(185 days)
Not Found
No
The device description and performance studies focus on the material properties (chitosan, radiopaque element) and physical characteristics of the dressing for hemostasis and radiodetection. There is no mention of AI/ML in the intended use, device description, or performance studies.
Yes
The device is a hemostatic dressing intended for the temporary control of severely bleeding wounds, which is a therapeutic function.
No
The device is a hemostatic dressing intended for the temporary control of bleeding wounds, not for diagnosing medical conditions. While it has a radiopaque element for detection via x-ray, this is for preventing it from being accidentally left in a surgical cavity, not for diagnostic imaging of the wound itself.
No
The device description clearly states it is a physical dressing composed of gauze, chitosan, and a radiopaque element. It is a tangible medical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "temporary control of severely bleeding wounds such as surgical wounds and traumatic injuries." This is a therapeutic and diagnostic use, not an in vitro diagnostic use.
- Device Description: The device is a hemostatic dressing applied directly to a wound. IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a person's health.
- Function: The device's function is to physically help control bleeding and to be detectable by x-ray if left in a surgical cavity. This is a direct interaction with the body and a physical property, not an analysis of a biological sample.
The mention of X-ray is for detecting the dressing in vivo (within the body), not for analyzing a sample in vitro (outside the body).
N/A
Intended Use / Indications for Use
HemCon GuardaCare™XR is a hemostatic dressing intended for the temporary control of severely bleeding wounds such as surgical wounds and traumatic injuries.
Product codes (comma separated list FDA assigned to the subject device)
QSY, FRO, KMF
Device Description
The GuardaCare™XR dressing is composed of a radiopaque element attached to standard polyester/ravon blend non-woven medical gauze that is coated with chitosan. The product is produced in multiple sizes; e.q. two (2) inches by two (2) inches, eightply: four (4) inches by four (4) inches, eight-ply; and four (4) inches by two (2) yards (zfolded 4"x4"). All sizes are a single continuous length that is z-folded to the appropriate size. The products are double-pouched. The inner pouch is peelable foil and the outer pouch is clear peelable polvethylene terephthalate (PET). The pouched dressings are terminally sterilized with gamma irradiation to a sterility assurance level (SAL) of 10 °.
The hemostatic properties of chitosan enhance the ability of the medical gauze to control bleeding. The radiopaque element allows for easy detection via x-ray to prevent the dressing from being inadvertently left in a surgical cavity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
Severely bleeding wounds such as surgical wounds and traumatic injuries.
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)
Biocompatibility: Biocompatibility has been demonstrated per ISO 10993.
In Vivo Efficacy: Two separate in vivo studies were designed and conducted to establish the hemostatic efficacy of the product in different injury types that were created to represent the likely use of the different product sizes. In both studies the device was tested side-by-side against a competitive hemostatic dressing. The first study tested the ability of the 4 inch by 4 yard size to control bleeding in 6mm femoral perforation injury in a swine. The second study measured the ability of a two inch by two inch 8-ply size to control bleeding in a splenic capsular strip injury in a swine. In both cases, the device proved to successfully control bleeding at least as well as the competitive product used as a reference.
Sterility: A sterility validation for GuardaCare™XR was completed following ISO 11137:2006 requirements to demonstrate a 10-8 SAL using the VDmax method.
Radiopacity: The radiopacity of GuardaCareXR was determined via testing performed in accordance with ASTM F640-07 Method C (Standard Test Methods for Determining the Radiopacity for Medical Use). The product was found to be equivalent to the radiopacity of the ASTM Radiopacity Standard (101x76x0.9 millimeter 99+% 1100 alloy aluminum sheet) and was therefore determined to be acceptable.
Clinical Performance Data: Based upon the substantial equivalence determination for the predicate device, no clinical data is required for evaluation of this 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.
mRDH Bandage - K082703
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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
HemCon Medical Technologies, Inc. c/o Kevin Hawkins VP, Quality & Regulatory Affairs 10575 SW Cascade Avenue, Suite 130 Portland, Oregon 97223-4363
July 28, 2023
Re: K103641 Trade/Device Name: Guardacare™ XR Regulatory Class: Unclassified Product Code: QSY
Dear Kevin Hawkins:
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 June 16, 2011. 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.
Sincerely,
Julie A. Morabito -S
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
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The bird is positioned to the right of a circular emblem that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. The text is in uppercase letters and is oriented to follow the curve of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
HemCon Medical Technologies, Inc. % Mr. Kevin Hawkins VP, Quality & Regulatory Affairs 10575 SW Cascade Avenue, Suite 130 Portland, Oregon 97223-4363
Re: K103641
Trade/Device Name: GuardaCare™ XR Regulatory Class: Unclassified Product Code: FRO Dated: June 13, 2011 Received: June 14, 2011
JUN 1 6 201
Dear Mr. Hawkins:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
2
Page 2 - Mr. Kevin Hawkins
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Eric S. Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 4: Indications for Use Statement
Applicant: HemCon Medical Technologies, Inc. 510(k) Number: K103641 Device Name: GuardaCare™XR
Indications for Use:
HemCon GuardaCare™XR is a hemostatic dressing intended for the temporary control of severely bleeding wounds such as surgical wounds and traumatic injuries.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use | (21 CFR 801 Subpart C)
(Please Do Not Write Below This Line - Continue On Another Page If Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Kurebeki MXU
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K103641
4
JUN 1 6 2011
Section 5: 510(k) Summary
| Trade Name: | GuardaCare™XR |
|---|---|
| Common Name: | Wound Dressing |
| Classification Name: | Dressing |
| Product Code: | FRO/KMF |
| Predicate Device(s): | mRDH Bandage - K082703 |
| Company Name: | HemCon Medical Technologies, Inc. |
| Company Address: | 10575 SW Cascade Avenue, Suite 130 |
| Portland, OR 97223 | |
| Contact Person: | Kevin Hawkins |
| Director - Quality & Regulatory | |
| Contact Phone: | (503)245.0459 x114 |
| Contact Fax: | (503)245.1326 |
| Date of Preparation: | 10 June 2011 |
Description of the Device:
The GuardaCare™XR dressing is composed of a radiopaque element attached to standard polyester/ravon blend non-woven medical gauze that is coated with chitosan. The product is produced in multiple sizes; e.q. two (2) inches by two (2) inches, eightply: four (4) inches by four (4) inches, eight-ply; and four (4) inches by two (2) yards (zfolded 4"x4"). All sizes are a single continuous length that is z-folded to the appropriate size. The products are double-pouched. The inner pouch is peelable foil and the outer pouch is clear peelable polvethylene terephthalate (PET). The pouched dressings are terminally sterilized with gamma irradiation to a sterility assurance level (SAL) of 10 °
The hemostatic properties of chitosan enhance the ability of the medical gauze to control bleeding. The radiopaque element allows for easy detection via x-ray to prevent the dressing from being inadvertently left in a surgical cavity.
Intended Use:
GuardaCare™XR is a hemostatic dressing intended for the temporary control of severely bleeding wounds such as surgical wounds and traumatic injuries.
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Technological Characteristics:
GuardaCare™XR is technologically similar to the predicate device. The mRDH dressing has demonstrated the safety and efficacy of a poly-N-acetylglucosamine based dressing for use in surgical procedures. It also has demonstrated the safety and efficacy of a gauze product with an integrated radiopaque element. GuardaCare ™XR is a poly-Nacetylglucosamine-based hemostatic with an x-ray detectable feature. It is therefore technologically similar to the mRDH dressing.
Non-Clinical Performance Data:
Biocompatibility
Biocompatibility has been demonstrated per ISO 10993.
In Vivo Efficacy
Two separate in vivo studies were designed and conducted to establish the hemostatic efficacy of the product in different injury types that were created to represent the likely use of the different product sizes. In both studies the device was tested side-by-side against a competitive hemostatic dressing. The first study tested the ability of the 4 inch by 4 yard size to control bleeding in 6mm femoral perforation injury in a swine. The second study measured the ability of a two inch by two inch 8-ply size to control bleeding in a splenic capsular strip injury in a swine. In both cases, the device proved to successfully control bleeding at least as well as the competitive product used as a reference.
Sterility
A sterility validation for GuardaCare™XR was completed following ISO 11137:2006 requirements to demonstrate a 10-8 SAL using the VDmax method.
Radiopacity:
The radiopacity of GuardaCareXR was determined via testing performed in accordance with ASTM F640-07 Method C (Standard Test Methods for Determining the Radiopacity for Medical Use). The product was found to be equivalent to the radiopacity of the ASTM Radiopacity Standard (101x76x0.9 millimeter 99+% 1100 alloy aluminum sheet) and was therefore determined to be acceptable.
Clinical Performance Data:
Based upon the substantial equivalence determination for the predicate device, no clinical data is required for evaluation of this device.
Substantial Equivalence:
The conclusion drawn from the technological characteristics and non-clinical performance data is that the device is as safe and effective as the predicate devices.