(155 days)
No
The description focuses on electrical stimulation modes and basic device functionality, with no mention of AI/ML terms or capabilities. The performance studies focus on software lifecycle processes and validation against design requirements, not AI/ML model performance.
Yes.
The device is specifically designed to relieve symptoms associated with muscle spasm, treat TMJ dysfunction, increase blood flow, and maintain or increase mandibular range of motion, all of which are therapeutic applications.
No
The device is described as a "current stimulation device with Therapeutic Electro Muscle Stimulator function" intended to "relieve symptoms," "treat TMJ dysfunction," "muscle re-education," "increasing blood flow," and "maintain or increase mandibular range of motion." These are therapeutic functions, not diagnostic ones. There is no mention of the device being used to identify or characterize a disease or condition.
No
The device description explicitly states it is a "current stimulation device" with a "main body" and "electrode" that supplies current to the user. It also mentions a "built-in rechargeable lithium battery" for power. These are all hardware components, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed (relieving muscle spasm, treating TMJ dysfunction, muscle re-education, increasing blood flow, maintaining mandibular range of motion) are all related to therapeutic treatment applied directly to the patient's body.
- Device Description: The device is described as a "current stimulation device" that applies electrical current to the user through electrodes. This is a form of physical therapy or electrotherapy.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, or disease. This device does not perform any such analysis of biological samples.
The device's function and intended use clearly place it in the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- To relieve symptoms associated with muscle spasm, to treat temporomandibular joint (TMJ) dysfunction and associated pain
- Muscle re-education
- Increasing blood flow
- Maintain or increase mandibular range of motion
Product codes
NUW
Device Description
This device is a current stimulation device with Therapeutic Electro Muscle Stimulator function. Power is supplied by the built-in rechargeable lithium batter. The stimulation current generated by the output circuit of the main body is supplied to the user through the electrode to realize current stimulation. The device is equipped with PAIN mode and MCR mode. Each CH can output independently and be adjusted. If it outputs in CARE mode, it can be used for both outputs at the same time.
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
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Non-clinical verification and validation testing was conducted on D function device.
The verification results demonstrate that the proposed device complies with the standard, IEC62304:2006/ Amd.1: 2015 Medical device software - Software life cycle processes. Additionally, the proposed device meets its design requirements in accordance with the requirements of FDA's guidance for the Content of Premarket Submissions for Software.
The validation results demonstrate that the software specifications conform to user needs and that the particular requiremented through the proposed device can be consistently fulfilled. In addition, the proposed validation plan, procedure, testing and result provides evidence that all requirements have been implemented correctly and completely and is traceable to system requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the name. The text reads "U.S. FOOD & DRUG ADMINISTRATION".
May 5, 2021
Ito Co., Ltd. Takeshi Kobayashi Manager 3-1-8 Sakae-cho Kawaguchi-shi, Saitama 332-0017 Japan
Re: K203525
Trade/Device Name: D function Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NUW Dated: April 2, 2021 Received: April 5, 2021
Dear Takeshi Kobayashi:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Michael Adjodha Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K203525
Device Name D function
Indications for Use (Describe)
- To relieve symptoms associated with muscle spasm, to treat temporomandibular joint (TMJ) dysfunction and associated pain
ssociated pain
2) Muscle re-educatio
-
Muscle re-education 3) Increasing blood flow
-
Maintain or increase mandibular range of motion
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Exemption Under Part 677.904: Category B | One-Time Activity Under 677.904: Category C |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
14.80
established in 1916
3-1-8, SAKAE-CHO, KAWAGUCHI-SHI, SAITAMA 332-0017 JAPAN
TEL: +81-48-252-5015 FAX: +81-48-254-1041
510(k) Summary (K203525)
D function
SUBMITTER I. ITO CO., LTD. 3-1-8, SAKAE-CHO, KAWAGUCHI-SHI, SAITAMA 332-0017 JAPAN
TEL: +81-48-252-5015 FAX: +81-48-254-1041
Contact Person: Takeshi Kobayashi Date Prepared: 05/04/2021
II. DEVICE
| Name of Device: | D function |
|---|---|
| Common name: | Stimulator, Muscle, Powered, Dental |
| Regulation Number: | 890.5850 |
| Classification Name: | Stimulator, Muscle, Powered, Dental |
| Regulatory Class: | II |
| Product Code: | NUW |
III. PREDICATE DEVICE PRIMARY PREDICATE DEVICE: MODEL J-5 MVO-MONITOR, K031998 REFERENCE DEVICE: TRIO 300, K990787
IV. DEVICE DESCRIPTION
This device is a current stimulation device with Therapeutic Electro Muscle Stimulator function. Power is supplied by the built-in rechargeable lithium batter. The stimulation current generated by the output circuit of the main body is supplied to the user through the electrode to realize current stimulation. The device is equipped with PAIN mode and MCR mode. Each CH can output independently and be adjusted. If it outputs in CARE mode, it can be used for both outputs at the same time.
4
1180
established in 1916
3-1-8, SAKAE-CHO, KAWAGUCHI-SHI, SAITAMA 332-0017 JAPAN
TEL: +81-48-252-5015 FAX: +81-48-254-1041
V. INDICATION FOR USE
- To relieve symptoms associated with muscle spasm, to treat temporomandibular joint (TMJ) dysfunction and
associated pain
-
Muscle re-education
-
Increasing blood flow
-
Maintain or increase mandibular range of motion
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The legally marketed predicate device and the legally marketed reference device were selected for comparison to the D function, regarding substantial equivalence.
The main different specifications between the proposed device and the proposed device are described as below;
| Proposed Device | Predicate Device | Differences | |
|---|---|---|---|
| Pulse Width | PAIN: 150 us | ||
| CARE: 488 us | |||
| MCR: 150 ms | 488 us | The pulse width of MCR mode of the | |
| proposed device is longer than the pulse | |||
| width of the predicate device. | |||
| Output | |||
| Frequency (Hz) | PAIN: 200 | ||
| CARE: 0.67 | |||
| MCR: 400 | 0.67 | The frequency of the PAIN mode and MCR | |
| mode of the proposed device are higher | |||
| than the frequency of the predicate device. | |||
| Output Current | PAIN: 80 mA | ||
| CARE: 24 mA | |||
| MCR: 750 µA | -24 mA | The current of PAIN mode of the proposed | |
| device is higher than the output current of | |||
| the predicate device. |
As shown in the table above, since the specifications of the proposed device and the predicate device are different, the reference device including fully specification ranges of the proposed device was indicated to support the substantial equivalence.
The proposed device is substantial equivalent to the predicate device, when each mode of the proposed device are used for the equivalent intended use of the predicate device or reference device, corresponding to intended use of each modes.
5
伊藤超短波株式会社 MANUFACTURERS & EXPORTERS
ITOco.,LTD.
established in 1916
3-1-8, SAKAE-CHO, KAWAGUCHI-SHI, SAITAMA 332-0017 JAPAN
TEL: +81-48-252-5015 FAX: +81-48-254-1041
| Feature/Description | Proposed Device | Primary Predicate Device | Reference Device |
|---|---|---|---|
| Model Number | D function | Model J-5 Myo-Monitor | TRIO 300 |
| Manufacturer | ITO CO., LTD. | Myotronics-Noromed, Inc. | ITO CO., LTD. |
| Regulatory Background | |||
| FDA 510(k) Number | K203525 | K031998 | K990787 |
| Device Type | Stimulator, Muscle, Powered, Dental | Stimulator, Muscle, Powered, Dental | Stimulator, Muscle, Powered |
| Stimulator, Nerve, Transcutaneous, For Pain | |||
| Relief | |||
| FDA Product Code | NUW | NUW | IPF, GZJ |
| FDA Regulatory Class | II | II | II |
| FDA Authorized Use | Prescription Use | Prescription Use | Prescription Use |
| Patient Therapy | |||
| Indications for Use | 1) To relieve symptoms associated with | ||
| muscle spasm, to treat temporomandibular | |||
| joint (TMJ) dysfunction and associated pain |
- Muscle re-education
- Increasing blood flow
- Maintain or increase mandibular range of
motion | Used to relieve symptoms associated with
muscle spasm, to treat temporomandibular
joint (TMJ) dysfunction and associated pain,
to relax muscles and establish a physiologic
occlusion, to take occlusal registrations, to
take denture impressions, to increase local
blood circulation and to increase or maintain
mandibular
range of motion. | Trio300 is indicated for the symptomatic
relief of chronic intractable pain, treatment
of post-traumatic and post-surgical pain,
relaxation of muscle spasm, prevention or
retardation of disuse muscle atrophy, muscle
reeducation, increase local blood circulation.
maintain or increase range of motion,
immediate post-surgical stimulation of calf
muscles to prevent venous thrombosis. |
| Physical Design | | | |
| Physical Dimensions (in.) [W x H x D] | 3.3 x 0.93 x 5.9 | 6.5x 2.56 x 6.97 | 2.7 x 0.98 x 4.4 |
| Gross Weight | 230 g | 480 g | 185 g |
| Accessory Attachment Method | Pad | Pad | Pad |
| Electrical Design | | | |
| Electrical Safety & EMC Testing | ANSI AAMI ES60601-1 IEC 60601-1-2 | unknown | IEC 60601-1 IEC 60601-1-2 |
Section 5
6
伊藤超短波株式会社 MANUFACTURERS & EXPORTERS
ITOco.,LTD.
established in 1916
3-1-8, SAKAE-CHO, KAWAGUCHI-SHI, SAITAMA
332-0017 JAPAN
TEL: +81-48-252-5015 FAX: +81-48-254-1041
| Feature/Description | Proposed Device | Primary Predicate Device | Reference Device |
|---|---|---|---|
| IEC 60601-2-10 | |||
| Electrical Safety Class | Class II internally powered equipment, Type BF | Internally powered equipment, Type BF | Class II internally powered equipment, Type BF |
| Power Supply | DC 7.4 (Lithium ion battery) | ||
| DC 12 V (AC adaptor) | |||
| AC 100-240V, 50/60Hz | DC 9V (battery) | DC 9V (battery) | |
| DC 9V (AC adaptor) | |||
| AC 120V, 60 Hz | |||
| Electrical input power | 30 VA | - | 420 mA |
| Output Specification | |||
| Pulse Width | PAIN: 150 $μ$ s | ||
| CARE: 488 $μ$ s | |||
| MCR: 150 ms | 488 $μ$ s | 250 ms | |
| Output Frequency (Hz) | PAIN: 200 | ||
| CARE: 0.67 | |||
| MCR: 400 | 0.67 | 400 | |
| Output Current | PAIN: 80 mA | ||
| CARE: 24 mA | |||
| MCR: 750 $μ$ A | -24 mA | 80 mA | |
| Pulse Shape | rectangular | rectangular | rectangular |
| Channel Numbers | 2 | 4 | 2 |
| Other Functions | |||
| Timer | Yes | No | Yes |
| Buzzer | Yes | No | Yes |
| LCD | Yes | Yes | Yes |
7
Image /page/7/Picture/1 description: The image shows the logo for ITO Co., LTD. The letters are in a bold, sans-serif font. The letters "CO." and "LTD." are in a smaller font size than the letters "ITO."
established in 1916
3-1-8, SAKAE-CHO, KAWAGUCHI-SHI, SAITAMA 332-0017 JAPAN
TEL: +81-48-252-5015 FAX: +81-48-254-1041
VII. PERFORMANCE DATA
Cited Standards to Determine Substantially Equivalence:
D function complies with the following FDA recognized:
- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 Medical electrical equipment – Part1: General requirements for basic safety and essential performance
- IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment -- Part1-2: General requirements for basic safety and essential performance - Collateral standard Electromagnetic phenomena - Requirements and tests
- IEC 60601-2-10 Edition 2.1 2016-04 Medical electrical equipment – Part2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
Non-clinical Testing:
Non-clinical verification and validation testing was conducted on D function device.
The verification results demonstrate that the proposed device complies with the standard, IEC62304:2006/ Amd.1: 2015 Medical device software - Software life cycle processes. Additionally, the proposed device meets its design requirements in accordance with the requirements of FDA's guidance for the Content of Premarket Submissions for Software.
The validation results demonstrate that the software specifications conform to user needs and that the particular requiremented through the proposed device can be consistently fulfilled. In addition, the proposed validation plan, procedure, testing and result provides evidence that all requirements have been implemented correctly and completely and is traceable to system requirements.
VIII. CONCULUSION
The non-clinical data support the substantial equivalence of the declared predicates and the hardware and software verification and validation demonstrate that the D function device should perform as intended in the specified use conditions.