(162 days)
No
The device description and performance studies focus on the material properties and physical function of the hemostatic dressing, with no mention of AI or ML. The radiopaque filament is a passive feature for X-ray detection, not an AI/ML-driven image processing system.
Yes
The device is a hemostatic dressing intended for the "temporary control of severely bleeding wounds," which is a direct therapeutic action to stop bleeding.
No
Explanation: The device is described as a hemostatic dressing for controlling bleeding, which is a therapeutic function. While it contains a radiopaque filament for detection via X-ray, this is to prevent it from being inadvertently left in a wound, not for diagnostic purposes. Its primary function is to stop bleeding, not to diagnose a condition.
No
The device description clearly states it is a physical hemostatic dressing made of gauze coated with chitosan and containing a radiopaque filament. It is a tangible medical device, not software.
Based on the provided information, the Prometheus ChitoGauze® XR PRO is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "for the external, temporary control of severely bleeding wounds." This describes a therapeutic action applied directly to a wound on the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a hemostatic dressing with a radiopaque filament. This is a physical device used to stop bleeding and be detectable by X-ray, not a reagent or instrument used for in vitro testing.
- Performance Studies: The performance studies focus on hemostatic efficacy (stopping bleeding) and radiopacity (detectability by X-ray). These are relevant to the device's function as a wound dressing, not to diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
Therefore, the Prometheus ChitoGauze® XR PRO is a medical device, specifically a hemostatic dressing, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Prometheus ChitoGauze® XR PRO is a hemostatic dressing for the external, temporary control of severely bleding wounds
Product codes (comma separated list FDA assigned to the subject device)
FRO, QSY
Device Description
Prometheus ChitoGauze® XR PRO is composed of standard polyester/ravon blend nonwoven medical gauze with a radiopaque filament that is coated with chitosan. The dressing is z-folded to the appropriate size and vacuum sealed in a pre-printed foil pouch. The pouched dressing is terminally sterilized with gamma irradiation to a sterility assurance level (SAL) of 10-6.
The hemostatic properties of chitosan enhance the ability of the medical gauze to control bleeding. The radiopaque filament allows for easy detection via X-ray to prevent the dressing from being inadvertently left on the wound.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
external
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)
Performance testing which has been performed on the device includes:
- Biocompatibility testing per ISO 10993
- . in vivo efficacy testing
- Radiopacity testing
Sterility: A sterility validation was completed following ISO 11137 requirements to demonstrate a 10-6 SAL using the VDmax25 method.
Biocompatibility Testing: Biocompatibility testing has been conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing", May 18 1995 and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process" as recognized by FDA.
ChitoGauze® XR PRO is a surface-contacting device, in contact with breached or compromised surfaces which may be used for prolonged exposure (≥ 24 hrs ≤ 30 days). Cytotoxicity, irritation, sensitization and acute systemic toxicity testing has been performed by contract testing laboratories under GLP conditions per standard protocols.
in vivo Efficacy - Hemostatic Properties: Two separate in vivo studies were designed and conducted to establish the hemostatic efficacy of the product in different injury types 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.
Radiopacity: The radiopacity of ChitoGauze® XR PRO 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 mm 99+% 1100 alloy aluminum sheet) and was therefore determined to be acceptable.
Clinical Performance Data: No clinical data was 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.
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.
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
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HemCon Medical Technologies, Inc. Máire Ní Beilliú, Ph.D. VP Regulatory & Quality 720 SW Washington Street, Suite 200 Portland, Oregon 97205
April 21, 2023
Re: K153582 Trade/Device Name: Prometheus ChitoGauze XR PRO Regulatory Class: Unclassified Product Code: QSY
Dear Máire Ní Beilliú, Ph.D .:
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 May 25, 2016. 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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 25, 2016
HemCon Medical Technologies, Inc. Máire Ní Beilliú. PhD VP Regulatory & Quality 720 SW Washington Street, Suite 200 Portland, Oregon 97205
Re: K153582
Trade/Device Name: Prometheus ChitoGauze XR Pro Regulatory Class: Unclassified Product Code: FRO Dated: April 26, 2016 Received: April 28, 2016
Dear Dr. Ní Beilliú:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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,
Jennifer R. Stevenson -A
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
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Indications for Use
510(k) Number (if known) K153582
Device Name Prometheus ChitoGauze® XR PRO
Indications for Use (Describe)
Prometheus ChitoGauze® XR PRO is a hemostatic dressing for the external, temporary control of severely bleding wounds
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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TEL: +1.503.245.0459 FAX: +1.503.245.1326 WEB: www.hemcon.com
510(k) Summary
I. Submitter:
Company Name: Company Address: HemCon Medical Technologies, Inc. 720 SW Washington Street, Suite 200 Portland, OR 97205-3504
Contact Person:
Contact Phone: Contact Fax:
Máire Ní Beilliú PhD VP Regulatory & Ouality (971) 327.5729 (503) 245.1326
23rd May 2016
Date of Preparation:
II. Device
Trade Name: Common Name: Classification Name: Product Code: Regulatory Class: Classification Panel:
Prometheus ChitoGauze® XR PRO Chitosan Wound Dressing Dressing, Wound, Drug FRO Unclassified 878 - General and Plastic Surgery
III. Predicate Device(s):
| Predicate Device: | HemCon® ChitoGauze® (K090026, K092357) |
|---|---|
| / ChitoGauze® XR (K102546) | |
| Reference Device: | HemCon GuardaCare™ XR (K103641) |
The predicate device has not been subject to a design related recall.
IV. Description of the Device:
Prometheus ChitoGauze® XR PRO is composed of standard polyester/ravon blend nonwoven medical gauze with a radiopaque filament that is coated with chitosan. The dressing is z-folded to the appropriate size and vacuum sealed in a pre-printed foil pouch. The pouched dressing is terminally sterilized with gamma irradiation to a sterility assurance level (SAL) of 10-6.
The hemostatic properties of chitosan enhance the ability of the medical gauze to control bleeding. The radiopaque filament allows for easy detection via X-ray to prevent the dressing from being inadvertently left on the wound.
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V. Indications for Use:
The Indications for Use statement for Prometheus ChitoGauze® XR PRO is identical to the predicate device, ChitoGauze® XR PRO (K102546).
Prometheus ChitoGauze® XR PRO is a hemostatic dressing for the external, temporary control of severely bleeding wounds
VI. Comparison of Technological Characteristics with the Predicate Device:
The subject device is technologically equivalent to the currently marketed ChitoGauze® XR product.
VII. Performance Data:
Performance testing which has been performed on the device includes:
- Biocompatibility testing per ISO 10993
- . in vivo efficacy testing
- Radiopacity testing
Sterility
A sterility validation was completed following ISO 11137 requirements to demonstrate a 10-6 SAL using the VDmax25 method.
Biocompatibility Testing
Biocompatibility testing has been conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing", May 18 1995 and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process" as recognized by FDA.
ChitoGauze® XR PRO is a surface-contacting device, in contact with breached or compromised surfaces which may be used for prolonged exposure (≥ 24 hrs ≤ 30 days). Cytotoxicity, irritation, sensitization and acute systemic toxicity testing has been performed by contract testing laboratories under GLP conditions per standard protocols.
in vivo Efficacy - Hemostatic Properties
Two separate in vivo studies were designed and conducted to establish the hemostatic efficacy of the product in different injury types 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.
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TEL: +1.503.245.0459 FAX: +1.503.245.1326 WEB: www.hemcon.com
Radiopacity:
The radiopacity of ChitoGauze® XR PRO 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 mm 99+% 1100 alloy aluminum sheet) and was therefore determined to be acceptable.
Clinical Performance Data:
No clinical data was required for evaluation of this device.
Summary:
The conclusion drawn from the technological characteristics and non-clinical performance data is that Prometheus ChitoGauze® XR PRO has been found to have a safety and efficacy profile that is substantially equivalent to the predicate device ChitoGauze® XR PRO which is marketed for the same intended use.