(90 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like deep learning, neural networks, or image processing that would typically indicate the presence of AI/ML in a medical device. The description focuses on the physical components and intended use for fluid infusion and thrombus removal.
Yes
The device is used for the infusion of fluids, including thrombolytics, and for the removal of thrombi from the peripheral vasculature, which are interventions aimed at treating a medical condition.
No
This device is indicated for therapeutic purposes (infusion of fluids and removal of thrombi), not for diagnosing conditions.
No
The device description explicitly states it is comprised of two major components: a sterile, single-use Kit and a multi-use Generator, indicating hardware components are included.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the infusion of fluids and removal of thrombi within the peripheral vasculature. This is a therapeutic and interventional procedure performed directly on the patient's body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description mentions a sterile kit and a generator, consistent with a system used for a medical procedure, not for analyzing samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, diagnostic purposes, or any of the typical components or processes associated with IVD devices.
Therefore, the Omniwave Endovascular System is a medical device used for treatment within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 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.
Product codes
QEY, KRA
Device Description
The Omniwave Endovascular System is comprised of two major components: (1) the sterile, single use Kit, and (2) the multi-use Generator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Product testing has demonstrated that the applicant device is substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K050147, K050130, K050563, K052428
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5150 Embolectomy catheter.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the agency's name, "U.S. Food & Drug Administration."
February 3, 2022
Omnisonics Medical Technologies Anne Kulis Vice President 66 Concord Street, Suite A Wilmington, Massachusetts 01887
Re: K071762
Trade/Device Name: 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 September 27, 2007. 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, (301) 796-6075, Gregory.Oconnell(@FDA.HHS.gov.
Sincerely,
Digitally signed by Gregory W. Gregory W. O'connell -O'connell -S Date: 2022.02.03 14:27:47 -05'00'
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
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 7 2007
OmniSonics Medical Technologies, Inc. c/o Ms. Anne M. Kulis Vice President Quality, Regulatory & Clinical Affairs 66 Concord Street Wilmington, MA 01887
Re: K071762 OmniWave Endovascular System Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II (Two) Product Code: KRA Dated: August 31, 2007 Received: September 4, 2007
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.
Image /page/1/Picture/9 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of a human figure with three heads, representing health, services, and people. The graphic is accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the graphic.
2
Page 2 - Ms. Anne M. Kulis
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 Biometric's (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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
er R. bochner
A Bram D. Zuckerman, M.D. Director
Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Section 4
Indications for Use
510(k) Number (if known): K ○7イー (2
Device Name: Omnisonics Omniwave Endovascular System
Indications For Use: ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
The 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
(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)
Duma R. Vohmes
sion Sign-Off)
on of Cardiovascular Devices
Number k07176.2
000011
4
p. 1 of 2
Section 5
SEF 2 7 2007
510(k) Summary Omnisonics Omniwave Endovascular System
| 510(k) Number: | K071762 |
|---|---|
| Submitter: | OmniSonics Medical Technologies, Inc. |
| 66 Concord Street | |
| Wilmington, MA 01887 | |
| Phone: 978-657-9980 | |
| Fax: 978-657-9982 | |
| Contact Person: | Anne M. Kulis |
| Vice President Quality, Regulatory & Clinical Affairs | |
| Date Prepared: | June 29, 2007 |
| Trade Name: | Omniwave Endovascular System |
| Classification Name: | CFR §870.1210, Catheter, Continuous Flush |
Predicate Devices:
-
- Bacchus Trellis®-8 Peripheral Infusion System K050147
-
- KPS Rinspiration™ System K050130
-
- EKOS Lysus® Infusion Catheter System K050563
-
- Omnisonics Resolution® Endovascular System K052428
Device Description:
The Omniwave Endovascular System is comprised of two major components: (1) the sterile, single use Kit, and (2) the multi-use Generator.
Intended Use:
The 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.
5
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 applicant device are substantially equivalent to the predicate devices with respect to device classifications, intended use, indications for use, target population, product design, materials, packaging, labeling, sterilization and product performance,
Support of Substantial Equivalence:
Both the applicant and predicate devices treat the same patient population and have the same intended use and indication for use. Product testing has demonstrated that the applicant device is substantially equivalent to the predicate devices.
Conclusion:
The Omniwave Endovascular System is substantially equivalent to the predicate devices.