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.

AI/ML Overview

The provided text is a 510(k) summary for the OmniSonics Resolution® Endovascular System. This document asserts substantial equivalence to a predicate device rather than presenting a study proving acceptance criteria for a new device's performance. Therefore, detailed information on acceptance criteria and a specific study proving those criteria are not available in this text.

However, based on the information provided, we can infer some aspects relevant to your request, especially regarding the claim of "substantial equivalence" and the types of testing typically involved in such a submission.

Here's an attempt to answer your questions based on the provided FDA documents. Please note that many details are not explicitly stated in this summary and would typically be found in the full 510(k) submission, which is not provided.

Based on the provided 510(k) Summary (K052428) for the Resolution Endovascular System:

The document states that the Resolution Endovascular System is substantially equivalent to the predicate device, the Resolution® Thrombectomy System – K041705. It does not present a de novo study with specific acceptance criteria and performance data for a new device but rather relies on the equivalence to a previously cleared device. Therefore, a table of acceptance criteria and reported device performance specific to a new study is not provided in these documents.

The core of this submission is the assertion: "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."

The "Support of Substantial Equivalence" section mentions: "product performance testing has demonstrated that the applicant device is substantially equivalent to the predicate device." However, no specific details about this "product performance testing" (e.g., criteria, results, methodology, sample sizes) are included in this summary.

Here's an attempt to answer your numbered questions based on the limited information:

1. A table of acceptance criteria and the reported device performance:

Not explicitly provided. The 510(k) summary does not contain a table of acceptance criteria or reported device performance for a new study. Instead, it asserts "substantial equivalence" to a predicate device based on unspecified "product performance testing." To gain market clearance via a 510(k), the new device must perform at least as well as the predicate device, meaning its performance would meet the unstated acceptance criteria established for the predicate device.

2. Sample size used for the test set and the data provenance:

Not explicitly provided. The 510(k) summary does not mention specific sample sizes for any test set or the provenance of data. Substantial equivalence typically relies on bench testing, material characterization, and potentially animal or limited human factor studies, but no details are given here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not explicitly provided. This type of information is typically relevant for studies involving human interpretation (e.g., image analysis, diagnostic devices). The Resolution Endovascular System is an interventional device for treating thrombosed grafts, and the "product performance testing" would likely involve engineering and functional assessments rather than expert-derived ground truth.

4. Adjudication method for the test set:

Not applicable/Not explicitly provided. Adjudication methods are usually for clinical trials involving human review of outcomes or data, which is not detailed in this 510(k) summary.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. The device is an Endovascular System (medical device for treatment), not primarily a diagnostic or AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance is not relevant or mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This question pertains to AI/algorithm performance. The Resolution Endovascular System is a physical medical device; there's no mention of an algorithm or AI component in this 510(k) summary.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not explicitly provided. For "product performance testing" of a physical device, ground truth would typically refer to established engineering standards, material specifications, and functional targets (e.g., clot removal efficiency, flow rates, durability) that are compared to the predicate device's known performance. No specific details are given.

8. The sample size for the training set:

Not applicable/Not explicitly provided. "Training set" is typically used for machine learning models. As this is a physical medical device, not an AI/ML product, this concept does not apply in the context of this 510(k) summary.

9. How the ground truth for the training set was established:

Not applicable/Not explicitly provided. See point 8.

In summary: The provided FDA 510(k) documents are for a medical device cleared through the substantial equivalence pathway. They assert that "product performance testing has demonstrated that the applicant device is substantially equivalent to the predicate device" but do not provide the detailed results, acceptance criteria, methodologies, or sample sizes of such testing. This information would typically be found in the full 510(k) submission, which is not included in the provided text.

Summary

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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

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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.

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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

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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

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K052428

DEC 8 2005

Section 9 510(k) Summary Resolution® Endovascular System

510(k) Number:
Submitter:	OmniSonics Medical Technologies, Inc.66 Concord StreetWilmington, MA 01887Phone: 978-657-9980Fax: 978-652-9152
Contact Person:	Anne M. KulisVice 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:

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.

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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

Regulation Number and Section

§ 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).