The NPseal is indicated for patients who would 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.

Device Description

The NPseal Neqative 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 time to wound closure and rate of exudate, 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 Small is intended for surgically closed incisions up to 5cm x 0.5 cm

The NPseal Medium is intended for surgically closed incisions up to 10 cm x 0.5 cm.

The NPseal Large is intended for surgically closed incisions up to 15 cm x 0.5 cm.

AI/ML Overview

The provided text is a 510(k) Summary for the NPseal device, specifically for the Medium and Large versions. It outlines the device description, indications for use, comparison to a predicate device, and functional/performance testing.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance (NPseal Large)
Pressure and Exudate Handling	Maintain negative pressure within the specified range (-75 mmHg to -125 mmHg).	Demonstrated that negative pressure could be maintained within the specified range.
	Capable of absorbing simulated exudate.	Demonstrated that the device was capable of absorbing simulated exudate.
	Volume of simulated exudate absorbed covers less than 50% of the foam pad.	Demonstrated that the volume of simulated exudate absorbed covered less than 50% of the foam pad.
Benchtop Usability Testing	Usability requirements for pump actuation met.	Demonstrated that usability requirements including pump actuation met acceptance criteria.
	Usability requirements for device removal from packaging met.	Demonstrated that usability requirements including device removal from packaging met acceptance criteria.
	Usability requirements for device application met.	Demonstrated that usability requirements including device application met acceptance criteria.
	Usability requirements for ability to generate negative pressure met.	Demonstrated that usability requirements including ability to generate negative pressure met acceptance criteria.
Packaging Validation	Sterile packaging seal maintained after environmental conditioning.	Demonstrated that sterile packaging seal was maintained after undergoing environmental conditioning.
	Sterile packaging seal maintained after simulated distribution.	Demonstrated that sterile packaging seal was maintained after undergoing simulated distribution.
Biocompatibility	Compliance with ISO 10993-1.	The predicate device (NPseal Small) complies with ISO 10993-1, and the subject devices use the same materials, implying continued compliance.
Negative Pressure Range Maintenance	Maintain negative pressure within -75 mmHg to -125 mmHg (± 17.5 mmHg).	The "Pressure and Exudate Handling Over Time" test demonstrated negative pressure could be maintained, aligning with this criterion.
Maximum Therapy Time	6 days.	The device is intended for 6 days of use. (This is a design specification, confirmed by comparison to predicate).
Maximum Number of Dressing Changes	1 dressing change.	The device can be replaced only one time. (This is a design specification, confirmed by comparison to predicate).
Wear Time per Dressing	Up to 6 days.	Up to 6 days. (This is a design specification, confirmed by comparison to predicate).
Sterility	Sterile - Gamma irradiation.	Sterile - Gamma irradiation. (This is a design specification, confirmed by comparison to predicate).

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

The document does not explicitly state the specific sample sizes (e.g., number of devices/units) for each of the performance tests. It mentions that testing was performed "exclusively on the NPseal Large as it represents the worst-case device size," indicating that the tests were conducted using physical samples of the NPseal Large.

Sample Size: Not explicitly stated for each test (e.g., how many NPseal Large devices were tested for pressure, usability, or packaging).
Data Provenance: The studies described appear to be prospective benchtop and in-house laboratory testing conducted by Guard Medical (or their designated testing facilities) as part of their design control and 510(k) submission process. There is no indication of external or retrospective data from patients. The country of origin of this testing data is not specified, but the applicant and consultant are based in the USA.

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

There is no mention of experts being used to establish ground truth for the test set. The tests described (Pressure and Exudate Handling, Benchtop Usability, Packaging Validation) are objective functional and performance tests with predefined acceptance criteria that do not typically require expert consensus for ground truth establishment. For usability, a group of users might be involved, but they would be testers, not "experts" establishing ground truth in the sense of a diagnostic interpretation.

4. Adjudication Method for the Test Set

Since the described studies are objective functional and performance tests (e.g., measuring pressure, observing exudate absorption, confirming sterilization seal integrity), an "adjudication method" as typically understood in studies involving subjective interpretations (like medical imaging) is not applicable and therefore not mentioned. The results are based on direct measurements and observations against pre-defined engineering and performance specifications.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical testing was applicable to this submission." The submission focuses on demonstrating substantial equivalence through bench testing, comparing the larger NPseal sizes to the already cleared smaller NPseal predicate.

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

This question is not applicable to this device. The NPseal is a physical medical device (a non-powered negative pressure wound therapy device), not a software algorithm or AI-driven system. Therefore, the concept of "standalone performance" for an algorithm is irrelevant. The focus is on the device's mechanical and material performance.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims are based on pre-defined engineering specifications, regulatory standards (e.g., ISO 10993-1), and the performance characteristics of the predicate device.

For pressure maintenance, the ground truth is the specified pressure range (-75 to -125 mmHg).
For exudate handling, the ground truth includes criteria like "capable of absorbing simulated exudate" and "less than 50% foam pad coverage."
For usability, the ground truth is the successful completion of specific tasks (pump actuation, removal from packaging, application, generation of negative pressure).
For packaging, the ground truth is maintaining seal integrity.
For biocompatibility, the ground truth is compliance with ISO 10993-1.

These are objective, measurable standards rather than subjective expert consensus, pathology, or outcomes data typically used for diagnostic or treatment effectiveness claims.

8. The Sample Size for the Training Set

This question is not applicable. The NPseal is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI or algorithms. The design and development process for a physical device involves engineering principles, material science, and iterative testing, not data-driven training of a model.

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

This question is not applicable for the same reason as point 8. There is no training set for a physical device.

Summary

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February 10, 2022

Guard Medical Inc % Eric Bannon VP of Regulatory Affairs Alvamed Inc 935 Great Plain Ave. Suite 166 Needham, Massachusetts 02492

Re: K212971

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: January 7, 2022 Received: January 11, 2022

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.

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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 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 mediation-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.

Julie Morabito, Ph.D. 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) K212971

Device Name NPseal

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Guard Medical. The word "GUARD" is in large, blue, sans-serif font, with the "A" stylized as an upside-down "V". Below the word "GUARD" is the word "MEDICAL", also in blue, sans-serif font, but smaller than the word "GUARD". The logo is simple and modern, and the blue color gives it a sense of trustworthiness and reliability.

1.0 TRADITIONAL 510(K) SUMMARY K212971

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

1.1 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
1.2 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

1.3 Submission Information

Date Summary Prepared:	September 16, 2021
Name of Device:	NPseal
Common or Usual Name:	Negative Pressure Wound Therapy Non-PoweredSuction Apparatus
Classification:	Class II
Product Code:	OKO (21 CFR 878.4683)
Predicate Device:	NPseal (K211130)

1.4 Device Description
The NPseal Neqative 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 time to wound closure and rate of

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exudate, 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 Small is intended for surgically closed incisions up to 5cm x 0.5 cm

The NPseal Medium is intended for surgically closed incisions up to 10 cm x 0.5 cm.

The NPseal Large is intended for surgically closed incisions up to 15 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.
1.6 Comparison of Manufacturer's Cleared Device and Modified Device

Table 1. Comparison of Subject Device to Cleared Device

	Subject DevicesNPseal MediumNPseal Large	Predicate DeviceNPseal Small
510(k) Number	K212971	K211130
510kSubmitter/Holder	Same as predicate	Guard Medical
Product Code	Same as predicate	OKO
Regulation No.	Same as predicate	878.4683
RegulationDescription	Same as predicate	Non-Powered suction apparatusdevice intended for negative pressurewound therapy
CommonName	Same as predicate	Negative Pressure Wound Therapynon-powered suction apparatus
Indications for Use	Same as predicate	The NPseal is indicated for patientswho would benefit from woundmanagement via application of anegative pressure, particularly as thedevice may promote wound healingthrough the removal of small amountsof exudates from closed surgicalincisions.
Wound types	Same as predicate	Closed surgical incisions
Incision sizes	NPseal Medium: Up to 10 cm x 0.5 cmNPseal Large: Up to 15 cm x 0.5 cm	Up to 5 cm x 0.5 cm

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Image /page/5/Picture/0 description: The image shows the logo for Guard Medical. The word "GUARD" is in a large, sans-serif font, with the "U" shaped like a shield. The word "MEDICAL" is in a smaller, sans-serif font and is located to the right of the word "GUARD" and slightly below it. The logo is a light blue color.

	Subject DevicesNPseal MediumNPseal Large	Predicate DeviceNPseal Small
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 pumpmanually actuated to generatenegative pressure. Multilayer padcomposed of hydrophilic foam withhigh fluid absorbency and topbreathable film designed to collect andmove exudate away from the woundbed.
Management ofExudates	Same as predicate	Managed by the dressing itself - viacombination of absorption into thefoam pad and evaporation through thebreathable upper film.
Materials	Same as predicate	Film: Polyurethane coated withadhesive acrylic,Pad: Hydrophilic polyurethane,Pump: Thermoplastic elastomer
Maximum therapytime	Same as predicate	6 days
Maximum number ofdressing changes	Same as predicate	1 dressing change
Wear Time perdressing	Same as predicate	Up to 6 days
Sterility	Same as predicate	Sterile - Gamma irradiation
Biocompatibility	Same as predicate	Complies with ISO 10993-1

1.7 Summary of Modification

The dimensions of the current NPseal device cleared in K200305 and K211130 (NPseal Small) is 11 x 8 cm for use on closed surgical incisions up to 5 cm in length and 0.5 cm in width. The corresponding foam pad size is 7.5 x 4.5 cm.

The subject devices are two longer versions of the NPseal Small:

. The NPseal Medium is 16 x 8 cm with a 12.65 x 4.65 cm foam pad for use on closed surgical incisions up to 10 cm in length and 0.5 cm in width.

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. The NPseal Large is 21 x 8 cm with a 17.65 x 4.65 cm foam pad for use on closed surgical incisions up to 15 cm in length and 0.5 cm in width.
All other dimensions including the foam thickness, as well as the pump system and device materials remain identical to the NPseal Small predicate.
1.8 Summary of Functional and Performance Testing
The NPseal dressing length increase for the NPseal Medium and Large was assessed based on risk and the Design Controls in 21 CFR 820.

The following verification and validation testing was performed exclusively on the NPseal Large as it represents the worst-case device size:

Pressure and Exudate Handling Over Time: Demonstrated that negative pressure could . be maintained, the device was capable of absorbing simulated exudate and the volume of simulated exudate absorbed covered less than 50% of the foam pad.
Benchtop Usability Testing: Demonstrated that usability requirements including pump . actuation, device removal from packaging, device application and ability to generate negative pressure met acceptance criteria.
Packaging Validation: Demonstrated that sterile packaging seal was maintained after . undergoing environmental conditioning and simulated distribution.
Summary of Clinical Testing 1.9

No clinical testing was applicable to this submission.

1.10 Conclusion
The NPseal Medium and NPseal Large have been shown to be as safe as the predicate device through bench testing. Size increases made to the device demonstrate substantial equivalence to the predicate device, NPseal Small. Functional and performance testing data demonstrate the substantial equivalence of the NPseal Medium and Large to the NPseal Small (K211130).

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.