(110 days)
No
The summary describes a standard electrosurgery device for cardiac ablation and makes no mention of AI or ML capabilities, image processing, or data sets typically associated with AI/ML development.
Yes
The device is intended to ablate cardiac tissue, which is a therapeutic intervention.
No
The device is described as an electrosurgery device used to ablate cardiac tissue, which is a treatment function, not a diagnostic one.
No
The device description explicitly states it is a "sterile, single use, electrosurgery device" and is used "in conjunction with an electrosurgical generator," indicating it is a hardware device that delivers radiofrequency current.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "ablate cardiac tissue during cardiac surgery using radiofrequency energy." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is described as an "electrosurgery device" used for delivering "radiofrequency current." This is consistent with a surgical tool, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's condition
- Using reagents or assays
IVD devices are used to perform tests on samples taken from the body to diagnose diseases or conditions. This device is used to treat a condition by altering tissue within the body.
N/A
Intended Use / Indications for Use
The Isolator ™ Transpolar™ pen is a device intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.
Product codes
OCL
Device Description
The Isolator Transpolar pen is a sterile, single use, electrosurgery device to be used in conjunction with an electrosurgical generator for the delivery of radiofrequency current.
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
Not Found
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.
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JUN 1 0 2005 AtriCure®
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510(k) Summary
General Information
| Classification | Class II |
|---|---|
| Trade Name | Isolator™ Transpolar™ pen |
| Manufacturer | AtriCure, Inc. |
| 6033 Schumacher Park Drive | |
| West Chester, OH 45069 | |
| Contact | Elsa Abruzzo |
| Vice President, Clinical and Regulatory Affairs |
Intended Use
The Isolator ™ Transpolar™ pen is a device intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.
Predicate Devices
The predicate device for the Isolator Transpolar Pen are the Medtronic Cardioblate Pen (K013392), the Tissue Link Bipolar Sealer 2.3 (Bipolar Floating Ball) device (K032132) and the AtriCure Bipolar System (K020919).
Device Description
The Isolator Transpolar pen is a sterile, single use, electrosurgery device to be used in conjunction with an electrosurgical generator for the delivery of radiofrequency current.
Materials
All materials used in the manufacture of the Isolator Transpolar Pen 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 is equivalent to the predicate products. The indications for use, basic overall function, and materials used are substantially equivalent.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 image of an eagle's head and neck, composed of three curved lines that suggest the profile of a human face. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.
MAR 1 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Atricure, Inc. c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, MN 55313
Re: K050459 Atricure Isolator™ Transpolar™ 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: March 11, 2005 Received: March 16, 2005
Dear Mr. Job:
This letter corrects our substantially equivalent letter of June 10, 2005.
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.
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Page 2 - Mr. Mark Job
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 yours,
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
AtriCure®
Indications for Use
510(k) Number (if known): Ko50459
Device Name: Atricure Isolator™ Transpolar™ pen
Indications For Use:
The Isolator™ Transpolar™ pen is a device intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.
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)
Bhummer
(Division Sign-Off)
ion of Cardiovascular Devices
510(k) Number K050459
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