(106 days)
Not Found
No
The device description and performance studies focus solely on the physical properties and function of a refrigerant gas cylinder used as an accessory to a laser device, with no mention of AI or ML.
No.
PURE CRYOGEN is described as an accessory to a Dynamic Cooling Device, which is used for skin cooling prior to laser treatment. While it aids in reducing pain and side effects during laser treatment, it does not directly treat a disease or condition itself.
No
Explanation: The device is described as an accessory for a laser device, used for cooling the skin prior to and during laser treatments to reduce pain and side effects. Its function is to facilitate laser treatment, not to diagnose any condition or disease.
No
The device description clearly states that the device consists of a disposable cylinder containing a gas, which is a physical component, not software.
Based on the provided information, the PURE CRYOGEN device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that PURE CRYOGEN is used as a skin refrigerant applied externally to the skin prior to laser treatment. It does not involve the analysis of any biological samples (blood, urine, tissue, etc.).
- The function is physical cooling. The device's mechanism of action is the physical cooling of the skin through the evaporation of the refrigerant gas. This is a physical process, not a diagnostic test.
- The intended use is for procedural support. The indications for use are all related to supporting laser treatment by cooling the skin, reducing pain, allowing for higher laser settings, and reducing side effects. These are all related to the procedure itself, not to diagnosing a condition or monitoring a patient's health status through the analysis of biological samples.
Therefore, PURE CRYOGEN is a medical device used in conjunction with a laser device for skin treatment, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
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
1
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)
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.
| 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 II |
| Laser surgical instrument for use in general and plastic surgery and in | |
| dermatology (21 CFR 878.4810) | |
| Product Code GEX |
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D. PREDICATE DEVICE
Candela Dynamic Cooling Device™ (K001589)
E. 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.
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.