(31 days)
The MDA is a multipurpose system for in vitro coagulation studies and is capable of running various clot based, chromogenic and immunoassays.
The Multi-Channel Discrete Analyzer (MDA) system is a fully automated, random access analyzer used to perform clinical analyses related to hemostasis and thrombosis. The instrument determines results or reaction rates by detecting changes in the light transmitted through a reaction mixture. Flexibility in optics, fluidics, and software allow the MDA to perform many different assays including traditional clotting assays, chromogenic assays, and immunoassays. The MDA B.30 software version Q08.00 is an update to the MDA B.23 software version Q05.00 and was developed with the same intended use. The modifications to the MDA B.30 software consists of the following: 1. add new methods in order to accommodate new OEM supplied chromogenic reagents; 2. new endpoint algorithms to reduce the erroneous error rate without increasing the erroneous result rate; 3. new wash macro for Simplastin HTF to minimize precipitate build up in Probe D; 4. add a new B4 latex method to allow customers to validate a Free Protein S assay; 5. add Italian and Spanish languages; and 6. new and enhanced waveform analysis features
Here's an analysis of the provided 510(k) summary regarding the MDA® B.30 device, structured to address your specific questions.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly Derived) | Reported Device Performance |
|---|---|---|
| Precision | Assays run on the MDA B.30 should meet established precision criteria. | Precision data for the 12 representative assays were all well within the criteria stated. |
| Agreement with Predicate | The MDA B.30 software should produce results in agreement with the predicate MDA B.23 software. | There was 100% agreement between the predicate software B.23 and new software version B.30 for all methods. |
| Interference Robustness | Ability to accurately determine clotting times in the presence of interfering substances. | MDA B.30 demonstrated its ability to determine correct clotting times for samples that had increased levels of interfering substances. |
| Erroneous Result Rate | Reduction or improvement in the rate of erroneous results compared to the predicate. | The erroneous result rate was much improved in B.30 when compared to B.23. |
| Erroneous Error Rate | Reduction or improvement in the rate of erroneous errors (possibly referring to device errors/malfunctions) compared to the predicate. | The erroneous error rate was much improved in B.30 when compared to B.23. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size used for the test set in terms of number of patient samples. It mentions "12 representative assays" for precision testing and "samples that had increased levels of interfering substances" for robustness testing.
- Sample Size: Not explicitly stated for each test, but "12 representative assays" are mentioned for precision.
- Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given 510(k) summary. The summary focuses on internal performance metrics and comparison to a predicate device, not on expert-adjudicated ground truth for a clinical test set.
4. Adjudication Method for the Test Set
This information is not applicable and not provided because the study described is a performance comparison of software versions on an in vitro diagnostic device, not a study involving human reader interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for imaging or diagnostic systems where human readers interpret output with and without AI assistance to assess human performance improvement. The MDA B.30 is an automated coagulation instrument, and the assessment focuses on its automated performance.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone study was done. The entire submission and the described tests refer to the performance of the MDA B.30 instrument's software and its associated algorithms directly comparing its output to that of the predicate device (MDA B.23) and general performance criteria (precision, robustness). There is no human-in-the-loop component discussed for the performance evaluation.
7. The Type of Ground Truth Used
The ground truth implicitly used for this device performance study appears to be:
- Predicate Device Performance: The MDA B.23 software served as the primary reference for comparison, with "100% agreement" being a key metric.
- Established Analytical Performance Criteria: For precision, there were "criteria stated" against which the 12 representative assays were measured.
- Known Reference Values: For samples with interfering substances, there was an implied "correct clotting time" that the device was expected to determine.
Essentially, the "ground truth" was based on the expected analytical performance of a clinical laboratory instrument and its consistency with a previously cleared version.
8. The Sample Size for the Training Set
The document does not provide information regarding a "training set" for the MDA B.30 software. This is because the MDA B.30 is an update to existing software (B.23), focusing on adding new methods, refining algorithms for existing methods, and improving error handling. It's not described as a machine learning system that undergoes explicit "training" with a distinct dataset in the common sense of AI development. The software development likely involved internal testing and refinement based on existing data and domain knowledge, rather than a separate "training set" as might be documented for a novel AI algorithm.
9. How the Ground Truth for the Training Set Was Established
Since no "training set" is explicitly mentioned or suggested in the context of typical AI algorithm training, this question is not applicable based on the provided document. The changes described are primarily software updates and algorithm refinements rather than training a new model from scratch.
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Premarket Notification 510(k) bioMérieux, Inc. MDA® B.30
510(k) SUMMARY
(a)(1) The submitter's name, address, telephone number, a contact person, and the date the summary was prepared:
bioMérieux, Inc. Submitter's Name: 100 Rodolphe Street Submitter's Address: Durham, North Carolina 27712 (919) 620-2968 Submitter's Telephone: Jocelyn Jennings, RAC Submitter's Contact: Associate Staff RA Specialist February 22, 2005 Date 510(k) Summary prepared:
- (a)(2) The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:
Trade or Proprietary Name:
MDA® 180:MDA II (B.30 software)
Common or Usual Name:
Coagulation instrument
Classification Name:
21CFR864.5425 Multipurpose system for in vitro coagulation studies
(a)(3) An identification of the legally marketed device to which the submitter claims substantial equivalence:
Device Equivalent to:
MDA® 180:MDA® B.23
- (a)(4) A description of the device
Device Description:
CONFIDENTIAL
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The Multi-Channel Discrete Analyzer (MDA) system is a fully automated, random access analyzer used to perform clinical analyses related to hemostasis and thrombosis. The instrument determines results or reaction rates by detecting changes in the light transmitted through a reaction mixture. Flexibility in optics, fluidics, and software allow the MDA to perform many different assays including traditional clotting assays, chromogenic assays, and immunoassays.
The MDA B.30 software version Q08.00 is an update to the MDA B.23 software version Q05.00 and was developed with the same intended use.
The modifications to the MDA B.30 software consists of the following:
-
- add new methods in order to accommodate new OEM supplied chromogenic reagents:
- new endpoint algorithms to reduce the erroneous error rate 2. without increasing the erroneous result rate;
-
- new wash macro for Simplastin HTF to minimize precipitate build up in Probe D;
-
- add a new B4 latex method to allow customers to validate a Free Protein S assay;
-
- add Italian and Spanish languages; and
-
- new and enhanced waveform analysis features
(a)(5) A statement of the intended use of the device.
Device Intended Use:
The MDA is a multipurpose system for in vitro coagulation studies and is capable of running various clot based, chromogenic and immunoassays.
(a)(6) A summary of the technological characteristics of the new device in comparison to those of the predicate device.
The data contained in this submission support the claim that the MDA B.30 software is substantially equivalent to the MDA B.23 software in terms of intended use, functional requirements and performance. The MDA instrument platform that contains B.23 software is the exact same instrument platform that contains B.30 software. The operating system, optics, sample type, reagent assays and target population are identical for both versions of software.
(b)(1) A brief discussion of the nonclinical tests submitted, referenced, or relied on in the Premarket notification submission for a determination of substantial equivalency.
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There were no nonclinical tests, referenced or relied on for this submission.
(b)(2) The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performed as well or better than the legally marketed device identified in (a)(3).
Precision data for the 12 representative assays were all well within the criteria stated. There was 100% agreement between the predicate software B.23 and new software version B.30 for all methods. MDA b.30 demonstrated its ability to determine correct clotting times for samples that had increased levels of interfering substances.
The erroneous result rate was much improved in B.30 when compared to B.23. The erroneous error rate was much improved in B.30 when compared to B.23.
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Image /page/3/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a stylized eagle with three heads, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Re:
Food and Druq Administration 2098 Gaither Road Rockville MD 20850
Ms. Jocelyn Jennings, RAC Associate Staff Regulatory Affairs Specialist bioMerieux, Inc. 100 Rodolphe Street Durham, North Carolina 27712
K050513 Trade/Device Name: MDA® 180:MDA II (B.30 software) Regulation Number: 21 CFR § 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: II Product Code: JPA Dated: February 25, 2005 Received: March 1, 2005
APR - 1 2005
Dear Ms. Jennings:
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 either class II (Special Controls) or class III (PMA), 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); and good manufacturing practice OFF Part 8017), systems (QS) regulation (QS) regulation (21 CFR Part 820). This letter requirements use in marketing your device as described in your Scction 510(k) premarket whitification. 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.
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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I va may obtain other getain onal and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
lobatz Beckerh
Robert L. Becker, Jr., MD, PH. Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS OF USE FORM
1050513 510(k) Number (if known):
Device Name: MDA®:MDA® II (B.30 software)
Indications For Use:
The MDA is a multipurpose system for in vitro coagulation studies and is capable of running various clot based, chromogenic and immunoassays.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Eyatuation (ODE)
(Per 21 CFR 801.109)
(ODE)
Division Sign-Off
Office of In Vitro Diag Evaluation and Sat
510(k) K050513
CONFIDENTIAL
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§ 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.