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. Each NPseal dressing is intended to be used up to 7 days. The total therapy time across multiple NPseal dressing changes is up to 14 days. NPseal therapy must be discontinued after 14 days. NPSeal dressing wear time may be less than indicated if clinical practice or other factors such as time to wound closure and rate of exudate, result in earlier removal or need for dressing change.

The NPseal 5 is intended for surgically closed incisions up to 5 cm × 0.5 cm.
The NPseal 10 is intended for surgically closed incisions up to 10 cm x 0.5 cm.
The NPseal 15 is intended for surgically closed incisions up to 15 cm x 0.5 cm.
The NPseal 20 is intended for surgically closed incisions up to 20 cm x 0.5 cm.
The NPseal 25 is intended for surgically closed incisions up to 25 cm x 0.5 cm.

AI/ML Overview

The provided 510(k) clearance letter and summary describe a modification to an existing medical device, the NPseal. The core of this submission is to extend the allowed "Total Therapy Time" from 7 days to 14 days, while the "Single Dressing Wear Time" remains 7 days.

Crucially, the document states that no functional, performance, or clinical testing was conducted for this specific submission (K251156) to support the extended therapy time. Instead, it relies on the safety and effectiveness established for the predicate device (K250708) and asserts that the labeling update itself does not raise new safety or effectiveness concerns.

Therefore, many of the requested details regarding acceptance criteria, study design, and performance metrics are not available within this document for the K251156 submission. The document explicitly states: "No functional or performance testing was completed based on the change" and "No clinical testing was applicable to this submission."

However, we can infer some information based on the nature of a 510(k) submission for a device like this and the reliance on a predicate. The original clearance (K250708) for the predicate device would have involved such testing.

Based on the provided text, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Not Applicable (N/A) for this specific K251156 submission.
The document explicitly states: "No functional or performance testing was completed based on the change." The acceptance criteria and performance data would have been part of the predicate device's (K250708) submission. Since no new testing was performed for K251156, no new performance data or specific acceptance criteria for the change are reported.

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

N/A for this specific K251156 submission.
No new test set was used, as no new functional, performance, or clinical testing was conducted. The reliance is on prior V&V data from the predicate device.

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)

N/A for this specific K251156 submission.
No new test set was evaluated with expert ground truth, as no new studies were conducted.

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

N/A for this specific K251156 submission.
No new test set was adjudicated.

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

N/A. This device (Negative Pressure Wound Therapy Non-Powered Suction Apparatus) is not an AI/imaging device that would typically involve human readers or MRMC studies.

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

N/A. This device does not incorporate an algorithm in the typical sense (e.g., for automated diagnosis or image analysis). It is a mechanical device.

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

N/A for this specific K251156 submission.
No new ground truth was established for the purpose of this submission, as no new studies were conducted. For the predicate device, ground truth for performance would likely have been established through physical and mechanical testing (e.g., pressure measurements, exudate absorption capacity, material biocompatibility) rather than clinical "ground truth" as seen in diagnostic device studies.

8. The sample size for the training set

N/A. This device does not involve machine learning or a "training set."

9. How the ground truth for the training set was established

N/A. This device does not involve machine learning or a "training set."

Summary of Device and Rationale for Clearance without New Testing:

The K251156 submission is a Special 510(k) based on the "The Special 510(k) Program" guidance. This program is for modifications to a manufacturer's own legally marketed device where the change does not pose new questions of safety or effectiveness.

Device Name: NPseal
Device Type: Non-Powered Suction Apparatus Device Intended For Negative Pressure Wound Therapy (NPWT)
Modification: Extension of the "Total Therapy Time" from 7 days to 14 days. Crucially, the "Single Dressing Wear Time" remains 7 days. This implies that therapy over 14 days would involve at least one dressing change.
Rationale for No New Testing: The FDA's clearance suggests that changing the total therapy duration from 7 to 14 days, while keeping the single dressing wear time at 7 days, was considered a minor labeling change that does not introduce new risks or alter the fundamental performance of the device that was already proven safe and effective for up to 7 days, presumably including multiple dressing changes within that 7-day period. The assumption is that if a patient can safely use the device for two 7-day periods (with a dressing change) in sequence, then extending the total therapy time to 14 days doesn't inherently change the device's mechanism of action or safety profile. The previous verification and validation data from the predicate (K250708) were deemed sufficient to support this extended timeframe.

Summary

U.S. Food & Drug Administration 510(k) Clearance Letter

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

May 15, 2025

Guard Medical, Inc.
℅ Eric Bannon
Sr. Vice President Regulatory and Clinical Affairs
AlvaMed, Inc.
935 Great Plain Avenue
Suite 166
Needham, Massachusetts 02492

Re: K251156
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 14, 2025
Received: April 15, 2025

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 (the 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 available 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.

Page 2

K251156 - Eric Bannon
Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

Page 3

K251156 - Eric Bannon
Page 3

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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,

Yu-Chieh Chiu, Ph.D.
Assistant Director
DHT4B: Division of Plastic and Reconstructive Surgery Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known): K251156
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)

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
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"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."

FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF

Page 5

SPECIAL 510(K) SUMMARY

K251156
Page 1 of 4

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).

1. Name and Address of Sponsor

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

2. Correspondent/Primary Contact Person

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

3. Submission Information

Date Summary Prepared: May 15, 2025
Name of Device: NPseal
Common or Usual Name: Negative Pressure Wound Therapy Non-Powered Suction Apparatus
Classification: Class II
Product Code: OKO (21 CFR 878.4683)
Predicate Device: NPseal (K250708)

4. Device Description

Page 6

K251156
Page 2 of 4

Each NPseal dressing is intended to be used up to 7 days. The total therapy time across multiple NPseal dressing changes is up to 14 days. NPseal therapy must be discontinued after 14 days. NPSeal dressing wear time may be less than indicated if clinical practice or other factors such as time to wound closure and rate of exudate, result in earlier removal or need for dressing change.

The NPseal 5 is intended for surgically closed incisions up to 5 cm × 0.5 cm.
The NPseal 10 is intended for surgically closed incisions up to 10 cm x 0.5 cm.
The NPseal 15 is intended for surgically closed incisions up to 15 cm x 0.5 cm.
The NPseal 20 is intended for surgically closed incisions up to 20 cm x 0.5 cm.
The NPseal 25 is intended for surgically closed incisions up to 25 cm x 0.5 cm.

5. Indications for Use

6. Comparison of Manufacturer's Cleared Device and Modified Device

Table 1. Comparison of Modified Device to Cleared Device

Subject	NPseal 5, NPseal 10, NPseal 15, NPseal 20, NPseal 25	Predicate Device
510(k) Number	To be assigned	K250708
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 device intended for negative pressure wound therapy.
Common Name	Same as predicate	Negative Pressure Wound Therapy non-powered suction apparatus
Indications for Use	Same as predicate	The NPseal is indicated for patients who would benefit from wound management via application of a negative pressure, particularly as the device may promote wound healing through the removal of small amounts of exudates from closed surgical incisions.

Page 7

K251156
Page 3 of 4

Subject	NPseal 5, NPseal 10, NPseal 15, NPseal 20, NPseal 25	Predicate Device
Wound types	Same as predicate	Closed surgical incisions, NPseal 5: Up to 5 cm x 0.5 cm NPseal 10: Up to 10 cm x 0.5 cm NPseal 15: Up to 15 cm x 0.5 cm NPseal 20: Up to 20 cm x 0.5 cm NPseal 25: Up to 25 cm x 0.5 cm
Single Use	Same as predicate	Yes
Negative Pressure Range	Same as predicate	-75 to -125 mmHg (± 17.5 mmHg)
Device Technology	Same as predicate	Nonpowered, integrated mechanical pump to generate negative pressure. Multilayer pad composed of hydrophilic foam with high fluid absorbency and top breathable film designed to collect and move exudate away from the wound bed.
Management of Exudates	Same as predicate	Managed by the dressing itself – via combination of absorption into the foam pad and evaporation through the breathable upper film.
Materials	Same as predicate	Film: Polyurethane coated with adhesive acrylic Foam Pad: Hydrophilic polyurethane Pump: Thermoplastic elastomer
Total Therapy Time	Up to 14 days	Up to 7 days
Single Dressing Wear Time	Same as predicate	Up to 7 days
Sterility	Same as predicate	Sterile – Gamma irradiation
Biocompatibility	Same as predicate	Complies with ISO 10993-1
MR Safe	Same as predicate	Yes

Page 8

K251156
Page 4 of 4

7. Summary of Modification

There is one modification to the device's labeling: Total therapy time is now 14 days instead of the predicate device's 7 days. The wear time of a single dressing remains 7 days.

8. Summary of Functional and Performance Testing

The NPseal modifications were assessed based on risk and the Design Controls in 21 CFR 820. No functional or performance testing was completed based on the change.

9. Summary of Clinical Testing

No clinical testing was applicable to this submission.

10. Conclusion

The labeling update does not raise any unanswered questions of safety or effectiveness. Like the predicate cleared by the FDA in K250708, the 14-day total therapy time NPseal has been shown to be safe and effective through testing. Previously performed verification and validation data support substantial equivalence of the 14-day total therapy time 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.