(168 days)
No
The description focuses on the mechanical function of the pump and dressing for negative pressure wound therapy, with no mention of AI or ML capabilities.
Yes.
The device is indicated for promoting wound healing and is used to remove excess exudate and infectious materials, which are therapeutic actions.
No
The device is a negative pressure wound therapy (NPWT) system designed to promote wound healing by removing exudate and infectious materials. It is a therapeutic device, not a diagnostic one.
No
The device description explicitly mentions physical components like a "SIMO Pump" and "SIMO Dressing," which are hardware.
Based on the provided information, the SIMO System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the SIMO System is a suction device (negative pressure wound therapy) used to promote wound healing by removing exudate and infectious materials. This is a therapeutic intervention applied directly to the body, not a test performed on samples taken from the body.
- Device Description: The description details a pump and dressing system for applying negative pressure to a wound. This aligns with a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on the physical and functional aspects of the device (tensile strength, adhesive, function after drop, lifetime, simulation) and biocompatibility, which are typical for therapeutic devices. There are no studies related to diagnostic accuracy or performance metrics like sensitivity, specificity, etc.
In summary, the SIMO System is a therapeutic device used for wound management, not a diagnostic device used for testing samples.
N/A
Intended Use / Indications for Use
SIMO System is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of excess exudate and infectious materials.
SIMO System is suitable for use in both hospital and homecare setting and is indicated for the following wound types:
- Chronic wounds
- Acute wounds
- Traumatic wounds
- Subacute and dehisced wounds
- Partial-thickness burns
- Ulcers (such as diabetic or pressure)
- Flaps and grafts
- Closed surgical incisions
Product codes
OKO
Device Description
Anscare SIMO Negative Pressure Wound Therapy (NPWT) System including non-sterilized SIMO Pump and sterilized SIMO Dressing. Patient is able to carry the SIMO Pump easily in the pocket or a belt holder (additional accessory). Anscare SIMO Negative Pressure Wound Therapy (NPWT) System is also called "SIMO System" in the following description.
SIMO System has 3 types of model variants including "2 SIMO Dressings and 1 SIMO Pump", "2 SIMO Dressings and 1 SIMO Pump with 1 holder" and "3 SIMO Dressings". Each type has 4 models, and each modelcontains 4 different sizes of SIMO dressing separately.
SIMO System is for single person use only. SIMO Pump could use for 30 days. The SIMO Dressing is sterilized by Ethylene Oxide and single-use.
SIMO System is suitable for use both in a hospital and homecare setting.
SIMO System including non-sterilized negative pump and sterilize dressing. The negative pressure wound therapy is provided by a pump (-125+/-15mmHg) up to 30 days by manual and may promote wound healing via the removal of exudate. The negative pressure is provided by the SIMO Pump, and the exudates of wound bed is managed by the dressing. SIMO Dressing is applied to the wound. It should be changed in line with standard wound management guidelines, typically every 3-4 days up to 7 days. More frequent dressing changes may be required depending on the level of exudates, condition of the dressing, wound type/size, orientation of dressing, environmental considerations and/or other patient the considerations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
SIMO System is suitable for use in both hospital and homecare setting.
Intended users (healthcare professional, a caregiver or patient)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing - Bench
- Tubing Tensile Strength Test: The testing is for tubing tensile strength test. Based on the test results, we can see that our SIMO System is within the safe range of tube tensile strength and will not fail the treatment due to careless pulling of the user and will not cause any user safety and functional problems.
- Adhesive test: To conduct this test for testing the product viscosity does not meet the specifications after sterilization, resulting in the user functional and safety concerns. Based on the test results, we can see that our dressing viscosity meet the specifications after sterilization, so it will not lead to user safety and functional problems.
- Function Test after Drop Testing: To conduct this test for testing the product would not cause component failure due to the user's careless dropping, resulting in the user's safety and functional risks. According to the test results, we can see that if the user uses the device without pay attention and caused falling, it will not lead to malfunction, caused by user safety and security concerns.
- Life Time for 30 Days Test: To conduct this test for testing the product does not cause fatigue or malfunction of the pump due to the increase in the frequency of uses, resulting in safety and functional risks to the user. According to the test results, we can see that our device has been pressed 150 times, the stable pressure output of the device does not cause malfunction due to falling, it is still normal use, does not lead to the user's safety and functionality problems.
- Simulation Test: To conduct this test for the make sure the product could be well-operated under different circumstances of exudate, low(0.3 ml/cm2/24h) and moderate (1.1 ml/cm-/24h), and the ability in providing stable pressure and managing exudate. We can conclude that Anscare SIMO System can provide effective and stable negative managing exudate, such as permeability. pressure for evapotranspiration rate, and the liquid reflux rate (the ability to keep exudate in the dressing), and the performance tests are all pass. Last but not least, the Smart pattern of Anscare SIMO System is designed not only to notify patients about the condition of negative pressure wound therapy, but to avoid patients failing to judge the changing timing of the dressing, making it more effective and efficient in wound healing.
- HFE/UE Report: Anscare SIMO NPWT system has been found to be safety and effective for the intended users (healthcare professional, a caregiver or patient) uses and use environments. 15 HCPs and 15 lay users were recruits for the validation testing with the different tasks and use scenario. The conclusion was supported by the HFE/UE processes which complied with "Applying Human Factors and Usability Engineering to Medical Devices Guidance for Industry and Food and Drug Administration Staff (2016)" and analysis of the results.
Biocompatibility and Sterilization Testing
Biocompatibility evaluation for the SIMO Dressing was conducted in accordance with ISO-10993-1, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'. The testing included:
- In Vitro Cytotoxicity Test
- Skin Sensitization Test
- Intracutanous Skin irritation Study
- Acute Intravenous Systemic Toxicity Study
- Acute Intraperitoneal Systemic Toxicity Study
- Pyrogen Test
- Subacute/subchronic toxicity study
- Implantation study
- Phthalate leachables study
The SIMO system passed the evaluated biocompatibility tests.
Sterilization valuation was conducted in accordance with ISO 11135, 'Sterilization of health-care products - Ethylene oxide -Requirement for the development, validation and routine control of a sterilization process for medical devices'. The residual testing had been performed in accordance with ISO 10993-7 which confirm the SIMO Dressing comply with the allowable residual limits for ethylene oxide (EO) and its reaction products.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4683 Non-Powered suction apparatus device intended for negative pressure wound therapy.
(a)
Identification. A non-powered suction apparatus device intended for negative pressure wound therapy is a device that is indicated for wound management via application of negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. It is further indicated for management of wounds, burns, flaps, and grafts.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Non-powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy (NPWT).” See § 878.1(e) for the availability of this guidance document.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 4, 2020
BenQ Materials Corporation Isabel Tsai Regulatory Affairs Department 29 Jianguo E. Rd., Guishan Taoyuan, TW 33341
Re: K193185
Trade/Device Name: Anscare SIMO Negative Pressure Wound Therapy (NPWT) System Regulation Number: 21 CFR 878.4683 Regulation Name: Non-Powered Suction Apparatus Device Intended For Negative Pressure Wound Therapy Regulatory Class: Class II Product Code: OKO Dated: January 15, 2020 Received: January 22, 2020
Dear Isabel Tsai:
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
1
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 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 (OS) 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 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,
Kimberly M. Ferlin, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K193185
Device Name
Anscare SIMO Negative Pressure Wound Therapy (NPWT) System (SIMO System)
Indications for Use (Describe)
SIMO System is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of excess exudate and infectious materials.
SIMO System is suitable for use in both hospital and homecare setting and is indicated for the following wound types:
- · Chronic wounds
- · Acute wounds
- · Traumatic wounds
- · Subacute and dehisced wounds
- · Partial-thickness burns
- · Ulcers (such as diabetic or pressure)
- · Flaps and grafts
- · Closed surgical incisions
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
Anscare SIMO Negative Pressure Wound Therapy (NPWT) System
510(k) Summary
General Information:
| Type of Submission: | Traditional |
|---|---|
| Submitter: | BenQ Materials Corporation |
| Address: | No. 29, Jianguo E. Rd., Gueishan, Taoyuan, |
| 33341, Taiwan, R.O.C | |
| Phone: | +886-3-374-8800 |
| Fax: | +886-3-374-8888 |
| Contact: | Isabel Tsai |
| (Isabel.Tsai@BenQMaterials.com) | |
| Registration number: | 3010256218 |
| Date prepared: | May 4, 2020 |
Identification of the Device:
| Device Name: | Anscare SIMO Negative Pressure Wound
Therapy (NPWT) System |
|-----------------------------------------|-----------------------------------------------------------------------------------------|
| Classification Name: | Non-Powered suction apparatus device
intended for negative pressure wound
therapy |
| Device Classification: | Class II |
| Regulation Number: | 21 CFR 878.4683 |
| Panel: | General & Plastic Surgery |
| Product Code: | OKO |
| Identification of the Predicate Device: | |
| Predicate Device Name: | SNaP® Wound Care System |
|---|---|
| Manufacturer: | Spiracur Inc. |
| Classification Name: | Non-Powered suction apparatus device |
| intended for negative pressure wound | |
| therapy | |
| Device Classification: | Class II |
4
| BenQ Materials Corporation
510(k) Notification | Anscare SIMO Negative
Pressure Wound Therapy
(NPWT) System |
|---------------------------------------------------|------------------------------------------------------------------|
| Regulation Number: | 21 CFR 878.4683 |
| Panel: | General & Plastic Surgery |
| Product Code: | OKO |
| 510(k) Number: | K151710 |
| Reference Device | PICO Single Use Negative Pressure Wound |
| Name: | Therapy System |
| Manufacturer: | Smith & Nephew Medical Inc. |
| Classification Name: | Powered suction pump |
| Device Classification: | Class II |
| Regulation Number: | 21 CFR 878.4780 |
| Panel: | General & Plastic Surgery |
| Product Code: | OMP |
| 510(k) Number: | K151436 |
| Clearance Date: | January 28, 2016 |
Device Descrintion
1.1 Device Identification:
Anscare SIMO Negative Pressure Wound Therapy (NPWT) System including non-sterilized SIMO Pump and sterilized SIMO Dressing. Patient is able to carry the SIMO Pump easily in the pocket or a belt holder (additional accessory). Anscare SIMO Negative Pressure Wound Therapy (NPWT) System is also called "SIMO System" in the following description.
SIMO System has 3 types of model variants including "2 SIMO Dressings and 1 SIMO Pump", "2 SIMO Dressings and 1 SIMO Pump with 1 holder" and "3 SIMO Dressings". Each type has 4 models, and each modelcontains 4 different sizes of SIMO dressing separately.
5
Anscare SIMO Negative Pressure Wound Therapy (NPWT) System
1.2 Device Characteristics:
SIMO System is for single person use only. SIMO Pump could use for 30 days. The SIMO Dressing is sterilized by Ethylene Oxide and single-use.
1.3 Environment of Use:
SIMO System is suitable for use both in a hospital and homecare setting.
1.4 Brief Written Description of the Device:
SIMO System including non-sterilized negative pump and sterilize dressing. The negative pressure wound therapy is provided by a pump (-125±15mmHg) up to 30 days by manual and may promote wound healing via the removal of exudate. The negative pressure is provided by the SIMO Pump, and the exudates of wound bed is managed by the dressing. SIMO Dressing is applied to the wound. It should be changed in line with standard wound management guidelines, typically every 3-4 days up to 7 days. More frequent dressing changes may be required depending on the level of exudates, condition of the dressing, wound type/size, orientation of dressing, environmental considerations and/or other patient the considerations.
Indication for use
SIMO System is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of excess exudate and infectious materials.
SIMO System is suitable for use in both hospital and homecare setting and is indicated for the following wound types:
- Chronic wounds
- Acute wounds
- Traumatic wounds ●
- Subacute and dehisced wounds
6
Anscare SIMO Negative Pressure Wound Therapy (NPWT) System
- Partial-thickness burns
- Ulcers (such as diabetic or pressure)
- Flaps and grafts
- Closed surgical incisions
Comparison of Technological characteristics with the predicate device SIMO System is substantially equivalent in intended use to the predicate devices: SNaP® Wound Care System (K151710).
The device is indicated for negative pressure wound therapy (NPWT) that is intended for wound management via application of continual negative pressure to the wound for removal of fluids, including wound exudate and infectious materials.
SIMO System and the predicate device (SNaP® Wound Care System) are both non-powered, negative pressure wound therapy device used for the same indicated use. Both systems utilize manually pump to generate the negative pressure gradient.
The SIMO System is canister-free. Exudate is retained in the absorbent dressing and allows fluid to evaporate. The technology is similar to the reference device: PICO Single Use Negative Pressure Wound Therapy System (K151436) which has similar absorbable NPWT dressing component, mechanism and performance compared with the subject device.
7
Device Comparison Table
Anscare SIMO Negative Pressure Wound Therapy
| Brand and product
Items | Anscare SIMO System | SNaP® Wound Care
System | PICO Single Use
Negative Pressure Wound
Therapy System | BenQ Materials Corporation
510(k) Notification | | Anscare SIMO Negative
Pressure Wound Therapy
(NPWT) System | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|--------------------------|------------------------------------------------------------------|--------------------------------------|---------------------------|
| FDA regulation status | K193185 | K151710 | K151436 | Technology | External use only | Yes | Yes | Yes |
| Regulatory Class | Class II | Class II | Class II | | Therap. Delivery
Mode | Continuous | Continuous | Continuous |
| Product code | OKO | OKO | OMP | | Structure | Pump + tube +
dressing | Pump + tube +
canister + dressing | Pump + tube +
dressing |
| Manufacturer | BenQ Materials Corp. | Spiracur Incorporated | Smith & Nephew
medical Ltd. | | Power supply | Manual | Manual | Powered |
| Indications for Use | SIMO System is
indicated for patients
who would benefit
from a suction device
(negative pressure
wound therapy) as it
may promote wound
healing via removal
of excess exudate and
infectious materials.
SIMO System is
suitable for use in
both hospital and
homecare setting and
is indicated for the
following wound
types:
• Chronic
wounds
• Acute wounds
• Traumatic
wounds
• Subacute and
dehisced wounds
• Partial-thickness
burns
• Ulcers (such as
diabetic or pressure)
• Flaps and grafts
• Closed surgical
incisions | SNaP System with
SNaP Cartridge
(60cc):
The SNaP® Wound
Care System is
indicated for patients
who would benefit
from wound
management via the
application of
negative pressure,
particularly as the
device may promote
wound healing
through the removal
of excess exudate,
infectious material
and tissue debris. The
SNaP® Wound Care
System is indicated
for removal of small
amounts of exudate
from chronic, acute,
traumatic, subacute
and dehisced wounds,
partial-thickness
burns, ulcers (such as
diabetic, venous or
pressure), surgically
closed incisions, flaps
and grafts.
SNaP System with
SNaP Plus Cartridge
(150cc):
The SNaP® Wound
Care System is | PICO is indicated for
patients who would
benefit from a suction
device (negative
pressure wound
therapy) as it may
promote wound healing
via removal of low to
moderate levels of
exudate and infectious
materials.
Appropriate wound
types include:
• Chronic
• Acute
• Traumatic
• Subacute and dehisced
wounds
• Partial-thickness burns
• Ulcers (such as
diabetic or pressure)
• Flaps and grafts
• Closed surgical
incisions
• PICO Single Use
Negative Pressure
Wound Therapy
System is suitable for
use in both hospital
and homecare setting. | | Max pump
pressure | 125 mmHg | 125 mmHg | 100 mmHg |
| Biocompatibility | Pass | Pass | Pass | | | | | |
| indicated for patients
who would benefit
from wound
management via the
application of
negative pressure,
particularly as the
device may promote
wound healing
through the removal
of excess exudate,
infectious material
and tissue debris. The
SNaP® Wound Care
System is indicated
for removal of
exudate from chronic,
acute, traumatic,
subacute and dehisced
wounds, partial-
thickness burns,
ulcers (such as
diabetic, venous or
pressure), surgically
closed incisions, flaps
and grafts. | | | | | | | | |
8
K193185
9
K193185
Anscare SIMO Negative
| BenQ Materials Corporation
510(k) Notification | | | Pressure Wound Therapy
(NPWT) System | |
|---------------------------------------------------|---------------|----------------|-----------------------------------------|----------------|
| Technology | Sterilization | Ethylene Oxide | Gamma | Ethylene Oxide |
| | Shelf-life | 3 Years | 2 Years | 3 Years |
10
Anscare SIMO Negative Pressure Wound Therapy (NPWT) System
Performance Testing - Bench
In order to ensure Anscare SIMO Negative Pressure Wound Therapy (NPWT) System effective, we designed performance test item to description of the evaluation and the test conclusion are as below:
-
Tubing Tensile Strength Test
To conduct this test for testing the user's pull on it, the testing is for tubing tensile strength test. Based on the test results, we can see that our SIMO System is within the safe range of tube tensile strength and will not fail the treatment due to careless pulling of the user and will not cause any user safety and functional problems. -
Adhesive test
To conduct this test for testing the product viscosity does not meet the specifications after sterilization, resulting in the user functional and safety concerns. Based on the test results, we can see that our dressing viscosity meet the specifications after sterilization, so it will not lead to user safety and functional problems. -
Function Test after Drop Testing
To conduct this test for testing the product would not cause component failure due to the user's careless dropping, resulting in the user's safety and functional risks. According to the test results, we can see that if the user uses the device without pay attention and caused falling, it will not lead to malfunction, caused by user safety and security concerns. -
Life Time for 30 Days Test
To conduct this test for testing the product does not cause fatigue or malfunction of the pump due to the increase in the frequency of uses, resulting in safety and functional risks to the user. According to the test results, we can see that our device has been pressed 150 times, the stable pressure output of the device does not cause malfunction due to falling, it is still normal use, does not lead to the user's safety and functionality problems.
11
Anscare SIMO Negative Pressure Wound Therapy (NPWT) System
-
Simulation Test
To conduct this test for the make sure the product could be welloperated under different circumstances of exudate, low(0.3 ml/cm2/24h) and moderate (1.1 ml/cm-/24h), and the ability in providing stable pressure and managing exudate. We can conclude that Anscare SIMO System can provide effective and stable negative managing exudate, such as permeability. pressure for evapotranspiration rate, and the liquid reflux rate (the ability to keep exudate in the dressing), and the performance tests are all pass. Last but not least, the Smart pattern of Anscare SIMO System is designed not only to notify patients about the condition of negative pressure wound therapy, but to avoid patients failing to judge the changing timing of the dressing, making it more effective and efficient in wound healing. -
HFE/UE Report
Anscare SIMO NPWT system has been found to be safety and effective for the intended users (healthcare professional, a caregiver or patient) uses and use environments. 15 HCPs and 15 lay users were recruits for the validation testing with the different tasks and use scenario.
The conclusion was supported by the HFE/UE processes which complied with "Applying Human Factors and Usability Engineering to Medical Devices Guidance for Industry and Food and Drug Administration Staff (2016)" and analysis of the results.
12
Anscare SIMO Negative Pressure Wound Therapy (NPWT) System
Biocompatibility and Sterilization Testing
SIMO dressing is the patient direct contacting component of the SIMO System. Further, in the choice of our materials, SIMO Dressing was similar to the predicate device, it was only different from two additional layers. To prove there is no additional safety concern, the biocompatibility evaluation for the SIMO Dressing was conducted in accordance with ISO-10993-1, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'. Appropriate tests had been conducted using final product that has been packaged and sterilized. The testing included the following tests:
- In Vitro Cytotoxicity Test
- Skin Sensitization Test
- Intracutanous Skin irritation Study
- Acute Intravenous Systemic Toxicity Study
- Acute Intraperitoneal Systemic Toxicity Study
- Pyrogen Test
- Subacute/subchronic toxicity study
- Implantation study
- Phthalate leachables study
From the results and analysis above, it shows that the SIMO system passed the evaluated biocompatibility tests.
Additional, SIMO Dressing is the part of SIMO System which will come in to direct contact with the wounds and normal skin of patients. Concerning the risk of the microbial infection, we conduct the EO sterilization to the SIMO Dressing. To make sure the sterile conditions and sterilization process, we conducted the sterilization valuation in accordance with ISO 11135, Sterilization of health-care products - Ethylene oxide -Requirement for the development, validation and routine control of a sterilization process for medical devices'. The residual testing had been performed in accordance with ISO 10993-7 which confirm the SIMO Dressing comply with the allowable residual limits for ethylene oxide (EO)
13
and its reaction products.
Conclusion
Anscare SIMO Negative Pressure Wound Therapy (NPWT) System has similar indications for use and technological characteristics to the predicate device. The non-clinical data, biocompatibility test, sterilization test demonstrates the substantial equivalence of the SIMO System to the SNaP® Wound Care System (K151710).
Anscare SIMO Negative Pressure Wound Therapy (NPWT) System