(281 days)
No
The document describes a negative pressure wound therapy dressing kit, which is a passive component of a system. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
Yes
The Foryou NPWT Dressing Kit is intended to be used with the Foryou NPWT Device to manage wounds through the removal of fluids, and the NPWT system is indicated for promoting wound healing.
No
The provided text describes a wound dressing kit used for negative pressure wound therapy, which promotes healing by removing fluids. It does not mention any diagnostic capabilities.
No
The device description clearly states it is a "wound dressing kit" consisting of physical components like foam dressing, tube unit, and transparent film. These are hardware components, not software.
Based on the provided information, the Foryou NPWT Dressing Kit is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to manage wounds through the removal of fluids and promote wound healing. This is a therapeutic and wound management function, not a diagnostic one.
- Device Description: The description details the components of a wound dressing kit used for negative pressure wound therapy. These components are physical materials applied to a wound, not reagents or instruments used to test samples outside the body.
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze samples (like blood, urine, tissue, etc.) to provide information about a patient's health status or diagnose a condition.
- Anatomical Site: The device is applied directly to wounds on the body. IVDs typically interact with samples taken from the body.
In summary, the Foryou NPWT Dressing Kit is a medical device used for wound therapy, not for performing diagnostic tests in vitro.
N/A
Intended Use / 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 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.
Product codes
OMP
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.
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
Healthcare professional only
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)
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.
- c. 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.
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
§ 878.4780 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.
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) |
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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.