(30 days)
No
The description focuses on a mechanical pump system for negative pressure wound therapy and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for promoting wound healing through the removal of exudates from surgical incisions, which is a therapeutic action.
No
Explanation: The device is described as a "Negative Pressure Advanced System" that "promotes wound healing through the removal of small amounts of exudates from closed surgical incisions." This indicates a therapeutic function, not a diagnostic one.
No
The device description explicitly states it includes an "integrated, mechanical pump system," which is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "wound management via application of negative pressure" and "promote 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 body for treatment.
- Device Description: The description details a "Negative Pressure Advanced System" with a "mechanical pump system" that applies negative pressure to a wound. This is consistent with a therapeutic device.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Testing for diseases or conditions
IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is used in vivo (on the body) for treatment.
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 Small is intended to remove small amounts of exudate from surgically closed incisions up to 5 cm × 0.5 cm.
The NPseal Medium is intended to remove small amounts of exudate from surgically closed incisions up to 10 cm x 0.5 cm.
The NPseal Large is intended to remove small amounts of exudate from surgically closed incisions up to 15 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 NPseal modifications were 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 .
- Benchtop Usability Testing .
- Pull Testing .
- Shipping 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.
NPseal (K212971)
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.
NPseal (K200305)
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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 29, 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: K240244
Trade/Device Name: NPseal (Small, Medium, Large) 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 29, 2024 Received: January 30, 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 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 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 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,
Yu-chieh Chiu -S
Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Infection Control and 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) K240244
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) |
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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 1.1
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 -
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 ebannon@alvamed.com Phone: +1 (781) 710-8243 Fax: +1 (617) 249-0955
- 1.3 Submission Information
| Date Summary Prepared: | February 26, 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 (K212971) |
| Reference 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 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.
5
The NPseal Small is intended to remove small amounts of exudate from surgically closed incisions up to 5 cm × 0.5 cm.
The NPseal Medium is intended to remove small amounts of exudate from surgically closed incisions up to 10 cm x 0.5 cm.
The NPseal Large is intended to remove small amounts of exudate from 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 Modified Device to Cleared Device | |||||
|---|---|---|---|---|---|
| ---------------------------------------------------------- | -- | -- | -- | -- | -- |
| | Subject
NPseal | Predicate Device
NPseal |
|----------------------------|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K240244 | K212971 |
| 510k Submitter/Holder | Same as predicate | Guard Medical |
| Product Code | Same as predicate | ОКО |
| 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. |
| Wound types | Same as predicate | Closed surgical incisions,
NPseal Small: Up to 5 cm x 0.5 cm
NPseal Medium: Up to 10 cm x 0.5 cm
NPseal Large: 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) |
6
| | Subject
NPseal | Predicate Device
NPseal |
|--------------------------------|--------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. |
| Device Design
Modifications | Tray sterile barrier
Pump body durometer Shore 43A
Release liner orientation: longitudinal | Pouch sterile barrier
Pump body durometer Shore 28A
Release liner orientation: perpendicular |
| 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 | Up to 7 days | Up to 6 days |
| Sterility | Same as predicate | Sterile - Gamma irradiation |
| Biocompatibility | Same as predicate | Complies with ISO 10993-1 |
Summary of Modification 1.7 -
There is one modification to the device's labeling: wear time is now 7 days instead of the predicate device's 6 days.
Following are the modifications to the product since the last K212971 510(k) submission:
- The pump body is modified to reduce the pump outer profile and facilitate the injection molding manufacturing process.
- The Dressing-Pump adhesive is updated for easier manufacturing. -
- -The orientation of the dressing release liners is rotated ninety degrees.
- The device packaging is changed from a pouch to a tray and Tyvek lid. The dimensions of the individual carton and shipper box are reduced accordingly.
- -The packaging graphics are modified to include QR code links to electronic Instructions for Use (e-IFU) and Patient Guide (PG). The e-IFU replaces the physical IFU. The Quick Start Guide (QSG) and PG's graphics are simplified solely to improve readability and clarity, and to remove language that became obsolete with the pump outer geometry change.
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-
Summary of Functional and Performance Testing 1.8
The NPseal modifications were 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 .
-
Benchtop Usability Testing .
-
Pull Testing .
-
Shipping Validation .
-
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 and effective as the predicate device through bench testing. Verification and validation data support substantial equivalence of the modified NPseal to the legally marketed predicate device.