(119 days)
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No
The description focuses on standard pulmonary function testing equipment and data processing, with no mention of AI or ML algorithms for analysis or interpretation. The performance studies are based on standard bench testing and clinical use history, not on the evaluation of AI/ML model performance.
No.
The device is used for diagnosis, monitoring, and assessment of pulmonary function, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is used for a variety of assessments, including "diagnosis, training, assessment, and other related activities," and specifically mentions "diagnosis" in the context of exercise and at-rest activities. The predicate devices also include "Diagnostic Instruments," further supporting its diagnostic function.
No
The device description explicitly lists multiple hardware components including pulmonary instruments, test gases, leads, tubes, valves, and an optional cart, in addition to the PC and software.
Based on the provided information, the ZAN Lung-Function Lab is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use describes measuring and monitoring pulmonary function in subjects (adult and pediatric) during exercise or at rest. This involves direct interaction with the patient's respiratory system and measuring physiological parameters.
- Device Description: The device description details a system that collects data from pulmonary instruments (flow sensor, gas analyzers, body plethysmograph) connected to the patient. It calculates lung function parameters based on these measurements.
- Lack of In Vitro Activity: An IVD device is specifically designed to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The ZAN Lung-Function Lab does not perform tests on such specimens. It directly measures physiological responses from the patient's respiratory system.
Therefore, the ZAN Lung-Function Lab is a medical device used for in vivo (within the body) measurement and monitoring of pulmonary function, not an IVD.
N/A
Intended Use / Indications for Use
ZAN Lung-Function Lab is used to measure or monitor pulmonary function in adult and pediatric subjects during exercise (including diagnosis, training, and stress testing) or while at rest (including Spirometry, airway strength and output, diffusion capacity, body plethysmography, nutritional assessment, and indirect cardiac output) for diagnosis, monitoring, and other related activities.
Product codes
BZC, BZG
Device Description
The ZAN Lung-Function Lab (LFL) is a full-featured, PC-based system for professional evaluation of pulmonary function, cardiopulmonary exercise capacity, and metabolism. A personal computer (PC) is the central component of this system, collecting data from pulmonary and/or physiologic instruments, calculating, storing demographic and other subject information, and displaying/reporting the results. The system comprises four pulmonary instruments (flow sensor with airway pressure capability, diffusion-gas analyzer, ventilation-gas analyzer, and body plethysmograph), a PC running a proprietary ZAN test program, test gases of known compositions (as needed), leads, tubes, and valves connecting the instruments and computer, and an optional cart. Optional physiologic sensing equipment (including exercise electrocardiographs, pulse oximeters) may supply data to the LFL for expanded testing capability. The LFL can meet the majority of lung-function testing needs: spirometry, pulmonary-function analysis, cardiopulmonary exercise testing, nutritional assessment, or combined pulmonary-function analysis cardiopulmonary-exercise testing applications.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Adult and pediatric subjects
Intended User / Care Setting
Professional
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Safety: Proprietary components of the LFL have been examined and bench tested by third-party examiners to demonstrate conformance to three recognized international consensus standards: EN 60601-1 for safety of medical electrical equipment; EN 60601-1-2 for electromagnetic compatibility.
Effectiveness: In-house and third-party testing demonstrate that the LFL measurement performance meets or exceeded published American Thoracic Society standards and the claimed performance requirements under stated and anticipated operating conditions. Pulmonary-function testing was compared against a medically approved gold standard unit (for measured and calculated measures) and competing units. Gas exchange was tested against a simulation system as well.
Clinical Performance Data: CE marking and years of successful operation in Europe demonstrate that patients and clinicians can safely and effectively use the LFL under actual-use conditions and that the human-factor characteristics of the LFL system are appropriate for the product’s intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 868.1880 Pulmonary-function data calculator.
(a)
Identification. A pulmonary-function data calculator is a device used to calculate pulmonary-function values based on actual physical data obtained during pulmonary-function testing.(b)
Classification. Class II (performance standards).
0
DEC 2 2 2005
510(k) Number K052328
Date 12/12/05
ZAN Lung-Function Lab 510(k) Summary
| Submitter | |
|---|---|
| Company: | ZAN Messgeräte GmbH |
| Schlimpfhofer Strasse 14, D-97723 Oberthulba, Germany | |
| Tel +49 97 36 81810, Fax +49 97 36 818120 | |
| Contact: | Jim Lewis |
| Ferraris Respiratory Inc, 908 Main Street, Louisville CO 80027, USA | |
| Tel 303 666 5555, Fax 303 666 5588 | |
| Prepared: | August 2005 |
| Device Name | |
| Trade: | ZAN Lung-Function Lab |
| Common: | Pulmonary function test equipment |
| Classification: | Pulmonary-function data calculator, 21 CFR 868.1880; Class II |
| Product code: | 73-BZC |
| Predicate Devices | |
| Trade Name: | CPL Pulmonary Function Test System |
| 510(k) Number: | K992743 |
| Manufacturer: | Ferraris Respiratory, Inc. |
| Trade Name: | Vmax Series Diagnostic Instruments |
| 510(k) Number: | K942211 |
| Manufacturer: | SensorMedics, Inc. |
The ZAN Lung-Function Lab (LFL) is a full-featured, PC-based system for professional i THE ZAN Lung-Function, cardiopulmonary exercise capacity, and metabolism in any evaluation of purmonaly function, our interest instructions and execute the test maneuvers.
A personal computer (PC) is the central component of thi lung-function test, stress, and training A personal computer (1 0) 15 the comic components, calculating System. Collecting udia from pulmonal j auto in month demographic and other subject information, and displaying/reporting the results.
The system comprises
- stem comprises
Four pulmonary instruments flow sensor with airway pressure capability, diffusion-gas . analyzer, ventilation-gas analyzer, and body plethysmograph - A PC running a proprietary ZAN test program .
1
- Test gases of known compositions, as needed .
- Test gases of known compositions, as novements to the subject and to each other
Leads, tubes, and valves connecting the instruments and semputer . - Leaus, lubes, and valvos othe instruments, gases, and computer. .
· · An optional cart for normaling expension · including execrise electrocardiographs,
In addition, optional physiologic sensing equipment · · may supply data to the In addition, optional physiologic seristing equipment -----------------------------------------------------------------------------------------------------------------------pulse oximotors, ide expanded testing capability.
The LFL can meet the majority of lung-function testing needs: spirometry, pulmonary-function The LFL can meet the majority of idig-lunction itsung neously of the "prombined pulmonaryanalysis, cardiopulmonary exercise testing, nutritional assessment, or combined pul analysis, Caralopulmonary-exercise testing applications.
Indications for Use
ZAN Lung-Function Lab may measure or monitor pulmonary function in adult and pediatric
. In the sunder of the county the same in training, and strest ZAN Lung-Function Lad may nieasure of monton pan. ond stress testing) or while at rest
subjects during exercise (including diagnosis, training, siffing sensaily, body subjects during exercise (including diagnoolo, influsion capacity, body, body, body, body, body, body, (including Spirometry, anway strength and output) for diagnosis,
plethysmography, nutritional assessment, and indirect cardiates pleinysmography, nuthtional abossement, and other related activities.
Summary of Technological Characteristics
Caminal Pow sensor measures gas flow rate using pneumotachometry (using differential The LFL flow sensor measures gas now face asing proumotion is a reusable
pressure across a known flow restrictor). The flow path is a reusable of the yeatla pressure across a known flow results). The new patin if the ventilation-gas
element mountable in pneumation to the diffusion-gas module, a static head element mountable in prieumatic communication to the unit to create a static head
module, or the plethysmograph. A shutter may be added to the unit module, or the pietrySthograph. 'A Shater may be acast of the unit.
proceded to the management of the supering of trace amounts of carbon Diffusion capacity is caculated by inspiration and expiract on ing a standard single-breath
monoxide (0.2% CO) and methane (0.3% CH.) in a test gas and measured used monoxide (0.2% CO) and methalle (0.5% Off, in a tool gas are detected and measured using
method or by a CO rebreathing technique. Both trace gases are detected and measured the common infrared absorption method.
പ്രവം (breath-by-breath) analysis techniques of ventilatory gases also use tried-and-true Fast-gas (breath-by-breath) analysis lectiniques or vontation are oxygen (Q2), carbon dioxide (CO2),
techniques. The three gases of interest in ventilation are oxygen (N- is techniques. The three gases of interest in vintialion are engled directly, Ny is calculated
and nitrogen (N₂). Two of these gases, O₂ and CO₂, are measured by and nitrogen (Nz). Two of the sther two gases. Oxygen concention is measured by
knowing the concentrations of the other two gases. Oxygen concention is measured by Knowing the concentrations of the other two gases of the successful of the
opilus in the smography indicates pulmonary parameters and capacities by measuring the Body plethysmography indicates pulmonary punchisered and sample ) compared to flow pressure change in a 'body box' (a sediod diaminamally and good be is well-known and standardized(1) in the industry.
1 American Association for Respiratory Care. Clinical Practice Guideline: Body Plethysmography, 2001 Revision & Update. Respir Care 2001:46(5):506-513.
2
Technical Specifications
- 10 to 40 °C Operating temperature range:
- . Operating temporature fung-forms.
Operating humidity: 10 to 90%, non-condensing . - 0 to 40 °C Storage temperature: .
- 0 to 90%, non-condensing Storage humidity: .
System cart
- 80x55x130 cm Dimensions: .
- 70 kg Weight: .
- /0 kg
Mains power supply and distribution with isolation transformer; shelves to Features: . r eatures.
hold modules, computer, mouse, and display - 120 V, 60 Hz . Power In:
- One 12 VDC, 5 A max; one 24 VDC, 3 A max Power Out: ●
- IPX0 Enclosure rating: .
Flow sense module
t
Flow sensor body
- Dimensions: 100x90x45 mm .
- 250 d Weight: .
- Flow sensing: .
- Pressure transducer: Volume resolution: Flow resolution: Flow sensor:
Semiconductor; 0 to 1.4 kPa; 0.1% accuracy