(375 days)
Not Found
No
The device description mentions a "proprietary algorithm" that uses biomarker values to calculate a risk score, but there is no mention of AI, ML, or any learning process. The algorithm appears to be a fixed calculation based on the input values and a predefined cutoff.
No
The device is a qualitative serum test that provides a numeric result to assess the likelihood of malignancy. It is a diagnostic aid, not a device used for therapy or treatment.
Yes
The device is described as an "aid to further assess the likelihood that malignancy is present" and is used in conjunction with a physician's evaluation to indicate a low or high risk of ovarian malignancy, which are characteristics of a diagnostic device.
No
The device description explicitly states that the OVA1 Next Generation test consists of "software, instruments, assays and reagents." While software is a component, it is not the sole component of the medical device. The device relies on physical instruments (Roche cobas® 6000 system), assays, and reagents to generate the input data for the software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "qualitative serum test" and an "aid to further assess the likelihood that malignancy is present". This indicates it's used to analyze a biological sample (serum) outside of the body to provide information about a patient's health status.
- Device Description: The description details the components, including "assays and reagents" and the use of a "fully automated, software-controlled system for clinical chemistry and immunoassay analysis" (Roche cobas® 6000 system) to determine "serum biomarker concentrations". This is characteristic of an in vitro diagnostic device.
- Biomarker Analysis: The test measures specific biomarkers (APO, CA 125 II, FSH, HE4, and TRF) in serum. Analyzing biomarkers in biological fluids is a core function of IVDs.
- Clinical Performance Studies: The document describes extensive clinical and analytical performance studies, including sensitivity, specificity, PPV, and NPV, which are standard metrics for evaluating the performance of IVD devices.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K081754; OVA1) strongly suggests that this device is being compared to a previously cleared IVD device, which is a common regulatory pathway for new IVDs.
All these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The OVA1 Next Generation test is a qualitative serum test that combines the results of five immunoassays into a single numeric result. It is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist.
The OVA1 Next Generation test is an aid to further assess the likelihood that malignancy is present when the physician's independent clinical and radiological evaluation does not indicate malignancy. The test is not intended as a screening or stand-alone diagnostic assay.
PRECAUTION: The OVA1 Next Generation test should not be used without an independent clinical and imaging evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of the OVA1 Next Generation test carries the risk of unnecessary testing, surgery, and/or delayed diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
ONX
Device Description
The OVA1 Next Generation (NG) test consists of software, instruments, assays and reagents. The software incorporates the results of serum biomarker concentrations from five immunoassays to calculate a single, unitless numeric result indicating a low or high risk of ovarian malignancy.
The assays used to generate the numeric result (OVA1 NG test result) are APO, CA 125 II, FSH, HE4 and TRF.
Biomarker values are determined using assays on the Roche cobas® 6000 system, which is a fully automated, software-controlled system for clinical chemistry and immunoassay analysis. The biomarker assays are run according to the manufacturer's instructions as detailed in the package insert for each reagent.
The OVA1 NG software (OvaCalc v4.0.0) contains a proprietary algorithm that utilizes the results (values) from the five biomarker assays, (APO, CA 125 II, FSH, HE4 and TRF). The assay values from the cobas 6000 system are either imported into OvaCalc through a .csv file or manually entered into the OvaCalc user interface to generate an OVA1 NG test result between 0.0 and 10.0. A low- or high-risk result is then determined by comparing the software-generated risk score to a single cutoff (low-risk result
§ 866.6050 Ovarian adnexal mass assessment score test system.
(a)
Identification. An ovarian/adnexal mass assessment test system is a device that measures one or more proteins in serum or plasma. It yields a single result for the likelihood that an adnexal pelvic mass in a woman, for whom surgery is planned, is malignant. The test is for adjunctive use, in the context of a negative primary clinical and radiological evaluation, to augment the identification of patients whose gynecologic surgery requires oncology expertise and resources.(b)
Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System.” For the availability of this guidance document,see § 866.1(e).(c)
Black box warning. Under section 520(e) of the Federal Food, Drug, and Cosmetic Act these devices are subject to the following restriction: A warning statement must be placed in a black box and must appear in all advertising, labeling, and promotional material for these devices. That warning statement must read:
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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" around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked on top of each other, with flowing lines representing hair or fabric.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 26, 2016
VERMILLION, INC. BENJAMIN A. KIMBALL SENIOR DIRECTOR OF REGULATORY AND QUALITY AFFAIRS, COMPLIANCE OFFICER 12117 BEE CAVES ROAD BUILDING 3 SUITE 100 AUSTIN, TEXAS 78738
Re: K150588
Trade/Device Name: OVA1 Next Generation Regulation Number: 21 CFR §866.6050 Regulation Name: Ovarian adnexal mass assessment score test system Regulatory Class: Class II Product Code: ONX Dated: February 22, 2016 Received: March 1, 2016
Dear Mr. Kimball:
This letter corrects our substantially equivalent letter of March 18, 2016.
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.
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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 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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 yours,
Kelly Olir er -S
FOR Leonthena Carrington, MS, MBA, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health (OIR) Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150588
Device Name OVA1 Next Generation
Indications for Use (Describe)
The OVA1 Next Generation test is a qualitative serum test that combines the results of five immunoassays into a single numeric result. It is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist.
The OVA1 Next Generation test is an aid to further assess the likelihood that malignancy is present when the physician's independent clinical and radiological evaluation does not indicate malignancy. The test is not intended as a screening or stand-alone diagnostic assay.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary OVA1 Next Generation
510(k) Number: K150588
| Manufacturer Identification | |
|---|---|
| Submitted by: | Vermillion, Inc. |
| 12117 Bee Caves Rd | |
| Building 3, Suite 100 | |
| Austin, Texas 78738 | |
| 512.519.0435 | |
| Contact Information: | |
| Benjamin A. Kimball | |
| Senior Director of Regulatory and Quality Affairs | |
| Vermillion, Inc. | |
| 12117 Bee Caves Rd | |
| Building 3, Suite 100 | |
| Austin, Texas 78738 | |
| 512.519.0435 | |
| bkimball@vermillion.com |
| Date Prepared: | 03.06.2015 |
|---|---|
| Proprietary Name | OVA1 Next Generation |
| Common Name | Ovarian adnexal mass assessment score test |
| system | |
| Device Classification | 21 CFR 866.6050 |
| Proposed Regulatory Class | Class II |
| Device Product Code | ONX |
Purpose of this Special 510(k)
This Traditional 510(k) seeks clearance for a new test.
Device Description
The OVA1 Next Generation (NG) test consists of software, instruments, assays and reagents. The software incorporates the results of serum biomarker concentrations from five immunoassays to calculate a single, unitless numeric result indicating a low or high risk of ovarian malignancy.
The assays used to generate the numeric result (OVA1 NG test result) are APO, CA 125 II, FSH, HE4 and TRF.
4
Biomarker values are determined using assays on the Roche cobas® 6000 system, which is a fully automated, software-controlled system for clinical chemistry and immunoassay analysis. The biomarker assays are run according to the manufacturer's instructions as detailed in the package insert for each reagent.
The OVA1 NG software (OvaCalc v4.0.0) contains a proprietary algorithm that utilizes the results (values) from the five biomarker assays, (APO, CA 125 II, FSH, HE4 and TRF). The assay values from the cobas 6000 system are either imported into OvaCalc through a .csv file or manually entered into the OvaCalc user interface to generate an OVA1 NG test result between 0.0 and 10.0. A low- or high-risk result is then determined by comparing the software-generated risk score to a single cutoff (low-risk result OVA1 510(k) K081754
All data indicates that the device will perform as intended.