(248 days)
PA&PR series:
The PA&PR series are a neuromuscular electrical stimulator indical supervision for adjunctive therapy in the treatment of medical diseases and conditions.
As a powered muscle stimulator, PA&PR series are indicated for the following conditions:
- · Relaxation of muscle spasms,
- · Prevention or retardation of disuse atrophy,
- · Increasing local blood circulation,
- · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis,
- · Maintaining or increasing range of motion,
- · Muscle re-education.
Environments of Use: Clinics, hospital. Patient population: Adults
S&Q series:
The S&O series are a neuromuscular electrical stimulator indical supervision for adjunctive therapy in the treatment of medical diseases and conditions.
As a powered muscle stimulator, S&Q series are indicated for the following conditions: - · Relaxation of muscle spasms,
- · Prevention or retardation of disuse atrophy,
- · Increasing local blood circulation,
- · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis,
- · Maintaining or increasing range of motion,
- · Muscle re-education.
As a transcutaneous electrical nerve stimulator for pain relief, S&Q series are indicated for the following conditions:
· Symptomatic relief and management of chronic (long-term), intractable pain, - · Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain.
Environments of Use: Clinics, hospital and home environments.
Patient population: Adults
Subject device have four series, which are PA series, PR series, Q series and S series. These four series are all electrical stimulating devices.
This document is an FDA 510(k) clearance letter for the "Stimulation System" manufactured by Edan Instruments, Inc. It asserts substantial equivalence to a predicate device, STIWELL med4 (K080950).
The provided text does not contain acceptance criteria for an AI-powered device, nor does it describe a study proving such a device meets acceptance criteria.
Instead, this document is a regulatory submission for a medical device (neuromuscular and transcutaneous electrical nerve stimulators) that appears to be hardware-based, with "software/firmware/microprocessor control" mentioned generally, but not as the primary component being evaluated for AI performance. The document focuses heavily on bench testing (electrical safety, EMC, performance to standards) and comparison to a predicate device's physical and electrical specifications, not on AI performance metrics like accuracy, sensitivity, or specificity.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance for an AI device.
- Sample sizes, data provenance, ground truth establishment, or expert involvement related to AI performance.
- MRMC studies or standalone AI performance.
The document's "Performance Data" section explicitly states: "Clinical data: Not applicable." This further confirms that no clinical studies (which would be necessary to prove performance of an AI system in a clinical context) were conducted or presented for this submission.
In summary, the provided text does not describe an AI medical device or its performance criteria/study.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo 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.
May 16, 2024
Edan Instruments, Inc. Tracy Yue Regulatory Affairs Engineer #15 Jinhui Road, Pingshan District Shenzhen, Shenzhen 518122 China
Re: K232786
Trade/Device Name: Stimulation System (PA series, S series and Q series) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, GZJ Dated: September 08, 2023 Received: September 11, 2023
Dear Tracy Yue:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a
{1}------------------------------------------------
change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,
Jitendra V. Virani -S
CDR Jitendra Virani, MS, MBA Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K232786
Device Name
Stimulation System
Model: PA4 Pro: PA4: PA36: PR4 Pro: PR4: PR36; PR38: O3: O9: O10: 012: S6; S9: S10: S12:
Indications for Use (Describe)
PA&PR series:
The PA&PR series are a neuromuscular electrical stimulator indical supervision for adjunctive therapy in the treatment of medical diseases and conditions.
As a powered muscle stimulator, PA&PR series are indicated for the following conditions:
- · Relaxation of muscle spasms,
- · Prevention or retardation of disuse atrophy,
- · Increasing local blood circulation,
- · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis,
- · Maintaining or increasing range of motion,
- · Muscle re-education.
Environments of Use: Clinics, hospital. Patient population: Adults
S&Q series:
The S&O series are a neuromuscular electrical stimulator indical supervision for adjunctive therapy in the treatment of medical diseases and conditions.
As a powered muscle stimulator, S&Q series are indicated for the following conditions:
- · Relaxation of muscle spasms,
- · Prevention or retardation of disuse atrophy,
- · Increasing local blood circulation,
- · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis,
- · Maintaining or increasing range of motion,
- · Muscle re-education.
As a transcutaneous electrical nerve stimulator for pain relief, S&Q series are indicated for the following conditions:
· Symptomatic relief and management of chronic (long-term), intractable pain,
- · Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain.
Environments of Use: Clinics, hospital and home environments.
Patient population: Adults
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(K) Summary Prepared in accordance with the content and format regulatory Requirements of 21 CFR Part 807.92
| 1. Submitter: | Edan Instruments, Inc.#15 Jinhui Road, Jinsha Community,Kengzi Sub-District, Pingshan District,Shenzhen, 518122 P.R.China.Tel: +86(0755) 26858736Fax: +86(0755) 26882223 | ||||||
|---|---|---|---|---|---|---|---|
| Contact person: | Liu Yongying | ||||||
| Preparing date: | April 29, 2024 | ||||||
| 2. Device name andclassification: | Trade Name: Stimulation SystemCommon/Usual Name: PA series, PR series, Q series, S seriesModel:PA series: PA4 Pro; PA4; PA36; PA38;PR series: PR4 Pro; PR4; PR36; PR38;Q series: Q3; Q9; Q10; Q12;S series: S6; S9; S10; S12; | ||||||
| Classification Name Product code 21 CFR 890.5850 Physical Medicine IPF 21 CFR 882.5890 Neurological GZJ | |||||||
| Regulatory Class: Class II | |||||||
| 3. Predicate Device(s): | 1) Otto Bock Healthcare Product GmbH, STIWELL med4, cleared underK080950 (Predicate device). | ||||||
| 4. Device Description: | Subject device have four series, which are PA series, PR series, Q series andS series. These four series are all electrical stimulating devices. | ||||||
| 5. Indication for Use | PA&PR series:The PA&PR series are a neuromuscular electrical stimulator indicated for useunder medical supervision for adjunctive therapy in the treatment of medicaldiseases and conditions.As a powered muscle stimulator, PA&PR series are indicated for the followingconditions: |
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- · Relaxation of muscle spasms,
- · Prevention or retardation of disuse atrophy,
- · Increasing local blood circulation.
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis,
- · Maintaining or increasing range of motion,
- Muscle re-education.
Environments of Use: Clinics, hospital. Patient population: Adults
S&Q series:
The S&Q series are a neuromuscular electrical stimulator indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions.
As a powered muscle stimulator, S&Q series are indicated for the following conditions:
- Relaxation of muscle spasms,
- · Prevention or retardation of disuse atrophy,
- · Increasing local blood circulation,
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
- · Maintaining or increasing range of motion,
- · Muscle re-education.
As a transcutaneous electrical nerve stimulator for pain relief, S&Q series are indicated for the following conditions:
- · Symptomatic relief and management of chronic (long-term), intractable pain,
• Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain.
Environments of Use: Clinics, hospital and home environments. Patient population: Adults
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6. Predicate Device Comparison
Comparison to the predicate devices, the subject device has the same intended use, similar performance effectiveness, the different technological characteristics of Subject device dose not raise different questions of safety and effectiveness. The summary is as following tables:
Subject device (PA&PR series)compares with predicate device
The following tabulation indicates the detailed differences between the subject device (PA&PR series) and the predicate device, we use the maximum configurations to compare with predicate device, and it can cover all other models.
| Item | < Predicate Device > | < Subject Device > | Comparison Result |
|---|---|---|---|
| STIWELL med4 | PA&PR series | ||
| Manufacturer/K# | K080950 | Current Submission | — |
| Indication for use | The STIWELL med4 is a neuromuscular electronicstimulator indicated for use under medicalsupervision for adjunctive therapy in the treatmentof medical diseases and conditions.As a powered muscle stimulator, STIWELLmed4 is indicated for the following conditions:• Relaxation of muscle spasms,• Prevention or retardation of disuse atrophy,• Increasing local blood circulation,• Immediate post-surgical stimulation of calfmuscles to prevent venous thrombosis,• Maintaining or increasing range of motion,• Muscle re-education. | The PA&PR series are a neuromuscular electronicstimulator indicated for use under medicalsupervision for adjunctive therapy in the treatmentof medical diseases and conditions.As a powered muscle stimulator, PA&PR seriesare indicated for the following conditions:• Relaxation of muscle spasms,• Prevention or retardation of disuse atrophy,• Increasing local blood circulation,• Immediate post-surgical stimulation of calfmuscles to prevent venous thrombosis,• Maintaining or increasing range of motion,• Muscle re-education. | Similar,Theindicationsfor use ofthe targeteddevice iswithin thatof thepredicatedevice |
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| As a transcutaneous electrical nerve stimulatorfor pain relief, STIWELL med4 is indicated for thefollowing conditions:• Symptomatic relief and management of chronic(long-term), intractable pain,• Adjunctive treatment in the management ofpost-surgical pain and post traumatic acute pain. |
|---|
| As a biofeedback device, STIWELL med4 isindicated for:• Biofeedback, relaxation, and muscle re-education. |
| As an external functional neuromuscularstimulator, STIWELL med4 is indicated for thefollowing conditions:- Helps to relearn voluntary motor functions of theextremities. |
| As a non-implanted electrical continence device,STIWELL med4 is indicated for the followingconditions:• Acute and ongoing treatment of stress, urge ormixed urinary incontinence and where thefollowing results may improve urinary control:inhibition of the detrusor muscles through reflexivemechanisms and strengthening of pelvic floormuscles.• Incontinence treatment for assessing EMGactivity of the pelvic floor and accessory musclessuch as abdominal and the gluteus muscles |
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Traditional 510(k) of Stimulation System
| Product codes | IPF, GZJ, HCC, GZI, KPI | IPF | Similar |
|---|---|---|---|
| Environment of Use | Clinics, hospital and home environments | Clinics, hospital | Similar |
| Patient population | Adults | Adults | Same |
| Power Source | Battery Pack Li-Ion 11.1 V | AC or Lithium-ion Battery 14.4V | Different |
| Method of Line Current Isolation | Medical Class II Power Adapter | Medical Class I Power Adapter | Note(1) |
| Patient Leakage Current (normal condition) | <100 μ A | <100μA | Same |
| Patient Leakage Current (single fault condition) | <100 μ A | <100μA | Same |
| Number of Output Modes | 4 | 3 | Different Note(2) |
| Number of Output Channels | 4 | 4 | Same |
| Synchronous or Alternating | Alternating | Alternating | Same |
| Method of channel isolation | Transformer, inductive couplers | Transformer | Different Note(3) |
| Regulated Current or Regulated Voltage | Regulated Current | Regulated Current | Same |
| Software/Firmware/Microprocessor Control | Yes | Yes | Same |
| Automatic Overload trip | Yes | Yes | Same |
| Automatic no-load trip | Yes | Yes | Same |
| Automatic Shut Off | Yes | Yes | Same |
| Patient override control | Yes(Stop Button) | Yes(Stop Button) | Same |
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| method | |||
|---|---|---|---|
| Indicator display-On/Off status-Low battery-Voltage/current level | Yes | Yes | Same |
| Compliance withvoluntary standards | IEC 60601-1;IEC 60601-1-2;IEC 60601-2-10;IEC 60601-2-40; | IEC 60601-1;IEC 60601-1-2;IEC 60601-2-10;IEC 60601-2-40; | Same |
| Compliance with 21CFR 898 | YES | YES | Same |
| Dimensions | 175×95×30mm | 270mm232mm55mm | Different |
| Weight | 440g | ≤3 kg | Note(4) |
| Housing materialand Construction | Plastic (Injection Molded ABS) | Plastic (Injection Molded ABS) | Same |
Note (1):
Although the "Power Source" and "Method of Line Current Isolation" are different from predicate device is compliant with IEC 62133 standard. Moreover, the Subject device is IEC 60601-1 compliant and has been tested for electrical safety. The difference between them does not raise different questions of safety and effectiveness of Subject device
Note (2):
The "Number of Output Modes" of Subject device are covered by predicate device, the difference between them does not raise different questions of safety and effectiveness of Subject device.
Note (3):
The "Method of chamel isolation" of Subject device is different from predicate device is IEC 60601-1 compliant and has been tested for electrical safety. Thus the different questions of safety and effectiveness of Subject device.
Note (4):
Although "Weight" and "Dimensions" of Subject device are different from predicate devices, they all comply with IEC 60601-2-10 requirements, thus the difference between them different questions of safety and effectiveness of Subject device.
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| As a powered muscle stimulator (PMS) | |||
|---|---|---|---|
| < Predicate Device > | < Subject Device > | Comparison Result | |
| Item | STIWELL med4 | PA&PR series | |
| Manufacturer/K# | K080950 | Current Submission | / |
| Output specifications | |||
| Waveform | Biphasic symmetrical | Biphasic symmetrical | Same |
| Shape | Rectangular | Rectangular | Same |
| Maximum outputVoltage(500Ω) | 50V | 50V | Same |
| Maximum outputcurrent(500Ω) | 100mA | 100mA | Same |
| Maximum outputVoltage(2kΩ) | 115V | 145V | |
| Maximum outputcurrent(2kΩ) | 58mA | 72.5mA | Similar |
| Maximum outputVoltage(10kΩ) | 125V | 150V | Note 1 PMS |
| Maximum outputcurrent(10kΩ) | 14mA | 15mA | |
| Pulse duration | 50-400μs | 50-400μs | Same |
| Pulse frequency | 1-140Hz | 2-140Hz | Similar |
| For interferentialmodes only:-Beat Frequency (Hz) | N/A | N/A | Same |
| For multiphasicwaveforms only:-Symmetrical phases? | N/A | N/A | Same |
| For multiphasic | N/A | N/A | Same |
| Traditional 510(k) of Stimulation System | |||
| waveforms only:-Phase Duration | |||
| Net Charge(per pulse)(500Ω) | 0μC | 0μC | Same |
| Maximum PhaseCharge (500Ω) | 40μC | 40μC | Same |
| Maximum currentdensity (500Ω) | 12.5mA/cm² | 12.5mA/cm² | Same |
| Maximum powerdensity (500Ω) | 7.9mW/cm² | 7.9mW/cm² | Same |
| Burst Mode | N/A | N/A | Same |
| ON Time | 1 - 20 s | 1 - 20 s | Same |
| OFF Time | 1 - 50 s | 1 - 20 s | Different |
| Treatment Time range | 2-120min | 1-60min, adjustable | Note2 PMS |
| Item | < predicate Device >STIWELL med4 | < Subject Device >S&Q series | Comparison Result |
| Manufacturer/K# | K080950 | Current Submission | — |
| Indication for use | The STIWELL med4 is a neuromuscular electronicstimulator indicated for use under medicalsupervision for adjunctive therapy in the treatmentof medical diseases and conditions.As a powered muscle stimulator, STIWELL med4is indicated for the following conditions:• Relaxation of muscle spasms,• Prevention or retardation of disuse atrophy,• Increasing local blood circulation,• Immediate post-surgical stimulation of calfmuscles to prevent venous thrombosis,• Maintaining or increasing range of motion.• Muscle re-education,As a transcutaneous electrical nerve stimulator forpain relief, STIWELL med4 is indicated for thefollowing conditions:• Symptomatic relief and management of chronic | The S&Q series are a neuromuscularelectronic stimulator indicated for useunder medical supervision foradjunctive therapy in the treatment ofmedical diseases and conditions.As a powered muscle stimulator, S&Qseries are indicated for the followingconditions:• Relaxation of muscle spasms,• Prevention or retardation of disuseatrophy,• Increasing local blood circulation,• Immediate post-surgicalstimulation of calf muscles to preventvenous thrombosis,• Maintaining or increasing range ofmotion.• Muscle re-education, | Similar,The indicationsof the targeted deviceis within that of thepredicate device |
| • Adjunctive treatment in the management ofpost-surgical pain and post traumatic acute pain. | As a transcutaneous electrical nervestimulator for pain relief, S&Q seriesare indicated for thefollowing conditions: | ||
| As a biofeedback device, STIWELL med4 isindicated for: | • Symptomatic relief and managementof chronic (long-term), intractable pain, | ||
| • Biofeedback, relaxation, and muscle re-education. | • Adjunctive treatment in themanagement of post-surgical pain andpost traumatic acute pain. | ||
| As an external functional neuromuscularstimulator, STIWELL med4 is indicated for thefollowing conditions: | |||
| - Helps to relearn voluntary motor functions of theextremities. | |||
| As a non-implanted electrical continence device,STIWELL med4 is indicated for the followingconditions: | |||
| • Acute and ongoing treatment of stress, urge ormixed urinary incontinence and where thefollowing results may improve urinary control:inhibition of the detrusor muscles through reflexivemechanisms and strengthening of pelvic floormuscles. | |||
| • Incontinence treatment for assessing EMGactivity of the pelvic floor and accessory musclessuch as abdominal and the gluteus muscles. | |||
| Product codes | IPF, GZJ, HCC, GZI, KPI | IPF, GZJ | Similar |
| Clinics, hospital and home | |||
| Environment of Use | Clinics, hospital and home environments | environments | Same |
| Patient population | Adults | Adults | Same |
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Note1 PMS:
At impedances of 2kΩ and 10kΩ, the Maximum output current is determined by the Maximum output Voltage of the subject device. The
Maximum output Voltage of the subject device is slightly higher than that of the maximum output current is also slightly higher than that of predicate device, but the maximum output current is within the range of 100mA.
Also, the working principle of the subject device is to electrically stimulate the human body through and performance is determined by the current density. The maximum current density of subject device is the same.
Therefore, the different technological characteristics of Subject device do not raise any different questions of safety and effectiveness.
Note2 PMS:
The "OFF Time" and "Treatment Time range" of Subject device are covered by the predicate device, thus the different technological characteristics of Subject device do not raise different questions of safety and effectiveness.
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Subject device (S&Q series) compares with predicate devices
The following tabulation indicates the detailed comparison between the subject device(S&Q series) and the predicate device, we use the Maximum configuration to compare with predicate device, and it can cover all other models.
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{14}------------------------------------------------
Traditional 510(k) of Stimulation System
| Power Source | Battery Pack Li-Ion 11.1 V | Lithium-ion Battery 3.7V | |
|---|---|---|---|
| Method of Line Current Isolation | Medical Class II Power Adapter | Internal Power Supply, Charging for class II | Different Note(1) |
| Patient Leakage Current (normal condition) | <100 μ Α | <100 μ Α | Same |
| Patient Leakage Current (single fault condition) | <100 μ Α | <100 μ Α | Same |
| Number of Output Modes | 4 | 3 | Different Note(2) |
| Number of Output Channels | 4 | 2 | |
| Synchronous or Alternating | Alternating | Alternating | Same |
| Method of channel isolation | Transformer, inductive couplers | Optocoupler | Different Note(3) |
| Regulated Current or Regulated Voltage | Regulated Current | Regulated Current | Same |
| Software/Firmware/Microprocessor Control | Yes | Yes | Same |
| Automatic Overload trip | Yes | Yes | Same |
| Automatic no-load trip | Yes | Yes | Same |
| Automatic Shut Off | Yes | Yes | Same |
| Patient override control method | Yes(Stop Button) | Yes(Stop Button) | Same |
| Indicator display -On/Off status -Low battery | Yes | Yes | Same |
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| -Voltage/current level | |||
|---|---|---|---|
| Compliance withvoluntary standards | IEC 60601-1;IEC 60601-1-2;IEC 60601-2-10;IEC 60601-2-40; | IEC 60601-1;IEC 60601-1-2;IEC 60601-2-10;IEC 60601-2-40;IEC 60601-1-11; | Similar |
| Compliance with 21CFR 898 | YES | YES | Same |
| Dimensions | 175×95×30mm | 127 mm×66 mm×25mm | Different Note(4) |
| Weight | 440g | ≤220g (including the battery ) | |
| Housing materialand Construction | Plastic (Injection Molded ABS) | Plastic (Injection Molded ABS) | Same |
Note (1):
Although the "Power Source" and "Method of Line different from Predicate Devices, Subject device are compliant with IEC 62133 standard. Moreover, the Subject device are IEC 60601-1 compliant and has been the different technological characteristics of the Subject device do not raise different questions of safety and effectiveness.
Note (2):
The "Number of Output Modes" and "Number of Output Channels" of Subject device are covered by predicate devices, the different technological characteristics of the Subject device do not raise different questions of safety and effectiveness.
Note (3):
Although "Method of chamel isolation" is different from the predicate devices, Subject device are IEC 60601-1 compliant and has been tested for electrical safety with a positive result and Patient Leakage Current. The different technological characteristic of the Subject device does not raise different questions of safety and effectiveness.
Note (4):
Although "Weight" and "Dimensions" of Subject device are different from the predicate devices, they all comply with IEC 60601-1, IEC 60601-2-10 requirements, thus the difference between them doesn't affect the performance and safety of the Subject device.
| As a powered muscle stimulator (PMS) | |||
|---|---|---|---|
| Item | < predicate Device > | < Subject Device > | Comparison Result |
| STIWELL med4 | S&Q series | / | |
| Manufacturer /K# | K080950 | Current Submission | |
| Output specifications | |||
| Waveform | Biphasic symmetrical | Biphasic symmetrical | Same |
| Shape | Rectangular | Rectangular | |
| Maximum outputVoltage(500Ω) | 50V | 50V | Same |
| Maximum outputcurrent(500Ω) | 100mA | 100mA | Same |
| Maximum outputVoltage(2kΩ) | 115V | 110V | |
| Maximum outputcurrent(2kΩ) | 58mA | 55mA | SimilarNote 1 PMS |
| Maximum outputVoltage(10kΩ) | 125V | 115V | |
| Maximum outputcurrent(10kΩ) | 14mA | 11mA | |
| Pulse duration | 50-400μs | 50-400μs | Same |
| Pulse frequency | 1-140Hz | 2-140Hz | Similar |
| For interferentialmodes only:-Beat Frequency (Hz) | N/A | N/A | Same |
| For multiphasicwaveforms only:-Symmetrical phases? | N/A | N/A | Same |
| For multiphasicwaveforms only:-Phase Duration | N/A | N/A | Same |
| Net Charge(per pulse) | 0μC | 0μC | Same |
| (500Ω) | |||
| Maximum PhaseCharge (500Ω) | 40μC | 40μC | Same |
| Maximum currentdensity (500Ω) | 12.5mA/cm² | 12.5mA/cm² | Same |
| Maximum powerdensity (500Ω) | 7.9mW/cm² | 7.9mW/cm² | Same |
| Burst Mode | N/A | N/A | Same |
| ON Time | 1 - 20 s | 1 - 20 s | Same |
| OFF Time | 1 - 50 s | 1 - 20 s | Different Note 2 PMS |
| Treatment Time range | 2-120min | ≤60min |
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Traditional 510(k) of Stimulation System
{17}------------------------------------------------
Note1&2 PMS:
These parameters of Subject device are covered by predicate device, thus the different technological characteristics of Subject device do not raise different questions of safety and effectiveness.
As a transcutaneous electrical nerve stimulator(TENS)
| Item | < Predicate Device >STIWELL med4 | < Subject Device >S&Q series | Comparison Result |
|---|---|---|---|
| Manufacturer/K# | K080950 | Current Submission | / |
| Output specifications | |||
| Waveform | Biphasic symmetrical | Biphasic symmetrical | Same |
| Shape | Rectangular | Rectangular | Same |
| Maximum outputVoltage(500Ω) | 50V | 50V | Same |
| Maximum outputcurrent(500Ω) | 100mA | 100mA | Same |
| Maximum outputVoltage(2kΩ) | 115V | 110V | SimilarNote1 TENS |
| Maximum outputcurrent(2kΩ) | 58mA | 55mA | |
| Maximum outputVoltage(10kΩ) | 125V | 115V | |
| Maximum outputcurrent(10kΩ) | 14mA | 11mA | |
| Pulse duration | 150-200μs | 150-200μs | Same |
| Pulse frequency | 2-100Hz | 2-100Hz | Same |
| For interferentialmodes only: | N/A | N/A | Same |
| -Beat Frequency (Hz) | |||
| For multiphasicwaveforms only: | N/A | N/A | Same |
| -Symmetrical phases? | |||
| For multiphasicwaveforms only: | N/A | N/A | Same |
| -Phase Duration | |||
| Net Charge(per pulse)(500Ω) | 0μC | 0μC | Same |
| Maximum PhaseCharge (500Ω) | 20μC | 20μC | Same |
| Maximum currentdensity (500Ω) | 12.5mA/cm² | 12.5mA/cm² | Same |
| Maximum powerdensity (500Ω) | 1.0mW/cm² | 1.0mW/cm² | Same |
| Burst Mode: Pulses perburst | 8 | 8 | Same |
| Burst Mode: Burstsper second | 2 | 2 | Same |
| Burst Mode: Burstduration (seconds) | 100ms | 100ms | Same |
| Burst Mode: Duty Cycle | 20% | 20% | Same |
| ON Time | Continuous or Burst | Continuous or Burst | Same |
| OFF Time | N/A | N/A | Same |
| Treatment Time range | 10-120min | <60min | DifferentNote2 TENS |
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Traditional 510(k) of Stimulation System
Note1&2 TENS:
These parameters of Subject device are covered by predicate device, thus the different technological characteristics of Subject device do not raise different questions of safety and effectiveness.
As seen in the comparison tables, the subject device have similar design features and performance specifications. The technological differences between the subject device do not raise different questions of safety or effectiveness.
7. Performance Data:
Non-clinical data:
Electrical safety and electromagnetic compatibility (EMC)
The subject device was assessed for conformity with the relevant requirements of the following standards and comply:
- ANSI AAMI ES 60601-1:2005/(R) 2012 and A1:2012, C1:2009/R) 2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2 Edition 4.1 2020-09. Medical electrical equipments for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Performance testing-Bench
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Edan has conducted functional and system level testing to validate the performance of the bench testing show that the subject device meets its accuracy specification and meet relevant consensus standards.
- . IEC 60601-2-10 Edition 2.1 2016-04. Medical electrical equipment - Part 2-10: Particular requirements for the basential performance of nerve and muscle stimulators
- IEC 60601-2-40 Edition 2.0 2016-08, Medical electrical equipment -Part 2-40: Particular requirements for the basential performance of electromyographs and evoked response equipment
- IEC 60601-1-11 Edition 2.1 2020-07, Medical electrical equirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical electrical systems used in the home healthcare environment
Biocompatibility testing
This is a surface contacting device with intact skin. The proposed device was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1 , "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
Software Verification and Validation Testing
Software verfication and validation testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Clinical data: Not applicable.
Summary
The non-clinical performance testing showed that the subject devices are as safe and as effective as the predicate device.
8. Conclusion
The bench testing data and software verification demonstrate that subject device 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).