RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2

K041705 · Omnisonics Medical Technologies · QEY · Sep 1, 2004 · Cardiovascular

Device Facts

• Record ID: K041705
• Device Name: RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2
• Applicant: Omnisonics Medical Technologies
• Product Code: QEY · Cardiovascular
• Decision Date: Sep 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OmniSonics Resolution® Thrombectomy System is intended for use in the treatment of thrombosed synthetic dialysis access grafts.

Device Story

Portable acoustic energy system for treating thrombosed synthetic dialysis access grafts; comprises disposable 360° Therapeutic Wire, reusable Handpiece/Cable Assembly, and multiuse Generator. System uses acoustic energy to remove thrombus from synthetic grafts. Operated by clinicians in clinical settings. Output is mechanical thrombus removal; assists physicians in restoring graft patency. Benefits include effective thrombus clearance in dialysis access sites.

Clinical Evidence

Clinical studies demonstrated substantial equivalence to predicate devices regarding thrombus removal in synthetic dialysis access grafts. Supporting evidence includes mechanical bench testing, biocompatibility testing, and in vivo animal testing.

Technological Characteristics

Portable acoustic energy system. Components: disposable therapeutic wire, reusable handpiece/cable assembly, multiuse generator. Accessories: torque wrench, irrigation tubing. Operates via acoustic energy for thrombus removal. Sterilization methods and materials are consistent with predicate devices.

Indications for Use

Indicated for the treatment of thrombosed synthetic dialysis access grafts.

Regulatory Classification

Identification

An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.

Predicate Devices

• Cordis Hydrolyser (K983534, K990771)
• Edwards Thrombex PMT System (K993816)
• Arrow-Trerotola PTD (K970080, K990829)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of human services. To the right of the symbol is the FDA acronym in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

October 8, 2021

Omnisonics Medical Technologies Anne Kulis VP Quality, Regulatory & Clinical Affairs 66 Concord Street, Suite A Wilmington, Massachusetts 01887

Re: K041705

Trade/Device Name: Resolution Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEY, KRA

Dear Anne Kulis:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated September 1, 2004. Specifically, FDA is updating this SE Letter as an administrative correction because FDA has created a new product code to better categorize your device technology.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, [phone], Gregory.Oconnell(@FDA.HHS.gov.

Sincerely,

Digitally signed by Gregory W. Gregory W. O'connell -O'connell -S Date: 2021.10.08 10:27:36 -04'00'

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized depiction of an eagle, which is a common symbol of the United States.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 1 2004

OmniSonics Medical Technologies, Inc. c/o Anne M. Kulis 66 Concord Street, Suite A Wilmington, MA 01887

K041705 Re: Resolution® Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: June 22, 2004 Received: June 23, 2004

Dear Ms. Kulis:

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.

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

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,

Dana R. LaClair

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

Enclosure

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

# Indications for Use

510(k) Number (if known): K0417 65

Device Name: Resolution® Thrombectomy System

Indications For Use:

The Omnisonics Resolution® Thrombectomy System is intended for use in the treatment of thrombosed synthetic dialysis access grafts.

Prescription Use X

AND/OR

Over-The-Counter Use_

(Part 21 CFR 801 Subpart D)

(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)

Donna R. Lachner

(Division Sign-Off) (Division of Cardiovascular Devices

510(k) Number Kod 1305

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

## SEP - 1 2004

## Section XI

### 510(k) Summary Resolution® Thrombectomy System

| 510(k) Number: | |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | OmniSonics Medical Technologies, Inc.<br>66 Concord Street<br>Wilmington, MA 01887<br>Phone: [phone]<br>Fax: [phone] |
| Contact Person: | Anne M. Kulis<br>Vice President Quality, Regulatory & Clinical Affairs |
| Date Prepared: | June 18, 2004 |
| Trade Name: | Resolution Thrombectomy System |
| Classification Name: | CFR §870.5151, Embolectomy Catheter |
| Predicate Devices: | Cordis Hydrolyser - K983534, K990771<br>Edwards Thrombex PMT System - K993816<br>Arrow-Trerotola PTD - K970080, K990829 |

### Device Description:

The Resolution Thrombectomy System is a portable acoustic energy system for the treatment of thrombosed synthetic dialysis access grafts. The system is comprised of three major components: (1) the disposable Resolution 360° Therapeutic Wire, (2) the reusable Handpiece/Cable Assembly, and (3) the multiuse Generator. Accessories include the Resolution Torque Wrench and Resolution Irrigation Tubing Set.

#### Intended Use:

The OmniSonics Resolution Thrombectorny System is intended for use in the treatment of thrombosed synthetic dialysis access grafts.

## Summary of Technological Characteristics of the Applicant Device Compared to the Predicate Device:

There are no significant technological differences between the applicant device and the predicate devices. The technological characteristics of the Resolution Thrombectomy System are substantially equivalent to the predicate devices with respect to indications for use, sterilization methods, product design, materials, labeling, packaging, and principles of operation.

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

#### Support of Substantial Equivalence:

It has been demonstrated through clinical studies that the Resolution Thrombectomy System is substantially equivalent to the predicate devices with respect to removal of thrombus within synthetic dialysis access grafts, Additionally, the results of mechanical bench testing, biocompatibility testing and in vivo animal testing support that the Resolution Thrombectorny System is substantially equivalent to the predicate devices.

#### Conclusion:

The Resolution Thrombectomy System is substantially equivalent to the predicate devices.