NPseal

K200305 · Guard Medical, Inc. · OKO · May 26, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K200305
• Device Name: NPseal
• Applicant: Guard Medical, Inc.
• Product Code: OKO · General, Plastic Surgery
• Decision Date: May 26, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4683
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

NPseal is a single-use, non-powered negative pressure wound therapy (NPWT) system for closed surgical incisions up to 5 cm x 0.5 cm. Device maintains negative pressure in -75 mmHg to -125 mmHg range. System includes integrated mechanical pump and high moisture vapor transmission rate (MVTR) breathable polyurethane film dressing. Intended for 3-day wear, with maximum 6-day total duration if replaced once. Used in clinical or home settings; operated by healthcare providers or patients. Device removes exudate from incision site to promote healing. Output is mechanical suction; provider monitors wound status and exudate levels to guide therapy. Benefits include simplified wound management and potential for improved healing outcomes.

Clinical Evidence

Bench testing only. Performance data included biocompatibility (ISO 10993-1: cytotoxicity, sensitization, irritation, systemic toxicity, implantation), pressure/exudate handling, foam characterization, adhesion, peel testing, MVTR, shelf life, and benchtop usability. Human factors user validation study performed.

Technological Characteristics

Non-powered mechanical suction pump; breathable polyurethane film dressing with high MVTR. Operating pressure: -75 to -125 mmHg. Sterile (gamma irradiation). Single-use. No software or electronic components.

Indications for Use

Indicated for patients requiring wound management via negative pressure to promote healing by removing small amounts of exudates from closed surgical incisions.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• SNaP Wound Care System (K151710)

Reference Devices

• PICO Single Use Negative Pressure Wound Therapy System (K180618)

Submission Summary (Full Text)

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May 26, 2020

Guard Medical Inc. % Eric Bannon Consultant AlvaMed. Inc. 935 Great Plain Avenue, #166 Needham, Massachusetts 02492

Re: K200305

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: May 1, 2020 Received: May 4, 2020

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Anjana Jain, 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) K200305

Device Name NPseal

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------|
| <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(K) SUMMARY

#### I. SUBMITTER

Guard Medical, Inc. 10 East 40th Street Suite 3310 New York, NY 10016

Phone: [phone] Fax: [phone]

Contact Person: Eric Bannon

Date Prepared: May 18, 2020

#### II. DEVICE

Name of Device: NPseal

Common or Usual Name: Negative Pressure Wound Therapy Non-powered Suction Apparatus

Classification Name: Non-Powered suction apparatus device intended for negative pressure wound therapy. (21 CFR 878.4683)

Regulatory Class: II

Product Code: OKO

#### III. PREDICATE & REFERENCE DEVICES

Predicate Device: SNaP Wound Care System, K151710

Reference Device: PICO Single Use Negative Pressure Wound Therapy System, K180618

#### IV. 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 mmHq to -125 mmHq nominal range.

The NPseal is intended for 3 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 results 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.

#### V. 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.

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# VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE AND REFERENCE DEVICES

| | Subject Device:<br>NPseal | Predicate Device:<br>SnAP Wound Care System | Reference Device:<br>PICO Single Use Negative<br>Pressure Wound Therapy<br>System |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Guard Medical | Spiracur | Smith & Nephew |
| 510(k) Number | K200305 | K151710 | K180618 |
| Product Code | OKO | OKO | OMP |
| Regulation<br>Number | 878.4683 | 878.4683 | 878.4780 |
| Regulation<br>Description | Non-Powered suction<br>apparatus device intended<br>for negative pressure<br>wound therapy | Non-Powered suction<br>apparatus device intended for<br>negative pressure wound<br>therapy | Powered suction pump |
| Common<br>Name | Negative Pressure Wound<br>Therapy non-powered suction<br>apparatus | Negative Pressure Wound<br>Therapy non-powered suction<br>apparatus | Powered suction pump and<br>wound dressing kit |
| | Subject Device:<br>NPseal | Predicate Device:<br>SNaP® Wound Care System | Reference Device:<br>PICO Single Use Negative<br>Pressure Wound Therapy<br>System |
| Intended Use | The NPseal is indicated for<br>patients who would benefit<br>from wound management<br>via application of negative<br>pressure, particularly as the<br>device may promote wound<br>healing through the removal<br>of small amounts of<br>exudates from closed<br>surgical incisions. | The SNaP® Wound Care<br>System is indicated for<br>patients who would benefit<br>from wound management<br>via the application of<br>negative pressure,<br>particularly as the device<br>may promote wound healing<br>through the removal of<br>excess exudate, infectious<br>material and tissue debris.<br>The SNaP® Wound Care<br>System is indicated for<br>removal of small amounts of<br>exudate from chronic, acute,<br>traumatic, subacute and<br>dehisced wounds, partial-<br>thickness burns, ulcers<br>(such as diabetic, venous or<br>pressure), surgically closed<br>incisions, flaps and grafts. | PICO is indicated for<br>patients who would benefit<br>from a suction device<br>(negative pressure wound<br>therapy) as it may promote<br>wound healing via removal of<br>low to moderate levels of<br>exudate and infectious<br>materials.<br>Appropriate wound types<br>include:<br>- Chronic<br>- Acute<br>- Traumatic<br>- Subacute and dehisced<br>wounds<br>- Partial-thickness burns<br>- Ulcers (such as diabetic or<br>pressure)<br>- Flaps and grafts<br>- Closed surgical incisions<br>PICO Single Use Negative<br>Pressure Wound Therapy<br>System is suitable for use<br>both in a hospital and<br>homecare setting. |
| Sterility | Sterile - Gamma irradiation | Sterile - Gamma irradiation | Sterile - EO |
| Single Use | Yes | Yes | Yes |
| Wear Time | 3 days | 7 days | 7 days |
| Dressing<br>film(s) | High Moisture Vapor<br>Transmission Rate (MVTR),<br>breathable polyurethane film | Single layer hydrocolloid<br>dressing, non-breathable | High Moisture Vapor<br>Transmission Rate (MVTR)<br>upper film, perforated silicone<br>adhesive skin layer |
| | Subject Device:<br>NPseal | Predicate Device:<br>SnaP Wound Care System | Reference Device:<br>PICO Single Use Negative<br>Pressure Wound<br>Therapy System |
| Negative<br>Pressure<br>Operating<br>Ranges | -75 to -125 mmHg | -75, -100, or -125 mmHg | -80 mmHg |

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The subject, predicate and reference devices are all NPWT dressing systems.

The subject and predicate devices are substantially equivalent, as evidenced by their shared characteristics:

- . Single use
- . Nonpowered
- Identical negative pressure operating ranges (-75 to -125 mmHg)
- Indicated for removal of small amounts of exudates. ●

#### VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

#### Biocompatibility Testing

The biocompatibility evaluation for the NPseal was conducted in accordance with the international standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA along with the agency's quidance document. "Use of International Standard ISO 10993-1. 'Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process:' Guidance for Industry and Food and Drug Administration Staff" (issued June 16, 2016). The tests performed included the following:

- . Cytotoxicity
- . Sensitization
- Irritation or Intracutaneous Reactivity
- Acute Systemic Toxicity
- . Material-Mediated Pyrogenicity
- . Subacute Systemic Toxicity
- . Subchronic Systemic Toxicity
- . Implantation

#### Bench Testing

- . Pressure and exudate handling over time test
- · Curved surface pressure over time
- Foam characterization test .
- . Pump body adhesion test
- Dressing peel test .
- Exudate handling without negative pressure test .
- Moisture vapor transmission rate (MVTR) test .

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- Shelf Life test .
- . Benchtop Usability Verification
- Set Negative Pressure test

#### Human Factors Testing

- User validation study .
# VIII. CONCLUSIONS

The test data support the safety of the device and the hardware verification and validation demonstrate that the NPseal shall perform as intended in the specified use conditions. The data demonstrate that the NPSeal is substantially equivalent to the predicate device with respect to the intended use and technological comparison. There were no new questions regarding safety or effectiveness.