(87 days)
The g-Lix Tissue Grasper is intended for use in minimally invasive procedures to facilitate tissue grasping and mobilization, especially for tissue which will be removed, such as the gall bladder.
The g-Lix Tissue Grasper is a sterile, single patient use device used for tissue grasping and mobilization. It is comprised of a proximal rotation knob, flexible or rigid shaft and distal helix tip.
The g-Lix Tissue Grasper is a manual surgical instrument for general use. The provided text is a 510(k) summary for the device, which focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel performance metrics or conducting extensive clinical efficacy studies with specific acceptance criteria as would be done for AI/ML devices or more complex medical devices.
Therefore, the requested information elements (1-9) which are typically associated with AI/ML device evaluations or detailed clinical studies for performance validation are not fully applicable or derivable from this submission for a simple manual grasper.
However, I can extract the relevant information concerning bench testing which serves as the "study" for this type of device and functional equivalence as the implicit "acceptance criteria."
Here's an analysis based on the provided document:
Acceptance Criteria and Device Performance for g-Lix Tissue Grasper
1. A table of acceptance criteria and the reported device performance
For a manual surgical instrument like the g-Lix Tissue Grasper, the "acceptance criteria" are primarily established in relation to its intended use and functional equivalence to legally marketed predicate devices. The performance is assessed through bench testing to ensure it functions as designed without specific quantitative metrics provided in this summary.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Functional Equivalence: Device performs as intended for tissue grasping and mobilization, comparable to predicate devices in terms of intended use, technology, and materials. | Bench testing was conducted to ensure that the device performs as intended when used according to its instructions for use. |
| Safety: Does not introduce new safety concerns compared to predicate devices. | The 510(k) summary asserts substantial equivalence to predicate devices, inferring comparable safety profiles. |
| Sterility: Device is sterile for single-patient use. | "The g-Lix Tissue Grasper is a sterile, single patient use device..." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the 510(k) summary. Bench testing typically involves a number of samples to ensure reproducibility and reliability, but the exact quantity is not disclosed.
- Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing conducted by USGI Medical (the manufacturer in San Clemente, CA, USA). The testing would be prospective in nature as it's performed on new devices to validate their design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For a manual surgical instrument, "ground truth" in the context of expert review is typically not established for bench testing. The testing would likely involve engineers and technicians evaluating mechanical performance, grasping capabilities, and material integrity against design specifications and functional requirements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As described above, this type of testing does not typically involve expert adjudication methods commonly seen in clinical or diagnostic studies.
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
Not applicable. This device is a manual surgical instrument, not an AI/ML diagnostic tool. Therefore, an MRMC study and AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a manual surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not explicitly defined as "ground truth" in the context of this 510(k) submission. The "ground truth" for bench testing of a manual instrument generally refers to adherence to engineering specifications, functional performance requirements (e.g., grasping strength, material durability, rotation capability), and comparison to the performance of predicate devices. These are typically assessed through objective measurements rather than expert consensus on a diagnostic outcome.
8. The sample size for the training set
Not applicable. There is no training set mentioned or implied for this manual device.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
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510(k) Premarket Notification g-Lix Tissue Grasper
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 Cordillera San Clemente, CA 92673 c. Telephone: (949) 369-3890 Fax: (949) 369-3891
- d. Contact Person:
- e. Date Summary Prepared:
DEVICE IDENTIFICATION 2.
- a. Trade/Proprietary Name: g-I.ixTM Tissue Grasper
- b. Common Name: Grasper
c. Classification Name:
Manual surgical instrument for general use, 878.4800
ﮯ
4.410.
ನ್ನೆ IDENTIFICATION OF PREDICATE DEVICES
| EndoPATH Tissue Grasper | Ethicon Endo-Surgery |
|---|---|
| (K930933) |
FG Grasping Forcep
Olympus America (K962474)
JUL 3 1 2006
JUL 31 2006
KO61268
ical
40 Calle Cordillera
Clemente, CA 92673
Mary Lou Mooney Vice President of Clinical, Regulatory & Quality
May 4, 2006
-l ix
Tissue Grasper
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DESCRIPTION OF THE DEVICE 4.
The g-Lix Tissue Grasper is a sterile, single patient use device used for tissue grasping and mobilization. It is comprised of a proximal rotation knob, flexible or rigid shaft and distal helix tip.
STATEMENT OF INTENDED USE પં
The g-Lix Tissue Grasper is intended for use in minimally invasive procedures to facilitate tissue grasping and mobilization, especially for tissue which will be removed, such as the gall bladder.
COMPARISON WITH PREDICATE DEVICES 6.
The g-Lix Tissue Grasper is comparable to the predicate devices in terms of intended use, technology, and materials.
Bench testing was conducted to ensure that the device performs as intended when used according to its instructions for use.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 1 2006
USGI Medical % Ms. Mary Lou Mooney Vice President of Clinical, Regulatory & Quality l 140 Calle Cordillera San Clemente, California 92673
Re: K061268
Trade/Device Name: G-Lix Tissue Grasper Regulation Number: 21 CFR 884.1720 Regulation Name: Gynecologic laparoscope and accessories Regulatory Class: I Product Code: HET Dated: July 18, 2006 Received: July 19. 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 Mav 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 vour 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
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Page 2 - Ms. Mary Lou Mooney
forth in the quality systems (OS) 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 legally 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/cdrl/industry/support/index.html.
Sincerely yours,
Herbert Lewandrow
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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CONFIDENTIAL USGI Medical May, 2006
510(k) Premarket Notification g-Lix Tissue Grasper
Indications for Use
KOb 510(k) Number (if known):
Device Name: g-Lix Tissue Grasper
Indications For Use:
The g-Lix Tissue Grasper is intended for use in minimally invasive procedures to facilitate tissue grasping and mobilization, especially for tissue which will be removed, such as the gall bladder.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
Herbert Remmer
(Division Division of General, Restorative, and Neurological Devices
510(k) Number K012668
Page 1 of 1
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.