(28 days)
The Suture Clinch fastens sterile non-absorbable sutures in sizes 0 to 4-0 USP by crimping the suture ends during soft tissue approximation.
The Suture Clinch fastens sterile non-absorbable sutures in sizes 0 to 4-0 USP by crimping the suture ends during soft tissue approximation. The Suture Clinch is manufactured from poly acetyl plastic. Its unique shape provides an optimum means of capturing and securing the suture. The unique shape of the Suture Clinch also allows the applicator (clip applier) to close the Suture Clinch completely around the suture. The single use Suture Clinch Cartridge is supplied sterile, packaged individually in a Tyvek® pouch. The method of sterilization is EO with a Sal of 10°.
Here's an analysis of the provided text regarding the Suture Clinch device's acceptance criteria and studies:
Based on the provided information, the Suture Clinch (K033024) is a predicate device, meaning its 510(k) submission primarily focuses on demonstrating substantial equivalence to a previously cleared device (K992852), rather than extensive de novo clinical trials. Therefore, the details regarding clinical study design, sample sizes, expert involvement, and ground truth are very limited or non-existent in this typical 510(k) summary for a predicate device.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (K992852) | "The Suture Clinch is substantially equivalent to the Applied Medical Suture Clinch cleared under Applied Medical's previous 510(k) filing number K992852.""The Technological characteristics are the same as or equivalent to the predicated device." |
| Biocompatibility (material in clinch) | "The polyacetal material used in the clinch is shown to be biocompatible according to ISO 10993-1 requirements." |
| Design control, risk analysis, design verification in accordance with 21 CFR § 820.30, EN 1441, ISO 9001/13485, AAMI/ISO TIR 14971. | "Design control, risk analysis and design verification activities...have been conducted in accordance with all applicable internal Applied Medical Procedures.""validation and verification activities addressed the profile." |
| Performance requirements specified by internal procedures (presumably related to crimping sutures and soft tissue approximation) | Not explicitly detailed in terms of quantitative performance metrics, but implicitly met by substantial equivalence and bench testing. |
| Sterility (SAL of 10⁻⁶) | "The single use Suture Clinch Cartridge is supplied sterile... The method of sterilization is EO with a Sal of 10⁻⁶." |
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 for Test Set: Not explicitly stated. The submission mentions "bench top testing was conducted and comparisons were made to the predicated device." This typically refers to laboratory testing, not human subject testing. The sample size for such bench testing (e.g., number of sutures crimped, force tests) is not provided.
- Data Provenance: The nature of "bench top testing" suggests it was conducted internally by the manufacturer. The country of origin and whether it was retrospective or prospective is not specified but likely internal lab data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable / Not specified. Given this is a 510(k) for a predicate device based on bench testing (not a clinical study involving diagnosis or interpretation), there's no mention of experts establishing a "ground truth" in the sense of clinical annotations or disease labels. The "ground truth" for non-clinical testing would be defined by engineering specifications and predicate device performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable / None specified. Adjudication methods are typically used in clinical studies when multiple human readers evaluate data (e.g., images) to resolve discrepancies. This device's submission revolves around bench testing, not clinical evaluation by multiple human assessors.
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. An MRMC study was not conducted. This device is a physical surgical clip, not an AI-powered diagnostic or assistive tool. Therefore, there's no concept of human readers improving with or without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a physical, mechanical medical device. It does not involve an algorithm or AI that would have a "standalone" performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the bench testing, the "ground truth" would be the engineering specifications and performance characteristics of the predicate device (K992852). For biocompatibility, the ground truth is established by the ISO 10993-1 requirements. No clinical data (pathology, outcomes data, expert consensus on clinical cases) is mentioned as being used for ground truth.
8. The sample size for the training set
- Not applicable / Not specified. This device does not involve machine learning or AI, so there is no concept of a "training set" in the conventional sense.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for an AI/ML algorithm for this physical device, there's no ground truth established for it.
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| OCT 2 4 2003 | |
|---|---|
| 510(k) SUMMARY | |
| 510(k) NUMBER: | K033024 |
| SUBMITTED BY: | Applied Medical Resources Corporation22872 Avenida EmpresaRancho Santa Margarita, CA 92688Phone: 949-713-8327Fax: 949-713-8205e-mail: cblake@appliedmed.com |
| CONTACT PERSON: | Cheryl BlakeDirector of Regulatory Affairs and Clinical Programs |
| DATE OF PREPARATION: | October 16, 2003 |
| NAME OF DEVICE: | Suture Clinch |
| TRADE NAME: | Not Determined |
| COMMON OR USUAL NAME: | Suture Fixation Device |
| CLASSIFICATION NAME: | Implantable Clip (21 CFR 878.4300) |
SUMMARY STATEMENT:
Identification of the legally marketed: The Applied Medical Suture Clinch is substantially equivalent to the Applied Medical Suture Clinch cleared under Applied Medical's previous 510(k) filing number K992852.
Description:
The Suture Clinch fastens sterile non-absorbable sutures in sizes 0 to 4-0 USP by crimping the suture ends during soft tissue approximation. The Suture Clinch is manufactured from poly acetyl plastic. Its unique shape provides an optimum means of capturing and securing the suture. The unique shape of the Suture Clinch also allows the applicator (clip applier) to close the Suture Clinch completely around the suture. The single use Suture Clinch Cartridge is supplied sterile, packaged individually in a Tyvek® pouch. The method of sterilization is EO with a Sal of 10°.
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K032034 2/2
Intended Use: The Sunce Clinch is a sterile single use clip intended fasten suture during laparoscopic surgery.
Non-clinical Testing: Bench top testing was conducted and comparisons were made to the predicated device.
Summary of Technological Characteristics: The Technological characteristics are the same as or equivalent to the predicated device and introduce no new safety and effectiveness issues when used as instructed. The polyacetal material used in the clinch is shown to be biocompatible according to ISO 10993-1 requirements.
Design Control / Risk Analysis/Design Verification: Design control, risk analysis and design verification activities for the subject of this Special 510(k) have been conducted in accordance with all applicable internal Applied Medical Procedures. The design control process employed is inclusive of the elements stipulated by 21 CFR § 820.30. The risk analysis preformed identified the risks relative to the performance requirements, as specified by Applied Medical internal procedures for risk analysis. The Design Risk Assessment Profile was conducted in accordance to Applied Medical internal Stand Operating Procedures, EN 1441 standards, ISO 9001/ISO 13485, AAMI/ISO TIR 14971, and 21 CFR § 820.30, validation and verification activities addressed the profile. Based on the risk analysis, validation and verification activities were formally controlled and addressed by Applied Medical, the activities included the methods, tests used, and acceptance criteria applied.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 4 2003
Ms. Cheryl Blake Director of Regulatory Affairs and Clinical Programs Applied Medical Resources Corporation 22872 Avenida Empresa Rancho Santa Margarita, California 92688
Re: K033024
Trade/Device Name: Suture Cinch Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: FZP Dated: September 23, 2003 Received: September 26, 2003
Dear Ms. Blake:
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 - Ms. Cheryl Blake
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. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
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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KO33034
INDICATIONS FOR USE
Applied Medical Resources is providing this separate cover page for the Suture Clinch "Indications for Use" as required.
510(k) Number: Unknown
Suture Clinch Device Name:
Indications for Use: The Suture Clinch fastens sterile non-absorbable sutures in sizes 0 to 4-0 USP by crimping the suture ends during soft tissue approximation.
Signature: Title: Director RA/Clinical Programs Date: 9-23-03
Miriam C. Provost
Division of General, Restorative and Neurological Devices
510(k) Number K033024
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR Over-The -Counter Use
(Optional Format 1-2-96)
§ 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.