NPseal

K211130 · Guard Medical, Inc. · OKO · May 14, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K211130
• Device Name: NPseal
• Applicant: Guard Medical, Inc.
• Product Code: OKO · General, Plastic Surgery
• Decision Date: May 14, 2021
• Decision: SESE
• Submission Type: Special
• 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. It consists of an integrated mechanical pump and a multilayer dressing (hydrophilic polyurethane foam pad with a breathable polyurethane film). The device is applied to closed surgical incisions to maintain negative pressure between -75 mmHg and -125 mmHg. The system manages exudate through absorption into the foam pad and evaporation through the breathable film. It is intended for use on incisions up to 5 cm x 0.5 cm for a total wear time of up to 6 days. The device is manually actuated by the user to generate negative pressure. By removing small amounts of exudate, the device aims to promote wound healing. It is a prescription-only device.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including pressure and exudate handling performance over the extended 6-day wear time and shelf-life validation.

Technological Characteristics

Non-powered, manually actuated integrated pump. Dressing materials: Polyurethane film with acrylic adhesive, hydrophilic polyurethane foam pad, thermoplastic elastomer pump. Sterile (gamma irradiation). Complies with ISO 10993-1 for biocompatibility. Operates in -75 to -125 mmHg range.

Indications for Use

Indicated for patients requiring wound management via negative pressure to promote healing of closed surgical incisions (up to 5 cm x 0.5 cm) through exudate removal.

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

• NPseal (K200305)

Submission Summary (Full Text)

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May 14, 2021

Guard Medical Inc. % Eric Bannon VP, Regulatory and Clinical Affairs AlvaMed. Inc. 935 Great Plain Avenue, Unit 166 Needham, Massachusetts 02492

Re: K211130

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 15, 2021 Received: April 16, 2021

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,

for Lixin Liu, 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) K21130

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)

| <div> <span> <span style="font-size: 12pt;">☑</span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </span> </div> |
|-------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 12pt;">☐</span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </span> </div> |

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#### 1.0 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).

- Name and Address of Sponsor 1.1
Guard Medical, Inc. 1221 Brickell Avenue, Suite 900 Miami, FL 33131 USA Phone: [phone] Machiel Van der Leest CEO [e-mail]

- Correspondent/Primary Contact Person 1.2
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 [e-mail] Phone: [phone] Fax: [phone]

- 1.3 Submission Information

| Date Summary Prepared: | May 14, 2021 |
|------------------------|------------------------------------------------------------------|
| Name of Device: | NPseal |
| Common or Usual Name: | Negative Pressure Wound Therapy Non-Powered Suction<br>Apparatus |
| Classification: | Class II |
| Product Code: | OKO (21 CFR 878.4683) |
| Predicate Device: | NPseal (K200305) |

#### 1.4 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 6 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 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.

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| GVARD<br>MEDICAL | Special 510(k): Labeling Modification<br>to NPseal | Page:<br>2 |
|------------------|----------------------------------------------------|------------|
|------------------|----------------------------------------------------|------------|

The NPseal is intended for surgically closed incisions up to 5 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.

- Comparison of Manufacturer's Cleared Device and Modified Device 1.6

| | | Table 1. Comparison of Modified Device to Cleared Device | | |
|--|--|----------------------------------------------------------|--|--|
| | | | | |

| | Subject<br>NPseal | Predicate Device<br>NPseal |
|---------------------------------------|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K211130 | K200305 |
| 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<br>intended for negative pressure wound<br>therapy |
| Common<br>Name | Same as predicate | Negative Pressure Wound Therapy non-<br>powered suction apparatus |
| Indications for Use | Same as predicate | The NPseal is indicated for patients who<br>would benefit from wound management<br>via application of a negative pressure,<br>particularly as the device may promote<br>wound healing through the removal of<br>small amounts of exudates from closed<br>surgical incisions. |
| Wound types | Same as predicate | Closed surgical incisions, less than 5 cm<br>in length and 0.5 cm in width. |
| Single Use | Same as predicate | Yes |
| Negative Pressure<br>Range | Same as predicate | -75 to -125 mmHg (± 17.5 mmHg) |
| Device Technology | Same as predicate | Nonpowered, integrated pump manually<br>actuated to generate negative pressure.<br>Multilayer pad composed of hydrophilic<br>foam with high fluid absorbency and top<br>breathable film designed to collect and<br>move exudate away from the wound bed. |
| Management of<br>Exudates | Same as predicate | Managed by the dressing itself - via<br>combination of absorption into the foam<br>pad and evaporation through the<br>breathable upper film. |
| | Subject<br>NPseal | Predicate Device<br>NPseal |
| Materials | Same as predicate | Film: Polyurethane coated with adhesive<br>acrylic,<br>Pad: Hydrophilic polyurethane,<br>Pump: Thermoplastic elastomer |
| Maximum Therapy time | Same as predicate | 6 days |
| Maximum number of<br>dressing changes | Same as predicate | 1 dressing change |
| Wear Time per dressing | Up to 6 days | Up to 3 days |
| Sterility | Same as predicate | Sterile - Gamma irradiation |
| Biocompatibility | Same as predicate | Complies with ISO 10993-1 |

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Image /page/5/Picture/1 description: The image shows the logo for Guard Medical. The logo is in blue and consists of the word "GUARD" in large letters, with the "A" shaped like a shield. Below the word "GUARD" is the word "MEDICAL" in smaller letters. The logo is simple and modern, and the use of the shield shape in the "A" suggests protection and safety.

### Page: Special 510(k): Labeling Modification to NPseal

- 1.7 Summary of Modification
There is one modification to the device's labeling: wear time is now 6 days instead of the predicate device's 3 days.

Shelf-life was extended from 6 to 24 months.

- 1.8 Summary of Functional and Performance Testing
The wear time change from 3 days to 6 days was assessed based on risk and the Design Controls in 21 CFR 820. The following verification and validation testing was performed:

- Pressure and Exudate Handling Over Time ●
- . Shelf-Life Testing using the test methods and acceptance criteria identical to the predicate device.
- Summary of Clinical Testing 1.9

No clinical testing was applicable to this submission.

- 1.10 Conclusion
The modified NPseal has been shown to be as safe as the predicate device through bench testing. Labeling changes made to the device do not raise any different questions of safety or effectiveness. Verification and validation data support substantial equivalence of the modified NPseal to the legally marketed predicate device.