(97 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML algorithms. The description focuses on the physical components and intended use of an ultrasound energy system.
Yes
The device is intended for "treatment of thrombosed synthetic dialysis access grafts" and the device description mentions a "Resolution Therapeutic Kit", indicating a therapeutic purpose.
No
The device is described as a "portable ultrasound energy system for the treatment of thrombosed synthetic dialysis access grafts," indicating a therapeutic rather than diagnostic purpose.
No
The device description explicitly states it is comprised of a "sterile, single use Resolution Therapeutic Kit" and a "multi-use Generator," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "in 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 a patient to diagnose a condition.
- Device Description: The device is described as a "portable ultrasound energy system" and includes components like a "Therapeutic Kit" and a "Delivery Catheter." These are consistent with a device used for a medical procedure, not for laboratory testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests to detect or measure substances, 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 physical blockage within a graft, which is a therapeutic action.
N/A
Intended Use / Indications for Use
The Omnisonics Resolution® Endovascular System is intended for use in the treatment of thrombosed synthetic dialysis access grafts.
Product codes
QEY, DXE
Device Description
The Resolution Endovascular System is a portable ultrasound energy system for the treatment of thrombosed synthetic dialysis access grafts. The System is comprised of two major components: (1) the sterile, single use Resolution Therapeutic Kit, and (2) the multi-use Generator. Required accessories include the Resolution Delivery Catheter and a commercially available hemostasis valve.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 performance testing has demonstrated that the applicant device is substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Resolution® Thrombectomy System – K041705
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). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 15, 2021
Omnisonics Medical Technologies Anne Kulis VP, Quality, Regulatory & Clinical Affairs 66 Concord Street, Suite A Wilmington, Massachusetts 01887
Re: K052428
Trade/Device Name: Resolution Endovascular System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEY
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 8, 2005. Specifically, FDA is updating this SE Letter 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,
Gregory W. Digitally signed by
Gregory W. Gregory W. O'connell -S ○'connell -S Date: 2021.09.15
09:12:32 -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
Public Health Service
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract eagle design with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.
DEC 8 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OmniSonics Medical Technologies, Inc. c/o Ms. Anne Kulis VP Quality, Regulatory and Clinical Affairs 66 Concord St., Suite A Wilmington, MA 01887
Re: K052428
Trade Name: Resolution Endovascular® System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: November 17, 2005 Received: November 18, 2005
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
Page 2 - Ms. Anne 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 Office of Compliance at (240) 276-0120. 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/industry/support/index.html.
Sincerely yours,
Dma R. Va. Janes
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): K 052428
Device Name: Omnisonics Resolution® Endovascular System
Indications For Use:
The Omnisonics Resolution® Endovascular 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)
Dana R. Vochner
(Division Sinn-Off) (Division Sign-Chi)
Division of Cardiovascular Devices
510(k) number K052428
000007
4
DEC 8 2005
Section 9
510(k) Summary Resolution® Endovascular 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: | August 30, 2005 |
| Trade Name: | Resolution® Endovascular System |
| Classification Name: | CFR §870.5151, Embolectomy Catheter |
| Predicate Devices: | Resolution® Thrombectomy System – K041705 |
Device Description:
The Resolution Endovascular System is a portable ultrasound energy system for the treatment of thrombosed synthetic dialysis access grafts. The System is comprised of two major components: (1) the sterile, single use Resolution Therapeutic Kit, and (2) the multi-use Generator. Required accessories include the Resolution Delivery Catheter and a commercially available hemostasis valve.
Intended Use:
The Resolution Endovascular 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 device. The technological characteristics of the applicant device are substantially equivalent to the predicate device with respect to device classification, intended use, indication for use, target population, product design, materials, packaging, labeling, sterilization and product performance.
5
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. Additionally, product performance testing has demonstrated that the applicant device is substantially equivalent to the predicate device.
Conclusion:
The Resolution Endovascular System is substantially equivalent to the predicate device.
000137