(29 days)
Not Found
No
The description focuses on the electro-mechanical delivery of cryogenic energy and does not mention any AI or ML components or functionalities.
Yes
The device is described as a "cryogenic surgical system" that uses "cryo-ablation" to "create lines of ablation through tissue," indicating it directly performs a therapeutic action on the body.
No
The device description clearly states it is an "electro-mechanical cryogenic surgical system that delivers a Nitrous Oxide (N₂O) cryo-genic energy source to a PROBE to create lines of ablation through tissue." This indicates a therapeutic, not diagnostic, function.
No
The device description explicitly states it is an "electro-mechanical cryogenic surgical system" and includes hardware components like a "cryolCE BOX (ACM)" and "PROBES".
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to deliver cryogenic energy to create lines of ablation through tissue. This is a therapeutic procedure performed directly on a patient's body.
- Device Description: The device is described as an "electro-mechanical cryogenic surgical system." This further reinforces its role in surgical procedures.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition. The device's function is to directly treat tissue.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The AtriCure cryolCE BOX is a non-sterile, reusable medical device which delivers cryogenic energy, namely nitrous oxide, to AtriCure's cryo-ablation PROBES.
Product codes
GEH
Device Description
The AtriCure cryolCE BOX (ACM) is an electro-mechanical cryogenic surgical system that delivers a Nitrous Oxide (N0) cryo-genic energy source to a PROBE to create lines of ablation through tissue. The ACM includes single use PROBES (not part of this submission), Component and Accessories. The ACM provides controlled lesion forming temperature that is below -40°C (-40°F).
In addition to the Activation Button on the front panel of the ACM, an accessory Footswitch can also be used to activate and terminate the cryo ablation cycle.
The ACM is designed to operate only with AtriCure's PROBES. Refer to the AtriCure's PROBE Instruction for Use for detailed use and description.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
The bench testing was conducted for design and performance elements deemed appropriate to demonstrate equivalence to the previously cleared AtriCure Cryo Module. The AtriCure cryolCE BOX device met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared AtriCure Cryo Module. No new safety or performance issues were raised during testing.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4250 Cryogenic surgical device.
(a)
Identification. A cryogenic surgical device is a device used to destroy nervous tissue or produce lesions in nervous tissue by the application of extreme cold to the selected site.(b)
Classification. Class II (performance standards).
0
October 29, 2024
Image /page/0/Picture/1 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
AtriCure, Inc. Ronit Shah Regulatory Affairs Specialist 7555 Innovation Way Mason, Ohio 45040
Re: K243157
Trade/Device Name: AtriCure cryoICE BOX (ACM) Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit And Accessories Regulatory Class: Class II Product Code: GEH Dated: September 30, 2024 Received: September 30, 2024
Dear Ronit Shah:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Sincerely,
Adam D. Digitally signed by Adam D. Pierce -S Pierce - - - - Date: 2024.10.29
Pierce - - - 11:06:03 -04'00'
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
AtriCure cryolCE BOX (ACM)
Indications for Use (Describe)
The AtriCure cryolCE BOX is a non-sterile, reusable medical device which delivers cryogenic energy, namely nitrous oxide, to AtriCure's cryo-ablation PROBES.
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 C)
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510(k) Summary
Applicant Information l.
| Manufacturer: | AtriCure, Inc.
7555 Innovation Way
Mason, Ohio 45040
P: 513-755-4100 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ronit Shah
Regulatory Affairs Specialist |
| Date Prepared: | September 30, 2024 |
| II. Device Information | |
| Proprietary Name: | AtriCure® cryoICE® BOX |
| Common Name: | Cryo Surgical Unit and Accessories |
| Classification: | Unit, Cryosurgical, Accessories
Surgical, General and Plastic Surgery, CFR 878.4350
Class II, Product Code: GEH
Classification Panel: General and Plastic Surgery |
| Predicate Device: | AtriCure Cryo Module (K142203, November 25, 2014) |
lll. Device Description
The AtriCure cryolCE BOX (ACM) is an electro-mechanical cryogenic surgical system that delivers a Nitrous Oxide (№0) cryo-genic energy source to a PROBE to create lines of ablation through tissue. The ACM includes single use PROBES (not part of this submission), Component and Accessories. The ACM provides controlled lesion forming temperature that is below -40°C (-40°F).
In addition to the Activation Button on the front panel of the ACM, an accessory Footswitch can also be used to activate and terminate the cryo ablation cycle.
The ACM is designed to operate only with AtriCure's PROBES. Refer to the AtriCure's PROBE Instruction for Use for detailed use and description.
Intended Use / Indications for Use
The AtriCure cryolCE BOX is a non-sterile, reusable medical device which delivers cryogenic energy, namely nitrous oxide, to AtriCure's cryo-ablation PROBES.
5
| # | Feature | Previously cleared AtriCure
Cryo Module (K142203) | Modified AtriCure cryolCE
BOX (Subject) |
|----|----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Proprietary Name | AtriCure Cryo Module | AtriCure cryolCE Box |
| 2 | Device Classification | Device, Surgical Cryogenic
Cryogenic Surgical Device, 21
CFR 882.4250
Product Codes: GEH, GXH | Unit, Cryosurgical,
Accessories
Surgical, General and Plastic
Surgery, CFR 878.4350 |
| 3 | Regulatory Class | Class II | Product Code: GEH
Class II |
| 4 | FDA Division | Neurology | General and Plastic Surgery |
| 5 | Performance Standards | No performance standards
applicable to this product have
been promulgated by FDA | No performance standards
applicable to this product have
been promulgated by FDA |
| 6 | Indications for Use | The AtriCure Cryo Module is a
nonsterile, reusable device
which delivers cryogenic energy,
namely nitrous oxide, to
AtriCure's cryo-ablation probes. | The AtriCure cryoICE BOX is a
non-sterile, reusable medical
device which delivers
cryogenic energy, namely
nitrous oxide, to AtriCure's
cryo-ablation PROBES. |
| 7 | Operating Principle | Joule-Thompson Effect | Joule-Thompson Effect |
| 8 | Energy Used | Nitrous Oxide | Nitrous Oxide |
| 9 | Power Source | Mains Powered | Mains Powered |
| 10 | Power Specification | 115 VAC, 50/60 Hz (nominal) | 115 VAC, 50/60 Hz (nominal) |
| 11 | Typical Minimum
Operating Steady State
Probe Temperature | Less than -55°C | Less than -55°C |
| 12 | Software version | V6.02 | V6.10 |
| 13 | Gas Purge System | Automatic | Automatic |
| 14 | Freeze Timer | Manual or Automatic | Manual or Automatic |
IV. Comparison of Technological Characteristics with the Predicate Device (AtriCure Cryo Module – K142203)
The devices have the same intended use. ●
No changes were made to the operating principle. ●
No changes to the overall design or function of the devices. ●
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V. Performance Data
The bench testing was conducted for design and performance elements deemed appropriate to demonstrate equivalence to the previously cleared AtriCure Cryo Module. The AtriCure cryolCE BOX device met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared AtriCure Cryo Module. No new safety or performance issues were raised during testing.
VI. Conclusions
AtriCure has demonstrated that the modifications made to the AtriCure cryolCE BOX are substantially equivalent in fundamental design, technology, function, device materials, packaging, operating principle, and intended use / indication for use as the previously cleared AtriCure Cryo Module per K142203.