(74 days)
Not Found
No
The device description and performance studies focus on the physical mechanism of cryosurgery using CO2 gas and do not mention any AI or ML components or functionalities.
Yes
The device is intended to destroy tissue during surgical procedures, which is a therapeutic action.
No
The device is a cryosurgical instrument intended to destroy tissue by applying extreme cold, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines a physical, hand-held instrument that uses a CO2 gas cylinder to perform cryosurgery. It is not solely software.
Based on the provided information, the Accurett® device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "To destroy tissue during surgical procedures by applying extreme cold." This describes a therapeutic or surgical intervention performed directly on a patient's body.
- Device Description: The device is a hand-held cryosurgical instrument that applies cold gas to tissue. This is a physical treatment method.
- Lack of In Vitro Activity: IVD devices are used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a patient's health. The Accurett® does not interact with or analyze such specimens.
The Accurett® is a surgical device used for tissue destruction in vivo (within the living body), not for diagnostic testing in vitro (in a lab setting).
N/A
Intended Use / Indications for Use
To destroy tissue during surgical procedures by applying extreme cold.
Product codes
GEH
Device Description
The Accurett® is a hand-held cryosurgical instrument for destroying tissue during surgical procedures by applying extreme cold gas, carbon dioxide (CO2). The device design is based on direct application of carbon dioxide in the liquid phase to the selected area. The CO2 gas is delivered to the treatment site at -79°C to effect cellular destruction. The hand-held device is shaped like a pencil to afford maximum user comfort. Prior to use, a commercially available 16g CO2 gas cylinder cartridge is loaded into the Accurett® device. The flow of gas is controlled by a trigger on the unit. Mode of operation: Joule-Thompson Principle to cool the gas.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
A Risk Analysis was performed according to ISO 14971:2012 and documentation was included in the 510(k) to assess the impact of the change of cryogenic gases. As a result, design verification testing was performed to assure the use of the CO2 gas was appropriate, safe and effective for the intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K024009, CryoProbe™
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 23, 2016
H&O Equipments, nv/sa % Ms. Patsy Trisler Qserve Group US, Inc. 5600 Wisconsin Avenue, #509 Chevy Chase, MD 20815
Re: K161615
Trade/Device Name: Accurett ® Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: August 2, 2016 Received: August 3, 2016
Dear Ms. Trisler:
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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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.
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.
Sincerely yours,
Christopher J. Ronk -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K161615
Device Name
Accurett®
Indications for Use (Describe)
To destroy tissue during surgical procedures by applying extreme cold.
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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FORM FDA 3881 (8/14)
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510(k) SUMMARY— Accurett®
K161615
| I. SUBMITTER | |
|---|---|
| Submitter Name: | H&O Equipments nv/sa |
| Submitter Address: | Rue des Journaliers 1 |
| 7822 Ghislenghien | |
| BELGUIM | |
| Contact Person: | |
| Telephone #: | Aline Frank, Quality Manager |
| +32 68 26 86 00 | |
| US Contact: | Patsy Trisler, Regulatory Consultant, Qserve Group US |
| 301.652.5344 | |
| Date Prepared: | 7 June 2016 |
| II. DEVICE | |
| Device Trade Name: | Accurett® |
| Common and | |
| Classification Name(s): | Cryosurgical Unit and Accessories |
| Classification #: | 21 CFR 878.4350 |
| Product Code | GEH |
| Regulatory Class | 2 |
| Review Panel | General and Plastic Surgery |
| III. PREDICATE DEVICE | K024009, CryoProbe™ |
| IV. DEVICE DESCRIPTION | |
| The Accurett® is a hand-held cryosurgical instrument for | |
| destroying tissue during surgical procedures by applying | |
| extreme cold gas, carbon dioxide (CO2). The device | |
| design is based on direct application of carbon dioxide in | |
| the liquid phase to the selected area. The CO2 gas is | |
| delivered to the treatment site at -79°C to effect cellular | |
| destruction. | |
| The hand-held device is shaped like a pencil to afford | |
| maximum user comfort. Prior to use, a commercially | |
| available 16g CO2 gas cylinder cartridge is loaded into | |
| the Accurett® device. The flow of gas is controlled by a | |
| trigger on the unit. | |
| Mode of operation: Joule-Thompson Principle to cool | |
| the gas. | |
| DESCRIPTION OF DEVICE | |
| MODIFICATIONS | The only modification to the marketed predicate |
| CryoProbe is the cryogen source, from N2O gas to CO2 | |
| gas. | |
| V. INDICATIONS FOR USE | To destroy tissue during surgical procedures by applying |
| extreme cold. | |
| VI. COMPARISON OF | |
| TECHNOLOGICAL | |
| CHARACTERISTICS | |
| WITH THE PREDICATE | |
| AND REFERENCE | |
| DEVICES | The Accurett® has the same intended use as the |
| predicate and reference devices. | |
| There are no technological differences between the | |
| marketed CryoProbe predicate and the Accurett®. The | |
| only modification, as noted, is the use of the alternative | |
| cryogen, CO2 gas. To address this difference, | |
| performance testing was provided. | |
| The Accurett® and the predicate have the same mode of | |
| operation: Joule-Thompson. | |
| The result of use of the different gas is the output | |
| temperature: for the CO2 it is -79ºC while for the N₂O it | |
| is -89°C. | |
| VI. SUMMARY OF | |
| PERFORMANCE DATA | |
| AND DESIGN | |
| CONTROLS | A Risk Analysis was performed according to ISO |
| 14971:2012 and documentation was included in the | |
| 510(k) to assess the impact of the change of cryogenic | |
| gases. | |
| As a result, design verification testing was performed to | |
| assure the use of the CO2 gas was appropriate, safe and | |
| effective for the intended use. | |
| VIII. CONCLUSION OF | |
| SUBSTANTIAL | |
| EQUIVALENCE | The information and data provided in this Special 510(k) |
| establish that H&O Equipment's modified cryosurgical | |
| instrument, the Accurett®, is substantially equivalent in | |
| the intended use, design, principle of operation, | |
| technology, materials, specifications and performance to | |
| the CryoProbe predicate. |
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