(29 days)
Not Found
No
The summary describes a mechanical grasping device and does not mention any AI/ML terms or functionalities.
No
The device is described as an endoscopic grasper used for tissue grasping and manipulation, which is a surgical tool rather than a device intended for treating or rehabilitating a disease or injury.
No
This device is described as a grasper for tissue manipulation during minimally invasive procedures, which is a surgical tool, not a device used to identify or analyze a medical condition.
No
The device description clearly states it is a physical, sterile, single-patient use device with a lumen, indicating it is a hardware medical device.
Based on the provided information, the USGI g-Prox Endoscopic Grasper is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "tissue grasping and manipulation" during minimally invasive procedures. This is a surgical/interventional use, not a diagnostic test performed on samples outside the body.
- Device Description: The description focuses on its function as a tool for grasping and mobilizing tissue, and its ability to accept other instruments. This aligns with a surgical device.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances
- Providing diagnostic information about a patient's condition
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The g-Prox Endoscopic Grasper is a tool used within the body during a procedure.
N/A
Intended Use / Indications for Use
The g-Prox Endoscopic Grasper is intended for use in minimally invasive procedures to facilitate tissue grasping and mobilization.
The USGI g-Prox Endoscopic Grasper is intended for use in minimally invasive procedures to facilitate tissue grasping and manipulation.
Product codes (comma separated list FDA assigned to the subject device)
GAT, GDW, HET
Device Description
The g-Prox Endoscopic Grasper is a sterile, single patient use device used for tissue grasping and mobilization. It includes a lumen that can accept the g-Cath Tissue Anchor Delivery Catheter and other small diameter instruments.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was conducted to ensure that the modified device performs as intended when used according to its instructions for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 Special 510(k) Device Modification USGI g-Prox Endoscopic Grasper
K093018
page 1/2
OCT - 7 2009
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
SUBMITTER INFORMATION 1.
a. Company Name:
b. Company Address:
USGI Medical
1140 Calle Cordillera San Clemente, CA 92673
- c. Telephone: (949) 369-3890 Fax:
- d. Contact Person:
(949) 369-3891
Mary Lou Mooney Vice President of Clinical, Regulatory & Quality
e. Date Summary Prepared: September 3, 2009
2. DEVICE IDENTIFICATION
con is 1. ing submittee. g-Prox Endoscopic Grasper a. Trade/Proprietary Name:
b. Common Name:
c. Classification Name:
Grasper
Medical
cologic laparoscope and accessories, 884.1720
IDENTIFICATION OF PREDICATE DEVICES 3.
g-Prox Endoscopic Grasper
Mooney
USGI Medical
(K061276)dent of Clinica!,
regulators & Quality
g-1 rux Endoscopie ( rasper
.
. Columbia 376
1
USGI Medical Special 510(k) Device Modification USGI g-Prox Endoscopic Grasper
4. DESCRIPTION OF THE DEVICE
The g-Prox Endoscopic Grasper is a sterile, single patient use device used for tissue grasping and mobilization. It includes a lumen that can accept the g-Cath Tissue Anchor Delivery Catheter and other small diameter instruments.
5. STATEMENT OF INTENDED USE
The g-Prox Endoscopic Grasper is intended for use in minimally invasive procedures to facilitate tissue grasping and mobilization.
6. COMPARISON WITH PREDICATE DEVICES
The g-Prox Endoscopic Grasper 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.
ing angle in ortherelades a haman dant can accept the groch in volk circle Catheter and other small diameter instruments.
has a mechanism to vary a
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..
sa findose whe brush in considerable in the predicate devices in terms
16 1 in Ted
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
USGI Medical % Ms. Mary Lou Mooney VP of Clinical, Regulatory & Quality 1140 Calle Cordillera San Clemente, California 92673
OCT - 7 2009
Re: K093018
Trade/Device Name: g-Prox Endoscopic Grasper Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: Class II Product Code: GAT, GDW, HET Dated: September 3, 2009 Received: September 8, 2009
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 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
3
Page 2 - Ms. Kirsten H. Paulson
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/ucm115809.htm for 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/cdrh/mdr/ 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 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 vours.
Sincerely yours,
Mark McMillan
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
USGI Medical Special 510(k) Device Modification USGI g-Prox Endoscopic Grasper
Indications for Use
510(k) Number (if known): K093018
Device Name: g-Prox Endoscopic Grasper
Indications For Use:
The USGI g-Prox Endoscopic Grasper is intended for use in minimally invasive procedures to facilitate tissue grasping and manipulation.
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)
:ございし minimally Concurrence of CDRH, Office of Device Evaluation (ODE)
David Krane for MXM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093018
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