(409 days)
The VisuCon-F Low Fibrinogen Control Plasma is an assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range. The VisuCon-F Low Fibrinogen Control Plasma may be used with mechanical instruments in conjunction with appropriate commercial reagents for determining fibrinogen levels in plasma by the clotting method of Clauss. This plasma is intended "For In Vitro Diagnostic Use".
The VisuCon-F Low Fibrinogen Control plasma is a pool of de-fibrinated citrated human plasma buffered with 0.02 M HEPES buffer, dispensed and rapidly frozen.
The provided text describes a 510(k) premarket notification for a medical device called "VisuCon-F Low Fibrinogen Control Plasma." This document is a regulatory submission to the FDA (Food and Drug Administration) for a Class II medical device.
The core of this submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a new device's absolute safety and effectiveness through extensive clinical trials. Therefore, the information provided focuses on the comparison to a predicate device and performance characteristics that support this equivalence, rather than a classical study design with acceptance criteria for a novel AI/imaging device.
Because the request asks for specific details relating to AI/imaging device acceptance criteria and study methodology (e.g., sample size for test set, expert ground truth, MRMC study, standalone performance), it's important to note that the provided document does not contain this type of information. This document is for an in-vitro diagnostic control plasma, not an imaging or AI diagnostic device.
However, I will extract the information that is present in the document and clearly state when the requested information is not available or not applicable based on the document's content.
Here's a breakdown based on the provided text:
Device Description and Intended Use:
- Trade/Device Name: VisuCon-F Low Fibrinogen Control Plasma
- Regulation Number: 21 CFR 864.5425
- Regulation Name: Multipurpose system for in vitro coagulation studies
- Regulatory Class: Class II
- Product Code: GGN
- Predicate Device: Cryocheck Low Fibrinogen Control Plasma (Precision Biologic Inc.)
- Device Description: A pool of de-fibrinated citrated human plasma buffered with 0.02 M HEPES buffer, dispensed and rapidly frozen.
- Device Intended Use: An assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range. It may be used with mechanical instruments in conjunction with appropriate commercial reagents for determining fibrinogen levels in plasma by the clotting method of Clauss. Intended for "In Vitro Diagnostic Use" by trained laboratory personnel in clinical laboratories.
Acceptance Criteria and Device Performance (based on comparison to Predicate):
The document details a "technical comparison" to the predicate device to demonstrate substantial equivalence, rather than defining explicit acceptance criteria in the sense of a target performance threshold for a new AI/imaging algorithm. The study proves the device meets the criteria by exhibiting similar characteristics and performance ("precision") to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (VisuCon-F Low Fibrinogen Control Plasma) |
|---|---|---|
| Intended Use | Recommended for use as an abnormal control in quantitative fibrinogen assays | An assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range |
| Analytes | Fibrinogen | Fibrinogen |
| Matrix | Citrated human plasma | Citrated human plasma |
| Format | Frozen | Frozen |
| Open-Vial Stability | 72 hours at 2-8°C | 72 hours at 2-8°C or 8 hours onboard instrument (19-22°C) |
| Precision (% Coefficient of Variation (CV)) | 2.8 - 3.7% (n=36 for predicate) | Within Run = 3.15% Between Day = 0.54% Between Run = 0% Within Device = 8.44% |
| Conclusion | Substantially equivalent (based on similar intended use, matrix, stability, and performance characteristics (precision)) | The VisuCon-F Low Fibrinogen Control plasma is substantially equivalent to its predicate device. |
Note: The "acceptance criteria" here are implied by the characteristics and performance of the chosen predicate device, as the goal is to show equivalence, not superiority or meeting an arbitrary threshold. The "study" described is the "technical comparison" presented in the table.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document reports precision data for the proposed device (VisuCon-F Low Fibrinogen Control Plasma) as: Within Run = 3.15%, Between Day = 0.54%, Between Run = 0%, Within Device = 8.44%. It also states the predicate's precision as 2.8 - 3.7% (n=36). However, the specific sample size (N) for the VisuCon-F device's precision calculations (e.g., number of runs, number of days, number of plasma samples) is not explicitly stated in this summary.
- Data Provenance: Not specified in terms of country of origin or whether it's retrospective/prospective. This is an in vitro diagnostic control, so "data provenance" in the sense of patient data is not applicable. The plasma is "human plasma" but no further detail on its origin is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is an in vitro diagnostic control plasma used for quality control of lab assays, not an imaging/AI device requiring expert interpretation or ground truth establishment by medical specialists like radiologists. The "ground truth" for this product would be the established fibrinogen concentration values from the manufacturer's own assay methods and validation, which is common for control plasmas.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As per point 3, this is an in vitro diagnostic control; expert adjudication methods for imaging or clinical cases are not relevant here.
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:
- Not Applicable. This is an in vitro diagnostic control and does not involve human readers or AI assistance in the context of diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is an in vitro diagnostic control, not an algorithm or an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For a control plasma, the "ground truth" (or accepted value) is typically the assigned value from the manufacturer's reference method, established through meticulous testing and calibration. This is not derived from expert consensus, pathology, or outcomes data in the clinical sense, but rather from the analytical performance of laboratory instruments and reagents.
8. The sample size for the training set:
- Not Applicable. This is a physical biological control product, not a software algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. As per point 8, there is no training set for this type of medical device.
In summary, the provided document is a 510(k) submission for an in vitro diagnostic control plasma. The "study" described is a comparison to a predicate device to demonstrate substantial equivalence, focusing on analytical performance characteristics like precision and stability. It does not contain the types of information (e.g., expert-based ground truth, MRMC studies, training/test sets for algorithms) that would be relevant for an AI or imaging-based medical device.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized image of three human profiles facing to the right, stacked one behind the other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 6, 2016
Affinity Biologicals Inc. Denise Foulon Scientific Director 1348 Sandhill Drive Ancaster, ON Canada, L9G 4V5
Re: K150144
Trade/Device Name: VisuCon-F Low Fibrinogen Control Plasma Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: Class II Product Code: GGN Dated: February 1, 2016 Received: February 2, 2016
Dear Ms. Foulon:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
{1}------------------------------------------------
CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical 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 control 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 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Leonthena R. Carrington -S
Leonthena R. Carrington, MS, MBA, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K150144
Device Name
VisuCon-F Low Fibrinogen Control Plasma
Indications for Use (Describe)
The VisuCon-F Low Fibrinogen Control Plasma is an assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range. The VisuOon-F Low Fibrinogen Control Plasma may be used with mechanical instruments in conjunction with appropriate commercial reagents for determining fibrinogen levels in plasma by the clotting method of Clauss. This plasma is intended "For In Vitro Diagnostic Use".
The intended users of the VisuCon-F Low Fibringen Control Plasma are trained laboratory personnel working in clinical laboratories.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
{3}------------------------------------------------
510(k) Summary for VisuCon-F Low Fibrinogen Control Plasma (Summary of Safety and Effectiveness)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Submitted By: | Affinity Biologicals Inc.1348 Sandhill DriveAncaster, ONCanada, L9G 4V5Phone: 905-304-9896Fax: 905-304-9897 |
|---|---|
| Contact Person: | Denise Foulon, Scientific DirectorPhone: 905-304-9896Fax: 905-304-9897 |
| Summary Prepared: | January 29, 2016 |
| Name of the Device: | VisuCon-F Low Fibrinogen Control PlasmaCommon Name: Abnormal Control Plasma |
| Classification of Device: | Class II21 CFR 864.5425Subpart H, Hematology Kits and PackagesProduct Code: GGN |
| Predicate Device: | Cryocheck Low Fibrinogen Control PlasmaPrecison Biologic Inc. |
| Device Description: | The VisuCon-F Low Fibrinogen Control plasma is a pool of de-fibrinated citrated human plasma buffered with 0.02 M HEPESbuffer, dispensed and rapidly frozen. |
| Device Intended Use: | The VisuCon-F Low Fibrinogen Control Plasma is an assayedcontrol plasma prepared from de-fibrinated human plasmaintended for use in the quality control of quantitative fibrinogenassays in the low abnormal range. The VisuCon-F LowFibrinogen Control Plasma may be used with mechanicalinstruments in conjunction with appropriate commercial reagentsfor determining fibrinogen levels in plasma by the clotting methodof Clauss. This plasma is intended "For In Vitro Diagnostic Use".The intended users of the VisuCon-F Low Fibrinogen ControlPlasma are trained laboratory personnel working in clinical |
{4}------------------------------------------------
Comparison to Predicate Device:
A technical comparison of the proposed device and the predicate device is illustrated in the following table:
| VisuCon-F Low FibrinogenControl Plasma(Proposed Device) | Cryocheck Low FibrinogenControl Plasma(Predicate Device) | |
|---|---|---|
| Intended Use | An assayed control plasmaprepared from de-fibrinatedhuman plasma intended for usein the quality control ofquantitative fibrinogen assays inthe low abnormal range | Recommended for use as anabnormal control in quantitativefibrinogen assays |
| Analytes | Fibrinogen | Fibrinogen |
| Matrix | Citrated human plasma | Citrated human plasma |
| Format | Frozen | Frozen |
| Open-VialStability | 72 hours at 2-8°C or 8 hours on-board instrument (19-22°C) | 72 hours at 2-8°C |
| Precision(% Coefficient ofVariation (CV)) | Within Run = 3.15%Between Day = 0.54%Between Run = 0%Within Device = 8.44% | 2.8 - 3.7% (n = 36) |
Conclusion: The VisuCon-F Low Fibrinogen Control plasma is substantially equivalent to its predicate device, Cryocheck Low Fibrinogen Control plasma, based on similar intended use, product matrix, stability and performance characteristics (precision).
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.