(60 days)
Not Found
No
The device description explicitly states that the device contains no software.
Yes
The device is intended for the surgical destruction of target tissue by applying cryogenic gases, which directly treats various lesions, aligning with the definition of a therapeutic device.
No
The device is intended for the surgical destruction of target tissue using cryotherapy, not for diagnosis.
No
The device description explicitly states "The device contains no software".
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- CryoLab® Function: The CryoLab® is used for the surgical destruction of target tissue by applying extreme cold. It directly interacts with the patient's tissue to treat lesions.
- Lack of Specimen Analysis: The device does not analyze any specimens from the human body. It's a therapeutic device, not a diagnostic one.
The description clearly states its purpose is for "surgical destruction of target tissue" and lists various types of lesions it can treat. This is a direct treatment method, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / 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
Product codes
GEH
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°).
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
-
Bench Testing:
- Bench testing data is provided in support of the substantial equivalence determination.
- Focus was on demonstrating the equivalency of gas dispensed per unit of time and the temperature attained using open sprays.
- Comparisons were made between CryOmega Flexx and CryoLab® with Nitrous Oxide.
- CryoClear device was compared to CryoLab® with Carbon Dioxide.
- A second bench test also compared spray of liquid nitrous oxide from CryOmega Flexx and CryoLab® for their 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.
-
Biocompatibility Testing: Not Applicable: the cryogen gas is the only patient contacting component.
-
Sterility Testing: Not Applicable: the cryogen gas is the only patient contacting component.
-
Electrical Safety and Electromagnetic Compatibility:
- Testing on the CryoLab® was conducted to verify compliance with IEC 60601-1:2005 3ed. +A1:2012 and IEC 60601-1-2:2015.
- Compliance to consensus standard 19-4 has been declared.
-
Software Verification and Validation: Not Applicable: no software.
-
Performance Testing - Animal: Animal performance testing was not required to demonstrate safety and effectiveness of the device.
-
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.
-
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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 |