(172 days)
No
The description mentions the device automatically modulating stimulation based on arm elevation angle detected by a goniometer, but it does not mention the use of AI or ML algorithms for this modulation or any other function. The "Mentions AI, DNN, or ML" section is also marked as "Not Found".
Yes
The device is described as an "electrotherapy device" intended for "neuromuscular electrical stimulation (NMES)" for purposes such as "prevention or retardation of disuse atrophy," "muscle re-education," and "maintaining or increasing range of motion," which are all therapeutic applications. It is also explicitly stated as being used for "rehabilitation/physiotherapy purposes to produce muscle contraction."
No
The device is an electrotherapy device intended for neuromuscular electrical stimulation (NMES) for therapeutic purposes, such as preventing disuse atrophy, muscle re-education, and maintaining or increasing range of motion. While it has a goniometer to estimate arm movement and modulate stimulation, its primary function is not to diagnose a condition but to provide therapy.
No
The device description explicitly states it is a "wearable muscle stimulator, powered by an internal battery" and includes hardware components like conductive electrodes, a saver protection, and a goniometer. It also mentions testing for electrical safety, electromagnetic compatibility, and battery testing, which are related to hardware.
Based on the provided information, the Shoulder Pacemaker is not an In Vitro Diagnostic (IVD) device.
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's surface (neuromuscular electrical stimulation - NMES) to cause muscle contraction. It works directly on the body, not on specimens taken from the body.
- Intended Use: The intended uses listed (prevention/retardation of disuse atrophy, muscle re-education, maintaining/increasing range of motion) are all related to physical therapy and rehabilitation, not diagnostic testing of biological samples.
Therefore, the Shoulder Pacemaker falls under the category of a therapeutic or rehabilitative medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
IPF, KQX
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 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.
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 only.
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
Non-clinical testing data are submitted, referenced, or relied upon, to support the demonstration of substantial equivalence of the Subject with the chosen Predicate devices. 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 Medical Electrical Equipment Part 1: General Requirements For Basic Safety And Essential Performance
- CEI EN 60601-1-2 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 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 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.
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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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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
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,
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
2
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 | |
| Number) | Powered Muscle Stimulator (21 CFR |
| 890.5850) | |
| Goniometer, AC-powered (21 CFR | |
| 888.1500) | |
| Device Class, Submission Type | Powered Muscle Stimulator Class II, 510(k) |
| Goniometer AC-powered Class I, 510(k) | |
| 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 | |||
| System; CY- | ||||
| 1000 | K163067 | CyMedica | ||
| Orthopedics, Inc | IPF, GZJ, KQX | |||
| Secondary Predicate | Chattanooga | |||
| Revolution | ||||
| 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.
4
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
Characteristic | Subject device
(This 510(k)
Application) | Primary
Predicate (PP) | Secondary
Predicate (SP) | Comparison | |
|-----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Manufacturer | NCS Lab Srl | CyMedica
Orthopedics, Inc. | DJO, LLC | - | |
| 510(k) Number | Under present review | K163067 | K153696 | - | |
| Device Name, Model | Shoulder Pacemaker | e-vive System;
CY-1000 | Chattanooga
Revolution
Wireless | - | |
| Classification
Regulation | 890.5850
888.1500 | 890.5850
888.1500
882.5890 | 890.5850
882.5890 | Subset to PP
and SP | |
| Product Code | IPF: Powered Muscle
Stimulator
KQX: Goniometer AC-
powered | IPF: Powered
Muscle Stimulator
KQX:
Goniometer AC-
powered
GZJ:
Stimulator, Nerve,
Transcutaneous,
For Pain Relief | IPF: Powered
Muscle Stimulator
GZJ:
Stimulator, Nerve,
Transcutaneous,
For Pain Relief | Same main
product code
to PP and SP
Subset to PP
and SP | |
| Class | II | II | II | Same | |
| Primary Function | Shoulder Pacemaker is
an electrotherapy
device intended for
neuromuscular
electrical stimulation
(NMES). | The CyMedica e-
vive System is a
multifunctional
electrotherapy
device that allow
for
neuromuscular
electrical
stimulation
(NMES) and
transcutaneous
electrical nerve
stimulation
(TENS). | The
Chattanooga®
Revolution
Wireless is a
neuromuscular
electrical
stimulation
(NMES)
device, which
stimulates nerve
fibers by means of
electrical
impulses
transmitted by
electrodes and
transcutaneous | Same | |
| Device
Characteristic | Subject device
(This 510(k)
Application) | Primary
Predicate (PP) | Secondary
Predicate (SP) | Comparison | |
| Indication for Use | 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. | The CyMedica e-
vive System is a
multifunctional
electrotherapy
device with two
treatment modes
that allow for
neuromuscular
electrical
stimulation
(NMES) and
transcutaneous
electrical nerve
stimulation
(TENS).
Indications for
Use:
As an NMES
device,
indications are for
the following
conditions: - Relaxation of
muscle spasms - Retardation or
prevention of
disuse atrophy - Increasing local
blood circulation - Re-educating
muscles - Immediate post-
surgical
stimulation of calf
muscles to
prevent venous
thrombosis - Maintaining or
increasing range
of motion
As a TENS
device,
indications are for
the following
conditions: - Symptomatic
relief and
management of
chronic
intractable pain - Adjunctive
treatment for
post-surgical and
post-trauma acute
pain. | The Chattanooga
Revolution
Wireless is a
clinical
electrotherapy
device intended
for use under the
supervision of a
Healthcare
Professional.
Indications for
Use:
As an NMES
device,
indications are for
the following
conditions: - Retarding or
preventing disuse
atrophy - Maintaining or
increasing range
of motion - Re-educating
muscles - Relaxation of
muscle spasms - Increasing local
blood circulation - Prevention of
venous
thrombosis of the
calf muscles
immediately after
surgery
As a TENS
device,
indications are for
the following
conditions: - Symptomatic
relief and
management of
chronic,
intractable pain - Post-surgical
and post-trauma
acute pain
As a pulsed mode
device,
indications are for
the following
conditions: - Relaxation of
muscle spasm | Same intended
use to PP and
SP
Subset
Indications for
use with
respect to PP
and SP | |
| Device
Characteristic | Subject device
(This 510(k)
Application) | Primary
Predicate (PP) | Secondary
Predicate (SP) | Comparison | |
| Basic Unit Characteristics | | | | | |
| Power Source(s) | Rechargeable Li-ion
battery, 3.7V / 550
mAh
1.01 x 1.67 x 0.25 (in) | Single
VD434053:
3.7V; 1000mAh;
Lithium-ion
polymer
battery | Remote control
battery:
Rechargeable
3.7[V] / ≥
1,500[mAh]
lithium polymer
(LiPo) battery.
Module battery:
Rechargeable
3.7[V] / ≥
450[mAh] lithium
polymer (LiPo)
battery. | Similar
Note 1 | |
| Method of Line
Current Isolation | N/A
Battery operated device | No line
connection | N/A
Battery operated
device | Same
Note 1 | |
| Patient
Leakage
Current | Normal
condition
(μΑ) | N/A
Battery operated device | 4.88 | N/A
Battery operated
device | Same to SP
Note 1 |
| | Single
fault
condition
(μΑ) | N/A
Battery operated device | 8.00 | N/A
Battery operated
device | Same to SP
Note 1 |
| Average DC current
through electrodes
when device is on but
no pulses are being
applied (μΑ) |