(269 days)
Not Found
No
The device description focuses on the material properties (chitosan) and its physical mechanism for hemostasis. There is no mention of AI, ML, image processing, or data-driven decision making.
Yes
The device is used for the management and control of surface bleeding from wounds, promoting coagulation and providing a barrier, which directly addresses a health condition.
No
The device is indicated for the management and control of surface bleeding from wounds, not for diagnosis. It is a hemostatic patch/dressing that promotes coagulation and creates a barrier, which are therapeutic functions.
No
The device description clearly states it is a non-woven fabric derived from chitosan fibers, which is a physical material, not software. The summary details physical properties, packaging, and sterilization methods, all indicative of a hardware-based medical device.
Based on the provided information, the StatGuard® Hemostatic Patch and StatGuard® Hemostatic Dressing are not IVD (In Vitro Diagnostic) devices.
Here's why:
- Intended Use: The intended use is for the management and control of surface bleeding from wounds. This is a direct therapeutic application on the patient's body.
- Device Description: The device is a physical dressing applied to a wound to promote hemostasis and provide a barrier. It interacts directly with the wound and blood externally.
- Mechanism of Action: The hemostatic properties are based on the chitosan material's ability to absorb blood and promote coagulation when applied to the wound. This is a physical and chemical interaction occurring at the wound site.
- Lack of In Vitro Testing: The description of performance studies focuses on biocompatibility, bench performance related to the dressing's properties (antibacterial, microbial barrier), and in-vivo hemostasis in animal models. There is no mention of testing performed on samples of human body fluids or tissues outside of the body for diagnostic purposes.
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic, monitoring, or screening purposes.
The StatGuard® devices are topical hemostatic dressings intended for direct application to a wound on the patient's body to control bleeding. This falls under the category of medical devices used for treatment or management of a physical condition, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The StatGuard® Hemostatic Patch is indicated for use, under the direction of a healthcare professional, in the management and control of surface bleeding from wounds, including vascular access sites.
The StatGuard® Hemostatic Dressing is indicated for use, under the direction of a healthcare professional, in the management and control of surface bleeding from wounds, including vascular access sites.
Product codes (comma separated list FDA assigned to the subject device)
QSY, FRO
Device Description
The StatGuard® Devices are based on a non-woven fabric derived from chitosan fibers. The hemostatic properties of chitosan are widely recognized in the biomedical field. When applied directly on a wound with firm pressure, the chitosan material will turn into a gel-like condition to absorb the blood. It promotes control of moderate to severe wound bleeding and exudates absorption, and promotes coagulation. The dressing provides a barrier to bacterial penetration through the dressing and has antibacterial properties that reduce bacterial growth within the dressing. No clinical studies have been conducted on the subject device and the clinical benefit of this antibacterial property is unknown.
The StatGuard® Hemostatic Patch is made of the non-woven fabric derived from chitosan fibers with a polyurethane backing. The StatGuard Hemostatic Patch is a 2" by 2" dressing that is placed directly over a wound for external control of bleeding. The Patch may be used with patients following a vascular procedure, hemodialysis, or other procedures resulting in bleeding wounds.
The StatGuard Hemostatic Patch is individually packaged in a peelable foil pouch and is sterilized by gamma irradiation. The hemostatic properties of chitosan enhance the ability of the StatGuard Hemostatic Patch to control bleeding.
The StatGuard® Hemostatic Dressing is made of the non-woven fabric derived from chitosan fibers with the addition of a backing that extends past the margins of the patch, with a pressure sensitive adhere to adhere to the patient. The StatGuard Hemostatic Dressings are provided in various sizes. The Dressing may be used with patients who have wounds that are bleeding or may be prone to bleeding. The hemostatic properties of chitosan enhance the ability of the StatGuard Hemostatic Dressing to control bleeding. The StatGuard® Hemostatic Dressings are packaged in a polyester laminated film pouch. Sterilization is by gamma radiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wounds, including vascular access sites.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare professional
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)
Non-clinical Testing:
Biocompatibility Testing:
- Cytotoxicity
- Intracutaneous Irritations
- Skin Irritation
- Skin Sensitization
- Acute Intravenous Systemic Toxicity
- Acute Intraperitoneal Systemic Toxicity
- Endotoxin
- Hemolysis
- Rabbit Pyrogen
Bench Performance Testing Including Function Testing:
- Platelet Aggregation
- Thromboelasticity
- Antibacterial within the dressing
- Microbial Barrier
- Heavy Metal
- Protein Content
- Residual Ethanol
- Sterilization Validation
- Package Validation
- Shelf Life
Animal Test:
- In-vivo Hemostasis
All the test results demonstrate that the submitted devices meet the requirements of the pre-defined acceptance criteria, specifications, and intended uses and are substantially equivalent to the predicate devices. Biocompatibility testing included cytotoxicity, sensitization, irritation, acute system toxicity, hemolysis, and pyrogenicity was conducted in accordance with ISO 10993. Antibacterial activity has been demonstrated within the dressing per AATCC 100, Assessment of Antibacterial Finishes on Textile Materials. Microbial Barrier performance testing has also been conducted.
The StatGuard® Hemostatic Patches and StatGuard® Hemostatic Dressings exhibited substantially equivalent efficacy in the ability to control bleeding to their predicate, AnsCare ChitoClot Gauze. All tests demonstrated the materials and processes used in the design and manufacture of the devices are non-cytotoxic, non-sensitizing, non-irritants and non-pyrogenic. The StatGuard® Hemostatic Patch and StatGuard® Hemostatic Dressing demonstrated microbial barrier properties.
Sterility Testing:
Sterility testing was conducted per ISO 11137 requirements to demonstrate a 10° SAL using the VDmax25 method.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Log Reduction for Antibacterial Effectiveness:
Microorganism: Micrococcus luteus ATCC 4698, Gram Stain: +, Log Reduction: > 4
Microorganism: Streptococcus mutans ATCC 25175, Gram Stain: +, Log Reduction: > 4
Microorganism: Streptococcus pneumoniae ATCC 33400, Gram Stain: +, Log Reduction: > 4
Microorganism: Streptococcus pyogenes ATCC 12344, Gram Stain: +, Log Reduction: > 4
Microorganism: Acinetobactor baumannii ATCC 19606, Gram Stain: -, Log Reduction: > 4
Microorganism: Klebsiella pneumoniae ATCC 4352, Gram Stain: -, Log Reduction: > 4
Microorganism: Proteus mirabilis ATCC 25933, Gram Stain: -, Log Reduction: > 4
Microorganism: Pseudomonas aeruginosa ATCC 9027, Gram Stain: -, Log Reduction: > 4
Microorganism: Escherichia coli ATCC 8739, Gram Stain: -, Log Reduction: 3.88 *
- Test results for E. coli did not meet the > 4 log reduction acceptance criteria.
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
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 21, 2023
StatGuard, LLC Gary Mills President 7555 Cason Lane Gladstone, Oregon 97027
Re: K172155
Trade/Device Name: StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing Regulatory Class: Unclassified Product Code: QSY
Dear Gary Mills:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 12, 2018. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code QSY.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, Julie.Morabito@fda.hhs.gov.
Image /page/0/Picture/8 description: The image shows the signature block of Julie A. Morabito. It includes her name, followed by "-S". Below that is her name again, followed by "Ph.D.", and her title as Assistant Director. The block also lists DHT4B: Division of Infection Control and Plastic Surgery Devices, OHT4: Office of Surgical and Infection Control Devices, and Office of Product Evaluation and Quality.
Center for Devices and Radiological Health
1
Image /page/1/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 12, 2018
StatGuard, LLC Gary Mills President 7555 Cason Lane Gladstone, Oregon 97027
Re: K172155
Trade/Device Name: StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing Regulatory Class: Unclassified Product Code: FRO Dated: March 1, 2018 Received: March 6, 2018
Dear Gary Mills:
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K172155
Device Name
StatGuard® Hemostatic Patch and StatGuard® Hemostatic Dressing
Indications for Use (Describe)
The StatGuard® Hemostatic Patch is indicated for use, under the direction of a healthcare professional, in the management and control of surface bleeding from wounds, including vascular access sites.
The StatGuard® Hemostatic Dressing is indicated for use, under the direction of a healthcare professional, in the management and control of surface bleeding from wounds, including vascular access sites.
| 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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4
510(k) Summary K172155
StatGuard, LLC Submitter's name: 7555 Cason Lane Gladstone, OR 97027
| Contact name and address: | Gary Mills, President |
|---|---|
| 7555 Cason Lane | |
| Gladstone, OR 97027 | |
| (503-657-4059) |
Date summary prepared: 12 March 2018
Device name:
| Proprietary name: | StatGuard® Hemostatic Patch |
|---|---|
| StatGuard® Hemostatic Dressing | |
| Common or usual name: | Wound Dressing |
| Classification: | Unclassified |
| Classification name: | Dressing, Wound, Drug |
| Classification product code: | FRO |
Legally marketed devices for substantial equivalence comparison:
The primary predicate device for this submission is the AnsCare ChitoClot Gauze from BenQ Materials Corp. (K143462). Additional predicate devices are identified as ChitoGauze from HemCon Medical Technologies, Inc. (K090026), and CELOX Vascular from Medtrade Products Ltd. (K093519).
Description of the device:
The StatGuard® Devices are based on a non-woven fabric derived from chitosan fibers. The hemostatic properties of chitosan are widely recognized in the biomedical field. When applied directly on a wound with firm pressure, the chitosan material will turn into a gel-like condition to absorb the blood. It promotes control of moderate to severe wound bleeding and exudates absorption, and promotes coagulation. The dressing provides a barrier to bacterial penetration through the dressing and has antibacterial properties that reduce bacterial growth within the dressing. No clinical studies have been conducted on the subject device and the clinical benefit of this antibacterial property is unknown.
5
The StatGuard® Hemostatic Patch is made of the non-woven fabric derived from chitosan fibers with a polyurethane backing. The StatGuard Hemostatic Patch is a 2" by 2" dressing that is placed directly over a wound for external control of bleeding. The Patch may be used with patients following a vascular procedure, hemodialysis, or other procedures resulting in bleeding wounds.
The StatGuard Hemostatic Patch is individually packaged in a peelable foil pouch and is sterilized by gamma irradiation. The hemostatic properties of chitosan enhance the ability of the StatGuard Hemostatic Patch to control bleeding.
The StatGuard® Hemostatic Dressing is made of the non-woven fabric derived from chitosan fibers with the addition of a backing that extends past the margins of the patch, with a pressure sensitive adhere to adhere to the patient. The StatGuard Hemostatic Dressings are provided in various sizes. The Dressing may be used with patients who have wounds that are bleeding or may be prone to bleeding. The hemostatic properties of chitosan enhance the ability of the StatGuard Hemostatic Dressing to control bleeding. The StatGuard® Hemostatic Dressings are packaged in a polyester laminated film pouch. Sterilization is by gamma radiation.
| Dressing | Chitosan pad size | Overall size |
|---|---|---|
| StatGuard ® Hemostatic Dressing, Small | 2 cm x 3 cm | 4 cm x 6 cm |
| StatGuard ® Hemostatic Dressing, Regular | 4 cm x 6 cm | 8 cm x 10 cm |
| StatGuard ® Hemostatic Dressing, Large | 5 cm x 7 cm | 10 cm x 12 cm |
The StatGuard® Hemostatic Dressings are initially provided in sizes as shown:
Intended use of the device:
The StatGuard® Hemostatic Patch is indicated for use, under the direction of a healthcare professional, in the management and control of surface bleeding from wounds, including vascular access sites.
The StatGuard® Hemostatic Dressing is indicated for use, under the direction of a healthcare professional, in the management and control of surface bleeding from wounds, including vascular access sites.
6
Technological characteristics:
The device features of the StatGuard® Hemostatic Patch and of the StatGuard® Hemostatic Dressing are similar to predicate devices, in that all use the hemostatic properties of chitosan to promote hemostasis of a bleeding wound. The Hemostatic Patch is a pad with a backing layer adhered on the back of the pad, only. The Hemostatic Dressing is a pad with an adhesive backing that extends past the margins of the patch to provide adhesion to the patient. Release liners are removed as the dressing is applied to the patient.
Non-clinical Testing:
Biocompatibility Testing:
- Cytotoxicity -
- Intracutaneous Irritations -
- -Skin Irritation
- -Skin Sensitization
- Acute Intravenous Systemic Toxicity -
- Acute Intraperitoneal Systemic Toxicity -
- -Endotoxin
- Hemolysis -
- Rabbit Pyrogen -
Bench Performance Testing Including Function Testing:
- -Platelet Aggregation
- -Thromboelasticity
- -Antibacterial within the dressing
- -Microbial Barrier
- Heavy Metal -
- Protein Content -
- Residual Ethanol -
- Sterilization Validation -
- Package Validation -
- Shelf Life -
Animal Test:
- In-vivo Hemostasis
StatGuard® Hemostatic Patches and Hemostatic Dressings were subjected a series of non-clinical studies. All the test results demonstrate that the submitted devices meet the requirements of the pre-defined acceptance criteria, specifications, and intended uses and are substantially equivalent to the predicate devices. Biocompatibility testing included cytotoxicity, sensitization, irritation, acute system toxicity, hemolysis, and pyrogenicity was conducted in accordance with ISO 10993. Antibacterial activity has been demonstrated within the dressing per AATCC 100,
7
Assessment of Antibacterial Finishes on Textile Materials. Microbial Barrier performance testing has also been conducted.
The StatGuard® Hemostatic Patches and StatGuard® Hemostatic Dressings exhibited substantially equivalent efficacy in the ability to control bleeding to their predicate, AnsCare ChitoClot Gauze. All tests demonstrated the materials and processes used in the design and manufacture of the devices are non-cytotoxic, non-sensitizing, non-irritants and non-pyrogenic. The StatGuard® Hemostatic Patch and StatGuard® Hemostatic Dressing demonstrated microbial barrier properties.
The gauze used in the StatGuard® Hemostatic Patch and StatGuard® Hemostatic Dressing was tested for antibacterial effectiveness against gram- and gram- bacterial strains per invitro testing based on a modified AATCC Test Method 100:
| Microorganism: | Gram Stain | Log Reduction |
|---|---|---|
| Micrococcus luteus ATCC 4698 | + | > 4 |
| Streptococcus mutans ATCC 25175 | + | > 4 |
| Streptococcus pneumoniae ATCC 33400 | + | > 4 |
| Streptococcus pyogenes ATCC 12344 | + | > 4 |
| Acinetobactor baumannii ATCC 19606 | - | > 4 |
| Klebsiella pneumoniae ATCC 4352 | - | > 4 |
| Proteus mirabilis ATCC 25933 | - | > 4 |
| Pseudomonas aeruginosa ATCC 9027 | - | > 4 |
| Escherichia coli ATCC 8739 | - | 3.88 * |
- Test results for E. coli did not meet the > 4 log reduction acceptance criteria.
The data demonstrates the bacteriostatic and bactericidal effectiveness within the dressing of the StatGuard® Hemostatic Patch and the StatGuard® Hemostatic Dressing.
Sterility Testing:
The StatGuard® Hemostatic Patch and the StatGuard® Hemostatic Dressing are gamma radiation sterilized. Sterility testing was conducted per ISO 11137 requirements to demonstrate a 10° SAL using the VDmax25 method.
8
Substantial Equivalence Comparison:
| Submitted Device | Predicate Device | Predicate Device | Predicate Device | |
|---|---|---|---|---|
| Item | StatGuard® Hemostatic | AnsCare ChitoClot | ChitoGauze | CELOX Vascular |
| Patch and Dressing | Gauze | (HemCon Medical | (Medtrade Products, | |
| (BenQ Materials Corp.) | Technologies, Inc.) | LTD) | ||
| K number | K172155 | K143462 | K090026 | K093519 |
| Classification | Unclassified | Unclassified | Unclassified | Unclassified |
| Product Code | FRO | FRO | FRO | FRO |
| Combination Product | No | No | No | No |
| Common or Usual | Wound Dressing | Dressing | Dressing | Dressing |
| Name | ||||
| Applicable Device | None | None | None | None |
| Standards | ||||
| Prescriptive Use | Yes | Yes | Yes | Yes |
| Indications for Use | The StatGuard® | For use as a temporary | ChitoGauze is a | CELOX Vascular is |
| (prescriptive use) | Hemostatic Patch is | external dressing to | hemostatic dressing for | indicated for the local |
| indicated for use, under | control moderate to | the external, temporary | management and control | |
| the direction of a | severe bleeding and | control of severely | of surface bleeding from | |
| healthcare professional, | manage external | bleeding wounds. | vascular access sites, | |
| in the management and | abrasions, lacerations. | percutaneous catheters | ||
| control of surface | or tubes utilizing | |||
| bleeding from wounds, | introducer sheaths up to | |||
| including vascular | 16 French. | |||
| access sites. | ||||
| The StatGuard® | ||||
| Hemostatic Dressing is | ||||
| indicated for use, under | ||||
| the direction of a | ||||
| healthcare professional, | ||||
| in the management and | ||||
| control of surface | ||||
| bleeding from wounds, | ||||
| including vascular | ||||
| access sites. | ||||
| Physical Composition | Soft absorbent, non- | Soft absorbent, non- | Polyester/rayon blend | CELOX hemostatic |
| woven gauze, with | woven gauze | non-woven medical | granules heat bonded | |
| backing material or with | grade gauze coated with | onto a viscous sheet | ||
| adhesive dressing | chitosan | |||
| Requires separate | Yes (patch) | Yes | Yes | Yes |
| wrap or adhesive | No (dressing) | |||
| Hemostatic Material | Chitosan (Poly N- | Chitosan (Poly N- | Chitosan | Chitosan |
| acetyl-glucosamine) | acetyl-glucosamine) | |||
| Chitosan Form | Non-woven fabric | Non-woven fabric | Coated on gauze | Granules |
| derived from chitosan | derived from chitosan | |||
| fibers | fibers | |||
| Antibacterial within the | Yes | Not claimed | Yes | Not claimed |
| dressing | ||||
| Sterility | Gamma-Sterilized | Gamma-Sterilized | Gamma-Sterilized | Gamma-Sterilized |
| Packaging | Foil pouch (patch) | Foil pouch | Foil pouch | Foil pouch |
| Polyester pouch | ||||
| (dressing) | ||||
| Duration of use | Temporary | Temporary | Temporary | Temporary |
| Specifications | 2" x 2" (patch) | Various widths and roll | 4" x 4 yds., | 2" x 2" |
| various (dressing) | lengths | z-folded |
9
Summary of Substantial Equivalence:
The StatGuard® Hemostatic Patch and the StatGuard® Hemostatic Dressing passed all testing and are as safe and effective and substantially equivalent to the indicated predicate devices. Any differences in technological characteristics between the StatGuard® Hemostatic Patch and the StatGuard® Hemostatic Dressings and the predicate devices do not raise new questions about safety and effectiveness.