(324 days)
Not Found
Not Found
No
The summary describes a mechanical steerable sheath and dilator, with no mention of AI/ML terms, image processing, or data-driven performance metrics.
No.
This device is an introducer sheath that facilitates the placement of other catheters into the heart and vasculature, rather than directly treating a condition itself.
No
The device is described as an introducer sheath and dilator, facilitating the placement of other catheters into the body. This is an interventional or access device, not a diagnostic one.
No
The device description explicitly states it is comprised of a shaft and a handle, and includes a dilator, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "percutaneous catheter introduction into the vasculature and into the chambers of the heart." This describes a procedure performed on the patient's body, not a test performed on a sample taken from the patient.
- Device Description: The description details a "deflectable catheter introducer" used to facilitate placing a catheter. This is a tool for a medical procedure, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely procedural.
N/A
Intended Use / Indications for Use
The FlexCath™ Steerable Sheath & Dilator is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning.
Product codes
DRA
Device Description
The FlexCath™ Steerable Sheath is a deflectable catheter introducer used to facilitate placing a catheter through the skin into the artery or vein. It is comprised of the following two (2) main sections: the shaft and the handle. A dilator is also part of the package.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vasculature and into the chambers of the heart
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
The Agilis Steerable Catheter introducer and the Enpath Deflectable Catheter
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1280 Steerable catheter.
(a)
Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.(b)
Classification. Class II (performance standards).
0
510(k) Summary
CryoCath Technologies Inc.
FlexCath™ Steerable Sheath & Dilator
- SPONSOR/MANUFACTURER 1. CryoCath Technologies Inc. 16771 Chemin Ste-Marie Kirkland, Quebec H9H 5H3 CANADA
DEC 28 2007
Official Correspondence Chief Scientific Officer Jean Pierre Desmarais (Telephone: 514-694-1212, Ext. 226) E-mail: desmarais@cryocath.com
-
- DEVICE NAME FlexCath™ Steerable Sheath & Dilator Proprietary Name:
Common/Usual Name: Introducer Classification Name: Catheter Introducer
- DEVICE NAME FlexCath™ Steerable Sheath & Dilator Proprietary Name:
3. PREDICATE DEVICES
The Agilis Steerable Catheter introducer and the Enpath Deflectable Catheter
4. DEVICE DESCRIPTION
The FlexCath™ Steerable Sheath is a deflectable catheter introducer used to facilitate placing a catheter through the skin into the artery or vein. It is comprised of the following two (2) main sections: the shaft and the handle. A dilator is also part of the package.
CryoCath Technologies Inc., Traditional 510(k) FlexCath™ Steerable Sheath & Dilator
1
5. INTENDED USE
The FlexCath™ Steerable Sheath & Dilator is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
Technological characteristics such as product design and materials of the FlexCath™ Steerable Sheath are substantially equivalent to the predicate devices. Where dimensional and slight material differences exist between the proposed device and the predicate devices, biocompatibility testing demonstrated that these differences do not adversely affect safety and effectiveness.
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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 stylized eagle-like symbol with three lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the symbol. The logo is presented in black and white.
DEC 2 8 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
CryoCath Technologies, Inc. c/o Dr. Fred Miller U.S. Agent for CryoCath Technologies Applied Physics 10B Tano Road Santa Fe, NM 87506
Re: K070357
FlexCath ™ Steerable Sheat & Dilator Regulation Number: 21 CFR 870.1280 Regulation Name: Steerable Catheter Regulatory Class: Class II (two) Product Code: DRA Dated: December 19, 2007 Received: December 20, 2007
Dear Mr. Desmarais:
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 - Dr. Fred Miller
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bhimimmar for
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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Image /page/4/Picture/0 description: The image shows the word "CryoCath" in black letters next to a black symbol. The symbol is made up of three curved lines that are stacked on top of each other. The word "CryoCath" is written in a simple, sans-serif font. The image is simple and clear, with a focus on the text and symbol.
CrvoCath Technologies Inc 16771 Chemin Ste-Marie, Kirkland, Québec, Canada H9H 5H3
Premarket Notification
Indications for Use Statement
510(k) Number (if known): K070357
Device Name: FlexCath™ Steerable Sheath & Dilator
Indications for Use: The FlexCath™ Steerable Sheath & Dilator is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning.
The FlexCath™ Steerable sheath is contraindicated for Contraindications: placement in the left atrium or ventricle if:
- The patient has an intra-atrial septal patch or has had . other surgical intervention in or adjacent to the intra-atrial septum.
- The patient has had previous embolic event from the left . side of the heart within 2 months of the procedure
- The patient has known or suspended atrial myxoma. .
FlexCath™ Steerable sheath should not be used to perform the transseptal puncture.
Prescription Use: × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter-Use: (Part 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)
Bhim
(Division Sign-Off)
CryoCath Technologies Inc., Traditional 510(k) FlexCath™ Steerable Sheath & Dilator
ardiovascular Devices