(311 days)
Not Found
No
The device description focuses on manual controls, preset modes, and standard electrical stimulation technology. There is no mention of AI, ML, or any data processing that would suggest the use of such technologies.
Yes
The device is indicated for use "as an adjunct in the treatment of high and low anorectal malformations," which implies a therapeutic purpose.
No
The device is a muscle stimulator intended to help identify striated muscles during surgery for anal reconstructions, not to diagnose a condition. Its purpose is to guide surgical intervention by locating muscles, not to provide a diagnosis of a disease or condition.
No
The device description explicitly states it is a "hand-held device," "9V battery-powered, one-channel muscle stimulator," and includes a "Sterile Stylus" and "control unit," indicating it is a hardware device with physical components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- MYOTouch Function: The MYOTouch Muscle Stimulator is used directly on the patient's body during surgery to stimulate muscles and aid in their identification for reconstruction. It does not analyze samples taken from the body.
The description clearly indicates the device is used in vivo (within the living body) during a surgical procedure, not in vitro.
N/A
Intended Use / Indications for Use
The MYOTouch Muscle Stimulator is indicated for use as an adjunct in the treatment of high and low anorectic malformations by helping with the identification of striated muscles to be used in anal reconstructions. The MYOTouch device is intended for use by trained personnel who are competent to apply the appropriate stimuli.
Product codes
IPF
Device Description
MYOTouch is a hand-held device designed to be used for surgical correction of neonatal anorectal malformations. MYOTouch is intended for prescription use.
The device is a 9V battery-powered, one-channel muscle stimulator. The device is supplied with a Sterile Stylus, which connects to the control unit by cable and plug. The MYOTouch muscle stimulator has been specially designed to meet the requirements of pediatric surgeons who need a reliable and easy to use muscle locating stimulator when carrying out the Pena, "Pull-through", or posterior sagittal anorectoplasty (PSARP) anorectal reconstruction technique.
A trained professional or pediatric surgeon must use the MYOTouch device. The pediatric surgeon uses manual, push-button controls to control the electrical stimulation level. The unit is intended for prescription use and is designed with simplicity and ease of use. It has two preset modes available.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anal reconstructions
Indicated Patient Age Range
The reconstruction surgeries for which the MYOTouch is intended are typically performed in newborns, infants, children, and adolescents (
§ 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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.
August 2, 2024
SunMed LLC. Robert Yamashita VP of Regulatory Affairs 2710 Northridge Dr. NW. Suite A Grand Rapids, Michigan 49544
Re: K233098
Trade/Device Name: MYOTouch Muscle Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF Dated: June 14, 2024 Received: June 14, 2024
Dear Robert Yamashita:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
Sincerelv.
Xiaorui Tang
For: CDR Jitendra Virani Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Submission Number (if known)
Device Name
MYOTouch Muscle Stimulator
Indications for Use (Describe)
The MYOTouch Muscle Stimulator is indicated for use as an adjunct in the treatment of high and low anorectic malformations by helping with the identification of striated muscles to be used in anal reconstructions. The MYOTouch device is intended for use by trained personnel who are competent to apply the appropriate stimuli.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary K233098
Date of Submission Prepared: 11 November 2023
l Submitter:
| Submitter: | Sunmed L.L.C. |
|---|---|
| Address: | 2710 Northridge Dr. NW, Suite A, |
| Grand Rapids, MI 49544, U.S.A. | |
| Telephone: | (616) 259-8419 |
| Fax: | (800) 400-8820 |
| E-Mail: | ryamashita@sun-med.com |
| Official Contact: | Robert Yamashita / VP of Regulatory Affairs |
| FDA Establishment Registration No: | 1314417 |
SunMed L.L.C.
Address of the manufacturing facility:
EasyMed Instruments Co Ltd 3/F-6F, Block A, No. 4, Fengxin Road, Fengxiang Industrial District, Daliang, Shunde, Foshan, Guangdong, 528300 China FDA Establishment Registration No: 3004049909
ll Submitted Device:
| Trade Name: | MYOTouch |
|---|---|
| Common Name: | Powered Muscle Stimulator Device |
| Regulation Name: | Powered Muscle Stimulator |
| Regulation Number: | 21 CFR 890.5850 |
| Product Code: | IPF |
| Classification Panel: | Physical Medicine |
| Device Class: | Class II |
��� Predicate Device:
| Trade / Device Name: | Digitimer DS7AP Constant Current Stimulator |
|---|---|
| Submitter: | Digitimer Ltd |
| 510(k) Number: | K172381 |
| Regulation Name: | Powered Muscle Stimulator |
| Regulation Number: | 21 CFR 890.5850 |
| Product Code | IPF |
| Classification Panel: | Physical Medicine |
| Device Class: | Class II |
4
IV Device Description:
MYOTouch is a hand-held device designed to be used for surgical correction of neonatal anorectal malformations. MYOTouch is intended for prescription use.
The device is a 9V battery-powered, one-channel muscle stimulator. The device is supplied with a Sterile Stylus, which connects to the control unit by cable and plug. The MYOTouch muscle stimulator has been specially designed to meet the requirements of pediatric surgeons who need a reliable and easy to use muscle locating stimulator when carrying out the Pena, "Pull-through", or posterior sagittal anorectoplasty (PSARP) anorectal reconstruction technique.
A trained professional or pediatric surgeon must use the MYOTouch device. The pediatric surgeon uses manual, push-button controls to control the electrical stimulation level. The unit is intended for prescription use and is designed with simplicity and ease of use. It has two preset modes available.
Intended Patient Population
The reconstruction surgeries for which the MYOTouch is intended are typically performed in newborns, infants, children, and adolescents ( Indications for Use of the device:
The MYOTouch Muscle Stimulator is indicated for use as an adjunct in the treatment of high and low anorectic malformations by helping with the identification of striated muscles to be used in anal reconstructions. The MYOTouch device is intended for use by trained personnel who are competent to apply the appropriate stimuli.
VI Equivalence Comparison to the Predicate Devices:
Electrical muscle stimulation is the technological principle for the MYOTouch and the predicate device Digitimer DS7AP (K172381).
The intended Patient Population of MYOTouch is different from those of the predicate device Digitimer DS7AP (K172381), including individuals 3 - 18 years of age. Both devices have included the highest risk population, i.e., Neonate/Newborn (birth through 28 days), Infant (from 29 days to 2 years of age), and children