The Rex Medical Cleaner II Rotational Thrombectomy System permits mechanical declotting and removal of thrombi and emboli in synthetic dialysis grafts. The Embolectorny balloon component, located on the Cleaner II Device, may be used for subsequent Embolectorny procedures to remove embol and thrombi in the arterial system communicating with the synthetic dialynisor afte

Device Description

The Rex Medical Cleaner II Rotational Thrombectorny System is a battery operated, hand held, wall contacting, rotational thrombectorny 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 II macerates clot into particulate size that is not harmful to the patient. The integrated Embolectorny balloon provides a means to remove macerated thrombi, as well as wall adherent thrombi, from the dialysis graft. If required, the Embolectomy balloon located on the Cleaner II device may be used to remove any additional thrombi or emboli from the patient after the initial thrombectorny procedure has been performed,

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Rex Medical Cleaner II Rotational Thrombectomy System:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes non-clinical performance testing rather than acceptance criteria for clinical efficacy. The device's "performance" is primarily assessed against predicate devices through various engineering and material tests, demonstrating substantial equivalence.

Acceptance Criteria (Test)	Reported Device Performance
Stall Torque Test	Performed, contributed to substantial equivalence
Tensile Test	Performed, contributed to substantial equivalence
Valve Compression Test	Performed, contributed to substantial equivalence
Contrast Infusion Test	Performed, contributed to substantial equivalence
Wire Fatigue Test	Performed, contributed to substantial equivalence
Clot Maceration in Graft	Performed, contributed to substantial equivalence
Dimensional Analysis of Balloon	Performed, contributed to substantial equivalence
Catheter	Performed, contributed to substantial equivalence
Balloon Leakage and Damage	Performed (Per ISO 10555-4), contributed to substantial equivalence
Overall Safety and Effectiveness	Determined to be as safe and effective as predicate devices

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document states that the "statistical sampling rationale for choosing the number of devices that were tested was based on ISO 2859-1 sampling plans in accordance with our projected lots (batch) size." However, the specific number of devices tested for each test is not provided in this summary.
Data Provenance: The tests are non-clinical, bench testing. Therefore, there is no country of origin for patient data or retrospective/prospective nature. It's laboratory-based testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Not Applicable: This was a non-clinical, bench testing study. No human experts were used to establish ground truth for a test set in the context of clinical performance or image interpretation. The ground truth for the engineering tests would be derived from physical measurements and standards (e.g., ISO standards).

4. Adjudication Method for the Test Set:

Not Applicable: There was no clinical test set requiring human adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No: The document does not mention any MRMC comparative effectiveness study. The evaluation focused on substantial equivalence through engineering bench tests, not comparative clinical performance with human readers/intervention.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not Applicable: This device is a mechanical thrombectomy system, not an AI algorithm or software. Therefore, the concept of "standalone performance" in the context of human-in-the-loop for AI is not relevant here. The device's performance is inherently mechanical, and its effectiveness is measured directly through its physical operation and effect on clots in a laboratory setting.

7. The Type of Ground Truth Used:

The ground truth for this device's evaluation was based on engineering standards and physical measurements. For example, the "Stall Torque Test" would have an engineering specification for acceptable torque; "Clot Maceration in Graft" would likely involve objective measures of clot breakdown and particulate size. These are derived from established scientific and engineering principles, often outlined in the referenced ISO standards (ISO 10555-1, ISO 10555-4).

8. The Sample Size for the Training Set:

Not Applicable: This is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI or algorithms.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable: As there is no training set, this question is not applicable.

Summary

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DEC 1 6 2003

Attachment 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.

K033793 The assigned 510(k) number is:

1. Submitter's Identification:

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

Contact: Mr. Michael Paris

Date Summary Prepared:

October 29, 2003

2. Name of the Device:

Rex Medical Cleaner II Rotational Thrombectomy System".

3. Common or Usual Name:

Intraluminal Artery Stripper (Peripheral Atherectomy Catheter)

4. Predicate Device Information:

1. K031610: Cleaner™ Rotational Thrombectomy System
1. K902327: Embolectorny Catheter
1. K032393: Stopcock
1. K022170: Inner-Lock™ Sheath Introducer
1. K032569: Short Sheath Introducer

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5. Device Description:

6. Intended Use:

The Rex Medical Cleaner II Rotational Thrombectomy System permits mechanical declotting and removal of thrombi and emboli in synthetic dialysis grafts. The Embolectory balloon component, located on the Cleaner II Device, may be used for subsequent Embolectomy procedures to remove emboli and thrombi in the arterial system communicating with the synthetic dialysis graft

7. Comparison to Predicate Devices:

The Cleaner II device has the same technological features as the predicate devices.

The following testing was performed to prove substantial equivalence of the Rex Medical Cleaner II Rotational Thrombectomy Device to the predicate devices:

Stall Torque Test
Tensile Test
Valve Compression Test
Contrast Infusion Test
Wire Fatigue Test
Clot Maceration in Graft
Dimensional Analysis of Balloon
Catheter
Balloon Leakage and Damage(Per ISO 10555-4)

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Testing proved that the Rex Medical Cleaner II device is as safe and effective as the predicate devices.

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

Performance testing, which includes testing protocols, testing results and conclusions, were based on ISO 10555-1, ISO 10555-4, and FDA's "Guidance on Pre-market Notification (510(k)) Submission for Short-Term and Long-Term Intravascular Catheters", was submitted with this submission.

Statistical sampling rationale for choosing the number of devices that were tested was based on ISO 2859-1 sampling plans in accordance with our projected lots (batch) size.

Testing results revealed that the Rex Medical Cleaner II Rotational Thrombectorny System device is substantially equivalent to the predicate devices.

். Conclusions:

The subject device, Rex Medical Cleaner II Rotational Thrombectorny System, has the same intended use as the predicate devices. Moreover, bench testing contained in our submission and the non-clinical testing supplied demonstrates that there are no differences in their technological characteristics, thereby not raising any new questions of safety or effectiveness. Thus, the Rex Medical Cleaner II Rotational Thrombectomy System is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized wing segments.

DEC 1 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Rex Medical Inc. c/o Mr. Robert Mosenkis President Citech 5200 Butler Pike Plymouth Meeting, PA 19462-1298

Re: K033793 Cleaner II Rotational Thrombectomy System Regulation Number: 21 CFR 870.4875 Regulation Name: Peripheral Atherectomy Catheter Regulatory Class: Class II Product Code: MCW Dated: December 4, 2003 Received: December 5, 2003

Dear Mr. Mosenkis:

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.

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Page 2 - Mr. Robert Mosenkis

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA S Issualice of a succession complies with other requirements of the Act
that FDA has made a determination that your device complies - You must that FDA has made a decertimation that your are res by other Federal agencies. You must a or any Federal statutes and regulations daminding, but not limited to: registration and listing (21 lot comply with all the Act s requirements, me; come, cannfacturing practice requirements as set a CFR Part 807); labeling (21 CFR 1 at 001); good if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 11 app 1000, 1050 forth in the quality systems (QD) regallations (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Declons of Pevice as described in your Section 5 10(k)
This letter will allow you to begin marketing your device as described in your de I his letter will anow you to ocgin marketing of substantial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivaliance and t premarket nonification. The I Dry Imaning of basification 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 If you desire specific advice ion your do rice at (301) 594-4692. Also, please note the regulation entitled, Contact the Office of Compulation at (301) of the Part 807.97). You may obtain "Misoraliding by reference to premainterialities under the Act from the Division of Small other general information on your responsion.com at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address

(501) 445 059 059 050 000 / cdrh / dsma / dsmamain. html

Sincerely yours,

Ashley B. Banam

Image /page/4/Picture/6 description: The image shows a signature in black ink on a white background. The signature appears to be cursive and somewhat stylized, with loops and curves forming the letters. It is difficult to discern the exact letters or name represented by the signature due to its abstract nature.

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

Enclosure

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Exhibit B

Page _ 1 of of 1

K033793 510(k) Number (if known):

Device Name; Rex Medical Cleaner II Rotational Thrombectomy System

Indications For Use:

(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)

Ashley B. Baum

(Division Sian-off) Division of Cardidnasgular Devices

510(K) N...

K033793 (SM. K)

Over-The-Counter Use (Optional Format 1-2-96)

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).