(28 days)
NPseal (K200305)
Not Found
No
The summary 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 indicated for promoting wound healing through the removal of exudates from surgical incisions, which is a therapeutic purpose.
No
The device is used for wound management by applying negative pressure to promote healing through the removal of exudates. It does not perform any diagnostic functions.
No
The device description explicitly states it includes an "integrated, mechanical pump system," which is a hardware component.
Based on the provided information, 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... through the removal of small amounts of exudates from closed surgical incisions." This describes a therapeutic intervention applied directly to a patient's wound, not a test performed on a sample taken from the body to diagnose or monitor a condition.
- Device Description: The description details a "Negative Pressure Advanced System" with a mechanical pump for applying negative pressure to a wound. This is consistent with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The NPseal's function is to manage and promote healing of a wound through physical means (negative pressure), which falls outside the scope of an IVD.
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 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.
The NPseal is intended for surgically closed incisions up to 5 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 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.
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 (K200305)
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.
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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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: +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: | May 14, 2021 |
|---|---|
| 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 (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
MEDICAL | Special 510(k): Labeling Modification
to NPseal | Page:
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
NPseal | Predicate Device
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
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, less than 5 cm
in length and 0.5 cm in width. |
| 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 pump manually
actuated 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. |
| | Subject
NPseal | Predicate Device
NPseal |
| Materials | Same as predicate | Film: Polyurethane coated with adhesive
acrylic,
Pad: Hydrophilic polyurethane,
Pump: Thermoplastic elastomer |
| Maximum Therapy time | Same as predicate | 6 days |
| Maximum number of
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.