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 7 days of use. Therapy duration of the system 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 system 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 text is a 510(k) clearance letter for a medical device called NPseal. It is crucial to understand that this document describes a Special 510(k) submission, which is used for minor changes to an already cleared device. In this case, the changes were:

Adding an MR safety statement to labeling.
Minor labeling updates regarding wear time and latex content.
Adding an alternate source for a material (hydrophilic polyurethane foam).

The core of a Special 510(k) is to demonstrate that the minor modifications do not raise new questions of safety or effectiveness and that the modified device remains substantially equivalent to the cleared predicate device. This is different from a de novo submission or a traditional 510(k) for a novel device or significant change, which would typically involve more extensive clinical performance studies.

Therefore, the "studies" mentioned in this document are primarily non-clinical performance testing to ensure the alternative material performs equivalently, and no clinical trials or human-in-the-loop studies (like MRMC studies) were conducted or needed for this specific Special 510(k) submission. The FDA's acceptance is based on the equivalency demonstrated through bench testing and material assessments, not on clinical performance criteria like diagnostic accuracy.

Analysis of the Provided Information against the Request:

Based on the nature of a Special 510(k) for these specific changes, many of the requested elements (especially those related to clinical performance, ground truth establishment, expert adjudication, and MRMC studies) are not applicable to this document. The "device performance" here refers to physical and material performance, not diagnostic accuracy or human-in-the-loop clinical benefit.

Here's an attempt to answer your questions based only on the provided text, highlighting what is applicable and what isn't:

Acceptance Criteria and Device Performance for NPseal (K250708)

The acceptance criteria for this Special 510(k) submission primarily revolved around demonstrating that the modifications (specifically, the alternative foam source) maintained the same performance and safety profile as the predicate device (K241522). This is centered on non-clinical performance specifications.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicitly from the changes)	Reported Device Performance (from K250708)
Material Performance	Equivalent physical and functional performance of the alternative hydrophilic polyurethane foam pad to the original source.	"Testing has shown that the alternative sourced material meets the same performance specifications as the predicate device."
Biocompatibility	Compliance with ISO 10993-1 for the alternative material.	"Biocompatibility: Same as predicate (Complies with ISO 10993-1)" (re-executed for alternative source)
Shelf-Life	Maintenance of device integrity and performance over its labeled shelf-life with the new material.	"Shelf-life testing was re-executed." (Implied successful, as clearance was granted)
Negative Pressure Range	Maintain -75 to -125 mmHg (± 17.5 mmHg)	"Same as predicate"
Exudate Management	Maintain management via absorption into foam and evaporation through film.	"Same as predicate"
Sterility	Maintain sterility (Gamma irradiation).	"Same as predicate" (Implied validated for new material/source if affected)
MR Safety	Demonstrating MR Safe status for the device.	"MR Status: MR Safe" (Previously "Not evaluated")
Labeling Accuracy	Accurate reflection of device capabilities and instructions.	Labeling updates made (MR safety, wear time, latex statement).

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

Sample Size for Test Set: Not explicitly stated in terms of number of units or patients for performance testing. As this is a Special 510(k) focused on material equivalency, "test sets" would refer to units used in bench testing.
Data Provenance: Not specified. Performance and shelf-life testing would typically be conducted in a laboratory setting, likely at the manufacturer's or a contract lab's facility. It's non-clinical data, not patient data. This was not a clinical study.

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

Not Applicable. No ground truth in the sense of clinical diagnoses or expert consensus was established for a "test set" from patient data, as this was not a clinical study assessing diagnostic performance or clinical outcomes. The "ground truth" here is the technical specification of the predicate device, against which the modified device's bench test results were compared.

4. Adjudication Method for the Test Set

Not Applicable. There was no expert adjudication process as this was non-clinical performance testing, not a clinical study requiring human interpretation of medical images or data.

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

No. An MRMC study was not done. This type of study is relevant for AI/imaging devices to show how AI assists human readers. The NPseal is a physical wound therapy device, and this particular submission involved material and labeling changes, not development or modification of an AI component or a diagnostic aid.
Effect Size: Not applicable, as no MRMC study was performed.

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

Not Applicable. The NPseal is a physical medical device, not a diagnostic algorithm. Therefore, "standalone performance" of an algorithm is not relevant. The closest analogous concept would be the device's physical performance (e.g., maintaining negative pressure), which was assessed via bench testing to be equivalent.

7. The Type of Ground Truth Used

Technical Specifications / Predicate Device Performance Data: The "ground truth" for affirming substantial equivalence in this context was the established, documented performance specifications and safety profile of the legally marketed predicate NPseal device (K241522). The new material and changes had to meet or exceed these existing, validated specifications through non-clinical testing.

8. The Sample Size for the Training Set

Not Applicable. There was no "training set" in the context of machine learning or AI, as this submission did not involve an AI/algorithm.

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

Not Applicable. (See #8)

In summary, this document highlights a Special 510(k) for minor changes to an already cleared physical medical device. The "study" proving acceptance was primarily non-clinical bench testing to demonstrate that the revised device, particularly with an alternate material source, met the same performance specifications as its predicate. Clinical trials, human reader studies, or AI algorithm training/testing were not part of this specific submission.

Summary

FDA 510(k) Clearance Letter - NPseal Device

Page 1

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

Doc ID # 04017.07.05

April 8, 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: K250708
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: March 6, 2025
Received: March 10, 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

K250708 - 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

K250708 - 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,

Mustafa A. Mazher - S

For 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: 06/30/2023
See PRA Statement below.

510(k) Number (if known): K250708
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.

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Page 5

SPECIAL 510(K) SUMMARY

K250708

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: March 6, 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 (K241522)

4. Device Description

Page 6

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	K241522
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

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, with an alternate source for hydrophilic polyurethane foam pad	Film: Polyurethane coated with adhesive acrylic, Foam Pad: Hydrophilic polyurethane, Pump: Thermoplastic elastomer
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 Status	MR Safe	Not evaluated

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7. Summary of Modification

The subject device labeling was updated to include a statement on the MR safety of the NPseal. The device has been assessed for MR safety and based on this assessment is considered "MR Safe". This had previously been unevaluated for MR Safety. Additional labeling updates were made to remove the wear time on the Quick Start Guide currently printed on the individual NPseal cartons and Tyvek lids, and to add a "not made with natural rubber latex" statement to the IFU. Finally, the subject device was updated to include an alternative source for the hydrophilic polyurethane foam component.

8. Summary of Functional and Performance Testing

Assessment of the MR Safety was evaluated via assessment of known materials, but no functional of performance testing was completed. No functional or performance testing was completed for the other labeling changes. Based on the addition of the alternative source for hydrophilic polyurethane foam component, biocompatibility, performance testing and shelf-life testing was re-executed.

9. Summary of Clinical Testing

No clinical testing was applicable to this submission.

10. Conclusion

The labeling updates do not raise any unanswered questions of safety or effectiveness. Testing has shown that the alternative sourced material meets the same performance specifications as the predicate device. Verification and validation data support substantial equivalence of the 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.