(122 days)
The Hybrid ArcticGel™ Pad is indicated as a standalone cooling device for the reduction of core temperature of adult patients where clinically indicated (e.g. heat stroke or hyperthermia). Additionally, the Hybrid ActicGel™ Pad is indicated as an adjunct to patient temperature control with the Arctic Sun® Temperature Management System. The Hybrid ArcticGel™ Pad is intended for use by health care professionals in all clinical environments, including, but not limited to in- hospital as well as EMS/transport settings.
The Arctic Sun Hybrid ArcticGel Pads are a modified version of the Arctic Sun ArcticGel Pads. The Hybrid ArcticGel Pad is designed to operate in two different modes, Ice Gel Mode in which is the pre-frozen pads are used as standalone devices to initiate patient cooling, and Water Flow Mode in which the pads are connected to the Arctic Sun Temperature Management System which is used to control the patient at a target temperature. These dual modes provide the opportunity for early initiation of cooling in the pre-hospital setting or the hospital emergency department followed by continued temperature management with the Arctic Sun once the ice gel is thawed. The Hybrid ArcticGel Pads are pre-frozen in a freezer operating between -3°C and -20°C (27°F and -4°F). The release liners are removed from the hydrogel adhesive, and the frozen Hybrid ArcticGel Pads are applied to the patient's skin. Between 4 and 8 pads are applied to the patient, depending on the patient's size and patient temperature reduction required. Heat from the patient is conducted through the hydrogel and pad layers into the ice gel compartment. The heat from the skin melts the ice gel. The duration of Ice Gel Mode is approximately 60 to 90 minutes from the time of application to complete melting of the Ice Gel. To convert to Water Flow Mode, pad lines are irreversibly snapped onto the inlet and outlet water ports of the Hybrid ArcticGel Pads. The pad line connectors are connected to the Arctic Sun fluid delivery line. Up to 6 Hybrid ArcticGel Pads may be connected to the Arctic Sun. Temperature controlled water from the Arctic Sun control module can then be circulated through the pad. The water passes through the water flow compartment, allowing heat to be transferred from the patient's skin across the hydrogel adhesive and into the circulating water.
The provided text describes a 510(k) summary for the Medivance Arctic Sun Hybrid ArcticGel Pad. It details the device, its intended use, and its substantial equivalence to predicate devices, supported by testing. However, it does not explicitly define acceptance criteria or detail a specific study proving the device meets those criteria in the typical sense of a clinical trial with statistical endpoints for performance.
Instead, the document focuses on comparative performance testing to demonstrate substantial equivalence to predicate devices and safety testing.
Here's an analysis based on the information provided:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria in the format of a table with thresholds and measured performance. However, based on the Testing section, the implicit acceptance criteria are:
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility: Non-cytotoxic, non-irritating, non-sensitizing. | "Biocompatibility testing performed in accordance with ISO 10993-05 and 10993-10 demonstrated the hydrogel patient adhesive to be non-cytotoxic, non-irritating and nonsensitizing." |
| Comparative Performance: Substantially equivalent cooling and temperature control performance to predicate devices. | "Comparative performance testing demonstrated that the cooling and temperature control performance of the Hybrid ArcticGel Pads is substantially equivalent to that of the predicate devices." (Predicate devices: Medivance Arctic Sun ArcticGel Pad, EMCOOLS Pad) The text also notes: "The Hybrid ArcticGel Pads and the predicate devices ... provide similar cooling capacities and durations." |
| Safety (Skin Temperature): Minimum mean skin temperature remains above freezing, reaches minimum within 15 minutes, and gradually rises over 90 minutes. Well-tolerated. | "Safety tests performed in the porcine skin model demonstrated that the minimum mean skin temperature remains above freezing, reaches its minimum value within the first 15 minutes after pad application, and gradually rises over the course of the 90 minute cooling treatment. The placement of the frozen Hybrid ArcticGel Pads on the pigs' skin of pigs was well-tolerated." |
2. Sample size used for the test set and the data provenance
- Biocompatibility Testing: The sample size for biocompatibility testing is not specified, nor is the data provenance.
- Comparative Performance Testing: The sample size for comparative performance testing is not specified, nor is the data provenance.
- Safety Tests (Porcine Skin Model): The sample size for the porcine skin model is not specified (e.g., number of pigs or number of pads tested). The provenance is an animal model, not human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish ground truth for any of the described tests. The tests appear to be primarily objective measurements (e.g., temperature, biocompatibility assays) rather than subjective expert evaluations.
4. Adjudication method for the test set
Not applicable, as no expert adjudication is mentioned.
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 is a medical device, not an AI or imaging diagnostic tool that would typically involve human readers for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a passive cooling device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Biocompatibility: Ground truth would be based on established international standards (ISO 10993-05 and 10993-10) for cytotoxicity, irritation, and sensitization, likely using laboratory assays.
- Comparative Performance: Ground truth for "substantially equivalent cooling and temperature control performance" would be based on direct measurement of cooling rates and temperature stability as compared to the predicate devices. The specific metrics are not detailed but would be quantifiable.
- Safety (Porcine Skin Model): Ground truth for skin temperature would be direct temperature measurements, and "well-tolerated" would be based on observation for adverse reactions in the animal model.
8. The sample size for the training set
Not applicable. This is a medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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JUL 20 2012
Image /page/0/Picture/1 description: The image shows the title "510(k) SUMMARY" followed by the date the document was prepared. The date is listed as May 15, 2012. The text is in black font and is centered on the page. The text is easy to read.
Device Name
Arctic Sun Hybrid ArcticGel Pad
Manufacturer Name , Address and Contact Information
Medivance. Inc. 321 South Taylor Avenue, Suite 200 Louisville, CO 80027 Lynne Aronson, Director Regulatory Affaris Contact: 303-926-1917 Phone: 720-880-5400 Fax:
Common, Classification & Proprietary Names
Common Name: Classification Name: Proprietary Name: Classification: Classification Panel: Classification Regulation: Product Code:
patient temperature management system system, thermal regulating Arctic Sun Hybrid ArcticGel Pad Class II Cardiovascular Devices 870.5900 DWJ
Predicate Devices
- Medivance Arctic Sun ArcticGel Pad
- 페 EMCOOLS Pad
Device Description
The Arctic Sun Hybrid ArcticGel Pads are a modified version of the Arctic Sun ArcticGel Pads.
The Hybrid ArcticGel Pad is designed to operate in two different modes, Ice Gel Mode in which is the pre-frozen pads are used as standalone devices to initiate patient cooling, and Water Flow Mode in which the pads are connected to the Arctic Sun Temperature Management System which is used to control the patient at a target temperature.
These dual modes provide the opportunity for early initiation of cooling in the pre-hospital setting or the hospital emergency department followed by continued temperature management with the Arctic Sun once the ice gel is thawed.
The Hybrid ArcticGel Pads are pre-frozen in a freezer operating between -3°C and -20°C (27°F and -4°F). The release liners are removed from the hydrogel adhesive, and the frozen Hybrid ArcticGel Pads are applied to the patient's skin. Between 4 and 8 pads are applied to the patient, depending on the patient's size and patient temperature reduction required. Heat from the patient is conducted through the hydrogel and pad layers into the ice gel compartment. The heat from the skin melts the ice gel. The duration of Ice Gel Mode is approximately 60 to 90 minutes from the time of application to complete melting of the Ice Gel.
Medivance, Inc.
510(k) K120849 Hybid ArcticGel Pad
ﻬﻢ ﺍﻟﻤﺴﺘﻘﺒﺔ ﻭﺍﻟﻤﻘﺎﺑﻠﺔ
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Image /page/1/Picture/1 description: The image contains the logo for Medivance. The logo features a stylized graphic element to the left of the word "Medivance" in a bold, sans-serif font. Below the company name is the tagline "Committed to Restoring Life" in a smaller, italicized font. The overall design is clean and professional.
To convert to Water Flow Mode, pad lines are irreversibly snapped onto the inlet and outlet water ports of the Hybrid ArcticGel Pads. The pad line connectors are connected to the Arctic Sun fluid delivery line. Up to 6 Hybrid ArcticGel Pads may be connected to the Arctic Sun. Temperature controlled water from the Arctic Sun control module can then be circulated through the pad. The water passes through the water flow compartment, allowing heat to be transferred from the patient's skin across the hydrogel adhesive and into the circulating water.
Indications for Use
The Hybrid ArcticGe!™ Pad is indicated as a standalone cooling device for the reduction of core temperature of adult patients where clinically indicated (e.g. heat stroke or hyperthermia).
Additionally, the Hybrid ActicGel™ Pad is indicated as an adjunct to patient temperature control with the Arctic Sun® Temperature Management System.
The Hybrid ArcticGel™ Pad is intended for use by health care professionals in all clinical environments, including, but not limited to in- hospital as well as EMS/transport settings.
Substantial Equivalence
The Arctic Sun Hybrid ArcticGel Pad was shown to be substantially equivalent in intended use, design, technological characteristics, materials and system features and functions to the predicate devices.
The Hybrid ArcticGel Pad and the predicated ArcticGel Pads and EMCOOLS Pads are noninvasive surface temperature management devices. The Hybrid ArcticGel Pads and the EMCOOLS Pads may be pre-frozen and used as standalone devices for use in patient temperature reduction. Additionally, the Hybrid ArcticGel Pads and the predicate ArcticGel Pads may be used in with the Artic Sun Temperature Management System for use in continuous patient temperature monitoring and control.
The Hybrid ArcticGel Pads and the predicate devices are manufactured from polymer materials that are common to many disposable medical devices, and utilize a biocompatible medical adhesive material to adhere the pads to the patient's skin. The Hybrid ArcticGel Pads and the predicate devices are of similar sizes and weights, and provide similar cooling capacities and durations.
Testing
Biocompatibility testing performed in accordance with ISO 10993-05 and 10993-10 demonstrated the hydrogel patient adhesive to be non-cytotoxic, non-irritating and nonsensitizing.
Comparative performance testing demonstrated that the cooling and temperature control performance of the Hybrid ArcticGel Pads is substantially equivalent to that of the predicate devices.
Medivance, Inc.
Page 17
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Image /page/2/Picture/1 description: The image shows the logo for Medivance. The logo consists of a stylized swoosh shape followed by the word "Medivance" in a bold, sans-serif font. Below the company name is the tagline "Committed to Restoring Life" in a smaller font size.
Safety tests performed in the porcine skin model demonstrated that the minimum mean skin temperature remains above freezing, reaches its minimum value within the first 15 minutes after pad application, and gradually rises over the course of the 90 minute cooling treatment. The placement of the frozen Hybrid ArcticGel Pads on the pigs' skin of pigs was welltolerated.
Conclusions
Based upon the testing and comparison to the predicate devices, the Arctic Sun Hybrid Arctic Gel Pad performs as intended and raises no new safety or effectiveness issues.
Image /page/2/Picture/6 description: The image shows a grainy, black and white picture. The image is mostly white, with black speckles and shapes scattered throughout. The black shapes are concentrated on the left side of the image, forming a vertical column.
Medivance, Inc.
ದ ಸಾವ್ಯ
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002
JUL 2002012
Medivance, Inc. c/o Ms. Lynne Aronson Director, Regulatory Affairs 321 South Taylor Avenue, Suite 200 Louisville, CO 80027
Re: K120849
Hybrid ArcticGel Pad Regulation Number: 21 CFR 870.5900 Regulation Name: System, Thermal Regulating Regulatory Class: Class II Product Code: DWJ Dated: May 21, 2012 Received: May 22, 2012
Dear Ms. Aronson:
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
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Page 2 - Ms. Lynne Aronson
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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
M.S. Hilliam
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE (FDA FORM)
Statement of Indications for Use (FDA Form)
510(k):
Device:
Hybrid ArcticGel Pad
Indications for Use:
The Hybrid ArcticGel™ Pad is indicated as a standalone cooling device for the reduction of core temperature of adult patients where clinically indicated (e.g. heat stroke or hyperthermia).
Additionally, the Hybrid ActicGel™ Pad is indicated as an adjunct to patient temperature control with the Arctic Sun® Temperature Management System.
The Hybrid ArcticGel™ Pad is intended for use by health care professionals in all clinical environments, including, but not limited to in- hospital as well as EMS/transport settings.
Prescription Use X Use (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ym. Yillebe
Division of Cardiovascular Devices
510(k) Number K120849
(Optional Format 1-2-96)
Over-the-Counter
Medivance, Inc.
510(k) K120849 Hybid ArcticGel Pad
Page 10
§ 870.5900 Thermal regulating system.
(a)
Identification. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.(b)
Classification. Class II (performance standards).