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.

Device Description

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.

AI/ML Overview

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.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 29, 2016

Air Liquide Healthcare America Corporation % Michael Hinckle Partner K&l Gates LLP 430 Davis Drive, Suite 400 Morrisville, North Carolina 27560

Re: K153564

Trade/Device Name: Pure Cryogen Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: February 23, 2016 Received: February 24, 2016

Dear Michael Hinckle:

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. 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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Jennifer R. Stevenson -A

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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Indications for Use

510(k) Number (if known) K153564

Device Name Pure Cryogen

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

The following summary is provided in accordance with 21 CFR 807.92:

A. SUBMITTER

Air Liquide Healthcare America Corporation 12800 West Little York Road Houston, TX 77041

Contact Person: Steve Miller Air Liquide Healthcare America Corporation Director, Quality and Regulatory Affairs Phone: (713) 896-2280 Fax: (713) 803-7427 stevenr.miller@airliquide.com
Consultant: Michael Hinckle K&L Gates LLP Partner 430 Davis Drive, Suite 400 Morrisville, NC 27560 Phone: (919) 466-1115 Fax: (919) 831-7040 michael.hinckle@klgates.com

Date Prepared: December 11, 2015

B. NAME/ADDRESS OF SPONSOR

Air Liquide Healthcare America Corporation 12800 West Little York Road Houston, TX 77041

Steve Miller Contact Person: Air Liquide Healthcare America Corporation Director, Quality and Requlatory Affairs Phone: (713) 896-2280 Fax: (713) 803-7427 stevenr.miller@airliquide.com

C. DEVICE

Trade Name of Device:	PURE CRYOGEN
Common or Usual Name:	Skin Refrigerant
Classification:	Class IILaser surgical instrument for use in general and plastic surgery and indermatology (21 CFR 878.4810)


	Product Code GEX

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D. PREDICATE DEVICE

Candela Dynamic Cooling Device™ (K001589)

E. DEVICE DESCRIPTION

F. INTENDED USE / INDICATIONS FOR USE

The 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 for 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 fluences for 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.

G. TECHNOLOGICAL CHARACTERISTICS

The PURE CRYOGEN device and the predicate device share technological characteristics. Both devices consist of a non-refillable, disposable steel cvlinder of identical dimensions containing 1,000 grams of a refrigerant with the chemical compound 1,1,1,2-tetrafluoroethane (commonly referred to as HFC-134a Low NAG Grade gas ("134a gas")) filled to an internal pressure of 81.9 pounds per square inch gage (PSIG). The cylinder of both the PURE CRYOGEN device and the predicate device is designed to be inserted into a Candela Corporation Dynamic Cooling Device (DCD) for use as a skin refrigerant fluid during laser procedures with a DCD-compatible laser system. Both devices connect to a DCD device using a connector/valve combination with the same design and construction.

H. NON-CLINICAL PERFORMANCE DATA

Non-clinical performance testing was completed to demonstrate the substantial equivalence of the PURE CRYOGEN device and the predicate device and to confirm the labeled shelf-life of the device. 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. 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.

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l. CONCLUSIONS

The PURE CRYOGEN device and the predicate device possess the same intended uses, indications for use, technological characteristics, and principles of operation. 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. Thus, the PURE CRYOGEN is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.