CT2011 SONICSTIMU PAIN RELIEF DEVICE

K092627 · Shenzhen Dongdixin Technology Co., Ltd. · IMG · Jan 14, 2010 · Physical Medicine

Device Facts

• Record ID: K092627
• Device Name: CT2011 SONICSTIMU PAIN RELIEF DEVICE
• Applicant: Shenzhen Dongdixin Technology Co., Ltd.
• Product Code: IMG · Physical Medicine
• Decision Date: Jan 14, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Therapeutic Ultrasound 1. Pain relief 2. Reduction of muscle spasm 3. Joint contractures Transcutaneous Electrical Nerve Stimulation 1. Symptomatic relief of chronic intractable pain 2. Post-traumatic pain 3. Post-surgical pain

Device Story

CT2011 SonicStimu is a single-channel combination device for therapeutic ultrasound and TENS. System includes console, control/display panel, AC-DC adaptor, and electrodes. Microprocessor generates pro-modulated low-frequency monophasic electrical pulses and 1 MHz ultrasound waves. User interface features LCD, control buttons, and audio feedback for adjusting signal intensities and operation modes. Device used for electrical stimulation, ultrasound, or combination therapy. Operator adjusts power settings via interface. Output provides therapeutic stimulation and ultrasound energy to target tissues. Benefits include pain management and muscle spasm reduction.

Clinical Evidence

Bench testing only. No clinical data was conducted or relied upon for this determination.

Technological Characteristics

System includes microprocessor-controlled console, LCD, and audio feedback. Ultrasound transducer uses aluminum; shell uses ABS plastic. Operates at 1 MHz ultrasound frequency. Electrical output: constant voltage, pro-modulated low-frequency monophasic pulses. Powered by 15V/1A DC. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, and IEC 60601-2-5. Dimensions: 14.1 x 2.5 x 3.8 inches. Weight: 0.84 lbs.

Indications for Use

Indicated for patients requiring pain relief, reduction of muscle spasm, or treatment of joint contractures via therapeutic ultrasound, and for patients requiring symptomatic relief of chronic intractable pain, post-traumatic pain, or post-surgical pain via transcutaneous electrical nerve stimulation (TENS).

Regulatory Classification

Identification

An ultrasound and muscle stimulator 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. The device also passes electrical currents through the body area to stimulate or relax muscles.

Predicate Devices

• Sonicator Plus 940, ME940 (K071137)

Submission Summary (Full Text)

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K092627

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JAN 1 4 2010

Caretalk®

File No: WMI-04-CT2011-FDA-05 Version: 1.1

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## 510(k) SUMMARY

CT2011 SonicStimu, K (

| Submitter's Name: | Shenzhen Dongdixin Technology Co., Ltd |
|-------------------|--------------------------------------------------------------------------------------------------------|
| Address: | No.3bldg. xiliyangguang industrial estae<br>xilixiaobaimang Nanshan district<br>Shenzhen, CHINA 518108 |
| Telephone: | [phone] |
| Fax: | [phone] |
| Contact: | Zhigang Zhao |
| Date Prepared: | Aug, 8 2009 |

Section 05-Page 1 of 5

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File No: WMI-04-CT2011-FDA-05 Version: 1.1

#### 1. Proposed Device:

Trade Name: CT2011 SonicStimu Pain Relief Device Classification Name: Ultrasound and Muscle Stimulator 21 CFR 890.5860 Class II Product Code: IMG, GZJ

#### Predicate Device: 2.

21 CFR 890.5860 Product Code: IMG, GZJ, LIH Device Class: II Legally Marketed Device: Sonicator Plus 940, ME940 Manufacturer: Mettler Electronics Corp 510(k) Number: K071137

#### 3. Description of Proposed Device:

The CT2011 SonicStimu Pain Relief Device is comprised of following main components:

- A system console including software and control electronics;
- A control and display panel;
- Device accessories including AC-DC Adaptor, Electrode 40*90mm, Lead for adapter, Lead for electrical.

The CT2011 is a single channel combination unit for therapeutic ultrasonic and transcutaneous electrical nerve stimulation. The microprocessor in CT2011 provides pro-modulated low frequency and monophasic electrical pulse waveforms with enhanced reliability and ease of using of the device. In the same time it offers I MHz ultrasound treatment also.

The user interface friendly comprises keys, LCD and audio feedback. The LCD provides operator information about operation mode and signal intensities. The user through control buttons to make adjusting power for ultrasound and stimulation. The CT2011 can be used as electrical stimulation or ultrasound therapeutic equipment separately or combination for both.

Section 05-Page 2 of 5

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### File No: WMI-04-CT2011-FDA-05 Version: 1.1

### Proposed Device Intended Use Statement: 4.

Device Name: CT2011 SonicStimu Pain Relief Device

## Proposed Device Indications for Use:

Therapeutic Ultrasound

- 1. Pain relief
- 2. Reduction of muscle spasm
- 3. Joint contractures

## Transcutaneous Electrical Nerve Stimulation

- 1. Symptomatic relief of chronic intractable pain
- 2. Post-traumatic pain
- 3. Post-surgical pain

#### Biocompatibility Certification: 5.

Electrodes to be provided with this device are from the manufacturer Top-Rank Health Care Equipment Co., Ltd (K070612) who submitted in 2007.

The shell of device is used ABS material; this material has passed Biocompatibility testing in Jiangsu TUV Product Service Ltd. Shanghai Branch. Identification No: 080960.

Ultrasound transducer attached to a metal surface and patient contact through the metal, this material is aluminum that passed biocompatibility testing in School of Radiation Medicine and Public Health Soochow University. The testing report No: SRPSU-2008-0544, SRPSU-2008-0545, SRPSU-2008-0546,

### Technological Characteristics and Substantial Equivalence 6.

Both the CT2011 SonicStimu Pain Relief Device and the Predicate device Stimulator. have the same intended use and fundamental technology under the same product code. A side-by-side comparison of the CT2011 SonicStimu Pain Relief Device and the cited predicate devices is included in the 510(k) submission. The CT2011 SonicStimu Pain Relief Device is substantially equivalent to the technological features as the predicate devices.

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### File No: WMI-04-CT2011-FDA-05 Version: 1.1

| 1 | 510K# | K | K071137 |
|----|---------------------------------------------|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| 2 | Device Name | CT2011 | Sonicator Plus940 |
| 3 | Manufacturer | Shenzhen Dongdixin Technology Co.,<br>Ltd. | Mettler Electronics |
| 4 | Power Source | DC 15V/1A | AC Line |
| | -Method of Line current isolation | Reinforced insulation | Reinforced insulation |
| | - Patient Leakage Current (μA) | | |
| | -Normal condition | <1 | >50 |
| | -Single fault condition | >50 | >50 |
| 5 | Number of Output Modes | 15 | 8 |
| 6 | Number of Output Channels | 1 | 4 |
| | Synchronous Or Alternating | N/A | 1&2 or 3&4 |
| 7 | Constant Current or Constant Voltage | Constant Voltage | Constant Current |
| 8 | Software/Firmware/Microprocessor<br>Control | Yes | Yes |
| 9 | Automatic Overload Trip | Yes | Yes |
| | Automatic Over Current Trip | Yes | Yes |
| 10 | Automatic No Load contact Trip | Yes | Yes |
| 11 | Automatic Shut off | No | Yes |
| 12 | Patient Override Control? | No | No |
| 13 | Indicator Display | | |
| | -On/Off Status | Yes | Yes |
| | -Voltage/Current Level? | Yes | Yes |
| | -Low Battery indicator | N/A | N/A |
| 14 | Timer Display | 0-30 minutes | 0-60 minutes |
| 15 | Standards | ISO14971, UL60601-1, IEC 60601-1, IEC<br>60601-1-2, IEC 60601-2-10, MDD<br>93/42/EEC, Annex II | ISO14971, UL2601-1, IEC 60601-1,<br>IEC 60601-1-2, IEC 60601-2-10, MDD<br>93/42/EEC, Annex II |
| 16 | Compliance with 21 CFR 898 | Yes | Yes |
| 17 | Weight (lbs.) | 0.84 | 11 |
| 18 | Dimensions (in.) H x W x L | 14.1x2.5x3.8 | 4.9x13.6x10.5 |

### Basic technological characteristics, new device vs. Predicate device

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

The CT2011 SonicStimu Pain Relief Device did not conduct, nor rely upon, clinical tests to determine substantial equivalence. Nonclinical testing was performed in order to validate the design according with the company's specified design requirements, and to assure conformance with the following voluntary design standards:

Section 05-Page 4 of 5

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File No: WMI-04-CT2011-FDA-05 Version: 1.1

- IEC 60601-1 "Medical electrical equipment Part 1: General requirements for safety". A
- A IEC 60601-1-2 "Medical electrical equipment - Part 1-2: General requirements for safety -Collateral Standard"
- ) IEC 60601-2-10 "Medical electrical equipment - Part 2: Particular requirements for the safety of nerve and muscle stimulators"
- ♪ IEC 60601-2-5 "Medical electrical equipment - Particular requirements for the safety of ultrasonic physiotherapy equipment ED "

#### Discussion of Clinical Tests Performed: 8.

Not applicable

#### 9. Conclusions:

The CT2011 SonicStimu Pain Relief Device has the same intended use and similar characteristics as the predicate device, the Sonicator Plus 940, Model ME940 device. Moreover, bench testing, safety report and Risk Analysis Report documentation supplied in this submission demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. In the other words, those engineering difference do not affect the intended use or alter the fundamental scientific technology of the device. Thus, The CT2011 SonicStimu Pain Relief Device is substantially equivalent to the predicate device.

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Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of a bird-like figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

JAN 1 4 2010

Shenzhen Dongdixin Technology Co., Ltd % Mr. Zhigang Zhao No. 3 Bldg. Xiliyangguang Industrial Estate Xilixiaobaimang Nanshan District Shenzhen, CN-44, Guangdong Province People's Republic of China 518108

Re: K092627

Trade/Device Name: CT2011 SonicStimu Pain Relief Device Regulation Number: 21 CFR 890.5860 Regulation Name: Ultrasound and muscle stimulator. Regulatory Class: Class II Product Code: IMG, GZJ Dated: January 8, 2010 Received: January 8, 2010

## Dear Mr. Zhao:

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. Ilsting 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.

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Page 2- Mr. Zhigang Zhao

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
For
Mark N. Malkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic. and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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File No: WMI-04-CT2011-FDA-04 Version: 1.1

## Indications for Use Statement

510(k) Number (

):

Device Name: CT2011 SonicStimu Pain Relief Device

## Indications for Use:

Therapeutic Ultrasound

- 】. Pain relief
- 2. Reduction of muscle spasm
- Joint contractures 3.

### Transcutaneous Electrical Nerve Stimulation

- 1. Symptomatic relief of chronic intractable pain
- 2. Post-traumatic pain
- 3. Post-surgical pain

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

WilliAM R. CARY FOR M. MELKERSON

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092627

Section 04 -Page 1 of 1