(110 days)
The Isolator ™ Transpolar™ pen is a device intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.
The Isolator Transpolar pen is a sterile, single use, electrosurgery device to be used in conjunction with an electrosurgical generator for the delivery of radiofrequency current.
This document is a 510(k) summary for the AtriCure Isolator™ Transpolar™ pen, a device intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy. The submission aims to establish substantial equivalence to predicate devices rather than present a study proving the device meets specific performance acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study to prove they are met is not available in the provided text.
Here's a breakdown of what can and cannot be provided based on the input:
1. A table of acceptance criteria and the reported device performance
Not available in the provided text. The submission focuses on substantial equivalence based on function, materials, and intended use, not on specific performance metrics with acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not available. The document states "Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices." However, no details on test protocols, sample sizes, or data provenance are provided. This is typical for a 510(k) summary relying on substantial equivalence to predicate devices, where extensive clinical trials or performance testing against specific acceptance criteria might not be required if the device is sufficiently similar to existing legally marketed devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No "test set" in the context of expert-adjudicated ground truth is mentioned or implied. The focus is on technical conformity and comparison to predicate devices, not on a clinical performance study with expert evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. See point 3.
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
Not applicable. This device is an electrosurgical pen, not an AI-powered diagnostic tool. MRMC studies are used for evaluating diagnostic performance of imaging systems or AI algorithms with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth in this context is established as the submission relies on substantial equivalence rather than a clinical performance study with diagnostic endpoints.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
Summary of Substantial Equivalence Information Provided:
The provided documents primarily serve as a 510(k) summary for regulatory clearance, focusing on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a detailed study with specific performance acceptance criteria for a novel device.
- Predicate Devices: The Isolator™ Transpolar™ pen is deemed substantially equivalent to the Medtronic Cardioblate Pen (K013392), the Tissue Link Bipolar Sealer 2.3 (Bipolar Floating Ball) device (K032132), and the AtriCure Bipolar System (K020919).
- Basis for Substantial Equivalence: The submission states that the Isolator™ Transpolar™ pen is substantially equivalent in its:
- Indications for use.
- Basic overall function.
- Materials used.
- Testing: "Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices." This included biocompatibility testing in accordance with ISO 10993-1. However, specific details of these "product specifications" or the results are not provided in this summary.
In essence, the "study" proving the device meets its requirements is the demonstration that it is sufficiently similar to already cleared devices, making it "substantially equivalent." This type of submission does not typically include detailed performance acceptance criteria or a clinical study in the way might be expected for novel devices or AI algorithms.
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JUN 1 0 2005 AtriCure®
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510(k) Summary
General Information
| Classification | Class II |
|---|---|
| Trade Name | Isolator™ Transpolar™ pen |
| Manufacturer | AtriCure, Inc.6033 Schumacher Park DriveWest Chester, OH 45069 |
| Contact | Elsa AbruzzoVice President, Clinical and Regulatory Affairs |
Intended Use
The Isolator ™ Transpolar™ pen is a device intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.
Predicate Devices
The predicate device for the Isolator Transpolar Pen are the Medtronic Cardioblate Pen (K013392), the Tissue Link Bipolar Sealer 2.3 (Bipolar Floating Ball) device (K032132) and the AtriCure Bipolar System (K020919).
Device Description
The Isolator Transpolar pen is a sterile, single use, electrosurgery device to be used in conjunction with an electrosurgical generator for the delivery of radiofrequency current.
Materials
All materials used in the manufacture of the Isolator Transpolar Pen are suitable for this use and have been used in numerous previously cleared products. Testing was conducted in Accordance with ISO 10993-1 to ensure appropriate biocompatibility of all materials.
Testing
Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices.
Summary of Substantial Equivalence
The Isolator Transpolar Pen is equivalent to the predicate products. The indications for use, basic overall function, and materials used are substantially equivalent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/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's head and neck, composed of three curved lines that suggest the profile of a human face. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.
MAR 1 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Atricure, Inc. c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, MN 55313
Re: K050459 Atricure Isolator™ Transpolar™ Pen Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II (two) Product Code: OCL Dated: March 11, 2005 Received: March 16, 2005
Dear Mr. Job:
This letter corrects our substantially equivalent letter of June 10, 2005.
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 - Mr. Mark Job
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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AtriCure®
Indications for Use
510(k) Number (if known): Ko50459
Device Name: Atricure Isolator™ Transpolar™ pen
Indications For Use:
The Isolator™ Transpolar™ pen is a device intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.
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)
Bhummer
(Division Sign-Off)
ion of Cardiovascular Devices
510(k) Number K050459
Page 1 of 1
§ 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.