(116 days)
Not Found
No
The document describes a standard electrosurgical and pacing/sensing device without mentioning any AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is intended to ablate cardiac tissue and perform temporary cardiac pacing, sensing, recording, and stimulation, which are all therapeutic interventions for cardiac conditions.
Yes
The device is intended for "temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery." The ability to sense and record for evaluation indicates a diagnostic function for cardiac arrhythmias.
No
The device description clearly states it is a "hand-held, sterile, single patient use electrosurgical instrument" and mentions physical components like a "pen" and connections to other hardware units (AtriCure Ablation and Sensing Unit, temporary pacemaker, recorder). This indicates it is a hardware device, not software-only.
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 the evaluation of cardiac arrhythmias during surgery. These are all procedures performed in vivo (within a living organism).
- Device Description: The description reinforces the in vivo nature of the device, describing it as a hand-held electrosurgical instrument used to ablate cardiac tissue and for pacing/sensing/recording/stimulation during surgery.
- Lack of In Vitro Activities: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are specifically designed to be used in vitro to analyze samples from the human body. This device operates directly on the patient's cardiac tissue during surgery.
N/A
Intended Use / Indications for Use
The Multifunctional 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 AtriCure Ablation and Sensing Unit or to the ASU Source Switch in Ablation mode and the Multifunctional 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 Multifunctional linear 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 AtriCure Ablation and Sensing Unit (ASU) directly or via the AtriCure ASU Source Switch in ablation mode, the device delivers RF energy for cardiac tissue ablation when the operator presses the Footswitch. When the pen is connected to a commercially available temporary pacemaker or recorder the pen is used for temporary cardiac pacing, sensing, recording, or stimulation for the evaluation of cardiac arrhythmias during surgery.
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
In-vitro and in-vivo testing demonstrated that the Multifunction linear pen is able to pace, sense, and stimulate and ablate cardiac tissue as safely and effectively as the AtriCure Isolator Transpolar pen and the AtriCure Coolrail linear pen.
Key Metrics
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
K10 0561 1/2
ATRICURE MULTIFUNCTIONAL LINEAR PEN 510(k) SUMMARY
General Information
JUN 1 8 2010
| Date Compiled | February 16, 2010 |
|---|---|
| Classification | Class II (Surgical device, for ablation of cardiac tissue) |
| Product Code | OCL |
| Trade Name | AtriCure Multifunctional linear pen |
| Manufacturer | AtriCure, Inc |
| 6217 Centre Park Drive | |
| West Chester, OH 45069 | |
| Contact | James L. Lucky |
| VP of Quality Assurance and Regulatory Affairs | |
| (513) 755-5754 |
Indications for Use
The Multifunctional 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 AtriCure Ablation and Sensing Unit or to the ASU Source Switch in Ablation mode and the Multifunctional 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.
Predicate Devices
The predicate devices for the AtriCure Multifunctional linear pen are the AtriCure Isolator Transpolar pen (K050459, K061593) and the AtriCure Coolrail linear pen (K073605).
Device Description
The Multifunctional linear 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 AtriCure Ablation and Sensing Unit (ASU) directly or via the AtriCure ASU Source Switch in ablation mode, the device delivers RF energy for cardiac tissue ablation when the operator presses the Footswitch. When the pen is connected to a commercially available temporary pacemaker or recorder the pen is used for temporary cardiac pacing, sensing, recording, or stimulation for the evaluation of cardiac arrhythmias during surgery.
Materials
1
All materials used in the manufacture of the AtriCure Multifunctional linear pen are suitable for their intended 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. In-vitro and in-vivo testing demonstrated that the Multifunction linear pen is able to pace, sense, and stimulate and ablate cardiac tissue as safely and effectively as the AtriCure Isolator Transpolar pen and the AtriCure Coolrail linear pen.
Summary of Substantial Equivalence
The Multifunctional linear pen is equivalent to the predicate products. The indications for use, basic overall function, and materials used are substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
JUN 1 8 2010
AtriCure, Inc. c/o Mr. James Lucky, RAC Vice President of Quality Assurance and Regulatory Affairs 6217 Centre Park Dr. West Chester, OH 45069
Re: K100501
Trade/Device Name: AtriCure Multifunctional Linear Pen Regulation Number: 21 CFR §878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II (two) Product Code: OCL Dated: May 20, 2010 Received: May 21, 2010
· Dear Mr. Lucky:
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.
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
3
Page 2 - Mr. James Lucky
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 device-related adverse events) (21 CFR 803); 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.
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/CDRH0ffices/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.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 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/Industrv/default.htm.
Sincerely yours,
For Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K100501 510(k) Number (if known) _
Device Name: AtriCure Multifunctional linear pen
Indications for Use:
- The Multifunctional 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 AtriCure Ablation and Sensing unit (ASU) or to the ASU Source Switch in Ablation mode.
- The Multifunctional 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 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)
WMP
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Numb