(21 days)
Not Found
No
The device description and intended use describe a purely mechanical clip applier with no mention of software, data processing, or any AI/ML related terms.
No
The device is used for surgical procedures to occlude vessels and tubular structures, which is an intervention during surgery, not a therapeutic treatment itself for a condition.
No
Explanation: The device is a clip applier used during surgical procedures to occlude blood vessels, ducts, and other tubular structures. Its function is interventional (occlusion), not diagnostic (identifying or characterizing a medical condition).
No
The device description clearly outlines a physical, mechanical device (clip applier with handle, shaft, jaws, etc.) and does not mention any software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "patients undergoing laparoscopic surgical procedures involving dissection and occlusion of blood vessels, ducts and other tubular structures, and for radiographic marking." This describes a surgical tool used in vivo (within a living organism).
- Device Description: The description details a mechanical device for applying clips to structures within the body during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) in vitro (outside the body) to provide diagnostic information.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Auto Suture™ ENDO CLIP™ III 5mm Clip Applier is primarily indicated for patients undergoing laproscopic surgical procedures involving dissection and occlusion of blood vessels, ducts and other tubular structures, and for radiographic marking.
Product codes
FZP, GDO
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
blood vessels, ducts 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
In-vitro and in-vivo tests were performed to verify that the ENDO CLIP™ III 5mm Clip Applier was substantially equivalent to the predicate devices in occluding vessels and other tubular structures and to validate that the ENDO CLIP™ III 5mm Clip Applier performed as intended.
Key Metrics
Not Found
Predicate Device(s)
Auto Suture™ ENDO CLIP™ III 5mm Clip Applier (K071406, K061288), 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
Surgical Devices, a global business unit of Tyco Healthcare Group LP (d/b/a Covidien)
:
KI00242
| 510(k) Summary of Safety and Effectiveness | |
|---|---|
| SUBMITTER: | FEB 1 7 2010 |
| Surgical Devices, a global business unit | |
| of Tyco Healthcare Group LP (d/b/a Covidien) | |
| 60 Middletown Avenue | |
| North Haven, CT - 06473 | |
| Tel. No.: (203) 492-6339 | |
| CONTACT PERSON: | Nishith Desai |
| Associate Manager, Regulatory Affairs | |
| DATE PREPARED: | January 20, 2010 |
| 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™ III 5mm Clip Applier (K071406, |
| K061288) and 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 is |
| primarily indicated for patients undergoing laparoscopic | |
| surgical procedures involving dissection and occlusion of blood | |
| vessels, ducts and other tubular structures, and for | |
| radiographic marking. | |
| 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 patient contact 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 devices in occluding vessels and | |
| other tubular structures and to validate that the ENDO CLIP™ | |
| III 5mm Clip Applier performed as intended. |
Confidential
Special 510(k) for Auto Suture ENDO CLIP III 5mm
Page 21 of 62
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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 eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Surgical Devices, a division of Tyco Healthcare Group LP % Nishith Desai 60 Middletown Avenue North Haven, Connecticut 06473
FEB 1 7 2010
Re: K100242
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, GDO Dated: January 26, 2010 Received: January 27, 2010
Dear Nishith Desai:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
2
Page 2 - Nishith Desai
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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
boirlane Bruchn
Mark N. Melkerso Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications For Use
KI00242 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 is primarily indicated for patients undergoing laproscopic surgical procedures involving dissection and occlusion of blood vessels, ducts and other tubular structures, and for radiographic marking.
Prescription Use × (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)
David Kreeftmann
(Division Sign-Off (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100242
Confidential
Special 510(k) for Auto_Suture ENDO CLIP III 5mm
Page 19 of 62