(146 days)
Not Found
No
The description focuses on a mechanical pump system for negative pressure wound therapy and does not mention any AI/ML components or capabilities.
Yes
The device is intended to promote wound healing through the removal of exudates from closed surgical incisions, which is a therapeutic function.
No
The device is described as a "Negative Pressure Advanced System" intended for "Negative Pressure Wound Therapy (NPWT)" to promote wound healing by removing exudates. This is 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 clearly states the device is for "management via application of a negative pressure" to "closed surgical incisions" to "promote wound healing through the removal of small amounts of exudates". This describes a therapeutic intervention applied directly to a patient's body, 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 system" and components like a "foam pad". These are all consistent with a wound therapy device, not an in vitro diagnostic device.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic or monitoring information about a patient's health status
Therefore, the NPseal is a therapeutic medical device, specifically a Negative Pressure Wound Therapy (NPWT) system, and 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 a 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 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 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.
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 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.
No clinical testing was applicable to this submission.
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.
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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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.
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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
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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)
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Image /page/3/Picture/0 description: The image shows the logo for Guard Medical. The word "GUARD" is in large, blue, sans-serif font, with the "A" stylized as an upside-down "V". Below the word "GUARD" is the word "MEDICAL", also in blue, sans-serif font, but smaller than the word "GUARD". 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 |
| 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
NPseal Medium
NPseal Large | Predicate Device
NPseal Small |
|---------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K212971 | K211130 |
| 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 |
| Incision sizes | NPseal Medium: Up to 10 cm x 0.5 cm
NPseal Large: Up to 15 cm x 0.5 cm | Up to 5 cm x 0.5 cm |
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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.
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| | Subject Devices
NPseal Medium
NPseal Large | Predicate Device
NPseal Small |
|---------------------------------------|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. |
| 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 | 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).