The BD Viper LT System is intended for in vitro diagnostic (IVD) use in clinical laboratories to perform automated extraction of nucleic acids from multiple specimen types, amplification of target nucleic acid sequences by Strand Displacement Amplification (SDA) and detection of amplified nucleic acid using a two color fluorescence detection system. The BD Viper LT is for use only with in vitro diagnostic tests labeled for use on the system.

Device Description

The BD Viper LT System is a table-top instrument that is designed to be fully contained on a standard laboratory bench-top. The system performs automated extraction of nucleic acids from multiple specimen types in addition to amplification and detection of target nucleic acid sequences when utilized with legally marketed in vitro diagnostic assays.

AI/ML Overview

Here's an analysis of the acceptance criteria and study data for the BD Viper™ LT System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on the technical specifications of the BD Viper LT System and states that its clinical utility was assessed in a separate submission. Therefore, the "acceptance criteria" presented here are the technical specifications of the instrument, and the "reported device performance" implies that internal studies validated these specifications. No specific pass/fail metrics or clinical performance numbers are provided within this document for the BD Viper LT System itself, beyond the statement that studies were conducted to validate the specifications.

Acceptance Criteria (Internal Study Validation)	Reported Device Performance (Internal Study Validation)
Thermal Specifications
Pre-warm heater fluid temperature	100°C >= 9 min. not to exceed 115°C > 8 min
Priming heater fluid temperature	70°C ± 2.0°C
Amplification heater fluid temperature	52.5°C ± 1.0°C
Temperature Accuracy	± 0.75°C
Temperature Uniformity	± 0.75°C
Optical Specifications
Excitation Wavelength (Set 1 - Green Channel)	460-480 nm
Emission Wavelength (Set 1 - Green Channel)	505-515 nm
Excitation Wavelength (Set 2 - Orange Channel)	575-597 nm
Emission Wavelength (Set 2 - Orange Channel)	610-630 nm
Maximum optical crosstalk	≤ 0.5%

2. Sample Size Used for the Test Set and Data Provenance:

The document states: "Internal studies were conducted to validate the instrument specifications presented in Tables 2-3." However, it does not provide any details regarding the sample size used for these internal studies, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective nature).

It does mention that the "Clinical utility of the BD Viper LT System was assessed during clearance of the BD ProbeTec GCQ Amplified DNA Assay as presented in a separate premarket submission (K140448)." This suggests that any clinical data pertaining to its actual performance with patient samples would be found in that separate submission, not in this one focused on the instrument itself.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable for the data presented in this document. The listed acceptance criteria relate to instrument specifications (temperature, optics), which would typically be validated through engineering and laboratory measurements, not through expert review for ground truth in a diagnostic sense.

4. Adjudication Method for the Test Set:

Not applicable. Given that the validation studies were for instrument specifications, there would not be an adjudication method in the way one would for diagnostic imaging or clinical interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

Not applicable. This document describes an automated laboratory instrument (BD Viper LT System). MRMC studies are typically performed for technologies that involve human interpretation, such as medical imaging AI, to assess how AI assistance impacts human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The entire "device" described here, the BD Viper LT System, is an automated standalone instrument designed for nucleic acid extraction, amplification, and detection. Its performance as an automated system is its standalone performance. The document explicitly states its function as performing "automated extraction of nucleic acids," "amplification," and "detection."

7. The Type of Ground Truth Used:

For the instrument specifications (thermal and optical), the "ground truth" would be established by precision laboratory instruments and calibration standards. These are objective physical measurements rather than expert consensus, pathology, or outcomes data, which are typically associated with diagnostic performance.

8. The Sample Size for the Training Set:

Not applicable. Automated laboratory instruments like the BD Viper LT System are typically designed and engineered based on physical principles, chemical reactions, and optical mechanics. They do not undergo "training" in the same way machine learning algorithms do, which require large training sets.

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

Not applicable for the same reasons as point 8. The "ground truth" for the development of such an instrument would be the accurate and precise operation of its various components as designed, validated through engineering tests and calibrations.

Summary

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KIYOY47

510(k) Summary

Image /page/0/Picture/2 description: The image contains the BD logo. The logo consists of a stylized human figure with arms outstretched, surrounded by a sunburst. To the right of the figure are the letters "BD" in a bold, sans-serif font. Below the letters is the text "Helping all people live healthy lives" in a smaller font.

BD Viper™ LT System

MAY 2 0 2014

Applicant	BD Diagnostic Systems7 Loveton CircleSparks, MD 21152
Establishment Registration No.	1119779
Contact Person	Sherma Winston, M.S., RACtel. 410-316-4145fax. 410-316-4188sherma_winston@bd.com
Summary Date	May 15, 2014
Proprietary Name	BD Viper TM LT System
Common Name	BD Viper LT
Classification	Class II
Classification Name	Instrumentation for clinical multiplex test systems
Regulation Number	862.2570
Product Code	OOI
Predicate Devices	BD Viper TM System (K081825)

Device Description

Intended Use

A comparison of the BD Viper LT System with the predicate BD Viper System is summarized below.

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510(k) Summary

Image /page/1/Picture/1 description: The image shows the BD logo, which consists of a stylized sun and human figure on the left, followed by the letters 'BD' in bold font. Below the letters, there is a tagline that reads 'Helping all people live healthy lives'. The logo is simple and conveys a message of health and well-being.

BD Viper™ LT System

Table 1 Comparison to Predicate Device

	BD Viper System(K081825)	BD Viper LT System(K140447)
Intended Use	The BD Viper System, whenused with the BD ProbeTecamplified nucleic assay(s), isintended for the in vitrodetection of targetedorganisms from specimens asidentified in the assay-specificreagent package insert(s).	The BD Viper LT System is intended for invitro diagnostic (IVD) use in clinicallaboratories to perform automatedextraction of nucleic acids from multiplespecimen types, amplification of targetnucleic acid sequences by StrandDisplacement Amplification (SDA), anddetection of amplified nucleic acids using atwo color fluorescence detection system.The BD Viper LT is for in vitro diagnosticuse only with tests labeled for use on thesystem
Technology	Strand DisplacementAmplification (SDA)	Strand Displacement Amplification (SDA)
Assay Results	Qualitative	Qualitative

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, ,

Instrument Specifications

Internal studies were conducted to validate the instrument specifications presented in Tables 2-3.

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510(k) Summary

Image /page/2/Picture/1 description: The image contains the BD logo. The logo consists of a stylized sun-like graphic on the left and the letters "BD" on the right. Below the letters, there is some text that reads "Helping all people live healthy lives."

BD Viper™ LT System

Thermal Specifications Table 2

Pre-warm heater fluid temperature	100°c >=9 min. not to exceed 115°c > 8 min
Priming heater fluid temperature	70°c ±2.0°c
Amplification heater fluid temperature	52.5°c ± 1.0°c
Temperature Accuracy: ±0.75°c; Temperature Uniformity: ±0.75°c

・・・・

Table 3 Optical Specifications

WaveLength	Set 1 (Green Channel)	Set 2 (Orange Channel)
Excitation	460-480 nm	575-597 nm
Emission	505-515 nm	610-630 nm
Maximum optical crosstalk ≤ 0.5%

Clinical Performance Characteristics

Clinical utility of the BD Viper LT System was assessed during clearance of the BD ProbeTec GCQ Amplified DNA Assay as presented in a separate premarket submission (K140448).

Conclusions

The submitted information for the BD Viper LT System supports the determination of substantial equivalence in accordance with the intended use as stated in the product labeling.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service .

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

BECTON, DICKINSON AND COMPANY SHERMA WINSTON, M.S. REGULATORY AFFAIRS PROJECT MANAGER 7 LOVETON CIRCLE SPARKS MD 21152

May 20, 2014

Re: K140447

Trade/Device Name: BD Viper LT System Regulation Number: 21 CFR 862.2570 Regulation Name: Instrumentation for clinical multiplex test systems Regulatory Class: II Product Code: OOI Dated: February 20, 2014 Received: February 21, 2014

Dear Ms. Winston:

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. Please note: CDRH does not evaluate information related to contractly and warranties. We remind you, however, that device labeling must be truthful and not musicading,

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major repulations 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: registred. - Tou hilast CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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Page 2-Ms. Winston

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

John Hobson -S for

Sally A. Hoivat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K140447

Device Name BD Viper™ LT System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

ال Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

12 14 6 1 1 6 1 1 2 1 2 1 2 1 5 FOR FDA USE ONLY 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

John Hobson -S 2014.05.20 09:36:58 -04

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Regulation Number and Section

§ 862.2570 Instrumentation for clinical multiplex test systems.

(a)
Identification. Instrumentation for clinical multiplex test systems is a device intended to measure and sort multiple signals generated by an assay from a clinical sample. This instrumentation is used with a specific assay to measure multiple similar analytes that establish a single indicator to aid in diagnosis. Such instrumentation may be compatible with more than one specific assay. The device includes a signal reader unit, and may also integrate reagent handling, hybridization, washing, dedicated instrument control, and other hardware components, as well as raw data storage mechanisms, data acquisition software, and software to process detected signals.(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. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems.” See § 862.1(d) for the availability of this guidance document.