(193 days)
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.
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.
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 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.
The provided text describes a 510(k) submission for the Shoulder PacemakerTM device, focusing on expanding its indications for use to include adolescents aged 14 and older. The submission primarily relies on demonstrating substantial equivalence to a previously cleared predicate device (K210674), which is also the "Shoulder PacemakerTM" from the same manufacturer, NCS Lab Srl.
The core of the submission addresses the device's safety and effectiveness through non-clinical testing and leveraging existing clinical data through pediatric extrapolation, rather than conducting a new clinical study.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" in the traditional sense for a new clinical study comparing the device to a threshold or another device. Instead, the "acceptance criteria" for this 510(k) submission revolve around demonstrating substantial equivalence to the predicate device (K210674) and compliance with relevant medical device standards. The "reported device performance" is primarily the affirmation that the device meets these standards and is functionally identical to the predicate for all characteristics except the expanded age range.
The "performance data" section states: "All non-clinical, BLE module, battery, electrical safety, EMC and software testing was reviewed in K210674. No substantial changes have been made to the device since it was cleared by the FDA on August 24, 2021 that would affect prior testing results."
This implies that the device's performance aligns with the predicate device, which had already met the necessary performance criteria for its original clearance.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (as stated or implied) |
|---|---|
| Compliance with IEC 60601-1 (Electrical Safety) | Complies with CEI EN 60601-1, IEC 60601-1:2005+AMD1:2012 |
| Compliance with IEC 60601-1-2 (EMC) | Complies with CEI EN 60601-1-2, IEC 60601-1-2:2014 |
| Compliance with IEC 60601-2-10 (Nerve/Muscle Stimulators) | Complies with CEI EN 60601-2-10, IEC 60601-2-10:2016 |
| Compliance with IEC 60601-1-11 (Home Healthcare) | Complies with CEI EN 60601-1-11, IEC 60601-1-11:2015 |
| Compliance with IEC 60601-1-6 (Usability) | Complies with IEC 60601-1-6 |
| Compliance with IEC 62366-1 (Usability) | Complies with CEI EN 62366-1 |
| Compliance with IEC 62304 (Software Life Cycle) | Complies with CEI EN 62304; Software validation tests demonstrated it meets design requirements. |
| Compliance with ISO 14971 (Risk Management) | Complies with ISO 14971 |
| Compliance with FCC 47 CFR PT 15 SPT B (BLE module) | Complies with FCC 47 CFR PT 15 SPT B |
| Compliance with FCC 47 CFR PT 15 SPT C (BLE module) | Complies with FCC 47 CFR PT 15 SPT C |
| Compliance with IEC 62133-1 (Battery Safety - Nickel) | Complies with IEC 62133-1:2017 (for relevant battery types) |
| Compliance with IEC 62133-2 (Battery Safety - Lithium) | Complies with IEC 62133-2:2017 (for relevant battery types) |
| Substantial equivalence in technological characteristics to predicate device | Stated as "substantially equivalent" with only differences in IFU age range. |
| Supported by pediatric extrapolation for expanded age range | Discussion provided based on FDA guidance and published literature. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
There was no new clinical "test set" or study conducted for this specific 510(k) submission in the traditional sense of prospectively enrolling patients for direct device performance testing. The clinical evaluation for the expanded age indication was based on pediatric extrapolation as per FDA guidance. This means:
- Sample Size: Not applicable for a new clinical test set. The submission relies on existing clinical literature and real-world use data.
- Data Provenance: The text mentions "Published literature and real-world use data." The specific countries or whether this data was retrospective or prospective from the original studies are not detailed within this summary, but it generally refers to existing, previously collected data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No new clinical test set was created, and thus no new ground truth was established by experts for this specific submission. The clinical evidence for pediatric extrapolation relied on published literature.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new clinical test set requiring adjudication was conducted.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a powered muscle stimulator, not an AI-powered diagnostic or assistive tool for human readers, so an MRMC study comparing human performance with and without AI assistance is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (muscle stimulator), not an algorithm in the context of standalone diagnostic performance. The device does operate in a "stand-alone mode" (uncontrolled by a wireless tablet) but this refers to its operational mode, not a standalone algorithm performance test.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the pediatric extrapolation, the "ground truth" would be considered the established clinical outcomes data from published literature and real-world use for NMES devices in both adult and pediatric populations, as well as the comparison of patient, disease, and device characteristics. This is a form of outcomes data and literature-based evidence analyzed to support equivalence in a younger population.
8. The sample size for the training set
Not applicable. This submission concerns a hardware device with an expanded indication for use, not an AI/ML algorithm requiring a training set in the typical sense. The software validation mentioned (IEC 62304) involves testing against design requirements, not training on a dataset.
9. How the ground truth for the training set was established
Not applicable. There was no training set for an AI/ML algorithm.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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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Image /page/3/Picture/0 description: The image shows a logo for "COMBINED SOLUTIONS FOR INDUSTRY". The logo consists of three abstract shapes, each resembling a letter. The first shape looks like a stylized "n", the second shape looks like a stylized "e", and the third shape looks like a stylized "s". The text "COMBINED SOLUTIONS FOR INDUSTRY" is written in all caps below the shapes.
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: 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 | ||||
| ShoulderPacemaker™ | 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(This 510(k) Application) | Predicate(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 | 890.5850888.1500 | 890.5850888.1500 | Same | |
| Product Code | IPF: Powered MuscleStimulatorKQX: Goniometer AC-powered | IPF: Powered MuscleStimulatorKQX: Goniometer AC-powered | Same | |
| Class | II | II | Same | |
| Primary Function | Shoulder Pacemaker is anelectrotherapy deviceintended forneuromuscular electricalstimulation (NMES). | Shoulder Pacemaker is anelectrotherapy deviceintended forneuromuscular electricalstimulation (NMES). | Same | |
| Indication for Use | The Shoulder Pacemaker™electrotherapy device isintended for neuromuscularelectrical stimulation(NMES).The Indications for Use forthe Shoulder Pacemaker™device are:- Prevention orretardation of disuseatrophy;- Muscle re-education- Maintaining or increasingrange of motion.The device is intended foradults and adolescents age14 and older. | The Shoulder Pacemaker™electrotherapy device isintended for neuromuscularelectrical stimulation(NMES).The Indications for Use forthe Shoulder Pacemaker™device are:- Prevention or retardation ofdisuse atrophy;- Muscle re-education- Maintaining or increasingrange of motion.The device is intended foradults only. | Subject device isintended forexpanded age rageto includeadolescents 14 andolder. | |
| 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,3.7V / 550 mAh1.01 x 1.67 x 0.25 (in) | Rechargeable Li-ion battery,3.7V / 550 mAh1.01 x 1.67 x 0.25 (in) | ||
| Method of LineCurrent Isolation | N/A Battery operated device | N/A Battery operated device | Same | |
| PatientLeakageCurrent | Normalcondition(μΑ) | N/A Battery operated device | N/A Battery operated device | Same |
| Single faultcondition(μΑ) | N/A Battery operated device | N/A Battery operated device | Same | |
| Average DC currentthrough electrodeswhen device is on butno pulses are beingapplied (µA) | <0.01μΑ | <0.01μΑ | Same | |
| Number of OutputModes | 1 | 1 | Same | |
| Number of OutputChannels | 1 | 1 | Same | |
| ● | Synchronous orAlternating? | N/A | N/A | Same |
| ● | Method of ChannelIsolation | N/A | N/A | Same |
| Regulated Voltage? | Regulated Current or | Regulated power | Regulated power | Same |
| Software/Firmware/MicroprocessorControl? | Yes | Yes | Same | |
| Automatic OverloadTrip? | No | No | Same | |
| Automatic No-LoadTrip? | No | No | Same | |
| Automatic Shut Off? | Yes | Yes | Same | |
| Patient OverrideControl? | Yes | Yes | Same | |
| IndicatorDisplay: | On/OffStatus? | Yes | Yes | Same |
| LowBattery? | Yes | Yes | Same | |
| Voltage/CurrentLevel? | Yes | Yes | Same | |
| Time Range (minutes) | 120 minutes | 120 minutes | Same | |
| Compliance withVoluntary Standards? | Yes:CEI EN 60601-1IEC 60601-1 | Yes:CEI EN 60601-1IEC 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 21CFR 898? | Yes | Yes | Same | |
| Weight | Electrostimulator: 4.62 oz.(131g)Tablet: 10.76 oz.(305g)Receiver: 0.49 oz. (14g) | Electrostimulator: 4.62 oz.(131g)Tablet: 10.76 oz.(305g)Receiver: 0.49 oz. (14g) | Same | |
| Dimensions (in.) [W xH x D] | Electrostimulator: 3.5 x0.81 x 3.5 (in) Tablet:4.79x0.32 x7.56 (in)Receiver: 2.75 x 0.55 x1.06 (in)Electrodes: 2 x 2 (in) or2 x 4 (in)Saver protection (height): 3(in) | Electrostimulator: 3.5 x0.81 x 3.5 (in) Tablet:4.79x0.32 x7.56 (in)Receiver: 2.75 x 0.55 x1.06 (in)Electrodes: 2 x 2 (in) or2 x 4 (in)Saver protection (height): 3(in) | Same | |
| Housing Materials andConstruction | Electrostimulator: ABSTablet: PlasticReceiver: PVCElectrodes: ConductivehydrogelSaver protection: Elastic | Electrostimulator: ABSTablet: PlasticReceiver: PVCElectrodes: ConductivehydrogelSaver protection: Elastic | Same | |
| DeviceCharacteristic | Subject device(This 510(k) Application) | Predicate(Shoulder PaceMaker™) | Comparison | |
| Output Specifications | ||||
| Waveform(e.g.,Pulsedmonophasic,biphasic) | Biphasic | Biphasic | Same | |
| Shape (e.g.,rectangular, spike,rectified sinusoidal) | Complex | Complex | Same | |
| MaximumOutput Voltage(specify units) (+/-%) | VRMS 4.7V@ 500 ΩVRMS 9.4V@2 kΩVRMS 17V@ 10 kΩ | VRMS 4.7V@ 500 ΩVRMS 9.4V@2 kΩVRMS 17V@ 10 kΩ | Same | |
| MaximumOutput Current(specify units) (+/-%) | IRMS 9.4mA @ 500 ΩIRMS 4.7mA@2 kΩ IRMS 1.7mA@10kΩ | IRMS 9.4mA @ 500 ΩIRMS 4.7mA@2 kΩ IRMS 1.7mA@10kΩ | Same | |
| Pulse Width(specify units) | 1-200 [μs](microseconds) | 1-200 [μs](microseconds) | Same | |
| Frequency(Hz) | 1 to 100 Hz | 1 to 100 Hz | Same | |
| For interferentialmodes only: BeatFrequency(Hz) | N/A | N/A | Same | |
| For multiphasicwaveforms only:Symmetricalphases? | N/A | N/A | Same | |
| For multiphasicwaveforms only:Phase Duration(include units)(state range, ifapplicable) (bothphases, ifasymmetrical) | Stim phase: 1-200[μs]Compensation phase: 9800-999.999 [μs] | Stim phase: 1-200[μs]Compensation phase: 9800-999.999 [μs] | Same | |
| Net Charge(μC per pulse)(If zero, state | 0 [μC] @ 500Ω Excitationpulse fully compensated | 0 [μC] @ 500Ω | Same | |
| method ofachieving zeronet charge) | ||||
| Maximum PhaseCharge(μC) | 10 [μC] @ 500 Ω | 10 [μC] @ 500 Ω | Same | |
| MaximumCurrentDensity(mA/cm²) | 0.48 mA/cm2 | 0.48 mA/cm2 | Same | |
| MaximumPower Density(W/cm²) (usingsmallestelectrodeconductivesurface area) | 0,003W/cm2@500Ω | 0,003W/cm2@500Ω | Same | |
| Burst Mode (i.e.,pulse trains):a. pulses per burstb. bursts per secondc. burst duration(seconds)d. Duty Cycle [Line(b) x Line (c)] | N/A, no burst mode | N/A, no burst mode | Same |
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Image /page/6/Picture/0 description: The image contains three black and white abstract shapes. The first shape resembles a stylized letter 'n' with rounded corners. The second shape is a horizontal bar with a square on the left side, also with rounded corners. The third shape is an 'L' shape with a small extension on the top right, and rounded corners.
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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 the predicate devices are substantially equivalent for all technical characteristics other than Indications for Use.
Note 2
The subject device has been tested according to IEC 60601-1, 60601-1-6, 60601-1-6, 60601-1-11, 60601-2-10 standards and meets all these standards requirements and FDA guidance requirements.
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Image /page/8/Picture/0 description: The image shows a logo with three distinct shapes, each resembling a letter or symbol. Below the logo, the text "COMBINED SOLUTIONS FOR INDUSTRY" is printed in a simple, sans-serif font. The logo's design is modern and abstract, suggesting a sense of innovation and collaboration. The shapes are bold and geometric, creating a visually striking and memorable image.
CERTIFIED QUALITY MANAGEMENT SYSTEM | UNI EN ISO 9001:2015 | UNI CEI EN ISO 13485:2016
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Image /page/9/Picture/0 description: The image shows three different black and white abstract designs. The first design is a square shape with a white space in the middle. The second design is a square shape with a white line in the middle. The third design is an L shape.
In conclusion, the there is one difference in the Basic Unit Characteristics and Output Specifications between the interested devices, as shown in above reported tables, but it does not raise any new questions of safety or effectiveness in the Shoulder Pacemaker, compared to the chosen predicate.
7 PERFORMANCE DATA
All non-clinical, BLE module, battery, electrical safety, EMC and software testing was reviewed in K210674. No substantial changes have been made to the device since it was cleared by the FDA on August 24, 2021 that would affect prior testing results.
Non-clinical testing data are submitted, referenced, or relied upon, to support the demonstration of substantial equivalence of the Subject with the chosen Predicate device. To demonstrate the safety, the Shoulder Pacemaker was tested for electrical safety, electromagnetic compatibility, usability, and risk management requirements, according to the following standards:
- CEI EN 60601-1 and IEC 60601-1:2005+AMD1:2012 Medical Electrical Equipment Part - 1: General Requirements For Basic Safety And Essential Performance
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Image /page/10/Picture/0 description: The image shows a logo with three distinct shapes in black, followed by the text "COMBINED SOLUTIONS FOR INDUSTRY" in a smaller font size. The shapes appear to be stylized letters or symbols, each with a unique geometric design. The text below the shapes suggests that the logo represents a company that provides combined solutions for the industry.
CERTIFIED QUALITY MANAGEMENT SYSTEM | UNI EN ISO 9001:2015 | UNI CEI EN ISO 13485:2016
- CEI EN 60601-1-2 and IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: । General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- CEI EN 60601-2-10 and IEC 60601-2-10:2016 Medical electrical equipment Part 2-10: - Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
- CEI EN 60601-1-11 and IEC 60601-1-11:2015 Medical electrical equipment General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- CEI EN 62366-1 Medical devices Part 1: Application of usability engineering to medical devices
- CEI EN 62304 Medical device software Software life cycle processes -
- ISO 14971 Application of risk management to medical devices ।
BLE module testing was conducted in accordance with the following standards:
- FCC 47 CFR PT 15 SPT B, Issued: 2013/01/28 Title 47 CFR Part 15 Subpart B: - Unintentional Radiators [FCC §15.107 & FCC §15.109]
- FCC 47 CFR PT 15 SPT C, Issued:2007/10/01 Title 47 CFR Part 15 Subpart C: Intentional - Radiators [FCC §15.247]
Battery testing was conducted in accordance with:
- IEC 62133-1:2017 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 1: Nickel systems
- IEC 62133-2:2017 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
To demonstrate the Shoulder Pacemaker' effectiveness and performance substantial equivalency with the chosen predicate devices and to draft the present submission, the following FDA guidance document was used:
- FDA Final Guidance Document for Powered Muscle Stimulator 510(k), issued on June 9. 1999.
Electrical safety and Electromagnetic Compatibility (EMC) testing were conducted on the Shoulder Pacemaker; It complies with CEI EN 60601-1, CEI EN 60601-2-10, and CEI EN 60601-11 standards for safety and with CEI EN 60601-1-2 standard for EMC as well as the
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following FDA recognized standards IEC 60601-1:2005+AMD1:2012, IEC 60601-2-10:2016, IEC 60601-1-11:2015 and IEC 60601-1-2:2014.
The device's software has been validated in accordance with the requirements set forth in the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) and according to CEI IEC 62304 Medical device software – Software life cycle processes. The software validation tests demonstrated that the software version meets its design requirements.
Clinical Testing and Extrapolation to Pediatric Use:
In support of expanding the eligible patient population to include individuals 14 and older, NCS has provided a discussion based on the June 2016 FDA guidance document, "Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices."
Published literature and real-world use data are provided to support extrapolation to the pediatric population. The clinical evidence, combined with comparisons of the patient, disease, and device characteristics for both the adult and pediatric sub-populations, supports the expansion of the indications for use down to age 14 via pediatric extrapolation.
8 CONCLUSIONS
Based on the performance testing and the supporting documentation, it can be concluded that the Shoulder Pacemaker is substantially equivalent to the predicate device.
§ 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).