(44 days)
No
The summary describes a cryosurgical system that uses argon gas to freeze tissue. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is intended for the minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias, by freezing target tissue to block electrical conduction pathways, which directly addresses a medical condition.
No
Explanation: The device description and intended use clearly state that the SurgiFrost® system is designed to freeze target tissue and block electrical conduction pathways for therapeutic purposes (treating cardiac arrhythmias), not to diagnose conditions.
No
The device description clearly outlines multiple hardware components including a Cryosurgical Console, Cryosurgical Device (probe), FrostByte™ Clamp, and accessories like a footswitch and gas tank regulator. This is a hardware-based system with potential software control, not a software-only device.
Based on the provided text, the SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias." This describes a surgical intervention performed directly on the patient's body.
- Mechanism of Action: The device "freezes the target tissue and blocks the electrical conduction pathways by creating an inflammatory response and cryonecrosis." This is a physical action applied to living tissue within the body.
- Device Description: The description details a system used to deliver cold temperatures to targeted tissue during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body. This device is used to directly treat tissue within the body.
N/A
Intended Use / Indications for Use
The SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console are intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console freezes the target tissue and blocks the electrical conduction pathways by creating an inflammatory response or cryonecrosis.
Product codes
OCL
Device Description
The SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console are intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console freezes the target tissue and blocks the electrical conduction pathways by creating an inflammatory response or cryonecrosis.
The SurgiFrost® 10 cm Cryosurgical Device used with or without the FrostByte™ Clamp, Cryosurgical Console and accessories act together as a System. The system is composed of the following components:
- . Cryosurgical Control Panel and Power Cord
- Cryosurgical Console
- Tank Carrier .
- Gas Tank Regulator and Wrench .
- Gas Hose .
- SurgiFrost® Cryosurgical Device (Single Use) ●
- . FrostByte™ Clamp (Single Use)
- . Footswitch (optional)
The SurgiFrost® Cryosurgical System consists of a compact, easy-to-operate Cryosurgical Console and associated accessories that include SurgiFrost® 10 cm Cryosurgical Probe to deliver cold temperatures to the targeted tissue. The control console operates off standard 120/230 VAC (60/50 Hz) wall power and utilizes inert argon gas. The Cryosurgical Console controls a single-use, disposable SurgiFrost® Cryosurgical Probe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac
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)
Information submitted in this premarket notification for the SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console is substantially equivalent to the predicate devices listed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K021010, K011040, K973190, K023288, K020919, K013392
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
510(k) Summary
CryoCath Technologies Inc. SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console
1. SPONSOR
| CryoCath Technologies Inc. | |
|---|---|
| 16771 Chemin Ste-Marie | |
| Kirkland, Quebec | |
| H9H 5H3, CANADA | |
| Contact Person: | Flor del Pilar Arana, Official Correspondent |
| Telephone: | 514-694-1212 |
Date Prepared: March 12, 2004
2. Device Name
| Device Trade Name: | SurgiFrost® 10 cm Cryosurgical Device plus
FrostByte™ Clamp and Cryosurgical Console |
|------------------------|-----------------------------------------------------------------------------------------|
| Common/Usual Name: | Cryosurgical system |
| Classification Name: | Cryosurgical Unit and Accessories |
| Device Classification: | Class II |
3. PREDICATE DEVICES
CryoCath Technologies - SurgiFrost® Cryosurgical System (K021010)
Endocare Inc. - CryoCare Cardiac Surgical System (K011040)
CryoMedical Sciences - AccuProbe 450, Accuprobe 550/530, Accuprobe 600 series (K973190)
Boston Scientific - Cobra Bipolar System (K023288)
Atricure Inc. - Atricure Bipolar Coagulation System (K020919)
Medtronic Inc. - Cardioblate™ Radiofrequency Ablation System (K013392)
4. Device Description
The SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console are intended for minimally invasive cardiac surgical
1
procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console freezes the target tissue and blocks the electrical conduction pathways by creating an inflammatory response or cryonecrosis.
The Intended Use does not change as a result of this special 510(k) submission.
The SurgiFrost® 10 cm Cryosurgical Device used with or without the FrostByte™ Clamp, Cryosurgical Console and accessories act together as a System. The system is composed of the following components:
- . Cryosurgical Control Panel and Power Cord
- Cryosurgical Console �
- Tank Carrier .
- Gas Tank Regulator and Wrench .
- Gas Hose .
- SurgiFrost® Cryosurgical Device (Single Use) ●
- . FrostByte™ Clamp (Single Use)
- . Footswitch (optional)
The SurgiFrost® Cryosurgical System consists of a compact, easy-to-operate Cryosurgical Console and associated accessories that include SurgiFrost® 10 cm Cryosurgical Probe to deliver cold temperatures to the targeted tissue. The control console operates off standard 120/230 VAC (60/50 Hz) wall power and utilizes inert argon gas. The Cryosurgical Console controls a single-use, disposable SurgiFrost® Cryosurgical Probe.
5. Intended Use
The SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console are intended for minimally invasive treatment of cardiac arrhythmias. The CryoCath SurgiFrost® System freezes the target tissue and blocks the electrical conduction pathways by creating an inflammatory response and cryonecrosis.
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console is substantially equivalent to the predicate devices based on intended use, design, materials, technological, and operational
2
KO40690 p.30f3
characteristics. The differences between the CryoCath devices are minor and raise no new issues of safety or effectiveness.
7. Performance Testing
Information submitted in this premarket notification for the SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console is substantially equivalent to the predicate devices listed.
3
Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with a bird-like figure wrapped around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
FEB 21 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
CryoCath Technologies, Inc. c/o Ms. Flor del Pilar Arana Director Regulatory Affairs 16771 Chemin Ste-Marie Kirkland, Quebec H9H 5H3, CANADA
Re: K040690
Trade Name: SurgiFrost® 10 cm Cryosurgical Device plus Frostbyte™ Clamp and Cryosurgical Console Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit and Accessories Regulatory Class: II (two) Product Code: OCL Dated: April 14, 2004 Received: April 20, 2004
Dear Ms. Pilar Arana:
This letter corrects our substantially equivalent letter of April 29, 2004.
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 (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 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.
4
Page 2 - Ms. Flor del Pilar Arana
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 continue 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/dsma/dsmamain.html
Sincerely yours,
elmee
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K0466 90
Device Name: SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console
Indications For Use: The SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console is intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console freezes the target tissue and blocks the electrical conduction pathways by creating an inflammatory response and cryonecrosis.
Prescription Use X
:
AND/OR
Over-The-Counter Use (21CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Diuna Riaclune1
Jivision Sign-Off) Nivision of Cardiovascular Devices
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310(k) Number_K040690