The BACTEC ® MYCO/F LYTIC Culture vial when used with the BACTEC 9000MB System is a qualitative test for the culture and recovery of mycobacteria in human blood speciments from patients who are suspected of having septicemia.

Device Description

BACTEC MYCO/F LYTIC blood culture medium is a non-selective growth medium intended for the culture and recovery of mycobacteria and designed for blood volumes of one to five mL. BACTEC MYCO/F LYTIC culture medium is a Middlebrook 7H9 and Brain Heart Infiusion broth formulation with specific formulation modifications made to enhance the growth of mycobacteria. It is used specifically with the BACTEC 9000MB instrument in the monitoring of clinical blood specimens for the presence of microorganisms. This medium contains the same fluorescence senor as the BACTEC MYCO/F Sputa culture medium and detection is based on changes in oxygen concentration in the vial resulting from metabolism and growth of microorganisms. The sensor is monitored by the BACTEC 9000MB System for increasing fluorescence which is proportinal to the decrease in oxygen. A positive determination indicates the presumptive presence of viable microorganisms in the vial.

AI/ML Overview

Here's an analysis of the acceptance criteria and study details for the BACTEC MYCO/F LYTIC Culture Medium, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define formal "acceptance criteria" with specific thresholds (e.g., "sensitivity must be >X%"). However, it implies acceptance criteria by comparing the performance of the BACTEC MYCO/F LYTIC medium to a predicate device (BACTEC 13A) and by reporting internal performance characteristics.

The implied objective is that the BACTEC MYCO/F LYTIC medium should be at least comparable to, or ideally better than, the predicate device in terms of mycobacteria recovery and detection, with acceptable false positive and false negative rates.

Since explicit acceptance criteria are missing as numerical targets, I will present the key performance metrics reported in the studies.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance (BACTEC MYCO/F LYTIC)
Clinical Recovery (Overall)	Comparable or improved recovery of pathogenic mycobacteria compared to BACTEC 13A.	Total 39 pathogenic mycobacterial isolates recovered. 5 (13%) recovered ONLY in BACTEC MYCO/F LYTIC. 2 (5%) recovered ONLY by BACTEC 13A. 32 recovered by both.
Clinical Recovery (Species-specific)	Demonstrate recovery of various pathogenic mycobacteria species.	Mycobacterium avium: 3/30 recovered only by MYCO/F LYTIC, 1/30 only by 13A, 26 by both. Mycobacterium tuberculosis: 6/6 recovered by both. Mycobacterium kansasii: 2/3 recovered only by MYCO/F LYTIC, 1/3 only by 13A.
Internal Recovery (Species Diversity)	Detect a variety of mycobacteria species as positive.	Detected: M. tuberculosis, M. kansasii, M. fortuitum, M. intracellulare, M. bovis, M. terrae, M. simiae, M gordonae, M. celatum, M. abscessus, M. maimoense. Unsatisfactory recovery: M. xenopi and M. szulgai.
False Positive Rate	Acceptably low false positive rate. (No explicit numerical threshold given, but generally, lower is better).	0.4% (1 out of 284 blood specimens). For instrument positive MYCO/F LYTIC vials: 2.6% (1 out of 38). (Note: 16 false positives out of 28 overfilled vials were excluded from the study due to protocol deviation).
False Negative Rate	Acceptably low false negative rate. (No explicit numerical threshold given).	0% (Based on terminal subcultures of 50% of negative vials).
Contamination Rate	Acceptably low contamination rate. (No explicit numerical threshold given).	0.9%
Time to Detection (Internal Study)	General indication of detection within a reasonable timeframe (implied, not explicitly quantified as a criterion for clinical relevance).	Varies by species and blood volume. Examples: M. tuberculosis avg 22.9 days (1 mL), 18.7 (3 mL), 17.3 (5 mL). M. avium avg 8.0-8.1 days. M. fortuitum avg 8.0-5.1 days. (See Table 2 for full details).

2. Sample Size and Data Provenance

Clinical Test Set Sample Size: 284 blood specimens.
Data Provenance: Prospective clinical study conducted at "two clinical sites considered large tertiary care teaching hospitals in geographically diverse areas." The specific country of origin is not mentioned but typically for FDA submissions of this era, the studies would be conducted in the United States.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number of experts or their specific qualifications for establishing the "ground truth" (e.g., "smear and/or subculture-negative/positive") for the clinical test set. It mentions "microbiological workup" and validation against "smear and/or subculture." This implies standard laboratory practices performed by qualified laboratory personnel, but details on expertise (e.g., years of experience, specific certifications) are absent.

4. Adjudication Method

The document does not describe an explicit adjudication method (like 2+1 or 3+1) for resolving discrepancies in the ground truth for the clinical test set. The ground truth ("smear and/or subculture-negative/positive") appears to be determined by confirmed laboratory results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This study compares a device (the BACTEC MYCO/F LYTIC medium) directly against a predicate device (BACTEC 13A medium) in a clinical evaluation, but it is not a "human reader" study; it's a comparison of culture media performance. Therefore, an effect size of human readers improving with or without AI assistance is not applicable.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was conducted. The "INTERNAL PERFORMANCE" section and "Table 2: Detection of Mycobacteria in the Myco/F Lytic Medium" represent a standalone evaluation. This study assessed the recovery and time to detection of various mycobacteria species at different CFU levels specifically with the BACTEC MYCO/F LYTIC medium and the BACTEC 9000MB instrument, without direct comparison to human reading or other media as the primary objective.

7. Type of Ground Truth Used

Clinical Study: The ground truth for the clinical performance evaluation was established through laboratory confirmation (smear and/or subculture results). This represents definitive microbiological results, which would fall under a form of "pathology" in a broader sense of laboratory diagnostics.
Internal Study: The ground truth for the internal performance study (Table 2) was based on known mycobacteria strains and quantified CFU/bottle (Colony Forming Units per bottle), with the outcome being the time to detection by the BACTEC 9000MB instrument.

8. Sample Size for the Training Set

The document does not mention a training set for the BACTEC MYCO/F LYTIC culture medium. This type of device (a culture medium for microbial growth detection) does not typically involve machine learning algorithms that require explicit "training sets" in the conventional sense. The "internal performance" study (Table 2) could be considered an initial validation or characterization of the medium's performance with known isolates under controlled conditions, serving a similar purpose to testing the device's inherent capabilities before clinical evaluation.

9. How the Ground Truth for the Training Set Was Established

Since there is no explicit mention of a "training set" in the context of machine learning, this question is not directly applicable. If the "internal performance" study is considered a foundational or characterization study, the ground truth was established by using known, cultured mycobacteria strains with quantified concentrations (CFU/bottle).

Summary

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1410512

JAN - 8 1998

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

BECTON DICKINSON MICROBIOLOGY SYSTEMS SUBMITTED BY: 7 LOVETON CIRCLE SPARKS, MD 21152

Dennis R. Mertz, Manager of Regulatory Affairs CONTACT:

(410) 316-4099 TELEPHONE:

FAX: (410) 316-4499

December 23, 1997 PREPARED:

BACTEC MYCO/F LYTIC BLOOD CULTURE MEDIUM DEVICE NAME:

DEVICE

CLASSIFICATION: Monitor, Microbial Growth, Class I

PREDICATE

BACTEC 13A MYCOBACTERIA CULTURE MEDIUM DEVICE:

BACTEC MYCO/F LYTIC when used with the BACTEC 9000MB INTENDED USE: instrument is a non-selelctive culture medium for the qualitative culture and recovery of mycobacteria from blood specimens.

DEVICE DESCRIPTION:

SUBSTANTIAL EQUIVALENCE:

Table 1 summarizes the similarities and differences between the BACTEC MYCO/F LYTIC Culture medium and the BACTEC 13A Mycobacteria culture medium.

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INTERNAL PERFORMANCE:

A study was conducted to evaluate the recovery and time to detection of a variety of mycobacteria species at different CFU levels with the BACTEC MYCOFF LYTIC Culture medium. The following isolates were detected as positive in the BACTEC 9000MB instrument using BACTEC MYCO/F Lytic medium: M. tuberculosis, M. kansasii, M. fortuitum, M. intracellulare, M. bovis, M. terrae, M. simiae, M gordonae, M. celatum, M. abscessus, M. maimoense. During internal studies, M. xenopi and M. szulgai exhibited unsetisfactory recovery with BACTEC MYCO/F LYTIC culture medium. TABLE 2 describes the results of this study.

CLINICAL PERFORMANCE:

The BACTEC MYCO/F Lytic culture medium was evaluated with the BACTEC 9000MB instrument at two clinical sites considered large tertiary care teaching hospitals in geographically diverse areas. The site populations included patients suspected of a mycobacterial infection, immunocompromised patients and transplant patients. The BACTEC MYCO/F Lytic culture medium was compared to the BACTEC 13A culture medium for the recovery and detection of mycobacteria from blood specimens. A total of 284 blood specimens were tested during the study. The total number of pathogenic mycobacterial isolates recovered in the study was 39 ( See TABLE 1). Of these positives, five (13%) were recovered in the BACTEC MYCO/F Lytic culture medium only and two (5%) were recovered by BACTEC 13A culture medium only. A total of 28 BACTEC MYCO/F LYTIC vials were over filled with specimen (between 6 to 20 mL) during the clinical evaluation and were not included in this study since they were above the maximum fill volume. Of these 28 BACTEC MYCO/F LYTIC vials, 16 (57%) were identified as false positive.

Of the 284 blood specimens tested in the clinical study, one BACTEC MYCO/F LYTIC vial (0.4%) was determined to be false positive (instrument-positive, smear and/or subculture-negative). Of the 38 instrument positive MYCO/F LYTIC vials, 1 (2.6%) was determined to be false positive. The false negative rate (instrument-negative, smear and/or subculture-positive) was determined to be 0% based on terminal subcultures of 50% of negative vials. The contamination rate during this evaluation was determination to be 0.9%.

Organism	TotalIsolates	Myco/F LyticMedium Only	13A MediumOnly	Both
All Pathogenic Mycobacteria:
Mycobacterium avium	30	3	1	26
Mycobacterium tuberculosis	6	0	0	6
Mycobacterium kansasii	3	2	1	0
Total	39	5	2	32

TABLE 1: SUMMARY OF MYCO/F LYTIC CULTURE MEDIUM ISOLATE RECOVERY DURING CLINICAL TRIALS

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	BACTEC MYCO/FLYTIC	BACTEC 13A
Intended Use	Qualitative culture andrecovery of myoobacteria	Qualitative culture andrecovery of mycobacteria
Sample Type	Blood, unprocessed andother sterile body fluids	Blood, unprocessed
Sample Volume	1 - 5 mL	1 - 5 mL
Blood to Broth Ratio	1 to 8	1 to 6
Growth Medium	Modified Middlebrook 7H9and enriched brain heartinfusion broth	Modified Middlebrook 7H9broth
Reactive ingredients:• Process water	40mL	30mL
• Brain heart infusion	0.5%w/v	---
• Soybean-Casein Digest	0.10%w/v	---
• 7H9 Broth Base	0.12%w/v	0.47%w/v
• Inositol	0.05%w/v	---
• Casein Hydrolysate	0.10%w/v	0.10%w/v
• Ferric Ammonium Citrate	0.006%w/v	---
• Glycerol	0.10%w/v	---
• Sodium Polysulfonate(SPS)	0.025%w/v	0.025%w/v
• Tween 80(Polysorbate)	0.0025%w/v	0.02%w/v
• Saponin	0.24%w/v	---
• L-Asparagine¹	0.10%w/v	---
• Catalase	---	1440 units
• Antifoam Agent	0.01%w/v	---
• Hemin	---	---
• ¹⁴C Substrate	---	5µCi
• Potassium Phosphate	0.024%w/v	---
• Pyridoxal HCL	0.0001%w/v	---
• Ammonium Sulfate	---	---
Supplement	None	BACTEC Enrichment
Instrument	BACTEC 9000MB	BACTEC 460TB
Growth Detection	O₂ metabolism	Palmitate Decarboxylation
Incubation T°/mixing	37°C ± 1.5°C; internalinstrument agitation every10 minutes	37° C ± 1.5°C; no agitationby instrument
Type of Monitoring	Non-invasive, fluorescentdetection	Invasive vial headspacesampling

Table 1. Substantial Equivalence of BACTEC MYCO/F LYTIC Culture Medium to

PACTEC 12 A

150

发出了我们的意见的

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Table 2

Detection of Mycobacteria in the Myco/F Lytic Medium.

. •

	strain	cfu/bottle	BACTEC 9000MB
			1 mL blood	3 mL blood	5 mL blood
M. tuberculosis	582	0, 0	20.7	18.7	17.3
Replicate			25.0	neg	neg
Average			22.9	18.7	17.3
M. avium	2638	49, 45	7.8	8.1	8.1
Replicate			8.1	8.1	8.1
Average			8.0	8.1	8.1
M. Intracellulare	2792	80, 44	25.8	16.7	10.5
Replicate			24.3	22.5	15.0
Average			25.0	19.6	12.8
M. fortuitum	3072	5, 0	9.1	5.6	5.0
Replicate			6.8	6.0	5.2
Average			8.0	5.8	5.1
M. bovis	2003	12, 13	24.4	20.0	20.0
Replicate			24.7	21.0	20.4
Average			24.5	20.5	20.2
M. kansasii	2205	7,3	12.3	14.3	14.3
Replicate			13.0	13.3	neg
Average			12.7	13.8	14.3
M. terrae	3001	0, 0	15.3	11.6	16.6
Replicate			17.0	32.4	neg
Average			16.2	22.0	16.6
M. azulgai	2353	1,2	15.7	neg	neg
Replicate			neg	22.7	neg
Average			15.7	22.7	neg
M. simiae	2304	68,58	7.2	7.4	7.7
Replicate			7.2	7.5	7.4
Average			7.2	7.5	7.6
M. gordonae	2454	2,5	26.4	28.7	neg
Replicate			24.0	32.0	neg
Average			25.2	30.4	neg
M. celatum	3661	53, 31	18.3	12.0	12.3
Replicate			18.3	15.0	12.3
Average			18.3	13.5	12.3
M. abscessus	3370	1,0	4.9	4.4	3.9
Replicate			9.3	4.3	neg
Average			7.1	4.4	3.9
M. malmoense	3472	16, 20	30.0	21.5	10.8
Replicate			32.0	21.1	18.6
Average			31.0	21.3	14.7
M. haemophilum	5121	1, 1	36.1	23.0	18.4
Replicate			39.3	23.4	24.4
Average			37.7	23.2	21.4
M. xenopi	3062	0, 0	neg	neg	neg
Replicate			neg	neg	neg
Average			neg	neg	neg

. .

: 上一篇:

: 上一

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN - 8 1998

Mr. Dennis R. Mertz Manager, Regulatory Affairs Becton Dickinson Microbiology Systems 7 Loveton Circle Sparks, Maryland 21152-0999

Re: K970512 Trade Name: BACTEC Myco/F Lytic Culture Vials Regulatory Class: I Product Code: MDB Dated: October 20, 1997 Received: October 21, 1997

Dear Mr. Mertz:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System " Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.

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 vour device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours.

Steven Autman

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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t111二十字127	4-C
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510(k) Number (if known): __ K970512

Device Name: Myco/F Lytic Culture Vials

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

John Titchurst MD 1/6/98

(Division Sign-Off) Intelian Chilian Chical I aboratory Devices Division of Clinical Laboratory Devices K970512 510(k) Number ..

Presoription Use (Par 21 OFF 801.109)

Over-The-Counter Use

(Optional Format 1-2-86)

Regulation Number and Section

§ 866.2560 Microbial growth monitor.

(a)
Identification. A microbial growth monitor is a device intended for medical purposes that measures the concentration of bacteria suspended in a liquid medium by measuring changes in light scattering properties, optical density, electrical impedance, or by making direct bacterial counts. The device aids in the diagnosis of disease caused by pathogenic microorganisms.(b)
Classification. Class I. With the exception of automated blood culturing system devices that are used in testing for bacteria, fungi, and other microorganisms in blood and other normally sterile body fluids, this device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.