(19 days)
The g-Cath Tissue Anchor Deliver 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.
The g-Cath Tissue Anchor Delivery Catheter is a sterile, single patient use device that contains a nitinol/polyester/titanium tissue anchor pair within the catheter lumen. The anchor pair is deployed through the catheter lumen to compress and approximate tissue.
The provided text describes a 510(k) summary for the g-Cath Tissue Anchor Delivery Catheter. It focuses on the device's substantial equivalence to predicate devices and does not contain detailed information about acceptance criteria or a specific study proving device performance in the manner requested by the prompt (e.g., in a clinical setting with human readers, AI assistance, ground truth establishment, or training set details). Instead, it refers to "bench testing" to ensure the modified device performs as intended.
Based on the information provided, here's an attempt to answer the questions, highlighting where specific details are missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "Bench testing confirmed that the device met its performance specifications." However, the specific acceptance criteria (e.g., tensile strength, deployment force, tissue approximation efficacy) and the quantitative reported device performance values are not provided in this summary.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Specified | Met performance specifications (Specifics not provided) |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Bench testing" but does not specify the sample size used for these tests. There is no information regarding the data provenance (e.g., country of origin) or whether the data was retrospective or prospective, as this was laboratory bench testing, not clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Since the testing was bench testing of a device's physical properties, there would not be "experts" establishing ground truth in the clinical sense (e.g., radiologists interpreting images). The "ground truth" would be established by the engineering specifications and measurement of physical properties. The document does not specify the number or qualifications of engineers or technicians involved in establishing the testing protocols or verifying results.
4. Adjudication Method for the Test Set
Not applicable. As the testing was bench testing of device performance against specifications, an adjudication method for a test set (like 2+1 or 3+1 for expert consensus) is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. An MRMC comparative effectiveness study is not mentioned. This type of study relates to the performance of human readers, potentially with AI assistance, in interpreting clinical cases. The document describes bench testing of a physical medical device (tissue anchor delivery catheter) and does not involve AI or human "readers" in this context.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This question is relevant to AI algorithms. The document describes a physical medical device (g-Cath Tissue Anchor Delivery Catheter) and its bench testing, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for the bench testing would be the predefined engineering specifications and measurable physical properties of the device (e.g., material strength, deployment accuracy, tissue compression characteristics). The document states, "Bench testing confirmed that the device met its performance specifications," indicating that the "ground truth" was these specifications.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical instrument, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The term "training set" is typically used for data that an AI model learns from.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for a physical device.
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K102916 page 1/2
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
OCT 2 0 2010
- a. Company Name: USGI Medical b. Company Address:
- c. Telephone: Fax:
d. Contact Person:
1140 Calle Cordillera San Clemente, CA 92673
(949) 369-3890 (949) 369-3891
October 21, 2010
Mary Lou Mooney Vice President of Clinical, Regulatory & Quality
e. Date Summary Prepared:
DEVICE IDENTIFICATION 2.
a. Trade/Proprietary Name:
g-Cath Tissue Anchor Delivery Catheter
b. Common Name:
c. Classification Name:
Non-absorbable surgical suture
Non-absorbable (PET surgical suture, 878.5000
3. IDENTIFICATION OF PREDICATE DEVICES
g-Cath Tissue Anchor Delivery Catheter USGI Medical (K061276, K100251)
DESCRIPTION OF THE DEVICE 4.
The g-Cath Tissue Anchor Delivery Catheter is a sterile, single patient use device that contains a nitinol/polyester/titanium tissue anchor pair within the catheter lumen. The anchor pair is deployed through the catheter lumen to compress and approximate tissue.
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USGI Medical
Special 510(k) Device Modification
USGI g-Cath Tissue Anchor Delivery Catheter
ડ. STATEMENT OF INTENDED USE
The g-Cath Tissue Anchor Deliver 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.
COMPARISON WITH PREDICATE DEVICES 6.
The g-Cath Tissue Anchor Delivery Catheter is comparable to the predicate devices in terms of intended use, technology, and materials.
Bench testing was conducted to ensure that the modified device performs as intended when used according to its instructions for use.
7. SUMMARY OF PERFORMANCE DATA
Design control activities for the device modifications were completed in accordance with 21CFR 820.30 and USGI Medical documented design control procedures. Human factors considerations were also incorporated into the device modifications. Risk analysis was performed in accordance with USGI Medical procedures and ISO 14971 to identify any risks associated with the modifications. Bench testing confirmed that the device met its performance specifications.
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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 stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
USGI Medical % Ms. Mary Lou Mooney VP, Clinical, Regulatory & Quality 1140 Calle Cordillera San Clemente, California 92673
OCT 2 0 2010
Re: K102916
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: September 30, 2010 Received: October 1, 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
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Page 2 - Ms. Mary Lou Mooney
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 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/ucm115800 htm fast the Center for Devices and Radiological 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 tollofre number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Malleus
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
OCT 2 0 2010
KIO2916 510(k) Number (if known): .
Device Name: g-Cath Tissue Anchor Delivery Catheter
Indications For Use
510(k) Number (if known):
The 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.
V Prescription Use (Part 21 CFR 801 Subpart D) 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)
Daniel Kramer her MIVIM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
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510(k) Number K102916
§ 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.