(426 days)
K911626/B
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No
The description mentions a "structured computer program" and "mathematical computations {proprietary algorithm}", which are typical of traditional software and algorithms, not necessarily AI/ML. There is no mention of learning, training data, or adaptive capabilities characteristic of AI/ML.
No
Explanation: The device is a computerized hematology system designed to measure 16 whole blood parameters for clinical applications. It performs analysis and display of blood cell parameters and processes test results, making it a diagnostic device rather than a therapeutic one.
Yes
The device is described as a "computerized, enhanced electronic Hematology System designed for clinical applications to allow 16 whole blood parameters to be measured." Measuring blood parameters for clinical applications is a diagnostic function.
No
The device description explicitly states it is a "computerized, enhanced electronic Hematology System" and a "microprocessor based device" that "sits on any desktop," indicating it is a physical instrument with hardware components, not solely software.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's designed for "clinical applications to allow 16 whole blood parameters to be measured." Measuring parameters in whole blood is a classic example of an in vitro diagnostic test.
- Device Description: The description details how the device processes and analyzes "test results" from blood samples to provide "blood parameters." This aligns with the function of an IVD device.
- Input: While not explicitly stated as an "imaging modality," the input is clearly "whole blood," which is a biological specimen used in in vitro testing.
The fact that it's a "computerized, enhanced electronic Hematology System" that measures parameters in whole blood for clinical applications strongly indicates its classification as an IVD.
N/A
Intended Use / Indications for Use
The Spirit " , is a computerized, enhanced electronic Hematology System designed for clinical applications to allow 16 whole blood parameters to be measured by a small table top computer driven instrument. This device is designed for use in small to medium clinics.
Product codes
81GKZ
Device Description
The Spirit " is a computerized, enhanced electronic Hematology System designed for clinical applications. It is a small table top computer driven instrument. This device uses three computers, each with a separate task, and less plumbing than its predicate. It is a microprocessor based device that sits on any desktop and provides analysis and display of key blood cells parameters by automatic processing and analyzing test results via a structured computer program. It retains electronically stored data and acts on that data using mathematical computations and computer programming to provide blood parameters. The Spirit is designed to measure multiple whole blood parameters during an unattended mode.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
small to medium clinics
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
K911626/B
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.5220 Automated differential cell counter.
(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”
0
KA60072
MAR -6 1997
Exhibit 14 Summary of Safety & Effectiveness
The Spirit " , is a computerized, enhanced electronic Hematology System designed for clinical applications to allow 16 whole blood parameters to be measured by a small table top computer driven instrument. BioChem immunesystems Incorporated has a history of developing such systems and offers this device as a technological innovational Hematology Systems. This device is designed for use in small to medium clinics. As such, this device, having, Classification Name: Electronic Hematology System, Product Code: 81GKZ as described in 21 CFR Part 864.5220. BioChem Immunosystems Incorporated has determined that this device is substantially equivalent to a predical device which is currently in commerce and has been submitted to the FDA via K911626/B as an electronic Hematology instrument and is identified as the System 9000 Plus, (Model 9018) also marketed by BioChem Immunosystems Incorporated.
A determination of substantial equivalence is based upon:
This device uses the same tried and proven chemistry but with fewer hardware parts. Instead of one computer, this new instrument would use three computers, each with a separate task as the process continued. The Spirit " uses more computers and less plumbing. Each process yields a higher throughput of analytical data resulting in a system easier to use, lower in oost and easier to maintain in the field.
The Spirit" Hematology System is a microprocessor based device which is designed to provide identical function as the System 9000 Plus, (Model 9018). This compact device sits on any desktop. It provides a fathful analysis and display of key blood cells parameters by automatic processing and analyzing test results via a structured computer program. Both the System 9000 Plus, (Model 9018) retain an electronically stored data and act on that data using mathematical computations {proprietary algorithm}and computer programming {stored in a Electronic media and PROM}to provide blood parameters.
Both the Spirit " and the System 9000 Plass, (Model 9018) are designed to measure multiple whole blood parameters during an unattended mode. Both provide the same acoustic qualities as the conventional Hematology System. Both devices retain a electronically stored sample and act on that sample using mathematical computations {proprietary algorithm} and computer programming stored in electronic memory to count whole blood parameters and issue measurements data relating to a specific patient/session for analysis. Neither device has claims or, is offered as, laboratory analysis equipment. Where either device is used, traditional medical practice requires additional analysis for any authentic diagnosis.
The Spirit m provides a facility to analyze whole blood on a repeatable basis with conventional accuracy. as also does the System 9000 Plus, (Model 9018).
The Spirit to has benefited from design, development, testing and production procedures that conform to Good Manufacturing Procedures. This device has performance characteristics substantially equivalent to its predicate device yet includes improvements to facilitate the various clinical applications for which it is intended.
This device is safe and effective for the application for which it is intended and has been tested to confirm safety and efficacy BioChem Immunosystems Incorporated continues to search all appropriate sources for information relating to safety and effectiveness and maintains an in-house reporting system to identify adverse safety and effectiveness information and as such, applicable data is recorded for this product.
CERTIFICATION: I hereby gertify that this Summary of Safety and Effectiveness applies for the above indicated device.
Laurence Potter
Mr. Laurence Potter Director, Regulatory Affairs, Quality Assurance BioChem Immunosystems Incorporated 100 Cascade Drive Allentown, PA 18103-9562 Tel 610 266 4315 Fax 610 266 0184
12/27/95
Date Signed
Date Signed