilitate viewing, not to perform a diagnosis itself.
No
The device description clearly identifies the Laparo-Tenser as a "Laparoscopic Abdominal Retractor," which is a physical medical device used in surgery, not a software-only application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as a "laparoscopic retractor in gasless laparoscopic procedures" to "create a gasless cavity to permit direct viewing of the organs within the peritoneal cavity for the purpose of performing diagnostic and surgical procedures." This describes a surgical tool used in vivo (within the body) to facilitate a procedure.
- IVD Definition: In Vitro Diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are performed in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic testing performed on samples, or any of the typical components or functions of an IVD.
Therefore, the Laparo-Tenser is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
85 HET
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
Not Found
Anatomical Site
peritoneal cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Rockville MD 20850
Food and Drug Administration 9200 Corporate Boulevard
Image /page/0/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the first profile being the largest and the third profile being the smallest.
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
1
Page 2 of 2_
| 510(k) Number (if known): | K970712
and 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 commen
was and the company of the comments of the comments of the consisted to the control of the control of |
| --------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
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)