(20 days)
Not Found
No
The summary describes a mechanical device for tissue approximation and does not mention any AI or ML components or functions.
No
The device is described as a tissue anchor delivery catheter intended for approximation of soft tissue, which is a mechanical function used in surgical procedures, not a therapeutic treatment of a disease or condition.
No
The device description and intended use indicate it is an interventional device used for tissue approximation, not for diagnosing conditions.
No
The device description clearly states it is a "sterile, single patient use device that contains a nitinol/polyester tissue anchor pair within the catheter lumen," indicating it is a physical medical 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 clearly states the device is for "approximation of soft tissue in minimally invasive gastroenterology procedures." This describes a surgical or interventional procedure performed directly on the patient's body.
- Device Description: The description details a catheter and tissue anchors used to "compress and approximate tissue." This is a mechanical action performed within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or 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, while this device is used to perform a procedure within the body.
N/A
Intended Use / Indications for Use
The USGI g- Cath Tissue Anchor Delivery Catheter is intended for approximation of soft tissue in minimally invasive gastroenterology procedures, e.g., fistula closure, perforation/leak closure and repair of dilated gastric tissue.
Product codes
GAT, GDW, HET
Device Description
The g-Cath Tissue Anchor Delivery Catheter is a sterile, single patient use device that contains a nitinol/polyester tissue anchor pair within the catheter lumen. The anchor pair is deployed through the catheter lumen to compress and approximate tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue in minimally invasive gastroenterology procedures
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
0
USGI Medical
(949) 369-3890
(949) 369-3891
Mary Lou Mooney
January 25, 2010
Catheter
Vice President of Clinical, Regulatory & Quality
1140 Calle Cordillera San Clemente, CA 92673
USGI Medical Special 510(k) Device Modification USGI g-Cath Tissue Anchor Delivery Catheter
. "4
FEB 1 7 2010
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92
1. SUBMITTER INFORMATION
a. Company Name:
b. Company Address:
c. Telephone: Fax:
d. Contact Person:
e. Date Summary Prepared:
DEVICE IDENTIFICATION 2.
a. Trade/Proprietary Name:
b. Common Name:
c. Classification Name:
Nonabsorbable (PET) surgical sutur, 878.5000
Nonabsorbable surgical suture
g-Cath Tissue Anchor Delivery
IDENTIFICATION OF PREDICATE DEVICES 3.
g-Cath Tissue Anchor Delivery Catheter
USGI Medical (K061276)
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USGI Medical Special 510(k) Device Modification USGI g-Cath Tissue Anchor Delivery Catheter
K100251 page 2/2
4. DESCRIPTION OF THE DEVICE
The g-Cath Tissue Anchor Delivery Catheter is a sterile, single patient use device that contains a nitinol/polyester tissue anchor pair within the catheter lumen. The anchor pair is deployed through the catheter lumen to compress and approximate tissue.
STATEMENT OF INTENDED USE ડ.
The USGI g-Cath Tissue Anchor Delivery Catheter is intended for soft tissue approximation in minimally invasive gastroenterology procedures, e.g., fistula closure, perforation/leak closure and repair of dilated gastric tissue.
COMPARISON WITH PREDICATE DEVICES 6.
The g- Cath Tissue Anchor Delivery Catheter is comparable to the predicate device in terms of intended use, technology, and materials.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the staff and two snakes intertwined around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB 1 7 2010
USGI Medical % Ms. Mary Lou Mooney VP, Clinical, Regulatory & Quality 1140 Calle Cordillera San Clemente, California 92673
Re: K100251
Trade/Device Name: g-Cath Tissue Anchor Delivery Catheter Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT, GDW, HET Dated: January 25, 2010 Received: January 28, 2010
Dear Ms. Mooney:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Mary Lou Mooney
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1.1.5809.html far the Center for Devices and Kadiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tollofire no ber (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K10025|
Device Name: g-Cath Tissue Anchor Delivery Catheter
Indications For Use:
The USGI g- Cath Tissue Anchor Delivery Catheter is intended for approximation of soft tissue in minimally invasive gastroenterology procedures, e.g., fistula closure, perforation/leak closure and repair of dilated gastric tissue.
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Kaine for MXM
(Division Sign-Off)
Division of Surgical, Cathopedie, and Restorative Devices
510(k) Number K100251 Page 1 of __
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