NPseal

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font. 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K212971 Device Name NPseal Indications for Use (Describe) 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. X 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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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-Powered<br>Suction 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 {4}------------------------------------------------ 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 Devices<br>NPseal Medium<br>NPseal Large | Predicate Device<br>NPseal Small | |---------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K212971 | K211130 | | 510k<br>Submitter/Holder | Same as predicate | Guard Medical | | Product Code | Same as predicate | OKO | | Regulation No. | Same as predicate | 878.4683 | | Regulation<br>Description | Same as predicate | Non-Powered suction apparatus<br>device intended for negative pressure<br>wound therapy | | Common<br>Name | Same as predicate | Negative Pressure Wound Therapy<br>non-powered suction apparatus | | Indications for Use | Same as predicate | The NPseal is indicated for patients<br>who would benefit from wound<br>management via application of a<br>negative pressure, particularly as the<br>device may promote wound healing<br>through the removal of small amounts<br>of exudates from closed surgical<br>incisions. | | Wound types | Same as predicate | Closed surgical incisions | | Incision sizes | NPseal Medium: Up to 10 cm x 0.5 cm<br>NPseal Large: Up to 15 cm x 0.5 cm | Up to 5 cm x 0.5 cm | {5}------------------------------------------------ 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. 3 | | Subject Devices<br>NPseal Medium<br>NPseal Large | Predicate Device<br>NPseal Small | |---------------------------------------|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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<br>manually actuated to generate<br>negative pressure. Multilayer pad<br>composed of hydrophilic foam with<br>high fluid absorbency and top<br>breathable film designed to collect and<br>move exudate away from the wound<br>bed. | | Management of<br>Exudates | Same as predicate | Managed by the dressing itself - via<br>combination of absorption into the<br>foam pad and evaporation through the<br>breathable upper film. | | Materials | Same as predicate | Film: Polyurethane coated with<br>adhesive acrylic,<br>Pad: Hydrophilic polyurethane,<br>Pump: Thermoplastic elastomer | | Maximum therapy<br>time | Same as predicate | 6 days | | Maximum number of<br>dressing changes | Same as predicate | 1 dressing change | | Wear Time per<br>dressing | 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. {6}------------------------------------------------ - . 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).