(242 days)
Not Found
No
The device description and mechanism of action are purely physical/chemical, and there are no mentions of AI, ML, or related concepts.
Yes
The device is intended for use to stop minor bleeding and to absorb body fluid in traumatic superficial lacerations or wounds, which is a therapeutic action. Its mechanism of action also states it achieves hemostasis by creating a physical barrier, directly addressing a health condition.
No
The device is described as stopping bleeding and absorbing body fluid, which is a therapeutic action, not a diagnostic one.
No
The device description clearly states it is composed of physical components (potassium iron oxyacid salt and a hydrophilic polymer) and functions through a physical mechanism of action, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to stop minor bleeding and absorb body fluid in traumatic superficial lacerations or wounds. This is a direct application to the body for a therapeutic purpose (hemostasis).
- Mechanism of Action: The mechanism of action is described as creating a physical barrier or seal to blood flow. This is a physical interaction with the wound, not an analysis of a biological sample.
- No mention of analyzing biological samples: The description does not mention the device being used to test or analyze any biological samples (like blood, urine, tissue, etc.) outside of the body. IVDs are specifically designed for in vitro (in glass) testing of these samples.
Therefore, the PRO QR Powder is a medical device intended for topical application to wounds, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
QSY, FRO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional Use (Non-Prescription) Device.
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)
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
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.
Hemostace, LLC; Sorbastace (K965034)
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.
Not Found
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
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size, also in blue.
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.
1
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.
2
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
3
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:
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.
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
4
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)
5
2070520
2/3
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
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.
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
6
7010
3/3
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.