(374 days)
The ANSiStim™ is an electro-acupuncture device for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
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.
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 Category | Acceptance Criteria/Requirement | Reported Device Performance (ANSiStim™) |
|---|---|---|
| Performance Testing | Effectiveness 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 Testing | No 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 (31.4V). 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:
-
A table of acceptance criteria and the reported device performance: See Table 1 above.
-
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.
- Test Set Sample Size:
-
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.
-
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.
-
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.
-
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.
-
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.
- 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.
-
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.
-
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.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is simple and professional, reflecting the department's role in public health and welfare.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 15, 2015
DyAnsys Inc. Srini Nageshwar CEO DyAnsys Inc. Contact Address
Re: K141168 Trade/Device Name: ANSiStim™ Regulation Name: Electro-Acupuncture Stimulator Regulatory Class: Unclassified Product Code: BWK Dated: April 20th 2015 Received: May 12, 2015
Dear Srini Nageshwar,
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. The general controls provisions of the Act include requirements for annual registration. Iisting 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
{1}------------------------------------------------
the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Felipe Aquel - S Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name ANSiStim™
Indications for Use (Describe)
The ANSiStim™ is an electro-acupuncture device 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)
[X] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
{3}------------------------------------------------
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for DyAnsys. The logo consists of a stylized red and black symbol to the left of the company name, which is written in black. The symbol appears to be an abstract representation of the letter 'A'.
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.87 and 21 CFR 807.92.
510(k) Number: K141168
1. Applicant Information:
| Date Prepared: | 30th January 2015 |
|---|---|
| Name: | DyAnsys, Inc |
| Address: | 300, North Bayshore Boulevard,San Mateo, CA 94401, USA |
| Contact Person: | Srini Nageshwar |
| Phone Number: | 408.480.4700 |
| Facsimile Number: | (650)556-1621 |
Device Information:
| Classification | :Unclassified |
|---|---|
| Trade Name | :ANSiStim™ |
| Common Name | :Electro-acupunture device |
| Classification Name :Electro-acupuncture stimulator | |
| Product Code | :BWK |
2. Predicate Device:
K Number: K050123 Model Name: P-Stim Manufacturer: Neuro Science Therapy Corp.
3. 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.
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for DyAnsys. The logo consists of a stylized red and black symbol to the left of the company name, "DyAnsys", which is written in a simple, bold, black font. The symbol appears to be a stylized letter "A" or an arrow-like shape.
4. 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.
5. Comparison to Predicate Device:
The DyAnsys, Inc ANSiStim™ device is substantially equivalent to the predicate device P-STIM (K050123). It was evaluated through Performance, Biocompatibility and Sterilization testing. The ANSiStim™ and the predicate device are both transcutaneous electrical nerve stimulators with a single output channel and mode with similar pulse width and frequency.
| Table | 1 |
|---|---|
| ------- | --- |
| MODEL NAME | P-STIM(K050123) | ANSiStim | JUSTIFICATION ONSAFETY& EFFECTIVENESSVARIATIONS |
|---|---|---|---|
| INDICATION OFUSE(INTENDED USE) | P-STIM is an electro-acupuncture devicefor use in the practice of acupuncture byqualified practitioners of acupuncture asdetermined by the states. | The ANSiStimTM is an electro-acupuncture device for use in thepractice of acupuncture by qualifiedpractitioners of acupuncture asdetermined by the states. | NA |
| DIMENSION, mm | 63288 mm | 63288 mm | NA |
| WEIGHT, Kg | 5 gm (including battery) | 5 gm (including battery) | NA |
| NEEDLEDIMENSIONS, mm | 0.42 mm (widthlength) | 0.42 mm (widthlength) | NA |
| POWER | NA | NA | NA |
| FREQUENCY | 1Hz | 1Hz | NA |
| CURRENT | ~1mA | ~1mA | NA |
| WAVEFORM | Square Pulse | Square Pulse | NA |
| BATTERYOPERATION | Yes | Yes | NA |
| BATTERY TYPE | Zinc Air batteries, AC A10 | Zinc Air batteries, AC A10 | NA |
| NO. / VOLTAGE | 3*1.4V | 3*1.4V | NA |
| OPERATING TIME,HOURS | 96 h | 96 h | NA |
| ENVIRONMENTAL | NA | NA | NA |
| OPERATINGTEMPERATURE | 5°C to 30°C | 5°C to 45°C | Improved specificationvalidated by test report. |
| OPERATING | 40% to 60% | 40% to 80% | Improved specification |
510(k) Number: K141168
{6}------------------------------------------------
| HUMIDITY (NONCONDENSING) | DyAnsysvalidated by test report. | ||
|---|---|---|---|
| PLANNING & PURCHASE | |||
| WARRANTY | NA | NA | Since it is a single usedevice. |
6. Performance Testing Summary
The ANSiStim™ device and its components are subjected to performance testing to validate the effectiveness of each unit. The tests performed are: (i) Physical Test- Bare Board test, (ii) Functional Test for ANSiStim™ and (iii) Comparative Performance Testing: ANSiStim™ Vs Predicate Device- wire assembly testing, PCB assembly testing and final product testing. The final product testing is performed to verify and compare the effectual output along with that of the predicate device. The functional test is performed for 96 hours to monitor the 3 hours ON state followed by 3 hours OFF state. The pulse width, pulse duration, amplitude and current values are captured for the ANSiStim™ device. A comparative performance analysis is performed with the ANSiStim™ and its predicate device.
7. Biocompatibilitv Testing Summary
All biocompatible testing was performed in accordance with ISO 10993: 2009 Biological Evaluation of Medical Devices.
7.1.Test Reports for Biocompatibility:
The following tests were done on the ANSiStim" needle and the wire assembly:
- A) Acute Systemic Toxicity study in Swiss albino mice as per Biological Evaluation of medical devices- Part 11: Tests for systemic toxicity [ISO 10993-11:2006 (E)].
- Subcutaneous Implantation (1- week) study in Wistar rats as per Biological Evaluation of medical devices- Part 6: Tests for local effects after implantation [ISO 10993-6:2007].
- Skin Sensitization Study in Guinea pigs as per Biological Evaluation of medical devices- Part 10: Tests for irritation and skin sensitization [ISO 10993-10:2010(E)].
- Intracutaneous Reactivity Test in New Zealand White rabbits as per Biological Evaluation of medical devices- Part 10: Tests for irritation and skin sensitization [ISO 109933-10: 2010(E)].
510(k) Number: K141168 Confidential A
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for DyAnsys. The logo consists of a stylized symbol to the left, resembling a combination of a greater-than sign and a curved line, with the right portion colored in red. To the right of the symbol is the text "DyAnsys" in a simple, sans-serif font, with each letter in black.
- Test for in vitro cytotoxicity: Elution method as per Biological Evaluation of E) medical devices- Part 5 Tests for in vitro cytotoxicity [ISO 10993-5:2009 (E)].
7.2.Test Reports for 3M Material:
The following tests were carried out by 3M as seen in the Product Clinical Data Summary:
- F) Foam Pad (9776): Biocompatibility Testing performed as per ISO 10993-1 : In Vitro Cytotoxicity (Agar Overlay), Repeat Skin Irritation in Albino Rabbits, Repeated Insult Patch Test (Draize) in Humans, 21-day Cumulative Irritation in Humans, Primary Skin Irritation Test, Ocular Irritation Study, Cytotoxicity-Agarose Overlay, Solid.
- G) Adhesive Tape (Oval & wing sticker, 1533L): Biocompatibility Testing performed as per ISO 10993-1: In Vitro Cytotoxicity, Guinea Pig Sensitization, Repeated Insult Patch Test (Draize) in Humans, 21-day Cumulative Irritation in Humans, Primary Skin Irritation Test.
- н) Conductive Adhesive (9880): Biocompatibility Testing performed as per ISO 10993-1: In Vitro Cytotoxicity (Agar Overlay), Repeat Skin Irritation in Albino Rabbits, Repeated Insult Patch Test (Draize) in Humans, 21-day Cumulative Irritation in Humans.
8. Sterilization Testing Summary
The needle package was subjected to Bio-burden test. The Needle packs are exposed to ETO Sterilization using bio-burden approach to curtail the presence of microorganisms and to achieve the defined sterility assurance level (SAL). During the sterilization process the biological indicators are used to ensure the desired sterility assurance level. These Bls were placed at the appropriate location, where the sterilizing conditions are the most difficult to achieve. These needle packages carry a chemical indicator on the rear side which indicates the exposure to ETO. The sterility test performed on the needles indicates that there is no turbidity. The residual risk report carried out on the sterilized needle packs evidenced that the results are inline with standards requirement. All Sterilization testing was performed in accordance with ISO 11135:2014-Sterilization of healthcare products- ethylene oxide, ISO 11140-1: 2005/(R) 2010 Sterilization of healthcare products- chemical indicators, ISO 10993-7: 2008/(R) 2012 Biological evaluation of medical devices- ethylene oxide sterilization ISO 11737-1:2006/(R) 2011 Sterilization of of medical residuals. devices-Microbiological methods- Part 1: Determination of a population of microorganisms on products. ISO 11737-2: 2009 Sterilization of medical devices- Microbiological
510(k) Number: K141168
Confidential
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo for DyAnsys. The logo consists of a stylized symbol to the left, resembling an abstract letter 'A' with an arrow-like shape, partially in red. To the right of the symbol is the company name, 'DyAnsys,' in a simple, sans-serif font, with the letters in black. The overall design is clean and modern.
methods- Part2: Tests of Sterility performed in the definition, validation and maintenance of a Sterilization process and ISO 11138-2:2006/(R) 2010- Sterilization Of Healthcare Products- Biological Indicators- Part2: Biological Indicators for ethylene oxide Sterilization Processes.
9. Conclusion
Hence it is concluded that by demonstrating Performance testing, Biocompatibility and Sterilization testing, the product ANSiStim™ is substantially equivalent to the predicate device P-STIM that was cleared under K050123.
As per the performance testing results and observations we can conclude that the 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.
As per biocompatibility the test item ANSiStim™ did not show any signs of toxicity, non-cytotoxic, no induced sensitization, non-irritant and intracutaneous reactivity within limits throughout the experimental period. Hence the test lab concluded that the test item ANSiStim" supplied by M/s DyAnsys India Pvt Ltd meets the requirements of Biological Evaluation of Medical Devices under the conditions of the present study.
| Test | Results | Conclusion |
|---|---|---|
| Acute SystemicToxicity studyin Swiss albinomice test | Mortality & Morbidity: No signsBody Weight Recording: All animals showed increase inbody weightClinical Observation: No signsNecropsy: All animals were euthanized by carbon dioxideGross Pathology, Clinical Pathology andHistopathology: No signs | No systemic toxicity |
| SubcutaneousImplantation (1-week) study isWistar rats test | Mortality & Morbidity: No signsBody Weight Recording: All animals showed increase inbody weightClinical Observation: No signsGross Pathology, Clinical Pathology andHistopathology:The average difference obtained from the biologicalresponse of the test site and control site is 0.4. | Non-irritant |
| SkinSensitization | Mortality & Morbidity: No signsBody Weight Recording: All animals showed increase inbody weight | No sensitizationreactions |
Table 2
510(k) Number: K141168 Confidential
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the logo for DyAnsys. The logo consists of a stylized symbol to the left, resembling a combination of a greater-than sign and an abstract shape in red and black. To the right of the symbol is the company name, "DyAnsys," in a simple, sans-serif font, with the letters in black.
| Study in Guineapigs test | body weightGrading of Skin Reactions: No sensitization reactionsNecropsy: All animals were euthanized by carbon dioxide | |
|---|---|---|
| IntracutaneousReactivity Testin New ZealandWhite rabbitstest | Mortality & Morbidity: No signsBody Weight Recording: All animals showed increase inbody weightClinical Observation: No signsNecropsy: All animals were euthanized by pentobarbitalinjectionScoring of Skin Reaction: No intracutaneous reactivity | No intracutaneousreactivity |
| In vitrocytotoxicity:Elution methodtest | The cultures treated with thetest item extracts in different dilutions are graded as 0. | Non-cytotoxic |
The sterilization and shelf-life section includes the following process for each batch:
- EtO sterilization for needle assembly with the parameters as arrived. ●
- Sterility assurance level ensured by using appropriate biological indicator during ETO sterilization process.
- Each batch of needle assembly is subjected to bio-burden test, sterility test and . residual risk test.
- Shelf-life of sterilized pack is evaluated and confirmed through necessary testings. Also Transportation and Distribution study has been conducted.
N/A