(36 days)
Not Found
No
The summary describes a standard electrosurgical and pacing device with no mention of AI or ML capabilities.
Yes.
The device's intended use includes ablating cardiac tissue and temporary cardiac pacing, sensing, recording, and stimulation, which are all therapeutic interventions for cardiac conditions.
Yes
Explanation: The device is described as being used for "temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery." The terms "sensing," "recording," and "evaluation" indicate that it gathers information about the cardiac condition, which is a diagnostic function. It also functions as a "surgical pacing and mapping tool."
No
The device description explicitly states the system is comprised of hardware components including a linear pen, ablation and sensing unit, footswitch, and source switch. It is an electrosurgical instrument.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for ablating cardiac tissue during cardiac surgery and for temporary cardiac pacing, sensing, recording, and stimulation during surgery. These are procedures performed directly on a living patient.
- Device Description: The description confirms the device is an electrosurgical instrument used to ablate cardiac tissues and as a surgical pacing and mapping tool. This involves direct interaction with the patient's body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) outside of the body to detect diseases, conditions, or infections. This device does not perform such tests.
The device is a surgical tool used in vivo (within the living body), not in vitro (in glass/outside the body).
N/A
Intended Use / Indications for Use
The Isolator® linear pen is a sterile, single use electrosurgery 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.
Product codes
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 per 21 CFR 820.30 and AtriCure's Quality System was performed to verify the modified Isolator linear pen conformance to design controls and specification. Testing determined that the modified Isolator® linear pen conformed to design controls and product specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
K130521
510(k) Summary
APR 0 5 2013
General Information
| Classification | Class 2 |
|---|---|
| Trade name | Isolator® Linear Pen |
| Classification Name | Surgical Device, For Ablation Of Cardiac Tissue |
| (21 CFR 878.4400, Product Code OCL) | |
| Manufacturer | AtriCure, Inc. |
| 6217 Centre Park Dr. | |
| West Chester, OH 45069 | |
| P: 513-755-4100 | |
| F: 513-755-4108 | |
| Contact | Rebecca Walters, RAC |
| Regulatory Affairs Manager |
Date of Submission February 27, 2013
Intended Use
The Isolator® linear pen is a sterile, single use electrosurgery 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.
Cleared Device
The device proposed for modification in this submission is the Isolator® linear pen cleared via 510(k) K100501 on June 18, 2010.
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.
Materials
All materials in the modified Isolator® linear pen are suitable for their intended use. Testing was conducted on all patient contacting materials in accordance with ISO 10993-1 to ensure appropriate biocompatibility of all appropriate materials.
Isolator® linear pen
1
Image /page/1/Picture/0 description: The image shows the word "AtriCure" in a stylized font. The "C" in "AtriCure" is designed with a circle around it, and there is a registered trademark symbol after the word. The font is bold and black, and the background is white.
Testing
Testing per 21 CFR 820.30 and AtriCure's Quality System was performed to verify the modified Isolator linear pen conformance to design controls and specification. Testing determined that the modified Isolator® linear pen conformed to design controls and product specifications.
Summary of Equivalence
The modified Isolator® linear pen proposed in this submission is considered substantially equivalent to the Isolator® linear pen cleared via K100501. The indications for use, basic overall function, and materials used are substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
April 5, 2013
Atricure, Inc. Rebecca Walters 6217 Centre Park Drive West Chester, OH 45069 US
Re: K130521
Trade/Device Name: Isolator 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: March 5, 2013 Received: March 7, 2013
Dear Ms. Walters:
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
3
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, Misbranding by reference to premarket notification (21CFR 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.htmfor 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 Small Manufacturers, International and Consumer Assistance 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 yours,
Owen P. Faris -S
for Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use
510(k) Number (if known)_K130521
Device Name: Isolator® linear pen
Indications for Use:
- The Isolator® linear pen is intended to ablate cardiac tissue during cardiac surgery using . radiofrequency (RF) energy when connected directly to the ASU or to the ASU Source Switch (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.
Prescription Use × (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)
Owen P. Faris -S
2013.04.05
13:35:26 -04'00'
Page 1 of 1