Foryou NPWT Dressing Kit is intended to be used with Foryou NPWT Device to manage wounds through removal of fluids, and the NPWT system is indicated for patients who would benefit from a suction device, particularly as it may promote wound healing by removal of fluids, excess exudate, infectious material, and tissue debris. Foryou NPWT Dressing Kit is indicated for use in patients with the following wounds: traumatic, dehisced wounds, partial-thickness burns, chronic wounds including pressure ulcers, diabetic foot ulcers and venous leg ulcers, acute wounds, flaps and grafts.

Device Description

Foryou NPWT Dressing Kit is the wound dressing kit to be used with Foryou NPWT Device for negative pressure wound therapy. It consists of three key components: the foam dressing, the tube unit, and the transparent film. The components are kitted into medical pouch and sterilized, or individually packaged and sterilized. Foryou NPWT Dressing Kit is single-use and sterile. It is available in different sizes: small, medium, large and extra large. The foam dressing should not be used for more than 24 hours and should be replaced with other dressings compatible with Foryou NPWT pump as stated in the Foryou NPWT pump labeling.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the "Foryou NPWT Dressing Kit." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical data often seen with novel Class III devices or those requiring a de novo classification.

Therefore, the information you're requesting regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, particularly in the context of an AI/ML device, is largely not present in this document. This document focuses on demonstrating that the new device performs similarly to an existing one through non-clinical performance and biocompatibility testing.

Here's a breakdown of why your specific questions cannot be fully answered by the provided text:

This is not an AI/ML device. The device described is a Negative Pressure Wound Therapy (NPWT) Dressing Kit, which is a physical consumable for wound management.
The submission is a 510(k). For 510(k) clearances, the primary goal is to show substantial equivalence to a predicate device. This often involves performance testing (non-clinical) and comparison of specifications, rather than full-blown clinical trials or detailed AI model validation studies.
Clinical tests were explicitly stated as NOT performed. (Section 10)

However, I can extract the information that is available related to acceptance criteria and performance, translating it to your requested table structure where possible, and explain what is missing.

Acceptance Criteria and Reported Device Performance (as inferred for a non-AI medical device 510(k))

For a physical device like a wound dressing kit, "acceptance criteria" primarily relate to product specifications, safety (biocompatibility, sterility), and core functional performance (e.g., ability to conduct pressure, remove exudate). These are typically verified through bench testing.

Acceptance Criteria (Inferred from 510(k) Requirements for this Device Type)	Reported Device Performance (from Section 9: "Discussion of Non-Clinical Tests")
Sterilization & Packaging Integrity: Maintain sterility and physical integrity over shelf life.	Package Integrity Tests: "The tests results show that the pouch can meet the requirements of package integrity."
Shelf-Life: Demonstrate stability and functionality for a specified duration.	Shelf-life Test: "Based on the evaluation of the results of the testing data, the Shelf life of Foryou NPWT Dressing Kit is 3 years." (Evaluated via accelerated aging per ASTM F1980-16).
Biocompatibility: Materials are safe for contact with human tissue.	Biocompatibility Tests: "Foryou NPWT Dressing Kits are biocompatible for the intended use for a 'limited' contact duration." (Tested per ISO 10993).
Functional Performance (Pressure Conduction & Exudate Removal): Device effectively performs its intended function in conjunction with an NPWT pump.	Performance tests: "The Foryou NPWT Dressing Kit met all pre-defined acceptance criteria and passed the tests for pressure conduction and exudate removal."

Information NOT Present in the Document (and why, given it's a 510(k) for a physical device, not AI)

Given this is a 510(k) for a physical medical device (NPWT dressing kit) and explicitly states "Clinical tests were not performed" (Section 10), the following information relevant to AI/ML device studies would not be found:

Sample size used for the test set and the data provenance: Not applicable in the context of an AI model's test set. The "test set" here refers to physical samples for engineering/bench tests. Data provenance (country of origin, retrospective/prospective) is typically for patient data used in clinical studies, which were not performed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's performance tests would be established by validated measurement standards and equipment, not human expert consensus.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for performance bench testing results.
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: Not applicable, as this is not an AI-assisted device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as there is no algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this device, ground truth for performance relates to physical measurements and material properties confirmed by laboratory testing (e.g., pressure values, material composition analysis, sterility validation).
The sample size for the training set: Not applicable, as there is no AI model.
How the ground truth for the training set was established: Not applicable, as there is no AI model.

In summary: The provided FDA document is a 510(k) clearance letter and summary for a physical medical device (NPWT dressing kit). It demonstrates substantial equivalence primarily through non-clinical performance and safety testing, not through clinical trials or the type of AI/ML performance studies you are asking about.

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.

November 1, 2019

4L Health Co., Ltd. Jackie Jian President No. 108, Dongxin Rd, DongJiang Hi-tech Dist. Huizhou, 516000 China

Re: K190119

Trade/Device Name: Foryou NPWT Dressing Kit Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: September 28, 2019 Received: October 1, 2019

Dear Jackie Jian:

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,

for Cynthia J. Chang, Ph.D. 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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Indications for Use

510(k) Number (if known) K190119

Device Name

Foryou NPWT Dressing Kit

Indications for Use (Describe)

partial-thickness burns, chronic wounds including pressure ulcers, diabetic foot ulcers and venous leg ulcers, acute wounds, flaps and grafts.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Submitter's Information 1.

Company:	4L Health Co., Ltd.
Address:	No. 108, Dongxin Road, Dong Jiang Hi-tech Dist., Huizhou City,
	Guangdong, 516000, China
Registration number:	3009425221
Contact Person:	Jackie JIAN
Tel:	+86-752-5300546
E-mail:	info@ForyouNPWT.com

Date Prepared: October 31, 2019

Trade Name of the Device 2.

Foryou NPWT Dressing Kit

Common or Usual Name 3.

Negative Pressure Wound Therapy Dressing Kit

4. Classification Name

Classification Name:	Negative Pressure Wound Therapy Powered Suction Pump
Review Panel:	General & Plastic Surgery
Regulation Description:	Powered suction pump
Product Code:	OMP
Regulation Number:	21 CFR 878.4780
Regulation Class:	II

Predicate Device Information 5.

Carilex VT Dressing Kits, Carilex Medical, K172725

6. Device Description

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7. Indications for Use

Foryou NPWT Dressing Kit is indicated for use in patients with the following wounds: traumatic, dehisced wounds, partial-thickness burns, chronic wounds including pressure injuries, diabetic foot ulcers and venous leg ulcers, acute wounds, flaps and grafts.

8. Technological Comparison to Predicate Device

The comparison between Proposed Device and Predicate Device is as follows:

Elements ofComparison	Proposed Device	Predicate Device
Device Name	Foryou NPWT Dressing Kit	Carilex VT Dressing Kits
510K number	K190119	K172725
Manufacturer	4L Health Co., Ltd	Carilex Medical, Inc.
Classification	Class II	Class II
RegulationNumber	21 CFR 878.4780	21 CFR 878.4780
Product Code	OMP	OMP
Target Area	For management of chronic, acute,traumatic, subacute and dehisced wounds,partial-thickness burns, ulcers (such asdiabetic or pressure), flaps and grafts.	For management of chronic, acute,traumatic, subacute and dehiscedwounds, partial-thickness burns, ulcers(such as diabetic or pressure), flaps andgrafts.
Review Panel	General & Plastic Surgery	General & Plastic Surgery
PrescriptionMedicalDevice	Yes	Yes
Compatible NPWTPump	Foryou NPWT Device(OMP: K113236)	Carilex VT Device(OMP: K112853, K161410)
Intended Use	Foryou NPWT Dressing Kit is intended to beused with Foryou NPWT Device to managewounds through removal of fluids, and theNPWT system is indicated for patients whowould benefit from a suction device,particularly as it may promote wound healingby removal of fluids, excess exudates,infectious material, and tissue debris.	Carilex VT Dressing Kits is intended tobe used with the Carilex VT device (S1series) to manage wounds throughremoval of fluids, and the NPWTsystem is indicated for patients whowould benefit from a suction device,particularly as the device may promotewound healing by removal of fluids,excess exudates, infectious material,and tissue debris.
Indications for Use	Foryou NPWT Dressing Kit is intended to beused with Foryou NPWT Device to managewounds through removal of fluids, and theNPWT system is indicated for patients whowould benefit from a suction device,particularly as it may promote wound healingby removal of fluids, excess exudates,infectious material, and tissue debris.	Carilex VT Dressing Kits is intended tobe used with the Carilex VT device (S1series) to manage wounds throughremoval of fluids, and the NPWTsystem is indicated for patients whowould benefit from a suction device,particularly as the device may promotewound healing by removal of fluids,excess exudates, infectious material,and tissue debris.
Elements ofComparison	Proposed Device	Predicate Device
	use in patients with the following wounds:traumatic, dehisced wounds, partial-thickness burns, chronic wounds includingpressure injuries, diabetic foot ulcers andvenous leg ulcers, acute wounds, flaps andgrafts.	and tissue debris.The Carilex VT Dressing Kits isindicated for use for patients with thefollowing wounds:TraumaticDehisced woundsPartial-thickness burnsChronic wounds including pressureulcers, diabetic foot ulcers and venousleg ulcersAcute woundsFlaps and grafts
Contraindications	Presence of Necrotic TissueMalignancyUntreated OsteomyelitisUntreated MalnutritionExposed Arteries, Veins, Nerves,or OrgansUse Over Anastomotic SitesUse in Non-enteric and Unexplored Fistulas,as well for Use Over Exposed Bone orTendon	Presence of Necrotic TissueMalignancyUntreated OsteomyelitisUntreated MalnutritionExposed Arteries, Veins, Nerves,or OrgansUse Over Anastomotic SitesUse in Non-enteric and UnexploredFistulas, as well for Use Over ExposedBone or Tendon
TechnologyPrinciple ofOperation	Foryou NPWT Dressing Kit is used withForyou NPWT Device to manage wound withnegative pressure and removal of exudate.	Carilex VT Dressing Kits is intended tobe used with the Carilex VT device (S1series) to manage wounds throughremoval of fluids.
User	Healthcare professional only	Healthcare professional only
Single Use orReusable	Single Use	Single Use
Sterile	YES	YES
SterilizationMethod	Ethylene Oxide	Ethylene Oxide
Biocompatibility	All components comply with ISO 10993	All components comply with ISO 10993
Packaging	Components are kitted into medical pouchand sterilized, or individually packaged andsterilized.	Individually packaged and sterilizedcomponents are kitted into Tyvekpouch.
Shelf Life	3 years	2 years
Dressing KitsComponents	Black Foam DressingTransparent FilmTube Unit (Composed of drainage tube, port,circle drape, clip, and strap)	Black Foam, Film Drape, Port Set(composed of Circle Drape, ConnectingTube, Port, Clip, Lockable Connector)
Foam Dimension	Small: 75x100x30 mmMedium: 125x180x30 mmLarge: 150x260x30 mmExtra Large: 250x350x15 mm	Small: 80x100x30 mmMedium: 125x200x30 mmLarge: 150x250x30 mm
Foam Material	Reticulated Flexible Polyurethane Foam	Reticulated Flexible Polyether BasedPolyurethane Foam
FilmDimension	300x200mm , 350x320mm	203x305mm
Film Quantity	Extra Large: 350x320mm, 4 pcsLarge Kits: 350x320mm, 2 pcsMedium Kits: 350x320mm, 2 pcsSmall Kits: 300x200mm, 1 pc	Large Kits: 3 pcsMedium Kits: 2 pcsSmall Kits: 1 pc
Film Material	Polyurethane Film Coated with AcrylicAdhesive	Polyurethane Film Coated with AcrylicAdhesive
Tube Unit Material	Polyvinyl chloride drainage tube,Thermoplastic urethane port,	Unknown
Elements ofComparison	Proposed Device	Predicate Device
	Acrylonitrile butadiene styrene clip,Paper&polyethylene terephthalate strap.
PackagingMaterial	83g coated medical paper pouch	Unknown

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4L Health Co., Ltd

Premarket Notification 510(k): Traditional

ーK190110
Page 3 / 4

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9. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

The following tests were performed to determine substantial equivalence:

a. Package Integrity Tests
The components of Foryou NPWT Dressing Kit are kitted into medical pouch and sterilized, or individually packaged and sterilized.

The pouch tests have been done during the validation of the sterilization cycle. The tests results show that the pouch can meet the requirements of package integrity.

b. Shelf-life Test
In accordance with ASTM F1980-16, the stability of the Proposed Device was established from the results of the testing data from an accelerated aging test. Based on the evaluation of the results of the testing data, the Shelf life of Foryou NPWT Dressing Kit is 3 years.

ﻦ Biocompatibility Tests

The biocompatibility tests were performed with Foryou NPWT Dressing Kits, which showed that Foryou NPWT Dressing Kits are biocompatible for the intended use for a 'limited' contact duration.

d. Performance tests

The Foryou NPWT Dressing Kit met all pre-defined acceptance criteria and passed the tests for pressure conduction and exudate removal.

10. Clinical Test

Clinical tests were not performed.

11. Conclusion

The proposed device is substantially equivalent to the predicate device. The differences between the proposed device and the predicate device do not raise different questions regarding its safety and effectiveness.

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.