(216 days)
No
The summary describes a cryoablation device that uses freezing to treat cardiac arrhythmias. There is no mention of AI or ML in the intended use, device description, or performance studies. The testing focuses on physical characteristics and biological effects of the cryoablation process.
Yes.
The device is intended for the "cryosurgical treatment of cardiac arrhythmias by freezing target tissues," which directly addresses a medical condition, making it a therapeutic device.
No
Explanation: The device is intended for the cryosurgical treatment of cardiac arrhythmias by freezing target tissues, which is a therapeutic action, not a diagnostic one.
No
The device description explicitly states it is a "sterile, single use, cryosurgical device" comprised of physical components like a cryotip, shaft, handle, thermocouple, inlet tube, and exhaust tube. The performance studies also involve testing on physical tissue models and include mechanical and reliability testing, indicating it is a hardware device.
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 the "cryosurgical treatment of cardiac arrhythmias by freezing target tissues." This is a surgical procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a surgical probe used in conjunction with a cryo module to freeze tissue. This aligns with a surgical device, not a diagnostic device that analyzes samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a therapeutic device used directly on the patient's tissue during a surgical procedure.
N/A
Intended Use / Indications for Use
AtriCure's cryoICE cryoFORM cryoablation probes are sterile, single use devices intended for use in the cryosurgical treatment of cardiac arrhythmias by freezing target tissues, creating an inflammatory response (cryonecrosis) that blocks the electrical conduction pathway.
Product codes (comma separated list FDA assigned to the subject device)
GEH, OCL
Device Description
AtriCure's cryolCE cryoFORM cryoablation probe (CRYOF) is a sterile, single use, cryosurgical device to be used in coniunction with the AtriCure Crvo Module [K111042. K11207. K140058, K142203) to freeze target tissue, blocking the electrical conduction pathways by creating an inflammatory response or cryonecrosis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac
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)
The modified cryolCE cryoablation probe was successfully tested on an animal model to confirm the modifications do not affect the ability to successfully ablate cardiac tissue.
Thigh Prep Study Testing
AtriCure conducted a GLP animal study to evaluate the performance of the CRYOF device in a live porcine thigh tissue model and to compare performance to the predicate CRYO2 device. Lesions were created by each of the cryoablation probes on porcine thigh muscle. The lesions were assessed using histopathology and morphometric measurements and the results demonstrated statistical equivalence via two one-sided tests (TOST) for lesion width and depth.
Additional testing per 21 CFR 820.30 and AtriCure's Quality System was performed to verify the modified cryoablation probe's conformance to design controls and specification. Testing determined that the modified cryoablation probe conformed to design controls and product specifications.
Non-clinical Bench Testing
- Mechanical Testing
- Reliability Testing
- Cryogen Performance Testing
- Bench Testing on an Animal Model
- Sterilization Validation
- LAL Testing
- Accelerated Aging Testing
- Transit Testing
Biocompatibility Testing
The biocompatibility evaluation for the cryolCE crypablation probe was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process" as recognized by FDA. The battery of testing included the following tests:
- Cytotoxicity
- Sensitization
- Irritation
- Systemic Toxicity
- Material Mediated Pyrogenicity
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
§ 878.4350 Cryosurgical unit and accessories.
(a)
Identification —(1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.(2)
Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.(3)
Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.(b)
Classification. Class II.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 22, 2016
Atricure, Inc % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, MN 55313
Re: K152337
Trade/Device Name: cryoFORM cryoICE Cryoablation Probe Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit and Accessories Regulatory Class: Class II Product Code: GEH, OCL Dated: March 7, 2016 Received: March 8, 2016
Dear Mark Job:
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. 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 (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerelv vours.
Mitchell Stein
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) K152337
Device Name
AtriCure® cryoICE™ cryoFORM cryo-ablation probe (CRYOF)
Indications for Use (Describe)
AtriCure's cryoICE cryoFORM cryoablation probes are sterile, single use devices intended for use in the cryosurgical treatment of cardiac arrhythmias by freezing target tissues, creating an inflammatory response (cryonecrosis) that blocks the electrical conduction pathway.
| 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 word "Atri" is in blue, and the word "Cure" is in orange. There is a blue dot above the letter "C" in "Cure". The logo is simple and modern.
510(k) Summary
l. Submitter
| Manufacturer: | AtriCure, Inc.
6217 Centre Park Dr.
West Chester, OH 45069
P: 513-755-4100
F: 513-755-4108 | |
|--------------------|--------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Jonathan McElwee, RAC
Senior Regulatory Specialist | |
| Alternate Contact: | Jim Taufen
Director of Regulatory Affairs | |
| Date Prepared: | 08/11/2015 | |
ll. Device
| Name of Device: | AtriCure® cryoICE™ cryoFORM™ cryoablation probe
(CRYOF) |
|----------------------|-------------------------------------------------------------------------------------------------------------|
| Common Name: | Cryosurgical probe |
| Classification Name: | Unit, Cryosurgical, Accessories
Surgical, General and Plastic Surgery, 878.4350 |
| | Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue,
Including Cardiac Tissue, 878.4400 |
| Regulatory Class: | Class II |
| Product Code: | GEH and OCL |
lll. Predicate Device
The primary predicate device, AtriCure cryolCE cryoablation probe (CRYO2), was cleared via 510(k) K142203 on December 8, 2014 under the Product Code GEH.
A secondary predicate device, Heartport Maze System: Cryoprobe Set, was cleared via 510(k) K970496 on May 9, 1997 under the Product Code OCL.
The predicate devices have not been subject to a design-related recall.
No reference devices were used in this submission.
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IV. Device Description
AtriCure's cryolCE cryoFORM cryoablation probe (CRYOF) is a sterile, single use, cryosurgical device to be used in coniunction with the AtriCure Crvo Module [K111042. K11207. K140058, K142203) to freeze target tissue, blocking the electrical conduction pathways by creating an inflammatory response or cryonecrosis.
V. Indications For Use
AtriCure's cryolCE cryoFORM cryoablation probes are sterile, single use devices intended for use in the cryosurgical treatment of cardiac arrhythmias by freezing target tissues, creating an inflammatory response (cryonecrosis) that blocks the electrical conduction pathway.
VI. Comparison Of Technological Characteristics With The Predicate Device
- Same intended use and; .
- . Same operating principle
- Same fundamental scientific technology
- Used with the same cryo module unit
- . The basic design of the proposed device and the previously cleared devices are the same. The devices are disposable, single-use instruments including a cryotip end effector, shaft. handle, thermocouple, inlet tube, and exhaust tube.
- . The modifications to the proposed cryolCE probe are designed to provide increased options for surgeons based on patient body habitus and surgeon preference. Major modifications compared to the predicate include a more malleable corrugated stainless steel cryotip. more flexible tubing, and a different colored rigid shaft.
5
AtriCure®
The AtriCure cryoFORM cryolCE cryoablation probe has the following similarities to the technological characteristics of the previously cleared predicate AtriCure cryolCE cryoablation probe K142203:
| Feature | AtriCure cryolCE™ cryoablation probe
(CRYO2)
(K142203) | AtriCure cryoFORM cryolCE cryoablation probe
(CRYOF)
(Proposed Device) |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | AtriCure, Inc. | Same |
| Proprietary Name | AtriCure cryoICE cryoablation probe | AtriCure cryoFORM cryoICE cryoablation probe |
| Product Code(s) | CRYO2 | CRY OF |
| 510k Reference | K142203 | Subject of this submission |
| Intended Use | AtriCure's cryoICE cryoablation probes are
sterile, single use devices intended for use in
the cryosurgical treatment of cardiac
arrhythmias by freezing target tissues,
creating an inflammatory response
(cryonecrosis) that blocks the electrical
conduction pathway. The probe is also
intended for use in blocking pain by
temporarily ablating peripheral nerves. | AtriCure's cryoFORM cryolCE cryoablation probes
are sterile, single use devices intended for use in
the cryosurgical treatment of cardiac arrhythmias
by freezing target tissues, creating an inflammatory
response (cryonecrosis) that blocks the electrical
conduction pathway. |
| Device Description | The probe is comprised of a cryotip end
effector, shaft, handle, thermocouple, inlet
tube, and exhaust tube. | The probe is comprised of a cryotip end effector,
shaft, handle, thermocouple, inlet tube, and
exhaust tube. |
| Cryotip | Material: Aluminum alloy
Construction: Smooth malleable probe | Material: Stainless Steel
Construction: Corrugated malleable probe |
| Method of Cryogen
Activation | Switch on AtriCure Cryo Module | Switch on AtriCure Cryo Module |
| Cryogen | Nitrous Oxide | Nitrous Oxide |
| Packaging | Sterile - single use, disposable device | Sterile - single use, disposable device |
| Biocompatibility | Biocompatible patient contacting materials | Biocompatible patient contacting materials |
| Sterilization | Gamma Irradiation | Gamma Irradiation |
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VII. Performance Data
The modified cryolCE cryoablation probe was successfully tested on an animal model to confirm the modifications do not affect the ability to successfully ablate cardiac tissue.
Thigh Prep Study Testing
AtriCure conducted a GLP animal study to evaluate the performance of the CRYOF device in a live porcine thigh tissue model and to compare performance to the predicate CRYO2 device. Lesions were created by each of the cryoablation probes on porcine thigh muscle. The lesions were assessed using histopathology and morphometric measurements and the results demonstrated statistical equivalence via two one-sided tests (TOST) for lesion width and depth.
Additional testing per 21 CFR 820.30 and AtriCure's Quality System was performed to verify the modified cryoablation probe's conformance to design controls and specification. Testing determined that the modified cryoablation probe conformed to design controls and product specifications.
Non-clinical Bench Testing
- Mechanical Testing
- Reliability Testing ●
- Cryogen Performance Testing
- . Bench Testing on an Animal Model
- . Sterilization Validation
- . LAL Testina
- Accelerated Aging Testing .
- . Transit Testing
Biocompatibility Testing
The biocompatibility evaluation for the cryolCE crypablation probe was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process" as recognized by FDA. The battery of testing included the following tests:
- . Cytotoxicity
- Sensitization .
- . Irritation
- Systemic Toxicity ●
- . Material Mediated Pyrogenicity
The cryolCE cryoFORM cryoablation probe is considered an "External Communicating Device," contact for "Tissue/Bone" and contact duration for "under 24 hours."
VIII. Conclusions
The proposed cryolCE cryoFORM cryoablation probe (CRYOF) is substantially equivalent to the previously cleared cryolCE cryoablation probe (CRYO2) as there is no change to intended use, the operating principle, or the basic design of the cryoablation probe. The totality of evidence supports a decision that the modifications to the cryoablation probe have been successfully evaluated for its intended use.