(123 days)
Not Found
No
The description focuses on the mechanical components and intended use of a physical snare device, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as retrieving and manipulating objects within the cardiovascular system, which are surgical procedures, not therapeutic ones in the sense of treating a disease or condition directly.
No
Explanation: The device description states its intended use is for retrieving and/or manipulating objects within the cardiovascular system, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical components made of stainless steel (outer sheath tube, core wire, loop snare) and packaging materials (mylat/Tyvek pouch). This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use within the cardiovascular system and hollow viscous to retrieve and manipulate objects. This is an in vivo procedure (performed within a living organism).
- Device Description: The description details a physical device (snare, sheath, core wire) used for mechanical manipulation.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Providing information about a patient's health status based on the analysis of samples.
- Reagents, calibrators, or controls typically associated with IVD tests.
IVD devices are designed to perform tests on samples taken from the body to provide diagnostic information. This device is designed to perform a physical action within the body.
N/A
Intended Use / 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.
Product codes
MMX
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°
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiovascular system and hollow viscous
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
Performance testing to assess the impact of the modifications was from the FDA guidance document "Coronary and Cerebrovascular Guidewire Guidance" dated January 1995.
Key Metrics
Not Found
Predicate Device(s)
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
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 Road |
| Acton, MA 01720 | |
| Contact Person: | Maureen A. Finlayson |
| Device Generic Name: | Snare |
| Device Trade Name: | Radius Snare |
| Classification Name: | Embolectomy Catheter (MMX) |
B. INDICATIONS
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.
C. DESCRIPTIVE CHARACTERISTICS
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°
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.
1
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.
2
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.
3
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
4
510(k) Number (if known):
Radius Snare Device Name:
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.
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