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.

AI/ML Overview

This document describes the premarket notification (510(k)) and substantial equivalence determination for Prometheus ChitoGauze® XR PRO. It is a hemostatic dressing for the external, temporary control of severely bleeding wounds.

Based on the provided text, the device is considered "unclassified" and the 510(k) submission primarily relies on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific quantitative acceptance criteria of a novel device. Therefore, a direct analogy to the requested acceptance criteria for an AI/ML device is not fully applicable. However, I can extract and structure the information related to its acceptance and the studies that supported its clearance.

Here's an interpretation of the requested information based on the provided text:

Device: Prometheus ChitoGauze® XR PRO

Regulatory Path: 510(k) Pre-market Notification, relying on Substantial Equivalence

1. A table of acceptance criteria and the reported device performance

As this is a 510(k) based on substantial equivalence to a predicate device (HemCon® ChitoGauze® / ChitoGauze® XR and reference device HemCon GuardaCare™ XR), the "acceptance criteria" are primarily met by demonstrating that the new device is as safe and effective as the predicate. The performance data presented focuses on biological safety and functional equivalence to the predicate.

Acceptance Criterion (Implicit)	Reported Device Performance (as demonstrated by testing)
Biocompatibility (e.g., non-toxic, non-irritating, non-sensitizing)	Met ISO 10993 requirements for a surface-contacting device (breached/compromised surfaces, prolonged exposure). Cytotoxicity, irritation, sensitization, and acute systemic toxicity testing performed under GLP conditions per standard protocols.
Hemostatic Efficacy (comparable to predicate)	In two separate in vivo swine studies (femoral perforation injury and splenic capsular strip injury), the device successfully controlled bleeding at least as well as a competitive hemostatic product used as a reference.
Sterility (Sterility Assurance Level)	A sterility validation was completed following ISO 11137 requirements, demonstrating a 10^-6 SAL using the VDmax25 method.
Radiopacity (detectable via X-ray)	Determined acceptable via testing in accordance with ASTM F640-07 Method C, found equivalent to the ASTM Radiopacity Standard (aluminum sheet).
Technological Characteristics	Found to be technologically equivalent to the currently marketed ChitoGauze® XR product.
Safety and Efficacy Profile	Concluded to have a safety and efficacy profile substantially equivalent to the predicate device.

2. Sample sizes used for the test set and the data provenance

Biocompatibility Testing: The specific "sample sizes" (e.g., number of animals for in vivo tests, replicates for in vitro tests) are not explicitly stated in the document, only that tests were performed "per standard protocols" under GLP conditions.
In Vivo Efficacy Testing: Two separate in vivo studies were conducted using swine models. The number of swine or specific test replicates per study is not provided.
- Study 1: Tested 4 inch by 4 yard size to control bleeding in a 6mm femoral perforation injury in a swine.
- Study 2: 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.
Radiopacity Testing: Performed per ASTM F640-07 Method C. Specific number of samples tested not specified.
Sterility Validation: Performed per ISO 11137. Specific number of samples not specified.

Data Provenance: The studies were prospective (conducted specifically for this submission). The origin of the biological models (swine) or test materials is not specified, but it implies laboratory-controlled conditions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable in the context of this device. The "ground truth" for non-clinical performance (e.g., hemostasis, biocompatibility) is established through standardized laboratory testing methods and biological models, not through expert human review of medical images or diagnoses.

4. Adjudication method for the test set

Not applicable. This device does not involve human interpretation or adjudication of outputs in the way an AI/ML diagnostic device would. Performance is measured through objective laboratory and animal model endpoints.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a hemostatic dressing, not an AI/ML diagnostic assistance device. Therefore, no MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML algorithm. Its "performance" is its physical and biological function to control bleeding.

7. The type of ground truth used

The "ground truth" for the performance studies was:

Biocompatibility: Established by adherence to ISO 10993 standards and observed biological responses (e.g., absence of cytotoxicity, irritation, sensitization).
Hemostatic Efficacy: Established by direct observation and measurement of bleeding control in established animal models (swine femoral perforation and splenic capsular strip injuries), comparing against a reference product.
Sterility: Established by microbiology testing confirming a 10^-6 Sterility Assurance Level.
Radiopacity: Established by physical testing against a standardized aluminum sheet.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI/ML algorithm requiring a training set. The "design" and "development" would involve standard engineering and material science, not machine learning training.

9. How the ground truth for the training set was established

Not applicable (as above).

Summary

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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.

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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:

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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.

Regulation Number and Section

N/A