Who is the manufacturer of CryoLab?

Cryoconcepts LP filed the 510(k) submission for CryoLab (K190407).

What is the FDA product code for CryoLab?

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 CryoLab?

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

What are the predicate devices for CryoLab?

CryOmega-Flexx (K172769); ERBOKRYO CA (K934261).

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

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.

CryoLab

K190407 · Cryoconcepts LP · GEH · Apr 22, 2019 · General, Plastic Surgery

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

Intended 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

CryOmega-Flexx (K172769)
ERBOKRYO CA (K934261)

Reference Devices

CryoClear

Related Devices

K172769 — CryOmega Flexx · Cryoconcepts LP · Nov 30, 2017
K183601 — CryoTouch · Cryoconcepts LP · Apr 18, 2019
K172049 — CryoIQ DERM, CryoIQ PRO, CryoIQ EquiMED · Cry IQ AB · Aug 30, 2017
K180211 — Freezpoint · Bovie Medical Corp. · Mar 21, 2018
K160669 — ClariFix Device · Arrinex, Inc. · Jun 24, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ #### 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°). {3}------------------------------------------------ # 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 {4}------------------------------------------------ | Technological Characteristics | CryOmega Flexx K172769 | Erbe ERBOKRYO CA K934261 | CryoLab® | |----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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 ERBE ERBOKRYO CA Cryosurgical Unit and Accessories are intended for devitalization (destruction) of tissue during surgical procedures by the application of extreme cold and for removal of foreign bodies, mucous plugs, necrotic tissue, and tissue biopsy by cryoadhesion. | Intended 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. | | Cryogen Characteristics | Nitrous Oxide, N2O 16g or 25g cylinders with internal valve | Nitrous Oxide, N2O or Carbon Dioxide, CO2 Cylinder | Nitrous Oxide, N2O or Carbon Dioxide, CO2 Cylinder with internal valve | | Materials | Housing: Metal/Glass Spray Tip Applicators Gas Cylinder: Metal | ERBOKRYO CA Cryosurgical Unit Pin Index Connectors for CO2 and N2O Flexible Hose Flexible Cryo Probe Connecting Adaptor Footswitch. Gas Cylinder: Metal | Housing: Plastic Filter: Metal O-rings: Butadiene-rubber- Gas Cylinder: Metal | | Mode of Use | Apply Spray Topically | Apply using cooled contact probe | Apply Spray Topically | | Mechanism of Action | Cryogen, N2O, is delivered to the treatment site to effect cellular destruction (3) | Cryogen, N2O or CO2 cools contact probe which is applied to the treatment site to effect cellular destruction | Cryogen, N2O or CO2, is delivered to the treatment site to effect cellular destruction. | | Storage Conditions | <50°C | Not Defined | <50°C | | Safety | Complies with ASTM: F882-84 (96) for Cryosurgical Medical Instruments | Has an added internal filter at the gas safety outlet in order to comply with the ASTM standard | Complies with ASTM: F882-84 (96) for Cryosurgical Medical Instruments | | Electrical Safety | Not Applicable | Compliance with IEC 60601- 1 | Compliance with IEC 60601-1 | | Gas Cartridge Safety | Cartridge is unscrewed from the unit and | External cryogen cylinder is fitted with a regulator | Cylinder is unscrewed from the unit and replaced | | Technological Characteristics | CryOmega Flexx K172769 | Erbe ERBOKRYO CA K934261 | CryoLab® | | Treatment Procedure | Cartridge may be removed between uses | Pressurized gas causes a temperature drop in the cryoprobe tip that, in turn, is applied to the target tissue to destroy or remove tissue. The unit has an analog switch and basic time display. | may be removed between uses Freezing of target tissue by open spray. Electronically controlled gas dispense increases accuracy of timed spray. | | Operation | Freezing of target tissue by open spray. Manual Valve control during gas dispense | A pedal footswitch is used to start or stop the flow of cryogen to the cryoprobe tip | Gas dispense controlled using electronically timed dispense which is actuated using button on the device wand. | | | Gas dispense control using actuator lever. Spray controlled by on/off actuator | | | | Disposal of Cylinder | Applicator Spray Unit is reusable with replaceable gas cylinder | Applicator Unit is reusable with replaceable gas cylinder | Applicator Spray Unit is reusable with replaceable gas cylinder | | Defined Operators | Licensed Practitioner | Licensed Practitioner | Licensed Practitioner | | Service/Repair | Return to Manufacturer | Return to Manufacturer | Return to Manufacturer | {5}------------------------------------------------ #### 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. {6}------------------------------------------------ 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. {7}------------------------------------------------ # Please wait... If this message is not eventually replaced by the proper contents of the document, your PDF viewer may not be able to display this type of document. You can upgrade to the latest version of Adobe Reader for Windows®, Mac, or Linux® by visiting http://www.adobe.com/go/reader_download. For more assistance with Adobe Reader visit http://www.adobe.com/go/acrreader. Windows is either a registered trademark of Microsoft Corporation in the United States and/or other countries. Mac is a trademark of Apple Inc., registered in the United States and other countries. 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