(184 days)
No
The device description and intended use describe a purely mechanical clip applier. There is no mention of any computational or data-driven components, let alone AI/ML.
No
The device is described as a surgical tool used to apply clips for occlusion of vessels and structures during laparoscopic procedures, making it an operative instrument rather than a therapeutic device designed for treatment or healing.
No
The device is a clip applier used for occluding vessels and other tubular structures during laparoscopic surgery. Its function is to apply clips, not to diagnose a condition or disease.
No
The device description clearly outlines a physical medical device (clip applier) with mechanical components (trigger handle, shaft, jaws) and contains physical clips. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used during surgical procedures to physically manipulate and occlude structures within the body. This is an in vivo application, not an in vitro (outside the body) diagnostic test.
- Device Description: The description details a surgical instrument with a handle, shaft, jaws, and clips, designed for direct application to tissues and vessels. This is consistent with a surgical tool, not a diagnostic device that analyzes samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a condition based on laboratory analysis.
Therefore, the Auto Suture™ Endo Clip III™ 5mm Clip Applier is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Auto Suture™ Endo Clip III™ 5mm Clip Applier is primarily indicated for patients undergoing laparoscopic surgical procedures involving dissection and occlusion of blood vessels, ducts and other tubular structures, and for radiographic markings.
Product codes
FZP, GDO
Device Description
The Autosuture™ ENDO CLIP™ III 5mm Clip Applier contains 18 titanium clips. The applier is designed for introduction and use through an appropriately sized Trocar sleeve, or larger with the use of a converter. The ENDO CLIP™ III 5mm Clip Applier consists of a trigger handle, shaft rotation knob, clip counter window and a 33 cm shaft with jaws at its distal end. Squeezing the handle places a titanium clip in the jaws and closes the jaws to close the clip on the vessel or structure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
In-vitro and in-vivo animal tests were performed to support the inclusion of "manipulation of tissue and the dissection of blood vessels and other tubular structures" to the general indications for the Autosuture™ ENDO CLIP™ III 5mm Clip Applier.
Key Metrics
Not Found
Predicate Device(s)
Autosuture™ ENDO CLIP™ III 5mm Clip Applier (K061288)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
0
510(k) Summary of Safety and Effectiveness
| SUBMITTER: | United States Surgical, a division of Tyco Healthcare Group LP
150 Glover Avenue
Norwalk, CT 06856
Tel. No.: (203) 492-5000
Fax No.: (203) 492-5029 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | NOV 2 1 2007
Jennifer Brennan
Manager, Regulatory Affairs |
| DATE PREPARED: | February 21, 2007 |
| TRADE/PROPRIETARY NAME: | Autosuture™ ENDO CLIP™ III 5mm Clip Applier |
| COMMON/USUAL NAME: | Implantable Clip |
| CLASSIFICATION NAME: | Implantable Clip |
| PREDICATE DEVICE(S): | Autosuture™ ENDO CLIP™ III 5mm Clip Applier (K061288) |
| DEVICE DESCRIPTION: | The Autosuture™ ENDO CLIP™ III 5mm Clip Applier contains
18 titanium clips. The applier is designed for introduction and
use through an appropriately sized Trocar sleeve, or larger
with the use of a converter. The ENDO CLIP™ III 5mm Clip
Applier consists of a trigger handle, shaft rotation knob, clip
counter window and a 33 cm shaft with jaws at its distal end.
Squeezing the handle places a titanium clip in the jaws and
closes the jaws to close the clip on the vessel or structure. |
| INTENDED USE: | The Auto Suture™ Endo Clip III™ 5mm Clip Applier is
primarily indicated for patients undergoing laparoscopic
surgical procedures involving dissection and occlusion of blood
vessels, ducts and other tubular structures, and for
radiographic markings. |
| TECHNOLOGICAL
CHARACTERISTICS: | The Autosuture™ ENDO CLIP™ III 5mm Clip Applier is
identical to the predicate device. The only change is the
inclusion of "manipulation of tissue and the dissection of blood
vessels and other tubular structures" to the general indications
for the Autosuture™ ENDO CLIP™ III 5mm Clip Applier. |
| MATERIALS: | All components of the Autosuture™ ENDO CLIP™ III 5mm
Clip Applier are comprised of materials which are in
accordance with ISO Standard 10993-1. |
| PERFORMANCE DATA: | In-vitro and in-vivo animal tests were performed to support the
inclusion of "manipulation of tissue and the dissection of blood
vessels and other tubular structures" to the general indications
for the Autosuture™ ENDO CLIP™ III 5mm Clip Applier. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular pattern around the symbol. The text is in all caps and is in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
United States Surgical % Ms. Jennifer Brennan Manager, Regulatory Affairs 150 Glover Avenue
NOV 2 1 2007
Re: K071406
Norwalk, Connecticut 06856
Trade/Device Name: Autosuture™ ENDO CLIP™ III 5 mm Clip Applier Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: FZP, GDO Dated: October 24, 2007 Received: November 15, 2007
Dear Ms. Brennan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 -- Ms. Jennifer Brennan
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N Millman
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K071406
Device Name: Autosuture™ ENDO CLIP™ III 5 mm Clip Applier
Indications for Use:
The Auto Suture™ Endo Clip III™ 5mm Clip Applier is primarily indicated for patients undergoing laparoscopic surgical procedures involving dissection and occlusion of blood vessels, ducts and other tubular structures, and for radiographic markings.
Mark M. Milliman
(Division Sign-Cal (Division of General. Restorative, Divisiourological Devices
510(k) Number_
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)