K Number
K182458
Device Name
Longterm NPWT Foam Dressing Kit
Date Cleared
2019-05-23

(255 days)

Product Code
Regulation Number
878.4780
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The dressing kit 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. The system is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The NPWT foam dressing kit is for use in professional healthcare facilities only.
Device Description
Longterm NPWT dressing kit is a single use device as an accessory to VCare 1000-300S pump, manufactured by VR Medical Technology Co., Ltd. The dressing kit consists of hydrophobic, reticulated Polyurethane foam, polyurethane film drape coated with acrylic adhesive, suction bell composed of a polyvinyl chloride (PVC) drainage tubing with a polypropylene pinch clamp, a bell shape dome made of polyvinyl chloride, a transparent polyurethane film coated with acrylic adhesive. Each component is individually packaged and sterilized. The suction bell is comprised of a polyvinyl chloride drainage tubing with a polypropylene pinch clamp, a bell shape dome made of polyvinyl chloride, a transparent poly urethane film coated with acrylic adhesive. Foam dressing is available in 4 sizes; small (10cmx7.5cmx2.5cm), medium (18cmx12.5cmx2.5cm), large (26cmx15cmx2.5cm) and extra large (45cmx30cmx2.5cm). PU film drape is available in 2 sizes; 30cmx30cm and 45cmx30cm. The foam dressing is used to pack the wound bed, the film drape is used to cover the packed wound bed and peri-wound area to create and maintain a sealed environment, the suction bell is served as a conduit between the wound bed and the suction pump to transfer the wound fluid to the canister attached to the suction pump. The foam dressing should not be used for more than 24 hours and should be replaced with other dressings compatible with the VCare 1000-300S pump after 24 hours.
More Information

Not Found

No
The document describes a negative pressure wound therapy (NPWT) dressing kit, which is a passive accessory to a pump. There is no mention of AI or ML in the intended use, device description, or performance studies.

Yes
The device is described as a "dressing kit" intended for "wound management via the application of negative pressure to the wound" for removing fluids and is indicated for various types of wounds, ulcers, flaps, and grafts, which are all conditions that require therapeutic intervention.

No.
The device is a dressing kit used for wound management via the application of negative pressure to remove fluids. It is a treatment device, not a diagnostic one.

No

The device description clearly outlines physical components like foam, film drape, and a suction bell made of PVC, indicating it is a hardware-based medical device accessory.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the device is for "wound management via the application of negative pressure to the wound, in order for the removal of fluids...". This is a therapeutic application, not a diagnostic one.
  • Device Description: The description details components like foam dressing, film drape, and a suction bell, all designed to physically manage a wound and remove fluids. There is no mention of analyzing biological samples or providing diagnostic information.
  • Lack of IVD Characteristics: IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis.

The device is a Negative Pressure Wound Therapy (NPWT) dressing kit, which is a medical device used for wound treatment.

N/A

Intended Use / Indications for Use

The dressing kit 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. The system is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The NPWT foam dressing kit is for use in professional healthcare facilities only.

Product codes (comma separated list FDA assigned to the subject device)

OMP

Device Description

Longterm NPWT dressing kit is a single use device as an accessory to VCare 1000-300S pump, manufactured by VR Medical Technology Co., Ltd. The dressing kit consists of hydrophobic, reticulated Polyurethane foam, polyurethane film drape coated with acrylic adhesive, suction bell composed of a polyvinyl chloride (PVC) drainage tubing with a polypropylene pinch clamp, a bell shape dome made of polyvinyl chloride, a transparent polyurethane film coated with acrylic adhesive. Each component is individually packaged and sterilized.

The suction bell is comprised of a polyvinyl chloride drainage tubing with a polypropylene pinch clamp, a bell shape dome made of polyvinyl chloride, a transparent poly urethane film coated with acrylic adhesive.

Foam dressing is available in 4 sizes; small (10cmx7.5cmx2.5cm), medium (18cmx12.5cmx2.5cm), large (26cmx15cmx2.5cm) and extra large (45cmx30cmx2.5cm). PU film drape is available in 2 sizes; 30cmx30cm and 45cmx30cm.

The foam dressing is used to pack the wound bed, the film drape is used to cover the packed wound bed and peri-wound area to create and maintain a sealed environment, the suction bell is served as a conduit between the wound bed and the suction pump to transfer the wound fluid to the canister attached to the suction pump.

The foam dressing should not be used for more than 24 hours and should be replaced with other dressings compatible with the VCare 1000-300S pump after 24 hours.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Wound bed, peri-wound area

Indicated Patient Age Range

Not Found

Intended User / Care Setting

professional healthcare facilities

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)

Non-clinical Testing Summary:
The following tests were performed to support the substantial equivalence of the subject device:
Biocompatibility Testing:

  • Cytotoxicity ISO 10993-5:2009 (Foam, Drape, Suction bell)
  • Irritation ISO 10993-10:2010 (Foam, Drape, Suction bell)
  • Sensitization ISO 10093-10:2010 (Foam, Drape, Suction bell)
  • Pyrogenicity -ISO 10993-11:2006/USP39-NF34 (Foam, Drape)
  • Acute systemic toxicity ISO 10993-11:2017 (Foam, Drape)

Bench testing:
Longterm NPWT Foam Dressing Kit was evaluated under of bench tests to ensure the dressing kit can be used along with VCare 1000-300S pump regarding performance and functionality requirements.

  • The foam dressing dimension test under continuous various negative pressure mode after 72 hours
  • The fluid removal rate under various negative pressure in 72 hours;
  • The pressure distribution under the foam dressing in 72 hours under continuous negative pressure mode;
  • The pressure difference under the foam dressing in 72 hours under intermittent negative pressure mode.
  • Mechanical properties (tensile strength and elongation, ASTM D3574)

No clinical testing was required to support substantial equivalence.
The non-clinical tests demonstrate that the subject device is as safe, as effective and performs as well as the legally marked predicate devices.

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.

K162159, K132004, K032310

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.

Not Found

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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable.

May 23, 2019

Zhejiang Longterm Medical Technology Co., LTD Claudia Zsang Director of Regulatory Affairs No. 493 North Huancheng Road Mogan Mountain National High-Tech District Deging, 313200 Cn

Re: K182458

Trade/Device Name: Longterm NPWT Foam Dressing Kit Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: April 14, 2019 Received: April 23, 2019

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.

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

1

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 David Krause, Ph.D. Acting Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K182458

Device Name Longterm NPWT Foam Dressing Kit

Indications for Use (Describe)

The dressing kit 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. The system is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The NPWT foam dressing kit is for use in professional healthcare facilities only.

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

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

Date Prepared:May 20, 2019
Applicant:Zhejiang Longterm Medical Technology Co., LTD
No. 493 North Huancheng Road, Mogan Mountain National High-
Tech District, Deqing Zhejiang, CHINA 313200
Official Correspondent:Claudia Zsang
claudiaz@longterm-health.com
Phone Number:416-276-9555
Device Name:Longterm NPWT Foam Dressing Kit
Common Name:NPWT System Accessories
FDA Panel:General & Plastic surgery
Product Code:OMP
Class:II
Predicate Devices:VCare 1000-300S Pump, VCare 1000-300S System, Perme-
foam Dressing (K162159)
Cork Medical Products- Cork Medical Products NPWT Wound Dressing
Kit (K132004)
V.A.C.® ATS, mini VAC, VAC Freedom (K032310)

2 Device Description:

Longterm NPWT dressing kit is a single use device as an accessory to VCare 1000-300S pump, manufactured by VR Medical Technology Co., Ltd. The dressing kit consists of hydrophobic, reticulated Polyurethane foam, polyurethane film drape coated with acrylic adhesive, suction bell composed of a polyvinyl chloride (PVC) drainage tubing with a polypropylene pinch clamp, a bell shape dome made of polyvinyl chloride, a transparent polyurethane film coated with acrylic adhesive. Each component is individually packaged and sterilized.

The suction bell is comprised of a polyvinyl chloride drainage tubing with a polypropylene pinch clamp, a bell shape dome made of polyvinyl chloride, a transparent poly urethane film coated with acrylic adhesive.

Foam dressing is available in 4 sizes; small (10cmx7.5cmx2.5cm), medium

4

(18cmx12.5cmx2.5cm), large (26cmx15cmx2.5cm) and extra large (45cmx30cmx2.5cm). PU film drape is available in 2 sizes; 30cmx30cm and 45cmx30cm.

The foam dressing is used to pack the wound bed, the film drape is used to cover the packed wound bed and peri-wound area to create and maintain a sealed environment, the suction bell is served as a conduit between the wound bed and the suction pump to transfer the wound fluid to the canister attached to the suction pump.

The foam dressing should not be used for more than 24 hours and should be replaced with other dressings compatible with the VCare 1000-300S pump after 24 hours.

3 Indications for Use:

The dressing kit 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. The system is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

The NPWT foam dressing kit is for use in professional healthcare facilities only.

5

4 Substantial Equivalence

ParameterSubject DevicePredicate Device #1Predicate Device #2Predicate Device #3
510(k)#K182458K162159K132004K032310
Device nameLongterm NPWT Foam
Dressing KitVCare 1000-300S Pump,
VCare 1000-300S System,
Perme-foam Dressing
(K162159)Cork NPWT Wound
Dressing KitKCI-V.A.C. ATS, mini
VAC, VAC Freedom
NoteAccessory to VCare pump (510
(k) K162159)--Only foam dressing is
used as the predicate
Classification
Regulation878.4780SameSameSame
Product CodeOMPSameSameSame
Skin Contact
Materials- Polyurethane ester foam with
0.1% carbon black colorant
  • Polyurethane film with acrylic
    adhesive | - Polyurethane ester foam;
  • Polyurethane drape | - Reticulated polyether based
    polyurethane foam (30
    pores per inch);
  • Transparent polyurethane
    film drape with adhesive
    backing | - Black, reticulated,
    polyurethane foam |
    | Non-Skin
    Contact
    Materials | Suction Bell comprised of a
    polypropylene drainage tubing
    with a polypropylene pinch
    clamp, a bell shape dome made
    of polyvinyl chloride, a
    transparent poly urethane film
    coated with acrylic adhesive. | Suction Bell with connecting
    (drainage) tube and clamp | port pad comprised of port
    pad, drainage tubing, luer
    connector, pinch clamp,
    transparent film drape with
    adhesive backing. | Suction bell with drainage
    tube |
    | Intended Use | The dressing kit 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 | The VR Medical VCare 1000-
    300S Negative Pressure Wound
    Therapy System is an
    integrated wound management
    system, indicated for wound
    management via the application
    of negative pressure to the
    wound, in order for the removal | Cork Medical Products
    NPWT Wound Dressing Kit
    is intended to be used in
    conjunction with the
    Genadyne XLRS Pump to
    deliver negative pressure
    wound therapy to the wound.
    When used in conjunction | The V.A.C. family of
    devices are feedback-
    controlled negative
    pressure devices used
    to help promote wound
    healing, through means
    including vacuum assisted
    drainage and |
    | | | | | |
    | | fluids and infectious materials.
    The system is intended for
    patients with chronic, acute,
    traumatic, subacute and dehisced
    wounds, partial-thickness burns,
    ulcers (such as diabetic or
    pressure), flaps and grafts. | of fluids, including wound
    exudates, irrigation fluids, body
    fluids and infectious materials.
    The system is intended for
    patients with chronic, acute,
    traumatic, subacute and
    dehisced wounds, partial-
    thickness burns, ulcers (such as
    diabetic or pressure), flaps and
    grafts. | with a NPWT pump system,
    Cork Medical Products
    NPWT Wound Dressing Kit
    is indicated for patients who
    would benefit from a suction
    device particularly as the
    device may promote wound
    healing by the removal of
    excess exudates, infectious
    material, and tissue debris. | removal of infectious
    material or other fluids,
    under the influence of
    continuous and or
    intermittent suction
    pressures, particularly for
    patients with chronic,
    acute, traumatic,
    subacute and dehisced
    wounds, partial-thickness
    burns, ulcers (such as
    diabetic or
    pressure), flaps and grafts.
    Feedback control is
    achieved by measuring the
    level of
    negative pressure at the
    wound site. |
    | Use environment | The foam dressing kit is for use
    in professional healthcare
    facilities only. | The subject device is for use in
    professional healthcare
    facilities only. | The subject device is for use
    in professional healthcare
    facilities only. | The subject device is for
    use in professional
    healthcare facilities only. |
    | Biocompatibility
    (Foam) | Non-cytotoxic, non-irritant, non-
    sensitizing, non- pyrogenic | Non-cytotoxic, non-irritant,
    non-sensitizing, non-toxic, non-
    pyrogenic | Non-cytotoxic, non-irritant,
    non-sensitizing | Biocompatible |
    | Biocompatibility
    (Drape) | Non-cytotoxic, non-irritant, non-
    sensitizing, non-toxic, non-
    pyrogenic | Non-cytotoxic, non-irritant,
    non-sensitizing, non-toxic, non-
    pyrogenic | Non-cytotoxic, non-irritant,
    non-sensitizing | Biocompatible |
    | Biocompatibility
    (Suction bell) | Non cytotoxic, non-irritant, non-
    sensitizing | Biocompatible | Biocompatible | Biocompatible |
    | Sterilization | Each kit components
    individually sterilized by
    Ethylene Oxide or Gamma
    Irradiation | Gamma Irradiation | Individual kit components
    individually sterilized by
    Ethylene Oxide or Gamma
    Irradiation | Gamma irradiation |
    | Sterility | SAL of 10-6 | SAL of 10-6 | SAL of 10-6 | SAL of 10-6 |
    | Assurance Level | | | | |

6

7

8

Non-clinical Testing Summary: 5

The following tests were performed to support the substantial equivalence of the subject device:

Biocompatibility Testing:

  • Cytotoxicity ISO 10993-5:2009 (Foam, Drape, Suction bell) ●
  • Irritation ISO 10993-10:2010 (Foam, Drape, Suction bell) ●
  • Sensitization ISO 10093-10:2010 (Foam, Drape, Suction bell) ●
  • Pyrogenicity -ISO 10993-11:2006/USP39-NF34 (Foam, Drape)
  • Acute systemic toxicity ISO 10993-11:2017 (Foam, Drape) ●

Bench testing:

Longterm NPWT Foam Dressing Kit was evaluated under of bench tests to ensure the dressing kit can be used along with VCare 1000-300S pump regarding performance and functionality requirements.

  • The foam dressing dimension test under continuous various negative pressure mode after 72 ● hours:
  • The fluid removal rate under various negative pressure in 72 hours;
  • . The pressure distribution under the foam dressing in 72 hours under continuous negative pressure mode;
  • The pressure difference under the foam dressing in 72 hours under intermittent negative pressure mode.
  • Mechanical properties (tensile strength and elongation, ASTM D3574) .

6 Clinical Testing:

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.