(177 days)
No
The device description and intended use describe a purely mechanical clip applier with no mention of AI or ML capabilities.
Yes
The device is used to achieve hemostasis, which is treating a medical condition (bleeding).
No
The device is described as an applier for titanium clips to achieve hemostasis and for radiographic markings, which are therapeutic and interventional functions, not diagnostic.
No
The device description clearly outlines a physical medical device with mechanical components (trigger handle, shaft, jaws, titanium clips) and does not mention any software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The Auto Suture™ ENDO CLIP™ III 5mm Clip Applier is a surgical instrument used inside the body during endoscopic procedures. Its function is to apply clips to vessels and other structures for hemostasis and marking.
- Intended Use: The intended use clearly describes a surgical application within the body, not the analysis of specimens outside the body.
Therefore, based on the provided information, the device is a surgical instrument, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Auto Suture™ ENDO CLIP™ III 5mm Clip Applier has applications in many types of endoscopic procedures to achieve hemostasis following transection of vessels and other tubular structures, and for radiographic markings.
Product codes
FZP
Device Description
The Auto Suture™ ENDO CLIP™ III 5mm Clip Applier contains 16 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
vessels and other tubular structures
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)
In-vitro and in-vivo tests were performed to verify that the ENDO CLIP™ III 5mm Clip Applier was substantially equivalent to the predicate device in occluding vessels and other tubular structures and to validate that the ENDO CLIP™ Ⅲ 5mm Clip Applier performed as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Auto Suture™ ENDO CLIP™ Disposable Clip Applier (K883018)
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) 845-1000 |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Frank Gianelli
Senior Associate, Regulatory Affairs
NOV - 2 2006 |
| DATE PREPARED: | October 2, 2006 |
| TRADE/PROPRIETARY NAME: | Auto Suture™ ENDO CLIP™ III 5mm Clip Applier |
| COMMON/USUAL NAME: | Implantable Clip |
| CLASSIFICATION NAME: | Implantable Clip |
| PREDICATE DEVICE(S): | Auto Suture™ ENDO CLIP™ Disposable Clip Applier (K883018) |
| DEVICE DESCRIPTION: | The Auto Suture™ ENDO CLIP™ III 5mm Clip Applier
contains 16 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 has
applications in many types of endoscopic procedures to
achieve hemostasis following transection of vessels and other
tubular structures, and for radiographic markings. |
| TECHNOLOGICAL
CHARACTERISTICS: | The Auto Suture™ ENDO CLIP™ III 5mm Clip Applier is
identical to the predicate device in terms of intended use and it
operates in a similar manner as the predicate device. |
| MATERIALS: | All components of the Auto Suture™ 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 tests were performed to verify that the
ENDO CLIP™ III 5mm Clip Applier was substantially
equivalent to the predicate device in occluding vessels and
other tubular structures and to validate that the ENDO CLIP™
Ⅲ 5mm Clip Applier performed as intended. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form. The symbol is composed of three curved lines that converge at the bottom.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
United States Surgical % Mr. Frank Gianelli Senior Associate, Regulatory Affairs 195 McDermott Road North Haven, Connecticut 06473
NOV - 2 2006
Re: K061288
Trade/Device Name: Auto Suture™ ENDO CLIP™ III 5mm Clip Applier Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: FZP Dated: October 3, 2006 Received: October 4, 2006
Dear Mr. Gianelli:
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 - Mr. Frank Gianelli
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.
Sincercly vours,
For Mark N. Mellon
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):
Device Name: Auto Suture™ ENDO CLIP™ III 5mm Clip Applier
Indications For Use:
The Auto Suture™ ENDO CLIP™ III 5mm Clip Applier has applications in many types of endoscopic procedures to achieve hemostasis following transection of vessels and other tubular structures, and for radiographic markings.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-On)
Division of General, Restorative, and Neurological Devices
510(k) Number K061264