(333 days)
Needle Stimulator is an electro-acupuncture stimulator device, which is indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
Needle Stimulator is an electro-acupuncture device for acupuncture therapy powered by 6 pieces of 1.5V batteries or AC 100-240V. It is composed of a console and 6 channels of electrode cables with alligator type connectors. The console has the operating controls including function knobs or buttons. Needle Stimulator does not equip with acupuncture needles. The practitioners should select legally marketed needles.
Based on the provided text, the device in question is a "Needle Stimulator," an electro-acupuncture stimulator. The document is a 510(k) Summary, which aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This type of submission relies on comparisons to demonstrate safety and effectiveness rather than conducting extensive clinical studies typically associated with novel devices.
Therefore, the acceptance criteria and the "study" proving the device meets them are primarily based on equivalence to a predicate device through engineering and performance testing, rather than a clinical efficacy study with human subjects.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the parameters of the predicate device (K130768) and compliance with relevant safety standards. The reported device performance is presented as a comparison to these predicate specifications.
| Parameter | Acceptance Criteria (Predicate Device K130768) | Reported Device Performance (Model CMNS6-1) | Reported Device Performance (Model CMNS6-2) | Remarks (from text) |
|---|---|---|---|---|
| Intended Use | Electro-acupuncture stimulator for qualified practitioners | Same | Same | Same |
| Type of Use | Prescription use | Same | Same | Same |
| Power Source(s) | DC 1.5Vx6 Type R14 | DC 1.5Vx6 Type R14 or AC 100-240V | DC 1.5Vx6 Type R14 or AC 100-240V | Note 1: AC power passed IEC 60601-1 and EMC tests |
| Method of Line Current Isolation | Type BF | Type BF | Type BF | Same |
| Patient Leakage Current (Normal) | 2µA | 2µA | 2µA | Same |
| Patient Leakage Current (Single Fault) | ≤50µA | ≤50µA | ≤50µA | Same |
| Avg DC current through electrodes (no pulses) | N/A | N/A | N/A | Same |
| Number of Output Modes | 3 (continuous/interrupted/dense-disperse wave) | Same | Same | Same |
| Number of Output channels | 6 (3 channels at most work together on single patient) | Same | Same | Same |
| Synchronous or Alternating | Synchronous | Synchronous | Synchronous | Same |
| Method of Channel Isolation | Transformer | Transformer | Transformer | Same |
| Regulated Current or Voltage? | Voltage Control | Voltage Control | Voltage Control | Same |
| Software/Firmware/Microprocessor Control? | Yes | Yes | Yes | Same |
| Automatic Overload Trip? | No | No | No | Same |
| Automatic No-Load Trip? | No | No | No | Same |
| Automatic Shut Off? | Yes | Yes | Yes | Same |
| User Override Control? | Yes | Yes | Yes | Same |
| On/Off Status Indicator? | Yes | Yes | Yes | Same |
| Low Battery Indicator? | Yes | Yes | Yes | Same |
| Voltage/Current Level Indicator? | Yes | Yes | Yes | Same |
| Timer Range (minutes) | 0-60min | 0-60min | 1-99min | Note 2 (for CMNS6-2): Difference insignificant |
| Compliance with Voluntary Standards? | IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2 | Same | Same | Same |
| Compliance with 21 CFR 898? | Yes | Yes | Yes | Same |
| Weight (grams) | 740g | 740g | approx. 657g | Note 2 (for CMNS6-2): Difference insignificant |
| Dimensions [W x H x D] | 23015555mm | 23015555mm | 23818475mm | Note 2 (for CMNS6-2): Difference insignificant |
| Housing Materials & Construction | ABS; Injection molded | ABS; Injection molded | ABS; Injection molded | Same |
| Waveform | Biphasic | Biphasic | Biphasic | Same |
| Shape | Asymmetric biphasic square wave | Asymmetric biphasic square wave | Asymmetric biphasic square wave | Same |
| Max Output Voltage (@500Ω) | 27V±10% | 27V±10% | 27V±10% | Same |
| Max Output Voltage (@2kΩ) | 60.4V±10% | 60.4V±10% | 60.4V±10% | Same |
| Max Output Voltage (@10kΩ) | 75V±10% | 75V±10% | 75V±10% | Same |
| Max Output Current (@500Ω) | 54mA±10% | 54mA±10% | 54mA±10% | Same |
| Max Output Current (@2kΩ) | 30.2mA±10% | 30.2mA±10% | 30.2mA±10% | Same |
| Max Output Current (@10kΩ) | 7.5mA±10% | 7.5mA±10% | 7.5mA±10% | Same |
| Pulse width (Positive) | 200µs±10% | 200µs±10% | 175µs±10% | Note 3 (for CMNS6-2): Passed IEC 60601-2-10 tests |
| Pulse width (Negative) | 1030µs (5.15 x (+Phase)) | 1030µs (5.15 x (+Phase)) | 1051µs (6 x (+Phase)) | Note 3 (for CMNS6-2): Passed IEC 60601-2-10 tests |
| Pulse Period (msec) | 10~1000ms | 10~1000ms | 10~1000ms | Same |
| Max. pulse frequency (Rate) | 1~100Hz±10% | 1~100Hz±10% | 1~100Hz±10% | Same |
| Net Charge (µC per pulse) | 0µC@500Ω, + and – pulses cancel | 0µC@500Ω, + and – pulses cancel | 0µC@500Ω, + and - pulses cancel | Same |
| Maximum Phase Charge (µC) | 9.4µC @500Ω | 9.4µC @500Ω | 8.225µC @500Ω | Note 4 (for CMNS6-2): Complies with standards |
| Maximum Average Current (mA) | 1.08mA @500Ω | 1.08mA @500Ω | 0.945mA @500Ω | Note 4 (for CMNS6-2): Better safety |
| Maximum Current Density (mA/cm², r.m.s.) | 13.3mA/cm²@500Ω | 9.4mA/cm²@500Ω | 8.225mA/cm² @500Ω | Note 2 (for K130768 vs CMNS6-1), Note 4 (for K130768 vs CMNS6-2). Calculated by different needle surface areas, within safety limit. |
| Maximum Average Power Density (W/cm²) | 0.2W/cm²@500Ω | 0.141W/cm²@500Ω | 0.1234W/cm²@500Ω | Note 2 (for K130768 vs CMNS6-1), Note 4 (for K130768 vs CMNS6-2). Calculated by different needle surface areas, within safety limit. |
| Biocompatibility | ISO10993-5, ISO 10993-10 | Same | Same | Same |
| Accessories | Lead wires, Alligator type connectors | Same | Same | Same |
2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in the context of clinical data for performance evaluation. Instead, the "testing" refers to engineering and compliance testing of the device prototypes themselves. Therefore, the "sample size" is the manufactured device unit or units tested for compliance.
- Sample Size: Not applicable in the context of a clinical test set. The testing was performed on the device models themselves (CMNS6-1 and CMNS6-2).
- Data Provenance: Not specified as clinical data. The tests were likely conducted by the manufacturer in China, given their location. The studies are retrospective in the sense that they are proving equivalency to a device already on the market, but the testing on the new device would have been done prospectively for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the ground truth for this type of submission is established through:
- Engineering specifications and design requirements.
- Compliance with recognized national and international safety standards (ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-10).
- Demonstration of substantial equivalence to a legally marketed predicate device.
No human expert interpretation of clinical data (like radiology reads) is involved in establishing "ground truth" for this device's safety and performance claim.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there is no clinical test set requiring human adjudication. The "adjudication" is done through engineering measurements and conformity assessments to established standards and predicate specifications.
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
This is not applicable. The device is an electro-acupuncture stimulator, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or required for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical instrument, not a software algorithm. Its performance is inherent in its electrical and mechanical properties, not an algorithm's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this submission is:
- Engineering specifications and performance characteristics of the predicate device (K130768).
- International and national safety standards (ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-10), which define acceptable limits for various electrical and physical parameters, ensuring patient and user safety.
- The premise that if the new device operates within the same safety and performance parameters as a previously cleared predicate and complies with relevant standards, it is "safe and effective."
8. The sample size for the training set
This is not applicable. This is not an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established
This is not applicable. As it is not an AI/ML device, there is no training set or associated ground truth establishment process.
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August 27, 2021
Wuxi Jiajian Medical Instrument Co., Ltd Caihong Sun Regulatory Assurance No. 35 Baiqiao Rd., Ehu Town, Xishan District, Wuxi, Jiangsu 214116 China
Re: K202861
Trade/Device Name: Needle Stimulator Regulatory Class: Unclassified Product Code: BWK Dated: August 9, 2021 Received: August 13, 2021
Dear Caihong Sun:
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 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
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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,
Jitendra V. Virani -S
For
Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine 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) K202861
Device Name Needle Stimulator
Indications for Use (Describe)
Needle Stimulator is an electro-acupuncture stimulator device, which is indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary [As required by 21 CFR 807.92]
1. Submission Information: 510(k) Number: K202861 Date: April 1st, 2021 Type of 510(k) Submission: Traditional Modified device Basis for 510(k) Submission: Submitter/Manufacturer: Wuxi Jiajian Medical Instrument Co., Ltd No. 35 Baiqiao Rd., Ehu Town, Xishan District, Wuxi, Jiangsu, China 214116 Contact: Doris Dong [Consultant, from Shanghai CV Technology Co., Ltd.] Add: Room 903, No. 19 Dongbao Road, Songjiang Area, Shanghai, 201613 China E-mail: doris.d(@ceve.org.cn Tel: 86 21-31261348 / Fax: 86 21-57712250
2. Device Description:
| Proprietary Name: | Needle Stimulator |
|---|---|
| Model: | CMNS6-1, CMNS6-2 |
| Common Name: | Electro-Acupuncture |
| Product Code: | BWK |
| Device Class: | Unclassified |
| Review Panel: Device | Neurology |
| Description: | Needle Stimulator is an electro-acupuncture device for acupuncture therapy powered by 6 pieces of 1.5V batteries or AC 100-240V. It is composed of a console and 6 channels of electrode cables with alligator type connectors. The console has the operating controls including function knobs or buttons. Needle Stimulator does not equip with acupuncture needles. The practitioners should select legally marketed needles. |
| Indications for use: | Needle Stimulator is an electro-acupuncture stimulator device, which is indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states. |
3. Substantial Equivalence to Predicate device:
Detailed comparison data is included in "Section 10.1 - Substantial Equivalence Discussion" of this 510(k) submission.
Table 1-
| Parameters | Modified Device | Predicate Device | Remark | ||
|---|---|---|---|---|---|
| 1 | 510(k) Number: | K202861 | K130768 | -- | |
| 2 | Marketing clearancedate: | No | August 16, 2013 | -- | |
| 3 | Device Name | Needle Stimulator | Jiajian® CMN Stimulator | -- | |
| 4 | Model | CMNS6-1 | / | -- | |
| 5 | Manufacturer | Wuxi Jiajian Medical Instrument Co.,Ltd | Wuxi Jiajian Medical Instrument Co.,Ltd | Same | |
| 6 | Intended use | Needle Stimulator is an electro-acupuncture stimulator device, which is indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states. | Jiajian® CMN Stimulator is an electro-acupuncture stimulator device, which is indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states. | Same | |
| 7 | Type of use | Prescription use | Prescription use | Same | |
| Power Source(s) | DC 1.5Vx6 Type R14 or AC 100-240V | DC 1.5Vx6 Type R14 | SameNote 1 | ||
| Method of Line Current Isolation | Type BF | Type BF | Same | ||
| 8 | Patient Leakage-Current | -- | -- | Same | |
| Normal Condition (μΑ) | 2μΑ | 2μΑ | |||
| Single Fault-Condition (μΑ) | ≤50μΑ | ≤50μΑ | |||
| 9 | Average DC current through electrodes when device is on but no pulses are being applied (μΑ) | N/A | N/A | Same | |
| 10 | Number of Output Modes | 3 (continuous wave/ interrupted wave/ Dense-disperse wave) | 3 (continuous wave/ interrupted wave/ Dense-disperse wave) | Same | |
| Number of Output channels: | 6 (3 channels at most work together on single patient) | 6 (3 channels at most work together on single patient) | Same | ||
| 11 | - Synchronous or Alternating? | Synchronous | Synchronous | Same | |
| Method of Channel Isolation | Transformer | Transformer | Same | ||
| 12 | Regulated Current or Regulated Voltage? | Voltage Control | Voltage Control | Same | |
| 13 | Software/Firmware/Microprocessor Control? | Yes | Yes | Same | |
| 14 | Automatic Overload Trip? | No | No | Same | |
| 15 | Automatic No-Load Trip? | No | No | Same | |
| 16 | Automatic Shut Off? | Yes | Yes | Same | |
| 17 | User Override | Yes | Yes | Same | |
| Control? | |||||
| 18 | On/OffStatus? | Yes | Yes | Same | |
| LowBattery? | Yes | Yes | Same | ||
| IndicatorDisplay: | Voltage/CurrentLevel? | Yes | Yes | Same | |
| 19 | Timer(minutes) | Range | 0-60min | 0-60min | |
| 20 | Compliance withVoluntary Standards? | IEC 60601-1, IEC 60601-2-10,IEC 60601-1-2 | IEC 60601-1, IEC 60601-2-10,IEC 60601-1-2 | Same | |
| 21 | Compliance with 21CFR 898? | Yes | Yes | Same | |
| 22 | Weight (grams) | 740g | 740g | Same | |
| 23 | Dimensions [W x H x D] | 23015555mm | 23015555mm | Same | |
| 24 | Housing Materials &Construction | ABS; Injection molded | ABS; Injection molded | Same | |
| 25 | Waveform | Biphasic | Biphasic | Same | |
| 26 | Shape | Asymmetric biphasic squarewave | Asymmetric biphasic squarewave | Same | |
| 27 | Maximum OutputVoltage (volts) | 27V±10% @500Ω | 27V±10% @500Ω | Same | |
| 60.4V±10% @2kΩ | 60.4V±10% @2kΩ | Same | |||
| 75V±10% @10kΩ | 75V±10% @10kΩ | Same | |||
| 28 | Maximum OutputCurrent (specify units) | 54mA±10% @500Ω | 54mA±10% @500Ω | Same | |
| 30.2mA±10% @2kΩ | 30.2mA±10% @2kΩ | Same | |||
| 7.5mA±10% @10kΩ | 7.5mA±10% @10kΩ | Same | |||
| 29 | Pulsewidth(µsec) | Positive | 200µs±10% | 200µs±10% | Same |
| Negative | 1030µs (5.15 x (+Phase) ) | 1030µs (5.15 x (+Phase) ) | Same | ||
| 30 | Pulse | Period (msec) | 10~1000ms | 10~1000ms | Same |
| 31 | Max. pulse frequency(Hz) [or Rate (pps)] | 1~100Hz±10% | 1~100Hz±10% | Same | |
| 32 | Net Charge (µC perpulse) | 0µC@500Ω, + and – pulsescancel | 0µC@500Ω, + and – pulsescancel | Same | |
| 33 | MaximumCharge, (µC) | Phase | 9.4µC @500Ω | 9.4µC @500Ω | Same |
| 34 | Maximum AverageCurrent, (mA) | 1.08mA @500Ω | 1.08mA @500Ω | Same | |
| 35 | Maximum CurrentDensity, (mA/cm², r.m.s.) | 9.4mA/cm² @500Ω | 13.3mA/cm² @500Ω | SameNote 2 | |
| 36 | Maximum Average | 0.141W/cm²@500Ω | 0.2W/cm²@500Ω | ||
| Power(W/cm²) | Density, | ||||
| 37 | Biocompatibility | ISO10993-5, ISO 10993-10 | ISO10993-5, ISO 10993-10 | Same | |
| 38 | Accessories | Lead wires, Alligator type connectors | Lead wires, Alligator type connectors | Same |
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Note 1:
Compared with the predicate device, the proposed device can be connected to AC power. Both of the AC power and DC power of the proposed device have passed IEC 60601-1 and EMC tests, and the description of AC power supply has been added to user manual. Therefore, this difference doesn't raise any safety and effectiveness issues.
Note 2:
The maximum current density and maximum power density are different between the proposed device and the predicate device because they are calculated by different needle surface areas. After calculation, both of them are within the safety limit. Therefore, this difference doesn't raise any safety and effectiveness issues.
Detailed comparison data is included in "Section 10.2 - Substantial Equivalence Discussion" of this 510(k) submission.
Table 2-
| Parameters | Modified Device | Predicate Device | Remark | |||
|---|---|---|---|---|---|---|
| 1 | 510(k) Number: | K202861 | K130768 | -- | ||
| 2 | Marketing clearance date: | No | August 16, 2013 | -- | ||
| 3 | Device Name | Needle Stimulator | Jiajian® CMN Stimulator | -- | ||
| 4 | Model | CMNS6-2 | / | -- | ||
| 5 | Manufacturer | Wuxi Jiajian Medical Instrument Co.,Ltd | Wuxi Jiajian Medical Instrument Co.,Ltd | Same | ||
| 6 | Intended use | Needle Stimulator is an electro-acupuncture stimulator device, which is indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states. | Jiajian® CMN Stimulator is an electro-acupuncture stimulator device, which is indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states. | Same | ||
| 7 | Type of use | Prescription use | Prescription use | Same | ||
| Power Source(s) | DC 1.5Vx6 Type R14 or AC 100-240V | DC 1.5Vx6 Type R14 | SameNote 1 | |||
| - Method of Line Current Isolation | Type BF | Type BF | Same | |||
| 8 | - Patient Leakage Current | -- | -- | Same | ||
| -- Normal Condition (μΑ) | 2μΑ | 2μΑ | ||||
| -- Single Fault Condition (μΑ) | ≤50μΑ | ≤50μΑ | ||||
| 9 | Average DC current | N/A | N/A | Same | ||
| through | electrodes | |||||
| when device is on but | ||||||
| no pulses are being | ||||||
| applied (µA) | ||||||
| 10 | Number of Output Modes | 3 (continuous wave/interrupted wave/Dense-disperse wave) | 3 (continuous wave/interrupted wave/Dense-disperse wave) | Same | ||
| 11 | Number of Output channels: | 6 (3 channels at most worktogether on single patient) | 6 (3 channels at most worktogether on single patient) | Same | ||
| - Synchronous or Alternating? | Synchronous | Synchronous | Same | |||
| - Method of Channel Isolation | Transformer | Transformer | Same | |||
| 12 | Regulated Current or Regulated Voltage? | Voltage Control | Voltage Control | Same | ||
| Software/Firmware/Microprocessor Control? | Yes | Yes | Same | |||
| 13 | ||||||
| 14 | Automatic Overload Trip? | No | No | Same | ||
| 15 | Automatic No-Load Trip? | No | No | Same | ||
| 16 | Automatic Shut Off? | Yes | Yes | Same | ||
| 17 | User Override Control? | Yes | Yes | Same | ||
| 18 | Indicator Display: | |||||
| On/Off Status? | Yes | Yes | Same | |||
| Low Battery? | Yes | Yes | Same | |||
| Voltage/Current Level? | Yes | Yes | Same | |||
| 19 | Timer (minutes) Range | 1-99min | 0-60min | SameNote 2 | ||
| 20 | Compliance with Voluntary Standards? | IEC 60601-1, IEC 60601-2-10,IEC 60601-1-2 | IEC 60601-1, IEC 60601-2-10,IEC 60601-1-2 | Same | ||
| 21 | Compliance with 21 CFR 898? | Yes | Yes | Same | ||
| 22 | Weight (grams) | approx. 657g | 740g | Same | ||
| 23 | Dimensions [W x H x D] | 23818475mm | 23015555mm | SameNote 2 | ||
| 24 | Housing Materials & Construction | ABS; Injection molded | ABS; Injection molded | Same | ||
| 25 | Waveform | Biphasic | Biphasic | Same | ||
| 26 | Shape | Asymmetric biphasic square | Asymmetric biphasic square | Same | ||
| wave | wave | |||||
| 27 | MaximumOutputVoltage (volts) | 27V±10% @500Ω | 27V±10% @500Ω | Same | ||
| 60.4V±10% @2kΩ | 60.4V±10% @2kΩ | Same | ||||
| 75V±10% @10kΩ | 75V±10% @10kΩ | Same | ||||
| 28 | Maximum | Output | 54mA±10% @500Ω | 54mA±10% @500Ω | Same | |
| Current | (specify | 30.2mA±10% @2kΩ | 30.2mA±10% @2kΩ | Same | ||
| units) | 7.5mA±10% @10kΩ | 7.5mA±10% @10kΩ | Same | |||
| 29 | Pulse | Positive | 175µs±10% | 200µs±10% | Same | |
| width(µsec) | Negative | 1051µs (6 x (+Phase) ) | 1030µs (5.15 x (+Phase) ) | Note 3 | ||
| 30 | PulsePeriod (msec) | 10~1000ms | 10~1000ms | Same | ||
| 31 | Max. pulse frequency(Hz) [or Rate (pps)] | 1~100Hz±10% | 1~100Hz±10% | Same | ||
| 32 | Net Charge (µC perpulse) | 0µC@500Ω, + and - pulsescancel | 0µC@500Ω, + and - pulsescancel | Same | ||
| 33 | MaximumPhaseCharge, (µC) | 8.225μC @500Ω | 9.4μC @500Ω | SameNote 4 | ||
| 34 | MaximumAverageCurrent, (mA) | 0.945mA @500Ω | 1.08mA @500Ω | |||
| 35 | MaximumDensity,r.m.s.) | Current(mA/cm², | 8.225mA/cm² @500Ω | 13.3mA/cm² @500Ω | ||
| 36 | MaximumPower(W/cm²) | AverageDensity, | 0.1234W/cm²@500Ω | 0.2W/cm²@500Ω | ||
| 37 | Biocompatibility | ISO10993-5, ISO 10993-10 | ISO10993-5, ISO 10993-10 | Same | ||
| 38 | Accessories | Leadwires, Alligatortypeconnectors | Leadwires, Alligatortypeconnectors | Same |
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Note 1:
Compared with the predicate device, the proposed device can be connected to AC power. Both of the AC power and DC power of the proposed device have passed IEC 60601-1 and EMC tests, and the description of AC power supply has been added to user manual. Therefore, this difference doesn't raise any safety and effectiveness issues.
Note 2:
The weight, dimensions and appearance of the proposed device are a little different from the predicate device K130768, but these differences are insignificant in the terms of safety or effectiveness. Besides, there is a difference in treatment time range between the proposed device and predicate device. The treatment time can be adjusted by user as they want. So, the difference of treatment time range will not raise any safety or effectiveness issue.
Note 3:
There is a difference in the pulse width between the proposed device and predicate device. Based on the calculation of maximum current density, maximum power density, these parameters don't exceed the safety limit. All deviation and the worst case have been considered in risk analysis report, and all parameters have passed IEC 60601-2-10 test codes. So, the difference doesn't raise any new safety and effectiveness issues.
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Note 4:
The Maximum Phase Charge of the proposed device are similar to the predicate device, and both of them comply with IEC 60601-1 and IEC 60601-2-10 requirements. So, the differences will not raise any safety or effectiveness issue.The maximum average current of the proposed device is smaller than that of the predicate device which means the better safety. The maximum current density and maximum power density are different between the proposed device and the predicate device because they are calculated by different needle surface areas. After calculation, both of them are within the safety limit. Therefore, this difference doesn't raise any safety and effectiveness issues.
4. Test summary:
Needle Stimulator is safe and effective as the predicate devices cited above. The new devices have passed testings according to the following standards:
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ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD);
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IEC 60601-1-2: Edition 4.0 2014-02 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances -Requirements And Tests;
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IEC 60601-2-10 Edition 2.1 2016-04 Medical Electrical Equipment - Part 2-10: Particular Requirements For The Basic Safety And Essential Performance Of Nerve And Muscle Stimulators;
The conclusion drawn from the testings are that the new devices are substantially equivalent to the predicate device. Furthermore, the new device complies with the recognized standards and performs its intended tasks as well as the legally marketed predicate device.
N/A