(29 days)
The AtriCure Bipolar System is intended to ablate and coagulate soft tissue during General, ENT, Thoracic, Gynecology, and Urology surgical procedures.
The system is comprised of the Bipolar Handpiece (single patient use) with integral cable and the re-usable Ablation and Sensing Unit (ASU).
The ASU is a portable reusable device that produces and delivers RF bipolar energy near the AM frequency band to coagulate and ablate biological tissue. The device consists of a RF PCB (printed circuit board), microprocessor PCB, measurement PCB, display PCB, AC power supply, power entry module, volume control, footswitch Interface, and Handpiece interface. Front panel indicators include an LED temperature display, a LCD graphics conductance display, and LED lamps indicating power on, fault condition, ready state, RF on, and conductance state. The ASU limits the amount of voltage, current and time at which power is output to the Handpiece. Upon reaching a threshold conductance, the ASU will light a visual indicator and sound an audible tone signaling that the conditions for a complete ablation have been satisfied. A footswitch is included in the Ablation System to activate RF energy delivery.
The system delivers Bipolar RF energy to tissue that is clamped between the Handpiece jaws. Pressing of the footswitch initiates the RF energy output. RF energy output is terminated by releasing the footswitch or upon expiration of the RF backup timer.
The Handpiece connects to the ASU and utilizes Bipolar RF energy to ablate tissue that is clamped between the instrument jaws. The Handpiece includes a set of jaws that are capable of grasping tissue up to 10mm in thickness. Each jaw is comprised of an electrode with surrounding insulators and imbedded temperature-sensing element allowing for the transfer of energy to tissue and the monitoring of temperature rise by the tissue. The handle includes a lever that applies a controlled force to the tissue in the jaws. At a predetermined force the jaws latch. A trigger is provided to release the latch at the end of the ablation.
The provided document is a 510(k) premarket notification for the AtriCure Bipolar System, dated April 19, 2002. It focuses on demonstrating substantial equivalence to predicate devices based on product description and adherence to performance standards. It is not a study that proves a device meets specific acceptance criteria in terms of clinical performance or algorithm accuracy.
Therefore, many of the requested fields cannot be directly extracted from this document, as they pertain to clinical or AI-related study design and outcomes, which are not present here.
Here's a breakdown of what can be inferred and what cannot:
1. Table of acceptance criteria and the reported device performance:
The document doesn't present "acceptance criteria" in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) for a particular clinical outcome, nor does it report "device performance" against such criteria. Instead, it lists performance industrial/international standards that the AtriCure Bipolar System meets. This indicates compliance with safety and engineering specifications, rather than clinical efficacy metrics.
| Acceptance Criteria (Standards Met) | Reported Device Performance (Compliance) |
|---|---|
| ANSI/AAMI HF 18 (Electrosurgical Devices) | Meets the standard |
| ISO 10993/EN 30993 (Biological Evaluation of Medical Devices) | Meets the standard |
| ISO 11607 (Packaging for Terminally Sterilized Medical Devices) | Meets the standard |
| ISO 11135 (Medical Devices, Validation and Routine Control of Ethylene Oxide Sterilization) | Meets the standard |
| IEC/EN 60601-1 (Medical Electrical Equipment - Part 1: General Requirements for Safety) | Meets the standard |
| IEC/EN 60601-1-1 (Medical Electrical Equipment - Collateral Standard: Safety Requirements for Medical Device Systems) | Meets the standard |
| IEC/EN 60601-1-2 (Medical Electrical Equipment - Part 1: General Requirements for Safety 2: Collateral Standard: Electromagnetic Compatibility - Requirements and Tests) | Meets the standard |
| IEC/EN 60601-2-2 (Medical Electrical Equipment - Part 2-2: Particular Requirements for the Safety of High Frequency Surgical Equipment) | Meets the standard |
| IEC/EN 60601-1-4 (Medical Electrical Equipment - Part 1-4: General Requirements for safety - Collateral Standard: Programmable Electrical Medical Systems) | Meets the standard |
| UL 2601-1 (Standard for Safety: Medical Electrical Equipment) | Meets the standard |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document does not describe a clinical study with a test set of data. It's a regulatory submission for device clearance based on substantial equivalence to predicate devices and compliance with engineering standards.
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, as no clinical study with a test set and ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical study with a test set and ground truth establishment is described.
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 device, not an AI-powered diagnostic tool, and no MRMC study is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a surgical instrument, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable, as no clinical study with ground truth is described. The "ground truth" in this context would be the successful and safe operation of the device in accordance with its specifications, which is addressed by meeting the listed engineering and biological safety standards.
8. The sample size for the training set
Not applicable, as no AI model or training set is mentioned.
9. How the ground truth for the training set was established
Not applicable, as no AI model or training set is mentioned.
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APR 1 9 2002
AtriCure Incorporated
Special 510(k) – AtriCure Bipolar System
510(k) SUMMARY ATRICURE COAGULATION SYSTEM 510(k) NOTIFICATION KXXXX
| K 020 919 | |
|---|---|
| General Information | |
| Manufacturer: | AtriCure Incorporated6033 Schumacher Park DriveWest Chester, OH 45069-3863(513) 755-4100Fax (513) 755-4108Est. Reg. No. 3003502 |
| Contact Person: | Mark L. Friedman, Ph.D.Vice President of Quality Assurance & Regulatory AffairsAtriCure Incorporated |
| Date Prepared: | [to be added after 510(k) process] |
| Device Description | |
| Classification: | Class II |
| Trade Name: | AtriCure Bipolar System |
| Generic/Common Name: | Electrosurgical cutting and coagulation device andAccessories 21CFR 878.4400 |
Predicate Devices
-
- AtriCure Inc. AtriCure Bipolar Coagulation System K011722
-
- AtriCure Inc. AtriCure Bipolar Coagulation System K010122
Indication For Use Statement
The AtriCure Bipolar Coagulation System is intended to ablate and coagulate soft tissue during General, ENT, Thoracic, Gynecology, and Urology surgical procedures.
Product Description
The system is comprised of the Bipolar Handpiece (single patient use) with integral cable and the re-usable Ablation and Sensing Unit (ASU).
The ASU is a portable reusable device that produces and delivers RF bipolar energy near the AM frequency band to coagulate and ablate biological tissue. The device consists of a RF PCB (printed circuit board), microprocessor PCB, measurement PCB, display PCB, AC power supply, power entry module, volume control, footswitch Interface, and Handpiece interface. Front panel indicators include an LED temperature display, a LCD graphics conductance display, and LED lamps indicating power on, fault condition, ready state, RF on, and conductance state. The ASU limits the amount of voltage, current and time at which power is output to the Handpiece. Upon reaching a threshold conductance, the ASU will light a visual indicator and sound an audible tone signaling that the conditions for a complete ablation have been satisfied. A footswitch is included in the Ablation System to activate RF energy delivery.
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Special 510(k) - AtriCure Bipolar System
K020919
2 of 2
The system delivers Bipolar RF energy to tissue that is clamped between the Handpiece jaws. Pressing of the footswitch initiates the RF energy output. RF energy output is terminated by releasing the footswitch or upon expiration of the RF backup timer.
The Handpiece connects to the ASU and utilizes Bipolar RF energy to ablate tissue that is clamped between the instrument jaws. The Handpiece includes a set of jaws that are capable of grasping tissue up to 10mm in thickness. Each jaw is comprised of an electrode with surrounding insulators and imbedded temperature-sensing element allowing for the transfer of energy to tissue and the monitoring of temperature rise by the tissue. The handle includes a lever that applies a controlled force to the tissue in the jaws. At a predetermined force the jaws latch. A trigger is provided to release the latch at the end of the ablation.
The AtriCure Bipolar System meets the following performance industrial/international standards.
| ANSI/AAMI HF 18 | Electrosurgical Devices |
|---|---|
| ISO 10993/EN 30993 | Biological Evaluation of Medical Devices |
| ISO 11607 | Packaging for Terminally Sterilized Medical Devices |
| ISO 11135 | Medical Devices, Validation and Routine Control of EthyleneOxide Sterilization |
| IEC/EN 60601-1 | Medical Electrical Equipment - Part 1: General Requirementsfor Safety |
| IEC/EN 60601-1-1 | Medical Electrical Equipment - Collateral Standard: SafetyRequirements for Medical Device Systems |
| IEC/EN 60601-1-2 | Medical Electrical Equipment - Part 1: General Requirementsfor Safety 2: Collateral Standard: ElectromagneticCompatibility - Requirements and Tests |
| IEC/EN 60601-2-2 | Medical Electrical Equipment - Part 2-2: ParticularRequirements for the Safety of High FrequencySurgical Equipment |
| IEC/EN 60601-1-4 | Medical Electrical Equipment - Part 1-4: GeneralRequirements for safety - Collateral Standard:Programmable Electrical Medical Systems |
| UL 2601-1 | Standard for Safety: Medical Electrical Equipment |
Summary
As contained in this 510(k) summary, the AtriCure Bipolar System is substantially equivalent to the predicate devices identified.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 9 2002
Mark L. Friedman, Ph.D. Vice President of Quality Assurance and Regulatory Affairs AtriCure, Inc. 6033 Schumacher Park Drive West Chester. Ohio 45069-3863
Re: K020919
Trade/Device Name: AtriCure Bipolar System Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 19, 2002 Received: March 21, 2002
Dear Dr. Friedman:
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 for association 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 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 Crth 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.
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Page 2 - Mark L. Friedman, Ph.D.
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
R. Mark A. Millener
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page
919 0 8/1 510(k) Number (if known):
Device Name:_AtriCure_Bipolar_System
Indications For Use:
"The AtriCure Bipolar System is intended to ablate and coagulate soft tissue during General, ENT, Thoracic, Gynecology and Urology surgical procedures."
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kozo919
for Mark N. Melkerson
Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_
(Optional Format 3-10-98)
§ 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.