(212 days)
The g-Cath Tissue Anchor Delivery Catheter is intended for approximation of soft tissue in minimally invasive gastroenterology procedures.
The g-Prox Endoscopic Grasper is intended for use in minimally invasive procedures to facilitate tissue grasping and mobilization.
The g-Prox Endoscopic Grasper is a sterile, single patient use device used for tissue grasping and mobilization. It is also used as an accessory to the g-Cath Tissue Anchor Delivery Catheter for placement of tissue anchors for soft tissue approximation in minimally invasive gastroenterology procedures. A nitinol/polyester tissue anchor pair is deployed through the g-Cath Tissue Anchor Delivery Catheter lumen and compressed to approximate soft tissue. Anchor tensile strength meets USP for a size 4-0 nonabsorbable suture. The anchor does not meet USP for diameter and is oversized by 100% compared to a 4-0 nonabsorbable suture.
The provided text describes a 510(k) submission for the g-Cath Tissue Anchor Delivery Catheter and g-Prox Endoscopic Grasper, focusing on their substantial equivalence to predicate devices. It does not present acceptance criteria or a study proving that the device meets specific acceptance criteria in the way a clinical performance study would for an AI/ML device.
Instead, the submission focuses on:
- Comparison with Predicate Devices: Demonstrating that the new devices are comparable to existing legally marketed devices in terms of intended use, technology, design, and materials.
- Preclinical Testing: Stating that "Bench and animal testing demonstrated satisfactory performance of the g-Prox Endoscopic Grasper and g-Cath Tissue Anchor Delivery Catheter." This is a general statement of satisfactory performance, not a detailed report against specific, quantified acceptance criteria.
- Compliance with Industry Standards: The g-Cath Tissue Anchor's tensile strength is stated to meet USP for a size 4-0 nonabsorbable suture, although its diameter is oversized. This is the closest thing to a specific performance metric mentioned.
Given this context, I cannot extract the information requested as it pertains to AI/ML device performance studies. The provided document is for a medical device clearance (510(k)) that relies on preclinical testing and substantial equivalence to predicate devices, not a human-in-the-loop or standalone AI/ML performance study.
Therefore, most of your requested table and points regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies for AI performance cannot be answered from the provided text.
Here's a breakdown of what information can be extracted or inferred based on the document's nature:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| g-Cath Anchor tensile strength (similar to predicate sutures) | Meets USP for a size 4-0 nonabsorbable suture. |
| General satisfactory performance during preclinical testing | Bench and animal testing demonstrated satisfactory performance. |
| Material and design compatibility with intended use | Comparable to predicate devices in materials and design. |
| Functionality (grasping, mobilization, tissue approximation) | Performs grasping, mobilization, and tissue approximation as intended. |
| Sterility, single-patient use (implied from description) | Described as sterile, single-patient use. |
| Anchor diameter consistency with USP (implied, though not met) | Oversized by 100% compared to a 4-0 nonabsorbable suture (for diameter). |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for bench or animal testing. The text only states "Preclinical testing was performed..."
- Data Provenance: The testing was "Bench and animal testing," indicating lab-based and in-vivo animal studies. Country of origin is not specified but implicitly US-based given the FDA submission. These are prospective tests for device validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. The "ground truth" here would relate to the physical and functional properties of the device, likely assessed by engineers and veterinarians/pathologists in animal studies, not human experts establishing ground truth for diagnostic AI.
4. Adjudication method for the test set
- Not applicable/Not provided. Adjudication methods are typically relevant for human reader studies or expert consensus, not for mechanical or animal performance testing.
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. This is not an AI/ML device, and no MRMC study was mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI/ML device. The "standalone performance" was the physical device independent of human assistance in a diagnostic context.
7. The type of ground truth used
- Bench Testing: Ground truth would be based on established engineering standards, physical measurements (e.g., tensile strength testing against USP standards), and functional tests.
- Animal Testing: Ground truth would be based on physiological observations, histological assessment of tissue approximation, and veterinary pathology.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device where a "training set" would be used in the same context.
9. How the ground truth for the training set was established
- Not applicable. (See #8)
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DEC - 6 2005
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: | USGI Medical |
|---|---|
| b. Company Address: | 1140 Calle CordilleraSan Clemente, CA 92673 |
| c. Telephone:Fax: | (949) 369-3890(949) 369-3891 |
| d. Contact Person: | Mary Lou MooneyVice President of Clinical,Regulatory & Quality |
| e. Date Summary Prepared: | May 5, 2006 |
| DEVICE IDENTIFICATION | |
| a. Trade/Proprietary Name: | g-Cath™ Tissue AnchorDelivery Catheter |
| g-Prox™ EndoscopicGrasper | |
| b. Common Name: | PET SutureImplantable stapleGrasper |
| c. Classification Name: | Suture, PET; 878.5000 (GAT)Implantable Staple; 878.4750(GDW)Gynecologic laparoscope andaccessories: 884.1720 (HET) |
3. IDENTIFICATION OF PREDICATE DEVICES
| Polyester Non-absorbable Surgical Sutures | Genzyme BioSurgery(K021019) |
|---|---|
| Coil Fixation Device | Onux Medical (K023372) |
KOL 1276
Page 10 of 2
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2061276
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EndoANCHOR Fixation Device Ethicon Endo-Surgery (K013749) Ethicon Endo-Surgery EndoPATH Tissue Grasper (K930933) Olympus America FG Grasping Forcep (K962474)
DESCRIPTION OF THE DEVICE 4.
The g-Prox Endoscopic Grasper is a sterile, single patient use device used for tissue grasping and mobilization. It is also used as an accessory to the g-Cath Tissue Anchor Delivery Catheter for placement of tissue anchors for soft tissue approximation in minimally invasive gastroenterology procedures. A nitinol/polyester tissue anchor pair is deployed through the g-Cath Tissue Anchor Delivery Catheter lumen and compressed to approximate soft tissue. Anchor tensile strength meets USP for a size 4-0 nonabsorbable suture. The anchor does not meet USP for diameter and is oversized by 100% compared to a 4-0 nonabsorbable suture.
STATEMENT OF INTENDED USE 5.
The g-Prox Endoscopic Grasper is intended for use in minimally invasive procedures to facilitate tissue grasping and mobilization.
The g-Cath Tissue Anchor Delivery Catheter is intended for soft tissue approximation in minimally invasive gastroenterology procedures.
COMPARISON WITH PREDICATE DEVICES 6.
The g-Prox Endoscopic Grasper is comparable to the predicate devices in terms of intended use, technology, design and materials. The g-Cath Tissue Anchor Delivery Catheter is similar to the predicate devices in that it is indicated for soft tissue approximation in minimally invasive gastroenterology procedures; however this device deploys a tissue anchor pair made of nitinol and polyester.
Preclinical testing was performed to ensure the devices perform as intended when used according to their instructions for use. Bench and animal testing demonstrated satisfactory performance of the g-Prox Endoscopic Grasper and g-Cath Tissue Anchor Delivery Catheter.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
USGI Medical % Ms. Mary Lou Mooney Vice President of Clinical, Regulatory & Quality 1140 Calle Cordillera San Clemente, California 92673
DEC - 6 2006
Re: K061276
Trade/Device Name: g-Cath Tissue Anchor Delivery Catheter g-Prox Endoscopic Grasper Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT, GDW, HET Dated: November 10, 2006 Received: November 13, 2006
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.
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
Image /page/2/Picture/11 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is facing to the right and has a sleek, modern design.
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Page 2 - Ms. Mary Lou Mooney
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.
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 logally 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 vo
for
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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KA61276
page 1 of 2
Indications for Use
510(k) Number (061276
Device Name: g-Cath Tissue Anchor Delivery Catheter
Indications For Use:
The g-Cath Tissue Anchor Delivery Catheter is intended for approximation of soft tissue in minimally invasive gastroenterology procedures
Prescription Use / (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)
Pdo
ivision Sign-O Division of General, Restorative, and Neurological Devices
Page 1 of 2
Number L061276
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061276
Indications for Use
510(k) Number (if known): [ 012-776
Device Name: g-Prox Endoscopic Grasper
Indications For Use:
The g-Prox Endoscopic Grasper is intended for use in minimally invasive procedures to facilitate tissue grasping and mobilization.
Prescription Use (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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
Page Lof _ % 510(k) Number
§ 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.