(375 days)
Not Found
No
The device description and performance studies focus on the physical components and mechanical function of a negative pressure wound therapy dressing kit, with no mention of AI or ML.
Yes.
The device is intended for wound management via the application of negative pressure, which is a therapeutic intervention for various wound types.
No
Explanation: The device description clearly states that the "Longterm NPWT Foam 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." This indicates a therapeutic function (wound management and fluid removal) rather than a diagnostic one (identifying a disease or condition).
No
The device description clearly outlines physical components (foam dressing, PU film drape, suction bell) and the performance studies focus on the physical and mechanical properties of these components, not software functionality.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for wound management via the application of negative pressure to remove fluids. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details components like foam dressing, film drape, and suction bell, all designed for physical interaction with a wound to facilitate healing. There is no mention of analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies focus on biocompatibility, bench testing related to fluid removal and pressure distribution, and animal wound healing studies. These are all relevant to the physical and functional performance of a wound care device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue), detecting specific analytes, or providing information for diagnosis, monitoring, or screening of diseases or conditions.
In summary, the Longterm NPWT Foam Dressing Kit is a therapeutic device used for wound treatment, not a diagnostic device used for analyzing samples to provide medical information.
N/A
Intended Use / Indications for Use
Longterm NPWT Foam 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. Longterm NPWT foam dressing kit is for use in professional healthcare facilities only.
Product codes
OMP
Device Description
Longterm NPWT Foam dressing kit is an accessory to VCare 1000-300S pump, manufactured by VR Medical Technology Co., Ltd. The dressing kit is composed of black foam dressing, polyurethane (PU) film drape and suction bell.
The foam dressing is used to pack the wound bed, the PU 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 negative pressure pump to transfer the wound fluid to the canister attached to the pump.
Longterm NPWT Foam 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 foam dressing should be changed every 2-3 days depending on the wound condition or according to the local protocol.
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.
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 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)
Non-clinical Testing Summary:
Biocompatibility Testing:
- Cytotoxicity - ISO 10993-5:2009
- Irritation ISO 10993-10:2010 ●
- Sensitization ISO 10093-10:2010 ●
- . Pyrogenicity -ISO 10993-11:2006/USP39-NF34
- Acute toxicity ISO 10993-11:2017 ●
- Subacute toxicity ISO 10993-11:2017/ ISO 10993-6:2016 ●
- Subchronic toxicity ISO 10993-11: 2017 / ISO 10993-2016 ●
- Muscle implantation ISO 10993-6:2016 .
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 various negative pressure after 72 hours at both continuous and intermittent modes;
- The fluid removal rate under various negative pressure at 72 hours at both continuous and intermittent modes;
- The pressure distribution under the foam dressing in 72 hours at both continuous and ● intermittent modes;
- The pressure difference under the foam dressing in 72 hours at both continuous and ● intermittent modes.
- Mechanical properties (tensile strength and elongation, ASTM D3574)
Animal testing:
Porcine wound healing study
Conclusion:
The non-clinical tests demonstrate that the subject device is as safe, as effective and performs as well as the legally marked predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 31, 2022
Zhejiang Longterm Medical Technology Co., LTD Claudia Zsang Director of Regulatory Affairs No. 493 North Huancheng Road Mogan Mountain National High-Tech District Deging, Zhejiang 313200 China
Re: K211571
Trade/Device Name: Small Foam Kit. Large Foam Kit. Extra Large Foam Kit. Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: November 29, 2021 Received: December 7, 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.
1
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 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.
Julie Morabito, 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) K211571
Device Name Longterm NPWT Foam Dressing Kit
Indications for Use (Describe)
Longterm NPWT Foam 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. Longterm 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) |
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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 03, 2022 |
|---|---|
| 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 |
| Claudia.zsang@gmail.com | |
| Phone Number: | 1-416-276-9555 |
| 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) (Primary) | |
| KCI USA Inc-V.A.C.® ATS, mini VAC, VAC Freedom | |
| (K032310) |
2 Device Description:
Longterm NPWT Foam dressing kit is an accessory to VCare 1000-300S pump, manufactured by VR Medical Technology Co., Ltd. The dressing kit is composed of black foam dressing, polyurethane (PU) film drape and suction bell.
The foam dressing is used to pack the wound bed, the PU 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 negative pressure pump to transfer the wound fluid to the canister attached to the pump.
Longterm NPWT Foam 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
4
K211571
adhesive. Each component is individually packaged and sterilized. The foam dressing should be changed every 2-3 days depending on the wound condition or according to the local protocol.
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.
3 Indications for Use:
Longterm NPWT Foam 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.
Longterm NPWT foam dressing kit is for use in professional healthcare facilities only
5
4 Substantial Equivalence
| Parameter | Subject Device | Predicate Device #1 (Primary) | Predicate Device #2 |
|---|---|---|---|
| 510(k)# | K211571 | K162159 | K032310 |
| Device name | Longterm NPWT Foam Dressing Kit | VCare 1000-300S Pump, VCare 1000-300S | |
| System, Perme-foam Dressing (K162159) | KCI-V.A.C. ATS, mini VAC, VAC Freedom | ||
| Note | Accessory to VCare pump (510 (k) K162159) | - | Only foam dressing is used as the predicate |
| Classification | |||
| Regulation | 878.4780 | Same | Same |
| Product Code | OMP | Same | Same |
| Skin Contact | |||
| Materials | - Polyurethane ester foam with 0.1% carbon | ||
| black colorant |
- Polyurethane film with acrylic adhesive | - Polyurethane ester foam;
- Polyurethane drape | - 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 | Non-specific |
| Mechanism of
Action | The foam dressing is used to pack the wound
bed, the PU 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 negative pressure pump to
transfer the wound fluid to the canister
attached to the pump. | Same | Same |
| 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 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 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 | 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
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 |
| Parameter | Subject Device | Predicate Device #1 (Primary) | Predicate Device #2 |
| 510(k)# | K211571 | K162159 | K032310 |
| | | burns, ulcers (such as diabetic or pressure), flaps
and grafts. | 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 device is for use in professional
healthcare facilities only. | Non-specific |
| Biocompatibility
(breached skin,
prolonged,
24hr to 30days) | Non cytotoxic, non-irritant, non-sensitizing,
non-toxic, none- pyrogenic | Non cytotoxic, non-irritant, non-sensitizing,
non-toxic, none- pyrogenic | Biocompatible |
| Sterilization | Each kit components individually sterilized
by Ethylene Oxide or Gamma Irradiation | Gamma Irradiation | Gamma Irradiation |
| Sterility
Assurance Level | SAL of 10-6 | SAL of 10-6 | SAL of 10-6 |
6
7
ਟ 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
- Irritation ISO 10993-10:2010 ●
- Sensitization ISO 10093-10:2010 ●
- . Pyrogenicity -ISO 10993-11:2006/USP39-NF34
- Acute toxicity ISO 10993-11:2017 ●
- Subacute toxicity ISO 10993-11:2017/ ISO 10993-6:2016 ●
- Subchronic toxicity ISO 10993-11: 2017 / ISO 10993-2016 ●
- Muscle implantation ISO 10993-6:2016 .
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 various negative pressure after 72 hours at both continuous and intermittent modes;
- The fluid removal rate under various negative pressure at 72 hours at both continuous and intermittent modes;
- The pressure distribution under the foam dressing in 72 hours at both continuous and ● intermittent modes;
- The pressure difference under the foam dressing in 72 hours at both continuous and ● intermittent modes.
- Mechanical properties (tensile strength and elongation, ASTM D3574)
Animal testing:
Porcine wound healing study
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 device.