(78 days)
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
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).
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the CryOmega Flexx device:
The document is a 510(k) premarket notification summary for the CryOmega Flexx, a cryosurgical unit. It focuses on demonstrating substantial equivalence to a predicate device (CryOmega-K102006) rather than defining and proving new acceptance criteria for novel performance claims. Therefore, the "acceptance criteria" here are essentially the performance characteristics of the predicate device, which the new device must meet or be substantially equivalent to.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from Predicate Device Performance) | Reported CryOmega Flexx Performance |
|---|---|
| Cryogen Temperature at Treatment Site: -89°C | "replicate measurements of gas sprayed onto a thermocouple from each device were all less than -90°C" (This indicates it meets or exceeds the predicate's reported temperature.) |
| Amount of Gas Dispensed: (Implied by predicate) | "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." (This demonstrates equivalency in gas dispensed.) |
| Cellular Destruction Efficacy: (Implied by predicate's mechanism of action) | "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." (This relies on prior validation of the predicate's mechanism, and confirms the new device achieves a similar physical effect (spray depth) which is linked to efficacy.) It's important to note this isn't a direct measure of efficacy for the listed lesions, but rather a physical proxy. |
| Safety: Complies with ASTM F882-84 (96) | "Complies with ASTM: F882-84 (96) for Cryosurgical Medical Instruments" (Declared compliance with the same standard as the predicate.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a precise sample size for the "replicate sprays" or "replicate measurements." It uses the term "replicate," implying multiple measurements were taken, but the exact number is not stated.
- Data Provenance: The study was a bench testing study conducted by the manufacturer, CryoConcepts LP. The data is prospective (generated specifically for this submission) and conducted in a controlled lab environment. There is no mention of country of origin for the data itself, but the manufacturer is based in Bethlehem, Pennsylvania, USA.
The study is essentially comparing the new device (CryOmega Flexx) directly against the predicate device (CryOmega-K102006) in terms of physical performance rather than against a clinical dataset of patients.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this study. The "ground truth" for this bench test study is objective physical measurements (temperature, mass, spray depth) taken by technical instruments, not expert human interpretation.
4. Adjudication Method for the Test Set
This is not applicable to this study as it involves objective physical measurements, not subjective human assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This is not applicable. This document describes a bench testing study for a cryosurgical device, not an AI-powered diagnostic system or a study involving human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This is not applicable. This device is a cryosurgical tool, not an algorithm. Performance is assessed through physical bench tests.
7. The Type of Ground Truth Used
The ground truth used in this study is based on objective physical measurements obtained from bench testing instruments (thermocouple for temperature, scale for mass, and a visual assessment of spray depth in agar for the cellular destruction proxy).
8. The Sample Size for the Training Set
This is not applicable. This device does not use machine learning or AI, and therefore does not have a "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as above; there is no training set.
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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.
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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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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
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- . 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.
| TechnologicalCharacteristics | CryOmega Flexx | PredicateCryOmega-K102006 |
|---|---|---|
| -Intended UseStatement | Intended Use: TheCryOmega Flexx utilizes areusable spray applicatorand disposable gascartridges intended forthe surgical destructionof target tissue byapplying cryogenic gasesat extreme lowtemperatures | Intended Use: TheCryOmega is a disposabledevice with a sprayapplicator intended forthe surgical destructionof target tissue byapplying cryogenic gasesat extreme lowtemperatures |
| -CryogenCharacteristics | Nitrous Oxide, N2O at 50bar pressure. 16g or 25gcartridges with internalvalve | Nitrous Oxide, N2O at 50bar pressure. 16gcartridge |
| -Materials | Housing: Metal/GlassSpray Tip ApplicatorsGas Cartridge: Metal | Housing: PlasticFilter: PlasticO-rings: Butadiene-rubberGas Cartridge: Metal |
| -Mode of Use | Apply Spray Topically | Apply Spray Topically |
| -Mechanism of action | N2O gas is delivered tothe treatment site at -89Cto effect cellulardestruction<50°C | N2O gas is delivered tothe treatment site at -89Cto effect cellulardestruction<50°C |
| -Storage Conditions | <50°C | <50°C |
| -Safety | Complies with ASTM:F882-84 (96) forCryosurgical MedicalInstruments | Complies with ASTM:F882-84 (96) forCryosurgical MedicalInstruments |
| -Gas Cartridge Safety | Cartridge is unscrewedfrom the unit and | Unit is discarded aftercartridge gas is emptied |
| replaced when empty.Cartridge may beremoved between usesdue to internal releasevalve. | ||
| -Treatment Procedure | Freezing of target tissueby open spray | Freezing of target tissueby open spray |
| -Operation | Gas dispense controlusing actuator lever.Spray controlled byon/off actuator | Gas dispense controlusing actuator lever.Spray controlled byon/off actuator |
| -Disposal | Applicator Spray Unit isreusable with replaceablegas cartridges | Whole Unit is disposableafter gas is emptied fromthe cartridge. |
| -Defined Operators | Licensed Practitioner | Licensed Practitioner |
| -Service/Repair | Return to Manufacturer | Dispose of once gascartridge is emptied. NoServicing |
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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.
§ 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.