CT2011 SONICSTIMU PAIN RELIEF DEVICE by SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the CT2011 SonicStimu Pain Relief Device:

This submission is a 510(k) Pre-Market Notification, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than proving independent efficacy or performance against specific clinical acceptance criteria. Therefore, the information typically found in efficacy studies (like clinical acceptance criteria or detailed performance metrics against a ground truth) is not present for the proposed device itself in this document.

The "acceptance criteria" discussed implicitly refer to regulatory compliance and the characteristics used to establish substantial equivalence with the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for substantial equivalence based on non-clinical testing, there isn't a table of specific clinical acceptance criteria and corresponding performance metrics for the CT2011 SonicStimu Pain Relief Device. Instead, a comparison to the predicate device (Sonicator Plus 940) is provided, and the "acceptance criteria" are implied to be that the proposed device performs at least as well as, or is technologically similar enough to, the predicate device such that it raises no new questions of safety or effectiveness.

Below is a table summarizing the technological characteristics compared from the provided text, which served as the basis for determining substantial equivalence rather than fulfilling specific performance acceptance criteria:

Characteristic	Acceptance/Comparison Point (Predicate: Sonicator Plus 940)	Reported Device Performance (CT2011 SonicStimu)
Intended Use	Pain relief, muscle spasm reduction, joint contractures; symptomatic relief of chronic intractable pain, post-traumatic, post-surgical pain	Same
Fundamental Technology	Ultrasound and Transcutaneous Electrical Nerve Stimulation (TENS)	Same
Power Source	AC Line	DC 15V/1A
Line Current Isolation	Reinforced insulation	Reinforced insulation
Patient Leakage Current (Normal Condition)	>50 µA (Max)	<1 µA (Max)
Patient Leakage Current (Single Fault Condition)	>50 µA (Max)	>50 µA (Max)
Number of Output Modes	8	15
Number of Output Channels	4 (1&2 or 3&4 synchronous/alternating)	1
Current/Voltage Control Type	Constant Current	Constant Voltage
Software/Firmware/Microprocessor Control	Yes	Yes
Automatic Overload Trip	Yes	Yes
Automatic Over Current Trip	Yes	Yes
Automatic No Load Contact Trip	Yes	Yes
Automatic Shut off	Yes	No
Patient Override Control	No	No
Indicator Display (On/Off Status)	Yes	Yes
Indicator Display (Voltage/Current Level)	Yes	Yes
Indicator Display (Low Battery)	N/A	N/A
Timer Display	0-60 minutes	0-30 minutes
Compliance with Standards	ISO14971, UL2601-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, MDD 93/42/EEC, Annex II	ISO14971, UL60601-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, MDD 93/42/EEC, Annex II
Compliance with 21 CFR 898	Yes	Yes
Weight	11 lbs.	0.84 lbs.
Dimensions (H x W x L)	4.9 x 13.6 x 10.5 in.	14.1 x 2.5 x 3.8 in.

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

The document explicitly states: "The CT2011 SonicStimu Pain Relief Device did not conduct, nor rely upon, clinical tests to determine substantial equivalence." (Section 7 and 8).

Therefore, there was no "test set" of clinical data, no sample size for such a set, and no data provenance (e.g., country of origin, retrospective/prospective). The evaluation was entirely non-clinical, based on engineering design validation and compliance with voluntary standards.

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

As no clinical test set was used, no experts were involved in establishing ground truth for a clinical test set. The validation was based on compliance with standards and internal design requirements.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC study was done. The submission explicitly states "Discussion of Clinical Tests Performed: Not applicable."

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

While the device itself is a "standalone" pain relief device (not an algorithm), the context of this question usually applies to AI/software. Since this device is a physical medical device (ultrasound and TENS stimulator), the concept of "standalone algorithm performance" doesn't directly apply. However, its performance claims are based on its physical characteristics and electrical/ultrasonic output, validated through non-clinical bench testing.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is effectively compliance with recognized electrical, mechanical, and safety standards (e.g., IEC 60601 series, ISO 14971) and successful completion of bench testing to validate design requirements. Biocompatibility was also assessed through testing of materials. There is no clinical ground truth (like pathology, expert consensus, or outcomes data) because no clinical studies were performed.

8. The Sample Size for the Training Set

Not applicable, as there was no "training set" in the context of collecting clinical or diagnostic data. The device's design and functionality are based on engineering principles and established medical device standards, not machine learning or AI.

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

Not applicable, as there was no "training set." The device's design and manufacturing are based on established engineering practices, safety standards, and the predicate device's characteristics.

Summary

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K092627

ﺎ

JAN 1 4 2010

Caretalk®

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

)

510(k) SUMMARY

CT2011 SonicStimu, K (

Submitter's Name:	Shenzhen Dongdixin Technology Co., Ltd
Address:	No.3bldg. xiliyangguang industrial estaexilixiaobaimang Nanshan districtShenzhen, CHINA 518108
Telephone:	+86(755) 27652471
Fax:	+86(755) 27652674
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.

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
1. Reduction of muscle spasm
1. Joint contractures

Transcutaneous Electrical Nerve Stimulation

1. Symptomatic relief of chronic intractable pain
1. Post-traumatic pain
1. 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.,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/MicroprocessorControl	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, IEC60601-1-2, IEC 60601-2-10, MDD93/42/EEC, Annex II	ISO14971, UL2601-1, IEC 60601-1,IEC 60601-1-2, IEC 60601-2-10, MDD93/42/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 (800) 638-2041 or (301) 796-7100 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
1. Reduction of muscle spasm
Joint contractures 3.

Transcutaneous Electrical Nerve Stimulation

1. Symptomatic relief of chronic intractable pain
1. Post-traumatic pain
1. 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

Regulation Number and Section

§ 890.5860 Ultrasound and muscle stimulator.

(a)
Ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions —(1)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.(2)
Classification. Class II (performance standards).(b)
Ultrasound and muscle stimulator for all other uses —(1)Identification. An ultrasound and muscle stimulator 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 applies to the body electrical currents and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues and the stimulation or relaxation of muscles 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 ultrasound and muscle stimulator 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 ultrasound and muscle stimulator described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasound and muscle stimulator described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.