PRO QR Powder is intended for use to stop minor bleeding and to absorb body fluid in traumatic superficial lacerations or wounds. Once exudation and bleeding have stopped, a protective dressing can be applied. It is intended to be distributed as a Professional Use (Non-Prescription) Device.

Device Description

Components - The PRO QR product is composed of two main components: potassium iron oxyacid salt and a hydrophilic polymer.

Mechanism of Action - The PRO QR achieves its principle intended action (hemostasis) by creating a physical barrier or seal to the blood flow.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the PRO QR (Quick Relief) Powder, based on the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text for K070520 does not explicitly list numerical acceptance criteria or performance metrics in a typical table format. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Sorbastace, K965034) based on shared intended use, satisfactory biocompatibility, high absorbency, and sterility.

However, based on the performance testing mentioned, we can infer some general performance goals:

Acceptance Criteria (Inferred from testing and equivalence claims)	Reported Device Performance (as described in the 510(k) Summary)
Biocompatibility: No adverse biological reactions	Demonstrated satisfactory biocompatibility through Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Ames Mutagenicity tests.
Absorption Capability: Ability to absorb body fluids	"Highly absorbent for collecting body fluids" (stated for both subject and predicate device). Confirmed by "Absorption Study" in in-vitro testing.
Hemostasis (Stopping Minor Bleeding): Ability to stop minor bleeding in traumatic superficial lacerations/wounds	Achieves hemostasis by creating a physical barrier/seal to blood flow. Demonstrated performance in "A swine model of lethal, arterial extremity injury."
Mechanism of Action Equivalence: Similar mechanism to predicate (fluid dehydration and protein coagulation/agglomeration)	Both PRO QR and predicate arrest fluid/blood flow by fluid dehydration (polymeric component) and protein coagulation/agglomeration (aluminum oxyacid salt vs. potassium iron oxyacid salt).
Sterility: Sterile for single-use application	"Sterile, single use devices" (stated for both subject and predicate).
Safety: No new safety concerns due to composition differences	Composition differs from predicate, but "has been shown to be biocompatible... and raises no issue of safety or effectiveness."
Effectiveness: Effective for control of bleeding wounds and absorption of body fluids	"Safe and effective for the control of bleeding wounds, absorption of body fluids and performs in a manner equivalent to the predicate" based on testing.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document only mentions "A swine model of lethal, arterial extremity injury" for the animal study. It does not specify the sample size (number of animals or wounds) used in this model.
Data Provenance: The animal study was conducted in a "swine model," indicating an animal study, not human data. The document does not specify the country of origin for the data. The study is prospective in nature, as it involves active animal experimentation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide any information regarding the number or qualifications of experts used to establish a ground truth for the animal study. Animal model outcomes (e.g., successful hemostasis) would typically be assessed by veterinary or medical researchers, but specifics are absent here.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for the test set.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study typically involves human readers evaluating medical images or data, which is not applicable to this device (a wound dressing powder).

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

This question is not applicable to the PRO QR Powder. "Standalone" performance generally refers to the performance of an AI algorithm operating independently. The PRO QR Powder is a physical medical device, not a software algorithm. Its performance is inherent in its physical properties and interaction with biological systems.

7. The Type of Ground Truth Used

For the animal study, the ground truth would have been physiological outcomes related to hemostasis and wound management, observed directly in the swine model (e.g., cessation of bleeding, time to hemostasis, blood loss measurements).

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here. PRO QR Powder is a physical device, not an AI algorithm that undergoes training. The development and testing of such a device rely on material science, chemical properties, and biological studies, not machine learning training sets.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reason as point 8. There is no training set or associated ground truth for a physical medical device like PRO QR Powder.

Summary

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June 11, 2023

Biolife, LLC c/o Karen O'Toole Manager, Quality Assurance and Regulatory Affairs 1235 Tallevast Road Sarasota, Florida 34243-3271

Re: K070520 Trade/Device Name: PRO QR (Quick Relief)® Powder Regulatory Class: Unclassified Product Code: QSY

Dear Karen O'Toole:

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 October 23, 2007 and correction letter dated November 6, 2007. 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/7 description: The image shows the end of a letter with the signature of Julie A. Morabito, Ph.D., Assistant Director. The letter is from DHT4B: Division of Infection Control and Plastic Surgery Devices. It also mentions OHT4: Office of Surgical and Infection Control Devices, as well as the Office of Product Evaluation and Quality Center for Devices and Radiological Health.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around it. Inside the circle is a stylized image of three human profiles facing right, with flowing lines above them that could be interpreted as hair or abstract shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 6 2007

Biolife, L.L.C. % Ms. Karen O'Toole Manager, Quality Assurance and Regulatory Affairs 1235 Tallevast Road Sarasota, Florida 34243

Re: K070520

Trade/Device Name: PRO OR (Ouick Relief)® Powder Regulatory Class: Unclassified Product Code: FRO Dated: September 14, 2007 Received: September 17, 2007

Dear Ms. O'Toole:

This letter corrects our substantially equivalent letter of October 23, 2007.

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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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Page 2 – Ms. Karen O'Toole

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Director Division of General, Restorativ and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/3/Picture/1 description: The image shows a logo for a product called "PRO QR QUICK RELIEF". The logo is in black and white and features the letters "QR" in a stylized font. Below the logo, there is a handwritten word that appears to be "K070Г30".

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

PRO QR (Quick Relief)® Powder Device Name:

(for Minor External Bleeding From Wound & Procedures)

Indications for Use:

Prescription Use __ AND/OR Over-The-Counter Use
(Part 21 CFR 801 Subpart D) (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) Page	of
(Division Sign-Off)
Division of General, Restorative,and Neurological Devices
510(k) Number	1070520

Biolife, L.L.C. 1235 Tallevast Road, Sarasota, FL 34243

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OCT 2 3 2007

Image /page/4/Picture/2 description: The image shows the logo for Pro QR Quick Relief. Below the logo is the number K070520 written in cursive. The image is in black and white.

SECTION 5:

510(k) SUMMARY

5.1 Sponsor

Biolife, LLC

1235 Tallevast Road

Sarasota, FL 34243

Telephone: 941-360-1300

Fax: 941-355-2187

Registration Number: 1066421

Contact Person: Karen O'Toole

5.2 Date Summary was Prepared

February 15, 2007

5.3 Device Information

Proprietary Name: PRO QR (Quick Relief) ® Powder (for Minor External Bleeding From Wounds and Procedures) Common Name: Powder Wound Dressing Classification Name: Dressing, Unclassified

5.4 Predicate Device

Hemostace, LLC; Sorbastace (K965034)

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2070520

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Image /page/5/Picture/2 description: The image shows a logo with the letters 'PRO QR' in a stylized font. The 'PRO' is smaller and positioned above the 'QR', which is much larger and bolder. To the right of the 'QR', there is smaller text that reads 'QUICK RELIEF' in a simple, sans-serif font. The overall design is simple and professional, likely representing a brand or product name.

5.5 Device Description

Components - The PRO QR product is composed of two main components: potassium iron oxyacid salt and a hydrophilic polymer.

Mechanism of Action - The PRO QR achieves its principle intended action (hemostasis) by creating a physical barrier or seal to the blood flow.

5.6 Intended Use

5.7 Substantial Equivalence

PRO QR has identical claims to the Sorbastace (K965034) predicate, in that it is intended to be applied to traumatic, superficial lacerations or wounds to absorb body fluid and stop minor bleeding for Over the Counter (OTC) use. The subject and predicate device are made from materials which have demonstrated satisfactory biocompatibility, are highly absorbent for collecting body fluids, and are sterile, single use devices.

5.8 Performance Testing

Biocompatibility - Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Ames Mutagenicity

In vitro Testing - Absorption Study, Acid Base Interaction Study, Scanning Electron Microscopy (SEM) Analysis, Potassium (K) and Iron (Fe) Extraction

Animal Study -- A swine model of lethal, arterial extremity injury

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7010

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Image /page/6/Picture/2 description: The image shows the text "510(k) Premarket Notification" in bold, black font. The text is presented on a white background. The text appears to be a title or heading, possibly indicating the subject matter of a document or presentation.

Image /page/6/Picture/3 description: The image shows a logo with the letters 'PRO QR' in a stylized font. The 'QR' is significantly larger than the 'PRO', and the words 'QUICK RELIEF' are written in a smaller font to the right of the 'R'. The logo has a slightly distressed or textured appearance.

5.9 Conclusion

PRO QR Powder has the same intended use as the predicate device and differs only in the composition which has been shown to be biocompatible (based on the data in the submission) and raises no issue of safety or effectiveness. Both products arrest the flow of body fluids or blood by fluid dehydration (polymeric component) and protein coagulation or agglomeration (aluminum oxyacid salt versus potassium iron oxyacid salt).

Biolife, LLC believes that, as a result of the biocompatibility testing, in vitro testing, and the animal study, PRO QR is safe and effective for the control of bleeding wounds, absorption of body fluids and performs in a manner equivalent to the predicate.

Regulation Number and Section

N/A