(184 days)
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.
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.
The provided text describes a 510(k) summary for the Autosuture™ ENDO CLIP™ III 5mm Clip Applier. However, it does not contain the specific details required to answer all aspects of your request, particularly regarding acceptance criteria, device performance, sample sizes, and expert qualifications for ground truth establishment in a study context. This document focuses on demonstrating substantial equivalence to a predicate device for an updated indication.
Here's the information that can be extracted and a note on what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "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."
Without access to the full test reports, specific acceptance criteria and detailed performance metrics are not provided in this summary. The summary only indicates that tests were performed to support the new indication.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided text. | Not specified in the provided text. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "in-vitro and in-vivo animal tests."
- Sample Size: Not specified for either in-vitro or in-vivo tests.
- Data Provenance: "in-vivo animal tests" imply animal data. The country of origin is not specified, but the submission is from the United States Surgical, a division of Tyco Healthcare Group LP in Norwalk, CT, USA. The study type (retrospective or prospective) is not explicitly stated, but typically these types of tests for 510(k) submissions would be prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This device is a surgical clip applier, not an AI/diagnostic device that typically relies on expert-established ground truth for its performance evaluation in the way a diagnostic algorithm would. The performance is assessed through mechanical and biological (animal) testing.
4. Adjudication Method
Not applicable for a device performance study of this nature. Adjudication is typically used for expert consensus in diagnostic ground truth establishment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for AI image analysis or diagnostic tools involving human readers. This document describes a physical medical device (clip applier) and its performance in a surgical context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
For the in-vivo animal tests, the "ground truth" would be the observed biological outcomes in the animals related to the new indications (e.g., successful occlusion of blood vessels, lack of adverse events related to tissue manipulation/dissection). For in-vitro tests, the ground truth would be established by direct measurement of device characteristics (e.g., clip closing force, material integrity).
8. The Sample Size for the Training Set
Not applicable. This involves performance testing of a physical device, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is involved.
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510(k) Summary of Safety and Effectiveness
| SUBMITTER: | United States Surgical, a division of Tyco Healthcare Group LP150 Glover AvenueNorwalk, CT 06856Tel. No.: (203) 492-5000Fax No.: (203) 492-5029 |
|---|---|
| CONTACT PERSON: | NOV 2 1 2007Jennifer BrennanManager, 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 contains18 titanium clips. The applier is designed for introduction anduse through an appropriately sized Trocar sleeve, or largerwith the use of a converter. The ENDO CLIP™ III 5mm ClipApplier consists of a trigger handle, shaft rotation knob, clipcounter window and a 33 cm shaft with jaws at its distal end.Squeezing the handle places a titanium clip in the jaws andcloses the jaws to close the clip on the vessel or structure. |
| INTENDED USE: | The Auto Suture™ Endo Clip III™ 5mm Clip Applier isprimarily indicated for patients undergoing laparoscopicsurgical procedures involving dissection and occlusion of bloodvessels, ducts and other tubular structures, and forradiographic markings. |
| TECHNOLOGICALCHARACTERISTICS: | The Autosuture™ ENDO CLIP™ III 5mm Clip Applier isidentical to the predicate device. The only change is theinclusion of "manipulation of tissue and the dissection of bloodvessels and other tubular structures" to the general indicationsfor the Autosuture™ ENDO CLIP™ III 5mm Clip Applier. |
| MATERIALS: | All components of the Autosuture™ ENDO CLIP™ III 5mmClip Applier are comprised of materials which are inaccordance with ISO Standard 10993-1. |
| PERFORMANCE DATA: | In-vitro and in-vivo animal tests were performed to support theinclusion of "manipulation of tissue and the dissection of bloodvessels and other tubular structures" to the general indicationsfor the Autosuture™ ENDO CLIP™ III 5mm Clip Applier. |
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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 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.
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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
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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)
§ 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.