The Time Machine Series Lasers Model TTML-8102000 - 810/830 nm is intended for use in temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, temporary increase in local blood circulation and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions.

Device Description

The TTML-8102000 hand held laser device operates in continuous wave mode at a fixed frequency. The Power is operated with lithium batteries. A cap covers the laser aperture and must be removed before treatment. Activating a mechanical button powers on the unit when operating by battery power. When a mechanical switch is pressed a LCD screen illuminates. The device can be operated in either of two modes which are selected by means of a mechanical switch: (1) a timer mode where treatment time is entered by means of a mechanical switch and time is displayed on the LCD screen. The device automatically shuts off when the set time is reached. (2) a manual mode where treatment continues until the device is manually shut off. The unit is powered down by pressing the power button (battery mode). None of these functions are controlled by software. The software controls only the timer and time display. Software is embedded into a single chip circuit which contains the CPU and memory. These chips are used in simple circuits. The device can maintain skin temperature of 40-45℃ for at least 10 minutes based on the study conducted on three live human subject.

AI/ML Overview

The provided text describes the 510(k) premarket notification for "The Time Machine Series Lasers" (Model TTML-8102000). The document outlines the device's indications for use, its comparison to a predicate device, and the testing performed to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the typical sense of quantitative thresholds for clinical performance metrics (like sensitivity, specificity, accuracy for a diagnostic device). Instead, the "acceptance criteria" are implied by the claim of substantial equivalence to a predicate device and adherence to safety and performance standards.

The primary "clinical performance" reported is related to maintaining skin temperature.

Acceptance Criteria (Implied)	Reported Device Performance
Clinical safety and non-harmfulness to end-users (implied by predicate equivalence and safety standards)	The skin temperature study "confirmed that the subject device passes the clinical test and it's safe and non-harmful to the end users."
Maintain skin temperature for therapeutic effect (40-45°C) for a specified duration	The device can maintain skin temperature of 40-45℃ for at least 10 minutes.

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

Sample Size: "three live human subjects"
Data Provenance: The study was conducted on "live human subjects," indicating a prospective human study for this specific aspect of performance. The country of origin is not specified in the provided text.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention the use of experts to establish a "ground truth" for the skin temperature study. The measurement of skin temperature is an objective physiological metric.

4. Adjudication Method for the Test Set

Not applicable, as no subjective interpretation or consensus among experts was required for the objective temperature measurement.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study is not relevant for a therapeutic laser device whose "clinical test" involved objective skin temperature measurement. The document focuses on demonstrating substantial equivalence to a predicate device based on indications for use and technical characteristics, and a small-scale human study for a specific physiological effect.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Not applicable. This device is a therapeutic laser and its performance is assessed by its physical output and direct physiological effect (skin temperature), not by an algorithm's classification or detection capabilities. The embedded software "controls only the timer and time display," and its performance is not evaluated in a standalone manner in the context of this FDA submission.

7. Type of Ground Truth Used

The "ground truth" for the skin temperature study was direct physiological measurement (skin temperature). The goal was to demonstrate that the device achieves and maintains a specific temperature range, not to diagnose a condition against a "true" diagnosis from pathology or expert consensus.

8. Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI that would require a "training set" in the conventional sense. The software's function is limited to controlling the timer and display, which are pre-programmed and do not learn from data.

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

Not applicable, as there is no training set for a machine learning algorithm.

Summary

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

July 8, 2016

Medical Lasers Manufacturer Incorporated % Jigar Shah MDI Consultants Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

Re: K152461

Trade/Device Name: The Time Machine Series Lasers Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: ILY Dated: August 27, 2015 Received: August 28, 2015

Dear Jigar Shah:

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 of medical devicerelated 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.

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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) K152461

Device Name

The Time Machine Series Lasers

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)

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510(k) Summary

The assigned 510(k) number is: K152461

Medical Lasers Manufacturer Inc. - The Time Machine Series Lasers

1. Date Prepared: June 01, 2016
1. Submitter's Name: MEDICAL LASERS MANUFACTURER INC.

and Address 4400 Route 9 South, Suite 1000 Freehold NJ 07728

1. Contact Person: Mr. Bruce Schoengood President TEL: +1- 732-786-8044 Fax: +1-561-293-2700 Email: Bruce@medifirstsolutions.com
1. Device Trade/Proprietary Name:

The Time Machine Series Lasers Model TTML-8102000

Common Name:	Powered Laser Surgical Instrument
Classification Name:	Regulation Number: 21 CFR Part 890.5500Regulation Name: Lamp, Infrared, Therapeutic HeatingRegulatory Class: IIProduct Code: ILY
Classification Panel:	Physical Medicine

5. Predicate Device:

The Time Machine Series Lasers device is substantially equivalent to the Joule 810/940/980 Multi-Platform System by Sciton, Inc. (K122567).

6. Device Description

Medical Lasers Manufacturer, Inc., 4400 Route 9 South, Suite 1000, Freehold NJ 07728 Office: 732-786-8044 Fax: 561-293-2700 Email: Info@mlasers.com

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The device automatically shuts off when the set time is reached. (2) a manual mode where treatment continues until the device is manually shut off. The unit is powered down by pressing the power button (battery mode). None of these functions are controlled by software. The software controls only the timer and time display. Software is embedded into a single chip circuit which contains the CPU and memory. These chips are used in simple circuits. The device can maintain skin temperature of 40-45℃ for at least 10 minutes based on the study conducted on three live human subject.

7. Indications for Use:

The Time Machine Series Lasers Model TTML-8102000 - 810/830 nm is intended for use in temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions.

8. Comparison to the Predicate Device:

Parameters	Subject Device	Predicate Device	SubstantiallyEquivalent(SE)
Name of thedevice	The Time Machine SeriesLasers	Joule 810/940/980Multiplatform System
Indicationsfor Use	Temporary relief of minormuscle and joint pain,stiffness, minor arthritispain, muscle spasm,temporary increase inlocal blood circulationand temporary relaxationof muscles by means oftopical elevated tissuetemperature from infraredspectral emissions.	Temporary relief of minormuscle and joint pain,stiffness, minor arthritispain, muscle spasm,temporary increase inlocal blood circulationand temporary relaxationof muscles by means oftopical elevated tissuetemperature from infraredspectral emissions.	YES
K Number	K152461	K122567

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Wavelength	810 IR/830 IR nm	810/940/980 nm	YES
Fluence	$120 J/cm^2$	$≤ 120 J/cm^2$	YES
PulseDuration	12.5 msec	≤ 2500 msec	YES
Spot Size	3.5 mm	0.6 mm to 7.7 cm²	YES
OutputMode	CW	CW, Pulsed single pulse-operation mode	YES
RepetitionRate	5 HZ	5-15 HZ	YES
Laser Media	Diode-pumped solid stateor Diode Laser	Fibre Optic with handpiece	NO
UserInterface	Push button control or LCDcolor touchscreen	LCD Touchscreen	YES
TreatmentBeamActivation	Tailswitch	Footswitch	NO
Skin Cooling	Air Cooling	Unknown	NO
Hand Held	YES	No	NO

Indications, characteristics, technologies and medical applications of the Time Machine Series Lasers are substantial equivalent to the predicate device. The minor differences between the subject and the predicate device do not affect the safety and effectiveness based on the data generated by performance testing identified below.

9. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Medical Lasers Manufacturer, Inc., 4400 Route 9 South, Suite 1000, Freehold NJ 07728 Office: 732-786-8044 Fax: 561-293-2700 Email: Info@mlasers.com

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Testing information demonstrating safety and effectiveness of the subject device in the intended environment of use is supported by testing that was conducted in accordance with the FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND, which outlines Electrical, Mechanical, Environmental and Performance Requirements.

None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was Medical Lasers Manufacturer Inc.'s conclusion that testing met all relevant requirements of the FDA's November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions".

The following National and International Standards were utilized for testing the subject device:

Performance Standards:

AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012,, c1:2009/(r)2012 and a2:2010/(r)2012 (consolidated text) medical electrical equipment - part 1: general requirements for basic safety and essential performance (iec 60601-1:2005, mod). (General II (ES/EMC)

IEC 60601-1-2 Edition 4.0 2014-02, medical electrical equipment - part 1-2: general requirements for basic safety and essential performance collateral standard: electromagnetic disturbances - requirements and tests. (General II (ES/EMC))

IEC 60601-2-22 Third Edition 2007-05 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

IEC 60825-1 Edition 2.0 2007-03 Safety of laser products - Part 1: Equipment classification, and requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007). Interpretation Sheet 2 (2007)]

10. Discussion of Clinical Tests Performed:

The skin temperature study has been conducted on three live human subjects to show that the skin temperature was maintained within 40 – 45° C for at least 10 minutes.

The results confirmed that the subject device passes the clinical test and it's safe and non-harmful to the end users.

Medical Lasers Manufacturer, Inc., 4400 Route 9 South, Suite 1000, Freehold NJ 07728 Office: 732-786-8044 Fax: 561-293-2700 Email: Info@mlasers.com

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11. Conclusions:

Conclusions drawn from the performance, bench, non-clinical and clinical tests demonstrate that the subject device is as safe, effective and performs as well as the predicate device.

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.