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.
Epicor Medical UltraCinch Tissue Ablation Device and Accessories
This document is a 510(k) premarket notification for the Epicor Medical UltraCinch Tissue Ablation Device and Accessories. It focuses on demonstrating substantial equivalence to previously marketed devices rather than establishing novel safety and effectiveness criteria through specific performance goals and studies.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth types cannot be fully provided from the given text. This type of submission relies on showing that the new device is as safe and effective as existing legally marketed predicate devices, often by demonstrating similar technological characteristics and performance in standard tests, rather than setting and meeting new, specific quantitative acceptance criteria for a novel clinical outcome.
However, based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance:
The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., specific percentages, measurements, or clinical outcomes) that the device must meet. Instead, it states that "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."
The device performance is generally reported as:
- "safe and effective for their intended use."
- "meet the requirements of ISO 10993-1." (for biocompatibility)
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified in the provided text. The document mentions "clinical studies" but does not give details about their size or structure.
- Data Provenance: Not explicitly stated. The document refers to "in vitro testing, in vivo testing, and human clinical studies." These could be retrospective or prospective, and the country of origin is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the text. As this is a 510(k) submission focused on substantial equivalence, the "ground truth" (in the sense of a diagnostic or predictive AI model) is not the primary focus. The "ground truth" for the device's function would be the physical effect of ablation, which is assessed through the "in vivo testing" and "human clinical studies" mentioned in a general sense.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided in the text.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable to this device. The Epicor Medical UltraCinch is a tissue ablation device, not an AI software or diagnostic imaging system that would involve human readers interpreting cases with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable to this device. As explained above, this is a physical medical device for cardiac tissue ablation, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For this type of device, the "ground truth" would likely relate to:
- Successful ablation: Confirmation of tissue destruction/modification.
- Clinical outcomes: Reduction of arrhythmias or other target conditions.
- Safety metrics: Absence of adverse events.
However, the specific methods for establishing this ground truth (e.g., pathology reports from ablated tissue, electrophysiological mapping results, long-term patient follow-up, etc.) are not detailed in the provided text.
8. The sample size for the training set:
This is not applicable as this is a physical medical device, not an AI/ML model that requires a training set. The "studies" mentioned would be for device validation, not model training.
9. How the ground truth for the training set was established:
This is not applicable as this is a physical medical device, not an AI/ML model that requires a training set.
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Public Health Service
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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.
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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
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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
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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 andAccessories |
| 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.
§ 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.