(30 days)
Not Found
No
The description focuses on mechanical and material properties of a surgical stapler and reinforcement material, with no mention of AI or ML.
No.
The device is used for surgical resection, transection of tissue, and creation of anastomosis, which are surgical procedures, not therapeutic treatments.
No
Explanation: The device is described as a surgical tool used for resection, transection of tissue, and creation of anastomosis. Its function is to place staples and divide tissue, which are therapeutic actions, not diagnostic ones. The performance evaluations also focus on mechanical and biological safety and efficacy, not diagnostic accuracy.
No
The device description clearly details a physical medical device (stapler reload with reinforcement material) and the performance studies involve bench and animal testing of this physical device. There is no mention of software as the primary or sole component.
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 device used for in vivo procedures (within a living organism) for resection, transection, and anastomosis of tissues. IVDs are used to examine specimens in vitro (outside of a living organism) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a surgical stapler and reinforcement material used to physically manipulate and join tissues during surgery. This is consistent with a surgical device, not an IVD.
- Performance Studies: The performance studies described are bench and animal studies evaluating the mechanical and biological performance of the device within a living system (in vivo). IVD performance studies typically involve testing the device's ability to accurately detect or measure analytes in biological samples.
The device is a surgical stapler with reinforcement material, designed for use during surgical procedures on patients.
N/A
Intended Use / Indications for Use
Endo GIA™ reinforced reload with Tri-Staple™ Technology preloaded with polyglycolic acid staple line reinforcement has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures, and for transection and resection of pancreas.
Product codes
GDW, ORQ
Device Description
The Endo GIA™ Reinforced Reload with Tri-Staple™ Technology places two, triple-staggered rows of titanium staples with a reinforcement material and simultaneously divides the tissue and the reinforcement material between the two, triple-the absorbable staple line reinforcement staggered rows. The absorbable staple line reinforcement material, comprised of a synthetic polyester composed of pure alvcolide, will be secured to the anvil and cartridge sides of the reload with four synthetic absorbable sutures. The size of the staples is determined by the selection of the 3.0-4.0 mm or 4.0-5.0 mm Reload. The Endo GIA™ Reinforced Reload with Tri-Staple™ Technology is only available in the articulating 45 mm and 60 mm length cartridges with the 3.0-4.0 mm or 4.0-5.0 mm staples, respectively.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal, gynecologic, pediatric, thoracic, liver, hepatic vasculature, biliary structures, pancreas
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
Bench and animal performance evaluations were completed to verify that the Endo GIA™ Reinforced Reload with Tri-Staple™ Technology are safe and effective and perform as intended.
The tests performed to show substantial equivalence of the Endo GIA™ Reinforced Reload with Tri-Staple™ Technology to the predicate device are as follows:
- In Vitro
- Insertion/removal force о
- Firing force 0
- Retraction force 0
- Staple formation о
- iDrive Ultra testing O
- Twek Pull apart 0
- Sequential firings O
- Perpendicular firings O
- L-shaped firings O
- In Vivo
- Atraumatic reload O
- Free bleed time
- Air leaks
- Burst
- Additional firings
- Biocompatibility
The results of the tests performed demonstrate that the subject device, Endo GIA™ Reinforced Reload with Tri-Staple™ Technology, is substantially equivalent to the predicate device(s).
Key Metrics
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.
0
K133938 Page 1 of 4
510(k) Summary
JAN 2 2 2014
This 510(k) summary information is submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990. The contents of the 510(k) summary have been provided in conformance with 21 CFR §807.98.
| Submitter Information | |
|---|---|
| Name: | Covidien IIc |
| Address: | 15 Hampshire Street |
| Mansfield, MA 02048 | |
| Establishment Registration: | 1282497 |
| Name of contact person: | Jose Marquez |
| Regulatory Affairs Manager | |
| Covidien | |
| 15 Hampshire Street | |
| Mansfield, MA 02048 USA | |
| Phone: (508) 452-4160 | |
| Date prepared: | January 22, 2014 |
| Trade or proprietary name: | Endo GIA™ Reinforced Reload with Tri-Staple™ Technology |
| Common or usual name: | Surgical Stapler with Implantable Staple |
| Classification name: | Staple, Implantable |
| Classification panel: | General and Plastic Surgery (79) |
| Regulation: | 21 CFR 878.4750 |
| Product Code(s): | GDW, ORQ |
| Legally marketed devices to | |
| which equivalence is claimed: | Endo GIA™ Stapler (K111825)NEOVEIL™ Reinforcement Staple Line Material (K130997) |
| Reason for 510(k) submission: | To obtain market clearance for the Endo GIA™ Reinforced |
| Reload with Tri-Staple™ Technology. | |
| Device description: | The Endo GIA™ Reinforced Reload with Tri-Staple™ |
| Technology places two, triple-staggered rows of titanium staples | |
| with a reinforcement material and simultaneously divides the |
1
tissue and the reinforcement material between the two, triple-The absorbable staple line reinforcement staggered rows. material, comprised of a synthetic polyester composed of pure alvcolide, will be secured to the anvil and cartridge sides of the reload with four synthetic absorbable sutures. The size of the staples is determined by the selection of the 3.0-4.0 mm or 4.0-5.0 mm Reload. The Endo GIA™ Reinforced Reload with Tri-Staple™ Technology is only available in the articulating 45 mm and 60 mm length cartridges with the 3.0-4.0 mm or 4.0-5.0 mm staples, respectively.
Endo GIA™ reinforced reload with Tri-Staple™ Technology Intended use of the device: preloaded with polyglycolic acid staple line reinforcement has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures, and for transection and resection of pancreas.
Summary comparing the technological characteristics of the subject and predicate devices:
Materials:
Performance Data:
GIA™ Reinforced Reload with Tri-Staple ™ The Endo Technology is substantially equivalent to the predicate devices staple line reinforcement regard to stapling and with technologies.
All components of the Endo GIA™ Reinforced Reload with Tri-Staple™ Technology are comprised of materials which are in
Bench and animal performance evaluations were completed to verify that the Endo GIA™ Reinforced Reload with Tri-Staple™ Technology are safe and effective and perform as intended.
The tests performed to show substantial equivalence of the Endo GIA™ Reinforced Reload with Tri-Staple™ Technology to the predicate device are as follows:
- . In Vitro
- Insertion/removal force o
accordance with ISO Standard 10993-1.
- Firing force 0
- Retraction force 0
- Staple formation o
- iDrive Ultra testing O
- Twek Pull apart 0
- Sequential firings 0
- Perpendicular firings O
- L-shaped firings O
- In Vivo · .
- Atraumatic reload O
2
.
Free bleed time ্ O Air leaks
:
. .
.
. . . . . . .
.
. .
.
3
- Burst o
- Additional firings o
- Biocompatibility .
Conclusion:
The results of the tests performed demonstrate that the subject device, Endo GIA™ Reinforced Reload with Tri-Staple™ Technology, is substantially equivalent to the predicate device(s). .
4
Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font and is black. The background is white.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 22, 2014
Covidien Ilc Mr. Jose Marquez Regulatory Affairs Manager 15 Hampshire Street Mansfield, Massachusetts 02048
Re: K133938
Trade/Device Name: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW, ORO Dated: December 20, 2013 Received: December 23, 2013
Dear Mr. Marquez:
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 note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
5
Page 2 - Mr. Jose Marquez
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
For
Sincerely yours,
Joshua FDMipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510{k} Number (if known) K133938
Device Name
Endo GLA™ Reinforced Reload with Tri-Staple™ Technology
Indications for Use (Describe)
Endo GIA™ reinforced reload with Tri-Staple™ Technology preloaded with polyglycolic acid staple line reinforcement has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures, and for transection and resection of pancreas.
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Slatement on last page.
Type of Use (Select one or both, as applicable)
[Z] Prescription Use (Part 21 CFR 801 Subpart D)
O Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY STATE AND STATE Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (9/13)
Page Lof 2
PSC Publishion Screlocs (3011 443-674)