(35 days)
The Autosuture™ ENDO GIA™ Staplers with ENDO GIA™ Single Use Loading Units with Staple Line Reinforcement have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and billary structures.
The Autosuture™ ENDO GIA™ Staplers with ENDO GIA™ Single Use Loading Units with Staple Line Reinforcement place 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 3.5 mm or 4.8 mm Single Use Loading Unit (SULU). The ENDO GIA™ UNIVERSAL Single Use Loading Units (SULUs) with Staple Line Reinforcement are only available in the straight and articulating 45 mm and 60 mm length cartridges with the 3.5 mm or 4.8 mm staples. The staple line reinforcement material is a synthetic absorbable film prepared from synthetic polyester composed of glycolide, dioxanone, and trimethylene carbonate. The staple line reinforcement material is supplied on each SULU undyed (natural) and is secured to the anvil and cartridge with BIOSYN™ synthetic absorbable suture. Studies indicate that the staple line reinforcement material can be expected to retain measurable mechanical strength through 14 days and absorption should be complete between 90 and 110 days.
The provided text describes a 510(k) summary for the Autosuture™ ENDO GIA™ Surgical Staplers with ENDO GIA™ Single Use Loading Units with Staple Line Reinforcement. However, it does not include information about specific acceptance criteria or an explicit study that proves the device meets those criteria in the context of a typical AI/software device evaluation.
The document mainly focuses on the device description, intended use, technological characteristics, and material safety. It states: "Performance evaluations were completed to verify that the Autosuture™ ENDO GIA™ Staplers with ENDO GIA™ Single Use Loading Units with Staple Line Reinforcement are safe and effective and perform as intended." This is a general statement and does not provide the detailed information requested regarding specific acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement, which are typical for studies assessing AI device performance.
Therefore, I cannot provide the requested information from the given text. The text does not contain:
- A table of acceptance criteria and reported device performance: No specific performance metrics or acceptance thresholds are listed.
- Sample size used for the test set and data provenance: No information on the number of cases or the origin of data used for performance evaluation.
- Number of experts used to establish ground truth and their qualifications: No mention of expert involvement in establishing ground truth.
- Adjudication method for the test set: Not applicable as no ground truth creation process is described.
- MRMC comparative effectiveness study: The document does not describe a study involving human readers with or without AI assistance.
- Standalone (algorithm only) performance: This device is a surgical stapler, not an AI algorithm, so standalone algorithm performance is not applicable in the usual sense. Its performance is inherent to its mechanical function and material properties.
- Type of ground truth used: Not applicable as it's a physical device and not an AI interpreting data. The "ground truth" for a physical device would relate to its mechanical integrity and biological interaction, which is assessed through various engineering and biocompatibility tests.
- Sample size for the training set: Not applicable as this is a physical device, not an AI system that requires a training set.
- How the ground truth for the training set was established: Not applicable for the same reason.
The "performance evaluations" mentioned in the document likely refer to laboratory testing, mechanical robustness tests, biocompatibility assessments, and potentially animal studies, which are standard for surgical devices, rather than clinical studies involving human readers or AI algorithms that would generate the kind of data you're asking for.
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Autosuture™ ENDO GIA™ Surgical Staplers with ENDO GIA™ Single Use Loading Units with Staple Line Reinforcement
510(k) Summary of Safety and Effectiveness
| SUBMITTER: | Surgical Devices, a global business unitof Tyco Healthcare Group LP (d/b/a Covidien)60 Middletown AvenueNorth Haven, CT 06473Tel. No.: (203) 492-6060 | MAY - 5 2008 |
|---|---|---|
| CONTACT PERSON: | Sharon AlexanderSenior Associate, Regulatory Affairs | |
| DATE PREPARED: | March 28, 2008 | |
| TRADE/PROPRIETARY NAME: | Autosuture™ ENDO GIA™ Staplers with ENDO GIA™ SingleUse Loading Units with Staple Line Reinforcement | |
| COMMON/USUAL NAME: | Surgical Stapler with Implantable Staple | |
| CLASSIFICATION NAME: | Staple, Implantable | |
| PREDICATE DEVICE(S): | Autosuture™ ENDO GIA™ Stapler (K061095)Monofilament BIOSYN™ Suture (K000037)Gore SEAMGUARD® Bioabsorbable Staple LineReinforcement (K043056)Synovis Peri-Strips® Staple Line Reinforcement (K040119) | |
| DEVICE DESCRIPTION: | The Autosuture™ ENDO GIA™ Staplers with ENDO GIA™Single Use Loading Units with Staple Line Reinforcementplace two, triple-staggered rows of titanium staples andsimultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by theselection of the 3.5 mm or 4.8 mm Single Use Loading Unit(SULU). The ENDO GIA™ UNIVERSAL Single Use LoadingUnits (SULUs) with Staple Line Reinforcement are onlyavailable in the straight and articulating 45 mm and 60 mmlength cartridges with the 3.5 mm or 4.8 mm staples. | |
| The staple line reinforcement material is a syntheticabsorbable film prepared from synthetic polyester composedof glycolide, dioxanone, and trimethylene carbonate. Thestaple line reinforcement material is supplied on each SULUundyed (natural) and is secured to the anvil and cartridge withBIOSYN™ synthetic absorbable suture. | ||
| Studies indicate that the staple line reinforcement material canbe expected to retain measurable mechanical strength through14 days and absorption should be complete between 90 and110 days. | ||
| INTENDED USE: | The Autosuture™ ENDO GIA™ Staplers with ENDO GIA™Single Use Loading Units with Staple Line Reinforcement haveapplications in abdominal, gynecologic, pediatric and thoracicsurgery for resection, transection, and creationofanastomoses. They may be used for transection and resectionof liver substance, hepatic vasculature and biliary structures. |
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Autosuture™ ENDO GIA™ Surgical Staplers with ENDO GIA™ Single Use Loading Units with Staple Line Reinforcement
- TECHNOLOGICAL CHARACTERISTICS: The Autosuture™ ENDO GIA™ Staplers with ENDO GIA™ Single Use Loading Units with Staple Line Reinforcement are substantially equivalent to the predicate devices with regard to the stapling and staple line reinforcement technologies. MATERIALS: All components of the Autosuture™ ENDO GIA™ Staplers with ENDO GIA™ Single Use Loading Units with Staple Line Reinforcement are comprised of materials which are in accordance with ISO Standard 10993-1. PERFORMANCE DATA: Performance evaluations were completed to verify that the Autosuture™ ENDO GIA™ Staplers with ENDO GIA™ Single Use Loading Units with Staple Line Reinforcement are safe
and effective and perform as intended.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY -5 2008
Tyco Healthcare Group, LP % Ms. Sharon Alexander Senior Associate, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473
Re: K080898
Trade/Device Name: Autosuture™ ENDO GLATM Staplers with ENDO GIA™ Single Use Loading Units with Staple Line Reinforcement Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW, GAG Dated: March 28, 2008 Received: March 31, 2008
Dear Ms. Alexander:
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 - Ms. Sharon Alexander
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) 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 the reporting 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 M. Mulleen
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: Autosuture™ ENDO GIA™ Staplers with ENDO GIA™ Single Use Loading Units with Staple Line Reinforcement
Indications For Use:
The Autosuture™ ENDO GIA™ Staplers with ENDO GIA™ Single Use Loading Units with Staple Line Reinforcement have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and billary structures.
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-Off) Division of General. Restorative. and Neurological Device
510(k) Number ll o 80 rar
§ 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.