(135 days)
No
The description focuses on mechanical and structural modifications to a surgical stapler and its loading units, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
A therapeutic device is one that treats a disease or condition. This device is a surgical stapler used for resection, transection, and creation of anastomosis, which are surgical procedures, not therapeutic actions.
No
Explanation: The device is described as a surgical stapler used for resection, transection, creation of anastomosis, and tissue dissection/manipulation. Its function is to perform surgical procedures, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly details a physical stapler instrument and single-use loading units with mechanical components (staples, anvil, etc.), indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes surgical procedures (resection, transection, anastomosis, dissection) performed on the body, not tests performed on samples taken from the body.
- Device Description: The device description details a surgical stapler and its components, which are used to physically manipulate and join tissue during surgery. This is not consistent with the function of an IVD, which analyzes biological samples.
- No mention of analyzing biological samples: The text does not mention the device being used to test blood, urine, tissue samples, or any other biological material.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is a surgical tool used directly on the patient during a procedure.
N/A
Intended Use / Indications for Use
The Autosuture™ ENDO GIA™ Staplers with ENDO GIA™ Single Use Loading Units (SULUs) 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 biliary structures.
The Autosuture™ ENDO GIA™ Staplers when used with the ENDO GIA™ Curved-Tip Single Use Loading Unit (SULUs) can be used to blunt dissect or separate target tissue from other certain tissue.
Product codes
GDW
Device Description
The Autosuture™ ENDO GIA™ Staplers 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 appropriate Single Use Loading Unit (SULU). The staplers will accommodate any of the single use loading units that are available in 30 mm, 45 mm and 60 mm lengths.
This 510(k) reports a new version of our currently marketed Autosuture™ ENDO GIA™ Staplers (K061095). This new version is considered a modification of the currently marketed Autosuture™ ENDO GIA™ Staplers. The modifications are as follows:
: Ergonomic and performance enhancements to the ENDO GIA™ Stapler Instrument.
. Addition of ENDO GIA™ Single Use Loading Units (SULUs) with Tri-Staple™ technology. Tri-Staple™ technology means that each of the two triple-staggered rows has a stepped configuration whereby the staples in the outer row are a taller height then the staples in the middle row which in turn are a taller height than the staples in the inner row. The ENDO GIA™ SULUs with Tri-Staple™ technology are available in articulating 30 mm, 45 mm and 60 mm length cartridges.
Addition of ENDO GIA™ Single Use Loading Units (SULUs) ● which have a curved-tip anvil configuration. The curved-tip can be used to dissect and manipulate tissue when locating target tissue for subsequent firing and placement of staples.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal, gynecologic, pediatric and thoracic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench and animal model performance evaluations were completed to verify that the Autosuture™ ENDO GIA™ Staplers with the new ENDO GIA™ Single Use Loading Units are safe and effective and perform as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Autosuture™ ENDO GIA™ Surgical Staplers
510(k) Summary of Safety and Effectiveness
APR 1 0 2009
| SUBMITTER: | Surgical Devices, a global business unit
of Tyco Healthcare Group LP (d/b/a Covidien)
60 Middletown Avenue
North Haven, CT 06473
Tel. No.: (203) 492-5352 |
| ------------ | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
CONTACT PERSON: Frank Gianelli Senior Associate, Regulatory Affairs
DATE PREPARED: November 24, 2008
TRADE/PROPRIETARY NAME: Autosuture™ ENDO GIA™ Staplers
COMMON/USUAL NAME: Surgical Stapler with Implantable Staple
CLASSIFICATION NAME: Staple, Implantable
PREDICATE DEVICE(S): Autosuture™ ENDO GIA™ Stapler (K061095)
The Autosuture™ ENDO GIA™ Staplers place two, triple-DEVICE DESCRIPTION: 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 appropriate Single Use Loading Unit (SULU). The staplers will accommodate any of the single use loading units that are available in 30 mm, 45 mm
and 60 mm lengths.
This 510(k) reports a new version of our currently marketed Autosuture™ ENDO GIA™ Staplers (K061095). This new version considered a modification of the currently marketed is Autosuture™ ENDO GIA™ Staplers. The modifications are as follows:
- : Ergonomic and performance enhancements to the ENDO GIA™ Stapler Instrument.
- . Addition of ENDO GIA™ Single Use Loading Units (SULUs) with Tri-Staple™ technology. Tri-Staple™ technology means that each of the two triple-staggered rows has a stepped configuration whereby the staples in the outer row are a taller height then the staples in the middle row which in turn are a taller height than the staples in the inner row. The ENDO GIA™ SULUs with Tri-Staple™ technology are available in articulating 30 mm, 45 mm and 60 mm length cartridges.
- Addition of ENDO GIA™ Single Use Loading Units (SULUs) ● which have a curved-tip anvil configuration. The curved-tip can be used to dissect and manipulate tissue when locating target tissue for subsequent firing and placement of staples.
1
The Autosuture™ ENDO GIA™ Staplers have applications in INTENDED USE: abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.
The Autosuture™ ENDO GIA™ Staplers when used with the ENDO GIA™ Curved-Tip Single Use Loading Units (SULUs) can be used to blunt dissect or separate target tissue from other certain tissue.
Autosuture™ ENDO GIA™ Staplers are substantially equivalent TECHNOLOGICAL to the predicate devices with regard to the stapling technologies. CHARACTERISTICS: The addition of ENDO GIA™ Single Use Loading Units (SULUs) with Tri-Staple™ technology provide additional selection for the surgeon depending upon the tissue thickness to be transected or resected. The new ENDO GIA™ Curved-Tip Single Use Loading Unit (SULU) can be used to blunt dissect or separate target tissue from other certain tissue.
10993-1.
MATERIALS:
PERFORMANCE DATA:
Bench and animal model performance evaluations were completed to verify that the Autosuture™ ENDO GIA™ Staplers with the new ENDO GIA™ Single Use Loading Units are safe and effective and perform as intended.
All components of the Autosuture™ ENDO GIA™ Staplers are
comprised of materials that are in accordance with ISO Standard
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Covidien % Mr. Frank Gianelli Senior Associate, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473
APR 1 0 2009
Re: K083519
Trade/Device Name: Autosuture™ ENDO GIA™ Staplers with ENDO GIA™ Single Use Loading Units Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: April 3, 2009 Received: April 6, 2009
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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
3
Page 2 - Mr. Frank Gianelli
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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
Sincerely yours,
Mark M Millman
Mark N. Melkerson Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications For Use
12083519 510(k) Number (if known): __
Device Name: Autosuture™ ENDO GIA™ Staplers with ENDO GIA™ Single Use Loading Units
Indications For Use:
The Autosuture™ ENDO GIA™ Staplers with ENDO GIA™ Single Use Loading Units (SULUs) 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 biliary structures.
The Autosuture™ ENDO GIA™ Staplers when used with the ENDO GIA™ Curved-Tip Single Use Loading Unit (SULUs) can be used to blunt dissect or separate target tissue from other certain tissue.
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)
Nil R. Ople fir mxn
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number K083519
Covidien Premarket Notification