(29 days)
No
The summary describes a standard electrosurgical device and does not mention any AI or ML capabilities.
Yes
The device is described as an electrosurgery device intended to ablate cardiac tissue and for temporary cardiac pacing, sensing, recording, and stimulation, all of which are therapeutic interventions.
Yes
This device is used for "sensing, recording, and stimulation during the evaluation of cardiac arrhythmias," which are diagnostic functions.
No
The device description clearly states it is comprised of hardware components including a pen, footswitch, and ablation/sensing unit, and it delivers RF energy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to ablate cardiac tissue during surgery using RF energy, and for temporary cardiac pacing, sensing, recording, and stimulation during surgery. These are all procedures performed on the patient's body, not on samples taken from the patient's body.
- Device Description: The device is an electrosurgical instrument used to apply energy and for pacing/monitoring in vivo.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is therapeutic (ablation) and procedural (pacing/monitoring).
IVD devices are designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Isolator linear pen is a sterile, single use electro surgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the ASU or ASB in Ablation mode.
The Isolator linear pen may be used for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias in surgery when connected to a temporary external cardiac pacemaker or recording device.
Product codes (comma separated list FDA assigned to the subject device)
OCL
Device Description
The Isolator™ linear pen System is comprised of the AtriCure® Ablation and Sensing Unit (ASU), Isolator™ linear pen (Pen), Footswitch, ASU Source Switch(ASB). The Pen is a single patient use electrosurgical instrument designed for use only with the ASU and ASB. The Pen is used to ablate cardiac tissues and as a surgical pacing and mapping tool. When the Pen is connected to the ASU, the ASU provides the bipolar radiofrequency (RF) energy flowing between both electrodes of the Pen. The Operator controls the application of this RF energy by pressing the Footswitch. When the Pen is connected to an auxiliary pace, sense, or stimulation device; the Pen is designed to provide temporary pacing or monitoring.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was completed per 21 CFR 820.30 and AtriCure's Quality System to verify the device's conformance to design controls and specification. Testing determined that the Isolator Multifunctional Linear Pen conformed to design controls and product specifications.
Non-clinical Bench Testing
- Reliability Testing
Biocompatibility Testing
The biocompatibility evaluation for the Isolator Multifunctional Linear Pen was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process" as recognized by FDA. The battery of testing included the following tests:
- Cytotoxicity
- Sensitization
- Irritation
- Systemic Toxicity
- Material Mediated Pyrogen
The Isolator Multifunctional Linear Pen is categorized as a class II, "Surgical device, for ablation of cardiac tissue", for contact with "Tissue/Bone" and permanent contact for a duration of "less than 24hrs".
Per the FDA final guidance issued in 1997, 'Deciding When to Submit a 510(k) for a Change to an Existing Device', PET is listed as a material in the Biomaterials Compendium, and would not necessitate additional biocompatibility testing. AtriCure conducted confirmatory biocompatibility testing to affectively assess additional risks associated with the modification to the PET material. The results indicated no additional risk has been introduced by the modified device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 3, 2017
AtriCure Inc. Melissa Smallwood Associate Regulatory Affairs Specialist 7555 Innovation Way Mason, Ohio 45040
Re: K163408
Trade/Device Name: Isolator Multifunctional Linear Pen Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: OCL Dated: December 2, 2016 Received: December 5, 2016
Dear Melissa Smallwood:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Sincerely,
for
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) K163408
Device Name Isolator Multifunctional Linear Pen
Indications for Use (Describe)
The Isolator linear pen is a sterile, single use electro surgery device intended to ablate cardiac surgery using radiofrequency (RF) energy when connected directly to the ASU or ASB in Ablation mode.
The Isolator linear pen may be used for temporary cardiac pacing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac or recording device.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image shows the logo for AtriCure. The logo is in two colors, blue and orange. The first three letters, "Atri", are in blue, while the rest of the word, "Cure", is in orange. There is a blue dot in the middle of the "C" in "Cure", and a registered trademark symbol to the right of the word.
510(k) Summary
I. Submitter
| Manufacturer: | AtriCure, Inc.
7555 Innovation Way
Mason, OH 45040
P: 513-755-4100 |
|----------------------|-----------------------------------------------------------------------------|
| Contact Person: | Melissa Smallwood
Associate Regulatory Affairs Specialist |
| Alternate Contact: | Jonathan McElwee
Regulatory Affairs Manager |
| Date Prepared: | 12/02/2016 |
| II.
Device | |
| Name of Device: | Isolator® Multifunctional Linear Pen |
| Common Name: | Surgical device, for ablation of cardiac tissue |
| Classification Name: | 21 CFR 878 4400 |
| Regulatory Class: | Class II |
| Product Code: | OCL |
Predicate Device III.
The predicate device, Isolator Multifunctional Linear Pen, was cleared via 510(k) K130521 on April 05, 2013 under the Product Code OCL.
The predicate device has not been subject to a design-related recall.
The following reference devices were also used in this submission:
- . K100501 Isolator linear pen original 510(k) cleared on June 18, 2010
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IV. Device Description
The Isolator™ linear pen System is comprised of the AtriCure® Ablation and Sensing Unit (ASU), Isolator™ linear pen (Pen), Footswitch, ASU Source Switch(ASB). The Pen is a single patient use electrosurgical instrument designed for use only with the ASU and ASB. The Pen is used to ablate cardiac tissues and as a surgical pacing and mapping tool. When the Pen is connected to the ASU, the ASU provides the bipolar radiofrequency (RF) energy flowing between both electrodes of the Pen. The Operator controls the application of this RF energy by pressing the Footswitch. When the Pen is connected to an auxiliary pace, sense, or stimulation device; the Pen is designed to provide temporary pacing or monitoring.
V. Indications for Use
The Isolator linear pen is a sterile, single use electro surgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the ASU or ASB in Ablation mode.
The Isolator linear pen may be used for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.
VI. Comparison of Technological Characteristics with the Predicate Device
- . Same intended use
- . Same operating principle
- . No changes were made in operating principle, or specifications of performance
- . The same sterilization parameters
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VII. Performance Data
Testing was completed per 21 CFR 820.30 and AtriCure's Quality System to verify the device's conformance to design controls and specification. Testing determined that the Isolator Multifunctional Linear Pen conformed to design controls and product specifications.
Non-clinical Bench Testing
- Reliability Testing
Biocompatibility Testing
The biocompatibility evaluation for the Isolator Multifunctional Linear Pen was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process" as recognized by FDA. The battery of testing included the following tests:
- Cytotoxicity
- . Sensitization
- Irritation
- . Systemic Toxicity
- . Material Mediated Pyrogen
The Isolator Multifunctional Linear Pen is categorized as a class II, "Surgical device, for ablation of cardiac tissue", for contact with "Tissue/Bone" and permanent contact for a duration of "less than 24hrs".
Per the FDA final guidance issued in 1997, 'Deciding When to Submit a 510(k) for a Change to an Existing Device', PET is listed as a material in the Biomaterials Compendium, and would not necessitate additional biocompatibility testing. AtriCure conducted confirmatory biocompatibility testing to affectively assess additional risks associated with the modification to the PET material. The results indicated no additional risk has been introduced by the modified device.
VIII. Conclusions
Based on the indications for use, technological characteristics, and safety and performance testing, the proposed AtriCure Isolator Multifunctional Linear Pen has been shown to be appropriate for its intended use and is considered substantially equivalent to the AtriCure Isolator linear pen previously cleared via 510(k) K130521 on April 05, 2013.