(72 days)
Not Found
Not Found
No
The description focuses on the mechanical and thermodynamic principles of cryoablation and does not mention any AI or ML components.
Yes
The device is intended for the "treatment of cardiac diseases, such as arrhythmia, by the application of extreme cold in order to ablate (destroy) electrically abnormal cardiac and vascular tissue," which classifies it as a therapeutic device.
No
The device is described as a "Surgical Probe" intended for "treatment of cardiac diseases" by "ablation (destroy) electrically abnormal cardiac and vascular tissue," indicating a therapeutic rather than diagnostic purpose.
No
The device description clearly states it is a "single-use, disposable device" that is a "Surgical Probe" and "delivers Cryoablation therapy," indicating it is a physical hardware device.
Based on the provided information, the CryoCor Model 1255 Surgical Probe is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of cardiac diseases by ablating tissue. This is a therapeutic intervention performed in vivo (within the living body).
- Device Description: The device is a surgical probe used to deliver cryoablation therapy directly to tissue.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The CryoCor Model 1255 Surgical Probe is a therapeutic medical device used in a surgical setting.
N/A
Intended Use / Indications for Use
The CryoCor Model 1250 ("Breva") Series Surgical Probes are intended to be used in thoracic surgery, specifically for the ablation of arrhythmic cardiac tissue.
Product codes (comma separated list FDA assigned to the subject device)
GEH, OCL
Device Description
The CryoCor Model 1255 Surgical Probe is a single-use, disposable device that interfaces with the Cryoablation console and delivers Cryoablation therapy to the target tissue, using N2O as a cryogen and employing the Joule-Thomson effect to cause a block of electrical conduction through tissue through cryonecrosis. Placement of the Probe tip is accomplished under direct visualization by manipulation of the Probe handle (applying torque to the shaft and/or deflecting the articulation segment). The Breva Model Series may include multiple articulation lengths and multiple tip lengths. The first model of the Breva Model Series to be commercialized will be the Breva 1255-15-12 (i.e. 5cm articulation length, 15 mm tip length, and 12cm shaft length).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
cardiac surgical setting
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
Bench testing confirmed that the Model 1255-15-12 Surgical Probe met its design and performance requirements.
Biocompatibility testing was performed on the materials which are blood contacting according to ISO 10993-1. All materials were found to be biocompatible.
The Model 1255-15-12 Surgical Probes are sterilized using a validated E-beam radiation sterilization cycle.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing, Biocompatibility testing, Sterilization Validation. Key results: The Model 1255-15-12 Surgical Probe met its design and performance requirements, all materials were found to be biocompatible, and the probes are sterilized using a validated E-beam radiation sterilization cycle.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
SEP 2 2 2004
K041890 p. 1 of 2
510(k) Summary of Substantial Equivalence
| Date Prepared | September 16, 2004 |
|---|---|
| Submitter | |
| Address | CryoCor, Inc. |
| 9717 Pacific Heights Blvd. | |
| San Diego, Ca 92121 | |
| Contact | |
| Phone | |
| Fax | |
| E-Mail Address | Jami Miller |
| Regulatory Affairs Specialist | |
| 858-909-2231 | |
| 858-909-2350 | |
| jmiller@cryocor.com | |
| Device Trade Name/ Model Numbers | 1255 Series Surgical Probe: |
| Model 1255-15-12 | |
| Device Common Name | Cryosurgical Probe |
| Device Classification Name | Cryosurgical unit and accessories |
| Classification Regulation | Class II, C.F.R. Section 878.4350 |
| Product Code | GEH |
Device Description
The CryoCor Model 1255 Surgical Probe is a single-use, disposable device that interfaces with the Cryoablation console and delivers Cryoablation therapy to the target tissue, using N2O as a cryogen and employing the Joule-Thomson effect to cause a block of electrical conduction through tissue through cryonecrosis. Placement of the Probe tip is accomplished under direct visualization by manipulation of the Probe handle (applying torque to the shaft and/or deflecting the articulation segment). The Breva Model Series may include multiple articulation lengths and multiple tip lengths. The first model of the Breva Model Series to be commercialized will be the Breva 1255-15-12 (i.e. 5cm articulation length, 15 mm tip length, and 12cm shaft length).
Intended Use
The CryoCor Model 1255 Surgical Probe is intended to be used for the treatment of cardiac diseases, such as arrhythmia, by the application of extreme cold in order to ablate (destroy) electrically abnormal cardiac and vascular tissue. The Probe is part of a
1
Cryoablation System, which includes a control console and a Probe/console interface. The Probe will be used under direct visualization to perform cardiac ablation procedures in the cardiac surgical setting. The intent of the device will be to treat patients either concomitant with or using techniques widely used in cardiac surgery, including thoracotomy or minimally invasive (MICS) techniques.
Substantially Equivalent Devices
The physical characteristics, the intended use, and the mode of use of the Model 1255 Surgical Probe are similar to the predicate device.
Test Summary
Performance Testing
Bench testing confirmed that the Model 1255-15-12 Surgical Probe met its design and performance requirements.
Biocompatibility Information
Biocompatibility testing was performed on the materials which are blood contacting according to ISO 10993-1. All materials were found to be biocompatible.
Sterilization Validation
The Model 1255-15-12 Surgical Probes are sterilized using a validated E-beam radiation sterilization cycle.
Conclusion
CryoCor, Inc. considers the Model 1255-15-12 Surgical Probe to be substantially equivalent to their legally marketed predicate device based on the data and information presented within this application.
2
Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is presented in black and white.
FEB 2 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cryocor, Inc. c/o Ms. Jami Miller Regulatory Affairs Specialist 9717 Pacific Heights Blvd. SanDiego, CA 92121
Re: K041890
Trade Name: Cryocor Model 1250 ("Breva") Series Surgical Probes Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit and Accessories Regulatory Class: II (two) Product Code: OCL Dated: August 05, 2004 Received: August 09, 2004
Dear Ms. Miller:
This letter corrects our substantially equivalent letter of September 22, 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.
3
Page 2 - Ms. Jami 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 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 vours.
Eemee
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number: K041890
Device Name: CryoCor Model 1250 ("Breva") Series Surgical Probes
Indications for Use:
The CryoCor Model 1250 ("Breva") Series Surgical Probes are intended to be used in thoracic surgery, specifically for the ablation of arrhythmic cardiac tissue.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bumima
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K041890