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

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 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device (Anscare SIMO Negative Pressure Wound Therapy (NPWT) System). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through performance and safety testing. It does not present a study proving the device meets acceptance criteria in the format of a clinical trial or a machine learning model's performance evaluation against specific metrics.

Therefore, I cannot extract the information required to answer your request in the specified format, as the document details bench testing, biocompatibility, and sterilization, but not a study designed to evaluate performance against the kind of "acceptance criteria" you've outlined (e.g., accuracy, sensitivity, specificity, or human improvement with AI assistance).

The provided text details the following:

Device: Anscare SIMO Negative Pressure Wound Therapy (NPWT) System
Intended Use: Promotes wound healing via removal of excess exudate and infectious materials. Suitable for hospital and homecare settings for various wound types (chronic, acute, traumatic, subacute/dehisced, partial-thickness burns, ulcers, flaps/grafts, closed surgical incisions).
Predicate Device: SNaP® Wound Care System (K151710) and Reference Device: PICO Single Use Negative Pressure Wound Therapy System (K151436).
Testing Performed:
- Bench Testing: Tubing Tensile Strength Test, Adhesive test, Function Test after Drop Testing, Life Time for 30 Days Test (pump performance over 150 presses), Simulation Test (performance with low/moderate exudate, pressure stability, exudate management, fluid reflux rate), HFE/UE Report (Human Factors and Usability Engineering).
- Biocompatibility Testing: In Vitro Cytotoxicity, Skin Sensitization, Intracutaneous Skin irritation, Acute Intravenous Systemic Toxicity, Acute Intraperitoneal Systemic Toxicity, Pyrogen Test, Subacute/subchronic toxicity, Implantation study, Phthalate leachables study.
- Sterilization Testing: Verification of Ethylene Oxide (EO) sterilization process and residual testing per ISO standards.

This documentation serves to demonstrate that the device is as safe and effective as a legally marketed predecessor, not to provide statistical performance metrics typically seen in AI/ML device submissions or clinical trials.

Summary

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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

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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

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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.

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:

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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 WoundTherapy (NPWT) System
Classification Name:	Non-Powered suction apparatus deviceintended for negative pressure woundtherapy
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 deviceintended for negative pressure woundtherapy
Device Classification:	Class II

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BenQ Materials Corporation510(k) Notification	Anscare SIMO NegativePressure 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:

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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:

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

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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.

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Device Comparison Table

Anscare SIMO Negative Pressure Wound Therapy

Brand and productItems	Anscare SIMO System	SNaP® Wound CareSystem	PICO Single UseNegative Pressure WoundTherapy System	BenQ Materials Corporation510(k) Notification		Anscare SIMO NegativePressure 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. DeliveryMode	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 & Nephewmedical Ltd.		Power supply	Manual	Manual	Powered
Indications for Use	SIMO System isindicated for patientswho would benefitfrom a suction device(negative pressurewound therapy) as itmay promote woundhealing via removalof excess exudate andinfectious materials.SIMO System issuitable for use inboth hospital andhomecare setting andis indicated for thefollowing woundtypes:• Chronicwounds• Acute wounds• Traumaticwounds• Subacute anddehisced wounds• Partial-thicknessburns• Ulcers (such asdiabetic or pressure)• Flaps and grafts• Closed surgicalincisions	SNaP System withSNaP Cartridge(60cc):The SNaP® WoundCare System isindicated for patientswho would benefitfrom woundmanagement via theapplication ofnegative pressure,particularly as thedevice may promotewound healingthrough the removalof excess exudate,infectious materialand tissue debris. TheSNaP® Wound CareSystem is indicatedfor removal of smallamounts of exudatefrom chronic, acute,traumatic, subacuteand dehisced wounds,partial-thicknessburns, ulcers (such asdiabetic, venous orpressure), surgicallyclosed incisions, flapsand grafts.SNaP System withSNaP Plus Cartridge(150cc):The SNaP® WoundCare System is	PICO is indicated forpatients who wouldbenefit from a suctiondevice (negativepressure woundtherapy) as it maypromote wound healingvia removal of low tomoderate levels ofexudate and infectiousmaterials.Appropriate woundtypes include:• Chronic• Acute• Traumatic• Subacute and dehiscedwounds• Partial-thickness burns• Ulcers (such asdiabetic or pressure)• Flaps and grafts• Closed surgicalincisions• PICO Single UseNegative PressureWound TherapySystem is suitable foruse in both hospitaland homecare setting.		Max pumppressure	125 mmHg	125 mmHg	100 mmHg
Biocompatibility	Pass	Pass	Pass
indicated for patientswho would benefitfrom woundmanagement via theapplication ofnegative pressure,particularly as thedevice may promotewound healingthrough the removalof excess exudate,infectious materialand tissue debris. TheSNaP® Wound CareSystem is indicatedfor removal ofexudate from chronic,acute, traumatic,subacute and dehiscedwounds, partial-thickness burns,ulcers (such asdiabetic, venous orpressure), surgicallyclosed incisions, flapsand grafts.

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K193185

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K193185

Anscare SIMO Negative

BenQ Materials Corporation510(k) Notification			Pressure Wound Therapy(NPWT) System
Technology	Sterilization	Ethylene Oxide	Gamma	Ethylene Oxide
	Shelf-life	3 Years	2 Years	3 Years

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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.

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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.

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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)

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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

Regulation Number and Section

§ 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.