(90 days)
Not Found
No
The description focuses on a mechanical fixation device and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a fixation device for prosthetic material and soft tissue, used in surgical procedures like hernia repair. It is a tool for mechanical fixation, not a therapeutic device that treats or cures a disease or condition.
No
The device is intended for fixation of prosthetic material and approximation of soft tissue during surgical procedures, which is a therapeutic rather than a diagnostic function.
No
The device description clearly describes physical instruments (shafts, anchors) and their dimensions, indicating it is a hardware 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 the device is for "fixation of prosthetic material to and approximation of soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair." This describes a surgical tool used during a procedure on a patient's body.
- Device Description: The description details a surgical instrument that deploys anchors into tissue. This is consistent with a surgical device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing information about a patient's health status or disease.
- Anatomical Site: The anatomical site is "soft tissue," which is where the surgical procedure is performed, not a sample being analyzed.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description. It is a surgical fixation device.
N/A
Intended Use / Indications for Use
The EndoANCHOR Fixation Device is intended for fixation of prosthetic material to and approximation of soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair.
The OpenANCHOR Fixation Device is intended for fixation of prosthetic material to and approximation of soft tissue in various open general surgical procedures, such as hernia repair.
Product codes
GDW, GCJ
Device Description
The EndoANCHOR and OpenANCHOR Fixation Devices are sterile, single patient use instruments that deploy nitinol anchors into prosthetic material and soft tissue for fixation and approximation applications. The nitinol anchors are 5.9 mm long and 6.7 mm wide. The EndoANCHOR fixation device is designed for endoscopic surgical use with a trocar or for oven surgical use. Two sizes of the EndoANCHOR Fixation Device are offered: a 3 mm and 5 mm diameter shaft. Both instrument shafts are 301 mm long and contain 20 nitinol anchors. The OpenANCHOR Fixation Device is designed for open surgical use. The instrument has a 132mm long, 3 mm diameter shaft and contains 10 nitinol anchors.
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
Preclinical testing was performed to ensure the device performs as intended when used I roomling to the instructions for use. Bench and animal testing demonstrated satisfactory according to the EndoANCHOR and OpenANCHOR Fixation Devices during surgical procedures.
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.
0
EndoANCHOR and OpenANCHOR 510(k) Summary of Safety and Effectiveness
Company:
Ethicon Endo-Surgery, Inc. 4545 Creek Rd. Cincinnati. OH 45242
FEB 1 1 2002
1/2
Contact:
Name: Doug Kentz Title: Regulatory Affairs Associate II
Date Prepared:
November 12, 2001
Name of Device:
Trade Name: EndoANCHOR and OpenANCHOR Fixation Devices Classification Name: Stapler, General & Plastic Surgery
Predicate Devices:
- Ethicon Endo-Surgery, Inc. ENDOPATH EMS cleared under K913469 on September . 30 1991.
- United States Surgical Corp. AutoSuture™ ProTack™ cleared under K963999 on . November 27, 1996.
Device Description:
The EndoANCHOR and OpenANCHOR Fixation Devices are sterile, single patient use instruments that deploy nitinol anchors into prosthetic material and soft tissue for fixation and approximation applications. The nitinol anchors are 5.9 mm long and 6.7 mm wide. The EndoANCHOR fixation device is designed for endoscopic surgical use with a trocar or for oven surgical use. Two sizes of the EndoANCHOR Fixation Device are offered: a 3 mm and 5 mm diameter shaft. Both instrument shafts are 301 mm long and contain 20 nitinol anchors. The OpenANCHOR Fixation Device is designed for open surgical use. The instrument has a 132mm long, 3 mm diameter shaft and contains 10 nitinol anchors.
Intended Use:
The EndoANCHOR Fixation Device is intended for fixation of prosthetic material to and approximation of soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair.
The OpenANCHOR Fixation Device is intended for fixation of prosthetic material to and approximation of soft tissue in various open general surgical procedures, such as hernia repair.
1
Technological Characteristics:
The EndoANCHOR and OpenANCHOR Fixation devices are similar to the predicate I ho Endor INON of the same intended use however these devices deploy an anchor shaped implant made of nitinol for fixation and approximation purposes.
Performance Data
Preclinical testing was performed to ensure the device performs as intended when used I roomling to the instructions for use. Bench and animal testing demonstrated satisfactory according to the EndoANCHOR and OpenANCHOR Fixation Devices during surgical procedures.
2
Image /page/2/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 an abstract image of an eagle or bird-like figure with three stylized wing or feather shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1 2002
Mr. Doug Kentz, RAC Senior Regulatory Affairs Associate Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242
Re: K013749
Trade/Device Name: EndoANCHOR and OpenANCHOR Fixation Devices Regulation Number: 878.4750, 876.1500 Regulation Name: Implantable staple Endoscope and accessories Regulatory Class: II
Product Code: GDW, GCJ Dated: November 12, 2001 Received: November 13, 2001
Dear Mr. Kentz:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreate) to regary the enactment date of the Medical Device Amendments, or to conniner of they 2011-11-11 accordance with the provisions of the Federal Food, Drug, de nees that have boon require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, clerelore, mains 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 11 your device to such additional controls. Existing major regulations affecting your device can may or babyer to back as a saterial 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 I lease of devices and i Drimination that your device complies with other requirements of the Act than I Dr Haral statutes and regulations administered by other Federal agencies. You must or any 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 form in and ation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 -- Mr. Doug Kentz, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) This lotter will and in you've FDA finding of substantial equivalence of your device to a legally prematicated 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 and If you dosille specific advices and vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of Compliance at (201) 594-461 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Other general information turers, 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,
Muriam C. Provost
for 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
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Image /page/4/Picture/0 description: The image shows a sequence of handwritten characters and numbers. The sequence starts with the letter 'K', followed by a zero with a diagonal line through it, then the numbers '13749'. The characters are written in a simple, clear style, making them easily readable.
Page / of /
510(k) Number (if known): Kol 3749
Device Name: EndoANCHOR and OpenANCHOR Fixation Devices
Indications for Use:
The EndoANCHOR Fixation Device is intended for fixation of prosthetic material I he EndoALVCHON Pradion between various minimally invasive and open general surgical procedures, such as hernia repair.
The OpenANCHOR Fixation Device is intended for fixation of prosthetic material t he Open in Croxia of soft tissue in various open general surgical procedures, such as hernia repair.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Miriam C. Provost
Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K013749