(56 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and intended use do not suggest the use of AI/ML.
Yes
The device is intended for the ablation of cardiac tissue during cardiac surgery, which is a therapeutic intervention.
No
Explanation: The device is described as an ablation device, intended for the "ablation of cardiac tissue," which is a treatment rather than a diagnostic function.
No
The device description explicitly states "Epicor Medical UltraCinch Tissue Ablation Device and Accessories," indicating a physical device and associated hardware components, not solely software. The intended use also describes a physical action (ablation of cardiac tissue).
Based on the provided information, the Epicor Medical UltraCinch is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "ablation of cardiac tissue during cardiac surgery." 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 device is described as a "Tissue Ablation Device and Accessories," which aligns with a surgical tool for modifying tissue.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Measuring analytes or biomarkers
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The UltraCinch is a surgical tool used for treatment.
N/A
Intended Use / Indications for Use
The Epicor Medical UltraCinch is intended for the ablation of cardiac tissue during cardiac surgery.
The items in the UltraCinch Accessory Pack are intended for use in 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 testing, in vivo testing, and human clinical studies demonstrate that the Epicor Medical UltraCinch tissue ablation device and accessories are safe and effective for their intended use.
Key Metrics
Not Found
Predicate Device(s)
K022894, K013392, K013873, K023291, K003978, K013946, K011988, K013901
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
Public Health Service
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
MAR 1 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Epicor Medical, Inc. c/o Ms. Kathi Guerrant Vice President, Regulatory Affairs and Quality Assurance 1635 Energy Park Drive St. Paul, MN 55108
Re: K040641 Trade Name: Epicor Medical UltraCinch Tissue Ablation Device and Accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II (two) Product Code: OCL, NTB Dated: March 09, 2004 Received: March 10, 2004
Dear Ms. Guerrant:
This letter corrects our substantially equivalent letter of May 5, 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 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 (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 yours,
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):
Device Name: Epicor Medical UltraCinch Tissue Ablation Device and Accessory Pack
Indications For Use:
The Epicor Medical UltraCinch is intended for the ablation of cardiac tissue during cardiac surgery.
The items in the UltraCinch Accessory Pack are intended for use in 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)
Ashley B. Boam
argiovascular Da
510(k) Number K040641
Page 1 of __
Epicor Medical, Inc.
CONFIDENTIAL
Page B-2
3
510(k) Notification
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: _______________________________________________________________________________________________________________________________________________________________
MAY - 5 2004
510(k) number:
| Applicant Information: | Contact Person |
|---|---|
| Epicor Medical, Inc. | Kathi M. Guerrant |
| 240 Santa Ana Court | Phone Number: (408) 733-6500 |
| Sunnyvale, CA 94085-4512 | Fax Number: (408) 733-6682 |
Device Information:
| Classification: | Unclassified |
|---|---|
| Trade Name: | Epicor Medical UltraCinch Tissue Ablation Device and |
| Accessories | |
| Classification Name: | Ultrasonic Surgical Instruments |
Equivalent Device:
The subject device is substantially equivalent in intended use and/or method of operation to the Epicor Medical UltraWand tissue ablation device (K022894), the Medtronic Cardioblate Radiofrequency Ablation System (K013392), the Boston Scientific Cobra RF and Cooled RF Family of Surgical Probes (K013873. K023291), the AFx Microwave Ablation System (K003978, K013946), and the CardioFocus Surgical Lightstic (K011988, K013901).
Intended Use:
The Epicor Medical UltraCinch is intended for the ablation of cardiac tissue during cardiac surgery.
The items in the UltraCinch Accessory Pack are intended for use in the ablation of cardiac tissue during cardiac surgery.
Test Results:
Performance
Results of in vitro testing, in vivo testing, and human clinical studies demonstrate that the Epicor Medical UltraCinch tissue ablation device and accessories are safe and effective for their intended use.
Biocompatibility
The materials used in the Epicor Medical UltraCinch tissue ablation device and accessories 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.