(106 days)
PURE CRYOGEN is indicated to be used as an accessory to Candela Corporation's Dynamic Cooling Device as a source of skin refrigerant fluid. The intended use of PURE CRYOGEN is (1) cooling of the skin prior to laser treatment, (2) reduction of pain during laser treatment, (3) allows for use of higher laser treatments, such as for hair removal and vascular lesions, and (4) reduces potential side effects of laser treatments, such as for hair removal and vascular lesions.
Air Liquide's PURE CRYOGEN consists of a disposable, non-refillable cylinder containing 1, 1,1,2-Tetrafluoroethane, commonly referred to as HFC-134a Low NAG gas ("134a gas"). The 134a gas cylinder is intended to be used as an accessory to Candela Corporation's Dynamic Cooling Device™ as a source of skin refrigerant fluid. The cylinder may be inserted into the Dynamic Cooling Device, which is then connected in line with Candela's laser device. Candela's laser controls the delivery of a pulsed spray of 134a gas just prior to the delivery of a laser pulsed spray of skin refrigerant cools the skin as it evaporates. Use of the 134a gas prior to laser treatment minizes thermal damage to skin during laser treatment and reduces pain associated with laser treatment.
The provided text describes a 510(k) premarket notification for a device called "PURE CRYOGEN". This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study where the device meets acceptance criteria related to a specific performance metric (like diagnostic accuracy or efficacy improvement).
Therefore, many of the requested elements for describing an acceptance criteria study (e.g., sample size for test set, number of experts, adjudication method, MRMC study, sample size for training set, ground truth methods for training set) are not applicable or cannot be extracted directly from this type of regulatory submission. The document explicitly states "Non-clinical performance data" was used.
Below is an attempt to structure the available information per your request, with significant caveats where information is unavailable or not relevant to the document's purpose.
This document describes a 510(k) submission for the PURE CRYOGEN device, which is an accessory to laser surgical instruments for skin cooling. The submission aims to establish substantial equivalence to a legally marketed predicate device (Candela Dynamic Cooling Device™ (K001589)). The "study" described focuses on non-clinical performance and a comparison of technological characteristics between the PURE CRYOGEN device and its predicate.
1. Table of Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" in this context refers to demonstrating that the PURE CRYOGEN device performs equivalently to the predicate device and does not raise new safety or effectiveness concerns, particularly regarding its compatibility and operation within the existing Dynamic Cooling Device (DCD) system.
| Acceptance Criteria (Demonstrated Equivalence/Compatibility) | Reported Device Performance (as presented in the 510(k) Summary) |
|---|---|
| Physical Compatibility with Predicate DCD | |
| (Dimensions, valve threads, cylinder engagement mechanism) | "A study was conducted to confirm that the PURE CRYOGEN device could be used in the parent DCD device in the same manner as the predicate device and without the need for any modification of the DCD. The study consisted of: (a) a comparison of the cylinder height, diameter, valve threads, and compatibility with the DCD's cylinder engagement mechanism; and (b) multiple manual comparative insertions of the PURE CRYOGEN and predicate devices into a DCD device." |
| (Implied: Successful compatibility) | |
| Functional Equivalence as a Source of Skin Refrigerant | |
| (Delivery mechanism and interaction with DCD and laser system; chemical compound of refrigerant) | "The PURE CRYOGEN device and the predicate device share technological characteristics. Both devices... containing 1,1,1,2-Tetrafluoroethane... filled to an internal pressure of 81.9 pounds per square inch gage (PSIG). The cylinder of both... is designed to be inserted into a Candela Corporation Dynamic Cooling Device (DCD) for use as a skin refrigerant fluid... Both devices connect to a DCD device using a connector/valve combination with the same design and construction." |
| (Implied: Functional equivalence) | |
| Shelf-life / Packaging Integrity | |
| (Maintain integrity and prevent leaks over stated shelf-life) | "Additionally, a leak rate test was conducted to determine the total gas leakage from the PURE CRYOGEN cylinder after five years in order to support the labeled shelf-life of the device." |
| (Implied: Shelf-life supported by acceptable leak rate) | |
| No New Issues of Safety or Effectiveness | |
| (Relative to the predicate device) | "Data from performance testing confirmed that the PURE CRYOGEN device is a compatible accessory to the DCD and does not raise any new issues of safety or effectiveness as compared to the predicate device." |
| (Conclusion: No new safety/effectiveness issues identified) | |
| Same Intended Use, Indications for Use, Technological Characteristics, and Principles of Operation | |
| (Demonstrated through comparison and testing) | "The PURE CRYOGEN device and the predicate device possess the same intended uses, indications for use, technological characteristics, and principles of operation." |
| (Conclusion: Substantial equivalence affirmed) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated numerically for the compatibility and leak rate tests. The text mentions "multiple manual comparative insertions" and a "leak rate test." It's likely involved a small number of device units for physical comparisons and a statistically appropriate sample for the leak rate test, but specific counts are absent.
- Data Provenance: The data is non-clinical performance data generated by the device manufacturer, Air Liquide Healthcare America Corporation. The country of origin of the data is not specified but is implicitly associated with the manufacturer's testing facilities (likely in the US given the submission to the FDA). The data is generated from prospective testing of the PURE CRYOGEN device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was a non-clinical, comparative engineering/performance study, not a study requiring expert clinical ground truth evaluation. The "ground truth" was based on established engineering specifications, physical measurements, and the operational characteristics of the predicate device and DCD system.
4. Adjudication method for the test set
Not applicable. There was no clinical ground truth to adjudicate. Physical compatibility and leak rate tests typically involve direct measurement and observation against predefined engineering standards.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is not an AI-powered diagnostic tool, and no MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable as this is not an AI algorithm. The device, PURE CRYOGEN, is an accessory that functions independently as a source of refrigerant fluid, but its intended use is as part of a system with a DCD and laser. The performance tests ("cylinder height, diameter, valve threads," "multiple manual comparative insertions," "leak rate test") are standalone tests for the accessory device's characteristics and its physical interaction with the DCD.
7. The type of ground truth used
The "ground truth" for this non-clinical performance data consisted of:
- Engineering specifications and measurements: For physical dimensions, valve threads, and gas pressure.
- Established operational parameters of the predicate device and DCD: To ensure compatibility and equivalent function within the system.
- Industry standards for leak rates: To assess shelf-life.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI algorithm.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.