Shear Stress Therapeutics SST 3000

K182163 · Shear Stress Therapeutics, LLC · IPF · Jul 9, 2019 · Physical Medicine

Device Facts

• Record ID: K182163
• Device Name: Shear Stress Therapeutics SST 3000
• Applicant: Shear Stress Therapeutics, LLC
• Product Code: IPF · Physical Medicine
• Decision Date: Jul 9, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Shear Stress Therapeutics SST 3000 can be used for the standard purposes of muscle stimulators: - 1. Relaxation of muscle spasms - 2. Prevention of retardation of disuse atrophy - 3. Increasing local blood circulation - 4. Muscle re-education - 5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - 6. Maintaining or increasing range of motion

Device Story

SST 3000 is a powered muscle stimulator; delivers electrical impulses to muscles to induce contraction. Used for relaxation of muscle spasms, prevention of disuse atrophy, blood circulation improvement, muscle re-education, post-surgical venous thrombosis prevention, and range of motion maintenance. Operated by healthcare professionals in clinical settings. Device applies electrical stimulation to target muscle groups; output parameters controlled by clinician to achieve therapeutic muscle contraction. Benefits include improved muscle function and reduced risk of post-surgical complications.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Powered muscle stimulator; Class II device (21 CFR 890.5850); product code IPF. Device utilizes electrical stimulation for muscle contraction. Specific materials, dimensions, and software architecture details are not provided in the document.

Indications for Use

Indicated for patients requiring muscle stimulation for relaxation of muscle spasms, prevention/retardation of disuse atrophy, increased local blood circulation, muscle re-education, immediate post-surgical calf muscle stimulation to prevent venous thrombosis, and maintenance/increase of range of motion.

Regulatory Classification

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.

Submission Summary (Full Text)

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July 9, 2019

Shear Stress Therapeutics, LLC John Owen President 6207 East 78th Place Tulsa, Oklahoma 74136

Re: K182163

Trade/Device Name: Shear Stress Therapeutics SST 3000 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF Dated: April 23, 2019 Received: April 23, 2019

Dear John Owen:

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

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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 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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Vivek Pinto, PhD 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

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## Indications for Use

510(k) Number (if known) K182163

Device Name Shear Stress Therapeutics SST 3000

Indications for Use (Describe)

The Shear Stress Therapeutics SST 3000 can be used for the standard purposes of muscle stimulators:

- 1. Relaxation of muscle spasms
- 2. Prevention of retardation of disuse atrophy
- 3. Increasing local blood circulation
- 4. Muscle re-education
- 5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- 6. Maintaining or increasing range of motion

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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