(177 days)
No
The device description and intended use focus on the physical and chemical properties of the hemostatic granules and sheet, with no mention of AI or ML technologies.
Yes
The device is described as "Hemostatic Granules on Sheet" and is "indicated for temporary external use to control moderate to severe bleeding" and "to control bleeding of lacerations, minor cuts and abrasions." Controlling bleeding is a therapeutic function.
No
Explanation: This device, CELOX Hemostatic Granules on Sheet, is intended to control bleeding (hemostasis) and is applied directly to wounds. It does not analyze patient data or provide information about a disease or condition, which are characteristics of a diagnostic device.
No
The device description clearly describes a physical product consisting of hemostatic granules bonded to a sheet, intended for external application to control bleeding. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "temporary external use to control moderate to severe bleeding" or "temporary external use to control bleeding of lacerations, minor cuts and abrasions." This describes a device that is applied directly to a wound on the body to stop bleeding.
- Device Description: The description details a product applied to a wound site to cause hemostasis (stop bleeding). It does not mention any analysis of samples taken from the body (like blood, urine, or tissue) to diagnose a condition or monitor health.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information.
- Using reagents or assays.
- Measuring analytes in a sample.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a topical hemostatic agent applied directly to a wound, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
For Prescription Use: MedTrade Products CELOX Hemostatic Granules on Sheet is indicated for temporary external use to control moderate to severe bleeding
For OTC (Over The Counter) Use: MedTrade Products CELOX Hemostatic Granules on Sheet is indicated for temporary external use to control bleeding of lacerations, minor cuts and abrasions.
Product codes
QSY, FRO
Device Description
The MedTrade Products CELOX Hemostatic Granules on Sheet is nearly identical to the legally marketed MedTrade Products CELOX Hemostatic Granules (K061079, cleared April 20, 2006) in product design composition and processing in that the same CELOX Hemostatic Granules are mechanically heat bonded on to a viscose sheet. The Sheet provides a controlled and accurate delivery System to ensure that the CELOX Hemostatic Granules are applied directly onto the wound site as quickly and efficiently as possible. On contact with blood CELOX Hemostatic Granules that are heat bonded on to the surface of the viscose sheet cause hemostasis.
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
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is a stylized depiction of a human figure, while the FDA logo features the agency's acronym in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. The logos are placed side-by-side, indicating a connection between the two organizations.
July 28, 2023
Medtrade Products Ltd. c/o Jonathan D. Ranfield Director, Quality Assurance & Regulatory Affairs Electra House, Crewe Business Park Crewe, Cheshire, CW1 6GL United Kingdom
Re: K080097
Trade/Device Name: Medtrade Products CELOX Hemostatic Granules On Sheet MedTrade Products CELOX Hemostatic Granules OTC on Sheet Regulatory Class: Unclassified Product Code: QSY
Dear Jonathan D. Ranfield:
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 July 9, 2008. 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
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medtrade Products Ltd. % Mr. Jonathan D. Ranfield Director, Quality Assurance & Regulatory Affairs Electra House, Crewe Business Park Crewe, Cheshire CW1 6GL United Kingdom
JUL - 9 2008
Re: K080097
Trade/Device Name: MedTrade Products CELOX Hemostatic Granules on Sheet MedTrade Products CELOX Hemostatic Granules OTC on Sheet Regulatory Class: Unclassified Product Code: FRO Dated: May 30, 2008 Received: June 17, 2008
Dear Mr. Ranfield:
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
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Page 2 - Mr. Jonathan D. Ranficid
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 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 M. Mulhern
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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Indications for Use
510(k) K080097
Device Name MedTrade Products CELOX Hemostatic Granules on Sheet
Indications For Prescription Use:
MedTrade Products CELOX Hemostatic Granules on Sheet is indicated for temporary external use to control moderate to severebleeding.
Prescription Use (Per 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE, CONTINUE ON ANOTHER PAGE IF NEEDED)
H. Office of Dexice Evaluation (ODE) Concurrence of
Barbara Bennett
livision Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_KC ≤00 97
4
Indications for Use
510(k) K080097
Device Name: MedTrade Products CELOX Hemostatic Granules OTC on Sheet
MedTrade Products CELOX Hemostatic Granules are intended to be available Over The Counter for the following indication.
Indications For OTC (Over The Counter) Use.
MedTrade Products CELOX Hemostatic Granules on Sheet is indicated for temporary external use to control bleeding of lacerations, minor cuts, and abrasions.
Prescription Use (Per 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE, CONTINUE ON ANOTHER PAGE
Dorberu Muehnd. Fai num
rision of General, Rastaraties of CDRH, Office of Device Evaluation (ODE) and Neurological Devices
(k) Number Kosc197
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Kобосот
510(k) SUMMARY MedTrade CELOX Hemostatic Granules on Sheet
JUL - 9 2008
Classification Name 878 - General and Plastic Surgery
Contact: Jonathan D Ranfield - Director. Quality Assurance & Regulatory Affairs
Prepared: December 20, 2007
General Description The MedTrade Products CELOX Hemostatic Granules on Sheet is nearly identical to the legally marketed MedTrade Products CELOX Hemostatic Granules (K061079, cleared April 20, 2006) in product design composition and processing in that the same CELOX Hemostatic Granules are mechanically heat bonded on to a viscose sheet. The Sheet provides a controlled and accurate delivery System to ensure that the CELOX Hemostatic Granules are applied directly onto the wound site as quickly and efficiently as possible. On contact with blood CELOX Hemostatic Granules that are heat bonded on to the surface of the viscose sheet cause hemostasis. The only major difference is the format in this respect; the indications for use are similar to the HemCon ChitoFlex Surgical (K071519) and Scion Cardio-Vascular Clo-Sur Plus PAD (K032986)
Indications for Use For Prescription Use: MedTrade Products CELOX Hemostatic Granules on Sheet is indicated for temporary external use to control moderate to severe bleeding
For OTC (Over The Counter) Use:
MedTrade Products CELOX Hemostatic Granules on Sheet is indicated for temporary external use to control bleeding of lacerations, minor cuts and abrasions.
Electra House, Crewe Business Park, Crewe, Cheshire CW1 6GL, UK Tel: +44 (0) 1270 500019 Fax: +44 (0) 1270 500045
Image /page/5/Picture/12 description: The image shows a circular logo with text surrounding it. The text reads "CERT NO FM 59067 ISO 13485:2016". The logo is black and white and appears to be a certification mark. The logo is small and the text is somewhat difficult to read.
Fegratured No. 3839609 Hogstered Office Liocra House. Crews Business Park. Crewe, Chesive CW1 6GL, UK