(81 days)
The Auto Suture* Premium Plus CEEA* Disposable Stapler has applications throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries, including bariatric surgery.
The Auto Suture* PREMIUM PLUS CEEA* Disposable Stapler is a single patient use device which places a double staggered row of titanium staples. Immediately after staple formation, the instrument's knife blade resects the excess tissue, creating a circular anastomosis.
This 510(k) submission (K024275) for the Auto Suture* PREMIUM PLUS CEEA* Disposable Stapler focuses on the substantial equivalence of the device to a legally marketed predicate device. As such, it does not include the detailed performance study information typically found in submissions for novel devices or AI-powered systems.
Therefore, many of the requested categories regarding acceptance criteria, study design, and ground truth are not applicable to this specific submission. This document primarily confirms the device's intended use, materials, and substantial equivalence to existing implantable staples.
Here's the breakdown of what can be gleaned from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantifiable criteria in this summary. | The device is deemed "substantially equivalent" to legally marketed predicate devices, implying it meets similar performance standards as those devices. The intended use includes creating end-to-end, end-to-side, and side-to-side anastomoses in open and laparoscopic surgeries, including bariatric surgery, throughout the alimentary tract. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable. This summary does not describe a performance study with a test set. The substantial equivalence determination is based on a comparison to predicate devices, not on a new clinical or performance study that would involve a test set.
3. 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)
- Not applicable. There is no mention of a test set requiring expert-established ground truth in this submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No test set is described.
5. 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
- Not applicable. This device is a surgical stapler, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to human readers and AI assistance is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a manual surgical tool, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.)
- Not applicable. As this is a substantial equivalence determination for a medical device (surgical stapler), the "ground truth" concept in the context of diagnostic or AI performance studies isn't directly relevant. The assessment revolves around whether the device performs as safely and effectively as its predicates based on its design, materials, and intended use.
8. The sample size for the training set
- Not applicable. There is no "training set" as this device is not an AI algorithm.
9. How the ground truth for the training set was established
- Not applicable. No training set is involved.
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KΨ24275
IX. 510(k) Summary of Safety and Effectiveness
| SUBMITTER: | United States Surgical150 Glover AvenueNorwalk, CT 06856MAR 1 4 2003 |
|---|---|
| CONTACT PERSON: | Sarah Hubeny |
| DATE PREPARED: | December 20, 2002 |
| CLASSIFICATION NAME: | Staple, Implantable |
| COMMON NAME: | Staple, Implantable |
| PROPRIETARY NAME: | Auto Suture* PREMIUM PLUS CEEA*Disposable Stapler |
| DEVICE DESCRIPTION: | The Auto Suture* PREMIUM PLUS CEEA* DisposableStapler is a single patient use device which places a doublestaggered row of titanium staples. Immediately after stapleformation, the instrument's knife blade resects the excesstissue, creating a circular anastomosis. |
| INTENDED USE: | The Auto Suture* Auto Suture* Premium Plus CEEA*Disposable Stapler has applications throughout thealimentary tract for the creation of end-to-end, end-to-sideand side-to-side anastomoses in both open and laparoscopicsurgeries, including bariatric surgery. |
| MATERIALS: | All component materials of the Auto Suture* Premium PlusCEEA* Disposable Stapler are comprised of materialswhich are in accordance with ISO Standard #10993-1. |
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Image /page/1/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
MAR 1 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sarah Hubeny Regulatory Affairs Associate United States Surgical, a division of Tyco Healthcare Group, LP 150 Glover Avenue Norwalk, Connecticut 06856
Re: K024275
Trade/Device Name: Auto SuturePremium Plus CEEA Disposable Stapler Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: December 20, 2002 Received: December 23, 2002
Dear Ms. Hubeny:
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. Iisting 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 (OS) 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. Sarah Hubeny
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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
W Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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IV. Indications For Use: 424275 510(k) Number (if known):
Name: Auto Suture* PREMIUM PLUS CEEA* Disposable Stapler
Indications For Use:
The Auto Suture* Premium Plus CEEA* Disposable Stapler has applications throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries, including bariatric surgery.
(Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Evaluation (ODE) OR Over-The-Counter Use: Prescription Use: (Per 21 CFR §801.109)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K024275
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.