MC1 Plus

• K Number: K161502
• Device Name: MC1 Plus
• Manufacturer: GENERAL PROJECT S.R.L.
• Date Cleared: 2016-08-16 ( 76 days)
• Product Code: IMI
• Regulation Number: 890.5300

Intended Use

The MC1 Plus is indicated for: a) Therapeutic Massager: 1. Provides temporary relief of minor muscle aches and pains; 2. Relieves muscle spasms; 3. Temporarily improves local blood circulation; 4. Temporarily reduces the appearance of cellulite. b) Ultrasonic Diathermy: 1. Relief of pain; 2. Muscle spasms; 3. Joint contractures; 4. NOT for the treatment of malignancies.

Device Description

MC1 Plus is a computerized body massager and ultrasound diathermy system. The MC1 Plus is supplied with two handpieces: one ultrasonic handpiece with two 1 MHz transducers mounted on it and one handpiece for computerized body massager.

Predicate Devices

K091615

Reference Devices

K091615

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a computerized device but does not mention any AI or ML capabilities, focusing instead on standard therapeutic functions and electrical safety testing.

Therapeutic

Yes
The device is indicated for therapeutic uses such as temporary relief of muscle aches and pains, relief of muscle spasms, and pain relief through ultrasonic diathermy.

Diagnostic

No

The provided text indicates the device is used for therapeutic purposes (massaging, pain relief, improving circulation, reducing cellulite, relieving spasms, and joint contractures) and does not mention any diagnostic functions.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the MC1 Plus is supplied with two handpieces, which are hardware components (ultrasonic handpiece and computerized body massager handpiece).

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended uses listed are for therapeutic purposes (muscle aches, spasms, circulation, cellulite, pain relief, joint contractures). These are all related to treating or alleviating physical conditions within the body.
• Device Description: The device is described as a body massager and ultrasound diathermy system, with handpieces for these functions. This aligns with physical therapy and therapeutic devices, not diagnostic testing of samples.
• Lack of IVD Indicators: There is no mention of:
  • Analyzing biological samples (blood, urine, tissue, etc.).
  • Providing information about a patient's health status based on the analysis of these samples.
  • Any diagnostic claims or procedures.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely external and therapeutic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The MC1 Plus is indicated for:

• Therapeutic Massager: a)
  • 1. Provides temporary relief of minor muscle aches and pains;
  • 2. Relieves muscle spasms;
  • 3. Temporarily improves local blood circulation;
  • 4. Temporarily reduces the appearance of cellulite.
• Ultrasonic Diathermy: b)
  • 1. Relief of pain;
  • 2. Muscle spasms;
  • 3. Joint contractures;
  • 4. NOT for the treatment of malignancies.

Product codes

IMI, ISA

Device Description

MC1 Plus is a computerized body massager and ultrasound diathermy system. The MC1 Plus is supplied with two handpieces: one ultrasonic handpiece with two 1 MHz transducers mounted on it and one handpiece for computerized body massager.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The MC1 Plus was tested and found to conform with AAMI/ANSI ES60601-1 for electrical safety, IEC 60601-1-2 for electromagnetic compatibility and IEC 60601-2-5 for electrical safety in ultrasonic physiotherapy equipment. The MC1 was found to conform with these same electrical safety standards. Performance data was presented which showed that the MC1 Plus performed similarly to the previously cleared MC1 in terms of tissue heating. Specifically, testing showed that the MC1 Plus increases tissue temperature as required for ultrasonic diathermy. The two 1 MHz ultrasound transducers can be considered equivalent to the MC1 in terms of heating tissue temperature to at least 40° C. These results are similar to those reported for the MC1.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K091615

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 890.5300 Ultrasonic diathermy.

(a)
Ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.(2)
Classification. Class II (performance standards).(b)
Ultrasonic diathermy for all other uses —(1)Identification. An ultrasonic diathermy for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999, for any ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasonic diathermy described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is simple and recognizable, representing the department's role in public health and human services.

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

August 16, 2016

General Project S.R.L. % Maureen O'Connell President O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, Massachusetts 01864

Re: K161502

Trade/Device Name: MC1 Plus Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic Diathermy Regulatory Class: Class II Product Code: IMI. ISA Dated: July 19, 2016 Received: July 20, 2016

Dear Ms. O'Connell:

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

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

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" (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 [phone] or [phone] or at its Internet address

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

Sincerely yours.

Michael J.Hoffmann -A

• 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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Indications for Use

510(k) Number (if known) K161502

Device Name MC1 Plus

Indications for Use (Describe) The MC1 Plus is indicated for:

• Therapeutic Massager: a)
  • 1. Provides temporary relief of minor muscle aches and pains;
  • 2. Relieves muscle spasms;
  • 3. Temporarily improves local blood circulation;
  • 4. Temporarily reduces the appearance of cellulite.

Ultrasonic Diathermy: b)

• 1. Relief of pain;
• 2. Muscle spasms;
• 3. Joint contractures;
• 4. NOT for the treatment of malignancies.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY K161502 As required by Section 807.82(c)

• 1. Submitter: [807.92 (a)(1)]
     General project s.r.1. Via della Gora 15/19 50025 Montespertoli (Firenze) Italy tel: [phone] fax: [phone] email: [e-mail] internet: www.generalproject.com
• 2. Contact Person: [807.92 (a)(1)] Maureen O'Connell Regulatory Affairs Consultant 5 Timber Lane North Reading, MA 01864 tel: [phone]
• 3. Date Summary Prepared: [807.92 (a)(1)] July 19, 2016

4. Device Names: [807.92 (a)(2)]

Proprietary	MC1 Plus
Common	Diathermy, Ultrasonic, For Use in Applying Therapeutic Deep Heat
and Therapeutic Massager
Classification Name	Prod. Code	CFR
Class II, Ultrasonic Diathermy For Use
In Applying Therapeutic Deep Heat		IMI	890.5300
Class I, Massager, Therapeutic, Electric	ISA	890.5660

5. Reason for Submission of Special 510(k):

Change of User Interface and power output level to comply with IEC 60601-2-5 3td ed. standard

6. Modification to Existing Device (Predicate): [807.92 (a)(3)]

MC1 computerized body massager and ultrasound diathermy device K091615 (Cleared May 6, 2010)

7. Reason for Device Modification: [807.92 (d)]

To better the usability of the device using a wider display and a software with improved graphic. To provide a better maintenance, a more robust software solution and an easier scalability. To comply the user interface to the status of art, in particular to comply standard IEC 60601-2-5 3rd ed.

• 8. Device Description: [807.92 (a)(4)+(6)]
     MC1 Plus is a computerized body massager and ultrasound diathermy system. The MC1 Plus is supplied with two handpieces: one ultrasonic handpiece with two 1 MHz transducers mounted on it and one handpiece for computerized body massager.

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9. Intended Use: [807.92 (a)(5)]

The MC1 Plus is indicated for:

• a) Therapeutic Massager:
  • 1. Provides temporary relief of minor muscle aches and pains;
  • 2. Relieves muscle spasms,
  • 3. Temporarily improves local blood circulation:
  • 4. Temporarily reduces the appearance of cellulite.
• b) Ultrasonic Diathermy:
  • 1. relief of pain;
  • 2. Muscle spasms;
  • 3. Joint contractures;
  • 4. NOT for the treatment of malignancies.

10. Industry Standards: [807.92 (d)]

General Project declares the conformance to the following standards:

AAMI/ANSI ES60601-1, Medical Electrical Equipment-Part 1: General Requirements for Safety, 3rd ed

IEC 60601-1-2, General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests, 3td ed

IEC 62304, Medical Device Software - Software Life Cycle Processes

IEC 60601-2-5, Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment, 3rd ed

11. Information Bearing on the Safety and Effectiveness

The General Project MC1 Plus has the same intended use as MC1 cleared device (K091615). There is no change in materials, classification or labeling. There is no change in the system of control of the device. There are no modifications that have the potential to alter the fundamental scientific technology. The only changes are in the Human Interface and the level of ultrasonic power output. These changes do not affect the safety or effectiveness of the device. Rather, the human interface changes improve the usability of the device using a wider display and a software with a improved graphic and furthermore provide a better maintenance, a more robust software solution and an easier scalability. The maximum ultrasonic power output (now 15 W with max intensity level of 3 W/cm², before 21 W with max intensity level of 7 W/cm²) has changed to comply IEC 60601-2-5 3rd ed. There are no additional characteristics known that should adversely affect the safety and effectiveness of this device. The results of design validation raise no new issues of safety and effectiveness.

12. COMPARISON of DESIGN, SAFETY and EFFECTIVENESS

Parameters	Subject device K161502	Predicate device K091615	Rationale
Manufacturer	General Project	General Project	Same
IFU	a. Therapeutic massager	a. Therapeutic massager	Same
	1. Provides temporary relief	1. Provides temporary relief
	of minor muscle aches and	of minor muscle aches and
	pains	pains
	2. Relieves muscle spasms	2. Relieves muscle spasms
	3. Temporarily improves	3. Temporarily improves
	local blood circulation	local blood circulation
	4. Temporarily reduces the	4. Temporarily reduces the
	appearance of cellulite	appearance of cellulite
	b) ultrasonic diathermy	b) ultrasonic diathermy
	1. Relief of pain	1. Relief of pain
	2. Muscle spasms	2. Muscle spasms
	3. Joint contractures	3. Joint contractures
	4. Not for the treatment of	4. Not for the treatment of
	malignancies	malignancies
Type	Ultrasound and vacuum	Ultrasound and vacuum	Same
	pressure massage	pressure massage
Product code	IMI, ISA	IMI, ISA	Same
Preselected programs	Ultrasound handpiece: 24	Ultrasound handpiece: 24	Same
	programs	programs
	Zonal massage handpiece: 6	Zonal massage handpiece: 6
	programs	programs
Protection grade	IP 20	IP 20	Same
Operating conditions	Temperature: 15 - 40 °C	Temperature: 15 - 40 °C	Same
	(59 - 104 °F)	(59 - 104 °F)
	RH 65% maximum	RH 65% maximum
	Max operative altitude:	Max operative altitude: 2000
	2000 m (6500 ft) above sea	m (6500 ft) above sea level
	level
Storage environmental	Temperature: 0 - 45 °C	Temperature: 0 - 45 °C	Same
conditions	(32 - 113°F)	(32 - 113 °F)
	RH 80% max	RH 80% max
Dimensions	700 x 675 x h1740 mm (28"	560 x 650 x h380 mm	Different, but does not
	x 26.6" x 68.5") with	(22"x25.6"x15") without	adversely impact safety
	articulated arm.	trolley	and effectiveness of the
			subject device
		560 x 650 x h1200 mm
		(22"x25.6"x47.2") with
		trolley
Weight	76 kg (167 lbs) with short	55 kg (121.25 lbs) with	Different, but does not
	arm	trolley	adversely impact safety
			and effectiveness of the
	78 kg (172 lbs) with		subject device
	articulated arm
Material	Baydur, Aluminium,	Baydur, Aluminium,	Same
	SEBS/SEPS Thermoplastic	SEBS/SEPS Thermoplastic
	Polymers	Polymers
Zonal massage handpiece
a. Max attainable	-55kPa	-55kPa	Same
vacuum
b. Suction time	200 - 300ms depending on	200 - 300ms depending on	Same
	the selected program	the selected program
c. Relax time	500 - 1500ms depending on	500 - 1500ms depending on	Same
	the selected program	the selected program
d. Treatment time	4 - 8 mins depending on the	4 - 8 mins depending on the	Same
	selected program	selected program
e. Dimensions of the	42 mm	42 mm	Same
massage head
Ultrasound handpiece
a. Applicator size	double applicator diameter
42 mm each

applicator area 13.8 cm²
each

total active surface 27.7cm² | double applicator diameter 42
mm each

applicator area 13.8 cm² each

total active surface 27.7cm² | Same |
| b. Crystal material | PZT | PZT | Same |
| c. Output mode | Continuous or pulsed
(sinusoidal wave mode) | Continuous or pulsed
(sinusoidal wave mode) | Same |
| d. Ultrasound frequency | 1 MHz (+ 20%) | 1 MHz (+ 20%) | Same |
| e. Modulated frequency | 20 - 60 kHz + 10% | 20 – 60 kHz + 10% | Same |
| f. Ultrasound intensity | 0.5 – 3W/cm² for each
transmitter in continuous
and modulated emission
mode | 1 - 7 W/cm² for each
transmitter in continuous
emission mode

1 - 5 W/cm² for each
transmitter in modulated
emission mode | Different but subject
device has reduced
intensity which does not
adversely impact safety
and effectiveness of the
subject device and
complies with IEC
60601-2-5 |
| g. BNR (Beam non-
uniformity ratio) | ≤ 4:1 | ≤ 4:1 | Same |
| h. ERA (Effective
Radiating Area) | 4.9 cm² | 3 cm² | Different but does not
adversely impact safety
and effectiveness of the
subject device and
complies with IEC
60601-2-5 |
| i. Duty cycle | N/A | N/A | N/A |
| j. Pulse duration | 50 – 8.33 µs | 50 – 8.33 µs | Same |
| k. Pulse frequency | 20 - 60 kHz | 20 – 60 kHz | Same |
| l. Treatment time | 5 – 8 mins depending on
selection, max activation
time 30 mins | 5 – 8 mins depending on
selection, max activation
time 30 mins | Same |
| m. Temporal max power
(if pulsed) (W) | 14.70 | 23.91 ± 20% | Different but subject
device has reduced
temporal max power
(when pulsed) which
does not adversely
impact safety and
effectiveness of the
subject device and
complies with IEC
60601-2-5 |
| n. Temporal max power
(if continuous) (W) | 14.60 | 20.55 ± 20% | Different but subject
device has reduced
temporal max power
(when continuous)
which does not
adversely impact safety
and effectiveness of the
subject device and
complies with IEC
60601-2-5 |
| o. Instantaneous peak
power | N/A | N/A | MC1 Plus ultrasound
emission modality
makes the instantaneous
peak power value
meaningless as it is |
| | | | |
| p. Temporal max
effective intensity
(W/cm2) | 3.00 | 7.97 | equal to the average
value and complies with
IEC 60601-2-5 |
| q. Temporal avg
effective intensity
(W/cm2) | 2.98 without modulation | 6.85 without modulation | The maximum emitted
power has been changed
from 7 W/cm2 to 3
W/cm2 and complies
with IEC 60601-2-5 |
| r. Max suction pressure | N/A | N/A | The average emitted
power has been changed
from 7 W/cm2 to 3
W/cm2 and complies
with IEC 60601-2-5 |
| r. Max suction pressure | N/A | N/A | These values are no
longer meaningful since |
| s. Suction time | N/A | N/A | the machine design had
been modified
eliminating the
vacuum suction from
the ultrasound
handpiece |
| t. Relax time | N/A | N/A | |
| Leakage current | | | |
| a. Ground leakage
current Normal
Condition (NC)
(