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K Number
K141168
Device Name
ANSISTIM
Manufacturer
DYANSYS, INC.
Date Cleared
2015-05-15

(374 days)

Product Code
BWK
Regulation Number
N/A
Type
Traditional
Panel
NE
Reference & Predicate Devices
K050123
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The ANSiStim™ is an electro-acupuncture device for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

Device Description

The ANSiStim™ is a wearable battery-operated device that is designed to administer continuous low-level electrical pulses at the ear over four days. The stimulation needles are inserted at three specific points, which have the ability to stimulate the acupoints in the human body. Three zinc air batteries with 1.4 V provide the required stimulation energy for a maximum of 96 hours. This constant current source guarantees equivalent stimulation energy regardless of the individual impedance of the skin. The stimulation pattern consists of 1 Hz single pulses with square waveform. The current direction is inverted every second pulse, which is intended to avoid polarization effects. To minimize the risk of adaption or tolerance to the electrical stimulation, stimulation is applied for 3 hours, followed by a pause of 3 hours.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ANSiStim™ device based on the provided text:

Acceptance Criteria and Device Performance

The ANSiStim™ device demonstrates substantial equivalence to its predicate device (P-STIM, K050123) through performance, biocompatibility, and sterilization testing.

Table 1: Acceptance Criteria and Reported Device Performance

Test CategoryAcceptance Criteria/RequirementReported Device Performance (ANSiStim™)
Performance TestingEffectiveness of each unit verified.
Comparison of effectual output to predicate device.
Functional test for 96 hours to monitor 3 hours ON/3 hours OFF state, capturing pulse width, pulse duration, amplitude, and current values.Physical Test: Bare board test performed.
Functional Test: Performed for 96 hours, monitoring 3 hours ON/3 hours OFF state. Pulse width, pulse duration, amplitude, and current values captured.
Comparative Performance Testing: Wire assembly testing, PCB assembly testing, and final product testing against predicate device.
Conclusion: "ANSiStim™ sub-system functionality is effectual, hence the final product is found working without any discrepancy in the output. The comparative performance testing highlights the effectiveness of ANSiStim™ with reference to the Predicate Device."
Biocompatibility TestingNo signs of systemic toxicity, non-irritant, no sensitization, no intracutaneous reactivity, non-cytotoxic, within limits as per ISO 10993:2009 standards.
  • Acute Systemic Toxicity study (ISO 10993-11:2006)
  • Subcutaneous Implantation (1-week) study (ISO 10993-6:2007)
  • Skin Sensitization Study (ISO 10993-10:2010)
  • Intracutaneous Reactivity Test (ISO 10993-10:2010)
  • Test for in vitro cytotoxicity (ISO 10993-5:2009)
  • Biocompatibility testing for 3M materials (Foam Pad, Adhesive Tape, Conductive Adhesive) per ISO 10993-1 standards (e.g., In Vitro Cytotoxicity, Skin Irritation, Sensitization). | Acute Systemic Toxicity study in Swiss albino mice: No mortality, morbidity, clinical signs, or gross/clinical/histopathology changes; all animals showed increased body weight. Conclusion: "No systemic toxicity."
    Subcutaneous Implantation (1-week) study in Wistar rats: No mortality, morbidity, or clinical signs; all animals showed increased body weight. Average difference in biological response between test and control sites was 0.4. Conclusion: "Non-irritant."
    Skin Sensitization Study in Guinea pigs: No mortality, morbidity, or sensitization reactions; all animals showed increased body weight. Conclusion: "No sensitization reactions."
    Intracutaneous Reactivity Test in New Zealand White rabbits: No mortality, morbidity, or clinical signs; all animals showed increased body weight. No intracutaneous reactivity. Conclusion: "No intracutaneous reactivity."
    Test for in vitro cytotoxicity (Elution method): Cultures treated with test item extracts in different dilutions graded as 0. Conclusion: "Non-cytotoxic."
    3M Material Testing: Foam Pad, Adhesive Tape, and Conductive Adhesive demonstrated compliance with ISO 10993-1 for relevant tests (Cytotoxicity, Skin Irritation, Sensitization).
    Overall Conclusion: "ANSiStim™ did not show any signs of toxicity, non-cytotoxic, no induced sensitization, non-irritant and intracutaneous reactivity within limits throughout the experimental period." |
    | Sterilization Testing | Needle package subjected to bio-burden test.
    EtO Sterilization using bio-burden approach to achieve defined sterility assurance level (SAL).
    Biological indicators (BIs) used to ensure sterility.
    Chemical indicator on needle packs.
    Sterility test shows no turbidity.
    Residual risk report in line with standards.
    Evaluated and confirmed shelf-life.
    Transportation and Distribution study conducted.
    Compliance with ISO 11135:2014, ISO 11140-1:2005/(R)2010, ISO 10993-7:2008/(R)2012, ISO 11737-1:2006/(R)2011, ISO 11737-2:2009, ISO 11138-2:2006/(R)2010. | Bio-burden test: Performed on needle package.
    EtO Sterilization: Used for needle assembly with defined parameters.
    Sterility Assurance: Ensured by appropriate biological indicators.
    Chemical Indicator: Present on needle packages.
    Sterility Test: Indicated no turbidity.
    Residual Risk Report: Evidenced results inline with standards.
    Shelf-life: Evaluated and confirmed.
    Transportation and Distribution Study: Conducted.
    Overall Conclusion: Sterilization process and results meet specified ISO standards. |
    | Device Specifications (Comparison to Predicate) | Indication of Use, dimensions, weight, needle dimensions, frequency, current, waveform, battery operation, battery type, number/voltage of batteries, operating time. Temperatures and Humidity may show "improved specification validated by test report" compared to predicate. | Indication of Use: Identical to predicate.
    Dimensions: Identical (63288 mm).
    Weight: Identical (5 gm including battery).
    Needle Dimensions: Identical (0.42 mm).
    Frequency: Identical (1Hz).
    Current: Identical (~1mA).
    Waveform: Identical (Square Pulse).
    Battery Operation: Identical (Yes).
    Battery Type: Identical (Zinc Air, AC A10).
    No./Voltage: Identical (3    1.4V).
    Operating Time: Identical (96 h).
    Operating Temperature: 5°C to 45°C (Predicate: 5°C to 30°C) - "Improved specification validated by test report."
    Operating Humidity (Non-Condensing): 40% to 80% (Predicate: 40% to 60%) - "Improved specification validated by test report." |

Study Details

The provided document describes a summative report for a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a previously cleared predicate device (P-STIM, K050123). This is primarily achieved through bench testing for performance, biocompatibility, and sterilization, rather than clinical trials involving human participants or elaborate AI model evaluation.

Regarding the specific questions:

  1. A table of acceptance criteria and the reported device performance: See Table 1 above.

  2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

    • Test Set Sample Size:
      • Performance Testing: Not explicitly stated but refers to "each unit" for functional tests and "the ANSiStim™ and its predicate device" for comparative analysis. This implies multiple units or components were tested.
      • Biocompatibility Testing:
        • Acute Systemic Toxicity: Swiss albino mice (number not specified).
        • Subcutaneous Implantation: Wistar rats (number not specified).
        • Skin Sensitization: Guinea pigs (number not specified).
        • Intracutaneous Reactivity: New Zealand White rabbits (number not specified).
        • In vitro cytotoxicity: Cell cultures (number not specified).
        • 3M Material Testing: Performed by 3M, details not specified but likely involves standard biological testing methodologies.
      • Sterilization Testing: "Each batch of needle assembly" is subjected to tests. Specific number of samples per batch not provided.
    • Data Provenance: The document states DyAnsys, Inc. is located in San Mateo, CA, USA, and refers to "DyAnsys India Pvt Ltd" in the biocompatibility conclusion. This suggests testing may have occurred in multiple locations or been managed by the Indian subsidiary. The testing is prospective in the sense that the device was specifically tested to demonstrate equivalence for this submission.

  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

    • Not applicable in the context of this 510(k) submission. The "ground truth" here is compliance with established engineering, electrical, and international biocompatibility/sterilization standards, as well as demonstrating comparable function to a legally marketed predicate device. This is evaluated by technical experts in those fields (e.g., toxicologists, microbiologists, electrical engineers) typically working for testing labs, consistent with the reference to "the test lab concluded." The document does not describe a clinical study requiring expert consensus on diagnoses or outcomes.

  4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

    • None. This type of adjudication is typically relevant for clinical studies or image-based diagnostic AI, where multiple human readers assess cases and discrepancies need resolution. This 510(k) predominantly relies on objective measurements from bench testing and adherence to published standards.

  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:

    • No, an MRMC comparative effectiveness study was not done. This device is an electro-acupuncture stimulator, not an AI-powered diagnostic or assistive tool for human readers. Its substantial equivalence is based on its physical properties, electrical performance, and safety (biocompatibility, sterilization), not on improving human interpretation of medical data.

  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

    • No. This device is a hardware electro-acupuncture stimulator, not an algorithm. Its "standalone performance" is demonstrated through its functional tests and comparison of its electrical output to the predicate device.

  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

    • The "ground truth" for this submission is primarily objective measurements against engineering specifications and international standards, along with demonstrated equivalence to the performance and safety profiles of the predicate device.
      • Performance: Measured electrical parameters (pulse width, duration, amplitude, current) against design specifications and comparison to predicate.
      • Biocompatibility: Biological responses (toxicity, irritation, sensitization, cytotoxicity) measured against acceptance criteria defined by ISO 10993 standards.
      • Sterilization: Microbiological tests (bio-burden, sterility), and chemical indicator checks against ISO 11135 and related standards.

  8. The sample size for the training set:

    • Not applicable. This device is a physical stimulator, not an AI/machine learning algorithm requiring a "training set" in the conventional sense.

  9. How the ground truth for the training set was established:

    • Not applicable. As a non-AI physical medical device, there is no "training set" or corresponding ground truth establishment process in the context of machine learning. The device's design and manufacturing are based on established engineering principles and prior validated devices.

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