(177 days)
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.
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.
The provided document is a 510(k) summary for the "Auto Suture™ ENDO CLIP™ III 5mm Clip Applier," a surgical device. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and an AI study. Therefore, most of the requested information regarding AI device performance, sample sizes for training/test sets, expert adjudication, MRMC studies, and ground truth establishment cannot be found in this document.
However, I can extract the relevant information that is available:
Table of Acceptance Criteria and Reported Device Performance:
The document states: "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."
This implies the acceptance criterion was "substantial equivalence," meaning the new device performed comparably to the predicate device in its intended function (occluding vessels/tubular structures). Specific quantitative performance metrics or thresholds are not provided in this summary.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device | Verified through in-vitro and in-vivo tests in occluding vessels and other tubular structures, and performed as intended. |
| Occlusion of vessels and tubular structures | Verified through in-vitro and in-vivo tests. |
| Performance as intended | Validated through in-vitro and in-vivo tests. |
Here's a breakdown of the other requested information based on the provided text, indicating where information is not available (N/A) for this type of device submission:
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A table of acceptance criteria and the reported device performance
- See table above. The acceptance criteria are implicitly tied to demonstrating "substantial equivalence" and "performing as intended" in occluding vessels and tubular structures. Specific quantitative performance figures are not provided in this summary.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. The document mentions "In-vitro and in-vivo tests" were performed but does not specify sample sizes, country of origin, or whether the tests were retrospective or prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A. This is a surgical clip applier, not an AI-driven diagnostic device. The concept of "ground truth" established by experts in the context of an AI study does not apply here. Performance would be assessed by engineers/scientists conducting the tests and potentially surgeons using the device.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication methods are relevant for ambiguous cases in diagnostic studies, particularly with AI. This does not apply to the performance testing of a mechanical surgical device.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- N/A. An MRMC study is specific to evaluating diagnostic AI systems and how they impact human reader performance. This device is a surgical instrument, not an AI solution.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a hardware device, not an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- N/A. For a mechanical device like this, "ground truth" would be established by direct observation of successful vessel occlusion and proper clip deployment in controlled in-vitro and in-vivo settings. It's not a diagnostic outcome requiring expert consensus, pathology, or long-term outcomes data in the way an AI diagnostic device would.
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The sample size for the training set
- N/A. This is not an AI device, so there is no training set.
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How the ground truth for the training set was established
- N/A. This is not an AI device, so there is no training set or ground truth in that context.
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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) 845-1000 |
|---|---|
| CONTACT PERSON: | Frank GianelliSenior Associate, Regulatory AffairsNOV - 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 Appliercontains 16 titanium clips. The applier is designed forintroduction and use through an appropriately sized trocarsleeve, or larger with the use of a converter. The ENDOCLIP™ III 5mm Clip Applier consists of a trigger handle, shaftrotation knob, clip counter window and a 33 cm shaft with jawsat its distal end. Squeezing the handle places a titanium clip inthe jaws and closes the jaws to close the clip on the vessel orstructure. |
| INTENDED USE: | The Auto Suture™ ENDO CLIP™ III 5mm Clip Applier hasapplications in many types of endoscopic procedures toachieve hemostasis following transection of vessels and othertubular structures, and for radiographic markings. |
| TECHNOLOGICALCHARACTERISTICS: | The Auto Suture™ ENDO CLIP™ III 5mm Clip Applier isidentical to the predicate device in terms of intended use and itoperates in a similar manner as the predicate device. |
| MATERIALS: | All components of the Auto Suture™ ENDO CLIP™ III 5mmClip Applier are comprised of materials which are inaccordance with ISO Standard 10993-1. |
| PERFORMANCE DATA: | In-vitro and in-vivo tests were performed to verify that theENDO CLIP™ III 5mm Clip Applier was substantiallyequivalent to the predicate device in occluding vessels andother tubular structures and to validate that the ENDO CLIP™Ⅲ 5mm Clip Applier performed as intended. |
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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.
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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
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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
§ 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.