(213 days)
The Radius Micro Snare is intended for use to retrieve and/or manipulate objects in the distal peripheral vessels of the cardiovascular system and hollow viscus. Manipulation procedures include retrieval and/or repositioning of intravascular foreign objects such as coils, balloons, catheters and/or guidewires within the peripheral and cardiovascular system.
The Radius Micro 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 tube joined to a polyimide tube. The stainless steel and polyimide tubes are covered with PTFE. The stainless steel core is a solid .008" diameter stainless steel core that is a smaller version of the solid core wire in the FDA cleared Radius PTCA Guidewire and the FDA cleared Radius Snare. A stainless steel loop is soldered to the distal end of the core. The Radius Micro Snare has loop sizes, which range from 2 - 7 millimeters. The over-all length of the device is 190 centimeters. A molded ABS operating handle is included on the proximal end of the Micro Snare to aid in advancing and retracting the outer sheath over the snare loop. The Radius Micro Snare will be packaged in a Mylar/Tyvek pouch and ETO sterilized to SAL 10-6.
The provided text describes the Radius Micro Snare and its clearance through the FDA 510(k) process. However, it does not contain the specific details required to fully address your request regarding acceptance criteria and the study proving the device meets those criteria.
Here's an analysis based on the information provided, highlighting what's present and what's missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in the document. The general acceptance criteria for a 510(k) device is "substantial equivalence" to a predicate device. This is determined by comparing technological characteristics and intended use.
- Reported Device Performance: The document only lists the types of in vitro performance tests conducted, but does not provide specific numerical results or acceptance thresholds for these tests. The tests listed are:
- Tensile Strength
- Torque Strength
- Tip Flexibility
- Biocompatibility
What is missing: Actual quantitative acceptance criteria (e.g., "Tensile strength must exceed X Newtons") and the corresponding measured performance data for the Radius Micro Snare.
2. Sample Size for the Test Set and Data Provenance:
- Sample Size: Not specified. The document mentions "in vitro performance tests" but does not give the number of devices tested for each performance characteristic.
- Data Provenance: The tests are stated to be "in vitro," meaning they were conducted in a lab environment. The country of origin of the data is not specified, but given the submission is to the FDA in the USA, it's likely the testing was conducted or overseen in the USA. The study design is implied to be a series of physical and mechanical bench tests, not a clinical study involving human or animal data, so "retrospective or prospective" is not directly applicable in the typical sense.
What is missing: Specific sample sizes for each in vitro test.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. For this type of mechanical and material performance testing (tensile strength, torque strength, tip flexibility, biocompatibility), ground truth is established through standardized engineering and laboratory testing protocols, not typically through human expert consensus in the way an imaging AI algorithm's performance might be evaluated. Biocompatibility testing involves specific biological assays.
4. Adjudication Method for the Test Set:
- Not Applicable. See point 3. Mechanical and biocompatibility tests have objective pass/fail criteria based on measured values, not subjective adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. The document does not describe any MRMC study. This type of study is relevant for diagnostic imaging devices where human readers interpret results, often with and without AI assistance. The Radius Micro Snare is a physical interventional device, not a diagnostic imaging tool.
6. Standalone (Algorithm Only) Performance Study:
- No. The Radius Micro Snare is a physical medical device, not a software algorithm. Therefore, "standalone algorithm performance" is not applicable.
7. Type of Ground Truth Used:
- Objective Laboratory Measurements and Standardized Biocompatibility Assays. For tensile strength, torque strength, and tip flexibility, the ground truth would be the measured physical properties of the device as per engineering standards. For biocompatibility, the ground truth would be the results from standardized biological tests (e.g., cytotoxicity, sensitization, irritation) confirming the material's safety in biological environments.
8. Sample Size for the Training Set:
- Not Applicable. The Radius Micro Snare is a physical device, not an AI/ML algorithm that requires a "training set" in the context of data science. Its design and manufacturing are based on established engineering principles and materials science.
9. How Ground Truth for the Training Set Was Established:
- Not Applicable. See point 8.
Summary of what the document implies about meeting acceptance criteria:
The FDA's 510(k) clearance letter (K022201) indicates that the device was found "substantially equivalent" to legally marketed predicate devices. This means the FDA determined that the Radius Micro Snare shared similar intended use and technological characteristics with the predicate devices, and that any differences did not raise new questions of safety or effectiveness. The performance testing mentioned (tensile strength, torque strength, tip flexibility, biocompatibility) would have been conducted to demonstrate that the device meets appropriate engineering and safety standards, thereby supporting the claim of substantial equivalence. The "acceptance criteria" here are inherently tied to ensuring the device performs comparably and safely to its predicates in these specific technical areas.
In essence, the document serves as a regulatory submission and approval, not a detailed scientific paper describing the specifics of each test and its numerical outcomes against predefined acceptance criteria.
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FEB 0 3 2003
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.
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- Sponsor Name
| Submitter's Name: | Radius Medical Technologies, Inc |
|---|---|
| Address: | 63 Great RoadMaynard, MA 01754 |
| Contact Person: | Maureen A. Finlayson |
| Date of Preparation: | June 28, 2002 |
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- Device Name
| Device Generic Name: | Snare |
|---|---|
| Device Trade Name: | Radius Micro Snare |
| Classification Name: | Wire, Guide, Cardiovascular (74DQX) |
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Identification of Predicate or Legally Marketed Device 3.
The Radius Micro Snare is substantially equivalent to the Microvena Amplatz Goose Neck Micro Snare (K970688), the Radius Snare (K021441) and the Radius PTCA Guidewire (K970466). -
- Device Description
The Radius Micro 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.
- Device Description
The outer sheath is a stainless steel tube joined to a polyimide tube. The stainless steel and polyimide tubes are covered with PTFE.
The stainless steel core is a solid .008" diameter stainless steel core that is a smaller version of the solid core wire in the FDA cleared Radius PTCA Guidewire
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and the FDA cleared Radius Snare. A stainless steel loop is soldered to the distal end of the core. The Radius Micro Snare has loop sizes, which range from 2 - 7 millimeters. The over-all length of the device is 190 centimeters. A molded ABS operating handle is included on the proximal end of the Micro Snare to aid in advancing and retracting the outer sheath over the snare loop.
The Radius Micro Snare will be packaged in a Mylar/Tyvek pouch and ETO sterilized to SAL 10-6.
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న్. Intended Use
The Radius Micro Snare is intended for use to retrieve and/or manipulate objects in the distal peripheral vessels of the cardiovascular system and hollow viscus. Manipulation procedures include retrieval and/or repositioning of intravascular foreign objects such as coils, balloons, catheters and/or guidewires within the peripheral and cardiovascular system.
The Radius Micro Snare is similar in materials, function and design to predicate Radius PTCA Guidewire (K970466) and Radius Snare (K021441). The Radius Micro 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 Micro Snare is the same as the Microvena Amplatz Goose Neck Micro Snare (K970668). Both are delivered via a cathether/outer sheath tube and both have a snare at the distal end. The intended use of both devices is the same: to retrieve and/or manipulate objects in the distal peripheral vessels of the cardiovascular system and hollow viscus.
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- Performance Testing
The following in vitro performance tests were performed on the Radius Micro Snare:
- Performance Testing
Tensile Strength Torque Strength Tip Flexibility Biocompatability
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Public Health Service
FEB 0 3 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Maureen A. Finlayson President Radius Medical Technologies, Inc. 63 Great Road Maynard, MA 01754
Re: K022201
Trade/Device Name: Radius Micro Snare Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter. Regulatory Class: Class II Product Code: MMX Dated: October 14, 2002 Received: November 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.
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
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Page 2 - Ms. Maureen A. Finlayson
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) 594-4586. 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,
Kaitlin Tea
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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KO2201 510(k) Number (if known):
Device Name: Radius Micro Snare
Indications For Use:
The Radius Micro Snare is intended for use to retrieve and/or manipulate objects in the distal peripheral vessels of the cardiovascular system and hollow viscus. Manipulation procedures include retrieval and/or repositioning of intravascular foreign objects such as coils, balloons, catheters and/or guidewires within the peripheral and 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
Norke Tlu
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K022201
§ 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).