OptonPro is a topical heat lamp with laser light. It emits energy in the infrared spectrum to provide topical heating for the purpose of elevating the tissue temperature. The OptonPro contents a Class IV laser unit with four simultaneously operating diodes with wavelengths of 810nm and 980mm transmitting their energy to an applicator through a flexible fibre optic cable. The applicator has an output spot size of 10 mm. The optimum ration of absorption and penetration depth quarantees efficient stimulation of tissue and pain receptors. The treatment effect of the OptonPro is achieved with 980nm and 810nm. Additionally the OptonPro contains an aiming beam with 650nm. Skin type, indication and desired depth of treatment define the operating mode and the required energy. Two operating modes are possible: continuous wave and serial pulse. The duty cycle can be adapted additionally (1:1 – 1:10). Patient feedback and direct access to the treatment parameters enable to adjust the application for individual requirements and to achieve treatment times of a few minutes. The OptonPro includes comprehensive safety features. In addition to multi-step activation of the laser by the software, with software security key lock and footswitch for starting treatment, protective glasses, an emergency off switch and a hardware interlock are included in the system. The performance of the laser unit can be tested with an integrated power control unit. A thermal threshold test offers a tool to assess the warmth sensitivity and the individual local absorption rate. Additionally the user is assisted with a special reminder function for a delivered particular amount of energy. OptonPro is an intuitive therapy system with touch screen and menu-quided operation. The maximum output power is 7 W. The adjustable output power corresponds with the chosen duty cycle. The OptonPro has a large colour display with 12 inch. A SD card is used as a memory, as a logbook and for updates. Individual adjustments can be made at any time and saved for easy access. A program menu with 3 fixed programs and a favourites and memory menu with 120 memory slots fur custom programs collects the most common settings and shows them when the OptonPro is started if required.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Zimmer MedizinSysteme OptonPro, an infrared lamp device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study with acceptance criteria for a new device's performance.

Therefore, many of the requested details about acceptance criteria, sample sizes, ground truth establishment, expert adjudication, and MRMC studies are not available in this document because they are typically required for demonstrating efficacy and safety of novel devices, or for AI/software devices, which this infrared lamp is not.

However, I can extract the information that is present concerning performance and testing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Therapeutic temperature range	40 – 45°C
Maximum transition time to reach therapeutic temperature range	5 minutes
Duration therapeutic temperature range is maintained	10 minutes

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: "a few test candidates" (No specific number provided)
Data Provenance: Not specified, but given it's a submission from Zimmer MedizinSysteme GmbH (Germany), it's likely originating from Europe.
Retrospective/Prospective: The wording "temperature measurements were conducted" suggests a prospective measurement approach for the non-clinical testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This information is not available in the document. The testing described is non-clinical performance measurement (temperature), not a diagnostic or clinical assessment requiring expert ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the described testing involves physical measurements, not observational or diagnostic interpretations that would require adjudication.

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

An MRMC study was not done. This device is an infrared lamp for therapeutic heating, not an AI or diagnostic imaging device that would typically involve human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

A standalone algorithm performance study was not done. This is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests was based on direct temperature measurements on test candidates, establishing whether the device could consistently reach and maintain a specified therapeutic temperature range.

8. The Sample Size for the Training Set

Not applicable/Not provided. This document describes the 510(k) submission for a physical device, an infrared lamp, not an AI or machine learning model that would have a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not provided. As there is no training set for an AI model, there is no ground truth establishment for it.

In summary: The document is primarily a regulatory submission demonstrating substantial equivalence for an infrared lamp based on technological characteristics and non-clinical performance data (temperature output). It does not present clinical trial data or performance metrics common for AI/diagnostic devices that would involve human experts, large test sets, or ground truth derived from pathology or outcomes data.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol depicts a stylized human figure with three faces in profile, representing the department's focus on health and human well-being.

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

October 24, 2014

Zimmer MedizinSysteme GmbH % Ms. Kirsten Langen Tuv Sud America Incorporated 1775 Old Highway, 8 North West New Brighton, Minnesota 55112

Re: K141564

Trade/Device Name: OptonPro Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: ILY Dated: September 10, 2014 Received: September 29, 2014

Dear Ms. Langen:

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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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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/Resourcesfor You/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.

for

Sincerely yours,

David Krause -S

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) K141564

Device Name OptonPro

Indications for Use (Describe)

· temporary relief of minor muscle and joint aches, pains and stiffness
· temporary relief of muscle spasm
· temporary relief of minor pain and stiffness associated with arthritis
· promoting relaxation of the muscle tissue
· temporary increase in local blood circulation

Type of Use (Select one or both, as applicable)

2 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)

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Image /page/3/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The logo consists of the word "zimmer" in a bold, sans-serif font, with a horizontal line above the "z" and "i". Below the word "zimmer" is the phrase "MedizinSysteme" in a smaller, lighter font. The logo is simple and modern, and the use of two different fonts creates a visual hierarchy.

Tel. 0731. 9761-0 Fax 0731.9761-118 info@zimmer.de www.zimmer.de

5. 510(k) Summary

The following information is provided as required in 21CFR807.87 and the "Guidance Document for Heating and Cooling Devices 510(k)s".

a.) General

510(k) Submitter:	Zimmer MedizinSysteme GmbHJunkersstrasse 9D-89231 Neu-UlmGermany
Contact person:	Mr. Armin PetraschkaProject ManagerPhone: +49-731-9761-140Fax: +49-731-9761-4475E-mail: a.petraschka@zimmer.de
EstablishmentRegistration:	8010720
Submission Date:	April 25th, 2014
Device Names:
Device Name:	Opton Pro
Trade Names:	Opton Pro
Common Names:	Heating and Cooling Devices
Regulation Numbersand ClassificationNames:	21 CFR 890.5500 – Infrared Lamp
Classification:	Class II
Product Codes:	ILY
Panel:	89 - Physical Medicine

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Image /page/4/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The word "zimmer" is in bold, gray letters. Underneath the word "zimmer" is the word "MedizinSysteme" in a smaller, gray font.

Fax 0731.9761-11

info@zimmer.de www.zimmer.de

b.) Predicate Devices

1.	2.
DeviceK-1200	Vectra Genisys Laser System
ManufacturerELTECH s.r.lVia Castagnole, 20/H31100 Trevisio, Italy	CHATTANOOGA GROUP (Encore Medical)4717 Adams Road. P.O. Box 489Hixson, Tennessee 37343-0489
510(k) numberK091497	K040662

c.) Device Description

OptonPro is a topical heat lamp with laser light. It emits energy in the infrared spectrum to provide topical heating for the purpose of elevating the tissue temperature.

The OptonPro contents a Class IV laser unit with four simultaneously operating diodes with wavelengths of 810nm and 980mm transmitting their energy to an applicator through a flexible fibre optic cable. The applicator has an output spot size of 10 mm.

The optimum ration of absorption and penetration depth quarantees efficient stimulation of tissue and pain receptors. The treatment effect of the OptonPro is achieved with 980nm and 810nm. Additionally the OptonPro contains an aiming beam with 650nm.

Skin type, indication and desired depth of treatment define the operating mode and the required energy. Two operating modes are possible: continuous wave and serial pulse. The duty cycle can be adapted additionally (1:1 – 1:10). Patient feedback and direct access to the treatment parameters enable to adjust the application for individual requirements and to achieve treatment times of a few minutes.

The OptonPro includes comprehensive safety features. In addition to multi-step activation of the laser by the software, with software security key lock and footswitch for starting treatment, protective glasses, an emergency off switch and a hardware interlock are included in the system. The performance of the laser unit can be tested with an integrated power control unit. A thermal threshold test offers a tool to assess the warmth sensitivity and the individual local absorption rate. Additionally the user is assisted with a special reminder function for a delivered particular amount of energy.

OptonPro is an intuitive therapy system with touch screen and menu-quided operation. The maximum output power is 7 W. The adjustable output power corresponds with the chosen duty cycle. The OptonPro has a large colour display with 12 inch. A SD card is used as a memory, as a logbook and for updates.

Individual adjustments can be made at any time and saved for easy access. A program menu with 3 fixed programs and a favourites and memory menu with 120 memory slots fur custom programs collects the most common settings and shows them when the OptonPro is started if required.

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Image /page/5/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The logo consists of the word "zimmer" in a bold, sans-serif font, with a horizontal line above the "z" and "i". Below the word "zimmer" is the phrase "MedizinSysteme" in a smaller, sans-serif font. The logo is in grayscale.

Tel. 0731. 9761-0 Fax 0731.9761-118 info@zimmer.de www.zimmer.de

d.) Statement of indications for use

The indications for use of the proposed device are the same as those for the predicate devices:

temporary relief of minor muscle and joint aches, pains, and stiffness ●
temporary relief of muscle spasm .
temporary relief of minor pain and stiffness associated with arthritis .
. promoting relaxation of the muscle tissue
temporary increase of local blood circulation .

e.) Comparison of Technological Characteristics

No	Feature	OptonPro	K-1200	Vectra Genisys Laser System
1.	power source	100 - 240 VAC, 50 / 60Hz	100 - 240 VAC, 47 - 63 Hz	120-240VAC, 50 / 60Hz
2.	battery powered	-	+	+
3.	dimensions(h x w x d) [cm]	30 x 35 x 20(11.81 x 13.78 x 7.87 in)	19 x 18 x 20(7.5 x 7 x 8 in)	16.3 x 28.8 x 32.8(6.4 x 11.3 x 12.9 in)
4.	weight [kg]	3.8(8.38 lb)	1.3(2.9 lb)	2.3(5.07 Ib)
5.	housing materials	plastic	plastic	plastic
6.	laser class	4	4	3B
7.	applied part	B	B	B
8.	protection class	ll	ll	ll
9.	laser system	laser diodes,fibre-optical cable	laser diodes,fibre-optical cable	laser diodes
10.	software control	+	+	+
11.	compliance withvoluntarystandards	Yes,-IEC/EN 60601-1-IEC/EN 60601-1-2-IEC 60601-2-22-IEC 60825-1	Yes,-IEC/EN 60601-1-IEC 60825-1	Yes,-IEC/UL/EN 60601-1-IEC/UL/EN 60601-1-2-IEC/UL/EN 60601-2-22-IEC 60825-1-21CFR 1040.10 & 1040.11-CAN/CSA C22.2 No.601.1-M90 w/A2
12.	prescription use	+	+	+
13.	intended use	emit energy in the infraredspectrum to provide topicalheating for the purpose ofelevating tissue temperatureheating for the followingindications for use:	emit energy in the infraredspectrum to provide topicalheating for the purpose ofelevating tissue temperatureheating for the followingindications for use:	indicated for topical heating forthe following indications foruse:
14.	indications foruse	- temporary relief of minormuscle and joint aches, painsand stiffness- temporary relief of musclespasm- temporary relief of minor painand stiffness associated witharthritis	- temporary relief of minormuscle and joint pain- temporary relief of musclespasm- temporary relief of minor painand stiffness associated witharthritis- promoting relaxation of the	- temporary increase in localblood circulation- temporary relief of minormuscle and joint aches, painsand stiffness- relaxation of muscles- temporary relief of musclespasm
		- promoting relaxation of themuscle tissue- temporary increase in localblood circulation	muscle tissue- temporary increase localblood circulation	- temporary relief of minor painand stiffness associated witharthritis
15.	touch screeninterface	+	+
16.	color LCD screen	+	+	-
17.	external memory	+	+	-
18.	functional cartoption	+	+	+
19.	number of outputchannels	1	1	1
20.	modifiablewaveformparameters /customizetreatmentparameters	+	+	+
21.	possibility toswitch the laseron and off	+	+	+
22.	interlock	+	+	+
23.	emergency offswitch	+	+	+
24.	laser warningsignal	+	+	+
25.	spacer	+ (optional)	+	-
26.	number of outputmodes	2	3	2
27.	output modes	continuous wave, serial pulse,	continuous wave, serial pulse,intense super pulse	continuous wave, serial pulse
28.	favorites / nameduser definedprograms	+	+	+
29.	laserperformancetesting	+	N/A	+
30.	electronic keylock	+	N/A	+
31.	calculated anddisplayed energy	+	+	+
32.	displayedtreatment time	+	+	+
33.	wavelengthaiming beam [nm]	650	635 or 650	670
34.	wavelength laserbeam [nm]	810 and 980	800 and / or 970	820 or 850
35.	output power [W]	1 - 7	0.1 - 12	0.1 - 1.44
36.	repetition rate f(Hz)	1 - 50CW	1 - 20 000CWIntense Super Pulse (ISP)	8 - 10 000CW
37.	area output spotsize [cm2]	0.8	1 - 5	0.07 - 31.2
38.	duty cycle [%]	10 - 50	50	90

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Image /page/6/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The word "zimmer" is in a bold, sans-serif font, with a horizontal line above the "z". Below the word "zimmer" is the word "MedizinSysteme" in a smaller, sans-serif font. The logo is in grayscale.

Tel. 0731. 9761-0
Fax 0731. 9761-118

info@zimmer.de
www.zimmer.de

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Image /page/7/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The logo is in a dark gray color. The word "zimmer" is in a bold, sans-serif font, and the words "MedizinSysteme" are in a smaller, lighter font below the word "zimmer."

Tel 0731 9761-0 Fax 0731.9761-118

info@zimmer.de www.zimmer.de

f.) Summary Comparison with predicate devices

The OptonPro shares the same intended use and the same or similar basic characteristics and features as the predicate devices. In addition, any differences in their technological characteristics are explained to demonstrate in this submission that these differences do not raise any new questions of safety and effectiveness.

q.) Non-clinical Tests Performed

Validation documentation, product testing and a comparison of the technical characteristics and features according to relevant standards were provided to demonstrate that OptonPro is as safe and effective in its intended use.

The OptonPro achieves a therapeutic temperature range of 40 – 45°C as accepted by the FDA.

The maximal transition time for reaching this therapeutic temperature range is 5 min.

The therapeutic temperature range was maintained for a recommended treatment time of 10 min.

The temperature measurements were conducted on a few test candidates on different physical locations.

h.) Conclusion Substantial Equivalence

Drawn from the comparison between the predicate devices and the OptonPro devices it demonstrates that the OptonPro device is as safe and effective as the predicate devices and therefore are substantially equivalent to the compared devices on the basis of similarities in operating principles, intended use and functional performance.

Regulation Number and Section

§ 890.5500 Infrared lamp.

(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.