FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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

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.