Innomed NPWT Silicone Foam Dressing is intended to be used along with VCare 1000- 300S pump for wound management via the application of negative pressure to the wound, in order for the removal of fluids, including wound exudates, irrigation fluids, body fluids and infectious materials.

When used along with VCare 1000-300S pump, Innomed NPWT Silicone Foam Dressing is intended for patients with the following wound types:

Chronic
Acute
· Traumatic
Subacute and dehisced wounds
· Partial-thickness burns,
· Ulcers (such as diabetic or pressure)
· Flaps and grafts

The device is for use in professional healthcare facilities only.

Device Description

Innomed NPWT Silicone foam dressing is a single-use device, as an accessory to VCare-1000-300S pump, manufactured by VR Medical Technology Co., Ltd. The NPWT Silicone foam dressing consists of silicone adhesive coated foam dressing attached with a suction bell and fixation film strips.

The silicone foam dressing is comprised of PU film, absorbent pad consisting of polyurethane (PU) foam, absorbent fibre and polyester fabric, a layer silicone adhesive is coated onto the entire surface.

The suction bell is comprised of a polyvinyl chloride drainage tubing with a polypropylene pinch clamp, a polypropylene luer taper, a bell shape dome made of polyvinyl chloride, a transparent poly urethane film coated with acrylic adhesive. The suction bell is attached on the silicone foam dressing surface.

Fixations film strips is composed of PU film coated with acrylic adhesive.

Machnism of Action: The silicone adhesive coated foam dressing is used to pack the wound bed and cover periwound area, and the fixation film strips are applied over the outside edges of the dressing to facilitate hold the silicone foam dressing in place and seal the wound bed area. The other end of the attached suction bell is connected to a canister attached to the negative pressure pump, VCare 1000-300S pump, and served as a conduit to transfer the wound exudate to the canister under negative pressure when the pump is turned on.

Innomed NPWT Silicone Foam Dressing is available in 10 sizes: SNPWT-1010 ( 10cm X 10cm ), SNPWT-1020 (10cm X 20cm ), SNPWT-1030 (10cm X 30cm ), SNPWT-1040( 10cm X 40cm ), SNPWT-1515(15cm X 15cm ), SNPWT-1520 (15cm X 20cm ), SNPWT-1530 (15cm X 30cm ), SNPWT-2020 (20cm X 20cm ), SNPWT-2025(20cm X 25cm ), SNPWT-2525(25cm X 25cm )

AI/ML Overview

The provided text describes the "Innomed NPWT Silicone Foam Dressing," an accessory for negative pressure wound therapy (NPWT). This device is cleared for marketing based on a 510(k) submission, meaning it was found substantially equivalent to existing predicate devices rather than requiring de novo approval or a PMA that would necessitate extensive clinical trials.

Therefore, the study design and acceptance criteria are evaluated against the substantial equivalence paradigm, not a traditional clinical trial proving efficacy against specific numerical thresholds in a clinical population. The performance is assessed by demonstrating similarity to predicate devices through non-clinical testing.

Here's the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, "acceptance criteria" are generally understood as demonstrating functional equivalence or similarity to predicate devices through a series of bench tests and biocompatibility assessments. The "reported device performance" refers to the results of these non-clinical tests for the subject device and the predicates.

Test Parameter / Acceptance Criteria (demonstrate similarity to predicate)	Subject Device Performance (K202823)	Primary Predicate Device (K162159) Performance (where applicable)	Secondary Predicate Device (K151436) Performance (where applicable)	Comment (from document)
Biocompatibility: Cytotoxicity (ISO 10993-5:2009)	Non-cytotoxic	Non cytotoxic	Non cytotoxic	Same to primary/secondary predicates
Biocompatibility: Irritation (ISO 10993-10:2010)	Non-irritating	Non-irritant	Negligible irritant	Same to primary/secondary predicates
Biocompatibility: Sensitization (ISO 10993-10:2010)	Non-sensitizing	Non-sensitizing	Non-sensitizing	Same to primary/secondary predicates
Biocompatibility: Acute and subacute systemic toxicity (ISO 10993-11:2017)	Non-toxic	Non-toxic	Non-toxic	Same to primary/secondary predicates
Biocompatibility: Material mediated pyrogenicity (ISO 10993-11:2017/USP<151>)	Non-pyrogenic	None-pyrogenic	N/A (not listed for secondary)	Same to primary/secondary predicates
Biocompatibility: Implantation (ISO 10993-6:2016)	N/A (listed as performed, but no specific result stated, likely passed)	N/A (listed as performed, but no specific result stated, likely passed)	N/A (listed as performed, but no specific result stated, likely passed)	Same to primary/secondary predicates
Silicone adhesive peel strength (N/25cm)	0.51	(not listed)	0.60	Similar
Water absorption	7	(not listed)	9	Similar
Moisture vapor transmission rate (MVTR)	699	(not listed)	1112	The secondary predicate does not work with a canister, therefore the wound exudate removal is dependent on the MVTR and the ability to retain the wound exudate in the dressing (Fluid Handling Capacity).
Fluid handling capacity	4.7	(not listed)	11	The secondary predicate does not work with a canister, therefore the wound exudate removal is dependent on the MVTR and the ability to retain the wound exudate in the dressing (Fluid Handling Capacity).
Pressure distribution underneath the dressings in 72 hours under various negative pressure conditions	Meet the requirements	Meet the requirements	Meet the requirements	Similar
Alarming functions	Meet the requirements	Meet the requirements	Meet the requirements	Similar
Liquid pooling	No	No	No	Similar

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of a clinical study with human subjects. The testing performed was non-clinical (bench and biocompatibility). Therefore, there is no information on human sample size or data provenance in terms of country of origin or retrospective/prospective nature. The tests involved material samples and simulated environments.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. As this was a non-clinical study, there was no "ground truth" established by human experts in the context of diagnostic interpretation or clinical outcomes. The "ground truth" for non-clinical tests comes from standardized testing methods and specifications (e.g., ISO standards for biocompatibility).

4. Adjudication Method for the Test Set

Not applicable, as there was no test set requiring human expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. A MRMC study is a clinical study involving human readers interpreting medical cases. This submission is for a medical device (dressing) and relies on non-clinical testing.

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

Not applicable. This device is a physical dressing used in conjunction with a pump, not an AI algorithm.

7. The type of ground truth used

For biocompatibility testing, the "ground truth" is derived from the established standards (e.g., ISO 10993 series) which define acceptable ranges or outcomes for various biological responses. For bench testing, the "ground truth" is typically defined by engineering specifications, performance requirements, and comparison to the predicate devices. There is no pathology or patient outcomes data directly determining "ground truth" for the device's performance in this 510(k) submission.

8. The sample size for the training set

Not applicable. The description is for a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable.

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 & 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.

December 15, 2021

Zhejiang Longterm Medical Technology Co., LTD Claudia Zsang Director of Regualtory Affair No. 493 North Huancheng Road, Mogan Mountain National High-Tech District Deqing, Zhejiang 313200 China

Re: K202823

Trade/Device Name: Innomed NPWT Silicone Foam Dressing Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: November 17, 2021 Received: November 17, 2021

Dear Claudia Zsang:

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.

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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 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 (QS) 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 medical devices and radiation-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.

Julie Morabito, PhD, RAC For Assistant Director DHT4B: Division of 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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Indications for Use

510(k) Number (if known) K202823

Device Name Innomed NPWT Silicone Foam Dressing

Indications for Use (Describe)

When used along with VCare 1000-300S pump, Innomed NPWT Silicone Foam Dressing is intended for patients with the following wound types:

Chronic
Acute
· Traumatic
Subacute and dehisced wounds
· Partial-thickness burns,
· Ulcers (such as diabetic or pressure)
· Flaps and grafts

The device is for use in professional healthcare facilities only.

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)

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510(k) SUMMARY

1 The 510(k) summary information is being submitted in accordance with the requirements of 21 CFR 807. 92(c).

Date Prepared:	December 10, 2021
Applicant:	Zhejiang Longterm Medical Technology Co., LTDNo. 493 North Huancheng Road, Mogan Mountain National High-Tech District, Deqing Zhejiang, CHINA 313200
Official Correspondent:	Claudia Zsangclaudia.zang@gmail.com
Phone Number:	416-276-9555
Device Name:	Innomed NPWT Silicone Foam Dressing
Common Name:	NPWT System Accessories
FDA Panel:	General & Plastic surgery
Product Code:	OMP
Regulation Number:	21 CFR 878.4780
Regulation Name:	Powered Suction Pump
Class:	II
Predicate Devices:	Primary Predicate Device:VCare 1000-300S Pump, VCare 1000-300S System, Perme-foamDressing (K162159)Secondary Predicate Device:PICO Single Use Negative Pressure Wound Therapy System(K151436)

2 Device Description:

The suction bell is comprised of a polyvinyl chloride drainage tubing with a polypropylene pinch clamp, a polypropylene luer taper, a bell shape dome made of polyvinyl chloride, a

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transparent poly urethane film coated with acrylic adhesive. The suction bell is attached on the silicone foam dressing surface.

Fixations film strips is composed of PU film coated with acrylic adhesive.

Indications for Use: 3

Innomed NPWT Silicone Foam Dressing is intended to be used along with VCare 1000-300S pump for wound management via the application of negative pressure to the wound, in order for the removal of fluids, including wound exudates, irrigation fluids, body fluids and infectious materials.

When used along with VCare 1000-300S pump, Innomed NPWT Silicone Foam Dressing is intended for patients with the following wound types:

Chronic
Acute
· Traumatic
· Subacute and dehisced wounds
· Partial-thickness burns,
· Ulcers (such as diabetic or pressure)
· Flaps and grafts

The device is for use in professional healthcare facilities only.

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4 Substantial Equivalence Comparison

Characteristics	Subject Device	Primary Predicate Device	Secondary Predicate Device	Comment
510(k)#	K202823	K162159	K151436
Device name	Innomed NPWT Silicone Foam Dressing	VCare 1000-300S Pump, Vcare 1000-300S System,	PICO Single Use Negative Pressure WoundTherapy System(K151436)
Note	Accessory to Vcare pump (510 (k)K162159)	Only the foam dressing is used as the predicate	Only silicone foam dressing is used asthe predicate
Class	Class II	Class II	Class II	Same
ClassificationRegulation	21CFR 878.4780	21CFR 878.4780	21CFR 878.4780	Same
Product Code	OMP	OMP	OMP	Same
Skin ContactMaterials	- Silicone foam dressing- PU film strips coated with acrylicadhesive	- Foam dressing	- Silicone foam dressing- PU film strips with acrylic adhesive	Similar tosecondarypredicate
Non-SkinContactMaterials	Suction Bell system	Suction Bell system	Suction bell system	Similar toprimary/secondarypredicates
Mechanism ofAction	The silicone foam dressing is used to packthe wound bed and provide a sealedenvironment. The wound fluid is removedfrom the wound bed to a canister throughthe attached suction bell tube under anegative pressure.	The foam dressing is used to pack the wound bedand provide a sealed environment. The wound fluidis removed from the wound bed to a canisterthrough the attached suction bell tube under anegative pressure.	The silicone foam dressing is used to packthe wound bed and provide a sealedenvironment. The wound fluid is removedfrom the wound bed to a canister through theattached suction bell tube under a negativepressure.	Similar toprimary/secondarypredicates
Indicationsfor Use	Innomed NPWT Silicone Foam Dressingis intended to be used along with VCare1000- 300S pump for wound managementvia the application of negative pressure tothe wound, in order for the removal offluids, including wound exudates,irrigation fluids, body fluids and infectiousmaterials.When used along with VCare 1000-300Spump, Innomed NPWT Silicone Foam	The VR Medical VCare 1000-300S NegativePressure Wound Therapy System is an integratedwound management system, indicated for woundmanagement via the application of negativepressure to the wound, in order for the removal offluids, including wound exudates, irrigation fluids,body fluids and infectious materials. The system isintended for patients with chronic, acute, traumatic,subacute and dehisced wounds, partial-thicknessburns, ulcers (such as diabetic or pressure), flapsand grafts.	PICO is intended for the patients whomay benefit from a suction device (NegativePressure Wound Therapy) as it may promotewound healing via removal of low tomoderate levels of exudate and infectiousmaterials.Appropriate wound types include:- Chronic- Acute- Traumatic- Subacute and dehisced wounds	A subset ofthe primary /secondarypredicates
Characteristics	Subject Device	Primary Predicate Device	Secondary Predicate Device	Comment
510(k)#	K202823	K162159	K151436
	Dressing is intended for patients with thefollowing wound types:• Chronic• Acute• Traumatic• Subacute and dehisced wounds• Partial-thickness burns,• Ulcers (such as diabetic or pressure)• Flaps and graftsThe device is for use in professionalhealthcare facilities only.	The device is for use in professional healthcarefacilities only.	• Partial-thickness burns• Ulcers(such as diabetic or pressure)• Flaps and grafts• Closed surgical incisionsPICO single use negative pressure woundtherapy system is suitable for use both in ahospital and homecare setting.
Useenvironment	The device is for use in professionalhealthcare facilities only.	The device is for use in professional healthcarefacilities only.	The device is suitable for use both in ahospital and homecare setting.	Same toprimarypredicate
Biocompatibility(silicone foamdressing,(breachedskin,prolonged,>24hr to30days)	Non-cytotoxic, non-irritating, non-sensitizing, non-toxic, non-pyrogenic	Non cytotoxic, non-irritant, non-sensitizing, non-toxic, none- pyrogenic	Non cytotoxic, Negligible irritant, non-sensitizing	Same toprimary/secondarypredicates
Sterilization	Ethylene Oxide	Gamma Irradiation	Ethylene Oxide	Same tosecondarypredicate
SterilityAssuranceLevel	SAL of 10-6	SAL of 10-6	SAL of 10-6	Same toprimary/secondarypredicates
Single Use	Yes	Yes	Yes	Same toprimary/secondarypredicates
Characteristics	Subject Device	Primary Predicate Device	Secondary Predicate Device	Comment
510(k)#	K202823	K162159	K151436
Prescription	Yes	Yes	Yes	Same to
				primary
				predicate
Shelf-life	3 years	3 years	2 years	Same to
				primary
				predicate

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5 Non-clinical Testing Summary:

The following tests were performed to support the safety and effectiveness of the subject device:

Biocompatibility Testing:

Cytotoxicity ISO 10993-5:2009 .
Irritation ISO 10993-10:2010 ●
Sensitization ISO 10093-10:2010 ●
Acute and subacute systemic toxicity- ISO 10993-11:2017
Material mediated pyrogenicity ISO 10993-11:2017/USP<151> ●
Implantation ISO 10993-6:2016 .

Bench testing:

Innomed NPWT Silicone Foam Dressing was evaluated under of bench tests, along with the predicate, to ensure the dressing can be used along with VCare 1000-300S pump regarding performance and functionality requirements and performs similarly as the predicates.

Test Parameters	SubjectDevice(K202823)	Secondarypredicate(K151436)	Comment
Silicone adhesive peelstrength (N/25cm)	0.51	0.60	Similar
Water absorption	7	9	Similar
Moisture vaportransmission rate(MVTR)	699	1112	The secondary predicate does notwork with a canister, therefore thewound exudate removal isdependent on the MVTR and theability to retain the wound exudatein the dressing (Fluid HandlingCapacity).
Fluid handlingcapacity	4.7	11	The secondary predicate does notwork with a canister, therefore thewound exudate removal isdependent on the MVTR and theability to retain the wound exudatein the dressing (Fluid HandlingCapacity).
Pressure distributionunderneath thedressings in 72 hoursunder variousnegative pressureconditions	Meet therequirements	Meet therequirements	Similar
Alarming functions	Meet therequirements	Meet therequirements	Similar
Liquid pooling	No	No	Similar

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Clinical Testing: 6

No clinical testing was required to support substantial equivalence.

7 Conclusion:

The non-clinical tests demonstrate that the subject device is as safe, as effective and performs as well as the legally marked predicate devices.

Regulation Number and Section

§ 878.4780 Powered suction pump.

(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.