(28 days)
Not Found
No
The summary describes a mechanical grasping device and does not mention any AI or ML components or functionalities.
No.
The device is described as a grasper used for tissue manipulation during minimally invasive procedures, which is an surgical instrument rather than a therapeutic device.
No
Explanation: The device description states its purpose is "tissue grasping and manipulation" and "tissue grasping and mobilization." It is an instrument used during procedures, not for diagnosis.
No
The device description explicitly states it is comprised of physical components like a polycarbonate handle, flexible shaft, and stainless steel jaws, 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 is for "tissue grasping and manipulation" during "minimally Invasive procedures." This describes a surgical or interventional tool used directly on the patient's body.
- Device Description: The description details a physical instrument with a handle, shaft, and jaws, designed for mechanical interaction with tissue.
- 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. IVDs are typically used for diagnosis, monitoring, or screening based on laboratory analysis.
Therefore, the USGI g-Prox EZ Endoscopic Grasper is a surgical/interventional device, not an IVD.
N/A
Intended Use / Indications for Use
The USGI g-Prox EZ 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)
OCZ, HET
Device Description
The g-Prox EZ Endoscopic Grasper is a sterile, single patient use device used for tissue grasping and mobilization. It is available in two jaw lengths. It includes a lumen that can accept the g-Cath Tissue Anchor Delivery Catheter and other small diameter instruments. It is comprised of a polycarbonate proximal handle, flexible shaft made of medical grade polymers and distal stainless steel jaws. It has a nominal working length and outer diameter of 111 cm and 5.5 mm, respectively.
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)
Non-clinical performance testing was conducted to ensure that the device performs as intended when used in accordance with its instructions for use and to demonstrate equivalence to the predicate device. Testing focused on those performance features related to the modifications and included device integrity testing (i.e., bond joint strength), functionality and in vivo simulated use testing. Test data confirmed that the modified g-Prox EZ device demonstrated equivalent safety and performance to the predicate device.
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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
K103688
Page 1/2
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 | JAN 14 2011 |
|---|---|---|
| a. Company Name: | USGI Medical | |
| b. Company Address: | 1140 Calle Cordillera | |
| San Clemente, CA 92673 | ||
| c. Telephone: | ||
| Fax: | (949) 369-3890 | |
| (949) 369-3891 | ||
| d. Contact Person: | Mary Lou Mooney | |
| Vice President of Clinical, | ||
| Regulatory & Quality | ||
| e. Date Summary Prepared: | January 14, 2011 | |
| 2. | DEVICE IDENTIFICATION | |
| a. Trade/Proprietary Name: | g-Prox EZ Endoscopic Grasper | |
| b. Common Name: | Grasper | |
| c. Classification Name: | Endoscope and accessories, 21 | |
| CFR 876.1500 |
3. IDENTIFICATION OF PREDICATE DEVICES
g-Prox Endoscopic Grasper
USGI Medical (K093018)
DESCRIPTION OF THE DEVICE 4.
The g-Prox EZ Endoscopic Grasper is a sterile, single patient use device used for tissue grasping and mobilization. It is available in two jaw lengths. It includes a lumen that can accept the g-Cath Tissue Anchor Delivery Catheter and other small diameter instruments. It is comprised of a polycarbonate proximal handle, flexible shaft made of medical grade polymers and distal
1
K103688
Page 2/2
stainless steel jaws. It has a nominal working length and outer diameter of 111 cm and 5.5 mm, respectively.
న్. STATEMENT OF INTENDED USE
The g-Prox EZ Endoscopic Grasper is intended for use in minimally invasive procedures to facilitate tissue grasping and mobilization.
6. COMPARISON WITH PREDICATE DEVICES
The g-Prox EZ Endoscopic Grasper is comparable to the predicate device in terms of intended use, technology, and materials. The shaft and distal jaw materials are identical to those used in the predicate device and are provided in the same sizes. The g-Prox EZ device handle is made of polycarbonate instead of Delrin. Both the g-Prox EZ and the predicate device have the identical intended use and principals of operation. Both the g-Prox EZ and the predicate device include a lumen that can accept the g-Cath Tissue Anchor Delivery Catheter and other small diameter instruments. The g-Prox EZ includes a suture cutting component in the jaw to allow the user to cut the g-Cath anchor suture tail with the g-Prox EZ.
7. SUMMARY OF PERFORMANCE DATA
Design control activities for the described 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 to identify any risks associated with the modifications.
Non-clinical performance testing was conducted to ensure that the device performs as intended when used in accordance with its instructions for use and to demonstrate equivalence to the predicate device. Testing focused on those performance features related to the modifications and included device integrity testing (i.e., bond joint strength), functionality and in vivo simulated use testing. Test data confirmed that the modified g-Prox EZ device demonstrated equivalent safety and performance to the predicate device.
In conclusion, non-clinical performance data demonstrate that the g-Prox EZ Endoscopic Grasper is as safe, effective and performs as well as the g-Prox predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
USGI Medical % Ms. Mary Lou Mooney Vice President of Clinical, Regulatory and Quality 1140 Calle Cordillera San Clemente, California 92673
JAN 1 4 201
Re: K103688
Trade/Device Name: g-Prox EZ Endoscopic Grasper Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OCZ, HET Dated: December 16, 2010 Received: December 17, 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.
3
Page 2 - Ms. Mary Lou Mooney
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 set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electionic 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.html far 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 toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely, yours,
AS B. nh
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K103688 510(k) Number (if known):
Device Name: g-Prox Endoscopic Grasper
Indications For Use 510(k) Number (if known):
The USGI g-Prox EZ Endoscopic Grasper is intended for use in minimally Invasive procedures to facilitate tissue grasping and manipulation.
Prescription Use V (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 Knaus
Page 1 of (
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K103688