(919 days)
The AtriCure Bipolar (Transpolar) System is intended for the ablation of cardiac tissue during surgery.
The Atricure Bipolar System is comprised of a bipolar clamping hand-piece with integral cable (Isolator™), and a re-useable generator, (Ablation and Sensing Unit, ASU).
The provided text describes a 510(k) submission for the AtriCure Bipolar System, a device intended for the ablation of cardiac tissue during surgery. However, the document does not contain detailed information regarding specific acceptance criteria, comprehensive study results, sample sizes for test or training sets, ground truth establishment, or expert qualifications in the way a clinical study report would.
The document states that "Appropriate preclinical product testing was conducted to evaluate conformance to the product specification and demonstrate substantial equivalence to predicate devices. Clinical data demonstrating the device's acute safety and ability to create lines of electrical conduction block in the heart as assessed intraoperatively were also provided in support of this submission." This is a high-level summary and lacks the specific details requested.
Therefore, many of the requested fields cannot be directly extracted from the provided text. I will fill in what can be inferred or explicitly stated, and note where information is missing.
Acceptance Criteria and Device Performance Study
| Category | Description/Information |
|---|---|
| 1. Acceptance Criteria & Performance | Acceptance Criteria: The document implies that the acceptance criteria were primarily related to "conformance to the product specification" and "substantial equivalence to predicate devices," as well as "acute safety and [the] ability to create lines of electrical conduction block in the heart as assessed intraoperatively." Specific quantitative thresholds for these criteria are not provided. Reported Device Performance: The document generally states that "Appropriate preclinical product testing was conducted" and "Clinical data demonstrating the device's acute safety and ability to create lines of electrical conduction block in the heart as assessed intraoperatively were also provided." However, no quantitative results or specific performance metrics are reported in the summary provided. |
| 2. Sample Size (Test Set) & Data Provenance | Sample Size: The document states "Clinical data..." but does not specify the sample size for any clinical or test sets used. Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It refers to "preclinical product testing" and "clinical data," indicating some prospective clinical testing was likely involved given the mention of "intraoperatively." |
| 3. Number & Qualifications of Experts (Ground Truth) | Number of Experts: The document does not specify the number of experts used to establish ground truth.Qualifications of Experts: The document does not specify the qualifications of any experts involved in ground truth establishment. It only mentions "clinical data demonstrating... as assessed intraoperatively." |
| 4. Adjudication Method (Test Set) | The document does not describe any adjudication method used for a test set. |
| 5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study | Not Applicable/Not Reported: The document describes a medical device for cardiac tissue ablation, not a diagnostic imaging device typically associated with MRMC studies comparing human readers with and without AI assistance. Therefore, such a study is not mentioned and likely not relevant in this context. |
| 6. Standalone Performance (Algorithm Only) | Not Applicable/Not Reported: The AtriCure Bipolar System is a surgical device, not a software algorithm. Therefore, a standalone (algorithm only) performance study as typically understood for AI/ML devices is not applicable and not reported. |
| 7. Type of Ground Truth Used | The document mentions "ability to create lines of electrical conduction block in the heart as assessed intraoperatively." This implies that the ground truth for device effectiveness was established through intraoperative assessment (likely physiological measurements/mapping) of electrical conduction block, which could be considered a form of physiological outcome data or direct expert observation within a clinical setting. |
| 8. Sample Size for Training Set | The document discusses "preclinical product testing" and "clinical data" but does not explicitly mention or specify any 'training set' sample size. This concept is more common in AI/ML device development and less so for traditional surgical devices, where the focus is on verification and validation testing. |
| 9. How Ground Truth for Training Set Was Established | As no explicit "training set" is mentioned in the context of AI/ML, the method for establishing its ground truth is not applicable/not detailed. For the overall device development, ground truth was implicitly established through standard engineering principles, preclinical studies, and clinical data showing conformance to specifications and desired physiological effects. |
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510(k) Summary
K043579
page 1/2
General Information
| Classification | Device, Electrosurgical, Cutting andCoagulation and Accessories (21CFR878.440) |
|---|---|
| Trade Name | AtriCure Bipolar System |
| Manufacturer | AtriCure, Inc.6033 Schumacher Park DriveWest Chester, OH 45069 |
| Contact | Elsa AbruzzoVice President, Clinical and Regulatory Affairs |
Intended Use
The AtriCure Bipolar (Transpolar) System is intended for the ablation of cardiac tissue during surgery.
Predicate Devices
The predicate devices for the AtriCure Bipolar System are the Atricure Bipolar System (K020919), the Medtronic Cardioblate Pen (K013392), the Boston Scientific Cobra Cardiac Surgical Probe (K013873), the CryoCath SurgiFrost Cryosurgical Device with FrostByte Clamp (K040690), the AFx Microwave Ablation System (K003978) and the Epicor Medical Ultracinch Tissue Ablation Device (K040641).
Device Description
The Atricure Bipolar System is comprised of a bipolar clamping hand-piece with integral cable (Isolator™), and a re-useable generator, (Ablation and Sensing Unit, ASU).
Materials
All materials used in the manufacture of the AtriCure Bipolar System 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.
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Testing
K043579
page 2/2
Appropriate preclinical product testing was conducted to evaluate conformance to the product specification and demonstrate substantial equivalence to predicate devices. Clinical data demonstrating the device's acute safety and ability to create lines of electrical conduction block in the heart as assessed intraoperatively were also provided in support of this submission.
Summary of Substantial Equivalence
The AtriCure Bipolar System is equivalent to the predicate products. The indications for use, basic overall function, and materials used are substantially equivalent.
AtriCure, Inc. CONFIDENTIAL
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
FEB 2 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Atricure, Inc. c/o Ms. Elsa C. Abruzzo Vice President of Regulatory and Clinical Affairs 6033 Schumacher Park Dr. West Chester, OH 45069
Re: K043579
Trade/Device Name: Atricure Bipolar System 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 30, 2007 Received: April 6, 2007
Dear Ms. Abruzzo:
This letter corrects our substantially equivalent letter of July 5, 2007.
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. Elsa C. Abruzzo
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,
el. Mdl.
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
page i/1
510(k) Number (if known) K043579
Device Name: AtriCure Bipolar (Transpolar) System
Indications for Use:
The AtriCure Bipolar (Transpolar) System is intended for the ablation of cardiac tissue during surgery.
Prescription Use . X (Part 21 CRF 801 Subpart D) AND/OR
Over-The-Counter Use (21 CRF 807 Subpart C)
(PLEASE: DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M.S. Wilhelme for Biam Zuckerman
diovascular Devices
510(k) I
AtriCure, Inc. CONFIDENTIAL
§ 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.