(25 days)
The Rex Medical Cleaner™ Rotational Thrombectomy System is designed for mechanical declotting of synthetic dialysis access grafts.
The Rex Medical Cleaner™ Rotational Thrombectomy System is percutaneous mechanical thrombectomy device which provides an effective means to restore patency to occluded synthetic dialysis access grafts. The device is used in exactly the same manner as the predicate devices.
Based on the provided text, the Cleaner™ Rotational Thrombectomy System is a medical device, and the submission is a Special 510(k) for device modification. This means the device is already cleared, and the submission addresses changes rather than proving initial effectiveness. Therefore, the information typically requested for AI/software-as-a-medical-device (SaMD) studies (like sample size, ground truth, expert adjudication, etc.) is largely "Not Applicable" or not explicitly detailed in this type of submission.
Here's the breakdown of the information as it relates to the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions that "Test methodology and acceptance criteria were derived from within Rex Medical and from related ISO standards for evaluation of this device" for the non-clinical tests. However, the specific acceptance criteria and the detailed results of these tests (e.g., in a table format) are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable/Not provided. The document states "Discussion of Clinical Tests Performed: Not Applicable." This indicates that no clinical studies were performed for this specific 510(k) submission, as it relates to a modification of an already cleared device. The non-clinical tests were likely bench or in-vitro tests, and the "sample size" in that context would refer to the number of devices or components tested, which is not specified.
- Data Provenance: Not applicable/Not provided, as no clinical data is presented for this modification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not applicable. Since no clinical studies were performed, there was no need for experts to establish ground truth in the context of clinical performance evaluation.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. As no clinical studies were performed, no adjudication method for a test set is mentioned.
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
- MRMC Study: No. This device is a mechanical thrombectomy system, not an AI or imaging diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this product.
- Effect Size: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: No. This device is a mechanical thrombectomy system, not an algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable for a clinical study. For the non-clinical tests, the "ground truth" would be engineering specifications, physical measurements, and performance benchmarks defined by Rex Medical and ISO standards. The specific details of these are not provided.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This document describes a physical medical device, not an AI or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.
Summary of Device Performance (from the document):
The document states: "The verification testing contained in our submission demonstrates that there are no differences in their technological characteristics due to the device modification, thereby not raising any new issues of safety or effectiveness." This implies that the device, with its modifications, performs identically to the predicate device in terms of safety and effectiveness. The specific details of how this was demonstrated (e.g., quantitative performance data) are not included in this 510(k) summary.
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Exhibit #1
APE 28 11
Special 510(k): Device Modification Cleaner™ Rotational Thrombectorny System
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510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: __ K 06 0904
1. Submitter's Identification:
Rex Medical, LP 1100 East Hector Street, Suite 245 Conshohocken, PA 19428
Contact: Mr. John Leedle
Date Summary Prepared: February 9, 2006
2. Name of the Device:
Cleaner™ Rotational Thrombectomy System
3. Predicate Device Information:
K031610, Cleaner™ Rotational Thrombectomy System K040252, Cleaner™ Rotational Thrombectomy System Kit
4. Device Description:
The Rex Medical Cleaner™ Rotational Thrombectomy System is percutaneous mechanical thrombectomy device which provides an effective means to restore patency to occluded synthetic dialysis access grafts. The device is used in exactly the same manner as the predicate devices.
5. Intended Use:
The Cleaner™ Rotational Thrombectomy System is designed for mechanical declotting of synthetic dialysis access grafts.
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6. Comparison to Predicate Devices:
The Cleaner™ Rotational Thrombectomy System is identical to the predicate Cleaner™ Rotational Thrombectomy Systems with some design improvements added to the rotational guidewire. A flexible safety core was added to the inside of the rotational guidewire and a lubricious coating was added over the macerating element.
7. Discussion of Non-Clinical Tests Performed:
All testing performed on the Cleaner™ Rotational Thrombectomy System was derived from the risk assessment which evaluated the safety and effectiveness of the design changes to the guidewire. Test methodology and acceptance criteria were derived from within Rex Medical and from related ISO standards for evaluation of this device.
8. Discussion of Clinical Tests Performed:
Not Applicable
ல் Conclusions:
The subject device, Cleaner™ Rotational Thrombectomy System, has identical indications for use as the predicate Cleaner™ Rotational Thrombectomy Systems (K040252 and K031610). The verification testing contained in our submission demonstrates that there are no differences in their technological characteristics due to the device modification, thereby not raising any new issues of safety or effectiveness. The Cleaner™ Rotational Thrombectorny System is therefore substantially equivalent to the predicate Cleaner™ Rotational Thrombectomy Systems (K040252 and K031610).
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 8 2005
Rex Medical c/o Ms. Susan Goldstein-Falk mdi Consultants, Inc. 55 Northern Blvd. Suite 200 Great Neck, NY 11021
Re: K060904
Trade Name: Rex Medical Cleaner™ Rotational System Regulation Number: 21CFR §870.4875 Regulation Name: Thrombectomy Catheter Regulatory Class: II (two) Product Code: MCW Dated: February 9, 2006 Received: April 03, 2006
Dear Ms. Goldstein-Falk:
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 mav publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Susan Goldstein-Falk
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. 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) 276-0120 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/industry/support/index.html.
Sincerely yours.
Duna R. Luchner
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Bram D. Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Exhibit B
Indications for Use
of of of 1 a Page 1
510(k) Number (if known): K060904
Device Name: Cleaner ™ Rotational Thrombectomy System
Indications For Use:
The Rex Medical Cleaner™ Rotational Thrombectomy System is designed for mechanical declotting of synthetic dialysis access grafts.
Prescription Use _ X (Per 21 CFR 801 Subpart D)
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)
Dougher 12 - Va
(Division Sign-Off) (Division Sign-On)
Division of Cardiovascular Devices
510(k) Number 166904
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).