CryoLab
Device Facts
| Record ID | K190407 |
|---|---|
| Device Name | CryoLab |
| Applicant | Cryoconcepts LP |
| Product Code | GEH · General, Plastic Surgery |
| Decision Date | Apr 22, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4350 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The CryoLab® utilizes a reusable spray applicator and disposable gas cylinder intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures.
Device Story
CryoLab is a cryosurgical device for the destruction of target tissue via extreme cold. It uses disposable cylinders of nitrous oxide (N2O) or carbon dioxide (CO2). The device features an electronically controlled timed dispense mechanism, actuated by a button on the device wand. It is intended for use by licensed practitioners in a clinical setting. The device delivers cryogen gas topically to the treatment site. The electronic control improves the accuracy of the timed spray compared to manual valve systems. The device is reusable with replaceable gas cylinders. The healthcare provider uses the device to freeze and destroy specific skin lesions, providing a therapeutic benefit through controlled tissue destruction.
Clinical Evidence
No clinical data. Substantial equivalence is supported by bench testing comparing gas delivery and temperature performance against predicates (CryOmega-Flexx and CryoClear). Bench tests included measuring gas dispensed per unit time and the ability to destroy red blood cells immobilized in agar. Human factors testing was conducted to ensure usability.
Technological Characteristics
Materials: Plastic housing, metal filter, butadiene-rubber O-rings, metal gas cylinder. Energy source: Pressurized gas (N2O or CO2). Operation: Electronically controlled timed gas dispense via wand button. Connectivity: None. Sterilization: Not applicable (gas is the only patient-contacting component). Compliance: ASTM F882-84 (96), IEC 60601-1, IEC 60601-1-2.
Indications for Use
Indicated for the surgical destruction of target tissue, 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
Reference Devices
- CryoClear
Submission Summary (Full Text)
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April 22, 2019
CryoConcepts LP Sam Niedbala, Ph.D. CEO 205 Webster St Bethlehem, Pennsylvania 18015
Re: K190407
Trade/Device Name: CryoLab® Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit and Accessories Regulatory Class: Class II Product Code: GEH Dated: February 18, 2019 Received: February 21, 2019
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. 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 located 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.
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-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,
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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#### 510(k) Summary
#### CryoLab®
#### 510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:
I. SUBMITTER
CryoConcepts LP, 205 Webster St, Bethlehem PA 18015 Email: sam@cryoconcepts.com Phone: 215-853-6276
Contact: Sam Niedbala, PhD Date Prepared: 18 February 2019
II. DEVICE
| Name of Device: | CryoLab® |
|----------------------|---------------------------------|
| Classification Name: | Unit, Cryosurgical, Accessories |
| Regulation Number: | 21 CFR 878.4350 |
| Regulatory Class: | Class II |
| Product Code: | GEH |
III. PREDICATE DEVICE
CryoConcepts Primary Predicate Manufacturer: Primary Predicate Trade Name: CryOmega-Flexx Primary Predicate 510(k): K172769
Secondary Predicate Manufacturer: Erbe Primary Predicate Trade Name: ERBOKRYO CA Secondary Predicate 510(k): K934261
IV. DEVICE DESCRIPTION
The CryoLab® device is designed to electronically control a timed dispense of cryogen gas when actuated. The device contains no software and uses a cylinder of nitrous oxide or carbon dioxide. Licensed Practitioners can dispense the gas for use in procedures requiring the surgical destruction of target tissue using the extreme cold of nitrous oxide, N2O (-89°C) or carbon dioxide, CO2 (-79°).
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# K190407
## V. INDICATIONS FOR USE
The CryoLab® is intended for the surgical destruction 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 ●
- Seborrheic Keratosis
# VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
The following characteristics were compared between the subject device and the predicate devices in order to demonstrate substantial equivalence.
A summary of the technological characteristics for the CryoLab® versus the CryOmega Flexx and the ERBOKRYO CA predicates is provided in the following table:
- Intended Use ●
- Cryogen Characteristics
- Materials ●
- Mode of Use
- Mechanism of Action
- Storage Conditions
- Safety
- Electrical Safety
- Gas Cartridge Safety
- Treatment Procedure
- Operation
- Disposal
- Defined Operators ●
- . Service / Repair
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| Technological<br>Characteristics | CryOmega Flexx<br>K172769 | Erbe ERBOKRYO CA<br>K934261 | CryoLab® |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use<br>Statement | Intended Use: The<br>CryOmega Flexx<br>utilizes a reusable<br>spray applicator and<br>disposable gas<br>cartridges intended for<br>the surgical<br>destruction of target<br>tissue by applying<br>cryogenic gases at<br>extreme low<br>temperatures. | Intended Use: The ERBE<br>ERBOKRYO CA<br>Cryosurgical Unit and<br>Accessories are intended for<br>devitalization (destruction)<br>of tissue during surgical<br>procedures by the application<br>of extreme cold and for<br>removal of foreign bodies,<br>mucous plugs, necrotic<br>tissue, and tissue biopsy by<br>cryoadhesion. | Intended Use: The<br>CryoLab® utilizes a<br>reusable spray applicator<br>and disposable gas<br>cylinder intended for the<br>surgical destruction of<br>target tissue by applying<br>cryogenic gases at<br>extreme low<br>temperatures. |
| Cryogen<br>Characteristics | Nitrous Oxide, N2O<br>16g or 25g cylinders<br>with internal valve | Nitrous Oxide, N2O or<br>Carbon Dioxide, CO2<br>Cylinder | Nitrous Oxide, N2O or<br>Carbon Dioxide, CO2<br>Cylinder with internal<br>valve |
| Materials | Housing: Metal/Glass<br>Spray Tip Applicators<br>Gas Cylinder: Metal | ERBOKRYO CA<br>Cryosurgical Unit<br>Pin Index Connectors for<br>CO2 and N2O<br>Flexible Hose<br>Flexible Cryo Probe<br>Connecting Adaptor<br>Footswitch.<br>Gas Cylinder: Metal | Housing: Plastic<br>Filter: Metal<br>O-rings: Butadiene-rubber-<br>Gas Cylinder: Metal |
| Mode of Use | Apply Spray Topically | Apply using cooled contact<br>probe | Apply Spray Topically |
| Mechanism of<br>Action | Cryogen, N2O, is<br>delivered to the<br>treatment site to effect<br>cellular destruction (3) | Cryogen, N2O or CO2 cools<br>contact probe which is<br>applied to the treatment site<br>to effect cellular destruction | Cryogen, N2O or CO2, is<br>delivered to the treatment<br>site to effect cellular<br>destruction. |
| Storage<br>Conditions | <50°C | Not Defined | <50°C |
| Safety | Complies with ASTM:<br>F882-84 (96) for<br>Cryosurgical Medical<br>Instruments | Has an added internal filter at<br>the gas safety outlet in order<br>to comply with the ASTM<br>standard | Complies with ASTM:<br>F882-84 (96) for<br>Cryosurgical Medical<br>Instruments |
| Electrical<br>Safety | Not Applicable | Compliance with IEC 60601-<br>1 | Compliance with IEC<br>60601-1 |
| Gas Cartridge<br>Safety | Cartridge is unscrewed<br>from the unit and | External cryogen cylinder is<br>fitted with a regulator | Cylinder is unscrewed<br>from the unit and replaced |
| Technological<br>Characteristics | CryOmega Flexx<br>K172769 | Erbe ERBOKRYO CA<br>K934261 | CryoLab® |
| Treatment<br>Procedure | Cartridge may be<br>removed between uses | Pressurized gas causes a<br>temperature drop in the<br>cryoprobe tip that, in turn, is<br>applied to the target tissue to<br>destroy or remove tissue. The<br>unit has an analog switch and<br>basic time display. | may be removed between<br>uses<br>Freezing of target tissue<br>by open spray.<br>Electronically controlled<br>gas dispense increases<br>accuracy of timed spray. |
| Operation | Freezing of target<br>tissue by open spray.<br>Manual Valve control<br>during gas dispense | A pedal footswitch is used to<br>start or stop the flow of<br>cryogen to the cryoprobe tip | Gas dispense controlled<br>using electronically timed<br>dispense which is<br>actuated using button on<br>the device wand. |
| | Gas dispense control<br>using actuator lever.<br>Spray controlled by<br>on/off actuator | | |
| Disposal of<br>Cylinder | Applicator Spray Unit<br>is reusable with<br>replaceable gas<br>cylinder | Applicator Unit is reusable<br>with replaceable gas cylinder | Applicator Spray Unit is<br>reusable with replaceable<br>gas cylinder |
| Defined<br>Operators | Licensed Practitioner | Licensed Practitioner | Licensed Practitioner |
| Service/Repair | Return to<br>Manufacturer | Return to Manufacturer | Return to Manufacturer |
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#### VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
# 1. Bench Testing
The use of either liquid Nitrous Oxide or Carbon Dioxide to effect cellular destruction in clinical tests is well established in the literature. Therefore, bench testing data is provided in support of the substantial equivalence determination.
The CryoLab® device utilizes either liquid nitrous oxide or carbon dioxide while the predicate CryOmega Flexx and ErbeKryo CA utilize liquid nitrous oxide and/or carbon dioxide.
Bench testing in this submission focused on demonstrating the equivalency of gas dispensed per unit of time and the temperature attained using open sprays comparing the CryOmega Flexx and CryoLab® with Nitrous Oxide. The ErbeKryo CA is a contact freeze device and not directly comparable in the bench tests performed. For this reason, the CryoClear device, which has a similar design and open spray mechanism as the CryOmega Flexx, was compared to the CryoLab® with Carbon Dioxide.
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A second bench test also used the CryOmega Flexx and CryoLab® comparing a spray of liquid nitrous oxide from each device and its ability to destroy red blood cells immobilized in agar.
Both bench tests adequately demonstrate the equivalent delivery of cryogen gas when comparing the CryOmega Flexx and CryoLab® devices. The procedures and results can be found in Section 17, Performance Bench Testing of this submissions.
# 2. Biocompatibility Testing
Not Applicable: the cryogen gas is the only patient contacting component.
## 3. Sterility Testing
Not Applicable: the cryogen gas is the only patient contacting component.
## 4. Electrical Safety and Electromagnetic Compatibility
CryoConcepts has conducted testing on the CryoLab® to verify compliance with IEC 60601-1 IEC 60601-1:2005 3ed. +A1:2012 and IEC 60601-1-2:2015. Compliance to the consensus standard 19-4 has been declared in Section 8 of this report, entitled Declaration of Conformity and Summary Reports.
# 5. Software Verification and Validation
Not Applicable: no software.
## 6. Performance Testing - Animal
Animal performance testing was not required to demonstrate safety and effectiveness of the device
# 7. Performance Testing - Clinical
Clinical testing was not required to demonstrate the safety and effectiveness of the device. Instead, substantial equivalence is based upon benchtop performance testing.
# 8. Human Factors Testing
Human Factors testing was performed as part of the performance testing. A usability engineering evaluation demonstrating the medical device design meets its intended purpose and incorporates human factors in engineering to ensure the product is safe and easy to use.
#### VII. CONCLUSIONS
Both Nitrous Oxide and Carbon Dioxide are well established as cryogen gases used in cryosurgical products. The comparison bench testing of the CryOmega Flexx to the CryoLab® show that the temperatures attained and amount dispensed are substantially the same when Nitrous oxide is used in the CryoLab® . Another device called CryoClear, was used to show that the temperatures attained and the amount dispensed are substantially the same when Carbon Dioxide is used in the CryoLab®. The CryoLab® is as safe and effective as the predicate devices. The CryoLab® has the same principal of action and intended use in regard to the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. The data therefore supports the substantial equivalence between the CryoLab® and the Predicates.
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