(29 days)
No
The summary describes a standard electrosurgery device using RF energy with no mention of AI or ML capabilities.
Yes
The device is described as an electrosurgery device intended to ablate cardiac tissue using radiofrequency energy, which directly modifies tissue for therapeutic purposes.
No
The device is an electrosurgery device intended to ablate cardiac tissue using radiofrequency energy, indicating a therapeutic function rather than a diagnostic one.
No
The device is a physical, hand-held surgical instrument that utilizes radiofrequency energy for ablation, clearly indicating it is a hardware device and 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 describes a surgical procedure performed directly on the patient's tissue, not a test performed on a sample taken from the patient.
- Device Description: The device is a "hand held, single use surgical instrument intended for the ablation of cardiac tissues during cardiac surgery." This further reinforces its use in a surgical setting for direct tissue modification.
- 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 samples, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
The device is clearly designed for therapeutic intervention (ablation) during surgery, which falls outside the scope of In Vitro Diagnostics.
N/A
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.
Product codes
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
Mechanical design verification testing 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 K122611 MCR1 device. No new safety or performance issues were raising during testing.
Non-clinical Bench Testing:
- Reliability Testing
- Thermistor Testing
- Mechanical testing
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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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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.
December 4, 2018
AtriCure, Inc. Caitlin Wunderlin Regulatory Affairs Specialist 7555 Innovation Way Mason, Ohio 45040
Re: K183065
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: October 24, 2018 Received: November 5, 2018
Dear Caitlin Wunderlin:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Minde Jellman
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183065
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) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the AtriCure logo. The logo is in blue and orange. The word "Atri" is in blue, and the word "Cure" is in orange. There is a blue dot above the "i" in "AtriCure". There is a registered trademark symbol next to the "e" in "Cure".
510(k) Summary
l. Applicant Information
| Manufacturer: | AtriCure®, Inc.
7555 Innovation Way
Mason, Ohio 45040
P: 513-755-4100 |
|--------------------|--------------------------------------------------------------------------------|
| Contact Person: | Caitlin Wunderlin
Regulatory Affairs Specialist |
| Alternate Contact: | Jonathan McElwee
Manager, Regulatory Affairs |
| Date Prepared: | 23 October 2018 |
. 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) |
| (K122611, 26 September 2012) |
III. 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.
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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.
Comparison of Technological Characteristics (MCR1 K122611) V.
- 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, and;
- The results of the verification and validation testing:
- o Demonstrated equivalency in performance
- Did not raise any new issues of safety o
Modifications included in the Coolrail linear pen were to increase the rigidity of the rigid zone of the shaft.
| MCR1 (Predicate) | MCR1 (Subject) | |
|---|---|---|
| Market Product Name | Coolrail Linear Pen | Coolrail Linear Pen |
| 510(k) Number | K122611 | Subject of this submission (K183065) |
| Intended Use | The Coolrail® linear pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy. | The Coolrail® linear pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy. |
| Contraindication | The device is not intended for contraceptive tubal coagulation (permanent female sterilization). | The device is not intended for contraceptive tubal coagulation (permanent female sterilization). |
| Method of Energy Activation | Footswitch | Footswitch |
| Energy Source | Bipolar radiofrequency energy is generated by the Ablation and Sensing Unit that is sold separately. | Bipolar radiofrequency energy is generated by the Ablation and Sensing Unit that is sold separately. |
| Ablating Element Length | 30 mm | 30 mm |
| Functional Shaft Length | 10.0 inches minimum | 10.0 inches minimum |
| Shaft - Outer Stiffener Length | 7.5 inches minimum | Lengthened by 0.5 inches |
| Shaft - Outer Stiffener Material (Non-patient contacting) | Nylon | Aluminum Alloy |
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| Outer Stiffener to Shaft Bonding Agent (Non-patient contacting) | Cyanoacrylate | Epoxy |
|---|---|---|
| Packaging | Sterile – Single use disposable device | Sterile – Single use disposable device |
| Sterilization | EtO | EtO |
VI. Performance Data
Mechanical design verification testing 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 K122611 MCR1 device. No new safety or performance issues were raising during testing.
Non-clinical Bench Testing:
- Reliability Testing ●
- . Thermistor Testing
- Mechanical testing .
VII. Conclusions
AtriCure has demonstrated that the Coolrail linear pen is substantially equivalent in fundamental design, technology, function, device materials, packaging, sterilization, operating principal, and intended use/ indication for use as the previously cleared Coolrail linear pen device via K122611 on 26 September 2012.