(35 days)
Not Found
No
The device description focuses on mechanical stapling and material properties, with no mention of AI/ML terms or functions.
No
The device is a surgical stapler used for cutting and sealing tissue, which is an operative tool, not a therapeutic device designed to cure, mitigate, treat, or prevent disease.
No
The device is a surgical stapler used for resection, transection, and creating anastomoses, not for diagnosing conditions or diseases.
No
The device description clearly details physical components like staplers, loading units, staples, and reinforcement material, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical stapling device used for physically manipulating and joining tissues within the body (resection, transection, anastomosis). This is an in vivo application, meaning it's used directly on a living organism.
- Device Description: The description details a mechanical device that places staples and divides tissue. It also mentions a synthetic absorbable film for reinforcement. These are all components and functions related to a surgical instrument, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status. The device's function is purely mechanical and surgical.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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 biliary structures.
Product codes
GDW, GAG
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K061095, K000037, K043056, K040119
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.
0
Page 1 of 2
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 unit
of Tyco Healthcare Group LP (d/b/a Covidien)
60 Middletown Avenue
North Haven, CT 06473
Tel. No.: (203) 492-6060 | MAY - 5 2008 |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| CONTACT PERSON: | Sharon Alexander
Senior Associate, Regulatory Affairs | |
| DATE PREPARED: | March 28, 2008 | |
| TRADE/PROPRIETARY NAME: | Autosuture™ ENDO GIA™ Staplers with ENDO GIA™ Single
Use 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 Line
Reinforcement (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 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. | |
| INTENDED 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
anastomoses. They may be used for transection and resection
of liver substance, hepatic vasculature and biliary structures. | |
1
Page 2 of 2.
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.
2
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
3
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
4
Page 1 of 1
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