(42 days)
Not Found
Not Found
No
The description focuses on the mechanical function of a surgical stapler and does not mention any AI/ML components or capabilities.
No
The device is a surgical stapler used for resection, transection, and creation of anastomoses, which are surgical procedures, not therapeutic treatments in themselves, but rather tools used during surgical interventions.
No
This device is a surgical stapler used for resection, transection, and creation of anastomoses, not for diagnosing medical conditions.
No
The device description clearly describes a physical surgical stapler with various hardware components (staples, loading units) and mentions in-vivo animal tests, indicating it is a hardware medical 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 stapler used for in-vivo procedures (within a living organism) like resection, transection, and creation of anastomoses in various surgical specialties.
- Device Description: The device description details a surgical instrument that places staples and divides tissue during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This device is a surgical tool used directly on the patient during a procedure.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GDW, GAG
Device Description
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.
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, liver substance, hepatic vasculature and biliary structures.
Indicated Patient Age Range
pediatric
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)
In-vivo animal tests were performed to support the inclusion of a specific indication as a subset of the general indication for the Auto Suture™ ENDO GIA™ Stapler. A clinical literature search was also performed to demonstrate and support the clinical application of the device for the resection and transection of liver.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Auto Suture™ ENDO GIA™ Stapler
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary of Safety and Effectiveness
| SUBMITTER: | United States Surgical, a division of Tyco Healthcare Group LP
150 Glover Avenue
Norwalk, CT 06856
Tel. No.: (203) 845-1000
MAY 31 2006 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Frank Gianelli
Senior 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 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. |
| INTENDED 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. |
| TECHNOLOGICAL
CHARACTERISTICS: | The Auto Suture™ ENDO GIA™ Stapler is identical to the
predicate device. The only change is the inclusion of a specific
indication concerning the device's use on liver tissue as a
subset of the general indication for the Auto Suture™ ENDO
GIA™ Stapler. |
| MATERIALS: | All components of the Auto Suture™ ENDO GIA™ Stapler are
comprised of materials which are in accordance with ISO
Standard 10993-1. |
| PERFORMANCE DATA: | In-vivo animal tests were performed to support the inclusion of
a specific indication as a subset of the general indication for
the Auto Suture™ ENDO GIA™ Stapler. A clinical literature
search was also performed to demonstrate and support the
clinical application of the device for the resection and
transection of liver. |
1
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
2
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 |
|---|---|
| --------------- | --------- |
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