(204 days)
The AutoMARQER™ is a differential spectrophotometer/reflectometer for sperm analysis and quantification, using MARQ™ Plus Test Kits.
The AutoMARQER™ functions as a differential spectrophotometer / reflectometer, using MARQ™ Plus Test Kits* for sperm analysis. The AutoMARQER conducts sequential measurement operations on a specimen introduced into the instrument on a special MARQ™ Plus Test Kit cassette designed for use with the AutoMARQER. When using the FertilMARQ Plus Test Kit,* the AutoMARQER measures sperm concentration, motility and velocity. The AutoMARQER performs as a spectrophotometer when measuring specimen concentration. When measuring motility and velocity, it measures light scatter that occurs as sperm intercept its laser beam. It measures number of sperm in a beam directly by counting sperm cells crossing the beam and determines their velocity by the length of bearn passage. Since the beam diameter is known, the crossing time gives the sperm velocity
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Hamilton Thorne Research AutoMARQER™ device:
1. A table of acceptance criteria and the reported device performance:
The provided document does not explicitly state numerical acceptance criteria. Instead, it makes a general claim regarding equivalence, which serves as the implicit performance standard.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Equivalent results to predicate device (IVOS™ Sperm analysis system) | "Equivalent results are obtained on semen samples analyzed by both the AutoMARQER™ and the IVOS™ Sperm analysis system." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). It only states that "Equivalent results are obtained on semen samples...".
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not provided in the document. The ground truth appears to be based on the results from the predicate device, the IVOS™ Sperm analysis system, rather than expert consensus on individual cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document. Given that the comparison is to a predicate device, it's unlikely an adjudication method for human readers was used in this context.
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:
A multi-reader multi-case (MRMC) comparative effectiveness study with human readers assisting an AI (or vice-versa) was not done. This device is a standalone analytical instrument, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, a standalone performance evaluation was conducted. The AutoMARQER™ is described as functioning independently to measure sperm concentration, motility, and velocity. The performance test involved directly comparing its results to those of a legally marketed predicate device, the IVOS™ Sperm analysis system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the performance study was established by the legally marketed predicate device, the IVOS™ Sperm analysis system. The study's objective was to demonstrate "equivalent results" to this established device.
8. The sample size for the training set:
The document does not provide any information about a training set since the device is not described as utilizing a machine learning algorithm that requires explicit training data in the context of this 510(k) submission. It functions as a spectrophotometer/reflectometer.
9. How the ground truth for the training set was established:
This question is not applicable as the document does not indicate the use of a machine learning model requiring a training set or ground truth for such a set.
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Hamilton Thorne Research 100 Cummings Center, 102 C 181 Elliott Street Beverly, Massachusetts 01915
MAR 1 3 2002
KO12805
510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
| 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,Vice President, Research and Development | |
| Date Summary Prepared: | August 17, 2001 | |
| 2. | Trade or proprietary name: | AutoMARQER™ |
- Differential spectrophotometer/reflectometer Common or usual name: Classification name: Hematology Class: प्रा
- Legally marketed predicate device: IVOS Sperm analysis system 3. [Hamilton Thorne Research (K920719, SE 6/29/92)]
4. Subject device description:
The AutoMARQER™ functions as a differential spectrophotometer / reflectometer, using MARQ™ Plus Test Kits* for sperm analysis.
The AutoMARQER conducts sequential measurement operations on a specimen introduced into the instrument on a special MARQ™ Plus Test Kit cassette designed for use with the AutoMARQER.
When using the FertilMARQ Plus Test Kit,* the AutoMARQER measures sperm concentration, motility and velocity. The AutoMARQER performs as a spectrophotometer when measuring specimen concentration. When measuring motility and velocity, it measures light scatter that occurs as sperm intercept its laser beam. It measures number of sperm in a beam directly by counting sperm cells crossing the beam and determines their velocity by the length of bearn passage. Since the beam diameter is known, the crossing time gives the sperm velocity
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- Embryotech Laboratories. Wilmington. MA. commercializes the MARQ™ Plus Test.
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Hamilton Thorne Research 100 Cummings Center, 102 C 181 Elliott Street Beverly, Massachusetts 01915
5. Subject device intended use:
The AutoMARQER™ is a differential spectrophotometer/reflectometer for sperm analysis and quantification, using MARQ™ Plus Test Kits.
Performance data: 6.
Equivalent results are obtained on semen samples analyzed by both the AutoMARQER™ and the IVOS™ Sperm analysis system.
Image /page/1/Picture/5 description: The image shows a black and white abstract pattern. The pattern consists of several small, irregular black shapes scattered across a white background. The shapes vary in size and density, with some appearing as small dots and others as larger, more amorphous blobs. The overall effect is a somewhat random distribution of dark elements against a light backdrop.
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Food and Drug Administration
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
Re: K012805
Trade/Device Name: AutoMARQERTM Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Date: January 12, 2002 Received: January 25, 2002
Dear Dr. Diarmaid Douglas-Hamilton:
This letter corrects our substantially equivalent letter of March 13, 2002.
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
Image /page/2/Picture/11 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 human profiles facing to the right, overlapping to create a sense of depth and connection.
JUN 1 5 2012
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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 (OS) 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,
Sincerely yours,
manai In Chan
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Hamilton Thorne Research Premarket 510 (k) Notification AutoMARQER™
C. Indications for use of the Device
Page 1 of 1
[To be assigned] 510(k) Number):
AutoMARQER™ Device Name:
Indications for Use:
The AutoMARQER™ is a differential spectrophotometer/reflectometer for sperm analysis and quantification, using MARQ™ Plus Test Kits.
(Please do not write below this line-continue on another page if needed)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Dauphine Buitoni
(Division Sigh-0
Division of Clinical Laboratory Devices
510(k) Number K012805
. .
Prescription Use
(Per 21 CFR 801.109) (Optional Format 1-2-96)
§ 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.”