MC1 Plus

K161502 · General Project S.R.L. · IMI · Aug 16, 2016 · Physical Medicine

Device Facts

• Record ID: K161502
• Device Name: MC1 Plus
• Applicant: General Project S.R.L.
• Product Code: IMI · Physical Medicine
• Decision Date: Aug 16, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.5300
• Device Class: Class 2
• Attributes: Therapeutic

Indications for 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 Story

MC1 Plus is a computerized body massager and ultrasound diathermy system. It utilizes two handpieces: one ultrasonic handpiece with two 1 MHz PZT transducers and one computerized body massager handpiece. The device is operated by a clinician in a clinical setting. The system provides therapeutic deep heat and massage. The clinician selects from pre-programmed settings (24 ultrasound, 6 massage) via a wider display and updated software interface. The device transforms electrical energy into ultrasonic waves or vacuum pressure to treat muscle/joint conditions. The output provides tissue heating (at least 40°C) and mechanical massage, which aids in pain relief, spasm reduction, and circulation improvement. The device is designed for improved usability, maintenance, and scalability compared to its predecessor.

Clinical Evidence

Bench testing only. Performance data demonstrated that the MC1 Plus conforms to AAMI/ANSI ES60601-1 (electrical safety), IEC 60601-1-2 (EMC), and IEC 60601-2-5 (ultrasonic physiotherapy). Comparative bench testing showed the MC1 Plus achieves tissue heating to at least 40°C, similar to the predicate device.

Technological Characteristics

Materials: Baydur, Aluminium, SEBS/SEPS Thermoplastic Polymers. Sensing/Actuation: 1 MHz PZT transducers for ultrasound; vacuum pressure for massage. Energy: Electrical. Connectivity: Standalone. Sterilization: Not specified. Software: IEC 62304 compliant. Dimensions: 700 x 675 x 1740 mm. Compliance: IEC 60601-2-5 3rd ed, AAMI/ANSI ES60601-1, IEC 60601-1-2.

Indications for Use

Indicated for patients requiring temporary relief of minor muscle aches/pains, muscle spasms, improved local blood circulation, cellulite reduction, or treatment for pain and joint contractures via ultrasonic diathermy. Contraindicated for treatment of malignancies.

Regulatory Classification

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.

Predicate Devices

• MC1 computerized body massager and ultrasound diathermy device (K091615)

Submission Summary (Full Text)

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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<br>and Therapeutic Massager | | |
| Classification Name | Prod. Code | CFR | |
| Class II, Ultrasonic Diathermy For Use<br>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<br>42 mm each<br><br>applicator area 13.8 cm²<br>each<br><br>total active surface 27.7cm² | double applicator diameter 42<br>mm each<br><br>applicator area 13.8 cm² each<br><br>total active surface 27.7cm² | Same |
| b. Crystal material | PZT | PZT | Same |
| c. Output mode | Continuous or pulsed<br>(sinusoidal wave mode) | Continuous or pulsed<br>(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<br>transmitter in continuous<br>and modulated emission<br>mode | 1 - 7 W/cm² for each<br>transmitter in continuous<br>emission mode<br><br>1 - 5 W/cm² for each<br>transmitter in modulated<br>emission mode | Different but subject<br>device has reduced<br>intensity which does not<br>adversely impact safety<br>and effectiveness of the<br>subject device and<br>complies with IEC<br>60601-2-5 |
| g. BNR (Beam non-<br>uniformity ratio) | ≤ 4:1 | ≤ 4:1 | Same |
| h. ERA (Effective<br>Radiating Area) | 4.9 cm² | 3 cm² | Different but does not<br>adversely impact safety<br>and effectiveness of the<br>subject device and<br>complies with IEC<br>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<br>selection, max activation<br>time 30 mins | 5 – 8 mins depending on<br>selection, max activation<br>time 30 mins | Same |
| m. Temporal max power<br>(if pulsed) (W) | 14.70 | 23.91 ± 20% | Different but subject<br>device has reduced<br>temporal max power<br>(when pulsed) which<br>does not adversely<br>impact safety and<br>effectiveness of the<br>subject device and<br>complies with IEC<br>60601-2-5 |
| n. Temporal max power<br>(if continuous) (W) | 14.60 | 20.55 ± 20% | Different but subject<br>device has reduced<br>temporal max power<br>(when continuous)<br>which does not<br>adversely impact safety<br>and effectiveness of the<br>subject device and<br>complies with IEC<br>60601-2-5 |
| o. Instantaneous peak<br>power | N/A | N/A | MC1 Plus ultrasound<br>emission modality<br>makes the instantaneous<br>peak power value<br>meaningless as it is |
| | | | |
| p. Temporal max<br>effective intensity<br>(W/cm2) | 3.00 | 7.97 | equal to the average<br>value and complies with<br>IEC 60601-2-5 |
| q. Temporal avg<br>effective intensity<br>(W/cm2) | 2.98 without modulation | 6.85 without modulation | The maximum emitted<br>power has been changed<br>from 7 W/cm2 to 3<br>W/cm2 and complies<br>with IEC 60601-2-5 |
| r. Max suction pressure | N/A | N/A | The average emitted<br>power has been changed<br>from 7 W/cm2 to 3<br>W/cm2 and complies<br>with IEC 60601-2-5 |
| r. Max suction pressure | N/A | N/A | These values are no<br>longer meaningful since |
| s. Suction time | N/A | N/A | the machine design had<br>been modified<br>eliminating the<br>vacuum suction from<br>the ultrasound<br>handpiece |
| t. Relax time | N/A | N/A | |
| Leakage current | | | |
| a. Ground leakage<br>current Normal<br>Condition (NC)<br>(<0.500 mA) | 0.085 | 0.065 | Similar |
| b. Ground leakage<br>current Single Fault<br>Condition (SFC)<br>(<1.0 mA) | 0.107 | 0.102 | Similar |
| c. Patient leakage current<br>NC DC<br>(<0.01 mA) | <0.001 | <0.001 | Same |
| d. Patient leakage current<br>NC AC<br>(<0.10 mA) | <0.01 | <0.001 | Patient leakage current<br>of subject device is 10x<br>higher but still under<br>the acceptable range as<br>per IEC 60601-1 and<br>does not adversely<br>affect the safety and<br>effectiveness of the<br>subject device |
| e. Patient leakage current<br>SFC DC<br>(<0.05 mA) | <0.001 | <0.001 | Same |
| f. Patient leakage current<br>SFC AC<br>(<0.50 mA) | <0.01 | <0.001 | Patient leakage current<br>of subject device is 10x<br>higher but still under<br>the acceptable range as<br>per IEC 60601-1 and<br>does not adversely<br>affect the safety and<br>effectiveness of the<br>subject device |

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# 13. Substantial Equivalence

The MC1 Plus is substantially equivalent to the MC1 cleared in K091615. The MC1 Plus has the same indications for use as the General Project MC1. Regarding technological characteristics, the MC1 Plus includes both massage and ultrasound

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diathermy handpieces as do the General Project MC1. The maximum ultrasound intensity has been reduced from 7 W/cm to 3 W/cm to comply standard IEC 60601-2-5 3"d ed; the maximum ultrasonic power output is 15 W, while in MC1 device was 21 W, the ERA is 4.9 cm2 instead of 3 cm2.

Differences between the MC1 Plus and the MC1 device were evaluated in performance and effectiveness testing and the MC1 Plus was found to be substantially equivalent to the MC1 device.

# 14. Performance Data

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.

#### 15. Conclusion

The MC1 Plus is substantially equivalent to the MC1 device in terms of indications for use, electrical safety testing and performance testing which indicated that the MC1 Plus and the MC1 were substantially equivalent in terms of tissue heating.