Who is the manufacturer of Foryou NPWT Dressing Kit?

4l Health Co., Ltd. filed the 510(k) submission for Foryou NPWT Dressing Kit (K190119).

What is the FDA product code for Foryou NPWT Dressing Kit?

OMP. It is classified under 21 CFR 878.4780 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Foryou NPWT Dressing Kit?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Foryou NPWT Dressing Kit?

Carilex VT Dressing Kits (K172725).

Who can help prepare an FDA 510(k) submission like Foryou NPWT Dressing Kit?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Foryou NPWT Dressing Kit

K190119 · 4l Health Co., Ltd. · OMP · Nov 1, 2019 · General, Plastic Surgery

Device Facts

Record ID	K190119
Device Name	Foryou NPWT Dressing Kit
Applicant	4l Health Co., Ltd.
Product Code	OMP · General, Plastic Surgery
Decision Date	Nov 1, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4780
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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 Story

Foryou NPWT Dressing Kit is a single-use, sterile wound dressing system used with the Foryou NPWT Device to provide negative pressure wound therapy. The kit includes reticulated flexible polyurethane foam, a transparent polyurethane film with acrylic adhesive, and a tube unit (drainage tube, port, clip, strap). The system is applied by healthcare professionals to manage wounds by removing fluids, excess exudate, infectious material, and tissue debris. The negative pressure environment promotes wound healing. The device is intended for clinical use in various wound types, including chronic and acute wounds. The kit components are sterilized via ethylene oxide and packaged in medical pouches. The device is substantially equivalent to the Carilex VT Dressing Kits.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including pressure conduction, exudate removal performance, package integrity testing (per sterilization validation), and biocompatibility testing (ISO 10993). Shelf-life was established via accelerated aging per ASTM F1980-16.

Technological Characteristics

Components: Reticulated flexible polyurethane foam, polyurethane film with acrylic adhesive, PVC/TPU/ABS tube unit. Sterilization: Ethylene Oxide. Biocompatibility: ISO 10993 compliant. Shelf life: 3 years (ASTM F1980-16). Form factor: Sterile, single-use kit in various sizes. Connectivity: None (mechanical interface with NPWT pump).

Indications for Use

Indicated for patients requiring suction for wound management, including traumatic, dehisced, acute, and chronic wounds (pressure, diabetic foot, venous leg ulcers), partial-thickness burns, flaps, and grafts. Contraindicated for necrotic tissue, malignancy, untreated osteomyelitis, untreated malnutrition, exposed arteries/veins/nerves/organs, anastomotic sites, non-enteric/unexplored fistulas, and exposed bone or tendon.

Regulatory Classification

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.

Predicate Devices

Carilex VT Dressing Kits (K172725)

Related Devices

K172725 — VT Dressing Kits · Carilex Medical, Inc. · Jun 8, 2018
K132004 — NPWT WOUND DRESSING KIT- MEDIUM, NPWT WOUND DRESSING KIT- LARGE · Creo Quality, LLC · May 2, 2014
K082211 — RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS · Smith & Nephew, Inc. · Nov 14, 2008
K133333 — UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT · Blue Ocean Medical Product, LLC · Dec 31, 2014
K161570 — Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large · Lc Medical Concepts, Inc. · Aug 29, 2016

Submission Summary (Full Text)

{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 & 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 {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, 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K190119 Device Name Foryou NPWT Dressing Kit ## Indications for Use (Describe) 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. 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) | # 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: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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 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. {4}------------------------------------------------ #### 7. Indications for Use 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 exudates, 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 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 of Comparison | 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 | | Regulation Number | 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 as diabetic or pressure), flaps and grafts. | For management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. | | Review Panel | General & Plastic Surgery | General & Plastic Surgery | | Prescription Medical Device | Yes | Yes | | Compatible NPWT Pump | Foryou NPWT Device (OMP: K113236) | Carilex VT Device (OMP: K112853, K161410) | | Intended Use | 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 exudates, infectious material, and tissue debris. | Carilex VT Dressing Kits is intended to be used with the Carilex VT device (S1 series) to manage wounds through removal of fluids, and the NPWT system is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of fluids, excess exudates, infectious material, and tissue debris. | | Indications for Use | 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 exudates, infectious material, and tissue debris. | Carilex VT Dressing Kits is intended to be used with the Carilex VT device (S1 series) to manage wounds through removal of fluids, and the NPWT system is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of fluids, excess exudates, infectious material, and tissue debris. | | Elements of Comparison | Proposed Device | Predicate Device | | | 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. | and tissue debris. The Carilex VT Dressing Kits is indicated for use for 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 | | Contraindications | Presence of Necrotic Tissue Malignancy Untreated Osteomyelitis Untreated Malnutrition Exposed Arteries, Veins, Nerves, or Organs Use Over Anastomotic Sites Use in Non-enteric and Unexplored Fistulas, as well for Use Over Exposed Bone or Tendon | Presence of Necrotic Tissue Malignancy Untreated Osteomyelitis Untreated Malnutrition Exposed Arteries, Veins, Nerves, or Organs Use Over Anastomotic Sites Use in Non-enteric and Unexplored Fistulas, as well for Use Over Exposed Bone or Tendon | | Technology Principle of Operation | Foryou NPWT Dressing Kit is used with Foryou NPWT Device to manage wound with negative pressure and removal of exudate. | Carilex VT Dressing Kits is intended to be used with the Carilex VT device (S1 series) to manage wounds through removal of fluids. | | User | Healthcare professional only | Healthcare professional only | | Single Use or Reusable | Single Use | Single Use | | Sterile | YES | YES | | Sterilization Method | Ethylene Oxide | Ethylene Oxide | | Biocompatibility | All components comply with ISO 10993 | All components comply with ISO 10993 | | Packaging | Components are kitted into medical pouch and sterilized, or individually packaged and sterilized. | Individually packaged and sterilized components are kitted into Tyvek pouch. | | Shelf Life | 3 years | 2 years | | Dressing Kits Components | Black Foam Dressing Transparent Film Tube Unit (Composed of drainage tube, port, circle drape, clip, and strap) | Black Foam, Film Drape, Port Set (composed of Circle Drape, Connecting Tube, Port, Clip, Lockable Connector) | | Foam Dimension | Small: 75x100x30 mm Medium: 125x180x30 mm Large: 150x260x30 mm Extra Large: 250x350x15 mm | Small: 80x100x30 mm Medium: 125x200x30 mm Large: 150x250x30 mm | | Foam Material | Reticulated Flexible Polyurethane Foam | Reticulated Flexible Polyether Based Polyurethane Foam | | Film Dimension | 300x200mm , 350x320mm | 203x305mm | | Film Quantity | Extra Large: 350x320mm, 4 pcs Large Kits: 350x320mm, 2 pcs Medium Kits: 350x320mm, 2 pcs Small Kits: 300x200mm, 1 pc | Large Kits: 3 pcs Medium Kits: 2 pcs Small Kits: 1 pc | | Film Material | Polyurethane Film Coated with Acrylic Adhesive | Polyurethane Film Coated with Acrylic Adhesive | | Tube Unit Material | Polyvinyl chloride drainage tube, Thermoplastic urethane port, | Unknown | | Elements of Comparison | Proposed Device | Predicate Device | | | Acrylonitrile butadiene styrene clip, Paper&polyethylene terephthalate strap. | | | Packaging Material | 83g coated medical paper pouch | Unknown | {5}------------------------------------------------ # 4L Health Co., Ltd Premarket Notification 510(k): Traditional ーK190110 Page 3 / 4 {6}------------------------------------------------ ### 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.