(110 days)
No
The description focuses on a mechanical pump system for negative pressure wound therapy and does not mention any AI or ML components.
Yes
The device is indicated for promoting wound healing through the removal of exudates from surgical incisions, which is a therapeutic function.
No
The device is described as promoting wound healing through the removal of exudates and maintaining negative pressure wound therapy, which are therapeutic functions, not diagnostic ones.
No
The device description explicitly states it is a "single-use device that includes an integrated, mechanical pump system" and mentions "hardware verification and validation," indicating it is a physical device with hardware components, not software-only.
Based on the provided information, the NPseal device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for wound management via negative pressure application to closed surgical incisions. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a mechanical pump system for applying negative pressure to a wound. This is a physical intervention, not a test performed on biological samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The NPseal's function is to physically manage a wound.
N/A
Intended Use / Indications for Use
The NPseal is indicated for patients who would benefit from wound management via application of negative pressure, particularly as the device may promote wound healing through the removal of small amounts of exudates from closed surgical incisions.
Product codes (comma separated list FDA assigned to the subject device)
OKO
Device Description
The NPseal Negative Pressure Advanced System is a single-use device that includes an integrated, mechanical pump system. The NPseal maintains Negative Pressure Wound Therapy (NPWT) in the -75 mmHq to -125 mmHq nominal range.
The NPseal is intended for 3 days of use. Therapy duration of the system may be less than indicated if clinical practice or other factors such as wound size, rate or volume of exudate, or orientation of the dressing results in earlier removal or need for system change. The NPseal can be replaced only one time for a total maximum wear time of 6 days.
The NPseal is intended for surgically closed incisions up to 5 cm x 0.5 cm.
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
Not Found
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 performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
The biocompatibility evaluation for the NPseal was conducted in accordance with the international standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA along with the agency's quidance document. "Use of International Standard ISO 10993-1. 'Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process:' Guidance for Industry and Food and Drug Administration Staff" (issued June 16, 2016). The tests performed included the following:
- Cytotoxicity
- Sensitization
- Irritation or Intracutaneous Reactivity
- Acute Systemic Toxicity
- Material-Mediated Pyrogenicity
- Subacute Systemic Toxicity
- Subchronic Systemic Toxicity
- Implantation
Bench Testing
- Pressure and exudate handling over time test
- Curved surface pressure over time
- Foam characterization test.
- Pump body adhesion test
- Dressing peel test.
- Exudate handling without negative pressure test.
- Moisture vapor transmission rate (MVTR) test.
- Shelf Life test.
- Benchtop Usability Verification
- Set Negative Pressure test
Human Factors Testing
- User validation study.
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
§ 878.4683 Non-Powered suction apparatus device intended for negative pressure wound therapy.
(a)
Identification. A non-powered suction apparatus device intended for negative pressure wound therapy is a device that is indicated for wound management via application of negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. It is further indicated for management of wounds, burns, flaps, and grafts.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Non-powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy (NPWT).” See § 878.1(e) for the availability of this guidance document.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 26, 2020
Guard Medical Inc. % Eric Bannon Consultant AlvaMed. Inc. 935 Great Plain Avenue, #166 Needham, Massachusetts 02492
Re: K200305
Trade/Device Name: NPseal Regulation Number: 21 CFR 878.4683 Regulation Name: Non-Powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy Regulatory Class: Class II Product Code: OKO Dated: May 1, 2020 Received: May 4, 2020
Dear Eric Bannon:
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/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 medical devices and radiation-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,
Anjana Jain, Ph.D. Acting 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) K200305
Device Name NPseal
Indications for Use (Describe)
The NPseal is indicated for patients who would benefit from wound management via application of negative pressure, particularly as the device may promote wound healing through the removal of small amounts of exudates from closed surgical incisions.
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
I. SUBMITTER
Guard Medical, Inc. 10 East 40th Street Suite 3310 New York, NY 10016
Phone: (888) 417-3644 Fax: (617) 249-0955
Contact Person: Eric Bannon
Date Prepared: May 18, 2020
II. DEVICE
Name of Device: NPseal
Common or Usual Name: Negative Pressure Wound Therapy Non-powered Suction Apparatus
Classification Name: Non-Powered suction apparatus device intended for negative pressure wound therapy. (21 CFR 878.4683)
Regulatory Class: II
Product Code: OKO
III. PREDICATE & REFERENCE DEVICES
Predicate Device: SNaP Wound Care System, K151710
Reference Device: PICO Single Use Negative Pressure Wound Therapy System, K180618
IV. DEVICE DESCRIPTION
The NPseal Negative Pressure Advanced System is a single-use device that includes an integrated, mechanical pump system. The NPseal maintains Negative Pressure Wound Therapy (NPWT) in the -75 mmHq to -125 mmHq nominal range.
The NPseal is intended for 3 days of use. Therapy duration of the system may be less than indicated if clinical practice or other factors such as wound size, rate or volume of exudate, or orientation of the dressing results in earlier removal or need for system change. The NPseal can be replaced only one time for a total maximum wear time of 6 days.
The NPseal is intended for surgically closed incisions up to 5 cm x 0.5 cm.
V. INDICATIONS FOR USE
The NPseal is indicated for patients who would benefit from wound management via application of negative pressure, particularly as the device may promote wound healing through the removal of small amounts of exudates from closed surgical incisions.
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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE AND REFERENCE DEVICES
| | Subject Device:
NPseal | Predicate Device:
SnAP Wound Care System | Reference Device:
PICO Single Use Negative
Pressure Wound Therapy
System |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Guard Medical | Spiracur | Smith & Nephew |
| 510(k) Number | K200305 | K151710 | K180618 |
| Product Code | OKO | OKO | OMP |
| Regulation
Number | 878.4683 | 878.4683 | 878.4780 |
| Regulation
Description | Non-Powered suction
apparatus device intended
for negative pressure
wound therapy | Non-Powered suction
apparatus device intended for
negative pressure wound
therapy | Powered suction pump |
| Common
Name | Negative Pressure Wound
Therapy non-powered suction
apparatus | Negative Pressure Wound
Therapy non-powered suction
apparatus | Powered suction pump and
wound dressing kit |
| | Subject Device:
NPseal | Predicate Device:
SNaP® Wound Care System | Reference Device:
PICO Single Use Negative
Pressure Wound Therapy
System |
| Intended Use | The NPseal is indicated for
patients who would benefit
from wound management
via application of negative
pressure, particularly as the
device may promote wound
healing through the removal
of small amounts of
exudates from closed
surgical incisions. | The SNaP® Wound Care
System is indicated for
patients who would benefit
from wound management
via the application of
negative pressure,
particularly as the device
may promote wound healing
through the removal of
excess exudate, infectious
material and tissue debris.
The SNaP® Wound Care
System is indicated for
removal of small amounts of
exudate from chronic, acute,
traumatic, subacute and
dehisced wounds, partial-
thickness burns, ulcers
(such as diabetic, venous or
pressure), surgically closed
incisions, flaps and grafts. | PICO is indicated for
patients who would benefit
from a suction device
(negative pressure wound
therapy) as it may promote
wound healing via removal of
low to moderate levels of
exudate and infectious
materials.
Appropriate wound types
include:
- Chronic
- Acute
- Traumatic
- Subacute and dehisced
wounds - Partial-thickness burns
- Ulcers (such as diabetic or
pressure) - Flaps and grafts
- Closed surgical incisions
PICO Single Use Negative
Pressure Wound Therapy
System is suitable for use
both in a hospital and
homecare setting. |
| Sterility | Sterile - Gamma irradiation | Sterile - Gamma irradiation | Sterile - EO |
| Single Use | Yes | Yes | Yes |
| Wear Time | 3 days | 7 days | 7 days |
| Dressing
film(s) | High Moisture Vapor
Transmission Rate (MVTR),
breathable polyurethane film | Single layer hydrocolloid
dressing, non-breathable | High Moisture Vapor
Transmission Rate (MVTR)
upper film, perforated silicone
adhesive skin layer |
| | Subject Device:
NPseal | Predicate Device:
SnaP Wound Care System | Reference Device:
PICO Single Use Negative
Pressure Wound
Therapy System |
| Negative
Pressure
Operating
Ranges | -75 to -125 mmHg | -75, -100, or -125 mmHg | -80 mmHg |
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6
The subject, predicate and reference devices are all NPWT dressing systems.
The subject and predicate devices are substantially equivalent, as evidenced by their shared characteristics:
- . Single use
- . Nonpowered
- Identical negative pressure operating ranges (-75 to -125 mmHg)
- Indicated for removal of small amounts of exudates. ●
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
The biocompatibility evaluation for the NPseal was conducted in accordance with the international standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA along with the agency's quidance document. "Use of International Standard ISO 10993-1. 'Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process:' Guidance for Industry and Food and Drug Administration Staff" (issued June 16, 2016). The tests performed included the following:
- . Cytotoxicity
- . Sensitization
- Irritation or Intracutaneous Reactivity
- Acute Systemic Toxicity
- . Material-Mediated Pyrogenicity
- . Subacute Systemic Toxicity
- . Subchronic Systemic Toxicity
- . Implantation
Bench Testing
- . Pressure and exudate handling over time test
- · Curved surface pressure over time
- Foam characterization test .
- . Pump body adhesion test
- Dressing peel test .
- Exudate handling without negative pressure test .
- Moisture vapor transmission rate (MVTR) test .
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- Shelf Life test .
- . Benchtop Usability Verification
- Set Negative Pressure test
Human Factors Testing
- User validation study .
VIII. CONCLUSIONS
The test data support the safety of the device and the hardware verification and validation demonstrate that the NPseal shall perform as intended in the specified use conditions. The data demonstrate that the NPSeal is substantially equivalent to the predicate device with respect to the intended use and technological comparison. There were no new questions regarding safety or effectiveness.