Shoulder Pacemaker
Device Facts
| Record ID | K210674 |
|---|---|
| Device Name | Shoulder Pacemaker |
| Applicant | Ncs Lab Srl |
| Product Code | IPF · Physical Medicine |
| Decision Date | Aug 24, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5850 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Shoulder Pacemaker™ is an electrotherapy device intended for neuromuscular electrical stimulation (NMES). The Indications for Use for Shoulder Pacemaker™ are: - Prevention or retardation of disuse atrophy; - Muscle re-education; - Maintaining or increasing range of motion. The device is intended for adults only.
Device Story
Shoulder Pacemaker is a wearable, battery-powered neuromuscular electrical stimulation (NMES) device for shoulder rehabilitation. It uses conductive electrodes applied to the skin to deliver biphasic electrical current to stimulate muscles. The device integrates a goniometer to measure arm elevation angle (acceleration and angular velocity), allowing automatic modulation of stimulation based on arm movement. It operates in stand-alone or wireless modes. Used in clinical or home settings by patients or healthcare providers, the device helps reduce functional pathologies by facilitating muscle contraction. The output is controlled via a microprocessor, with safety features including automatic shut-off and patient override. By providing targeted stimulation, the device aids in muscle re-education and atrophy prevention, potentially improving patient mobility and recovery outcomes.
Clinical Evidence
Bench testing only. The device underwent electrical safety (IEC 60601-1, 60601-2-10, 60601-1-11), electromagnetic compatibility (IEC 60601-1-2), usability (IEC 60601-1-6, 62366-1), software validation (IEC 62304), battery safety (IEC 62133), and wireless module testing (FCC Part 15). No clinical data was required or presented.
Technological Characteristics
Wearable NMES device; rechargeable 3.7V/550mAh Li-ion battery; biphasic waveform; 1 output channel; integrated goniometer for motion tracking; wireless connectivity (BLE); ABS housing; conductive hydrogel electrodes (K130987). Complies with IEC 60601-1, 60601-1-2, 60601-1-6, 60601-1-11, 60601-2-10, 62304, 62366-1, and ISO 14971.
Indications for Use
Indicated for adults requiring neuromuscular electrical stimulation (NMES) for prevention/retardation of disuse atrophy, muscle re-education, and maintaining or increasing 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.
Predicate Devices
Submission Summary (Full Text)
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August 24, 2021
NCS Lab Srl Matteo Mantovani Technical Director- CEO Via Pola Esterna 4/12 Carpi, Modena, Italy 41012
Re: K210674
Trade/Device Name: Shoulder Pacemaker™ Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF. KOX Dated: May 18, 2021 Received: May 24, 2021
Dear Matteo Mantovani:
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Patrick Antkowiak, PhD Assistant Director (Acting) 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) K210674
Device Name Shoulder PacemakerTM
Indications for Use (Describe)
Shoulder PacemakerTM is an electrotherapy device intended for neuromuscular electrical stimulation (NMES).
- The Indications for Use for Shoulder PacemakerTM are:
- Prevention or retardation of disuse atrophy;
- Muscle re-education;
- Maintaining or increasing range of motion.
The device is intended for adults only.
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) |
|----------------------------------------------|---------------------------------------------|
|----------------------------------------------|---------------------------------------------|
|| | Prescription Use (Part 21 CFR 801 Subpart D)
|_ | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows a logo for "COMBINED SOLUTIONS FOR INDUSTRY". The logo consists of three stylized letters, "N", "C", and "S", each formed by a combination of black and white blocks with rounded corners. The letters are arranged horizontally, with the text "COMBINED SOLUTIONS FOR INDUSTRY" appearing in a smaller font size below the letters.
## 510(k) Summary (21 CFR 807.92)
## 1 GENERAL INFORMATION
### Submitter
NCS Lab Srl Via Pola Esterna 4/12 Carpi (MO), Italy 41012 Telephone: +39 059 669813 Fax: +39 059 669813
### Contact Person
Matteo Mantovani Technical Director – CEO E-mail: quality@ncs-company.com
Date Prepared: 30,07,2021
## 2 DEVICE
| Trade Name | Shoulder Pacemaker™ |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------|
| Common/Usual Name | Muscle Stimulator |
| Regulation Description (Regulation<br>Number) | Powered Muscle Stimulator (21 CFR<br>890.5850)<br>Goniometer, AC-powered (21 CFR<br>888.1500) |
| Device Class, Submission Type | Powered Muscle Stimulator Class II, 510(k)<br>Goniometer AC-powered Class I, 510(k)<br>exempt |
| Product Code | IPF, KQX |
| Review Panel | Physical Medicine, Orthopedic |
## 3 PREDICATE DEVICE
| | Brand Name | 510(k) number | Manufacturer | Product code |
|---------------------|----------------------------------------|---------------|------------------------------|---------------|
| Primary Predicate | CyMedica e-vive<br>System; CY-<br>1000 | K163067 | CyMedica<br>Orthopedics, Inc | IPF, GZJ, KQX |
| Secondary Predicate | Chattanooga<br>Revolution<br>Wireless | K153696 | DJO, LLC | IPF, GZJ |
## 4 DEVICE DESCRIPTION
The Subject device, Shoulder Pacemaker, is a wearable muscle stimulator, powered by an internal battery, used for rehabilitation/physiotherapy purposes to produce muscle contraction, through the passage of electric current, by means of conductive electrodes positioned on the body area of interest, in patients with shoulder functional pathologies.
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Image /page/4/Picture/0 description: The image shows a logo with three distinct symbols, each resembling a stylized letter. The first symbol looks like a modified 'n' or 'H', the second resembles a 'C', and the third is similar to a 'Z' or 'S'. Below the symbols, the text "COMBINED SOLUTIONS FOR INDUSTRY" is displayed in all caps. The logo appears to be for a company that provides combined solutions for the industry.
The Shoulder Pacemaker device is intended to be used as a shoulder muscle stimulation tool to reduce and eliminate related functional pathologies.
The subject device can be used in stand-alone mode or in wireless mode.
The Shoulder Pacemaker should be used in combination with:
- conductive electrodes, that are applied directly to the patient's skin to ensure muscle । electrostimulation;
- saver protection, interposed between the stimulator and the patient's arm. -
The electrodes, identified to meet the requirements to be compatible accessories of the Subject device, are FDA cleared:
- "ValuTrode® Neurostimulation Electrodes" (K130987), made by Axelgaard manufacturing co., Ltd. Therefore, the biocompatibility aspects of these electrodes were already reviewed and cleared.
The device is equipped with a goniometer (product code KQX, Class I, 510 (k) exempt), which can record the acceleration and angular velocity data of the device and allows to estimate the movement of the subject's arm. In this way, the device automatically detects the elevation angle of the arm and based on that information it can modulate the electrical stimulation.
The Shoulder Pacemaker is a prescription device and is intended to be used following the directions of a healthcare provider; additionally, the device may be used in a healthcare facility setting or by a patient or lay operator in a home environment.
## 5 INDICATIONS FOR USE
Shoulder Pacemaker™ is an electrotherapy device intended for neuromuscular electrical stimulation (NMES).
The Indications for Use for Shoulder Pacemaker™ are:
- Prevention or retardation of disuse atrophy;
- Muscle re-education;
- Maintaining or increasing range of motion.
The device is intended for adults only.
# 6 COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
The present 510(k) submission would demonstrate that the Shoulder Pacemaker results substantially equivalent to the following predicate devices:
- Primary Predicate: CyMedica e-vive System; CY-1000, which has been cleared through
- 510(k) application K163067
- Secondary Predicate: Chattanooga Revolution Wireless, which has been cleared through 510(k) application K153696
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Image /page/5/Picture/0 description: The image shows a logo with three distinct symbols, each resembling a stylized letter. The first symbol looks like a modified "n", the second resembles a "c", and the third appears to be a "j". Below the symbols, the text "COMBINED SOLUTIONS FOR INDUSTRY" is printed in a smaller font, indicating the name or slogan associated with the logo.
Multiple predicate devices, as listed above, have been identified, to support the substantial equivalence determination for the Shoulder Pacemaker; the Applicant would combine features from the two predicates with the same intended use into the subject device, to provide a complete muscle stimulator system, according to the user's needs.
Both the subject and the predicate devices are intended for the neuromuscular electrical stimulation (NMES). Although there are few minor differences, the indications for use of the Shoulder Pacemaker device can be considered as a subset of those of the predicates.
The predicate devices have additional features, and applications that are not included in the Shoulder Pacemaker.
Concerning the technological characteristics, the following tables summarizes similarities and differences among the subject and the predicate devices. A discussion on the comparison about the technological characteristics, underlying that the differences do not raise any new questions of safety or effectiveness in the Shoulder Pacemaker, compared to the chosen predicates, is reported below the following tables.
| Device<br>Characteristic | Subject device<br>(This 510(k)<br>Application) | Primary<br>Predicate (PP) | Secondary<br>Predicate (SP) | Comparison | |
|-----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Manufacturer | NCS Lab Srl | CyMedica<br>Orthopedics, Inc. | DJO, LLC | - | |
| 510(k) Number | Under present review | K163067 | K153696 | - | |
| Device Name, Model | Shoulder Pacemaker | e-vive System;<br>CY-1000 | Chattanooga<br>Revolution<br>Wireless | - | |
| Classification<br>Regulation | 890.5850<br>888.1500 | 890.5850<br>888.1500<br>882.5890 | 890.5850<br>882.5890 | Subset to PP<br>and SP | |
| Product Code | IPF: Powered Muscle<br>Stimulator<br>KQX: Goniometer AC-<br>powered | IPF: Powered<br>Muscle Stimulator<br>KQX:<br>Goniometer AC-<br>powered<br>GZJ:<br>Stimulator, Nerve,<br>Transcutaneous,<br>For Pain Relief | IPF: Powered<br>Muscle Stimulator<br>GZJ:<br>Stimulator, Nerve,<br>Transcutaneous,<br>For Pain Relief | Same main<br>product code<br>to PP and SP<br>Subset to PP<br>and SP | |
| Class | II | II | II | Same | |
| Primary Function | Shoulder Pacemaker is<br>an electrotherapy<br>device intended for<br>neuromuscular<br>electrical stimulation<br>(NMES). | The CyMedica e-<br>vive System is a<br>multifunctional<br>electrotherapy<br>device that allow<br>for<br>neuromuscular<br>electrical<br>stimulation<br>(NMES) and<br>transcutaneous<br>electrical nerve<br>stimulation<br>(TENS). | The<br>Chattanooga®<br>Revolution<br>Wireless is a<br>neuromuscular<br>electrical<br>stimulation<br>(NMES)<br>device, which<br>stimulates nerve<br>fibers by means of<br>electrical<br>impulses<br>transmitted by<br>electrodes and<br>transcutaneous | Same | |
| Device<br>Characteristic | Subject device<br>(This 510(k)<br>Application) | Primary<br>Predicate (PP) | Secondary<br>Predicate (SP) | Comparison | |
| Indication for Use | Shoulder PacemakerTM<br>is an electrotherapy<br>device intended for<br>neuromuscular<br>electrical stimulation<br>(NMES).<br>The Indications for Use<br>for Shoulder<br>PacemakerTM are:<br>- Prevention or<br>retardation of disuse<br>atrophy;<br>- Muscle re-education<br>- Maintaining or<br>increasing range of<br>motion.<br>The device is intended<br>for adults only. | The CyMedica e-<br>vive System is a<br>multifunctional<br>electrotherapy<br>device with two<br>treatment modes<br>that allow for<br>neuromuscular<br>electrical<br>stimulation<br>(NMES) and<br>transcutaneous<br>electrical nerve<br>stimulation<br>(TENS).<br>Indications for<br>Use:<br>As an NMES<br>device,<br>indications are for<br>the following<br>conditions:<br>- Relaxation of<br>muscle spasms<br>- Retardation or<br>prevention of<br>disuse atrophy<br>- Increasing local<br>blood circulation<br>- Re-educating<br>muscles<br>- Immediate post-<br>surgical<br>stimulation of calf<br>muscles to<br>prevent venous<br>thrombosis<br>- Maintaining or<br>increasing range<br>of motion<br>As a TENS<br>device,<br>indications are for<br>the following<br>conditions:<br>- Symptomatic<br>relief and<br>management of<br>chronic<br>intractable pain<br>- Adjunctive<br>treatment for<br>post-surgical and<br>post-trauma acute<br>pain. | The Chattanooga<br>Revolution<br>Wireless is a<br>clinical<br>electrotherapy<br>device intended<br>for use under the<br>supervision of a<br>Healthcare<br>Professional.<br>Indications for<br>Use:<br>As an NMES<br>device,<br>indications are for<br>the following<br>conditions:<br>- Retarding or<br>preventing disuse<br>atrophy<br>- Maintaining or<br>increasing range<br>of motion<br>- Re-educating<br>muscles<br>- Relaxation of<br>muscle spasms<br>- Increasing local<br>blood circulation<br>- Prevention of<br>venous<br>thrombosis of the<br>calf muscles<br>immediately after<br>surgery<br>As a TENS<br>device,<br>indications are for<br>the following<br>conditions:<br>- Symptomatic<br>relief and<br>management of<br>chronic,<br>intractable pain<br>- Post-surgical<br>and post-trauma<br>acute pain<br>As a pulsed mode<br>device,<br>indications are for<br>the following<br>conditions:<br>- Relaxation of<br>muscle spasm | Same intended<br>use to PP and<br>SP<br>Subset<br>Indications for<br>use with<br>respect to PP<br>and SP | |
| Device<br>Characteristic | Subject device<br>(This 510(k)<br>Application) | Primary<br>Predicate (PP) | Secondary<br>Predicate (SP) | Comparison | |
| Basic Unit Characteristics | | | | | |
| Power Source(s) | Rechargeable Li-ion<br>battery, 3.7V / 550<br>mAh<br>1.01 x 1.67 x 0.25 (in) | Single<br>VD434053:<br>3.7V; 1000mAh;<br>Lithium-ion<br>polymer<br>battery | Remote control<br>battery:<br>Rechargeable<br>3.7[V] / ≥<br>1,500[mAh]<br>lithium polymer<br>(LiPo) battery.<br>Module battery:<br>Rechargeable<br>3.7[V] / ≥<br>450[mAh] lithium<br>polymer (LiPo)<br>battery. | Similar<br>Note 1 | |
| Method of Line<br>Current Isolation | N/A<br>Battery operated device | No line<br>connection | N/A<br>Battery operated<br>device | Same<br>Note 1 | |
| Patient<br>Leakage<br>Current | Normal<br>condition<br>(μΑ) | N/A<br>Battery operated device | 4.88 | N/A<br>Battery operated<br>device | Same to SP<br>Note 1 |
| | Single<br>fault<br>condition<br>(μΑ) | N/A<br>Battery operated device | 8.00 | N/A<br>Battery operated<br>device | Same to SP<br>Note 1 |
| Average DC current<br>through electrodes<br>when device is on but<br>no pulses are being<br>applied (μΑ) | <0.01μΑ | N/A | N/A | Different<br>Note 1 | |
| Number of Output<br>Modes | 1 | 3 | Muscle<br>stimulator:<br>Electrodes | Different<br>Note 2 | |
| Number of Output<br>Channels | 1 | 2 | 4 | Different<br>Note 2 | |
| ● | Synchronous or<br>Alternating? | N/A | Alternating | See Output<br>Specifications<br>Below<br>(Ref. 510(k)<br>summary -<br>K153696) | |
| ● | Method of<br>Channel<br>Isolation | N/A | Transistor | Each channel is<br>the<br>middle of a H<br>Bridge.<br>Except when it is<br>activated, each<br>channel is always<br>in<br>high impedance | |
| COMBINED SOLUTIONS FOR INDUSTRY<br>CERTIFIED QUALITY MANAGEMENT SYSTEM UNI EN ISO 9001:2015 UNI CEI EN ISO 13485:2016 6 | | | | | |
| Regulated Current or<br>Regulated Voltage? | Regulated power | Regulated power | Regulated current<br>on<br>all channels | Same to PP<br>Note 3 | |
| Software/Firmware/<br>Microprocessor<br>Control? | | Yes | Yes | Yes | Same |
| Automatic Overload<br>Trip? | | No | No | Yes | Same to PP<br>Note 3 |
| Automatic No-Load<br>Trip? | | No…
