Shoulder PacemakerTM

K220994 · Ncs Lab Srl · IPF · Oct 14, 2022 · Physical Medicine

Device Facts

• Record ID: K220994
• Device Name: Shoulder PacemakerTM
• Applicant: Ncs Lab Srl
• Product Code: IPF · Physical Medicine
• Decision Date: Oct 14, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K220994 · Oct 14, 2022	Shoulder PacemakerTM	Ncs Lab Srl	Published clinical literature; Real-world use data	The sponsor provided published literature and real-world use data to support the extrapolation of the device's indications for use from adults to adolescents (age 14 and older), in accordance with the FDA guidance 'Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices'.	Pediatric extrapolation; Literature review; Real-world use data

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Pediatric Extrapolation Analysis; Literature review and real-world data analysis	Adolescents (age 14 and older)	Not applicable for this study	Safety and effectiveness for pediatric use via extrapolation

Indications for Use

The Shoulder Pacemaker™ electrotherapy device is intended for neuromuscular electrical stimulation (NMES). The Indications for Use for the Shoulder Pacemaker™ device are: - Prevention or retardation of disuse atrophy; - Muscle re-education; - Maintaining or increasing range of motion. The device is intended for adults and adolescents age 14 and older.

Device Story

Shoulder Pacemaker is a wearable, battery-powered neuromuscular electrical stimulator (NMES) for shoulder rehabilitation. It uses conductive electrodes applied to the skin to deliver biphasic electrical pulses to induce muscle contraction. The device integrates a goniometer to record arm acceleration and angular velocity, enabling automatic detection of arm elevation and modulation of stimulation based on movement. It operates in stand-alone or wireless modes. Used in healthcare facilities or home environments by patients or lay operators under healthcare provider direction. Output is controlled via a tablet interface. By automating stimulation based on real-time movement, the device assists in muscle re-education and atrophy prevention, potentially improving functional outcomes for patients with shoulder pathologies.

Clinical Evidence

No new clinical trials were conducted. Substantial equivalence for the expanded pediatric indication (age 14+) is supported by pediatric extrapolation based on existing clinical data, published literature, and real-world use data, consistent with FDA guidance on leveraging clinical data for pediatric populations.

Technological Characteristics

Wearable NMES device; ABS/plastic/PVC housing; conductive hydrogel electrodes (K130987). Powered by 3.7V/550mAh Li-ion battery. Sensing via integrated goniometer (KQX). Connectivity: wireless/standalone. Software: microprocessor-controlled. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-2-10, IEC 62304, ISO 14971, IEC 62133. Output: Biphasic waveform, 1-100 Hz, 1-200 μs pulse width.

Indications for Use

Indicated for adults and adolescents age 14 and older with shoulder functional pathologies requiring neuromuscular electrical stimulation (NMES) for prevention/retardation of disuse atrophy, muscle re-education, or maintaining/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

• Shoulder Pacemaker™ (K210674)

Submission Summary (Full Text)

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October 14, 2022

NCS Lab Srl % Tim Marjenin Vice-President Mcra. LLC 803 7th St. NW Washington, District of Columbia 20001

Re: K220994

Trade/Device Name: Shoulder PacemakerTM Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF. KOX. HCC Dated: August 23, 2022 Received: August 25, 2022

Dear Tim Marjenin:

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,

CDR Jitendra Virani, MS MBA Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K220994

Device Name Shoulder PacemakerTM

Indications for Use (Describe)

The Shoulder PacemakerTM electrotherapy device is intended for neuromuscular electrical stimulation (NMES).

The Indications for Use for the Shoulder PacemakerTM device are:

- Prevention or retardation of disuse atrophy;
- Muscle re-education;
- Maintaining or increasing range of motion.

The device is intended for adults and adolescents age 14 and older.

| 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)

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## 510(k) Summary (21 CFR 807.92)

## 1 GENERAL INFORMATION

### Submitter

NCS Lab Srl Via Pola Esterna 4/12 Carpi (MO), Italy 41012 Telephone: [phone] Fax: [phone]

### Contact Person

Matteo Mantovani Technical Director - CEO E-mail: [e-mail]

Date Prepared: August 23, 2022

# 2 DEVICE

Trade Name Common/Usual Name Regulation Description (Regulation Number)

Shoulder Pacemaker™ Muscle Stimulator Powered Muscle Stimulator (21 CFR 890.5850)

Device Class, Submission Type

Powered Muscle Stimulator Class II, 510(k)

Product Code Additional Product Codes Review Panel

IPF KQX, HCC Physical Medicine, Orthopedic, Neurology

### 3 PREDICATE DEVICE

| | Brand Name | 510(k) number | Manufacturer | Product code |
|-----------|------------------------|---------------|--------------|--------------|
| Predicate | | | | |
| | Shoulder<br>Pacemaker™ | K210674 | NCS Lab Srl | IPF, KQX |

### 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 composed of geometric shapes in black and white. The symbols appear to be stylized letters or abstract designs. Below the symbols, the text "COMBINED SOLUTIONS FOR INDUSTRY" is printed in a simple, sans-serif font. The logo has a modern and industrial feel.

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

The purpose of this 510(k) was to expand the indications for use to include a younger population of patients. It was originally cleared for use by adults.

The Shoulder Pacemaker™ electrotherapy device is intended for neuromuscular electrical stimulation (NMES).

The Indications for Use for the Shoulder Pacemaker™ device are:

- Prevention or retardation of disuse atrophy;
- Muscle re-education;
- Maintaining or increasing range of motion.

The device is intended for adults and adolescents age 14 and older.

## 6 COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

The present 510(k) submission would demonstrate that the Shoulder Pacemaker is substantially equivalent to the following predicate device:

- Shoulder Pacemaker™, which has been cleared through 510(k) application K210674.

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Image /page/5/Picture/0 description: The image shows a logo with three distinct shapes, each resembling a stylized letter. Below the shapes, the text "COMBINED SOLUTIONS FOR INDUSTRY" is printed in a simple, sans-serif font. The shapes are bold and geometric, with rounded corners, giving them a modern and industrial feel. The logo appears to represent a company or organization focused on providing combined solutions for the industry.

The Shoulder Pacemaker™ subject device is equivalent to the Shoulder Pacemaker™ (K210674). Electrical stimulation is well documented in the literature and confirmed in clinical performance as a safe and effective treatment for neuromuscular electrical stimulation (NMES). The following tables summarizes similarities and differences among the subject and the predicate devices. The comparison of the technological characteristics indicates that the differences do not raise any new questions of safety or effectiveness in the Shoulder Pacemaker compared to the chosen predicate.

| Device Characteristic | Subject device<br>(This 510(k) Application) | Predicate<br>(Shoulder Pacemaker™) | Comparison | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|------|
| Manufacturer | NCS Lab Srl | NCS Lab Srl | Same | |
| 510(k) Number | Under present review | K210674 | - | |
| Device Name, Model | Shoulder Pacemaker | Shoulder Pacemaker | Same | |
| Classification Regulation | 890.5850<br>888.1500 | 890.5850<br>888.1500 | Same | |
| Product Code | IPF: Powered Muscle<br>Stimulator<br>KQX: Goniometer AC-powered | IPF: Powered Muscle<br>Stimulator<br>KQX: Goniometer AC-powered | Same | |
| Class | II | II | Same | |
| Primary Function | Shoulder Pacemaker is an<br>electrotherapy device<br>intended for<br>neuromuscular electrical<br>stimulation (NMES). | Shoulder Pacemaker is an<br>electrotherapy device<br>intended for<br>neuromuscular electrical<br>stimulation (NMES). | Same | |
| Indication for Use | The Shoulder Pacemaker™<br>electrotherapy device is<br>intended for neuromuscular<br>electrical stimulation<br>(NMES).<br>The Indications for Use for<br>the Shoulder Pacemaker™<br>device are:<br>- Prevention or<br>retardation of disuse<br>atrophy;<br>- Muscle re-education<br>- Maintaining or increasing<br>range of motion.<br>The device is intended for<br>adults and adolescents age<br>14 and older. | The Shoulder Pacemaker™<br>electrotherapy device is<br>intended for neuromuscular<br>electrical stimulation<br>(NMES).<br>The Indications for Use for<br>the Shoulder Pacemaker™<br>device are:<br>- Prevention or retardation of<br>disuse atrophy;<br>- Muscle re-education<br>- Maintaining or increasing<br>range of motion.<br>The device is intended for<br>adults only. | Subject device is<br>intended for<br>expanded age rage<br>to include<br>adolescents 14 and<br>older. | |
| COMBINED SOLUTIONS FOR INDUSTRY | | | CERTIFIED QUALITY MANAGEMENT SYSTEM UNI EN ISO 9001:2015 UNI CEI EN ISO 13485:2016 | |
| Power Source(s) | | Rechargeable Li-ion battery,<br>3.7V / 550 mAh<br>1.01 x 1.67 x 0.25 (in) | Rechargeable Li-ion battery,<br>3.7V / 550 mAh<br>1.01 x 1.67 x 0.25 (in) | |
| Method of Line<br>Current Isolation | | N/A Battery operated device | N/A Battery operated device | Same |
| Patient<br>Leakage<br>Current | Normal<br>condition<br>(μΑ) | N/A Battery operated device | N/A Battery operated device | Same |
| | Single fault<br>condition<br>(μΑ) | N/A Battery operated device | N/A Battery operated device | Same |
| | Average DC current<br>through electrodes<br>when device is on but<br>no pulses are being<br>applied (µA) | <0.01μΑ | <0.01μΑ | Same |
| Number of Output<br>Modes | | 1 | 1 | Same |
| Number of Output<br>Channels | | 1 | 1 | Same |
| ● | Synchronous or<br>Alternating? | N/A | N/A | Same |
| ● | Method of Channel<br>Isolation | N/A | N/A | Same |
| Regulated Voltage? | Regulated Current or | Regulated power | Regulated power | Same |
| Software/Firmware/<br>Microprocessor<br>Control? | | Yes | Yes | Same |
| Automatic Overload<br>Trip? | | No | No | Same |
| Automatic No-Load<br>Trip? | | No | No | Same |
| | Automatic Shut Off? | Yes | Yes | Same |
| Patient Override<br>Control? | | Yes | Yes | Same |
| Indicator<br>Display: | On/Off<br>Status? | Yes | Yes | Same |
| | Low<br>Battery? | Yes | Yes | Same |
| | Voltage/<br>Current<br>Level? | Yes | Yes | Same |
| | Time Range (minutes) | 120 minutes | 120 minutes | Same |
| Compliance with<br>Voluntary Standards? | | Yes:<br>CEI EN 60601-1<br>IEC 60601-1 | Yes:<br>CEI EN 60601-1<br>IEC 60601-1 | Same |
| COMBINED SOLUTIONS FOR INDUSTRY | | CERTIFIED QUALITY MANAGEMENT SYSTEM UNI EN ISO 9001:2015 UNI CEI EN ISO 13485:2016 | | |
| | 2005+AMD1:2012 | 2005+AMD1:2012 | | |
| | CEI EN 60601-1-2 | CEI EN 60601-1-2 | | |
| | IEC 60601-1-2:2014 | IEC 60601-1-2:2014 | | |
| | IEC 60601-1-6 | IEC 60601-1-6 | | |
| | CEI EN 60601-2-10 | CEI EN 60601-2-10 | | |
| | IEC 60601-2-10:2016 | IEC 60601-2-10:2016 | | |
| | CEI EN 62304 | CEI EN 62304 | | |
| | CEI EN 62366-1 | CEI EN 62366-1 | | |
| | CEI EN 60601-1-11 | CEI EN 60601-1-11 | | |
| | IEC 60601-1-11:2015 | IEC 60601-1-11:2015 | | |
| | IEC 62133 | IEC 62133 | | |
| Compliance with 21<br>CFR 898? | Yes | Yes | Same | |
| Weight | Electrostimulator: 4.62 oz.<br>(131g)<br>Tablet: 10.76 oz.<br>(305g)<br>Receiver: 0.49 oz. (14g) | Electrostimulator: 4.62 oz.<br>(131g)<br>Tablet: 10.76 oz.<br>(305g)<br>Receiver: 0.49 oz. (14g) | Same | |
| Dimensions (in.) [W x<br>H x D] | Electrostimulator: 3.5 x<br>0.81 x 3.5 (in) Tablet:<br>4.79x0.32 x7.56 (in)<br><br>Receiver: 2.75 x 0.55 x<br>1.06 (in)<br><br>Electrodes: 2 x 2 (in) or<br>2 x 4 (in)<br><br>Saver protection (height): 3<br>(in) | Electrostimulator: 3.5 x<br>0.81 x 3.5 (in) Tablet:<br>4.79x0.32 x7.56 (in)<br><br>Receiver: 2.75 x 0.55 x<br>1.06 (in)<br><br>Electrodes: 2 x 2 (in) or<br>2 x 4 (in)<br><br>Saver protection (height): 3<br>(in) | Same | |
| Housing Materials and<br>Construction | Electrostimulator: ABS<br>Tablet: Plastic<br>Receiver: PVC<br>Electrodes: Conductive<br>hydrogel<br><br>Saver protection: Elastic | Electrostimulator: ABS<br>Tablet: Plastic<br>Receiver: PVC<br>Electrodes: Conductive<br>hydrogel<br><br>Saver protection: Elastic | Same | |
| Device<br>Characteristic | Subject device<br>(This 510(k) Application) | Predicate<br>(Shoulder PaceMaker™) | Comparison | |
| Output Specifications | | | | |
| Waveform<br>(e.g.,<br>Pulsed<br>monophasic,<br>biphasic) | Biphasic | Biphasic | Same | |
| Shape (e.g.,<br>rectangular, spike,<br>rectified sinusoidal) | Complex | Complex | Same | |
| Maximum<br>Output Voltage<br>(specify units) (+/-<br>%) | VRMS 4.7V@ 500 Ω<br>VRMS 9.4V@<br>2 kΩ<br>VRMS 17V@ 10 kΩ | VRMS 4.7V@ 500 Ω<br>VRMS 9.4V@<br>2 kΩ<br>VRMS 17V@ 10 kΩ | Same | |
| Maximum<br>Output Current<br>(specify units) (+/-<br>%) | IRMS 9.4mA @ 500 Ω<br>IRMS 4.7mA<br>@2 kΩ IRMS 1.7mA<br>@10kΩ | IRMS 9.4mA @ 500 Ω<br>IRMS 4.7mA<br>@2 kΩ IRMS 1.7mA<br>@10kΩ | Same | |
| Pulse Width<br>(specify units) | 1-200 [μs]<br>(microseconds) | 1-200 [μs]<br>(microseconds) | Same | |
| Frequency<br>(Hz) | 1 to 100 Hz | 1 to 100 Hz | Same | |
| For interferential<br>modes only: Beat<br>Frequency<br>(Hz) | N/A | N/A | Same | |
| For multiphasic<br>waveforms only:<br>Symmetrical<br>phases? | N/A | N/A | Same | |
| For multiphasic<br>waveforms only:<br>Phase Duration<br>(include units)<br>(state range, if<br>applicable) (both<br>phases, if<br>asymmetrical) | Stim phase: 1-200[μs]<br>Compensation phase: 9800-<br>999.999 [μs] | Stim phase: 1-200[μs]<br>Compensation phase: 9800-<br>999.999 [μs] | Same | |
| Net Charge<br>(μC per pulse)<br>(If zero, state | 0 [μC] @ 500Ω Excitation<br>pulse fully compensated | 0 [μC] @ 500Ω | Same | |
| method of<br>achieving zero<br>net charge) | | | | |
| Maximum Phase<br>Charge<br>(μC) | 10 [μC] @ 500 Ω | 10 [μC] @ 500 Ω | Same | |
| Maximum<br>Current<br>Density<br>(mA/cm²) | 0.48 mA/cm2 | 0.48 mA/cm2 | Same | |
| Maximum<br>Power Density<br>(W/cm²) (using<br>smallest<br>electrode<br>conductive<br>surface area) | 0,003<br>W/cm2@500Ω | 0,003<br>W/cm2@500Ω | Same | |
| Burst Mode (i.e.,<br>pulse trains):<br>a. pulses per burst<br>b. bursts per second<br>c. burst duration<br>(seconds)<br>d. Duty Cycle [Line<br>(b) x Line (c)] | N/A, no burst mode | N/A, no burst mode | Same | |

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Image /page/7/Picture/0 description: The image shows three different black and white abstract designs. The first design looks like a stylized letter 'n' with rounded corners. The second design features a horizontal bar with a square on the left side, also with rounded corners. The third design is an 'S' shape with rounded corners.

## Note 1

The subject and…