(58 days)
The Automarqer™ is a differential spectrophotometer for quantification of results using MARQTM Test Kits for sperm analysis.
The Automarqer™ is a differential spectrophotometer for quantification of results for sperm analysis. The MARQ test kits employ a unique test cassette with four wells, each containing a filter to retain the test reagents and sample suspension. The test cassette is designed to be inserted into the Automarqer for reading of results after the sample has been processed. The Automarger provides the numeric analysis of the quantity of sperm or other sperm ejaculate component being evaluated.
The Automarqer operates by measuring the well reflectivity in two wavelengths (red and green) and deriving the optical absorption in DNA-specific dyes within the wells, generated by the staining reagents used in the MARQ test kits. Each well emits a signal in the color with which it is illuminated (either red or blue dye). The first well of the test cassette provides a standard signal (using a standardized latex bead suspension), the second well provides a null signal, and the third and fourth wells provide sample signals.
The Automarqer contains an optical assembly, microprocessor and program, cassette position sensor and readout screen. Software in the microprocessor ROM directs the operations. The microprocessor detects position of the cassette as each well is inserted, stores the value of the signal from each well separately under red and green wavelength illuminations, and computes the corresponding reflectivity of the sample, using the scale defined by the difference between the first two wells (the standard signal and the null signal). In this way, the system is self-calibrating on each cassette.
Here is an analysis of the provided text regarding the Automarqer™ device, focusing on its acceptance criteria and the study proving it.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" with numerical targets in the way typically seen in device submissions (e.g., "accuracy > 95%"). Instead, it describes performance in terms of variability and correlation to a predicate device. The implied acceptance criteria are that the device should have low internal variability and high correlation with the legally marketed predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Low variability due to equipment (Automarqer and cassette) | Automarqer well variability: < 0.15% Cassette well variability: 1.1% |
| High precision and repeatability in application | "very good" precision and repeatability |
| High correlation with legally marketed predicate (IVOS system) | Correlation (r) = 0.997 on 35 clinical samples |
| Reproducibility across different operators | Reproducibility shown with 3 different operators on 11 samples |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Clinical Samples for Correlation: 35 clinical samples.
- Samples for Operator Reproducibility: 11 samples (tested by 3 different operators).
- Data Provenance: The document does not specify the country of origin for the clinical samples. It indicates they are "clinical samples," suggesting they were collected from human subjects. The study appears to be retrospective in nature, as it is comparing results obtained by the new device with an existing, legally marketed device (IVOS).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for the sperm concentration analysis. The ground truth for the comparative study appears to be based on the measurements obtained from the predicate device, the IVOS sperm analysis system. Therefore, no information on the number or qualifications of experts for ground truth is provided.
4. Adjudication Method for the Test Set
No adjudication method is mentioned. Since the ground truth for the comparative study uses the predicate device's measurements, and the sample variability is tied to "sample and its administration in the test," it implies a direct comparison without an external adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study explicitly designed to measure the improvement of human readers with AI assistance is described. The study mentioned involves comparing the Automarqer™ device to the IVOS system, and then examining reproducibility with different operators for the Automarqer™. This is a device-to-device and intra-device reproducibility study, not an AI-assisted human reader study.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone performance study was done. The Automarqer™ itself is the device being evaluated. Its performance is measured through:
- Its own internal well variability (< 0.15%).
- Cassette well variability (1.1%).
- The correlation of its output to the IVOS sperm analysis system (r = 0.997).
- The reproducibility of its results when operated by different individuals (using 11 samples and 3 operators).
The device provides a "numeric analysis of the quantity of sperm," and the performance data presented are direct measurements from the device.
7. Type of Ground Truth Used
The ground truth for the main comparative study (correlation study) is the measurements obtained from the legally marketed predicate device, the IVOS sperm analysis system. For the variability and reproducibility studies, the "ground truth" is essentially the expected consistency of the device's own measurements.
8. Sample Size for the Training Set
The document does not provide information regarding a "training set" or its sample size. This suggests that the device's internal algorithms might be based on pre-established optical principles and calibration methods rather than machine learning requiring a distinct training phase.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned, information on how its ground truth was established is not applicable.
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3/19/99
(A
Image /page/0/Picture/2 description: The image shows a sequence of handwritten alphanumeric characters. The sequence appears to be 'K990184'. The characters are written in a dark ink, and the image has a clear background.
510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
| A)(1) Submitter's name: | Hamilton Thorne Research |
|---|---|
| Submitter's address: | 100 Cummings Center, Suite 102-CBeverly, MA 01915 |
| Submitter's telephone no.: | 978-921-2050 |
| Contact Person: | Diarmaid Douglas-Hamilton |
| Date Summary Prepared: | January 8, 1999 |
| (2) Trade or proprietary device name: | Automarqer™ |
| Common or usual name: | Differential spectrophotometer |
| Classification name: | Hematology |
| (3) Legally marketed predicate device: | IVOS sperm analysis system [HamiltonThorne Research (K920719, SE 6/29/92)] |
(4) Subject device description:
The Automarqer™ is a differential spectrophotometer for quantification of results The ? Hatomarqo. - 115 Kits * for sperm analysis. The MARQ test kits employ a unique test cassette with four wells, each containing a filter to retain the test reagents and sample suspension. The test cassette is designed to be inserted into the Automarqer for reading of results after the sample has been processed. The Automarger provides the numeric analysis of the quantity of sperm or other sperm ejaculate component being evaluated.
The Automarqer operates by measuring the well reflectivity in two wavelengths (red and green) and deriving the optical absorption in DNA-specific dyes within the wells, generated by the staining reagents used in the MARQ test kits. Each well emits a signal in the color with which it is illuminated (either red or blue dye). The first well of the test cassette provides a standard signal (using a standardized latex bead suspension), the second well provides a null signal, and the third and fourth wells provide sample signals.
The Automarqer contains an optical assembly, microprocessor and program, cassette position sensor and readout screen. Software in the microprocessor ROM directs the operations. The microprocessor detects position of the cassette as each well is inserted, stores the value of the signal from each well separately under red and green wavelength illuminations, and computes the corresponding reflectivity of the sample, using the scale defined by the difference between the first two wells (the standard signal and the null signal). In this way, the system is self-calibrating on each cassette.
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- MARQ™ Test Kits are being developed for commercialization by Embryotech Laboratories, Wilmington, MA.
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(5) Subject device intended use:
The Automarqer™ is a differential spectrophotometer for quantification of results using Ferto;MARQTM Test Kit for sperm concentration analysis.
(6) Performance data:
Equivalent results are obtained on semen samples analyzed by both the Automarqer™ and the IVOS sperm analysis system. Only slight variability has been observed due to the instrument and test cassette design themselves, or to the bead suspension used in the test well for self-calibration. The precision and repeatability of the Automarqer in application is very good, with most of the repeatuonity of the riatorias coming from the differences in the sample and its administration in the test.
Coefficients of Variation due to equipment (Automarqer, cassette) and sample
| Automarger well variability | < 0.15% |
|---|---|
| Cassette well variability | 1.1% |
| Sample well variability | 2.4% |
| simulated sample variability | 20% |
| actual sample variability | 16% |
35 clinical samples obtained for analysis of sperm concentration by both the Automarger and the IVOS show high degree of correlation, r = 0.997, and samples run by three different operators on 11 samples also showed reproducibility.
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Image /page/2/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 a stylized symbol that resembles a human figure in profile, with flowing lines suggesting movement or energy.
10903 New Hampshire Avenue Silver Spring, MD 20993
Hamilton Thorne Research c/o Diarmaid Douglas-Hamilton Vice President, Research and Development 100 Cummings Center, Suite 102-C Beverly, MA. 01915
DEC 2 1 2012
Re: K990184
Trade/Device Name: AutoMARQER™ Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Date: January 8, 1999 Received: January 20, 1999
Dear Dr. Diarmaid Douglas-Hamilton:
This letter corrects our substantially equivalent letter of March 19, 1999.
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
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Page 2 - Diarmaid Douglas-Hamilton
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. mana in there in there
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
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C. Indications for use of the Device
Page 1 of 1
510(k) Number): Not tenown K 990184
Automarqer™ Device Name:
Indications for Use:
The Automarqer™ is a differential spectrophotometer for quantification of results using MARQTM Test Kits for sperm analysis.
(Please do not write below this line-continue on another page if needed)
美 * * * 头 美
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rita E. Madari
(Divisior. Sign Off) Division _: _!imical Laboratory Devices 510jkj Number -
Over-the-Counter Use Prescription Use_X Or (Optional Format 1-2-96) (Per 21 CFR 801.109)
§ 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.”