The Radius Snare is intended for use in the cardiovascular system and hollow viscous to retrieve and/or manipulate objects using minimally invasive surgical procedures. Manipulation procedures include retrieval and/or repositioning of intravascular foreign objects such as coils, balloons, catheters and/or guidewires within the cardiovascular system.

Device Description

The Radius Snare is composed of two primary parts: a stainless steel outer sheath tube and a stainless steel core wire with a loop snare attached to the distal end. The outer sheath acts as a catheter through which the core wire, with snare, slides. The Radius Snare has loop sizes which range from 5 - 35 millimeters. The over-all length of the device is 150 centimeters. The Radius Snare is packaged in a mylat/Tyvek pouch and ETO sterilized to SAL 10°.

AI/ML Overview

The provided text describes a medical device, the Radius Snare, and its 510(k) submission to the FDA. However, the document does NOT contain information about acceptance criteria for performance metrics or a study detailing specific device performance against such criteria. The "Performance Testing" section states that modifications were assessed based on an FDA guidance document, but it does not present any quantitative performance data, sample sizes, or details about ground truth establishment.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's an analysis of what information can be extracted:

A table of acceptance criteria and the reported device performance
- Not Available. The document states that "Performance testing to assess the impact of the modifications was from the FDA guidance document 'Coronary and Cerebrovascular Guidewire Guidance' dated January 1995." It concludes that the device "meets the minimum requirements that are considered adequate for its intended use." However, it does not specify what those minimum requirements (acceptance criteria) were, nor does it present any specific performance metrics (e.g., retrieval success rate, deployment accuracy, force required, etc.) or a table comparing them to acceptance criteria.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available. The document does not mention any sample sizes for testing, nor does it specify data provenance. It only refers to "Performance testing."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable/Not Available. There is no mention of expert-established ground truth or any clinical study involving experts. The performance testing appears to be primarily bench or in-vitro testing based on device characteristics.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Available. The concept of "adjudication" typically applies to clinical studies or assessments where human judgment is involved in determining outcomes or ground truth, which is not described here.
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. This device is a physical medical snare, not an AI or imaging diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Available. Given the nature of the device (a snare for retrieving objects), the "performance testing" likely involved evaluating physical characteristics, retrieval forces, deployment, and material integrity against predetermined engineering specifications, rather than clinical ground truth like pathology or expert consensus. The specific metrics and how they constituted "ground truth" for the device's function are not detailed.
The sample size for the training set
- Not Applicable/Not Available. This is a physical medical device, not a machine learning model, so there is no concept of a "training set" in the context of the provided document.
How the ground truth for the training set was established
- Not Applicable/Not Available. As above, no training set is relevant.

In summary, the provided document focuses on the regulatory submission and essential equivalence of a physical medical device based on design and general performance testing against a guidance document, rather than detailing a specific study with quantitative acceptance criteria and performance data for a diagnostic or AI-driven device.

Summary

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K071457 p1/2

Radius Medical Technologies 510(k) Summary of Safety and Effectiveness May 22, 2007

SEP 2 5 2007

GENERAL INFORMATION A.

Submitter's Name:	Radius Medical Technologies, Inc
Address:	15 Craig RoadActon, MA 01720
Contact Person:	Maureen A. Finlayson
Device Generic Name:	Snare
Device Trade Name:	Radius Snare
Classification Name:	Embolectomy Catheter (MMX)

B. INDICATIONS

C. DESCRIPTIVE CHARACTERISTICS

The Radius Snare has loop sizes which range from 5 - 35 millimeters. The over-all length of the device is 150 centimeters.

The Radius Snare is packaged in a mylat/Tyvek pouch and ETO sterilized to SAL 10°

D. COMPARATIVE INFORMATION

Substantial equivalence of the modified Radius Snare is based on Design similarities and Performance testing equivalency to the currently marketed Snare (K021441)

The modified Radius Snare and currently marketed Radius Snare (K021441) are substantially equivalent in terms of size, materials of construction, performance characteristics, and basic design. The differences have no effects on the performance or safety of the Radius snare as evaluated in the performance testing.

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PERFORMANCE TESTING E.

Performance testing to assess the impact of the modifications was from the FDA guidance document "Coronary and Cerebrovascular Guidewire Guidance" dated January 1995.

CONCLUSION:

Based on the indications for use, technological characteristics, and safety and performance testing, the proposed modifications to the Radius Snare meets the minimum requirements that are considered adequate for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure, with three curved lines representing its wings or body. The logo is surrounded by a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Radius Medical Technologies, Inc. c/o Ms. Maureen A. Finlayson President 15 Craig Road Action, MA 01720

SEP 2 5 2007

Re: K071457
Radius Snare Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: MMX Dated: August 27, 2007 Received: August 28, 2007

Dear Ms. Finlayson:

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. Maureen A. Finlayson

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 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,
Qmal

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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510(k) Number (if known):

K071457

Radius Snare Device Name:

Indications For Use:

Prescription Use X (Per 21 CFR 801.109 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Q.moll

510(k) Number

(Division Sign-Off) Division of Cardiovascular Devices K071457

Page __ of

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).