(139 days)
Not Found
No
The summary describes a standard electrosurgery device that uses RF energy for ablation, with no mention of AI or ML capabilities in its operation or control.
Yes
The device is described as an electrosurgery device intended to ablate cardiac tissue using radiofrequency energy, which directly modifies tissue for a medical purpose.
No
This device is described as a surgical instrument for ablating cardiac tissue using radiofrequency energy, which is a therapeutic function, not a diagnostic one. It delivers energy to modify tissue, rather than analyze or identify a medical condition.
No
The device description clearly states it is a hand-held, single-use surgical instrument that utilizes bipolar energy and has internally cooled electrodes. This indicates it is a physical 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 is to "ablate cardiac surgery using radiofrequency (RF) energy." This is a therapeutic procedure performed directly on the patient's tissue.
- Device Description: The device is a "hand held, single use surgical instrument intended for the ablation of cardiac tissues during cardiac surgery." It uses RF energy to modify tissue.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such testing on samples.
The device is a surgical tool used for treatment, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The Coolrail linear pen is a sterile, single use electrosurgery device intended to ablate cardiac surgery using radiofrequency (RF) energy.
Product codes (comma separated list FDA assigned to the subject device)
OCL
Device Description
The AtriCure Coolrail Linear Pen (MCR1) is a hand held, single use surgical instrument intended for the ablation of cardiac tissues during cardiac surgery. The pen utilizes bipolar energy generated by the AtriCure Ablation and Sensing Unit (ASU) and is used with the AtriCure Switch Matrix (ASB3), a passive source switch, and footswitch. The Coolrail linear pen is designed with internally cooled electrodes to reduce thermal heating allowing for the energy to traverse deeper and more consistently into the target tissue. The ASU delivers bipolar radiofrequency (RF) energy, which flows between the internally cooled electrodes of the Coolrail linear pen. The Operator controls the application of energy by pressing the footswitch.
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)
Verification testing for the thermistor circuit board modification was completed per AtriCure's Quality System to verify the device's conformance to appropriate design controls and specifications to demonstrate equivalence to the previously cleared Coolrail linear pen device. The Coolrail linear pen device met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared K183065 MCR1 device. No new safety or performance issues were raising during testing.
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.
Not Found
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 24, 2019
AtriCure, Inc Jake Lawson Associate Regulatory Affairs Specialist 7555 Innovation Way Mason, Ohio 45040
Re: K190587
Trade/Device Name: Coolrail Linear Pen (MCR1) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: OCL Dated: March 6, 2019 Received: March 7, 2019
Dear Jake Lawson:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark Fellman Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190587
Device Name Coolrail Linear Pen (MCR1)
Indications for Use (Describe)
The Coolrail linear pen is a sterile, single use electrosurgery device intended to ablate cardiac surgery using radiofrequency (RF) energy.
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 D) |
|---|---|
| ☑ | ☐ |
| X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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l. Applicant Information
| Manufacturer: | AtriCure®, Inc.
7555 Innovation Way
Mason, Ohio 45040
P: 513-755-4100 |
|--------------------|--------------------------------------------------------------------------------|
| Contact Person: | Jake Lawson
Associate Regulatory Affairs Specialist |
| Alternate Contact: | Jim Taufen
Principal Regulatory Affairs Specialist |
| Date Prepared: | 03 April 2019 |
II. Device Information
| Proprietary Name: | Coolrail® Linear Pen (MCR1) |
|---|---|
| Common Name: | Electrosurgical device |
| Classification: | Surgical device for cutting, coagulation, and/or ablation of tissue, |
| including cardiac tissue | |
| Regulatory Class: Class II; per 21 CFR 878.4400 | |
| Product Code: OCL | |
| Classification Panel: Cardiovascular | |
| Predicate Device: | Coolrail Linear Pen (MCR1) |
| (K183065, 4 December 2018) |
lll. Device Description
The AtriCure Coolrail Linear Pen (MCR1) is a hand held, single use surgical instrument intended for the ablation of cardiac tissues during cardiac surgery. The pen utilizes bipolar energy generated by the AtriCure Ablation and Sensing Unit (ASU) and is used with the AtriCure Switch Matrix (ASB3), a passive source switch, and footswitch. The Coolrail linear pen is designed with internally cooled electrodes to reduce thermal heating allowing for the energy to traverse deeper and more consistently into the target tissue. The ASU delivers bipolar radiofrequency (RF) energy, which flows between the internally cooled electrodes of the Coolrail linear pen. The Operator controls the application of energy by pressing the footswitch.
4
IV. Intended Use/ Indications for Use
The Coolrail® linear pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy.
V. Comparison of Technological Characteristics
- The proposed device has modified circuitry (within the RF and Pump control module) to add an additional thermistor safeguard, and;
- The devices include the same intended use, and; ●
- . No changes were made in operating principle, or specifications of performance, and;
- . The contraindications, warnings, and precautions remain the same for both the proposed and predicate, and;
- The devices are applied to the tissue in the same manner with the same method of ablation,
- Both the predicate and proposed devices are made of similar materials with long and safe ● histories of use, and;
- . The results of the verification and validation testing:
- o Demonstrated the subject device met the predetermined performance specifications
- Did not raise any new risks or issues of safety O
VI. Performance Data
Verification testing for the thermistor circuit board modification was completed per AtriCure's Quality System to verify the device's conformance to appropriate design controls and specifications to demonstrate equivalence to the previously cleared Coolrail linear pen device. The Coolrail linear pen device met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared K183065 MCR1 device. No new safety or performance issues were raising during testing.
VII. Conclusions
AtriCure has demonstrated that the Coolrail linear pen is substantially equivalent in fundamental design, technology, function, device materials, packaging, operating principal, and intended use/ indication for use as the previously cleared Coolrail linear pen device via K183065 on 4 December 2018.