(28 days)
The autosuture™ Circular EEA™ Staplers have application 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 autosuture™ Circular EEA™ family of staplers place a circular, double staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis. They are indicated for use in the creation of anastomoses in various surgical procedures in both open and laparoscopic surgeries.
This document is a 510(k) summary for a surgical stapler, not a study evaluating an AI-powered device. Therefore, most of the requested information regarding acceptance criteria, study design, and AI performance metrics is not present in the provided text.
The document focuses on demonstrating substantial equivalence of the new stapler to a predicate device, which is a regulatory pathway for medical devices that are similar to devices already on the market. It does not involve clinical studies or performance evaluations intended for AI devices.
However, I can extract the following relevant information:
1. Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative "acceptance criteria" in the way one would for an AI device's performance (e.g., a specific sensitivity or specificity threshold). Instead, it states that the device was deemed "substantially equivalent" to its predicate.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | In-vitro and in-vivo tests were performed to verify that the modified autosuture™ EEA™ stapler is substantially equivalent to the predicate device. |
| Compliance with ISO 10993-1 | All components are comprised of materials in accordance with ISO Standard 10993-1. |
2. Sample Size for Test Set and Data Provenance:
- Sample Size: Not specified. The document mentions "in-vitro and in-vivo tests," but does not provide details on the number of samples or subjects used in these tests.
- Data Provenance: Not specified. It's likely these tests were conducted internally or by a contracted lab, but the country of origin or whether they were retrospective/prospective is not mentioned.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. The "ground truth" for a surgical stapler involves mechanical and biological performance, not interpretive tasks requiring expert radiologists or similar specialists.
4. Adjudication Method for Test Set:
Not applicable. This concept is relevant for reconciling discrepancies among human readers or between human and AI interpretations, which is not the nature of this device's evaluation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This type of study is for evaluating the impact of AI on human reader performance, which doesn't apply to a surgical stapler.
6. Standalone Performance Study:
A standalone performance evaluation (in-vitro and in-vivo tests) was conducted for the device itself to verify substantial equivalence. However, this is not a standalone algorithm performance in the context of AI.
7. Type of Ground Truth Used:
The "ground truth" would have been established through a combination of:
- Engineering measurements (e.g., staple formation, anastomotic strength).
- Biological observations (e.g., tissue healing, leak rates) in animal models (for in-vivo tests).
8. Sample Size for Training Set:
Not applicable. This device is a mechanical surgical stapler, not an AI algorithm, so there is no training set in the AI sense.
9. How Ground Truth for Training Set Was Established:
Not applicable (as above).
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K062850 page 1/1
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
DATE PREPARED: September 21, 2006
TRADE/PROPRIETARY NAME: autosuture™ Circular EEA™ surgical staplers
COMMON/USUAL NAME: Implantable Staple
CLASSIFICATION NAME: Implantable Staple
PREDICATE DEVICE(S): autosuture™ Premium Plus CEEA™ Disposable Stapler (K024275)
DEVICE DESCRIPTION: The autosuture™ Circular EEA™ family of staplers place a circular, double staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis. They are indicated for use in the creation of anastomoses in various surgical procedures in both open and laparoscopic surgeries.
INTENDED USE: The autosuture™ Circular EEA™ Staplers have application 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.
TECHNOLOGICAL The autosuture™ EEA™ stapler is identical to the predicate CHARACTERISTICS: device in terms of intended use and it operates in a similar manner as the predicate device. The only difference is a modification of the wire gauge diameter of the titanium staple.
MATERIALS: All components of the autosuture™ EEA™ stapler 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 modified autosuture™ EEA™ stapler is substantially equivalent to the predicate device for use in the creation of anastomoses in various surgical procedures in both open and laparoscopic surgeries.
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, composed of three abstract human profiles facing right. The profiles are arranged in a stacked formation, creating a sense of depth and unity. Encircling the caduceus is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
United States Surgical a division of Tyco Healthcare Group, LP % Mr. Frank Gianelli Senior Associate, Regulatory Affairs 195 McDermott Road North Haven, Connecticut 06473
OCT 2 3 2006
Re: K062850
Trade/Device Name: autosuture™ EEA" Surgical Stapler Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW, GAG Dated: September 22, 2006 Received: September 26, 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.
Sincerely yours,
elkerson
Mark N. Melker 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): K0628SO
Device Name: autosuture™ EEA™ Surgical Stapler
Indications For Use:
The autosuture™ Circular EEA™ Staplers have application 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.
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
Division of General, Restorative. and Neurological Devices
510(k) Number L062850
United States Surgical Premarket Notification
Page 19 ™Trademark
§ 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.