(78 days)
CryOmega-K102006
Not Found
No
The 510(k) summary describes a cryogenic device that dispenses nitrous oxide for tissue destruction. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The performance studies focus on gas dispensing and temperature, not algorithmic performance.
Yes
The device is intended for the surgical destruction of tissue to treat various lesions, which describes a therapeutic purpose.
No
The device is intended for the "surgical destruction of tissue" using cryogenic gases, which is a treatment modality, not a diagnostic one. It dispenses liquid nitrous oxide to destroy lesions.
No
The device description clearly states it is a physical device that dispenses liquid nitrous oxide from a cartridge, indicating it is a 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 for the "surgical destruction of tissue by applying cryogenic gases." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device dispenses nitrous oxide to freeze and destroy tissue. This is a physical intervention, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition. The device's function is purely therapeutic.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The CryOmega Flexx does not fit this description.
N/A
Intended Use / Indications for Use
The CryOmega Flexx is intended for the surgical destruction of tissue by applying cryogenic gases at extreme low temperatures The List below shows examples of the types of lesions that may be treated: - Molluscum Contagiosum - · Skin Tags - · Actinic Keratosis - Lentigo - · Verruca Plana - · Verruca Vulgaris - Verruca Plantaris - · Genital Lesions - · Seborrheic Keratosis
Product codes (comma separated list FDA assigned to the subject device)
GEH
Device Description
The CryOmega Flexx device is designed to dispense a continuous stream of liquid nitrous oxide when actuated. The device uses a 16g or 25g cartridge of nitrous oxide that is sprayed once the gas cartridge has been screwed onto the applicator. Licensed Practitioners can then dispense the gas for use in procedures requiring the destruction of tissue using the extreme cold of nitrous oxide, N2O (-89ºC).
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
Licensed Practitioner
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 following bench testing data was provided in support of the substantial equivalence determination. The CryOmega Flexx and predicate CryOmega devices both utilize liquid nitrous oxide. Bench testing therefore focused on demonstrating the equivalency of gas dispensed per unit of time and the temperature attained. Replicate sprays of each device were performed, weighing the devices before and after a 5 second spray. The amount dispensed for the CryOmega Flexx and CryOmega were calculated and found to be
§ 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 image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 30, 2017
CryoConcepts, LP R. Sam Niedbala, Ph.D Chief Executive Officer 205 Webster Street Bethlehem, Pennsylvania 18015
Re: K172769
Trade/Device Name: CryOmega Flexx Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit and Accessories Regulatory Class: Class II Product Code: GEH Dated: September 29 2017 Received: October 4, 2017
Dear Dr. Niedbala:
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 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.
1
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.
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.
Jennifer R. Stevenson -S3
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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Indications for Use
510(k) Number (if known) K172769
Device Name CryOmega Flexx
Indications for Use (Describe)
The CryOmega Flexx is intended for the surgical destruction of tissue by applying cryogenic gases at extreme low temperatures
The List below shows examples of the types of lesions that may be treated:
- Molluscum Contagiosum
- · Skin Tags
- · Actinic Keratosis
- Lentigo
- · Verruca Plana
- · Verruca Vulgaris
- Verruca Plantaris
- · Genital Lesions
- · Seborrheic Keratosis
Type of Use (Select one or both, as applicable)
☑ Remediation Use (Part 21 CFR 604 Subpart D) |
---|
☐ Over-The-Counter Use (21 CFR 604 Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
I. SUBMITTER
CryoConcepts LP, 205 Webster St, Bethlehem PA 18015. Phone: 855-355-2796 Contact: Dr Sam Niedbala Prepared 29 November 2017
II. DEVICE
Name of Device: CryOmega Flexx Usual Name – Cryosurgical unit and accessories Classification Name -General & Plastic Surgery (21CFR 878.4350) Regulatory Class: II Product Code: GEH
III. PREDICATE DEVICE
CryOmega-K102006
IV. DEVICE DESCRIPTION
The CryOmega Flexx device is designed to dispense a continuous stream of liquid nitrous oxide when actuated. The device uses a 16g or 25g cartridge of nitrous oxide that is sprayed once the gas cartridge has been screwed onto the applicator. Licensed Practitioners can then dispense the gas for use in procedures requiring the destruction of tissue using the extreme cold of nitrous oxide, N2O (-89ºC).
V. INDICATIONS FOR USE
The CryOmega Flexx is intended for the surgical destruction of tissue of target tissue by applying cryogenic gases at extreme low temperatures.
The List below shows examples of the types of lesions that may be treated:
- Molluscum Contagiosum ●
- Skin Tags ●
- Actinic Keratosis ●
- Lentigo
- Verruca Plana ●
- Verruca Vulgaris ●
- Verruca Plantaris ●
- . Genital Lesions
4
- . Seborrheic Keratosis
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
A summary of the technological characteristics for the CryOmega Flexx versus the CryOmega predicate is provided in the following table.
| Technological
Characteristics | CryOmega Flexx | Predicate
CryOmega-K102006 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| -Intended Use
Statement | Intended Use: The
CryOmega Flexx utilizes a
reusable spray applicator
and disposable gas
cartridges intended for
the surgical destruction
of target tissue by
applying cryogenic gases
at extreme low
temperatures | Intended Use: The
CryOmega is a disposable
device with a spray
applicator intended for
the surgical destruction
of target tissue by
applying cryogenic gases
at extreme low
temperatures |
| -Cryogen
Characteristics | Nitrous Oxide, N2O at 50
bar pressure. 16g or 25g
cartridges with internal
valve | Nitrous Oxide, N2O at 50
bar pressure. 16g
cartridge |
| -Materials | Housing: Metal/Glass
Spray Tip Applicators
Gas Cartridge: Metal | Housing: Plastic
Filter: Plastic
O-rings: Butadiene-
rubber
Gas Cartridge: Metal |
| -Mode of Use | Apply Spray Topically | Apply Spray Topically |
| -Mechanism of action | N2O gas is delivered to
the treatment site at -89C
to effect cellular
destruction