(541 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices.
Yes
The device is intended for the "ablation of cardiac tissue," which is a medical treatment.
No
The device is described as an "Ablation System" intended for the "ablation of cardiac tissue." Ablation is a treatment, not a diagnostic procedure.
No
The device description explicitly lists hardware components: "UltraWand Ablation Device, Ablation Control System, and Connecting Cable".
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "ablation of cardiac tissue during cardiac surgery." This describes a procedure performed on the patient's body (in vivo), not a test performed on samples taken from the body (in vitro).
- Device Description: The components listed (UltraWand Ablation Device, Ablation Control System, Connecting Cable) are consistent with a surgical device used for tissue modification, not for analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue samples, or any other biological material. The focus is on the direct application of energy to cardiac tissue.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to physically alter tissue during surgery.
N/A
Intended Use / Indications for Use
The Epicor Medical Ablation System (the UltraWand Ablation Device, Ablation Control System, and Connecting Cable) is Intended for the ablation of cardiac tissue during cardiac surgery.
Product codes
OCL, NTB
Device Description
Not Found
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
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
Results of in vitro and in vivo testing demonstrate that the Epicor Medical Ablation System is safe and effective for its intended use.
Key Metrics
Not Found
Predicate Device(s)
K010956, K013873, K011722, K020919, K003978, K013946, K013392, K013901, K021010, K022008
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
Image /page/0/Picture/1 description: The image contains the text 'Public Health Service'. The text is displayed in a simple, sans-serif font. The words are arranged on a single line, with 'Public' and 'Health' capitalized, followed by 'Service'.
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
MAR 1 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Epicor Medical, Inc. c/o Ms. Kathi M. Guerrant Vice President, Regulatory Affairs and Quality Assurance 240 Santa Ana Court Sunnyvale, CA 94085-4512
Re: K022894
Trade Name: Epicor Medical Ablation System, including UltraWand Ablation Device, Ablation Control System and Connecting Cable Regulatory Number: 21 CFR 878.4400 Common Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II (two) Product Code: OCL, NTB Dated: December 12, 2003 Received: December 15, 2003
Dear Ms. Guerrant:
This letter corrects our substantially equivalent letter of November 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.
1
Page 2 - Ms. Kathi M. Guerrant
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,
elgmall
Bram D. Zuckerman
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K022894
Device Name: Epicor Medical Ablation System, including the UltraWand Ablation Device, Ablation Control System, and Connecting Cable
Indications For Use:
The Epicor Medical Ablation System (the UltraWand Ablation Device, Ablation Control System, and Connecting Cable) is Intended for the ablation of cardiac tissue during cardiac surgery.
Prescription Use × (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 IF NEEDED) - -
Concurrence of CDRH, Office of Device Evaluation (ODE)
R. Vochusel
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number ≤622 8 94
3
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:
510(k) number: _______________________________________________________________________________________________________________________________________________________________
Applicant Information:
Epicor Medical, Inc. 240 Santa Ana Court Sunnyvale, CA 94085-4512
Contact Person
Kathi M. Guerrant Phone Number: (408) 733-6500 Fax Number: (408) 733-6682
Device Information:
| Classification: | Unclassified |
|---|---|
| Trade Name: | Epicor Medical Ablation System, including the UltraWand |
| Ablation Device, Ablation Control System, and Connecting Cable | |
| Classification Name: | Ultrasonic Surgical Instruments |
Equivalent Device:
The subject device is substantially equivalent in intended use and/or method of operation to the Boston Scientific Cobra Flex Family of Surgical Probes (K010956, K013873), the AtriCure Coagulation System (K011722, K020919); the AFx Microwave Ablation System (K003978, K013946); the Medtronic Cardioblate Radiofrequency Ablation System (K013392); CardioFocus Malleable Surgical Lightstic (K013901); the CryoCath SurgiFrost probe (K021010) and the Cardima Ablation System (K022008).
Intended Use:
The Epicor Medical Ablation System (the UltraWand Ablation Device, Ablation Control System, and Connecting Cable) is intended for the ablation of cardiac tissue during cardiac surgery.
Test Results:
Performance
Results of in vitro and in vivo testing demonstrate that the Epicor Medical Ablation System is safe and effective for its intended use.
Biocompatibility
The materials used in the Epicor Medical Ablation System meet the requirements of ISO 10993-1.
Summary: Based on the intended use, product, performance and biocompatibility information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate devices.