(42 days)
The Auto Suture™ ENDO GIA™ Staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomoses. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.
The Auto Suture™ ENDO GIA™ Stapler places two, triple- staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the 2.0 mm, 2.5 mm 3.5 mm or 4.8 mm single-use loading unit (SULU). The ENDO GIA™ Stapler will accommodate any of the single-use loading units that are available in 30 mm, 45 mm and 60 mm sizes.
The provided text describes a 510(k) submission for the Auto Suture™ ENDO GIA™ Stapler. This is a surgical stapling device, not an AI or imaging device, so many of the requested categories related to AI performance, imaging, and ground truth establishment are not applicable.
Here's an analysis based on the information provided for this specific medical device:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state quantitative "acceptance criteria" in the format typically seen for AI/software devices (e.g., minimum sensitivity, specificity). Instead, for this surgical stapler, the acceptance criteria are implicitly met by demonstrating substantial equivalence to a predicate device and supporting the expanded indication through performance data.
The "performance data" section indicates:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device is substantially equivalent to a predicate device. | Device is identical to the predicate device (Auto Suture™ ENDO GIA™ Stapler). |
| Materials are biocompatible. | All components are comprised of materials in accordance with ISO Standard 10993-1. |
| Supported new indication for use on liver tissue. | In-vivo animal tests performed to support inclusion of the specific liver indication. |
| Clinical application for liver resection and transection supported. | Clinical literature search performed to demonstrate and support the clinical application. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a numerical sample size in the document. The performance data section vaguely mentions "in-vivo animal tests" and a "clinical literature search."
- Data Provenance:
- In-vivo animal tests: The country of origin is not specified, nor is whether this data was retrospective or prospective. It is implied to be prospective testing for the K061095 submission.
- Clinical literature search: This would involve existing published data, likely from various countries and methodologies (retrospective/prospective, depending on the individual studies included). The specifics are not detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This category is not applicable for this type of medical device submission. The "ground truth" for a surgical stapler's performance is typically established through observable clinical outcomes, tissue integrity, and successful procedural results, not through expert consensus on image interpretation. The submission discusses animal testing and literature review, which are forms of performance data, not expert-adjudicated ground truth as understood in AI/imaging studies.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where multiple human readers interpret data (e.g., images) to establish a consensus ground truth. For animal testing and clinical literature review, the "adjudication" is inherent in the study design and clinical assessments, rather than a separate expert-consensus process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
This is not applicable. MRMC studies are specific to evaluating imaging devices or AI algorithms that assist human readers in interpreting medical images. The Auto Suture™ ENDO GIA™ Stapler is a physical surgical tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. This question pertains to AI algorithms.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to the evidence used to validate the device's performance for the new indication. It includes:
- In-vivo animal test results: Direct observation and assessment of the stapler's performance in living tissue (likely related to staple line integrity, hemostasis, tissue healing, etc.).
- Clinical literature: Published evidence of the device's or similar devices' performance and safety when used in liver resection/transection. This could include pathology reports, surgical outcomes, patient follow-up data, etc., as documented in the literature.
8. The Sample Size for the Training Set
This is not applicable. "Training set" refers to data used to train an AI algorithm. For a physical medical device, there is no AI training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable.
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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) 845-1000MAY 31 2006 |
|---|---|
| CONTACT PERSON: | Frank GianelliSenior Associate, Regulatory Affairs |
| DATE PREPARED: | April 17, 2006 |
| TRADE/PROPRIETARY NAME: | Auto Suture™ ENDO GIA™ Stapler |
| COMMON/USUAL NAME: | Staple, Implantable |
| CLASSIFICATION NAME: | Staple, Implantable |
| PREDICATE DEVICE(S): | Auto Suture™ ENDO GIA™ Stapler |
| DEVICE DESCRIPTION: | The Auto Suture™ ENDO GIA™ Stapler places two, triple-staggered rows of titanium staples and simultaneously dividesthe tissue between the two, triple-staggered rows. The size ofthe staples is determined by the selection of the 2.0 mm, 2.5mm, 3.5 mm or 4.8 mm single-use loading unit (SULU). TheENDO GIA™ Stapler will accommodate any of the single-useloading units that are available in 30 mm, 45 mm and 60 mmsizes. |
| INTENDED USE: | The Auto Suture™ ENDO GIA™ Staplers have applications inabdominal, gynecologic, pediatric and thoracic surgery forresection, transection, and creation of anastomoses. It may beused for transection and resection of liver substance, hepaticvasculature and biliary structures. |
| TECHNOLOGICALCHARACTERISTICS: | The Auto Suture™ ENDO GIA™ Stapler is identical to thepredicate device. The only change is the inclusion of a specificindication concerning the device's use on liver tissue as asubset of the general indication for the Auto Suture™ ENDOGIA™ Stapler. |
| MATERIALS: | All components of the Auto Suture™ ENDO GIA™ Stapler arecomprised of materials which are in accordance with ISOStandard 10993-1. |
| PERFORMANCE DATA: | In-vivo animal tests were performed to support the inclusion ofa specific indication as a subset of the general indication forthe Auto Suture™ ENDO GIA™ Stapler. A clinical literaturesearch was also performed to demonstrate and support theclinical application of the device for the resection andtransection of liver. |
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 3 1 2006
United States Surgical % Mr. Frank Gianelli Senior Associate, Regulatory Affairs 150 Glover Avenue Norwalk, Connecticut 06856
Re: K061095
Trade/Device Name: Auto Suture™ ENDO GIA™ Stapler Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW & GAG Dated: April 17, 2006 Received: April 19, 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
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Page 2 - Mr. Frank Gianelli
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. This letter will allow you to begin marketing your device as described in your Section 510(k) remarket 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
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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Auto Suture™ ENDO GIA™ Surgical Stapler
Indications For Use
510(k) Number (if known): _K061095
Device Name: Auto Suture™ ENDO GIA™ Stapler
Indications For Use:
The Auto Suture™ ENDO GIA™ Staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomoses. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.
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)
| (Division Sign-Off) |
|---|
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K061095 |
|---|---|
| --------------- | --------- |
Page 20 TMTrademark
§ 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.