(52 days)
The GeniCon Clip Applier and implantable clips are intended for use during laparoscopic procedures for the purpose of approximating soft tissue, closing off vessels and other structures in order to stop bleeding or to connect internal tissues to aid in healing.
The Genicon Clip Applier is a disposable device with a plastic handle and a working shaft that is approximately 32cm in length. Within the shaft are 20 titanium clips. The handle of the instrument is depressed and a titanium clip, which resides in the distal iaw of the instrument. is pressed together around whatever structure is within the jaw of the instrument.
The GeniCon Clip Applier is a disposable device used in laparoscopic procedures for approximating soft tissue, closing off vessels and other structures to stop bleeding, or connecting internal tissues to aid in healing.
Here's an analysis of its acceptance criteria and the study that proves its performance:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Integrity and Durability | 1. Stress/Exposure Testing | Successfully performed (implied, no specific metrics provided) |
| Functional Safety | 2. Cleaning/Disinfection/Sterilization Testing | Successfully performed (implied, no specific metrics provided) |
| Clinical Efficacy | Ability to approximate soft tissue | Effective for its intended use (implied by substantial equivalence) |
| Ability to close off vessels and other structures | Effective for its intended use (implied by substantial equivalence) | |
| Ability to stop bleeding | Effective for its intended use (implied by substantial equivalence) | |
| Ability to connect internal tissues to aid in healing | Effective for its intended use (implied by substantial equivalence) |
Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with specific performance metrics against pre-defined acceptance criteria. The "Performance" section lists general categories of testing but does not provide quantitative results or explicit acceptance thresholds. The conclusion states that the device is "effective for its intended use" based on these tests and design characteristics.
2. Sample Size and Data Provenance
The document does not describe a clinical study with a "test set" in the conventional sense of human or animal subjects for evaluating clinical effectiveness. The performance tests mentioned ("Stress/Exposure Testing" and "Cleaning/Disinfection/Sterilization Testing") appear to be laboratory-based validation tests performed on the device itself. Therefore, information regarding sample size used for a test set, countries of origin of data, or retrospective/prospective nature is not applicable in this context.
3. Number of Experts and Qualifications for Ground Truth
For the performance tests described (Stress/Exposure, Cleaning/Disinfection/Sterilization), the concept of "ground truth" derived from expert consensus on medical images or pathology is not applicable. These are engineering and sterilization validation tests. The results would likely be evaluated against pre-defined engineering specifications or industry standards by qualified technical personnel rather than medical experts establishing a diagnostic ground truth.
4. Adjudication Method
As there is no described clinical study involving human assessment of outcomes or imaging, an adjudication method like 2+1 or 3+1 is not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was mentioned. The 510(k) submission primarily relies on demonstrating substantial equivalence to a predicate device through technological characteristics and performance testing, rather than a direct comparison of human reader performance with and without AI assistance. Therefore, information on effect size of human reader improvement with AI assistance is not applicable.
6. Standalone Performance Study
The document describes "performance tests" on the GeniCon Clip Applier itself. These tests (Stress/Exposure, Cleaning/Disinfection/Sterilization) are essentially evaluations of the standalone device's physical and functional properties. However, these are not clinical standalone performance studies in terms of diagnostic accuracy or a specific clinical endpoint typically seen with AI-powered devices. The clinical effectiveness is inferred through substantial equivalence to a predicate device.
7. Type of Ground Truth Used
For the described performance tests (Stress/Exposure, Cleaning/Disinfection/Sterilization), the ground truth would be based on:
- Engineering specifications: For stress/exposure testing, ensuring the device meets predefined strength, durability, and material integrity criteria.
- Regulatory standards: For cleaning/disinfection/sterilization, ensuring the device meets established standards for sterility and biocompatibility.
There is no mention of ground truth derived from expert consensus (beyond the designers/engineers establishing specifications), pathology, or outcomes data for these specific tests.
8. Sample Size for the Training Set
Since the GeniCon Clip Applier is a medical device (surgical clip applier) and not an AI/machine learning algorithm, the concept of a "training set" for an algorithm is not applicable.
9. How Ground Truth for the Training Set Was Established
As there is no AI/machine learning component or a "training set" in the context of this device, this question is not applicable.
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Section II: 510(k) Summary
MAR 2 0 2003
GeniCon, L.C. Contact: Frank Goldfarb P.O. Box 780038 Orlando, FL 32878-0038 Telephone: 407 616 3019 Fax: 407 306 9356
Date Prepared: February 28, 2003
Trade Name: GeniCon Clip Applier Common Name: GeniCon Clip Applier
Classification Name: According to Section 513 of the Federal Food, Drug, Cosmetic Act, the device classification is Class II, performance Standards (21 CFR 878.4800).
Predicate Device: United States Surgical Corporation
Product Description: The Genicon Clip Applier is a disposable device with a plastic handle and a working shaft that is approximately 32cm in length. Within the shaft are 20 titanium clips. The handle of the instrument is depressed and a titanium clip, which resides in the distal iaw of the instrument. is pressed together around whatever structure is within the jaw of the instrument.
Indications for Use:
The GeniCon Clip applier am implantable clips are intended for use during laparoscopic procedures for the purpose of approximating soft tissue, closing off vessels and other structures in order to stop bleeding or to connect internal tissues to aid in healing.
Performance:
A series of performance tests were performed on the GeniCon Clip Applier to test such areas as:
-
- Stress/Exposure Testing
-
- Cleaning/Disinfection/Sterilization Testing
The FDA has not adopted performance standards for this product.
Conclusion:
Based on the indications for use, technological characteristics and performance testing, the GeniCon Clip Applier has been shown to be effective for its intended use and substantially equivalent to the predicate device.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The profiles are facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 0 2003
Mr. Frank Goldfarb Sales Manager GeniCon, L.C. P.O. Box 780038 Orlando, Florida 32878-0038
Re: K030269
Trade/Device Name: Disposable Clip Applier Regulation Number: 21 CFR 878.4300, 21 CFR 878.4800 Regulation Name: Implantable Clip, Surgical Clip Applier Regulatory Class: II Product Code: FZP, GDO Dated: March 3, 2003 Received: March 6, 2003
Dear Mr. Goldfarb:
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 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.
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Page 2 - Mr. Frank Goldfarb
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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Mark N Millan
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image shows the text '510(k):' followed by 'K030269' on the right side of the image. The text is written in a simple, handwritten style. The numbers are clearly visible and the text is easy to read.
Section I. Indications for Use
Page: I-1
Device Name: Disposable Clip Applier
Indications for Use:
The GeniCon Clip Applier and implantable clips are intended for use during laparoscopic procedures for the purpose of approximating soft tissue, closing off vessels and other structures in order to stop bleeding or to connect internal tissues to aid in healing.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use
Use ✓
OR
Over-The-Counter
(Optional Format 1-2-96)
Mark N. Mulker
gn-Of era). Restorative
510(k) Number K030269
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.