(78 days)
No
The document describes a mechanical pump system for negative pressure wound therapy and does not mention any AI or ML components or capabilities.
Yes
The device is intended to promote wound healing through the removal of exudates, which is a therapeutic function.
No
The device is described as a "Negative Pressure Advanced System" intended for "wound management via application of negative pressure" and for "promoting wound healing." Its function is to remove exudates from closed surgical incisions and maintain negative pressure wound therapy. It does not mention any diagnostic capabilities, such as identifying diseases, disorders, or conditions, or providing information for diagnosis.
No
The device description explicitly states it is a "single-use device that includes an integrated, mechanical pump system," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "wound management via application of negative pressure" and promotes "wound healing through the removal of small amounts of exudates from closed surgical incisions." This describes a therapeutic device used directly on a patient's wound.
- Device Description: The description details a "Negative Pressure Advanced System" with a "mechanical pump system" that maintains negative pressure. This aligns with a medical device used for treatment, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status. IVDs are used to diagnose, monitor, or screen for diseases or conditions by testing samples.
Therefore, the NPseal is a therapeutic medical device, not an In Vitro Diagnostic device.
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 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)
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
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.
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.
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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.
2
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
3
Indications for Use
510(k) Number (if known) K241522
Device Name
NPseal (20 and 25)
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) |
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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).
-
- 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
- Name and Address of Sponsor
-
- Correspondent/Primary Contact Person
Eric Bannon Vice President of Regulatory and Clinical Affairs
- Correspondent/Primary Contact Person
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
-
- Submission Information
| Date Summary Prepared: | August 15, 2024 |
|---|---|
| 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 (K240244) |
-
- 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.
- Device Description
5
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.
-
- 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.
- Indications for Use
-
- Comparison of Manufacturer's Cleared Device and Modified Device
| | Subject
NPseal 20, NPseal 25 | Predicate Device
NPseal 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 device
intended for negative pressure wound
therapy. |
| Common
Name | Same as predicate | Negative Pressure Wound Therapy non-
powered suction apparatus |
| | Subject
NPseal 20, NPseal 25 | Predicate Device
NPseal 5, NPseal 10, NPseal 15 |
| 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. |
| Wound types | Closed surgical incisions,
NPseal 20: Up to 20 cm x 0.5 cm
NPseal 25: Up to 25 cm x 0.5 cm | 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 |
| 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 | Film: Polyurethane coated with adhesive
acrylic,
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
7
- 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.
-
- 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.
- Summary of Functional and Performance Testing
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
-
- Summary of Clinical Testing
No clinical testing was applicable to this submission.
-
- 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.
- Conclusion