(90 days)
Not Found
Not Found
No
The summary describes a mechanical stapling device and does not mention any AI or ML components or functionalities.
No
The device is described as a surgical stapler used for resection, transection, and creation of anastomoses, which are surgical procedures, not therapeutic interventions in themselves.
No
Explanation: The device is described as a stapler used for resection, transection, and creation of anastomoses, which are surgical procedures, not diagnostic ones. It places staples in tissues rather than diagnosing conditions.
No
The device description explicitly states it is a stapler designed to place staples, which are physical components, 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 describes surgical procedures (resection, transection, creation of anastomoses, occlusion of the left atrial appendage) performed on the patient's body. IVDs are used to examine specimens from the human body (like blood, urine, tissue samples) to provide information about a person's health.
- Device Description: The device description details a surgical stapler that places staples in tissues during surgery. This is a surgical instrument, not a device used for laboratory testing of samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on laboratory results.
Therefore, the Auto Suture* TA* & knifeless GIA* staplers are surgical devices, not IVDs.
N/A
Intended Use / Indications for Use
The Auto Suture* TA* & knifeless GIA* staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomoses, including occlusion of the left atrial appendage in open procedures.
Product codes
GDW
Device Description
The Auto Suture* TA* & GIA* Staplers are designed to place multiple staggered rows of titanium or stainless steel staples in various types of tissues.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Auto Suture* TA* & GIA* Staplers
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
DEC - 1 2003
K03 2696
IX. 510(k) Summary of Safety and Effectiveness
| SUBMITTER: | United States Surgical
150 Glover Avenue
Norwalk, CT 06856 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Chester McCoy |
| DATE PREPARED: | November 14, 2003 |
| CLASSIFICATION NAME: | Staple, Implantable |
| COMMON NAME: | Staple, Implantable |
| PROPRIETARY NAME: | Auto Suture* TA* & GIA* Staplers |
| PREDICATE DEVICES: | Auto Suture* TA* & GIA* Staplers |
| TECHNOLOGICAL CHARACTERISTICS: | The Auto Suture* TA* & GIA* Staplers are identical to the predicate devices. The only changes are in the indication for use statement. |
| DEVICE DESCRIPTION: | The Auto Suture* TA* & GIA* Staplers are designed to place multiple staggered rows of titanium or stainless steel staples in various types of tissues. |
| INTENDED USE: | The Auto Suture* TA* & knifeless GIA* staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomoses, including occlusion of the left atrial appendage in open procedures. |
| MATERIALS: | All component materials of the Auto Suture TA* & GIA* staplers are comprised of materials which are in accordance with ISO Standard #10993-1 |
United States Surgical *Trademark of United States Surgical
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three wavy lines, which represent the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 1 2003
Mr. Chester McCoy Director of Regulatory Affairs United States Surgical 150 Glover Avenue Norwalk, Connecticut 06856
Re: K032696
Trade/Device Name: Auto Suture TA Surgical Staplers Auto Suture Knifeless GIA Surgical Staplers Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: August 29, 2003 Received: September 2, 2003
Dear Mr. McCoy:
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. Insting 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. FIDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination docs 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 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.
2
Page 2 - Mr. Chester McCoy
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 Office of Compliance at (301) 594-4659. 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,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K 032696
IV. Indications For Use:
510(k) Number (if known): K032696
Name: Auto Suture* TA* Surgical Staplers Auto Suture* Knifeless GIA* Surgical Staplers
Indications For Use:
The Auto Suture* TA* & knifeless GIA* staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomoses, including occlusion of the left atrial appendage in open procedures.
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Evaluation (ODE)
| Prescription Use:
| (Per 21 CFR §801.109) | OR Over-The-Counter Use: |
|---|---|
| --------------------------------------------- | -------------------------- |
Miriam C. Provost
- Restorative al Devic
510(k) Number K032696