(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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