(172 days)
The Epicor Medical Ablation Control System is intended for the ablation of cardiac tissue during cardiac surgery
The UltraCinch LP is intended for the ablation of cardiac tissue during cardiac surgery
The UltraWand LP is intended for the ablation of cardiac tissue during cardiac surgery
The items in LP PAS System are part of the Epicor Cardiac Ablation System. The System is intended for the ablation of cardiac tissue during cardiac surgery
The LP Oblique Introducer is part of the Epicor Cardiac Ablation System. The System is intended for the ablation of cardiac tissue during cardiac surgery
The LP Connecting Cable is part of the Epicor Cardiac Ablation System. The System is intended for the ablation of cardiac tissue during cardiac surgery
The Epicor Ablation System is designed to deliver ultrasound energy to tissue in order to create an ablation lesion. Specifically, the system is intended for the ablation of cardiac tissue during cardiac surgery. The Ablation System consists of the Ablation Control System instrument, a reusable connecting cable, a family of sterile, disposable ablation devices, and accessories.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Epicor™ Ablation System:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific numerical acceptance criteria (e.g., a target accuracy or lesion size) and their corresponding reported device performance metrics are not explicitly stated. The document primarily focuses on establishing substantial equivalence to a predicate device through technological characteristics and non-clinical performance data.
Instead, the "acceptance criteria" can be inferred as demonstration of safety and effectiveness equivalent to the predicate device and that the changes do not raise any new issues of safety and effectiveness. The reported performance is that the device met these inferred criteria.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Device is as safe and effective as the previously marketed predicate device. | "An evaluation of the device changes indicates that the devices are as safe and effective as the previously marketed device to which they are being compared." |
| Device changes do not raise any new issues of safety and effectiveness. | "...and do not raise any new issues of safety and effectiveness." |
| New device has the same technological characteristics as the legally marketed predicate device. | "The new device has the same technological characteristics as the legally marketed predicate device." |
| Non-clinical performance demonstrates functionality and safety. (Implied for 510(k) submission) | "The changes made to the Epicor Ablation System underwent a battery of bench and user tests. Device validation testing was conducted in accordance with in-house procedures." (Specific results or metrics are not detailed, but the conclusion implies satisfactory performance.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states that "a battery of bench and user tests" were conducted. However, the sample size for these tests is not specified.
- Data Provenance: The data comes from non-clinical (bench and user) tests conducted by St. Jude Medical ("in-house procedures"). There is no mention of clinical data, country of origin, or whether it was retrospective or prospective in the context of this 510(k) summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The document refers to "user tests," suggesting involvement of users (likely medical professionals), but details on their number or qualifications for establishing specific ground truth are absent.
4. Adjudication Method for the Test Set
The adjudication method is not described in the provided text. The document refers to "in-house procedures" for validation, but specific details on how disagreements or ambiguous results were resolved are not given.
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
No, an MRMC comparative effectiveness study was not conducted or reported in this 510(k) summary. This document pertains to a medical device for ultrasound energy delivery and ablation, not an AI or imaging-based diagnostic tool that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable to the Epicor Ablation System as described. This is a procedural device that physically ablates tissue, not an algorithm, and does not have a "standalone" algorithmic performance in the typical sense of AI/image analysis. Its performance is tied to its physical interaction with tissue and control system.
7. The Type of Ground Truth Used
The ground truth used for the non-clinical performance data would be based on the physical outcomes of the bench and user tests. This would likely include:
- Direct measurements of ablation lesion characteristics (e.g., size, depth, contiguity) in tissue samples (ex-vivo or in-vivo animal models, though the document doesn't specify in-vivo).
- Functional tests of the device's ability to deliver energy, maintain temperature, and operate within specifications.
- User feedback regarding ease of use and functionality.
It is not expert consensus, pathology (in the clinical diagnosis sense), or outcomes data from human patients, as this is a non-clinical submission for substantial equivalence.
8. The Sample Size for the Training Set
There is no mention of a training set in this document. This submission is for a medical device (ablation system), not an AI or machine learning algorithm that typically requires distinct training and test sets.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set, this question is not applicable.
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K080292
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| 510(k) Summary for Public Disclosure | |
|---|---|
| St. Jude Medical240 Santa Ana CourtSunnyvale, CA 94085-4512 USAPhone: 651-632-9454 ext. 2024Fax:651-644-7897 | JUL 2 5 2008 |
| Karen J. McKelveyPrincipal Regulatory Compliance Engineer | |
| February 1, 2008 | |
| Epicor™ Medical Ablation Control System (ACS)Epicor™ UltraCinch™ LP Ablation DeviceEpicor™ UltraWand™ LP Tissue Ablation WandEpicor™ LP Positioning and Sizing (LP PASTM) SystemEpicor™ LP Oblique IntroducerEpicor™ LP Connecting Cable | |
| Ultrasonic Surgical Instrument | |
| System, Ablation, Ultrasound and Accessories(21 CFR 878.4400) | |
| U(K) Numb | |
| K022894 | |
| UltraCinch Tissue Ablation Device | K040641 |
| UltraWand Ablation Device | K022894 |
| UltraCinch Accessory Pack | K040641 |
| UltraMaze Connecting Cable | K040641 |
| Epicor Ablation Control System (ACS) |
Device Description: The Epicor Ablation System is designed to deliver ultrasound energy to tissue in order to create an ablation lesion. Specifically, the system is intended for the ablation of cardiac tissue during cardiac surgery. The Ablation System consists of the Ablation Control System instrument, a reusable connecting cable, a family of sterile, disposable ablation devices, and accessories.
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K080292
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:
| Epicor AblationControl SystemIntended use: | The Epicor Medical Ablation Control System is intended for theablation of cardiac tissue during cardiac surgery |
|---|---|
| UltraCinch LPIntended use: | The UltraCinch LP is intended for the ablation of cardiac tissueduring cardiac surgery |
| UltraWand LPIntended use: | The UltraWand LP is intended for the ablation of cardiac tissueduring cardiac surgery |
| LP PAS SystemIntended use: | The items in LP PAS System are part of the Epicor CardiacAblation System. The System is intended for the ablation ofcardiac tissue during cardiac surgery |
| LP Oblique IntroducerIntended use: | The LP Oblique Introducer is part of the Epicor Cardiac AblationSystem. The System is intended for the ablation of cardiac tissueduring cardiac surgery |
| LP Connecting CableIntended use: | The LP Connecting Cable is part of the Epicor Cardiac AblationSystem. The System is intended for the ablation of cardiac tissueduring cardiac surgery |
| TechnologicalCharacteristics: | The new device has the same technological characteristics as thelegally marketed predicate device. |
| Non-clinicalPerformance Data: | The changes made to the Epicor Ablation System underwent abattery of bench and user tests. Device validation testing wasconducted in accordance with in-house procedures. |
| Conclusion: | An evaluation of the device changes indicates that the devicesare as safe and effective as the previously marketed device towhich they are being compared and do not raise any new issuesof safety and effectiveness. |
- September 19.
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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract emblem that resembles an eagle or other bird-like figure, composed of three curved lines above a ribbon-like element.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 5 2008
St. Jude Medical c/o Ms. Karen McKelvey Principal Regulatory Compliance Engineer 1350 Energy Lane, Suite 110 St. Paul, MN 55108
Re: K080292
Trade Name: Epicor Ablation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: OCL Dated: July 14, 2008 Received: July 17, 2008
Dear Ms. McKelvey:
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 application (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 such 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.
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
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Page 2 - Ms. Karen J. McKelvey
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 begin 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.
Sincerely yours.
Qomell
Bram D. Zuckerman M.D.
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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9. Indications for Use
510(k) Number (if known): N/A Ko80292-
Device Name: The Epicor™ Ablation System, including
- ♥ Epicor Medical Ablation Control System (ACS)
- Epicor™ UltraCinch™ LP Ablation Device .
- Epicor™ UltraWand™ LP Tissue Ablation Wand �
- Epicor™ LP Positioning and Sizing (LP PAS™) System .
- Epicor™ LP Oblique Introducer .
- Epicor™ LP Connecting Cable .
Indications for Use:
The Epicor Medical Ablation Control System is intended for the ablation of cardiac tissue during cardiac surgery
Indications for Use:
The UltraCinch LP is intended for the ablation of cardiac tissue during cardiac surgery Indications for Use:
The UltraWand LP is intended for the ablation of cardiac tissue during cardiac surgery Indications for Use:
The items in LP PAS System are part of the Epicor Cardiac Ablation System. The System is intended for the ablation of cardiac tissue during cardiac surgery Indications for Use:
The LP Oblique Introducer is part of the Epicor Cardiac Ablation System. The System is intended for the ablation of cardiac tissue during cardiac surgery
Indications for Use:
The LP Connecting Cable is part of the Epicor Cardiac Ablation System. The System is intended for the ablation of cardiac tissue during cardiac surgery
স Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
| 510(k) Number | K080292 |
|---|---|
| --------------- | --------- |
SJM Response to FDA Request 16
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§ 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.