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 mmHg to -125 mmHg nominal range. The NPseal is intended for 6 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 result 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

This document describes a Special 510(k) submission for the NPseal device, focusing on a labeling modification to extend the wear time from 3 days to 6 days. Due to this being a Special 510(k) and the nature of the device (non-powered suction apparatus for negative pressure wound therapy), the study performed is primarily performance and functional testing rather than a complex clinical or AI-based study.

Here's the breakdown of the acceptance criteria and the study, addressing your specific points:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What was tested)	Device Performance (Result)
Pressure and Exudate Handling Over Time	The document states that this testing was performed to assess the impact of extending the wear time from 3 to 6 days. While specific numerical results (e.g., precise pressure maintenance values, exudate absorption rates) are not provided in this summary, the conclusion drawn from this testing is that the modified NPseal is "as safe as the predicate device" and that the labeling changes "do not raise any different questions of safety or effectiveness." This implies that the device successfully maintained its intended pressure range (-75 mmHg to -125 mmHg nominal range, ± 17.5 mmHg) and adequately handled exudate over the extended 6-day period, meeting the implicit functional acceptance criteria of the predicate device.
Shelf-Life Testing	Shelf-life was extended from 6 to 24 months. The testing used "identical test methods and acceptance criteria to the predicate device." While specific test methods (e.g., accelerated aging, real-time aging data) and acceptance criteria (e.g., maximum allowable change in material properties, sustained negative pressure over time after aging) are not detailed here, the successful extension of the shelf-life to 24 months indicates that the device met these criteria, maintaining its integrity and functionality over the extended storage period.
Biocompatibility	"Complies with ISO 10993-1." This signifies that the materials used in the device are considered biocompatible and suitable for direct or indirect patient contact for the intended duration of use (up to 6 days), as per international standards.
Sterility	"Sterile - Gamma irradiation." This indicates the device achieved and maintained sterility as validated by appropriate methods (e.g., bioburden testing, sterility assurance level (SAL) validation) following gamma irradiation, in line with regulatory requirements.
Negative Pressure Range	The device maintains Negative Pressure Wound Therapy (NPWT) in the "-75 mmHg to -125 mmHg nominal range (± 17.5 mmHg)." This is a key functional requirement, and the comparative table states this is "Same as predicate," implying the modified device continues to meet this defined pressure range.
Management of Exudates (Mechanism)	"Managed by the dressing itself - via combination of absorption into the foam pad and evaporation through the breathable upper film." This describes the mechanism, which is indicated as "Same as predicate," suggesting the effectiveness of this mechanism was sustained with the extended wear time.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not explicitly state the sample sizes (e.g., number of devices or test units) used for the pressure and exudate handling over time, or for the shelf-life testing. These would typically be determined based on statistical justification for engineering bench testing, but are not disclosed in this summary.

The data provenance is from bench testing (laboratory-based performance and functional testing). The country of origin for the data is implicitly the United States, given Guard Medical Inc.'s location in Miami, FL, and the FDA submission. The testing would be considered prospective in the sense that it was conducted specifically to support this 510(k) submission for the modified device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of submission (Special 510(k) for a non-AI/imaging device with a labeling change based on performance testing) does not involve medical experts establishing ground truth in the way an AI diagnostic tool would. The "ground truth" here is based on engineering specifications, validated test methods, and performance against established benchmarks (i.e., the predicate device's performance over its shorter wear time). The experts involved would be engineers, materials scientists, and quality/regulatory personnel who designed and executed the tests and interpreted the results against defined acceptance criteria. Their qualifications would be in their respective technical fields.

4. Adjudication Method for the Test Set

No adjudication method as typically understood in human-reader studies (e.g., 2+1, 3+1 consensus) was performed. The data generated is from objective, quantitative bench testing, assessed against predefined engineering specifications and performance targets from the predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for AI-powered diagnostic devices where the performance of human readers with and without AI assistance is compared. The NPseal is a physical medical device, and the changes relate to its wear time and shelf-life, not its diagnostic capability or a human-in-the-loop diagnostic process.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

No, this question is not applicable. The NPseal is a physical device, not an algorithm. Its "standalone" performance refers to its ability to maintain negative pressure and manage exudate, which was evaluated through the "Pressure and Exudate Handling Over Time" and "Shelf-Life Testing" mentioned.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on:

Engineering Specifications and Performance Benchmarks: The device must maintain specific negative pressure ranges and manage exudate effectively over the specified wear time.
Predicate Device Performance: The modified device's performance must be substantially equivalent to, or better than, the predicate device's performance regarding safety and effectiveness, even with the extended wear time.
International Standards: Compliance with standards like ISO 10993-1 for biocompatibility is also a form of established "ground truth" for material safety.

It is not based on expert consensus, pathology, or outcomes data in the context of diagnostic accuracy, as this is not a diagnostic device.

8. The Sample Size for the Training Set

This question is not applicable. The NPseal is a physical medical device, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no training set for this device.

Summary

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May 14, 2021

Guard Medical Inc. % Eric Bannon VP, Regulatory and Clinical Affairs AlvaMed. Inc. 935 Great Plain Avenue, Unit 166 Needham, Massachusetts 02492

Re: K211130

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: April 15, 2021 Received: April 16, 2021

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,

for Lixin Liu, 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) K21130

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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1.0 SPECIAL 510(K) SUMMARY

This Special 510(k) for the NPseal is submitted based on the FDA Guidance document "The Special 510(k) Program: Guidance for Industry and Food and Drug Administration Staff" (issued September 13, 2019).

Name and Address of Sponsor 1.1
Guard Medical, Inc. 1221 Brickell Avenue, Suite 900 Miami, FL 33131 USA Phone: +1 (888) 417-3644 Machiel Van der Leest CEO m.vanderleest@guard-medical.com
Correspondent/Primary Contact Person 1.2
Eric Bannon Vice President of Regulatory and Clinical Affairs

AlvaMed, Inc. (consultant to Guard Medical) 935 Great Plain Avenue, Unit 166 Needham, MA 02492 USA ebannon@alvamed.com Phone: +1 (781) 710-8243 Fax: +1 (617) 249-0955

1.3 Submission Information

Date Summary Prepared:	May 14, 2021
Name of Device:	NPseal
Common or Usual Name:	Negative Pressure Wound Therapy Non-Powered SuctionApparatus
Classification:	Class II
Product Code:	OKO (21 CFR 878.4683)
Predicate Device:	NPseal (K200305)

1.4 Device Description

The NPseal is intended for 6 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 result 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.

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GVARDMEDICAL	Special 510(k): Labeling Modificationto NPseal	Page:2
------------------	----------------------------------------------------	------------

The NPseal is intended for surgically closed incisions up to 5 cm x 0.5 cm.

1.5 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.
Comparison of Manufacturer's Cleared Device and Modified Device 1.6

		Table 1. Comparison of Modified Device to Cleared Device

	SubjectNPseal	Predicate DeviceNPseal
510(k) Number	K211130	K200305
510k Submitter/Holder	Same as predicate	Guard Medical
Product Code	Same as predicate	OKO
Regulation No.	Same as predicate	878.4683
Regulation Description	Same as predicate	Non-Powered suction apparatus deviceintended for negative pressure woundtherapy
CommonName	Same as predicate	Negative Pressure Wound Therapy non-powered suction apparatus
Indications for Use	Same as predicate	The NPseal is indicated for patients whowould benefit from wound managementvia application of a negative pressure,particularly as the device may promotewound healing through the removal ofsmall amounts of exudates from closedsurgical incisions.
Wound types	Same as predicate	Closed surgical incisions, less than 5 cmin length and 0.5 cm in width.
Single Use	Same as predicate	Yes
Negative PressureRange	Same as predicate	-75 to -125 mmHg (± 17.5 mmHg)
Device Technology	Same as predicate	Nonpowered, integrated pump manuallyactuated to generate negative pressure.Multilayer pad composed of hydrophilicfoam with high fluid absorbency and topbreathable film designed to collect andmove exudate away from the wound bed.
Management ofExudates	Same as predicate	Managed by the dressing itself - viacombination of absorption into the foampad and evaporation through thebreathable upper film.
	SubjectNPseal	Predicate DeviceNPseal
Materials	Same as predicate	Film: Polyurethane coated with adhesiveacrylic,Pad: Hydrophilic polyurethane,Pump: Thermoplastic elastomer
Maximum Therapy time	Same as predicate	6 days
Maximum number ofdressing changes	Same as predicate	1 dressing change
Wear Time per dressing	Up to 6 days	Up to 3 days
Sterility	Same as predicate	Sterile - Gamma irradiation
Biocompatibility	Same as predicate	Complies with ISO 10993-1

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Image /page/5/Picture/1 description: The image shows the logo for Guard Medical. The logo is in blue and consists of the word "GUARD" in large letters, with the "A" shaped like a shield. Below the word "GUARD" is the word "MEDICAL" in smaller letters. The logo is simple and modern, and the use of the shield shape in the "A" suggests protection and safety.

Page: Special 510(k): Labeling Modification to NPseal

1.7 Summary of Modification
There is one modification to the device's labeling: wear time is now 6 days instead of the predicate device's 3 days.

Shelf-life was extended from 6 to 24 months.

1.8 Summary of Functional and Performance Testing
The wear time change from 3 days to 6 days was assessed based on risk and the Design Controls in 21 CFR 820. The following verification and validation testing was performed:
Pressure and Exudate Handling Over Time ●
. Shelf-Life Testing using the test methods and acceptance criteria identical to the predicate device.
Summary of Clinical Testing 1.9

No clinical testing was applicable to this submission.

1.10 Conclusion
The modified NPseal has been shown to be as safe as the predicate device through bench testing. Labeling changes made to the device do not raise any different questions of safety or effectiveness. Verification and validation data support substantial equivalence of the modified NPseal to the legally marketed predicate device.

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.