The Fibron-1 is a photo-optical instrument used for the performance of in-vitro diagnostic clotting testing of citrated plasma samples in the clinical laboratory. The Fibrin-1, which uses clot formation as an endpoint, may be used for the performance of the Prothrombin Time Test (PT) and the Activated Partial Thromboplastin Test (APTT).

Device Description

The Fibron-1 is a photo-optical instrument used for the performance of in-vitro diagnostic clotting testing of citrated plasma samples in the clinical laboratory. The instrument utilizes photo-optical principles for clot detection. The light source is a high intensity photodiode. The incubator block is temperature regulated to 36.5 - 37.5℃ and contains four measuring positions, 4 reagent and 4 cuvette pre-warming positions.

AI/ML Overview

Here's a summary of the acceptance criteria and study findings for the Fibron-1 Coagulation Analyzer, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Metric	Fibron-1 Performance	Notes
Instrument Correlation (PT)	Correlation (vs ACL 100)	0.972	Strong positive correlation
Instrument Correlation (PT)	Slope (vs ACL 100)	1.24
Instrument Correlation (PT)	Intercept (vs ACL 100)	-2.46
Instrument Correlation (APT)	Correlation (vs ACL 100)	0.976	Strong positive correlation
Instrument Correlation (APT)	Intercept (vs ACL 100)	6.68
Instrument Correlation (APT)	Slope (vs ACL 100)	0.763
Instrument Correlation (APT)	Correlation (vs Electra 900C)	0.981	Strong positive correlation
Instrument Correlation (APT)	Intercept (vs Electra 900C)	2.05
Instrument Correlation (APT)	Slope (vs Electra 900C)	0.892
Within-run Precision (PT, Control Level 1)	Average ± %CV	12.0 ± 2.0 % (n=20)	Compared favorably to MLA 900C (11.5 ± 2.0%)
Within-run Precision (PT, Control Level 2)	Average ± %CV	20.0 ± 1.9 % (n=19)	Compared favorably to MLA 900C (18.7 ± 1.2%)
Day-to-Day Precision (PT, Normal)	Average ± %CV	11.6 ± 3.2 %	Compared favorably to MLA 900C (11.5 ± 1.2%)
Day-to-Day Precision (PT, Low Abnormal)	Average ± %CV	19.6 ± 2.1 %	Compared favorably to MLA 900C (18.3 ± 2.0%)
Within-run Precision (PT, Normal Control)	Average %CV of Duplicates	1.28% (n=18 duplicates)
Within-run Precision (PT, Low Abnormal)	Average %CV of Duplicates	1.12% (n=17 duplicates)
Within-run Precision (PT, High Abnormal)	Average %CV of Duplicates	1.01% (n=18 duplicates)
Within-run Precision (APTT, Normal Control)	Average %CV of Duplicates	1.90% (n=18 duplicates)
Within-run Precision (APTT, Low Abnormal)	Average %CV of Duplicates	0.86% (n=16 duplicates)
Within-run Precision (APTT, High Abnormal)	Average %CV of Duplicates	2.45% (n=18 duplicates)

Study Details

Sample size used for the test set and the data provenance:
- Instrument Correlation Studies (PT & APTT):
  - The exact sample size for the correlation studies (Fibron-1 vs. ACL 100 and Fibron-1 vs. Electra 900C) is not explicitly stated as a total number of patients, but rather states "Specimens were evaluated from healthy individuals and from patients with different pathological conditions." The clotting time range observed was 10 to 39 seconds.
  - Data Provenance: "in-house and at a community hospital." This suggests a mix of controlled laboratory environments and a real-world clinical setting. The country of origin is not specified but given the submitter's address (Newton, MA) and the FDA submission, it's likely US-based, at least for the community hospital. The study appears to be prospective, as specimens were evaluated as part of this specific testing.
- Precision Studies:
  - Within-run Precision:
    - PT Control Level 1: n = 20
    - PT Control Level 2: n = 19
  - Day-to-Day Precision:
    - PT Normal Control: Day 1 (n=20), Day 2 (n=4), Day 3 (n=4), Day 4 (n=4), Day 5 (n=4)
    - PT Low Abnormal: Day 1 (n=19), Day 2 (n=4), Day 3 (n=4), Day 4 (n=4), Day 5 (n=4)
  - Precision (Duplicates):
    - PT Normal Control: 18 duplicates
    - PT Low Abnormal: 17 duplicates
    - PT High Abnormal: 18 duplicates
    - APTT Normal Control: 18 duplicates
    - APTT Low Abnormal: 16 duplicates
    - APTT High Abnormal: 18 duplicates
  - Data Provenance: "in-house" based on the context of the document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This device is a laboratory instrument that provides quantitative measurements of clotting times. The "ground truth" for the test set is established by the measurements from the predicate devices (ACL 100, MLA-900C, Electra 900C) and established laboratory control materials. There is no mention of human experts establishing ground truth for the test set in the way one would for diagnostic imaging.
Adjudication method for the test set:
- Not applicable. This is a comparison of instrument performance against predicate devices and known control values, not a subjective interpretation task requiring adjudication.
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 MRMC study was performed. This device is a standalone laboratory instrument, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the entire study focuses on the standalone performance of the Fibron-1 instrument. Its accuracy and precision are evaluated against predicate devices and control materials without any human interpretive component beyond operating the machines.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for evaluating the Fibron-1's performance is derived from:
  - Measurements from legally marketed predicate devices (ACL 100, MLA-900C, Electra 900C).
  - Known values of laboratory control materials (Normal, Low Abnormal, High Abnormal levels).
  - Actual clotting times from patient and healthy individual samples.
The sample size for the training set:
- This is a traditional medical device (a photo-optical instrument), not an AI/ML-based device that would typically have a separate "training set" for an algorithm. Therefore, no training set is mentioned or applicable in the context of this 510(k) summary.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.

Summary

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510(k) Summary

Fibron-1 Coagulation Analyzer

vital scientific

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.

The assigned 510K number is: K021976

Applicant:	Vital Scientific NVOne Gateway Center, Suite 415Newton, MA 02158Phone: 1-617-527-9933 x41Fax: 1-617-527-8230
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Israel M. Stein MD Contact:

August 22, 2002 Date:

Device Name:

Fibron-1 (Coagulation Instrument).

Common Name:

Coagulation Instrument

Classification Name:

Coagulation Instrument has been classified as Class II device. 21 CFR 864.5400 (Product Code KQG). This device is intended for clinical use in conjunction with certain materials to measure a clot formation.

Description of the Fibron-1

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Intended Use

Substantial Equivalence:

The Fibron-1 is comparable to the MLA-900C (K884863) and the ACL 100 (K881367). The instruments have a similar intended use for in-vitro diagnostic coagulation testing in the clinical laboratory. Further, the proposed device and the predicate devices utilize photo-optical measurement principles for clot detection. The Fibron-1 is also typical of photo-optical coagulation systems in general.

Fibron-1 is a "manual" coagulation instrument, in that the user must pipettes both sample and test reagent. In contrast, the MLA-900C is semi-automated which requires manual sample addition, but has an automatic pipette for reagent addition. The light source for the MLA instruments is a halogen lamp and the wavelenath is set at 550 nm for clotting assays. An LED at 620 nm is used by the Fibron-1. Although the Fibron-1 uses a different wavelength for clotting assays compared to the MLA, it has been optimized for this specific light source. The performance data generated support this statement.

Comparison instrument testing was performed in-house and at a community hospital and the results are shown in Tables 1 and 2. Specimens were evaluated from healthy individuals and from patients with different pathological conditions, which are expected to affect the results for a particular assay. Clotting time ranged from 10 to 39 seconds.

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Image /page/2/Figure/0 description: The image contains a table and a scatter plot. The table shows the instrument, parameter, slope, intercept, and correlation for Fibron-1 vs ACL 100 for clotting time and INR. For clotting time, the slope is 1.24, the intercept is -2.46, and the correlation is 0.972. The scatter plot shows the correlation between Fibron PT clotting times and ACL 100 PT clotting times, with a correlation of 0.972.

Table 1 Instrument to Instrument Correlation with PT Reagent.

Table 2: Instrument to Instrument Correlation with APTT Reagent.
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Instruments	Correlation	Intercept	Slope
Fibron-1 / ACL 100	0.976	6.68	0.763
Fibron-1 / Electra 900C	0.981	2.05	0.892

Image /page/2/Figure/4 description: The image is a scatter plot titled "Intrument Correlation with APTT: Fibron-1 vs Electra 900C". The x-axis is labeled "Electra 900C APTTclotting times (sec.)" and ranges from 20.0 to 90.0. The y-axis is labeled "Fibron APTT clotting times (sec.)" and ranges from 20.0 to 90.0. The data points are clustered around a straight line, indicating a strong positive correlation, and the correlation coefficient is 0.981.

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Within-run and Day--to-Day run precision studies were performed as shown in Tables 3 and 4 which summarize the data obtained from these studies.

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Control	Fibron-1	MLA 900C
Control Level 1	$12.0 \pm 2.0 %$	$11.5 \pm 2.0 %$
Average ± %CV	(n = 20)	(n = 20)
Control Level 2	$20.0 \pm 1.9 %$	$18.7 \pm 1.2 %$
Average ± %CV	(n = 19)	(n = 20)

Table 3 Within-run Precision

Table 4 – Day-to-Day Precision

ﮯ

Table 4 - Day-to-Day Precision
Control and Day	Fibron-1Average ± %CV	MLA 900CAverage ± %CV
Normal - Day 1	12.0 ± 2.0 %(n = 20)	11.6 ± 0.7 %(n = 20)
Normal - Day 2	11.0 ± 2.4 %(n = 4)	11.3±0.4 %(n = 4)
Normal - Day 3	11.6 ± 1.5 %(n = 4)	11.6 ± 1.6 %(n = 3)
Normal - Day 4	11.6 ± 2.1 %(n = 4)	11.4 ± 0.9 %(n = 3)
Normal - Day 5	11.8 ± 1.3 %(n = 4)	11.6 ± 1.8 %(n = 4)
Average ± %CV	11.6 ± 3.2 %	11.5 ± 1.2 %
Low Abnormal - Day 1	20.0 ± 1.9 %(n = 19)	18.7 ± 1.2 %(n = 20)
Low Abnormal - Day 2	19.1 ± 1.4 %(n = 4)	17.7±0.7 %(n = 4)
Low Abnormal - Day 3	19.5 ± 1.6 %(n = 4)	18.4 ± 0.6 %(n = 3)
Low Abnormal - Day 4	19.4 ± 1.1 %(n = 4)	18.3 ± 0.3 %(n = 3)
Low Abnormal - Day 5	20.1 ± 1.2 %(n = 4)	18.3 ± 1.4 %(n = 3)
Average ± %CV	19.6 ± 2.1 %	18.3 ± 2.0 %

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Precision and correlation studies were performed for PT and APTT. Tables 5 and 6 summarize the data obtained from these studies.

PT	Average%CVofDuplicates	Stand. Dev.Average%CV
Normal Control18 duplicates	1.28%	1.28%
Low Abnormal17 duplicates	1.12%	0.77%
High Abnormal18 duplicates	1.01%	0.75%
All levels52 duplicates	1.14%	1.14%

Table 4

Table 5

APTT	Average%CVofDuplicates	Stand. Dev.Average%CV
Normal Control18 duplicates	1.90%	1.75%
Low Abnormal16 duplicates	0.86%	0.60%
High Abnormal18 duplicates	2.45%	2.77%
All levels51 duplicates	1.59%	2.03%

The data for precision and accuracy demonstrate general agreement with levels that are comparable to other systems approved for marketing commercially in the United States. The data demonstrate positive correlation and substantial equivalence.

The Fibron-1 operates in the normal laboratory environment. The product does not support or sustain life and does not present a reasonable risk of illness or injury. When procedures found in the Operations Manual are followed the device is safe in general laboratory use.

Vital Scientific NV, concludes that the Fibron-1 has a similar intended use, technological characteristics and combined performance data which support the statement that the Fibron-1 is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. The logo is in black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Israel M. Stein, M.D. Managing Director Vital Scientific NV One Gateway Center, Suite 415 Newton, Massachusetts 02158

K021976 Trade/Device Name: Fibron-1 Regulation Number: 21 CFR § 864.5400 Regulation Name: Coagulation Instrument Regulatory Class: II Product Code: KQG, JBT Dated: September 18, 2002 Received: September 23, 2002

Dear Dr. Stein:

Re:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 "http://www.fda.gov/cdrl/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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INDICATIONS FOR USE STATEMEN

510(k) Number (if known): K 021976

Device Name: Fibron -1

Indications For Use: ·

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Josephine Bautista

(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number-

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use (Optional Format 1-2-96)

Regulation Number and Section

§ 864.5400 Coagulation instrument.

(a)
Identification. A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.(b)
Classification. Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.