(28 days)
Not Found
No
The summary describes surgical staples and their compatibility with existing staplers, with no mention of AI or ML.
No
The device is surgical staples, intended for use with surgical staplers. Surgical staples are used to close wounds and approximate tissues, which is a surgical tool/material rather than a therapeutic device that treats or cures a disease or condition.
No
Explanation: The device, Auto Suture Surgical Staples, is intended for use with surgical staplers for mechanical fastening of tissue, not for diagnosis. Its "Intended Use" describes a surgical function, and there is no mention of diagnostic capabilities, imaging, or analysis of medical conditions.
No
The 510(k) summary describes surgical staples, which are physical medical devices, and their intended use with staplers and loading units, also physical devices. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the surgical staples are for use with surgical staplers. This indicates a direct interaction with tissue within the body during a surgical procedure.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.) outside the body.
- Providing diagnostic information about a patient's health status.
- Using reagents or other substances to perform tests.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. Surgical staples, on the other hand, are surgical instruments used to join or close tissues during surgery.
N/A
Intended Use / Indications for Use
The Auto Suture Surgical Staples are intended to be used with the currently marketed Auto Suture TA Stapler and Single Use Loading Unit (SULU), Auto Suture GIA Stapler and SULU, and Auto Suture EEA Stapler and SULU.
Product codes
GDW
Device Description
Not Found
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)
In vitro and in vivo testing was performed to verify that the Auto Suture* Surgical Staples can be used with the Auto Suture TA Stapler and Single Use Loading Unit (SULU), Auto Suture GIA Stapler and SULU, and Auto Suture EEA Stapler and SULU.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Summary of Safety and Effectiveness IX.
DEC 1 9 2001
United States Surgical SUBMITTER: A division of Tyco Healthcare Group, LP 150 Glover Avenue Norwalk, CT 06856
Chester McCoy CONTACT PERSON:
DATE PREPARED: November 20, 2001
Implantable Staple CLASSIFICATION NAME:
Implantable Staple, General and Plastic Surgery COMMON NAME:
Auto Suture* Surgical Staples PROPRIETARY NAME:
Auto Suture* Modified Surgical Staples (K855047). PREDICATE DEVICES:
The Auto Suture Surgical Staples are intended to be used INTENDED USE: with the currently marketed Auto Suture TA Stapler and Single Use Loading Unit (SULU), Auto Suture GIA Stapler and SULU, and Auto Suture EEA Stapler and SULU.
MATERIALS:
Titanium – The staples are comprised of a material which is in compliance to ISO Standard #10993-1
PERFORMANCE DATA: In vitro and in vivo testing was performed to verify that the Auto Suture* Surgical Staples can be used with the Auto Suture TA Stapler and Single Use Loading Unit (SULU), Auto Suture GIA Stapler and SULU, and Auto Suture EEA Stapler and SULU.
1
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 9 2001
Chester McCoy Program Manager Regulatory Affairs United States Surgical 150 Glover Avenue Norwalk, Connecticut 06856
Re: K013860
Trade Name: Auto Suture Surgical Staples Regulation Number: 878.4750 Regulation Name: Implantable Staple Regulatory Class: II Product Code: GDW Dated: November 20, 2001 Received: November 21, 2001
Dear Mr. McCoy:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, (Trefore, market the device, subject to the general controls provisions of the Act. The general therefore, mainions of the Act include requirements for annual registration, listing of devices, controls provisions or actice, 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 If your device 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 that + Drederal 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) This icher will anow you to ogen maing of substantial equivalence of your device to a legally prematication. The PDF micing of casification 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 and IT you desire specific acrise for you invitro diagnostic devices), please contact the Office of additionally 21 OF ICT at 659. Additionally, for questions on the promotion and advertising of Compinatee at (301) of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). I centrion children, "Nilocranisms on responsibilities under the Act may be obtained from the Outcr general informational 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,
Neil R.l. Ogden
Celia M. Witten, Ph.D., M.D. for
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use V. 013860 510(k) Number (if known): Auto Suture Surgical Staples Device Name:
Indications For Use:
The Auto Suture Surgical Staples are intended to be used with the currently marketed Auto The Auto Suture Burgles areastes areastes in over and Suture GIA Stapler and SULU, and Auto Suture EEA Stapler and SULU.
(Please do not write below this line - continue on another page if needed)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| Prescription Use: | X |
|---|---|
| OR Over-The-Counter | |
| Use: | |
| (Per 21 CFR 801.109) |
Mo farcmw
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K013860