(154 days)
Not Found
No
The device description focuses on mechanical features and surgical function, with no mention of AI/ML terms or capabilities.
No
The device is a surgical stapler used for cutting and stapling tissues during various surgical procedures, primarily for transection, resection, and/or creation of anastomoses. It does not treat or cure a disease or condition.
No
The CONTOUR™ Curved Cutter Stapler is intended for transection, resection, and/or creation of anastomoses, which are surgical procedures, not diagnostic activities. It is a surgical tool that cuts and staples tissue.
No
The device description clearly details a physical surgical stapler with mechanical components (staples, knife, triggers, pins, etc.) and reload cartridges, 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 surgical procedures involving transection, resection, and creation of anastomoses in various anatomical sites. This is a direct surgical intervention on the patient's body.
- Device Description: The device is a surgical stapler that cuts and staples tissue. This is a mechanical tool used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is a surgical instrument used directly on the patient during a procedure.
N/A
Intended Use / Indications for Use
The CONTOUR™ Curved Cutter Stapler and Reloads is intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general (gastrointestinal and skeletal muscle), gynecologic, urologic, and thoracic surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
GDW, GAG
Device Description
The CONTOUR™ Curved Cutter Stapler is a multifire, single patient use device with a curved head that cuts and staples. The device delivers four staggered rows of titanium staples, with a knife between the second and third row of staples, and creates a 40 mm curved transection. The device is designed with a feature which 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 five times, for a maximum of six firings per instrument during a single procedure. Each reload cartridge module includes a knife blade with two staggered rows of staples on each side, an anvil, a cutting washer, a retaining pin, and a staple retainer. Reload cartridges are available in two sizes: a blue cartridge for compressed tissue with a thickness of 1.5mm, and a green cartridge for compressed tissue with a thickness of 2.0mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal, skeletal muscle, gynecologic, urologic, thoracic
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
EB 26 200;
ア
510(k) Summary
- Company Ethicon Endo-Surgery, LLC Angora Industrial Park, Building G Caguas, Puerto Rico 00725
Contact Dennis Hahn Director, Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242 Phone: (513) 337-3134 FAX: (513) 337-1444 Email: dhahn1@eesus.ini.com
Date Prepared February 21, 2006
- Trade Name: CONTOUR™ Curved Cutter Stapler and Reloads Device Name Common or Usual Name: Cutter/Stapler and Reloads Classification Name: Staple, Implantable
- Predicate Devices K040038 Curved Cutter Stapler K061156 - ENDOPATH® Linear Cutters and Staplers
Device Description: The CONTOUR™ Curved Cutter Stapler is a multifire, single patient use device with a curved head that cuts and staples. The device delivers four staggered rows of titanium staples, with a knife between the second and third row of staples, and creates a 40 mm curved transection. The device is designed with a feature which 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 five times, for a maximum of six firings per instrument during a single procedure. Each reload cartridge module includes a knife blade with two staggered rows of staples on each side, an anvil, a cutting washer, a retaining pin, and a staple retainer. Reload cartridges are available in two sizes: a blue cartridge for compressed tissue with a thickness of 1.5mm, and a green cartridge for compressed tissue with a thickness of 2.0mm.
Indications for Use: The CONTOUR™ Curved Cutter Stapler and Reloads is intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general (gastrointestinal and skeletal muscle), gynecologic, urologic, and thoracic surgical procedures.
Technological Characteristics: The CONTOUR™ Curved Cutter Stapler is identical to the Curved Cutter Stapler predicate device with respect to technological characteristics. The CONTOUR™ Curved Cutter Stapler has the same intended use as the ENDOPATH® Linear Cutters and Staplers.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and tail. The eagle faces left. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, U.S.A."
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ethicon Endo-Surgery, LLC % Mr. Dennis Hahn, RAC Director, Regulatory Affairs 4545 Creek Road Cincinnati, Ohio 45242
2 8 8 8 2007
Re: K062869
Trade/Device Name: CONTOUR"" Curved Cutter Stapler and Reloads Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW, GAG Dated: January 29, 2007 Received: January 31, 2007
Dear Mr. Hahn:
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 sct 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 Hahn, RAC
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,
Neil R. Ogden
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K062869
Device Name: CONTOUR™ Curved Cutter Stapler and Reloads
Indications for Use:
The CONTOUR™ Curved Cutter Stapler and Reloads is intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general (gastrointestinal and skeletal muscle), gynecologic, urologic, and thoracic surgical procedures.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
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