MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM

K083335 · Omnisonics Medical Technologies · QEY · Dec 15, 2008 · Cardiovascular

Device Facts

• Record ID: K083335
• Device Name: MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM
• Applicant: Omnisonics Medical Technologies
• Product Code: QEY · Cardiovascular
• Decision Date: Dec 15, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Modified Omniwave Endovascular System is indicated for use in the infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature and for removal of thrombi from the peripheral vasculature.

Device Story

Modified Omniwave Endovascular System consists of a sterile, single-use kit and a multi-use generator. Device functions as an endovascular catheter system for fluid infusion and thrombus removal in peripheral vasculature. Operated by physicians in clinical settings. System delivers thrombolytics or other fluids while facilitating mechanical thrombus removal. Output allows physicians to clear peripheral vascular obstructions, potentially restoring blood flow and improving patient outcomes.

Clinical Evidence

No clinical data provided; substantial equivalence supported by product performance testing.

Technological Characteristics

System comprises a sterile, single-use kit and a multi-use generator. Designed for peripheral vascular infusion and thrombus removal. Technological characteristics, including materials, packaging, and sterilization, are equivalent to the predicate device.

Indications for Use

Indicated for patients requiring infusion of physician-specified fluids (including thrombolytics) into the peripheral vasculature and for the removal of thrombi from the peripheral vasculature.

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

• Omniwave Endovascular System (K071762)

Submission Summary (Full Text)

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February 3, 2022

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

Re: K083335

Trade/Device Name: Modified Omniwave Endovascular 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 December 15, 2008. 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 -S O'connell -S Date: 2022.02.03

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

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## DEC 1 5 2008

OmniSonics Medical Technologies, Inc. c/o Ms. Anne Kulis 66 Concord Street, Suite A Wilmington, MA 01877

Re: K083335

Trade/Device Name: Modified Omniwave Endovascular System Regulation Number: 21 CFR 870.1210 Regulation Name: Catheter, Continuous Flush Regulatory Class: Class II Product Code: KRA Dated: November 11, 2008 Received: November 12, 2008

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.

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

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#### Ms. Anne Kulis - Page 2

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely yours,

Dona R. buhner

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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# Indications for Use

510(k) Number (if known): K (283335

Device Name: Modified Omniwave Endovascular System

Indications For Use:

The Modified Omniwave Endovascular System is indicated for use in the infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature and for removal of thrombi from the peripheral vasculature.

Prescription Use X

#### AND/OR -

Over-The-Counter Use

C30010

(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)

Duna D. be Anner

(Divini is Star-Off) Cardiovascular Devices ﻟﻠﺘﻘ

5 . U(K) Number_Ko 8 3335

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| 510(k) Number: | K083335 |
|----------------------|-----------------------------------------------------------------------------------------------------------|
| Submitter: | OmniSonics Medical Technologies, Inc.<br>66 Concord Street<br>Wilmington, MA 01887<br>Phone: [phone] |
| Contact Person: | Anne M. Kulis, VP QA, RA & CA |
| Date Prepared: | 11/01/2008 |
| Trade Name: | Modified Omniwave Endovascular System |
| Classification Name: | CFR §870.1210, Catheter, Continuous Flush |
| Predicate Device: | Omniwave Endovascular System K071762 |

### 510(k) Summary Modified Omnisonics Omniwave Endovascular System

#### Device Description:

The Modified Omniwave Endovascular System is comprised of two major components: (1) the sterile, single use Kit, and (2) the multi-use Generator.

### Intended Use:

The Modified Omniwave Endovascular System is indicated for use in the infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature and for removal of thrombi from the peripheral vasculature,

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

The technological characteristics of the applicant device are substantially equivalent to the predicate device with respect to device classifications, intended use, indications for use, target population, product design, materials, parkaging, labeling, sterilization and product performance.

### Support of Substantial Equivalence:

Both the applicant and predicate device treat the same patient population and have the same intended use and indication for use. Product testing hand demonstrated that the applicant device is substantially equivalent to the predicate devices.

#### Conclusion:

The Modified Omniwave Endovascular System is substantially equivalent to the predicate device.