(379 days)
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.
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.
The document provided is a 510(k) premarket notification for the PRO QR (Quick Relief)® Powder, indicating substantial equivalence to already marketed predicate devices. Unfortunately, the document does not contain the specific acceptance criteria and detailed study results in a format that directly addresses all the points requested.
Here's an attempt to extract relevant information and highlight what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, AUC, or other quantitative measures typically found in a clinical study report for AI/CADe devices. Instead, it relies on demonstrating substantial equivalence through various studies.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied from Summary) |
|---|---|
| Biocompatibility: | The device underwent comprehensive biocompatibility testing including 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. The conclusion states that "PRO QR Powder is safe and effective." |
| Hemostasis Efficacy: (for moderate to severe bleeding) | "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." |
| Safety Advantage: (vs. predicate) | "In addition study results for safety showed that QR Powder provided a significant advantage over QuikClot." |
| Efficacy in vascular access procedures: | "Safety and efficacy was also demonstrated for bleeding control in vascular access procedures using a swine model both acutely and subchronically (2 weeks)." |
| Physical/Chemical Properties (In vitro): | In vitro testing included 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. The conclusion states: "PRO QR Powder induce hemostasis by fluid dehydration, protein coagulation and agglomeration the same as PRO QR (K070520) predicate device." |
| Substantial Equivalence to Predicate Devices (K070520, K021678, K013390): | "PRO QR Powder has substantially equivalent indications to the HemaDerm (K021678) and QuikClot (K013390) predicates... PRO QR Powder (K080210) uses the same safe and effective technology as PRO QR (K070520)." The devices are similar in materials, absorbency, sterility, and single-use functionality. |
Missing Information/Not Applicable (N/A) for AI/CADe Specifics:
The questions you've posed (sample size for test set, experts, adjudication, MRMC, standalone performance, training set details) are highly specific to studies evaluating Artificial Intelligence (AI) or Computer-Aided Detection (CADe) devices, especially those involving image interpretation. The device described in this 510(k) (PRO QR Powder) is a topical hemostatic agent, not an AI/CADe device. Therefore, many of the requested data points are not applicable to this type of medical device submission.
Here's why and what can be inferred for the relevant parts:
2. Sample size used for the test set and the data provenance:
- N/A for typical test set as this is not an AI/CADe device.
- For the animal studies: "swine model" is mentioned for three studies. The exact number of swine used is not specified in the summary.
- Data provenance: "swine model" indicates animal studies. The country of origin is not specified but generally, such studies for US FDA submissions are conducted in accredited facilities in the US or internationally under GLP (Good Laboratory Practice) standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A, as ground truth involving human expert interpretation is not relevant for this device. Animal study outcomes would be assessed by veterinarians or researchers experienced in animal models of hemorrhagic injury.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A, as adjudication is typically for discordant interpretations in human reader studies, not for the performance of a topical hemostatic agent. The assessment in animal models would follow specific experimental protocols.
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:
- N/A, no MRMC study was conducted as this is not an AI/CADe device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A, as this is not an AI/CADe algorithm. The device's performance is standalone in its application as a hemostatic agent.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For animal studies assessing hemostasis, the ground truth would likely involve direct observation of bleeding cessation, measurement of blood loss, and potentially physiological parameters (e.g., blood pressure) and survival rates. Histologic assessment was mentioned for the porcine wound model (biocompatibility).
8. The sample size for the training set:
- N/A, as this device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
- N/A, as there is no training set for this type of device.
In summary: The provided document is a 510(k) summary for a hemostatic powder, not an AI/CADe device. Therefore, a direct mapping to your specific questions about AI/CADe acceptance criteria, study design, and performance metrics is not possible. The submission focuses on demonstrating safety and efficacy through biocompatibility tests, in vitro studies, and animal models, and ultimately, substantial equivalence to previously cleared predicate devices.
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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, 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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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 (240) 276-0115. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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. 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: 941-360-1300
Fax: 941-355-2187
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.
N/A