(198 days)
K/DEN number: K061095
No
The description focuses on mechanical function and reprocessing, with no mention of AI/ML terms or capabilities.
No
Explanation: A therapeutic device is designed to provide treatment for a disease or condition. This device is a surgical stapler used for resection, transection, and anastomosis of tissue, which are procedures performed during surgery, but the device itself does not provide treatment in the way a therapeutic device would (e.g., drug delivery, radiation therapy, etc.).
No
The device description indicates it is a surgical stapler used for resecting and transecting tissue, which is a therapeutic rather than diagnostic function.
No
The device description clearly describes a physical, mechanical surgical stapler and its components (staples, cartridge, blade). 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 describes a surgical device used for cutting and stapling tissue during various surgical procedures (abdominal, gynecologic, pediatric, thoracic). This is a direct surgical intervention on the patient's body.
- Device Description: The description details a mechanical stapling device that places staples and cuts tissue. This is a surgical instrument.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information about a patient's health status, diagnosis, or treatment.
IVD devices are used to perform tests on samples taken from the body, not to directly perform surgical procedures on the body itself.
N/A
Intended Use / Indications for Use
The Reprocessed Reloadable AutoSuture GIA staplers are intended to be used in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and anastomosis. In addition the AutoSuture ENDO GIA Staplers may be used for transection of liver lissue, hepatic vasculature and biliary structures.
Product codes
NLL
Device Description
SterilMed's reprocessed AutoSuture GIA Endoscopic Stapler places two triple staggered rows of titanium staples and the blade, contained in the reload, simultaneously divides the tissue between the two rows. These devices allow for a maximum of 8 reloads in a single surgical procedure. The OEM has specified that the subject staplers may be fired up to 25 times in a single surgical procedure. SterilMed has lowered the number of firings allowed to 8 based upon clinical input, the procedures these devices are used for and the maximum allowable firings for similar devices of other manufactures. Note: Only the stapler is the subject of this submission, the implantable staple and the staple cartridge are not reprocessed and therefore are not included.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal, gynecologic, pediatric and thoracic; liver lissue, hepatic vasculature and biliary structures
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
Functional and Safety Testing: Representative samples of reprocessed staplers are tested to demonstrate appropriate functional characteristics. Process validation testing is performed to validate the cleaning and sterilization procedures as well as device packaging. In addition, the manufacturing process includes visual and validated functional testing of all products produced.
Key Metrics
Not Found
Predicate Device(s)
AutoSuture GIA Endoscopic Stapler (K061095)
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
070930 pg 1 of 1
RILMED INC
510(K) PREMARKET NOTIFICATION SUBMISSION MARCH 30, 2007
For Reprocessed Autosuture Gia Endoscopic Staplers
II. SUMMARY AND CERTIFICATION
0CT 1 8 2007
A. 510(k) Summary
| Submitter: | SterilMed, Inc. |
|---|---|
| Contact Person: | Caroline Butterfield |
| 11400 73rd Avenue North | |
| Maple Grove, MN 55369 | |
| Ph: 888-856-4870 | |
| Fax: 763-488-3350 | |
| Date Prepared: | March 30, 2007 |
| Trade Name: | Reprocessed AutoSuture GIA Endoscopic Staplers |
| Classification Name: | Staple, Implantable |
| Classification Number: | Class II, 21 CFR 878.4750 |
| Product Code: | NLL |
| Predicate
Devices: | The reprocessed AutoSuture GIA Endoscopic Staplers are substantially equivalent to the
AutoSuture GIA Endoscopic Stapler (K061095). |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Description: | SterilMed's reprocessed AutoSuture GIA Endoscopic Stapler places two triple staggered rows
of titanium staples and the blade, contained in the reload, simultaneously divides the tissue
between the two rows. These devices allow for a maximum of 8 reloads in a single surgical
procedure. The OEM has specified that the subject staplers may be fired up to 25 times in a
single surgical procedure. SterilMed has lowered the number of firings allowed to 8 based
upon clinical input, the procedures these devices are used for and the maximum allowable
firings for similar devices of other manufactures.
Note: Only the stapler is the subject of this submission, the implantable staple and the staple
cartridge are not reprocessed and therefore are not included. |
| Intended Use: | |
| Functional and
Safety Testing: | Representative samples of reprocessed staplers are tested to demonstrate appropriate functional
characteristics. Process validation testing is performed to validate the cleaning and sterilization
procedures as well as device packaging. In addition, the manufacturing process includes visual
and validated functional testing of all products produced. |
| Conclusion: | The reprocessed endoscopic staplers are substantially equivalent to the GIA Endoscopic Stapler
(K061095) manufactured by AutoSuture.
This conclusion is based upon the devices' similarities in functional design (principle of
operation), materials, indications for use and methods of construction. |
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 stylized eagle or bird-like symbol with three overlapping, curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 8 2007
SterilMed, Inc. % Mr. Dennis J. Toussaint Director, Regulatory Affairs 11400 73td Avenue North, Suite 100 Maple Grove, Minnesota 55369
Re: K070930
Trade/Device Name: Reprocessed AutoSuture GIA Endoscopic Staplers Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: NLL Dated: October 10, 2007 Received: October 11, 2007
Dear Mr. Toussaint:
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 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. Dennis J. Toussaint
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 (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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson De
Director
10
Division of General, Restorative
and Neurological Devices
Office of Device Evaluation
17
Center for Devices and Radiological Health
Enclosure
3
topsiof
Devices Included in this Submission List of
| OEM | Model | Description | A MILL CLASS AND ALL ALL ALL PLAN A BLACK A STATUS A STATUS A FLA PARTY A BELL A FLA FLA FLA FLA FLA FLA FLA FLA FLA FLA FLA FLA FLA FLA FLA FLA FLA FLA FLA FLA FLA FLA FLA F
Reprocesso | SterilMed Part |
|------------|------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| | | | | |
| | 030403 | GIA Universal 12mm dia., 63 | | Number AUT030403 |
| | | mm long shaft Endo GIA Universal 12mm dia., | | |
| AutoSuture | 030449 | | SterilMed, Inc. | AUT030449 |
| | | 155 mm long shaft | | |
| | EGIAUNIVXL | Endo GIA Universal XL – Long | | AUTEGIAUNIVXI |
| | | 12 mm dia., 255mm long shaft
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | |
4
070930 pg 1 of 1
510(K) PREMARKET NOTIFICATION SUBMISSION MARCH 30, 2007
For Reprocessed Autosuture Gia Endoscopic Staplers
Indications for Use
510(k) Number (if known):
Device Name: Reprocessed AutoSuture GIA Endoscopic Staplers
Indications For Use:
The Reprocessed Reloadable AutoSuture GIA staplers are intended to be used in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and anastomosis. In addition the AutoSuture ENDO GIA Staplers may be used for transection of liver lissue, hepatic vasculature and biliary structures.
| Prescription Use
(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use
(21 CFR 807 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 | 14070930 |
|---|---|
| --------------- | ---------- |
CONFIDENTIAL & PROPRIETARY INFORMATION OF STERILMED, INC.