The Rex Medical Cleaner™ Rotational Thrombectomy System Kit is a battery operated, hand held, wall contacting, rotational thrombectomy device which provides an effective means to restore patency to occluded synthetic dialysis grafts. The rotational wire, with integrated soft distal tip, provides an atraumatic approach to mechanical thrombectorny. The Cleaner™ macerates clot into particulate size that is not harmful to the patient.

AI/ML Overview

This document is a 510(k) summary for the Rex Medical Cleaner™ Rotational Thrombectomy System Kit, which is a medical device. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, the input does not contain information on acceptance criteria, reported device performance, sample sizes for test sets, data provenance, number of experts or their qualifications for ground truth, adjudication methods, MRMC studies, standalone performance, or details on training sets.

The relevant sections are:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in the document as performance metrics. The focus is on demonstrating that modifications do not adversely affect safety and effectiveness compared to predicate devices.
Reported Device Performance:
- The original Cleaner™ Rotational Thrombectomy System had a specified rotational velocity of 4000 ± 500 RPM.
- The Cleaner™ Rotational Thrombectomy System Kit has a rotational velocity specified as 3000 - 4500 RPM.
- "Testing proved that there is no effect on the safety and efficacy of the Cleaner™ Rotational Thrombectomy System Kit with the additions and modification noted above."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not specified. The document mentions "Verification testing was performed" but does not detail the sample size or data provenance.

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. This device submission is about verifying manufacturing and design changes, not evaluating diagnostic performance against ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This type of adjudication is for studies involving multiple readers evaluating a test set against ground truth, which is not the nature of this submission.

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 mechanical thrombectomy system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a mechanical thrombectomy system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable in the context of diagnostic ground truth. The "ground truth" here is the established safety and effectiveness of the predicate device, against which the modified device is compared to ensure no adverse effects.

8. The sample size for the training set

Not applicable. This device does not involve a training set as it is not an AI/machine learning product.

9. How the ground truth for the training set was established

Not applicable.

Summary

{0}------------------------------------------------

FEB 2 6 2004

Exhibit #1

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:_K040252

Submitter's Identification: 1.

Rex Medical 555 North Lane Suite 6101 Conshohocken, PA 19428 (610) 940-0665

Ms. Susan Goldstein-Falk Contact: Alternate contact: Ms. Denise Flamer

Date Summary Prepared:

January 14, 2004

2. Name of the Device:

Rex Medical Cleaner™ Rotational Thrombectomy System Kit

3. Predicate Device Information:

Trade Name	510(k) Number
Rex Medical Cleaner™ Rotational Thrombectomy System	K031610
Rex Medical Inner-Lock™ Introducer Sheath	K022170
Rex Medical Short Introducer Sheath	K032569
Cleaner II Rotational Thrombectomy System	K033793
Arrow-Trerotola™ PTD Percutaneous Thrombolytic Device	K990829
Arrow-Trerotola™ PTD Percutaneous Thrombolytic Device	K970080

{1}------------------------------------------------

4. Device Description:

5. Intended Use:

The Cleaner™ Rotational Thrombectomy System Kit is designed for mechanical declotting in synthetic dialysis access grafts.

6. Comparison to Predicate Devices:

The Cleaner™ Rotational Thrombectomy System Kit is identical to the predicate Cleaner™ Rotational Thrombectomy System with the exception that the kit incorporates either an Inner-Lock™ Introducer Sheath or a Short Introducer Sheath.

The rotational velocity of the wire was originally specified as 4000 ± 500 RPM for the Cleaner™ Rotational Thrombectomy System. The rotational velocity of the wire for the Cleaner™ Rotational Thrombectomy System Kit is being specified as 3000 - 4500 RPM based on additional verification testing.

7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Verification testing was performed to ensure that the addition of the Inner-Lock Introducer Sheath or the Short Introducer Sheath did not adversely affect the use of the Cleaner™ Rotational Thrombectorny System. Verification testing was also performed to ensure that the change in the rotational velocity of the wire did not affect the safety and effectiveness of the Cleaner™ Rotational Thrombectorny System. Testing proved that there is no effect on the safety and efficacy of the Cleaner™ Rotational Thrombectorny System Kit with the additions and modification noted above.

{2}------------------------------------------------

Conclusions: 8.

The subject device, Rex Medical Cleaner™ Rotational Thrombectorny System Kit, has the same intended use as the predicate devices. Verification testing contained in our submission demonstrates that there is no difference in the technological characteristics of the device, thereby not raising any new questions of safety or effectiveness. Thus, the Rex Medical Cleaner™ Rotational Thrombectomy System Kit is substantially equivalent to the predicate devices.

{3}------------------------------------------------

Public Health Service

Image /page/3/Picture/11 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 26 2004

Rex Medical c/o Ms. Susan D. Goldstein-Falk Official Correspondent for Rex Medical mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, NY 11021

K040252 Rc:

Trade Name: Cleaner Rotational Thrombectomy System Kit Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: II (two) Product Code: MCW Dated: January 26, 2004 Received: February 04, 2004

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 may publish further announcements concerning your device in the Federal Register.

{4}------------------------------------------------

Page 2 - Ms. Susan D. 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 (301) 594-4648. 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,

Duna R. lochner

Bram D
Director
Division

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Exhibit B

Page ______ of ___ of __ 1 __

510(k) Number (if known): K# 040252

Device Name: Rex Medical Cleaner ™ Rotational Thrombectomy System Kit

Indications For Use:

The Cleaner ™ Rotational Thrombectomy System Kit is designed for mechanical declotting in synthetic dialysis access grafts.

Prescription Use X (Per 21 CFR 801 Subpart D)

Over-The Counter Use (21 CFT 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duns R to drages

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_k040252

Regulation Number and Section

§ 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).