(32 days)
Not Found
Not Found
No
The description focuses on mechanical features and surgical function, with no mention of AI or ML.
No.
The device is a surgical stapler used for cutting and stapling tissue during general surgical treatment of anorectal wall defects, which is a surgical tool, not a therapeutic device that directly treats a condition.
No.
This device is a surgical stapler used for cutting and stapling tissue, which is a therapeutic function, not a diagnostic one.
No
The device description clearly details a physical surgical stapler with mechanical components (staples, knife, triggers, etc.) and accessories, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculomucosal tissue." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "Curved Cutter Stapler" that cuts and staples tissue. This is a surgical instrument used for physical manipulation of tissue during a procedure.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body to provide information for diagnosis, monitoring, or compatibility. IVDs are typically used to analyze samples like blood, urine, or tissue outside of the body.
Therefore, the CONTOUR® TRANSTAR™ Curved Cutter Stapler is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CONTOUR® TRANSTAR™ Curved Cutter Stapler and accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculomucosal tissue.
Product codes
GDW
Device Description
The CONTOUR® TRANSTAR™ Curved Cutter Stapler is a multifire, single patient use device with a curved head that cuts and staples. The device delivers three staggered rows of titanium staples, with a knife between the first and second row of staples, and creates a 30 mm curved transection. The device is designed with a feature that prevents closing if a used reload or no reload is in the instrument. Another feature is provided to prevent firing unless the closure trigger is latched in the closed position. A retaining pin holds tissue in place and can be positioned either manually or by squeezing the closure trigger. The instrument may be reloaded seven times, for a maximum of eight firings per instrument during a single procedure. Each reload cartridge module includes a knife blade with two staggered rows of staples on the patient side, one staggered row of staples on the specimen side, an anvil, a cutting washer, a retaining pin, a knife guide pin, and a staple retainer. Additional reload cartridges will be available in one size: a green cartridge for compressed tissue with a thickness of 2.0mm.
The CONTOUR® TRANSTAR™ Curved Cutter Stapler is packaged sterile as a single patient use device with two accessories, a Circular Anal Dilator with Obturator and an Access Suture Anoscope. This set is commonly referred to by the product code STR5G.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anorectal wall
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)
Bench testing and preclinical laboratory evaluations were performed to demonstrate that the new device will perform as intended. A clinical literature search was also conducted and the literature supports the intended use of the new device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
PROXIMATE® (currently marketed as CONTOUR®) 40mm Curved Cutter Stapler and Reloads, PROXIMATE® HCS Hemorrhoidal Circular Stapler Set
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
K053631/1/2
JAN 3 0 2006
510(k) Summary
- Ethicon Endo-Surgery, Inc. Company 4545 Creek Road Cincinnati, OH 45242
- Contact Wendy L. Turner, RAC Group Manager, Regulatory Affairs Telephone: (513) 337-8807 Fax: (513) 337-2807 Email: wturner@eesus.jnj.com
Date Prepared December 28 , 2005
Trade Name: CONTOUR® TRANSTAR™ Curved Cutter Stapler Set Device Name Common or Usual Name: Curved Cutter Stapler Classification Name: Staple, Implantable [21 CFR 878.4750 (GDW)]
Predicate Devices PROXIMATE® (currently marketed as CONTOUR®) 40mm Curved Cutter Stapler and Reloads PROXIMATE® HCS Hemorrhoidal Circular Stapler Set
Device Description The CONTOUR® TRANSTAR™ Curved Cutter Stapler is a multifire, single patient use device with a curved head that cuts and staples. The device delivers three staggered rows of titanium staples, with a knife between the first and second row of staples, and creates a 30 mm curved transection. The device is designed with a feature that prevents closing if a used reload or no reload is in the instrument. Another feature is provided to prevent firing unless the closure trigger is latched in the closed position. A retaining pin holds tissue in place and can be positioned either manually or by squeezing the closure trigger. The instrument may be reloaded seven times, for a maximum of eight firings per instrument during a single procedure. Each reload cartridge module includes a knife blade with two staggered rows of staples on the patient side, one staggered row of staples on the specimen side, an anvil, a cutting washer, a retaining pin, a knife guide pin, and a staple retainer. Additional reload cartridges will be available in one size: a green cartridge for compressed tissue with a thickness of 2.0mm.
The CONTOUR® TRANSTAR™ Curved Cutter Stapler is packaged sterile as a single patient use device with two accessories, a Circular Anal Dilator with Obturator and an Access Suture Anoscope. This set is commonly referred to by the product code STR5G.
Indications for Use The CONTOUR® TRANSTAR™ Curved Cutter Stapler and accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculomucosal tissue.
Technological Characteristics The CONTOUR® TRANSTAR™ Curved Cutter Stapler is similar to the design of the predicate device, the PROXIMATE® (or CONTOUR®) 40mm Curved Cutter Stapler. The new device is different from the predicate device in that it produces a 30mm curved staple line.
1
K053631²/₂
Performance Data. Bench testing and preclinical laboratory evaluations were performed to demonstrate that the new device will perform as intended. A clinical literature search was also conducted and the literature supports the intended use of the new device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The eagle and profiles are black, and they are surrounded by a circular border. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is written along the border of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 0 2006
Ms. Wendy L. Turner, RAC Group Manager, Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242
Re: K053631
Trade/Device Name: CONTOUR® TRANSTAR™ Curved Cutter Stapler Set Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: December 28, 2005 Received: December 29, 2005
Dear Ms. Turner:
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 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
3
Page 2 - Ms. Turner
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) 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" (21 CFR 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/industry/support/index.html.
Sincerely yours,
Barclay Brechin
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K05363j
Indications for Use
510(k) Number (if known):
Device Name: CONTOUR® TRANSTAR™ Curved Cutter Stapler Set
Indications for Use:
The CONTOUR® TRANSTAR™ Curved Cutter Stapler and accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculomucosal tissue.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Page 1 of 1
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Labare Buchar
Division of General, Restorative. and Neurological Devices
(Posted November 13, 2003)
KUS 363 510(k) Number_