PRO QR ADVANCED FORMULA POWDER

K080210 · Biolife, LLC · QSY · Feb 10, 2009 · SU

Device Facts

• Record ID: K080210
• Device Name: PRO QR ADVANCED FORMULA POWDER
• Applicant: Biolife, LLC
• Product Code: QSY · SU
• Decision Date: Feb 10, 2009
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

PRO QR Powder for minor external bleeding from wounds and procedures is intended for use as a topical dressing for bleeding control associated with minor wounds, including control of minor external bleeding and exudate from sutures and/or surgical procedures. PRO QR Powder for moderate to severe external bleeding wounds is intended for emergency use of temporary external treatment for controlling moderate to severe bleeding.

Device Story

PRO QR Powder is a topical hemostatic wound dressing; composed of potassium iron oxyacid salt and hydrophilic polymer. Applied by pouring onto wounds; functions by creating physical barrier/seal upon contact with blood/exudate; combined with manual pressure. Mechanism involves fluid dehydration, protein coagulation, and agglomeration. Used in clinical or emergency settings; operated by clinicians or patients (OTC). Output is a physical seal over the wound; aids in rapid hemorrhage control. Benefits include temporary bleeding cessation for minor to severe wounds.

Clinical Evidence

No clinical data. Evidence based on bench testing (biocompatibility, SEM, absorption, chemical analysis) and animal studies (swine models for lethal arterial extremity injury, hemostasis efficacy, and wound healing assessment).

Technological Characteristics

Composition: potassium iron oxyacid salt and hydrophilic polymer. Form factor: powder. Principle: physical barrier/seal formation via dehydration and protein coagulation. Single-use, sterile. No electronic components or software.

Indications for Use

Indicated for patients with minor external bleeding from wounds, sutures, or surgical procedures (OTC) and patients with moderate to severe external bleeding wounds requiring emergency temporary treatment (Rx).

Regulatory Classification

Identification

To temporarily control bleeding and cover external wounds.

Predicate Devices

• PRO QR (Quick Relief) ® Powder (K070520)
• HemaDerm (K021678)
• QuikClot (K013390)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.

July 28, 2023

Biolife, LLC c/o Karen O'Toole Manager, QA/RA 1235 Tallevast Road Sarasota, Florida 34243-3271

Re: K080210 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 February 10, 2009. 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, [e-mail].

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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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved strokes representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## FEB 1 0 2009

Biolife, LLC % Ms. Karen O'Toole Manager, QA/RA 1235 Tallevast Road Sarasota, Florida 34243

Re: K080210

Trade/Device Name: PRO QR (Ouick Relief)® Powder Regulatory Class: Unclassified Product Code: FRO Dated: January 12, 2009. Received: January 13, 2009

Dear Ms. O'Toole:

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. 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

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Page 2 - Ms. Karen O'Toole

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Millman

Mark N. Melkerson Director Division of General, Restorative 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 with the letters 'PR' and 'QR' in a stylized font. The letters are interconnected and have a textured appearance. To the right of the 'QR', the words 'QUICK RELIEF' are written in a smaller font size. The logo has a vintage or slightly distressed look.

Device Name:

PRO QR (Quick Relief)® Powder

Indications for Use:

# OTC:

PRO QR Powder for minor external bleeding from wounds and procedures is intended for use as a topical dressing for bleeding control associated with minor wounds, including control of minor external bleeding and exudate from sutures and/or surgical procedures.

### Rx:

PRO QR Powder for moderate to severe external bleeding wounds is intended for emergency use of temporary external treatment for controlling moderate to severe bleeding.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use X (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

Nil R. Parke-6

Division of General, Restorative. and Neurological Devices

**510(k) Number** K080210

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

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page 1/3

510(k) Premarket Notification: K080210

Image /page/4/Picture/2 description: The image shows a logo with the letters "PPO QR" in a stylized font. The letters "PPO" are smaller and positioned to the left of the larger "QR". To the right of the "QR", the words "QUICK RELIEF" are written in a smaller, sans-serif font. The overall design has a vintage or classic feel due to the font choices and layout.

## SECTION 5:

## 510(k) SUMMARY

FEB 1 0 2009

- 5.1 Sponsor
Biolife, LLC

1235 Tallevast Road

Sarasota, FL 34243

Telephone: [phone]

Fax: [phone]

Registration Number: 1066421

Contact Person: Karen O'Toole

#### 5.2 Date Summary was Prepared

January 12, 2009

#### 5.3 Device Information

Proprietary Name:

PRO QR (Quick Relief)® for Minor External Bleeding from Wounds and Procedures PRO QR (Quick Relief)® for Moderate to Severe External Bleeding Wounds Hemostatic Powder Wound Dressing Dressing, Unclassified

Classification Name:

Common Name:

#### 5.4 Predicate Device

Biolife, L.L.C.; PRO QR (Quick Relief) ® Powder (K070520)

Medafor, Inc.; HemaDerm (K021678)

On Site Gas Systems, Inc.; QuikClot (K013390)

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K060210 page 2/3

510{k) Premarket Notificatio

Image /page/5/Picture/2 description: The image shows a logo with the letters 'PR' and 'QR' in a stylized font. The letters are large and bold, with a textured appearance. To the right of 'QR', the words 'QUICK HELP' are written in a smaller, simpler font.

#### 5.5 Device Description

Components - QR Powder is composed of two main components: potassium iron oxyacid salt, and a hydrophilic polymer.

Mechanism of Action - QR Powder achieves its principle intended action (hemostasis) by creating a physical barrier or seal to stop the flow of blood. When poured on a wound and upon contact with blood or exudate, in combination with manual pressure to the wound, QR Powder quickly forms a strong seal that completely covers the wound.

#### 5.6 Intended Use

PRO QR Powder for minor external bleeding from wounds and procedures is intended for OTC use as a topical dressing for bleeding control associated with minor wounds, including control of minor external bleeding and exudate from sutures and/or surgical procedures.

PRO QR Powder for moderate to severe external bleeding wounds (Rx) is intended for emergency use of temporary external treatment for controlling moderate to severe bleeding.

#### 5.7 Substantial Equivalence

PRO QR Powder has substantially equivalent indications to the HemaDerm (K021678) and QuikClot (K013390) predicates in that they are indicated for topical application as an aid in the control of temporary external bleeding associated with minor to severely bleeding wounds. PRO QR Powder (K080210) uses the same safe and effective technology as PRO QR (K070520). The subject and predicate devices 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 Testing-

Cytotoxicity, Sensitization. Irritation (skin and mucosal surface), Acute Systemic Toxicity, Ames Mutagenicity, Endotoxin, Pyrogen, Analysis of Hydrophilic Polymer for Styrene, Ethylstyrene and DVB, Histologic Assessment of Acute PRO QR Exposure in a Porcine Wound Model; IR Analysis of QR Powder and hydrophilic polymer for cellulose, XRD and XRF for potassium iron oxyacid salt impurities.

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K080210 page 3/3

510(k) Premarket Notific

Image /page/6/Picture/2 description: The image shows a logo with the letters 'PR' and 'QR' in a stylized font. The letters are interconnected, with 'PR' appearing smaller and positioned above the larger 'QR'. To the right of the 'R' in 'QR', the words 'QUICK RELIEF' are written in a smaller, simpler font. The overall design has a textured, slightly distressed appearance.

In vitro Testing - Absorption Study, Acid Base Interaction Study, Scanning Electron Microscopy (SEM) Analysis, Potassium (K) and Iron (Fe) Extraction, Gravimetric Determinations of PRO QR, Hemostatic Properties of PRO QR Powder as a function of its Quantitative Stability-Indicating Moisture and Potassium Iron Oxyacid Salt content.

### Animal Studies

Animal Study 1 - A GLP Preclinical Study Evaluating Hemostasis Efficacy and Safety Using PRO QR Advanced Formula Powder in the Swine Model - QRPA Series

Animal Study 2 - Evaluation of a Novel Hemostatic Agent for Rapid Hemorrhage Control in a Model of Lethal Arterial Extremity Injury in Swine.

Animal Study 3 - A Swine Model to Demonstrate Powder Coverage Area and to Demonstrate That PRO QR Does Not Impede Healing

Clinical Study - Not Applicable.

#### 5.9 Conclusion

PRO QR Powder induce hemostasis by fluid dehydration, protein coagulation and agglomeration the same as PRO QR (K070520) predicate device. QR Powder has been shown in testing to be equivalent to, if not better than, the QuikClot Powder predicate device in rapid hemorrhage control in a swine model of lethal arterial extremity. In addition study results for safety showed that QR Powder provided a significant advantage over QuikClot. Safety and efficacy was also demonstrated for bleeding control in vascular access procedures using a swine model both acutely and subchronically (2 Biolife, LLC believes that, as a result of the biocompatibility weeks). testing, in vitro testing, and non-clinical animal testing, PRO QR Powder is safe and effective as an aid in the control of temporary external bleeding associated with moderate to severe bleeding. PRO QR Powder is substantially equivalent to the predicate devices, PRO QR Powder, HemaDerm, and QuikClot.