(27 days)
Not Found
No
The description focuses on the mechanical function of cutting and stapling, with no mention of AI/ML terms or capabilities.
No
The device's function is to cut and staple tissues during surgical procedures. While these actions are part of a therapeutic process, the device itself is a surgical instrument and not designed for direct medical treatment or diagnosis in the way a therapeutic device (e.g., drug delivery system, pain relief device, or imaging device used for therapy guidance) is typically defined.
No
The device is described as a surgical stapler for transection and resection of tissues, which is a therapeutic rather than a diagnostic function.
No
The device description clearly describes a physical, sterile, single-use device with a curved head that cuts and staples, delivering titanium staples. This is a hardware device, not software.
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, or tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Description: The Curved Cutter Stapler is a surgical instrument used directly on tissues within the body during a surgical procedure. It cuts and staples tissue.
- Intended Use: The intended use is for "transection and resection of tissues" during "gastrointestinal surgical procedures." This is a direct surgical intervention, not a diagnostic test performed on a sample.
The description clearly indicates a surgical tool used in vivo (within the living body), not a device for performing tests on samples in vitro.
N/A
Intended Use / Indications for Use
The Curved Cutter Stapler is intended for use in gastrointestinal surgical procedures for transection and resection of tissues.
Product codes
GDW
Device Description
The Curved Cutter Stapler is a sterile, single use device with a curved head that cuts and staples. It delivers four staggered rows of titanium staples, two rows on each side of a cut line. The device is supplied with one cartridge and can be reloaded for a total of six (6) firings. The reloads will be 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
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
Bench and pre-clinical testing was performed to demonstrate that the device performs as intended.
Key Metrics
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.
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FEB = 4 2004
Curved Cutter Stapler and Reloads 510(k) Summary of Safety and Effectiveness
Company
Ethicon Endo-Surgery, Inc. 4545 Creek Rd. Cincinnati, OH 45242
Contact
Katie Fordyce Regulatory Affairs Associate II
Date Prepared:
January 8, 2004
Name of Device
Trade Name: Curved Cutter Stapler Classification Name: Staple, Implantable
Predicate Devices:
PROXIMATE ACCESS 55 Articulating Linear Stapler, cleared under K932434 on 02/07/94. PROXIMATE Linear Cutter, cleared under K843034 on 09/17/84.
Device Description
The Curved Cutter Stapler is a sterile, single use device with a curved head that cuts and staples. It delivers four staggered rows of titanium staples, two rows on each side of a cut line. The device is supplied with one cartridge and can be reloaded for a total of six (6) firings. The reloads will be 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.
Intended Use
The Curved Cutter Stapler is intended for use in gastrointestinal surgical procedures for transection and resection of tissues.
Technological Characteristics
The Curved Cutter Stapler is similar to the predicate devices in that it has the same intended use and is a single use sterile device. The Curved Cutter Stapler is different from the predicate devices in that it produces a curved staple line.
Performance Data
Bench and pre-clinical testing was performed to demonstrate that the device performs as intended.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 4 2004
Ms. Katie Fordyce, MBA Regulatory Affairs Associate II Ethicon Endo-Surgery, Inc. 4545Creek Road Cincinnati, Ohio 45242-2839
Re: K040038
Trade/Device Name: Curved Cutter Stapler Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: January 8, 2004 Received: January 8, 2004
Dear Ms. Fordycc:
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 enclosurc) 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 - Ms. Katie Fordyce, MBA
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. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
( 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
K040038
Page / of /
510(k) Number (if known): KO40038
Device Name: Curved Cutter Stapler
Indications for Use:
The Curved Cutter Stapler is intended for use in gastrointestinal surgical procedures for transection and resection of tissues.
Prescription Use
(Part 21 CFR 801 Subpart D) $\checkmark$
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)
Miriam C. Provost
. Ivision Sign-Off) sivision of General, Restorative Devices and Neurologic
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