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 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 U.S. FDA 510(k) summary for the NPseal device. It states that the device is a Non-Powered Suction Apparatus Device Intended For Negative Pressure Wound Therapy. The document describes modifications to an already cleared device, specifically the introduction of longer versions (NPseal 20 and NPseal 25).

Crucially, the document does not describe the specific acceptance criteria or a study that proves the device meets those acceptance criteria in the context of typical AI/ML medical device performance studies (e.g., sensitivity, specificity, AUC). This is because the device, Guard Medical's NPseal, is a negative pressure wound therapy device, not an AI/ML diagnostic or prognostic device. The 510(k) submission is for a physical medical device with design modifications (longer versions), not a software or AI algorithm.

Therefore, many of the requested information points (like AI performance metrics, sample size for test/training sets, expert consensus for ground truth, MRMC studies) are not applicable to this type of device and submission.

However, I can extract information related to the performance testing that was conducted for this device modification, which served as the "proof" that the modified device is substantially equivalent to its predicate.

Here's the reinterpretation of your request based on the provided document:

Device: Guard Medical NPseal (Negate Pressure Wound Therapy Device)

Nature of the Submission: Special 510(k) for device modification – introducing longer versions (NPseal 20 and NPseal 25) of an already cleared negative pressure wound therapy (NPWT) device.

Acceptance Criteria and Reported Device Performance (Non-AI/ML Context)

Since this is a physical medical device and not an AI/ML product, the "acceptance criteria" and "performance" relate to its physical and functional characteristics remaining equivalent or safe despite the size change.

The document refers to "Verification and validation data" supporting substantial equivalence. Based on the "Summary of Functional and Performance Testing," the acceptance criteria would be that the modified devices maintain the crucial functionalities of the predicate device.

Table of Performance Testing and Implied Acceptance Criteria:

Performance Test (Analogous to "Acceptance Criteria Review Area")	Reported Device Performance (Implicitly Met)
Pressure and Exudate Handling Over Time	Functions in the specified negative pressure range (-75 to -125 mmHg nominal) and effectively handles exudates over its intended 7-day use, similar to the predicate.
Pull Testing	The device's adhesion or structural integrity under tension remains adequate for its intended use.
Benchtop Usability Testing	The device can be used safely and effectively by its intended users in a lab/simulated environment.
Packaging Validation	The packaging effectively protects the device, maintains sterility, and ensures device integrity until use.
Sterility	Remains sterile via Gamma irradiation, as per predicate.
Biocompatibility	Complies with ISO 10993-1, as per predicate, indicating materials are safe for patient contact.

Study that Proves the Device Meets the Acceptance Criteria:

The studies conducted were benchtop performance and functional tests, not clinical trials in the sense of large patient cohorts, as this was a Special 510(k) for a modification (size increase).

2. Sample Size and Data Provenance:

Sample Size: Not explicitly stated as a numerical sample size of "patients" or "images" as it's a physical device. For benchtop testing, typically multiple units of the device would be tested to ensure consistency and reliability. The document states testing was performed "exclusively on the NPseal 25 as it represents the most challenging device size," implying tests were sufficient to address the change.
Data Provenance: Not applicable in terms of country of origin for clinical data or retrospective/prospective collection, as no clinical testing was performed for this submission (as stated in Section 9: "No clinical testing was applicable to this submission."). The data originates from internal engineering and quality validation testing by Guard Medical, Inc.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. This information is relevant for AI/ML diagnostic devices where human experts establish ground truth for image or data interpretation. For a physical device like NPseal, "ground truth" is typically defined by engineering specifications, material properties, and established medical standards for wound care devices, validated through physical and functional testing.

4. Adjudication Method for Test Set:

Not applicable. No human interpretation or adjudication of test results in the context of diagnostic agreement was required here. Performance was assessed against engineering specifications and functional requirements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This type of study is for evaluating human reader performance with and without AI assistance for diagnostic tasks. It is not relevant to a negative pressure wound therapy device.

6. Standalone (Algorithm Only) Performance:

Not applicable. The NPseal is a physical medical device, not an algorithm.

7. Type of Ground Truth Used:

The "ground truth" for this device modification was based on engineering specifications, functional requirements, and performance data from the predicate device. The aim was to demonstrate that the increased sizes (NPseal 20 and NPseal 25) perform equivalently to the predicate devices (NPseal 5, 10, and 15) in terms of established parameters like negative pressure maintenance, exudate handling, and material integrity.

8. Sample Size for the Training Set:

Not applicable. There is no "training set" as this is not an AI/ML device. The "training" in a broad sense would be the cumulative design and manufacturing experience for the predicate device.

9. How Ground Truth for Training Set was Established:

Not applicable. See point 8.

In summary: The provided document is a 510(k) notice for a physical medical device modification, not an AI/ML software device. Therefore, the detailed questions pertaining to AI/ML study methodologies (e.g., AI performance metrics, expert labeling, MRMC studies) are not relevant to this specific FDA submission. The "proof" of meeting acceptance criteria for this device involved benchtop functional and performance testing to demonstrate substantial equivalence to an already cleared predicate device, despite the change in size.

Summary

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August 15, 2024

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

Re: K241522

Trade/Device Name: NPseal (20 and 25) 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 29, 2024 Received: July 18, 2024

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

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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 OS 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 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-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 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.

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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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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,

Yu-chieh Chiu -S

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

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Indications for Use

510(k) Number (if known) K241522

Device Name

NPseal (20 and 25)

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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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).

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. 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. Submission Information

Date Summary Prepared:	August 15, 2024
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 (K240244)

1. 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.

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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 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.

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

	SubjectNPseal 20, NPseal 25	Predicate DeviceNPseal 5, NPseal 10, NPseal 15
510(k) Number	K241522	K240244
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
	SubjectNPseal 20, NPseal 25	Predicate DeviceNPseal 5, NPseal 10, NPseal 15
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	Closed surgical incisions,NPseal 20: Up to 20 cm x 0.5 cmNPseal 25: Up to 25 cm x 0.5 cm	Closed surgical incisions,NPseal 5: Up to 5 cm x 0.5 cmNPseal 10: Up to 10 cm x 0.5 cmNPseal 15: Up to 15 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 mechanicalpump 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.
Materials	Same as predicate	Film: Polyurethane coated with adhesiveacrylic,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

Table 1. Comparison of Modified Device to Cleared Device

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K241522 Page 3 of 4

1. Summary of Modification
  The dimensions of the current NPseal devices cleared initially in K212971 and most recently in K240244 are:

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NPseal 5 (Small) is 11 x 8 cm with a 7.5 x 4.5 cm foam pad for use on closed surgical incisions up to 5 cm in length and 0.5 cm in width.
NPseal 10 (Medium) is 16 x 8 cm with a 12.7 x 4.7 cm foam pad for use on closed surgical incisions up to 10 cm in length and 0.5 cm in width.
-NPseal 15 (Large) is 21 x 8 cm with a 17.7 x 4.7 cm foam pad for use on closed surgical incisions up to 15 cm in length and 0.5 cm in width.

The subject devices are two longer versions:

-NPseal 20 is 26 x 8 cm with a 22.7 x 4.7 cm foam pad for use on closed surgical incisions up to 20cm in length and 0.5 cm in width.
-NPseal 25 is 31 x 8 cm with a 27.7 x 4.7 cm foam pad for use on closed surgical incisions up to 25cm 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. Summary of Functional and Performance Testing
  The NPseal dressing length increase for the NPseal 25 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 25 as it represents the most challenging device size:

Pressure and Exudate Handling Over Time -
-Pull testing
-Benchtop Usability Testing
-Packaging Validation
1. Summary of Clinical Testing

No clinical testing was applicable to this submission.

1. Conclusion
  Like the three sizes (NPseal 5, NPseal 10, and NPseal 15) of the predicate device cleared by the FDA in K212971 and updated in K240244, the longer NPseal 20 and NPseal 25 have been shown to be safe through bench testing. Size increases made to the device do not raise any unanswered questions of safety or effectiveness. Verification and validation data support substantial equivalence of the NPseal 25 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.