(193 days)
No
The description mentions the device uses a goniometer to estimate arm movement and modulate electrical stimulation based on the elevation angle. This is a rule-based or algorithmic approach, not indicative of AI/ML. There are no mentions of AI, ML, DNN, training data, or performance metrics typically associated with AI/ML models.
Yes
The device is described as an "electrotherapy device" intended for "neuromuscular electrical stimulation (NMES)" and aims to "reduce and eliminate related functional pathologies" related to the shoulder, which are therapeutic claims.
No
The device is described as an electrotherapy device intended for neuromuscular electrical stimulation (NMES) for rehabilitation/physiotherapy purposes, specifically for muscle stimulation and re-education, and maintaining / increasing range of motion. It does not state that it is used to diagnose a medical condition.
No
The device description explicitly states it is a "wearable muscle stimulator, powered by an internal battery" and requires "conductive electrodes" and a "saver protection," indicating it includes hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Shoulder Pacemaker Function: The Shoulder Pacemaker is an electrotherapy device that applies electrical stimulation to the body for therapeutic purposes (neuromuscular electrical stimulation). It works directly on the patient's body, not on a specimen taken from the body.
The description clearly states its intended use is for neuromuscular electrical stimulation for rehabilitation/physiotherapy purposes, not for analyzing biological samples.
N/A
Intended Use / Indications for Use
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.
Product codes
IPF, KQX, HCC
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder
Indicated Patient Age Range
The device is intended for adults and adolescents age 14 and older.
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- 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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
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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
1
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
2
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 | ||||
| Shoulder | ||||
| 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.
4
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 | 890.5850
888.1500 | 890.5850
888.1500 | Same | |
| Product Code | IPF: Powered Muscle
Stimulator
KQX: Goniometer AC-powered | IPF: Powered Muscle
Stimulator
KQX: Goniometer AC-powered | Same | |
| Class | II | II | Same | |
| Primary Function | Shoulder Pacemaker is an
electrotherapy device
intended for
neuromuscular electrical
stimulation (NMES). | Shoulder Pacemaker is an
electrotherapy device
intended for
neuromuscular electrical
stimulation (NMES). | Same | |
| Indication 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. | 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 only. | Subject device is
intended for
expanded age rage
to include
adolescents 14 and
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,
3.7V / 550 mAh
1.01 x 1.67 x 0.25 (in) | Rechargeable Li-ion battery,
3.7V / 550 mAh
1.01 x 1.67 x 0.25 (in) | |
| Method of Line
Current Isolation | | N/A Battery operated device | N/A Battery operated device | Same |
| Patient
Leakage
Current | Normal
condition
(μΑ) | N/A Battery operated device | N/A Battery operated device | Same |
| | Single fault
condition
(μΑ) | N/A Battery operated device | N/A Battery operated device | Same |
| | Average DC current
through electrodes
when device is on but
no pulses are being
applied (µA) |