(29 days)
Not Found
No.
The device description and intended use do not mention any AI capabilities, and the "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is intended to promote wound healing through the removal of exudates, which is a therapeutic function.
No
The device is used for wound management and promotes healing by removing exudates, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a "single-use device that includes an integrated, mechanical pump system" and "maintains Negative Pressure Wound Therapy (NPWT)". This clearly indicates it is a hardware device with a physical mechanism, not solely software.
No
The device is a Negative Pressure Wound Therapy (NPWT) system used for wound management, not for in vitro examination of specimens derived from the human body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OKO
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 5 is intended for surgically closed incisions up to 5 cm × 0.5 cm.
- The NPseal 10 is intended for surgically closed incisions up to 10 cm x 0.5 cm.
- The NPseal 15 is intended for surgically closed incisions up to 15 cm x 0.5 cm.
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Assessment of the MR Safety was evaluated via assessment of known materials, but no functional of performance testing was completed. No functional or performance testing was completed for the other labeling changes. Based on the addition of the alternative source for hydrophilic polyurethane foam component, biocompatibility, performance testing and shelf-life testing was re-executed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
NPseal (K241522)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
FDA 510(k) Clearance Letter - NPseal Device
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
April 8, 2025
Guard Medical, Inc.
℅ Eric Bannon
Sr. Vice President Regulatory and Clinical Affairs
AlvaMed, Inc.
935 Great Plain Avenue
Suite 166
Needham, Massachusetts 02492
Re: K250708
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: March 6, 2025
Received: March 10, 2025
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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Page 2
K250708 - Eric Bannon
Page 2
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 QS 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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
Page 3
K250708 - Eric Bannon
Page 3
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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,
Mustafa A. Mazher - S
For 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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
510(k) Number (if known): K250708
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)
- ☒ 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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Page 5
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
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
3. Submission Information
Date Summary Prepared: March 6, 2025
Name of Device: NPseal
Common or Usual Name: Negative Pressure Wound Therapy Non-Powered Suction Apparatus
Classification: Class II
Product Code: OKO (21 CFR 878.4683)
Predicate Device: NPseal (K241522)
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.
Page 6
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 5 is intended for surgically closed incisions up to 5 cm × 0.5 cm.
- The NPseal 10 is intended for surgically closed incisions up to 10 cm x 0.5 cm.
- The NPseal 15 is intended for surgically closed incisions up to 15 cm x 0.5 cm.
- 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.
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.
6. Comparison of Manufacturer's Cleared Device and Modified Device
Table 1. Comparison of Modified Device to Cleared Device
| Subject | NPseal 5, NPseal 10, NPseal 15, NPseal 20, NPseal 25 | Predicate Device |
|---|---|---|
| 510(k) Number | To be assigned | K241522 |
| 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 intended for negative pressure wound therapy. |
| Common Name | Same as predicate | Negative Pressure Wound Therapy non-powered suction apparatus |
| Indications for Use | Same as predicate | The NPseal is indicated for patients who would benefit from wound 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. |
Page 7
| Subject | NPseal 5, NPseal 10, NPseal 15, NPseal 20, NPseal 25 | Predicate Device |
|---|---|---|
| Wound types | Same as predicate | Closed surgical incisions, NPseal 5: Up to 5 cm x 0.5 cm, NPseal 10: Up to 10 cm x 0.5 cm, NPseal 15: Up to 15 cm x 0.5 cm, NPseal 20: Up to 20 cm x 0.5 cm, NPseal 25: Up to 25 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 mechanical pump to generate negative pressure. Multilayer pad composed of hydrophilic foam with high fluid absorbency and top breathable film designed to collect and move exudate away from the wound bed. |
| Management of Exudates | Same as predicate | Managed by the dressing itself – via combination of absorption into the foam pad and evaporation through the breathable upper film. |
| Materials | Same as predicate, with an alternate source for hydrophilic polyurethane foam pad | Film: Polyurethane coated with adhesive acrylic, Foam 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 |
| MR Status | MR Safe | Not evaluated |
Page 8
7. Summary of Modification
The subject device labeling was updated to include a statement on the MR safety of the NPseal. The device has been assessed for MR safety and based on this assessment is considered "MR Safe". This had previously been unevaluated for MR Safety. Additional labeling updates were made to remove the wear time on the Quick Start Guide currently printed on the individual NPseal cartons and Tyvek lids, and to add a "not made with natural rubber latex" statement to the IFU. Finally, the subject device was updated to include an alternative source for the hydrophilic polyurethane foam component.
8. Summary of Functional and Performance Testing
Assessment of the MR Safety was evaluated via assessment of known materials, but no functional of performance testing was completed. No functional or performance testing was completed for the other labeling changes. Based on the addition of the alternative source for hydrophilic polyurethane foam component, biocompatibility, performance testing and shelf-life testing was re-executed.
9. Summary of Clinical Testing
No clinical testing was applicable to this submission.
10. Conclusion
The labeling updates do not raise any unanswered questions of safety or effectiveness. Testing has shown that the alternative sourced material meets the same performance specifications as the predicate device. Verification and validation data support substantial equivalence of the to the legally marketed predicate device.