(59 days)
Not Found
No
The summary explicitly states "Not Found" for mentions of AI, DNN, or ML, and the device description focuses on hardware components and energy management.
Yes
The device is intended to ablate cardiac tissue during cardiac surgery, which is a therapeutic intervention.
No
The device is used to ablate cardiac tissue during surgery, indicating a therapeutic rather than diagnostic function.
No
The device description explicitly lists hardware components: a disposable probe, a reusable energy management device, and associated cables.
Based on the provided information, the Cardima Ablation System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "ablate cardiac tissue during cardiac surgery using radiofrequency energy." This describes a therapeutic procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The components (ablation probe, energy management device, cables) are consistent with a surgical device used for treatment, not for analyzing biological samples.
- Anatomical Site: The target is "cardiac tissue," which is part of the living patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), performing tests in vitro (outside the body), or providing diagnostic information based on sample analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Cardima Ablation System's function is to treat tissue in vivo.
N/A
Intended Use / Indications for Use
The Cardima Ablation System is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.
Product codes (comma separated list FDA assigned to the subject device)
OCL
Device Description
The Cardima Ablation System consists of the disposable Cardima Ablation Probe with Stabilization Sheath, the reusable INTELLITEMP® energy management device, and associated cables.
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 surgery
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)
- Performance
Results of in-vitro testing demonstrate that the Cardima Ablation System is safe and effective for its intended function.
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.
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
Ko60715
510 (k) Summary
Page 181
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Date Prepared: March 16, 2006
510(k) number:
11 11 1 5 2005
Applicant Information:
Cardima, Inc.
47266 Benicia Street
Fremont, CA 94538
| Contact Person: | Eric Chan, Ph.D. |
|---|---|
| Phone Number: | (510) 354-0176 |
| Fax Number: | (510) 657-4476 |
Device Information:
| Classification: | Class II |
|---|---|
| Trade Name: | Cardima Ablation System |
| Classification Name: | Electrosurgical Device and accessories (21 CFR 870.4400) |
Equivalent Device:
The subject device and accessory are substantially equivalent in intended use and/or method of operation to the Cardima Ablation System (K022008)
Intended Use:
The Cardima Ablation System is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.
Device Description:
The Cardima Ablation System consists of the disposable Cardima Ablation Probe with Stabilization Sheath, the reusable INTELLITEMP® energy management device, and associated cables.
Test Results:
- Performance
Results of in-vitro testing demonstrate that the Cardima Ablation System is safe and effective for its intended function.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.
MAR 1 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cardima, Inc. c/o Eric Chan, Ph.D. Vice President, Product Development 47266 Benicia Street Fremont, CA 94538-73303
Re: K060715
Trade/Devices Name: Cardima Ablation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II (two) Product Code: OCL Dated: April 21, 2006 Received: April 21, 2006
Dear Dr. Chan:
This letter corrects our substantially equivalent letter of May 15, 2006.
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.
2
Page 2 - Dr. Eric Chan
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 (OS) 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.
elgmee.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
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Indications for Use
510(k) Number (if known):
Cardima Ablation System Device Name:
Indications for Use:
The Cardima Ablation System is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.
Prescription Use ﮯ (Part 21 CFR 801 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 ( of Device Evaluation (ODE) (Division Sign-Division of General, Restorative, and Neurological Devices Page __ of_
KOSOTIS
Cardima, Inc.