(81 days)
Not Found
Not Found
No
The summary describes a mechanical surgical stapler and does not mention any AI or ML components or functionalities.
Yes
The device is used to create anastomoses and resect tissue during surgery, which are therapeutic interventions.
No
This device is a surgical stapler used for creating anastomoses in the alimentary tract, which is a therapeutic function, not a diagnostic one. It resects tissue and places staples, rather than gathering information for diagnosis.
No
The device description clearly describes a physical, disposable surgical stapler, which is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The description clearly states that the Auto Suture* Premium Plus CEEA* Disposable Stapler is a surgical instrument used within the body to create anastomoses (connections between tissues) during surgery. It places staples and resects tissue.
- Intended Use: The intended use describes a surgical procedure performed directly on the alimentary tract, not a laboratory test on a sample.
Therefore, based on the provided information, this device is a surgical instrument, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Auto Suture* Premium Plus CEEA* Disposable Stapler has applications throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries, including bariatric surgery.
Product codes
GDW
Device Description
The Auto Suture* PREMIUM PLUS CEEA* Disposable Stapler is a single patient use device which places a double staggered row of titanium staples. Immediately after staple formation, the instrument's knife blade resects the excess tissue, creating a circular anastomosis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alimentary tract
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
KΨ24275
IX. 510(k) Summary of Safety and Effectiveness
| SUBMITTER: | United States Surgical
150 Glover Avenue
Norwalk, CT 06856
MAR 1 4 2003 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Sarah Hubeny |
| DATE PREPARED: | December 20, 2002 |
| CLASSIFICATION NAME: | Staple, Implantable |
| COMMON NAME: | Staple, Implantable |
| PROPRIETARY NAME: | Auto Suture* PREMIUM PLUS CEEA*
Disposable Stapler |
| DEVICE DESCRIPTION: | The Auto Suture* PREMIUM PLUS CEEA* Disposable
Stapler is a single patient use device which places a double
staggered row of titanium staples. Immediately after staple
formation, the instrument's knife blade resects the excess
tissue, creating a circular anastomosis. |
| INTENDED USE: | The Auto Suture* Auto Suture* Premium Plus CEEA*
Disposable Stapler has applications throughout the
alimentary tract for the creation of end-to-end, end-to-side
and side-to-side anastomoses in both open and laparoscopic
surgeries, including bariatric surgery. |
| MATERIALS: | All component materials of the Auto Suture* Premium Plus
CEEA* Disposable Stapler are comprised of materials
which are in accordance with ISO Standard #10993-1. |
:
1
Image /page/1/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
MAR 1 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sarah Hubeny Regulatory Affairs Associate United States Surgical, a division of Tyco Healthcare Group, LP 150 Glover Avenue Norwalk, Connecticut 06856
Re: K024275
Trade/Device Name: Auto SuturePremium Plus CEEA Disposable Stapler Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: December 20, 2002 Received: December 23, 2002
Dear Ms. Hubeny:
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. Iisting 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 forth in the quality systems (OS) 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 - Ms. Sarah Hubeny
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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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
W 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
IV. Indications For Use: 424275 510(k) Number (if known):
Name: Auto Suture* PREMIUM PLUS CEEA* Disposable Stapler
Indications For Use:
The Auto Suture* Premium Plus CEEA* Disposable Stapler has applications throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries, including bariatric surgery.
(Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Evaluation (ODE) OR Over-The-Counter Use: Prescription Use: (Per 21 CFR §801.109)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K024275