(34 days)
Not Found
No
The device description focuses on the delivery of radiofrequency energy and electrical signals for ablation, pacing, sensing, and recording. There is no mention of AI or ML in the intended use, device description, or the "Mentions AI, DNN, or ML" section. The performance studies section also does not indicate any AI/ML-related evaluation.
Yes
The device is intended to ablate cardiac tissues and can be used for temporary cardiac pacing and sensing, all of which are therapeutic or diagnostic interventions.
Yes
The device is intended for "temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery." The "evaluation" of arrhythmias indicates a diagnostic purpose.
No
The device description explicitly states the system is comprised of hardware components including a hand-held pen, an ablation and sensing unit, a footswitch, and a source switch accessory.
Based on the provided information, the Isolator™ Transpolar™ Pen is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for ablating cardiac tissues during cardiac surgery or for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery. These are procedures performed directly on the patient's body.
- Device Description: The description details a hand-held electrosurgical instrument used for delivering RF energy or connecting to a pacemaker/recorder. This is an invasive device used in a surgical setting.
- Lack of In Vitro Activity: IVD devices are intended for the examination of specimens derived from the human body in vitro (outside the body) to provide information for diagnostic, monitoring, or compatibility purposes. The Isolator™ Transpolar™ Pen does not perform any analysis on bodily fluids, tissues, or other specimens outside of the body.
The device is used for direct intervention and evaluation within the patient's body during surgery, which is characteristic of a surgical or therapeutic device, not an IVD.
N/A
Intended Use / Indications for Use
The Isolator™ Transpolar™ Pen is a sterile, single use electrosurgery device intended to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the Atricure Ablation and Sensing Unit or for temporary cardiac pacing, 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™ Transpolar™ pen System (Pen) is comprised of the AtriCure® Ablation and Sensing Unit (ASU), Isolator " Transpolar™ pen, a footswitch, and the ASB1 Source Switch accessor. The Pen is a hand-held, sterile, single patient use electrosurgical instrument intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy. When the Pen is connected to the ASU, either directly or via the ASB1 Source Switch set to the ASU port, the device delivers RF energy for cardiac tissue ablation when the operator presses the Footswitch. When the ASB1 is set to the auxiliary port the pen may be used with a commercially available temporary pacemaker or recorder for temporary cardiac pacing, sensing, recording, or stimulation for the evaluation of cardiac arrhythmias during surgery, based on the function of the device to which it is connected. The two modes of operation, ablation and pacing/sensing cannot be active at the same time.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
cardiac surgery
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)
Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices.
The Isolator Transpolar Pen System is equivalent to the predicate products. The indications for use, basic overall function, and materials used are substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K050459, K040812, K971265, K051749
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
510(k) Summary
JUL 1 2 2005
000223
General Information
Classification Class II, Electrosurgical cutting and coagulation device and accessories (21 CFR 878.4400)
Product Cod
Trade Name Isolator™ Transpolar™ Pen System
Elsa Abruzzo
GEI
Manufacturer
AtriCure, Inc. 6033 Schumacher Park Drive West Chester, OH 45069
Contact
Vice President, Clinical and Regulatory Affairs
Intended Use
The Isolator™ Transpolar™ Pen is a sterile, single use electrosurgery device intended to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the Atricure Ablation and Sensing Unit or for temporary cardiac pacing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.
Predicate Devices
- AtriCure Isolator Transpolar Pen (K050459) ಂ
- Medtronic Detect Mapping and Sensing Tool (K040812) 0
- 0 Viking Diagnostic Electrode Catheter (K971265)
- 0 Estech Cobra System (K051749)
Device Description
The Isolator™ Transpolar™ pen System (Pen) is comprised of the AtriCure® Ablation and Sensing Unit (ASU), Isolator " Transpolar™ pen, a footswitch, and the ASB1 Source Switch accessor. The Pen is a hand-held, sterile, single patient use electrosurgical instrument intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy. When the Pen is connected to the ASU, either directly or via the ASB1 Source Switch set to the ASU port, the device delivers RF energy for cardiac tissue ablation when the operator presses the Footswitch. When the ASB1 is set to the auxiliary port the pen may be used with a commercially available temporary pacemaker or recorder for temporary cardiac pacing, sensing, recording, or stimulation for the evaluation of cardiac arrhythmias during surgery, based on the function of the device to which it is connected. The two modes of operation, ablation and pacing/sensing cannot be active at the same time.
Materials
All materials used in the manufacture of the Isolator Transpolar Pen 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.
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 System is equivalent to the predicate products. The indications for use, basic overall function, and materials used are substantially equivalent.
page 1 of 1
1
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 eagle with three wing-like shapes, symbolizing care and protection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The overall design is simple and professional, reflecting the department's role in public health and welfare.
FEB 2 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Atricure, Inc. c/o Ms. Elsa C. Abruzzo, RAC Vice President, Regulatory and Clinical Affairs 6033 Schumacher Park Dr. West Chester, OH 45069
Re: K061593
Trade Name: Atricure Isolator Transpolar Pen 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: June 7, 2006 Received: June 8, 2006
Dear Ms. Abruzzo:
This letter corrects our substantially equivalent letter of July 12, 2006.
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.
2
Page 2 - Ms. Elsa C. Abruzzo. RAC
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 vours
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K061593
Device Name: Atricure Isolator Transpolar Pen™
Indications For Use:
The Isolator™ Transpolar™ Pen is intended to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the Atricure Ablation and Sensing Unit or 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 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)
B. Aymuma
ular Devices 510(k) Number
Page 1 of 1
000225