(70 days)
-
- As a component of the standard analysis of semen in the diagnosis of suspected male infertility,
-
- As a component of analyses for determining the proper course of IVF treatment of infertility.
Not Found
This is an FDA 510(k) clearance letter, which means the device has been found substantially equivalent to a predicate device. It does not typically contain the detailed study results and acceptance criteria in the format requested. The letter primarily confirms regulatory approval based on the information submitted by the manufacturer.
However, based solely on the provided text, here's what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance:
This information is not provided in the FDA clearance letter. Acceptance criteria and specific performance metrics are typically detailed within the 510(k) submission itself, not in the clearance letter.
2. Sample size used for the test set and the data provenance:
This information is not provided in the FDA clearance letter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the FDA clearance letter.
4. Adjudication method for the test set:
This information is not provided in the FDA clearance letter.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not provided in the FDA clearance letter. The device, "HBA Sperm-Hyaluronan Binding Assay," sounds like a diagnostic assay rather than an AI-assisted imaging device, so an MRMC study with human readers assisting AI (or vice-versa) is unlikely to be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not explicitly provided in the FDA clearance letter. The device name "HBA Sperm-Hyaluronan Binding Assay" suggests a lab-based assay, which typically operates in a standalone manner to produce a result, which is then interpreted by a human. However, the details of its performance study, including whether it's standalone, are not in this document.
7. The type of ground truth used:
This information is not provided in the FDA clearance letter. For a "Sperm-Hyaluronan Binding Assay," ground truth would likely be established through other recognized methods of evaluating sperm functionality or infertility, but these methods are not detailed here.
8. The sample size for the training set:
This information is not provided in the FDA clearance letter.
9. How the ground truth for the training set was established:
This information is not provided in the FDA clearance letter.
In summary: The provided document is an FDA 510(k) clearance letter, which confirms that the device, HBA Sperm-Hyaluronan Binding Assay, is substantially equivalent to a legally marketed predicate device. It does not contain the detailed study information, acceptance criteria, sample sizes, or ground truth methodologies that would typically be found in the manufacturer's 510(k) submission or a peer-reviewed study publication. The letter focuses on the regulatory decision rather than the technical specifics of the validation study.
{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 stylized eagle with three lines representing its wings and head. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in all capital letters.
10903 New Hampshire Avenue Silver Spring, MD 20993
DEC 2-1- 2012
Biocoat Inc. c/o James Johnston, Ph.D. Principal Investigator 455 Pensylvania Avenue, Suite 120 Ft. Washington, Pennsylvania 19034
Re: K032874
Trade/Device Name: HBA Sperm-Hyaluronan Binding Assay Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Date: September 9, 2003 Received: September 17, 2003
Dear Dr. Johnston:
This letter corrects our substantially equivalent letter of November 24, 2003.
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
{1}------------------------------------------------
Page 2 - James Johnston, Ph.D.
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 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,
ei m Chan
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
SECTION 10
Indications for use statement
510(k) Number : K 03 28 74
Device Name: HBA Sperm-Hyaluronan Binding Assay
Indications For Use:
-
- As a component of the standard analysis of semen in the diagnosis of suspected male infertility,
-
- As a component of analyses for determining the proper course of IVF treatment of infertility.
Taylor
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K03 2874
§ 864.5220 Automated differential cell counter.
(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”