(39 days)
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.
The Radius Snare is composed of two primary parts: an outer sheath tube and a core wire with a snare attached to the distal end. The outer sheath acts as a catheter through which the core wire, with snare, slides. The outer sheath is a stainless steel coil with a PTFE overjacket. The stainless steel core is the same solid .0135" diameter stainless steel core wire in the FDA cleared Radius PTCA Guidewire. A stainless steel loop is soldered to the distal end of the core wire. 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 will be packaged in a mylar/Tyvek pouch and ETO sterilized to SAL 10-2.
The provided text describes specific performance tests conducted on the Radius Snare device. However, it does not explicitly state numerical acceptance criteria for these tests, nor does it provide detailed results demonstrating the device meets specific criteria. Instead, the document focuses on demonstrating substantial equivalence to predicate devices through design, materials, and function, and then lists the types of performance tests performed.
Therefore, for aspects like "Table of acceptance criteria and reported device performance," "sample sizes used for the test set," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone study," "type of ground truth," "sample size for training set," and "how ground truth for training set was established," the information is not available within the provided text.
Here's a breakdown of what is available and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified numerically. The document states that "in vitro performance tests were performed" to support substantial equivalence. | |
| Tensile Strength | "Performed" (Specific results not provided) |
| Torque Strength | "Performed" (Specific results not provided) |
| Torqueability | "Performed" (Specific results not provided) |
| Tip Flexibility | "Performed" (Specific results not provided) |
| Coating Adherence/Integrity | "Performed" (Specific results not provided) |
| Biocompatibility | "Performed" (Specific results not provided) |
| Sterilization | "ETO sterilized to SAL 10-2" |
Study Information (Based on Available Text):
- Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not available. The document only mentions that "in vitro performance tests were performed," but does not specify the number of units tested or any details about data provenance.
- 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. The study described involves in vitro performance testing of the device's physical and mechanical properties, not an assessment of diagnostic performance that would require expert ground truth.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not available. As above, this is not a clinical study involving human assessment.
- 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:
- No. This is not an AI-powered device, nor is an MRMC study described. The device is a medical snare used in interventional procedures.
- 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 Radius Snare is a physical medical device. The "performance testing" referenced is for the device's mechanical and material properties.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable/Not available in the context of clinical outcomes. For the in vitro performance tests, the "ground truth" would be established engineering or material science standards and specifications, but these are not detailed in the document.
- The sample size for the training set:
- Not applicable. This refers to a machine learning context.
- How the ground truth for the training set was established:
- Not applicable. This refers to a machine learning context.
In summary: The provided document is a 510(k) summary for a medical device (Radius Snare). It focuses on demonstrating substantial equivalence to predicate devices and lists types of in vitro performance tests conducted (Tensile Strength, Torque Strength, Torqueability, Tip Flexibility, Coating Adherence/Integrity, Biocompatibility). It explicitly states the sterilization method. However, it does not provide detailed acceptance criteria, specific test results, or any information related to clinical studies, human reader performance, or artificial intelligence algorithms.
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JUN 1 4 2002
K021441 Page 1 of 2
510(K) SUMMARY
Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Radius Medical Technologies, Inc. is required to submit with this Premarket Notification either an "...adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Radius Medical Technologies, Inc. chooses to submit a summary of information respecting safety and effectiveness.
- نسم Sponsor Name
| Submitter's Name: | Radius Medical Technologies, Inc |
|---|---|
| Address: | 63 Great Road |
| Maynard, MA 01754 | |
| Contact Person: | Maureen A. Finlayson |
| Date of Preparation: | April 29, 2002 |
-
- Device Name
| Device Generic Name: | Snare |
|---|---|
| Device Trade Name: | Radius Snare |
| Classification Name: | Wire, Guide, Cardiovascular (74DQX) |
-
Device Description 4.
The Radius Snare is composed of two primary parts: an outer sheath tube and a core wire with a snare attached to the distal end. The outer sheath acts as a catheter through which the core wire, with snare, slides.
The outer sheath is a stainless steel coil with a PTFE overjacket.
The stainless steel core is the same solid .0135" diameter stainless steel core wire in the FDA cleared Radius PTCA Guidewire. A stainless steel loop is soldered to
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K021441 Page 2 of 2
Page 52
the distal end of the core wire. 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 will be packaged in a mylar/Tyvek pouch and ETO sterilized to SAL 10-2.
-
- Intended Use
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.
- Intended Use
-
Comparison of Technological Characteristics 6.
The Radius Snare is substantially equivalent in material, design and function to the following predicate devices: the Microvena Amplatz Goose Neck Snare/Catheter (K972511) and the Radius PTCA Guidewire (K970466).
The Radius Snare is similar in materials, function and design to predicate Radius PTCA Guidewire (K970466). The Radius Snare uses the Radius PTCA Guidewire as its base and adds a snare onto the distal tip of the core guidewire.
The design and function of the Radius Snare is the same as the Microvena Amplatz Goose Neck Snare/Catheter (K972511). Both devices are delivered via a cathether/outer sheath tube and both have a snare at the distal end. The intended use of the two devices is the same: to retrieve and/or manipulate objects in the cardiovascular system and hollow viscous.
-
Performance Testing 7.
The following in vitro performance tests were performed on the Radius Snare: -
- Tensile Strength
-
- Torque Strength
-
- Torqueability
-
Tip Flexibility 4,
-
Coating Adherence/Integrity న్న
-
- Biocompatability
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, arranged in a row.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 4 2002
Radius Medical Technologies, Inc. c/o Ms. Maureen A. Finlayson President 63 Great Road Maynard, MA 01754
Re: K021441 Trade Name: Radius Snare Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II (two) Product Code: MMX Dated: May 3, 2002 Received: May 6, 2002
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
N Dee N Tell
Joanne Dee Tillman, Ph.D.
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Ko21441 510(k) Number (if known):
Device Name: Radius Snare
Indications For Use:
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.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use | ||
|---|---|---|---|---|
| --------------------------------------- | --------------------------------------------------------- | ---- | ---------------------- | -- |
Division of Cardiovascular & Respiratory Devices
510(k) Number K021441Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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).