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.

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.

AI/ML Overview

The provided text does not describe a study involving acceptance criteria for device performance in the context of an AI/ML algorithm. Instead, it is an FDA 510(k) summary for a medical device called "AVACEN 100," which is a heat therapy system.

This document focuses on demonstrating substantial equivalence to a predicate device (Shenzhen Anpan FIR Heat Therapy Systems) for regulatory clearance. It outlines the device description, indications for use, comparison with the predicate device, and compliance with nonclinical safety standards (electrical safety, electromagnetic compatibility, and biocompatibility).

Therefore, I cannot provide the requested information about acceptance criteria, device performance from a study, sample sizes, ground truth establishment, or multi-reader multi-case studies, as none of this pertains to the content of the provided document. The device in question is a physical heat therapy system, not an AI/ML algorithm.

Summary

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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 (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" (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 (800) 638-2041 or (301) 796-7100 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)

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.7920 Silverton Avenue, Suite LSan Diego, CA 92126Tel: (888) 428.2236 x 701Fax: (888) 428.2236
Contact person:	Mr. Thomas G. Muehlbauer, CEO

Summary prepared: July 7, 2014

Device Description

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 HeatTherapySystems	AVACEN 100	Note
Trade name	FIR Heat TherapySystems	AVACEN 100	-
Model	EH-6601- 6614	AVACEN 100	-
510(k)	K111273	K133981	-
Manufacturer	Shenzhen AnpanTechnology Co., Ltd.	AVACEN, Inc.	-
Date Cleared	November 08, 2011	510(k) Pending	-
FDA Reg	890.5740	Same as FIR HeatTherapy Systems	-
Descriptionas found in 510(k)application	The FIR Heat TherapySystem provides heat tothe patient's body usinginfrared technology.	The AVACEN 100provides heat to thepatient's body usingsubatmospheric pressure.	-
Indications for Use	The FIR Heat TherapySystems are indicated forthe temporary relief ofminor muscle and jointpain and stiffness; thetemporary relief of jointpain associated witharthritis, muscle spasms,minor strains and sprainsand minor muscular backpain; muscularrelaxation; and thetemporary increase oflocal circulation whereapplied.	The AVACEN 100 is aheat therapy systemindicated for thetemporary relief of minormuscle and joint pain andstiffness; the temporaryrelief of joint painassociated with arthritis,muscle spasms, minorstrains and sprains;muscular relaxation; andthe temporary increase oflocal circulation whereapplied.	-
Design principle	Heat therapy	Same as FIR HeatTherapy Systems	-
Heat delivery method	Conduction to skinsurface	Same as FIR HeatTherapy Systems	-
Heating Environment	Standard atmosphere	-25 to -35 mm Hg belowstandard atmosphere	Note 1
Parameter	Anpan FIR HeatTherapySystems	AVACEN 100	Note
Therapeutictemperature range	40-45°C	40-43°C	Note 2
Approximate skintemperature	41-42°C	Same as FIR HeatTherapy Systems	-
Time to reachmaximum temperature	10 minutes	5 minutes	Note 2
Time to reachtherapeutictemperature range	5 minutes	3 minutes	Note 2
Recommendedtreatment time	30-45 minutes	10-30 minutes	Note 2
Maximum Duration pertreatment session	45 minutes	30 minutes	-
Patient contactingmaterial	Nylon-cotton blend pad	HDPE	Note 3
Heating element	Carbon fiber	NiChrome wire-woundresistors	-
Device design	Multiple models to fitonto different body parts	Countertop module	Note 4
Electricallypowered?	Yes	Yes	-
Power source	6Vdc (4 x "AA" alkalineBatteries)	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.

Regulation Number and Section

§ 890.5740 Powered heating pad.

(a)
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.(b)
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.