(78 days)
The ENZ 6 CAL is an in vitro diagnostic product for the calibration of the Creatine Kinase (CKI) and Creatine Kinase MB (MBI) methods on the Dimension Mista® System.
The Dimension Vista® System Enzyme 6 Calibrator (Enz 6 CAL) is a liquid, multianalyte, human serum albumin based product containing creatine kinase MM (human source) and creatine kinase MB (porcine source). The kit consists of three vials of Calibrator A, 2.0 ml per vial. Level 1 calibrator for Enz 6 CAL is not included. Purified Water Diluent or reagent grade water is required for use as Calibrator Level 1. Description of the manufacturing, value assignment and stability testing process are provided in this submission report.
The provided document is a 510(k) Summary for a medical device calibrator, the "Dimension Vista® System Enzyme 6 Calibrator (KC360)". It does not contain detailed information about specific acceptance criteria, a comprehensive study design with sample sizes for test and training sets, expert involvement, or adjudication methods in the format requested. The document primarily focuses on establishing substantial equivalence to a predicate device.
However, I can extract and infer some information based on the typical content of a 510(k) submission for a calibrator.
Here's an attempt to answer your questions based on the available text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for performance metrics (like accuracy, precision, stability, etc.) in a table format. It states: "Comparative testing described in the protocol included in this submission demonstrates substantial equivalent performance." This implies that the device's performance met criteria that demonstrated equivalence to the predicate device. Without the actual protocol, the specific acceptance criteria and performance data are not available in this summary.
2. Sample sized 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. It mentions "comparative testing" but does not detail the number of samples or runs. There is no information about the data provenance (country of origin, retrospective/prospective).
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 applicable or not provided. For a calibrator, "ground truth" typically refers to the assigned target values for the analytes, which are established through a robust value assignment process (often involving reference methods or extensive inter-laboratory studies) rather than expert consensus on individual "cases." The document states, "Description of the manufacturing, value assignment and stability testing process are provided in this submission report," but details are not included in the summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable to a calibrator's performance study as described here. Adjudication methods are typically used in clinical studies where expert interpretation of results is involved (e.g., imaging studies).
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
No. This type of study (MRMC for human readers with/without AI assistance) is not relevant to a calibrator device. Calibrators are reagents used in automated laboratory systems and do not directly involve human "readers" interpreting results in the same way an imaging AI might.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable to a calibrator. A calibrator's performance is assessed by how well it enables the analytical system to accurately measure analytes. The "algorithm" here would be the instrument's measurement algorithm, and its performance is evaluated in conjunction with the calibrator. The document implies a standalone evaluation of the calibrator's properties (like value assignment and stability) and then its performance when used with the Dimension Vista® System.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a calibrator, the "ground truth" for the assigned values would be established through a value assignment process, likely involving:
- Reference methods: Highly accurate and precise analytical methods.
- Traceability to international reference materials: Ensuring that the values are consistent with established standards.
- Extensive internal studies: Multiple measurements by qualified personnel using validated methods.
The document states, "Description of the manufacturing, value assignment and stability testing process are provided in this submission report," indicating that a robust process for establishing these values exists.
8. The sample size for the training set
The document does not mention a training set. Calibrators are not typically "trained" in the machine learning sense. Their properties (value, stability) are determined through analytical testing.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of this calibrator's development.
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510(k) Summary of Safety and Effectiveness for the Dimension Vista® System Enzyme 6 Calibrator (KC360)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| A. 510(k) Number: | K083579 |
|---|---|
| ------------------- | --------- |
B. Date of Preparation: November 24, 2008
C. Proprietary and Established Names:
Enzyme 6 Calibrator
D. Applicant:
Siemens Healthcare Diagnostics Inc., P.O. Box 6101, Newark, DE 19714-6101 Victor M. Carrio, Senior Manager, Regulatory Affairs Office: (302) 631-0376 Fax: (302) 631-6299
E. Requiatory Information:
Regulation section: 21 CFR § 862.1150 Calibrator Classification: Class II Product Code: JIX, Calibrator, Multi-Analyte Mixture Panel: Clinical Chemistry
F. Predicate Devices: '
Dimension® CKI/MBI Calibrator (K081731)
G. Device Description:
The Dimension Vista® System Enzyme 6 Calibrator (Enz 6 CAL) is a liquid, multianalyte, human serum albumin based product containing creatine kinase MM (human source) and creatine kinase MB (porcine source). The kit consists of three vials of Calibrator A, 2.0 ml per vial. Level 1 calibrator for Enz 6 CAL is not included. Purified Water Diluent or reagent grade water is required for use as Calibrator Level 1. Description of the manufacturing, value assignment and stability testing process are provided in this submission report.
H. Intended Use:
The ENZ 6 CAL is an in vitro diagnostic product for the calibration of the Creatine Kinase (CKI) and Creatine Kinase MB (MBI) methods on the Dimension VIsta® System.
I. Substantial Equivalence Information:
The Dimension Vista® Enzyme 6 Calibrator (KC360) was compared to the Dimension® CKI/MBI Calibrator (K081731). A comparison of the important similarities and differences between the device and the predicate is provided in the following table:
| Feature | Dimension Vista® Enzyme 6Calibrator | Dimension® CKI/MBICalibrator (K081731) |
|---|---|---|
| Intended Use | The ENZ 6 CAL is an in vitrodiagnostic product for thecalibration of the Creatine | The CKI/MBI CAL is an in vitrodiagnostic product for thecalibration of the Creatine |
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| Kinase (CKI) and CreatineKinase MB (MBI) methods onthe Dimension Vista® System. | Kinase (CKI) and CreatineKinase MB (MBI) methods onthe Dimension® clinicalchemistry system. | |
|---|---|---|
| Analyte | Creatine kinase (humansource) and creatine kinase-MB(porcine source) | Creatine kinase (humansource) and creatine kinase-MB(porcine source) |
| Matrix | Human serum albumin | Human serum albumin |
| Form | Liquid | Liquid |
| Levels | CKI — Two levelsMBI — Two levels | CKI - Three levelsMBI - Five levels |
J. Conclusion:
.
.
:
.
。
The Dimension Vista® Enzyme 6 Calibrator (KC360) is substantially equivalent to the Dimension® CKI/MBI Calibrator (K081731). Comparative testing described in the protocol included in this submission demonstrates substantial equivalent performance.
,
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird-like figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Siemens Healthcare Diagnostics Inc. c/o Mr. Victor M. Carrio Senior Manager Regulatory Affairs P.O. Box 6101 Newark, DE 19714-6101
FEB 2 0 2009
Re: K083579
Trade/Device Name: Dimension Vista® Enzyme 6 Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator, Multi-Analyte Regulatory Class: Class II Product Code: JIX Dated: December 3, 2008 Received: December 4, 2008
Dear Mr. Carrio:
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 requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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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 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 (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its' Internet address of the contra ಿ ಮಾರ್ ರೇಸ್ ನಿರ್ವಹಿಸಿ ಪ್ರಮುಖ http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Corg C. He
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
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Indication for Use
K083579 510(k) Number (if known):
Device Name:
Dimension Vista® Enzyme 6 Calibrator
Indication For Use:
The ENZ 6 CAL is an in vitro diagnostic product for the calibration of the Creatine Kinase (CKI) and Creatine Kinase MB (MBI) methods on the Dimension Mista® System.
Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concerrence of CDRH) Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) 1
Violet May
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K083579
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.