(141 days)
No
The description mentions a microprocessor and software for control and user interface, but there is no mention of AI, ML, or related concepts like learning, adaptation, or complex data analysis beyond basic control functions.
Yes
The device description and intended use explicitly state therapeutic applications such as "pain relief," "reduction of muscle spasm," "joint contractures," and "symptomatic relief of chronic intractable pain," classifying it as a therapeutic device.
No
The device is described as a "Pain Relief Device" that provides therapeutic ultrasound and transcutaneous electrical nerve stimulation for conditions like pain relief, muscle spasm reduction, and joint contractures. Its intended use is therapeutic rather than diagnostic.
No
The device description explicitly lists hardware components such as a system console including control electronics, a control and display panel, and various accessories (AC-DC Adaptor, Electrodes, Leads). It is a physical device that delivers therapeutic ultrasound and electrical stimulation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses listed are for therapeutic purposes (pain relief, muscle spasm reduction, joint contractures) using physical modalities (ultrasound and electrical stimulation). IVDs are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a device that delivers energy (ultrasound and electrical pulses) to the body for therapeutic effect. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD-related information: The document does not mention any aspects typically associated with IVDs, such as sample types, reagents, analytical methods, or diagnostic outputs.
The device described is a therapeutic medical device, specifically a combination unit for physical therapy.
N/A
Intended Use / Indications for Use
Proposed Device Indications for Use:
Therapeutic Ultrasound
- Pain relief
- Reduction of muscle spasm
- Joint contractures
Transcutaneous Electrical Nerve Stimulation
- Symptomatic relief of chronic intractable pain
- Post-traumatic pain
- Post-surgical pain
Product codes
IMG, GZJ
Device Description
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.
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 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:
- 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 "
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 estae |
| xilixiaobaimang Nanshan district | |
| Shenzhen, CHINA 518108 | |
| Telephone: | +86(755) 27652471 |
| Fax: | +86(755) 27652674 |
| Contact: | Zhigang Zhao |
| Date Prepared: | Aug, 8 2009 |
Section 05-Page 1 of 5
1
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
2
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
-
- Pain relief
-
- Reduction of muscle spasm
-
- Joint contractures
Transcutaneous Electrical Nerve Stimulation
-
- Symptomatic relief of chronic intractable pain
-
- Post-traumatic pain
-
- 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.
3
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 | 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 | ||
| 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 | |
| 60601-1-2, IEC 60601-2-10, MDD | |||
| 93/42/EEC, Annex II | ISO14971, UL2601-1, IEC 60601-1, | ||
| IEC 60601-1-2, IEC 60601-2-10, MDD | |||
| 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
4
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.
5
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.
6
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
7
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
-
- Reduction of muscle spasm
- Joint contractures 3.
Transcutaneous Electrical Nerve Stimulation
-
- Symptomatic relief of chronic intractable pain
-
- Post-traumatic pain
-
- 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