AVACEN 100

K133981 · Avacen, Inc. · IRT · Aug 15, 2014 · Physical Medicine

Device Facts

• Record ID: K133981
• Device Name: AVACEN 100
• Applicant: Avacen, Inc.
• Product Code: IRT · Physical Medicine
• Decision Date: Aug 15, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 890.5740
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The AVACEN 100 is a heat therapy system indicated for the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains and sprains; muscular relaxation; and the temporary increase of local circulation where applied.

Device Story

AVACEN 100 is a countertop dry heat therapy device for home or clinic use. User inserts hand into vacuum chamber; device applies dry heat via temperature-controlled thermal transfer pad while vacuum pump creates slight negative pressure (25-35 mm Hg) to accelerate heat transfer. Treatment lasts 10-30 minutes. Device intended for temporary relief of minor aches, pains, and stiffness; promotes muscular relaxation and local circulation. Healthcare providers or patients use device to manage symptoms of arthritis, muscle spasms, and strains. Output is therapeutic heat; clinical benefit is symptomatic relief of pain and stiffness.

Clinical Evidence

Bench testing only. Device conformity demonstrated via ANSI/AAMI ES60601-1 (electrical safety), AAMI/ANSI/IEC 60601-1-2 (EMC), and ISO 10993 series (biocompatibility, including cytotoxicity, irritation, and skin sensitization). No clinical data provided.

Technological Characteristics

Countertop module; NiChrome wire-wound resistor heating element; HDPE patient-contacting material; vacuum pump (25-35 mm Hg); 12 VDC operation via external power supply (100-240V, 50-60Hz). Conforms to IEC 60601-1, IEC 60601-1-2, and ISO 10993 standards.

Indications for Use

Indicated for temporary relief of minor muscle/joint pain and stiffness, arthritis-related joint pain, muscle spasms, minor strains/sprains, muscular relaxation, and temporary increase of local circulation.

Regulatory Classification

Identification

A powered heating pad is an electrical device intended for medical purposes that provides dry heat therapy for body surfaces. It is capable of maintaining an elevated temperature during use.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E part 807 of this chapter subject to § 890.9.

Predicate Devices

• FIR Heat Therapy Systems, Models EH-6601-6612 (K111273)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of a human profile, repeated three times, with flowing lines that resemble hair or a wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

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

August 15, 2014

Avacen, Inc. Thomas G. Muehlbauer, CEO 7920 Silverton Avenue, Suite L San Diego, CA, 92126

Re: K133981

Trade Name: Avacen 100 Regulation Number: 21 CFR 890.5740 Regulation Name: Powered Heating Pad Regulatory Class: Class II Product Code: IRT Dated: July 17, 2014 Received: July 18, 2014

Dear Mr. Muehlbauer:

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. Isting 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

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] 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" (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/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 [phone] or [phone] or at its Internet address

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

Sincerely yours.

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known) K133981

Device Name Avacen 100

#### Indications for Use (Describe)

The AVACEN 100 is a heat therapy system indicated for the temporary relief of minor muscle and joint pain and stiffiess; the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains and sprains; muscular relaxation; and the temporary increase of local circulation where applied.

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)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (1/14)

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# IAVAC

# 510(k) Summary

#### General Information

| Device | Trade Name: | AVACEN 100 |
|-----------------|---------------------------------------------------------------------------------------------------------------------------|-------------------------|
| | Common name: | Dry Heat Therapy Device |
| | Classification name: | Pad, Heating, Powered |
| | Regulation number: | 890.5740 |
| | Product code: | IRT |
| | Classification panel: | Physical Medicine |
| | Classification: | Class II device |
| 510(k) Owner: | AVACEN, Inc.<br>7920 Silverton Avenue, Suite L<br>San Diego, CA 92126<br>Tel: [phone] x 701<br>Fax: [phone] | |
| Contact person: | Mr. Thomas G. Muehlbauer, CEO | |

Summary prepared: July 7, 2014

# Device Description

The AVACEN 100 consists of a control panel, temperature-controlled raised thermal transfer pad, and a vacuum chamber. The AVACEN 100 is designed to comfortably and noninvasively apply dry heat to the hand for the temporary relief of minor aches and pains. The user places their hand into the AVACEN 100 for approximately 10-30 minutes per treatment session. A vacuum pump creates a slight vacuum (25-35 mm Hg) on the hand, which accelerates the transfer of heat.

# Indications for Use

The AVACEN 100 is a heat therapy system indicated for the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains and sprains: muscular relaxation; and the temporary increase of local circulation where applied.

# Predicate Device Information

The AVACEN 100 is substantially equivalent to the following legally marketed predicate device:

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| Company | Device | 510 (k) |
|----------------------|--------------------------------------|---------|
| Shenzhen Anpan | FIR Heat Therapy Systems, Models EH- | |
| Technology Co., Ltd. | 6601-6612 | K111273 |

A summary of the technological characteristics of the AVACEN 100 and the predicate device is presented in the following table:

| Parameter | Anpan FIR Heat<br>Therapy<br>Systems | AVACEN 100 | Note |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Trade name | FIR Heat Therapy<br>Systems | AVACEN 100 | - |
| Model | EH-6601- 6614 | AVACEN 100 | - |
| 510(k) | K111273 | K133981 | - |
| Manufacturer | Shenzhen Anpan<br>Technology Co., Ltd. | AVACEN, Inc. | - |
| Date Cleared | November 08, 2011 | 510(k) Pending | - |
| FDA Reg | 890.5740 | Same as FIR Heat<br>Therapy Systems | - |
| Description<br>as found in 510(k)<br>application | The FIR Heat Therapy<br>System provides heat to<br>the patient's body using<br>infrared technology. | The AVACEN 100<br>provides heat to the<br>patient's body using<br>subatmospheric pressure. | - |
| Indications for Use | The FIR Heat Therapy<br>Systems are indicated for<br>the temporary relief of<br>minor muscle and joint<br>pain and stiffness; the<br>temporary relief of joint<br>pain associated with<br>arthritis, muscle spasms,<br>minor strains and sprains<br>and minor muscular back<br>pain; muscular<br>relaxation; and the<br>temporary increase of<br>local circulation where<br>applied. | The AVACEN 100 is a<br>heat therapy system<br>indicated for the<br>temporary relief of minor<br>muscle and joint pain and<br>stiffness; the temporary<br>relief of joint pain<br>associated with arthritis,<br>muscle spasms, minor<br>strains and sprains;<br>muscular relaxation; and<br>the temporary increase of<br>local circulation where<br>applied. | - |
| Design principle | Heat therapy | Same as FIR Heat<br>Therapy Systems | - |
| Heat delivery method | Conduction to skin<br>surface | Same as FIR Heat<br>Therapy Systems | - |
| Heating Environment | Standard atmosphere | -25 to -35 mm Hg below<br>standard atmosphere | Note 1 |
| Parameter | Anpan FIR Heat<br>Therapy<br>Systems | AVACEN 100 | Note |
| Therapeutic<br>temperature range | 40-45°C | 40-43°C | Note 2 |
| Approximate skin<br>temperature | 41-42°C | Same as FIR Heat<br>Therapy Systems | - |
| Time to reach<br>maximum temperature | 10 minutes | 5 minutes | Note 2 |
| Time to reach<br>therapeutic<br>temperature range | 5 minutes | 3 minutes | Note 2 |
| Recommended<br>treatment time | 30-45 minutes | 10-30 minutes | Note 2 |
| Maximum Duration per<br>treatment session | 45 minutes | 30 minutes | - |
| Patient contacting<br>material | Nylon-cotton blend pad | HDPE | Note 3 |
| Heating element | Carbon fiber | NiChrome wire-wound<br>resistors | - |
| Device design | Multiple models to fit<br>onto different body parts | Countertop module | Note 4 |
| Electrically<br>powered? | Yes | Yes | - |
| Power source | 6Vdc (4 x "AA" alkaline<br>Batteries) | 100-240V, 50-60Hz | Note 5 |
| Operating voltage | 6 VDC | 12 VDC | Note 5 |
| Leakage Current | N/A | 79 μA | Note 6 |

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Note 1: Operation at a slight negative pressure (0.5 to 0.7 psi below standard atmospheric pressure)

Note 2: Difference from predicate device is not significant.

Note 3: Although the patient contacting material of the AVACEN 100 device is different from the predicate device, both materials are considered safe for their intended use and do not raise any safety or effectiveness issues.

Note 4: Although the device design of the AVACEN 100 device is different from that of the predicate device, both of them comply with IEC 60601-1. This difference does not raise any safety or effectiveness issues.

Note 5: The AVACEN 100 device operates from an external power supply that complies with IEC 60601-1. The power supply output is 12 VDC and connects to the AVACEN 100. The predicate device operates from battery power. Since both of the devices comply with IEC 60601-1, this difference does not raise any safety or effectiveness issues.

Note 6: Predicate device is battery powered and has no connector to mains therefore leakage current test is not performed. AVACEN 100 allowed value in normal conditions per IEC 60601-1 is 100uA

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The AVACEN 100 uses the same fundamental technology as the predicate device and the same intended uses. The fundamental purpose of both devices is to provide heat to relieve common aches, muscle tightness, strains, etc. There is nothing new in the treatment goal, only variations in getting the heat to the site.

# Nonclinical Testing

The AVACEN 100 is in conformity with the following standards and normative documents.

- ANSI/AAMI ES60601-1: Medical Electrical Equipment - Part 1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012
- AAMI/ANSI/IEC 60601-1-2: Medical Electrical Equipment - Part 1-2: Collateral Standard: Electromagnetic compatibility -Requirements and tests (Edition 3): 2007
- AAMI/ANSI/ISO 10993-1: 2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing, Risk Management Process
- AAMI/ANSI/ISO 10993-5: 2009, Biological Evaluation of Medical Devices Part 5: ● Tests for In Vitro Cytotoxicity - Biocompatibility
- ISO 10993-10 3td Edition 2010-08-01 Biological Evaluation of Medical Devices -● Part 10: Tests for Irritation and Skin Sensitization.

# Conclusion

The AVACEN 100 is substantially equivalent to the predicate device, the Shenzhen Anpan FIR Heat Therapy Systems, their indications for use are essentially the same, they utilize similar technologies, and they meet the same conformance test standards.