Who is the manufacturer of CryOmega Flexx?

Cryoconcepts LP filed the 510(k) submission for CryOmega Flexx (K172769).

What is the FDA product code for CryOmega Flexx?

GEH. It is classified under 21 CFR 878.4350 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for CryOmega Flexx?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like CryOmega Flexx?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CryOmega Flexx

K172769 · Cryoconcepts LP · GEH · Nov 30, 2017 · General, Plastic Surgery

Device Facts

Record ID	K172769
Device Name	CryOmega Flexx
Applicant	Cryoconcepts LP
Product Code	GEH · General, Plastic Surgery
Decision Date	Nov 30, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4350
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The CryOmega Flexx is intended for the surgical destruction of tissue by applying cryogenic gases at extreme low temperatures

Device Story

Cryosurgical device for tissue destruction; utilizes liquid nitrous oxide (N2O) stored at 50 bar in 16g or 25g cartridges. Device features reusable metal/glass housing and spray applicator; gas dispensed via actuator lever at -89°C. Operated by licensed practitioners in clinical settings. Mechanism involves topical application of cryogenic spray to target site; extreme cold induces cellular destruction. Benefits include precise, controlled freezing of benign skin lesions. Device allows for cartridge replacement via internal release valve, distinguishing it from disposable predicate models.

Clinical Evidence

Bench testing only. Comparison of gas dispense rate and temperature between CryOmega Flexx and predicate. Results: dispense rate difference <1.0%; both devices achieved temperatures < -90°C. Efficacy demonstrated via destruction of red blood cells in agar model, reaching 1.0 mm depth after 5-second spray.

Technological Characteristics

Materials: Metal/glass housing, metal gas cartridge. Energy: Compressed N2O gas (50 bar). Principle: Cryosurgical tissue destruction via -89°C spray. Form factor: Handheld reusable applicator. Compliance: ASTM F882-84 (96) for Cryosurgical Medical Instruments.

Indications for Use

Indicated for surgical destruction of tissue in patients requiring cryosurgery for lesions including Molluscum Contagiosum, skin tags, actinic keratosis, lentigo, verruca plana, verruca vulgaris, verruca plantaris, genital lesions, and seborrheic keratosis.

Regulatory Classification

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.

Predicate Devices

CryOmega (K102006)

Related Devices

K180211 — Freezpoint · Bovie Medical Corp. · Mar 21, 2018
K102006 — CRYOMEGA · Stc Consulting, LLC · Oct 6, 2010
K172049 — CryoIQ DERM, CryoIQ PRO, CryoIQ EquiMED · Cry IQ AB · Aug 30, 2017
K190407 — CryoLab · Cryoconcepts LP · Apr 22, 2019
K091721 — CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23 · New Medical Technologies GmbH · Oct 2, 2009

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {2}------------------------------------------------ # 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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 <50°C | N2O gas is delivered to the treatment site at -89C to effect cellular destruction <50°C | | -Storage Conditions | <50°C | <50°C | | -Safety | Complies with ASTM: F882-84 (96) for Cryosurgical Medical Instruments | Complies with ASTM: F882-84 (96) for Cryosurgical Medical Instruments | | -Gas Cartridge Safety | Cartridge is unscrewed from the unit and | Unit is discarded after cartridge gas is emptied | | | replaced when empty. Cartridge may be removed between uses due to internal release valve. | | | -Treatment Procedure | Freezing of target tissue by open spray | Freezing of target tissue by open spray | | -Operation | Gas dispense control using actuator lever. Spray controlled by on/off actuator | Gas dispense control using actuator lever. Spray controlled by on/off actuator | | -Disposal | Applicator Spray Unit is reusable with replaceable gas cartridges | Whole Unit is disposable after gas is emptied from the cartridge. | | -Defined Operators | Licensed Practitioner | Licensed Practitioner | | -Service/Repair | Return to Manufacturer | Dispose of once gas cartridge is emptied. No Servicing | {5}------------------------------------------------ ### VII. PERFORMANCE DATA 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 <1.0% different. The difference in amount dispensed was therefore negligible. Additionally replicate measurements of gas sprayed onto a thermocouple from each device were all less than -90°C substantiating the low boiling point of the dispensed liquid nitrous oxide for its intended use. Lastly, the spray of liquid nitrous oxide was previously shown to destroy red blood cells immobilized in agar. A spray of the device was able to reach a depth of approximate 1.0 mm after a 5 second spray. #### VIII. CONCLUSIONS Nitrous oxide is well established as a gas used in cryosurgical products. The comparison bench testing shown between the CryOmega and CryOmega Flexx show that the temperatures attained and amount dispense are substantially the same. The data therefore supports the substantial equivalence between the CryOmega Flexx and the predicate.