(70 days)
Not Found
No
The summary describes a mechanical/acoustic system for thrombectomy and does not mention any AI or ML components or functionalities.
Yes
The device is described as "intended for use in the treatment of thrombosed synthetic dialysis access grafts," which indicates a therapeutic purpose.
No
This device is intended for the treatment of thrombosed synthetic dialysis access grafts, not for diagnosis.
No
The device description clearly lists multiple hardware components: a disposable therapeutic wire, a reusable handpiece/cable assembly, and a multiuse generator, along with accessories. This indicates it is a hardware-based system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "treatment of thrombosed synthetic dialysis access grafts." This describes a therapeutic intervention performed directly on a patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device components (therapeutic wire, handpiece, generator) are designed for delivering acoustic energy to break down thrombus within the graft, which is a physical treatment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to treat a condition directly within the body.
N/A
Intended Use / Indications for Use
The Omnisonics Resolution® Thrombectomy System is intended for use in the treatment of thrombosed synthetic dialysis access grafts.
Product codes
QEY, KRA, DXE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
synthetic dialysis access grafts
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K983534, K990771, K993816, K970080, K990829
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 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, (301) 796-6075, 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 (301) 594-4646 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 (800) 638-2041 or (301) 443-6597 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. |
| 66 Concord Street | |
| Wilmington, MA 01887 | |
| Phone: 978-657-9980 | |
| Fax: 978-652-9152 | |
| Contact Person: | Anne M. Kulis |
| 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 |
| Edwards Thrombex PMT System - K993816 | |
| 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.