(606 days)
Reprocessed multiple clip appliers are intended for the ligation of vessels or other tubular structures.
The reprocessed multiple clip applier is an automatic ligating clip applier. The device is preloaded with a minimum of 10 titanium ligating clips that individually advance after each clip application.
Acceptance Criteria and Study Details for ClearMedical Reprocessed Multiple Clip Appliers
The provided documents describe the 510(k) summary for the ClearMedical Reprocessed Multiple Clip Appliers, which are reprocessed versions of the Ethicon Ligaclip Multiple Clip Appliers. The submission focuses on demonstrating substantial equivalence to the predicate device through validation of reprocessing procedures, rather than a de novo clinical study with specific performance metrics for the reprocessed device's function in a surgical setting.
Therefore, the "acceptance criteria" and "reported device performance" are primarily related to the successful validation of the reprocessing process and the maintenance of equivalence to the predicate device in terms of function and safety.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (as per submission) |
|---|---|---|
| Cleaning Validation | Reprocessed devices must be effectively cleaned to remove biological and other contaminants to a pre-defined acceptable level. | "Validation of cleaning... demonstrate[s] reprocessed clip appliers perform as intended and are safe and effective." (No specific quantitative levels or tests are detailed in the summary, but this indicates successful completion of such validation.) |
| Performance Validation | Reprocessed devices must maintain the design, material, and functional performance characteristics equivalent to new predicate devices (e.g., clip advancement, clip formation, jaw closure, overall mechanical integrity). | "The technological characteristics of design, material, and functional performance of reprocessed multiple clip appliers are unchanged and remain equivalent to the predicate devices." "Validation of... performance... demonstrate[s] reprocessed clip appliers perform as intended and are safe and effective." (Implies testing was conducted to confirm functional equivalence, though specific tests and thresholds are not provided in this summary.) |
| Packaging Validation | Reprocessed devices must be packaged to maintain sterility and physical integrity until point of use. | "Validation of... packaging... demonstrate[s] reprocessed clip appliers perform as intended and are safe and effective." (Implies testing was conducted to confirm shelf-life and integrity of packaging.) |
| Sterilization Validation | Reprocessed devices must be resterilized to a Sterility Assurance Level (SAL) appropriate for the intended use and equivalent to the predicate device. | "Validation of... sterilization... demonstrate[s] reprocessed clip appliers perform as intended and are safe and effective." (Implies successful validation of the sterilization process.) |
| Biocompatibility Testing | Materials of construction, after reprocessing, must remain biocompatible and not leach harmful substances into the patient's body. | "Biocompatibility testing demonstrate[s] reprocessed clip appliers perform as intended and are safe and effective." (Implies successful completion of biocompatibility evaluations.) |
| Substantial Equivalence | The device must be demonstrated to be as safe and effective as a legally marketed predicate device, with equivalent intended use, technological characteristics, and performance. | "Based on information provided in this submission, ClearMedical Reprocessed Clip Appliers are substantially equivalent to the identified predicate devices and are safe and effective for their intended use." (This is the ultimate conclusion, supported by the validations mentioned above.) |
Study Details:
The provided 510(k) summary is for a reprocessed medical device. The "study" described is primarily a series of validation tests for the reprocessing procedures and comparison to the predicate device. It is not a clinical study evaluating the surgical or diagnostic performance of the device in patients in the same way an AI/software device would be.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document does not specify the exact sample sizes used for each validation test (e.g., cleaning, performance, packaging, sterilization, biocompatibility).
- Data Provenance: The data would have been generated internally by ClearMedical, Inc. during their reprocessing validation activities. This would be prospective testing conducted to support the 510(k) submission. No information on country of origin for this testing is provided, but it is implicit that it was conducted by or for ClearMedical, Inc. in the context of a US regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This type of information is generally not applicable to a reprocessing validation study for a manual surgical instrument. Ground truth would be defined by validated testing methods and specifications (e.g., cleanliness levels, sterility assurance levels, mechanical performance thresholds) rather than expert consensus on clinical findings or images. The "experts" would be individuals with expertise in:
* Reprocessing validation (cleaning, sterilization)
* Materials science and biocompatibility
* Mechanical engineering and functional testing of surgical instruments
The document does not detail the specific number or qualifications of these individuals.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or studies involving human interpretation of data where there might be disagreement among experts. Here, the "truth" is determined by objective physical and chemical testing against pre-defined specifications.
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:
This is not applicable. The device is a reprocessed manual surgical instrument, not an AI or imaging diagnostic device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This is not applicable. The device is a reprocessed manual surgical instrument, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for this device's validation is based on:
- Engineering specifications and performance standards: For mechanical function (e.g., clip apposition, jaw closure, clip retention, tensile strength, fatigue resistance).
- Microbiological standards: For sterility assurance and cleanliness levels.
- Chemical standards: For residual levels of cleaning agents or material degradation products.
- Biocompatibility standards: (e.g., ISO 10993 series) for material safety.
Essentially, the ground truth is "the device successfully meets its pre-defined engineering, performance, safety, and regulatory specifications after reprocessing, demonstrating equivalence to the new predicate."
8. The Sample Size for the Training Set:
This is not applicable. The device is a reprocessed manual surgical instrument, not an AI or machine learning model that requires a training set. The validation involves testing samples of the reprocessed physical device.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable for the same reason as #8.
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JUL 1 1 2005
510(k) Summary
.
| Submitter: | ClearMedical, Inc.1776 136th Place NEBellevue, WA 98005 |
|---|---|
| Contact: | Gene LimPh: (425) 460-2779Fax: (425) 401-1515 |
| Trade name: | ClearMedical Reprocessed Multiple Clip Appliers |
| Common name: | Non-reloadable Multiple Clip Appliers |
| Classification name: | Manual surgical instrument for general use (21 CFR 878.4800) |
| Product code: | GDO - Applier, Surgical, Clip |
| Predicate device: | K771412 - Ethicon Ligaclip MCA clip appliers |
| Device description: | The reprocessed multiple clip applier is an automatic ligating clipapplier. The device is preloaded with a minimum of 10 titaniumligating clips that individually advance after each clip application. |
| Intended use: | Reprocessed multiple clip appliers are intended for the ligation ofvessels or other tubular structures. |
| Technologicalcharacteristics: | Reprocessed multiple clip appliers are used devices that arecleaned, inspected, tested, packaged, and sterilized for anadditional single patient use. The technological characteristics ofdesign, material, and functional performance of reprocessedmultiple clip appliers are unchanged and remain equivalent to thepredicate devices. |
| Test data: | Validation of cleaning, performance, packaging, and sterilizationtogether with biocompatibility testing demonstrate reprocessed clipappliers perform as intended and are safe and effective. |
| Conclusion: | Based on information provided in this submission, ClearMedicalReprocessed Clip Appliers are substantially equivalent to theidentified predicate devices and are safe and effective for theirintended use. |
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Image /page/1/Picture/2 description: The image is a black and white seal for the U.S. Department of Health and Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
OCT 1 6 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Clear Medical Corporation % Mr. Mike Kovacs 1776 136th Place Northeast Bellevue, Washington 98005
Re: K033579
Trade/Device Name: Reprocessed Multiple Clip Appliers Models, MCL20, MCM20, MCM30, MCS20 Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: NMJ Dated: July 11, 2005 Received: May 31, 2005
Dear Mr. Kovacs:
This letter corrects our substantially equivalent letter of July 11, 2005.
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 (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); 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. Mike Kovacs
This letter will allow you to continue 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/cdrh/dsma/dsmamain.html
Sincerely yours,
Pue Dally
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): K033579
Ethicon Ligaclip Multiple Clip Appliers Device Name:
Indications for Use:
The Ethicon Ligaclip Multiple Clip Appliers are instruments used for ligation of tubular structures and vessels.
AND/OR Over-The-Counter Use Prescription Use X (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT MRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
of Device Evaluation (ODE) Concurrence of CDRH, Off.
De of
Division of General, Restorative, and Neurological Devices
510(k) Number K033575
Page 1 of
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Device Listing:
MCL20 MCM20 MCM30 MCS20
§ 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.