REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEM

K031610 · Rex Medical · MCW · May 27, 2003 · Cardiovascular

Device Facts

• Record ID: K031610
• Device Name: REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEM
• Applicant: Rex Medical
• Product Code: MCW · Cardiovascular
• Decision Date: May 27, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4875
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Rex Medical Cleaner™ Rotational Thrombectomy System device permits mechanical declotting in synthetic dialysis grafts.

Device Story

Battery-operated, hand-held, rotational thrombectomy device; restores patency to occluded synthetic dialysis grafts. Input: mechanical rotation of wire within graft. Operation: integrated soft distal tip macerates clot into small, non-harmful particles; sinusoidal wave formed in drive wire facilitates cleaning. Output: macerated clot particulate. Used in clinical setting by physicians. Device features ergonomic handle with push-button activation and slide mechanism to protect distal wire segment. Benefits: atraumatic mechanical declotting.

Clinical Evidence

In-vivo animal studies performed. Results demonstrated that the device macerates clot formation in synthetic dialysis grafts as effectively, efficiently, and safely as the predicate devices. No human clinical trial data provided.

Technological Characteristics

Mechanical thrombectomy catheter; 6F sheath compatible; 65cm length. Energy source: battery-operated. Cleaning mechanism: sinusoidal wave formed in .035" drive wire. Features atraumatic radiopaque soft distal tip. Materials/standards: ISO 10555-1 compliance. Packaging: tray with Tyvek lid.

Indications for Use

Indicated for mechanical declotting in synthetic dialysis grafts.

Regulatory Classification

Identification

An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)

Predicate Devices

• Arrow-Trerotola™ PTD Percutaneous Thrombolytic Device (K990829)
• Arrow-Trerotola™ PTD Percutaneous Thrombolytic Device (K970080)
• Solera™ Bacchus™ Thrombectomy Catheter (BTC) (K003570)

Submission Summary (Full Text)

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MAY 27 2003

K031610

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 assianed 510(k) number is:

### 1. Submitter's Identification:

Rex Medical 555 North Lane Suite 6101 Conshohochen, PA 19428

Contact: Mr. Michael Paris

# Date Summary Prepared:

April 14, 2003

### 2. Name of the Device:

Rex Medical Cleaner™ Rotational Thrombectomy System".

#### 3. Predicate Device Information:

- 1. K#990829, Arrow-Trerotola™ PTD Percutaneous Thrombolytic Device, Arrow International, Inc., Reading, PA K#970080, Arrow-Trerotola™ PTD Percutaneous Thrombolytic Device, Arrow International, Inc., Reading, PA
- 2. K#003570, Solera™ Bacchus™ Thrombectomy Catheter (BTC), Bacchus Vascular, Inc. Santa Clara, CA

### 4. Device Description:

The Rex Medical Cleaner™ Rotational Thrombectomy System 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 thrombectomy. The Cleaner™ macerates clot into particulate size that is not harmful to the patient.

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## 5. Intended Use:

The Rex Medical Cleaner™ Rotational Thrombectomy System device permits mechanical declotting in synthetic dialysis grafts.

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# Comparison to Predicate Devices: 6.

| Attribute | Rex Medical Cleaner™ Rotational<br>Thrombectomy System (Subject<br>Device) | Arrow PTD (Predicate Device) |
|-----------------------------------------------------------|----------------------------------------------------------------------------|---------------------------------------------------------------------|
| Catheter Type | Mechanical Thrombectomy Catheter | Mechanical Thrombectomy Catheter |
| Intended Use | Maceration of Clot | Maceration of Clot |
| Catheter Outer Diameter | 6F Sheath Compatible | 6F Sheath Compatible |
| Catheter Length | 65cm | 65cm |
| Drive Wire Diameter | .035" | 0.041" |
| Cleaning Device Wire | .035" Guidewire | Nitinol Basket (0.015" X 4 Wires) |
| Distal Catheter Tip Configuration | Radiopaque Tip | Radiopaque Tip |
| Distal Wire Tip Configuration | Atraumatic Radiopaque Soft Distal<br>Tip | Atraumatic Radiopaque Soft Distal<br>Tip |
| Cleaning Device | Sinusoidal Wave formed in Drive<br>Wire | Wire Basket Added to End of Drive<br>Wire |
| Activation Switch | Push Button Switch Located on<br>Handle | Push Button Switch Located on<br>Handle |
| Means to Protect Distal Wire<br>Segment | Slide Mechanism on Handle to Slide<br>Catheter Over Cleaning Device | Slide Mechanism on Handle to Slide<br>Catheter Over Cleaning Device |
| Side-Port Extension | Located on Handle | Locate on Handle |
| w/Female Luer | | |
| Ergonomic Handle | Yes | Yes |
| Packaging | Tray w/Tyvek Lid | Tray w/Tyvek Lid |
| Energy Transmitted to Graft from<br>Device (6mm Id Graft) | 22.6J | 31.1J |

.

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

Performance testing, which includes testing protocols, testing results and conclusions, based on ISO 10555-1, 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™ Rotational Thrombectomy System device is substantially equivalent to the predicate device.

## 8. Discussion of Clinical Tests Performed:

In-Vivo (animal) test studies have proven that the Cleaner™ Rotational Thrombectomy device will macerate clot formation in synthetic dialysis grafts as effectively, efficiently, and as safely as the predicate device.

### ல் Conclusions:

The subject device, Rex Medical Cleaner™ Rotational Thrombectomy System. has the same intended use as the predicate devices, the Arrow-Trerotola™ PTD Percutaneous Thrombolytic Device, and the Solera™ Bacchus™Thrombectomy Catheter (BTC). 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™ Rotational Thrombectomy System is substantially equivalent to the predicate devices.

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Image /page/4/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with its wings spread, with three human profiles incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle image.

MAY 27 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Rex Medical, Inc. c/o Ms. Susan D. Goldstein-Falk MDI Consultants, Inc. 55 Northern Boulevard, Suite 200 Great Neck, NY 11021

Re: K031610

Cleaner™ Rotational Thrombectomy System Regulation Number: 21 CFR 870.4875 Regulation Name: Catheter, Peripheral, Atherectomy Regulatory Class: Class II (two) Product Code: MCW Dated: May 21, 2003 Received: May 22, 2003

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. Iisting 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 - 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 [phone]. 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Kelleher

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

Enclosure

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Exhibit B

ﻨﺪ ﺗﻢ ﺗﺮ

Page _ 1 of

**510(k) Number (if known):** K031610

Device Name: Rex Medical Cleaner™ Rotational Thrombectomy System

Indications For Use:

The Rex Medical Cleaner™ Rotational Thrombectomy System device permits mechanical declotting in synthetic dialysis grafts.

(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)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K031610