CELOX Vascular is indicated for the local management and control of surface bleeding from vascular access sites, perculaneous catheters or tubes utilizing introducer sheaths up to 16French
CELOX Vascular is a kit that consists of a hemostatic pad and an optional adhesive bandage. The adhesive bandage is a 3M Tegaderm 4" x 4-3/4" bandage (reference K973036), or equivalent self adhesive security bandage. The hemostatic pad is a CELOX Hemostatic Granules on Sheet cleared in K080079 on July 9, 2008.
The provided document describes the CELOX Vascular device and its substantial equivalence determination. Here's a breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a quantitative manner (e.g., minimum sensitivity, specificity, or specific hemostasis rates to be achieved in a clinical trial). Instead, it describes demonstrating hemostasis and performance as effectively as a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Achieve hemostasis | Demonstrated hemostasis following the removal of percutaneous vascular access catheters in a pre-clinical porcine model. |
| Control bleeding | Successfully controlled all bleeding following 11 vascular access procedures when up to a 16French tissue dilator was used. |
| Equivalence to predicate device | CELOX Vascular dressing controlled bleeding as effectively as the D-Stat Dry (a predicate device). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 11 vascular access procedures.
- Data Provenance: Pre-clinical porcine model testing. (The country of origin for the testing is not specified, but the company is based in the UK.)
- Retrospective/Prospective: The nature of "pre-clinical porcine model testing" typically implies a prospective design for the animal study itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The document refers to the results of a "pre-clinical porcine model testing" and the observation of "demonstrated hemostasis" and "successfully controlling all bleeding." The methods for assessing hemostasis and whether experts were involved in defining "ground truth" for the success of these procedures are not detailed.
4. Adjudication Method for the Test Set
This information is not provided in the document.
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 conducted. The study described is a pre-clinical animal (porcine) model assessing the device's ability to achieve hemostasis, not a study involving human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This question is not applicable as the CELOX Vascular is a physical medical device (hemostatic pad and adhesive bandage), not an AI algorithm or software. No standalone algorithm performance was assessed.
7. The Type of Ground Truth Used
The ground truth for the device's performance (i.e., hemostasis) was established through direct observation and measurement of bleeding control in a pre-clinical porcine model. This can be considered outcomes data in an animal model context – the direct outcome being the cessation of bleeding.
8. The Sample Size for the Training Set
This question is not applicable. The CELOX Vascular is a physical medical device, not a machine learning model. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for a physical device.
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MedTrade Products Limited c/o Jonathan Ranfield Director, Quality Assurance & Regulatory Affairs Electra House, Crewe Business Park Crewe, Cheshire, CW1 6GL United Kingdom
July 28, 2023
Re: K093519 Trade/Device Name: CELOX Vascular Regulatory Class: Unclassified Product Code: QSY
Dear Jonathan 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 January 14, 2010. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code OSY.
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Medtrade Products Limited % Mr. Jonathan Ranfield Director, Quality Assurance and Regulatory Affairs Electra House, Crewe Business Park Crewe, Cheshire CW1 6GL United Kingdom
JAN 1 4 2010
Re: K093519
Trade/Device Name: CELOX Vascular Regulatory Class: Unclassified Product Code: FRO Dated: November 05, 2009 Received: November 13, 2009
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 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); medical device reporting (reporting of medical
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Page 2 - Mr. Jonathan Ranfield
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation contrôl provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Malkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K093519 510(k) Number (if known)
Device Name: CELOX Vascular
Indications For Prescription Use:
CELOX Vascular is indicated for the local management and control of surface bleeding from vascular access sites, perculaneous catheters or tubes utilizing introducer sheaths up to 16French"
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Krane
(Division Sign-Of Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093519
2 A
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510(k) SUMMARY
Innovative Medical Products Trade Name: CELOX Vascular Device Class: Unclassified JAN 1 4 2010 General and Plastic Surgery Classification Panel: Classification Name: Dressing Classification Code: FRO CELOX Hemostatic Granules on Sheet (K080097) Predicate Devices: QuilkClot Interventional hemostatic bandage (K090620) D-Stat Dry Hemostatic Bandage (K061219) ChitoFlex-Surgical dressing (K080818) Jonathan Ranfield, Director Quality Assurance & Regulatory Affairs Submitted By: Company Name: MedTrade Products Limited Company Address: Electra House, Crewe Business Park, Crewe, Cheshire, CW1 6GL. UK Telephone: +44 1270 500019 +44 1270 500045 Fax: Registration Number: 9614493 Prepared: November 5, 2009.
Description of Device
CELOX Vascular is a kit that consists of a hemostatic pad and an optional adhesive bandage. The adhesive bandage is a 3M Tegaderm 4" x 4-3/4" bandage (reference K973036), or equivalent self adhesive security bandage. The hemostatic Ro1.5000), or
an Shart deservation (6000070 - 1 July 9 Sec on Sheet cleared in K080079 on July 9, 2008.
Intended Use of Device
Prescription use: CELOX Vascular is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 16French"
Discussion of Data to Support Substantial Equivalence
In pre-clinical porcine model testing, CELOX Vascular has demonstrated hemostasis following the removal of perculaneous vascular access catheters. The dressing successfully controlling all bleeding following 11 vascular access procedures when up to a 16French tissue diator was used. CELOX Vascular dressing controlled bleeding as effectively as the D-Stat Dry.
CELOX Vascular is identical to CELOX Hemostatic Granules on Sheet cleared in K080079 on July 9, 2008, therefore the successful biocompatibility testing for CELOX Hemostatic Granules on Sheet also applies to the CELOX Vascular.
Conclusion
Based on the in-vivo test data and the device description, CELOX Vascular is substantially equivalent in indications for use and technology to the predicate devices CELOX Hemostatio Granules on Sheet (K080097) QuikClot Interventional hemostatic bandage (K090620) D-Stat Dry Hemostatic Bandage (K061219) and ChitoFlex-Surgical dressing (K080818)
Medtrade Products Ltd Electra House, Crewe Business Park, Crewe, Cheshire CW1 6GL T: +44 (0) 1270 500019 F: +44 (0) 1270 500045 Registered No: 3839609 Registered Office: Electra House, Crewe Business Park, Crewe, Cheshire CW1 6GL, UK
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N/A