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.

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.

AI/ML Overview

(1) A table of acceptance criteria and the reported device performance:

The provided text does not contain explicit acceptance criteria in a table format with corresponding reported device performance, as one might find in a detailed study report. Instead, it lists the types of performance data submitted for FDA's substantial equivalence determination.

Summary of Performance Data Submitted:

Test Category	Specific Tests Performed
Biocompatibility Testing	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

The "Conclusions" section states: "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." This implies that the device met the internal acceptance criteria for each of these tests, although the specific numerical or qualitative targets for these criteria are not detailed in this summary.

(2) Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The provided document is a 510(k) summary for a medical device (NPseal). It summarizes the performance data used to support substantial equivalence. It does not provide details on the sample sizes, data provenance (e.g., country of origin), or whether the studies were retrospective or prospective for the various tests mentioned (Biocompatibility, Bench, and Human Factors). These details would typically be found in the full study reports, which are not part of this summary document.

(3) Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not provided in the document. The NPseal is a physical device (non-powered suction apparatus for negative pressure wound therapy), not an AI/imaging diagnostic device that would typically rely on expert ground truth for a "test set" in the way an AI algorithm for image analysis does. The studies mentioned (biocompatibility, bench testing, human factors) involve laboratory or user-based assessments, not an expert panel reviewing diagnostic outcomes for ground truth establishment.

(4) Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials or studies involving expert interpretation of data (e.g., medical images) where discrepancies need to be resolved to establish ground truth. As the NPseal is a physical medical device for wound therapy and the studies mentioned are largely laboratory or performance-based, such adjudication would not be relevant.

(5) If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable and therefore not provided. An MRMC study is relevant for evaluating the performance of diagnostic imaging devices or AI algorithms where multiple human readers interpret cases. The NPseal is a non-powered suction apparatus for negative pressure wound therapy, not a diagnostic imaging device or an AI assistance tool for human readers.

(6) If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This information is not applicable and therefore not provided. The NPseal is a physical medical device, not a standalone algorithm. The performance data provided relate to the physical and functional aspects of the device, as well as its interaction with users (human factors).

(7) The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The concept of "ground truth" in the context of an AI or diagnostic study does not directly apply to the testing of the NPseal device as described. The testing (biocompatibility, bench testing, human factors) would have established expected performance parameters and safety profiles against predetermined engineering specifications, international standards (e.g., ISO 10993-1), and user requirements. For example:

Biocompatibility: Ground truth would be the established safety limits and biological responses as defined by ISO standards.
Bench Testing: Ground truth would be the engineering specifications for pressure, exudate handling, material strength, etc.
Human Factors Testing: Ground truth would be the user performance against predefined usability objectives and safety critical tasks.

(8) The sample size for the training set:

This information is not applicable and therefore not provided. The NPseal is a physical medical device, not an AI algorithm that requires a training set. The various tests performed (biocompatibility, bench, human factors) are part of the verification and validation process for a hardware device, not model training.

(9) How the ground truth for the training set was established:

This information is not applicable and therefore not provided, as there is no "training set" for this physical medical device.

Summary

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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

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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)

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 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

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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 NegativePressure Wound TherapySystem
Manufacturer	Guard Medical	Spiracur	Smith & Nephew
510(k) Number	K200305	K151710	K180618
Product Code	OKO	OKO	OMP
RegulationNumber	878.4683	878.4683	878.4780
RegulationDescription	Non-Powered suctionapparatus device intendedfor negative pressurewound therapy	Non-Powered suctionapparatus device intended fornegative pressure woundtherapy	Powered suction pump
CommonName	Negative Pressure WoundTherapy non-powered suctionapparatus	Negative Pressure WoundTherapy non-powered suctionapparatus	Powered suction pump andwound dressing kit
	Subject Device:NPseal	Predicate Device:SNaP® Wound Care System	Reference Device:PICO Single Use NegativePressure Wound TherapySystem
Intended Use	The NPseal is indicated forpatients who would benefitfrom wound managementvia application of negativepressure, particularly as thedevice may promote woundhealing through the removalof small amounts ofexudates from closedsurgical incisions.	The SNaP® Wound CareSystem is indicated forpatients who would benefitfrom wound managementvia the application ofnegative pressure,particularly as the devicemay promote wound healingthrough the removal ofexcess exudate, infectiousmaterial and tissue debris.The SNaP® Wound CareSystem is indicated forremoval of small amounts ofexudate from chronic, acute,traumatic, subacute anddehisced wounds, partial-thickness burns, ulcers(such as diabetic, venous orpressure), surgically closedincisions, flaps and grafts.	PICO is indicated forpatients who would benefitfrom a suction device(negative pressure woundtherapy) as it may promotewound healing via removal oflow to moderate levels ofexudate and infectiousmaterials.Appropriate wound typesinclude:- Chronic- Acute- Traumatic- Subacute and dehiscedwounds- Partial-thickness burns- Ulcers (such as diabetic orpressure)- Flaps and grafts- Closed surgical incisionsPICO Single Use NegativePressure Wound TherapySystem is suitable for useboth in a hospital andhomecare setting.
Sterility	Sterile - Gamma irradiation	Sterile - Gamma irradiation	Sterile - EO
Single Use	Yes	Yes	Yes
Wear Time	3 days	7 days	7 days
Dressingfilm(s)	High Moisture VaporTransmission Rate (MVTR),breathable polyurethane film	Single layer hydrocolloiddressing, non-breathable	High Moisture VaporTransmission Rate (MVTR)upper film, perforated siliconeadhesive skin layer
	Subject Device:NPseal	Predicate Device:SnaP Wound Care System	Reference Device:PICO Single Use NegativePressure WoundTherapy System
NegativePressureOperatingRanges	-75 to -125 mmHg	-75, -100, or -125 mmHg	-80 mmHg

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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.

Regulation Number and Section

§ 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.