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°).

AI/ML Overview

The document does not explicitly state acceptance criteria in a quantitative table or a study proving that the device meets specific performance thresholds. Instead, it demonstrates substantial equivalence through comparative bench testing against predicate devices.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table with explicit acceptance criteria (e.g., "Device must maintain a temperature of X for Y duration") and corresponding reported performance values for each criterion in the way typical for software or diagnostic device evaluations.

Instead, the performance data section focuses on demonstrating equivalency to predicate devices. The key performance indicators mentioned and their comparative results are:

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance (CryoLab® vs. Predicates)
Gas Dispensed per Unit of Time	Equivalent to predicate devices (CryOmega Flexx for N2O, CryoClear for CO2).	With Nitrous Oxide: Bench testing showed "equivalent delivery of cryogen gas" when comparing the CryoLab® and CryOmega Flexx. The "amount dispensed" was "substantially the same."With Carbon Dioxide: Bench testing showed "equivalent delivery of cryogen gas" when comparing the CryoLab® and CryoClear. The "amount dispensed" was "substantially the same."
Temperature Attained (Open Spray)	Equivalent to predicate devices.	With Nitrous Oxide: Bench testing showed that the "temperatures attained" were "substantially the same" when comparing the CryoLab® and CryOmega Flexx.With Carbon Dioxide: Bench testing showed that the "temperatures attained" were "substantially the same" when comparing the CryoLab® and CryoClear.
Ability to Destroy Red Blood Cells	Equivalent to predicate device.	A second bench test comparing CryOmega Flexx and CryoLab® (both using N2O) demonstrated their "ability to destroy red blood cells immobilized in agar" was equivalent.
Electrical Safety	Compliance with IEC 60601-1 and IEC 60601-1-2.	CryoConcepts conducted testing on the CryoLab® to verify compliance with IEC 60601-1:2005 3ed. +A1:2012 and IEC 60601-1-2:2015. Compliance was declared.
ASTM Compliance	Compliance with ASTM: F882-84 (96) for Cryosurgical Medical Instruments.	CryoLab® "Complies with ASTM: F882-84 (96) for Cryosurgical Medical Instruments."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not explicitly stated in terms of a "test set" with a specific number of instances. The performance evaluation was based on bench testing rather than a typical clinical patient-based test set. The document refers to testing "liquid Nitrous Oxide or Carbon Dioxide" and "comparing the CryOmega Flexx and CryoLab® with Nitrous Oxide" and "CryoClear...compared to the CryoLab® with Carbon Dioxide." This implies a series of laboratory experiments but the number of repetitions or samples tested is not quantified.
Data Provenance: The data is from "bench testing" conducted by CryoConcepts LP. It is not patient or country-specific data. It is prospective in the sense that the tests were conducted specifically for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not Applicable. Since the performance evaluation involved bench testing of physical characteristics (gas dispense, temperature, red blood cell destruction) rather than a diagnostic interpretation, there was no "ground truth" to be established by clinical experts in the traditional sense. The accuracy of measurements would be validated by standard laboratory practices.

4. Adjudication Method for the Test Set:

Not Applicable. No human interpretation or diagnostic assessment requiring adjudication was performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No. The document explicitly states: "Clinical testing was not required to demonstrate the safety and effectiveness of the device. Instead, substantial equivalence is based upon benchtop performance testing." Therefore, an MRMC study comparing human readers with and without AI assistance was not performed, as the device is a cryosurgical unit, not an AI diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done:

Not Applicable. This is a physical medical device (cryosurgical unit) and does not involve an algorithm or AI. Its performance is inherent in its mechanical and thermodynamic function.

7. The Type of Ground Truth Used:

Bench Testing Data / Physical Measurements: The "ground truth" for the performance claims (e.g., temperature attained, gas dispensed) was established through direct physical measurements and observations during bench testing. For example, temperature was measured, and the destruction of red blood cells in agar was observed.
Not: Expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set:

Not Applicable. This device does not use machine learning or AI algorithms, so there is no concept of a "training set."

9. How the Ground Truth for the Training Set was Established:

Not Applicable. (No training set).

Summary

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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

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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

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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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TechnologicalCharacteristics	CryOmega FlexxK172769	Erbe ERBOKRYO CAK934261	CryoLab®
Intended UseStatement	Intended Use: TheCryOmega Flexxutilizes a reusablespray applicator anddisposable gascartridges intended forthe surgicaldestruction of targettissue by applyingcryogenic gases atextreme lowtemperatures.	Intended Use: The ERBEERBOKRYO CACryosurgical Unit andAccessories are intended fordevitalization (destruction)of tissue during surgicalprocedures by the applicationof extreme cold and forremoval of foreign bodies,mucous plugs, necrotictissue, and tissue biopsy bycryoadhesion.	Intended Use: TheCryoLab® utilizes areusable spray applicatorand disposable gascylinder intended for thesurgical destruction oftarget tissue by applyingcryogenic gases atextreme lowtemperatures.
CryogenCharacteristics	Nitrous Oxide, N2O16g or 25g cylinderswith internal valve	Nitrous Oxide, N2O orCarbon Dioxide, CO2Cylinder	Nitrous Oxide, N2O orCarbon Dioxide, CO2Cylinder with internalvalve
Materials	Housing: Metal/GlassSpray Tip ApplicatorsGas Cylinder: Metal	ERBOKRYO CACryosurgical UnitPin Index Connectors forCO2 and N2OFlexible HoseFlexible Cryo ProbeConnecting AdaptorFootswitch.Gas Cylinder: Metal	Housing: PlasticFilter: MetalO-rings: Butadiene-rubber-Gas Cylinder: Metal
Mode of Use	Apply Spray Topically	Apply using cooled contactprobe	Apply Spray Topically
Mechanism ofAction	Cryogen, N2O, isdelivered to thetreatment site to effectcellular destruction (3)	Cryogen, N2O or CO2 coolscontact probe which isapplied to the treatment siteto effect cellular destruction	Cryogen, N2O or CO2, isdelivered to the treatmentsite to effect cellulardestruction.
StorageConditions	<50°C	Not Defined	<50°C
Safety	Complies with ASTM:F882-84 (96) forCryosurgical MedicalInstruments	Has an added internal filter atthe gas safety outlet in orderto comply with the ASTMstandard	Complies with ASTM:F882-84 (96) forCryosurgical MedicalInstruments
ElectricalSafety	Not Applicable	Compliance with IEC 60601-1	Compliance with IEC60601-1
Gas CartridgeSafety	Cartridge is unscrewedfrom the unit and	External cryogen cylinder isfitted with a regulator	Cylinder is unscrewedfrom the unit and replaced
TechnologicalCharacteristics	CryOmega FlexxK172769	Erbe ERBOKRYO CAK934261	CryoLab®
TreatmentProcedure	Cartridge may beremoved between uses	Pressurized gas causes atemperature drop in thecryoprobe tip that, in turn, isapplied to the target tissue todestroy or remove tissue. Theunit has an analog switch andbasic time display.	may be removed betweenusesFreezing of target tissueby open spray.Electronically controlledgas dispense increasesaccuracy of timed spray.
Operation	Freezing of targettissue by open spray.Manual Valve controlduring gas dispense	A pedal footswitch is used tostart or stop the flow ofcryogen to the cryoprobe tip	Gas dispense controlledusing electronically timeddispense which isactuated using button onthe device wand.
	Gas dispense controlusing actuator lever.Spray controlled byon/off actuator
Disposal ofCylinder	Applicator Spray Unitis reusable withreplaceable gascylinder	Applicator Unit is reusablewith replaceable gas cylinder	Applicator Spray Unit isreusable with replaceablegas cylinder
DefinedOperators	Licensed Practitioner	Licensed Practitioner	Licensed Practitioner
Service/Repair	Return toManufacturer	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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Regulation Number and Section

§ 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.