(224 days)
None
No
The description focuses on manual operation and mechanical components, with no mention of AI/ML terms or functionalities.
No
The device is described as a surgical instrument used to establish and maintain surgical access, not to treat a specific medical condition or disease.
No
Explanation: This device is described as a surgical instrument used to establish and maintain surgical access to body cavities and provide ports for instruments and insufflation. Its function is to facilitate surgical procedures, not to identify or characterize a disease or condition.
No
The device description clearly states it is a "manually operated surgical instrument" consisting of physical components like a "stainless steel mandrel" and a "sleeve," which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used to "establish and maintain surgical access to the abdominal or thoracic cavity, access for surgical and laparoscopic instruments, and may provide a port with stopcock for insufflation." This describes a surgical instrument used during a procedure on a patient's body.
- Device Description: The description details a "manually operated surgical instrument" consisting of a mandrel and sleeve for surgical access. This aligns with a surgical tool, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue, etc.) in vitro (in a lab setting). The purpose is direct surgical access.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely mechanical and procedural within the body.
N/A
Intended Use / Indications for Use
The trocars and accessories are intended to establish and maintain surgical access to the abdominal or thoracic cavity for surgical and laparoscopic instruments. The trocars may include an automatic valve feature and a port with stopcock for insufflation.
Product codes
HET
Device Description
Micro-France trocars are manually operated surgical instruments. They consist of a stainless steel mandrel used to establish surgical access to the abdominal or thoracic cavity, and a sleeve the maintain access for surgical and laparoscopic instruments. The trocars may include an automatic valve feature and a port with stopcock for insufflation. Trocar accessories include threaded and smooth sleeves, reduction sleeves, and parietal elevators.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal or thoracic 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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
JUN - 9 200
K993653
Page 1 of 2
510(k) Summary
1.0 Date Prepared
October 28, 1999
2.0 Submitter (Contact)
Martin D. Sargent Xomed Surgical Products Jacksonville, FL (904) 279-7586
3.0 Device Name
| Proprietary Name: | Micro-France trocars and accessories |
|---|---|
| Common Name(s): | Trocars and accessories |
| Classification Name(s): | Laparoscopic accessories |
5.0 Device Classification
Gynecologic laparoscope accessories: Procode HET Class II 21 CFR 884.1720
6.0 Device Description
Micro-France trocars are manually operated surgical instruments. They consist of a stainless steel mandrel used to establish surgical access to the abdominal or thoracic cavity, and a sleeve the maintain access for surgical and laparoscopic instruments. The trocars may include an automatic valve feature and a port with stopcock for insufflation. Trocar accessories include threaded and smooth sleeves, reduction sleeves, and parietal elevators.
7.0 Intended Use
The trocars and accessories are used to establish and maintain surgical access to the abdominal or thoracic cavity, access for surgical and laparoscopic instruments, and may provide a port with stopcock for insufflation.
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K993653
Page 2 of 2
8.0 Substantial Equivalence
The trocars and accessories are substantially equivalent to devices marketed by Richard Wolf (K960299), Pilling Weck (K964450), and Ethicon Endo-Surgery (K965045).
.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted as a staff with two snakes coiled around it and wings at the top.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 9 2000
Mr. Martin D. Sargent Sr. Regulatory Affairs Specialist Medtronic Xomed Surgical Products 6743 Southpoint Dr., N. Jacksonville, FL 32216-0980
Re: K993653 Micro-France Trocars and Accessories Dated: March 31, 2000 Received: April 6, 2000 Regulatory Class: II 21 CFR §884.1720/Procode: 85 HET
Dear Mr. Sargent:
We have reviewed your Section 510(k) notification of intent to market the device and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Aproval), 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 (QS) for Medical Devices: General requlation (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 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) 594-4591. 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" (21CFR 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.
Daniel G. Schultz, M.D.
Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
· Enclosure(s)
3
510(k) Number (if known): 1993653 Device Name: __ Trocars and Accessories Indications for Use:
The trocars and accessories are intended to establish and maintain surgical access to the abdominal or thoracic cavity for surgical and laparoscopic instruments. The trocars may include an automatic valve feature and a port with stopcock for insufflation.
(Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ (Per 21 CFR 801.109)
Or
Over-the-Counter Use __
(Optional Format 1-2-96)
Ginid li. Bergman
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
Radiological
510(k) Number K993653