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, training, assessment, and other related activities.

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 the system, collecting data from pulmonary instruments, calculating lung-function test, stress, and training parameters, entering 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, leads, tubes, and valves connecting the instruments and computer, and an optional cart for normalizing expansion. In addition, optional physiologic sensing equipment (including exercise electrocardiographs, pulse oximeters, etc.) may supply data to the LFL to provide expanded testing capability.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ZAN Lung-Function Lab, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for the ZAN Lung-Function Lab primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant standards, rather than defining explicit acceptance criteria for specific performance metrics with target values to achieve. However, based on the text, we can infer some performance expectations and the reported compliance.

Acceptance Criteria (Inferred from text)	Reported Device Performance
Conformance to international consensus standards (e.g., EN 60601-1, EN 60601-1-2) for safety and electromagnetic compatibility.	Proprietary components "demonstrate conformance" to these standards.
Measurement performance meets or exceeds "published American Thoracic operating conditions" requirements under stated and anticipated operating conditions.	"In-house and third-party testing demonstrate that the LFL measurement performance meets or exceeds published American Thoracic operating conditions requirements under stated and anticipated operating conditions."
Effective and safe use in actual-use conditions by patients and clinicians.	"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."
Accuracy for CO analyzer (0.2% CO test gas)	<1%
Accuracy for CH4 analyzer (0.3% CH4 test gas)	1%
Accuracy for O2 analyzer	0.1%
Accuracy for CO2 analyzer	0.1%
Accuracy for Flow Sensor (pressure transducer)	0.1%
Accuracy for Mouth/Nasal pressure sensing (pressure transducer)	0.1%
Accuracy for Body Plethysmograph (pressure transducer)	0.05%
Max linearity error for Flow Sensor	2.5% (corrected)
Flow resistance for Flow Sensor	<0.03 kPa/l/s
Effective dead space for Flow Sensor	<50 ml
Additional dead space for Shutter valve	<30 ml
Neutral point drift for CO analyzer	<2% per week
Neutral point drift for CH4 analyzer	<2% per week

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

Test Set Sample Size: The document does not explicitly state a specific "test set" sample size in terms of patient numbers. The effectiveness claims are based on "in-house and third-party testing" against published operating conditions and comparison to competing units/simulation systems. The clinical performance refers to "years of successful operation in Europe" but not a structured clinical study for this 510(k) submission.
Data Provenance:
- Effectiveness Testing: "In-house and third-party testing" (no specific country mentioned, likely Germany where the company is based, and potentially in the US for third-party). The nature of this testing (bench, in-vitro) suggests it's not patient-based in the traditional sense of a clinical trial.
- Clinical Performance: "CE marking and years of successful operation in Europe" indicates retrospective data from real-world use in Europe.

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

The document does not describe a clinical study with human experts establishing ground truth for a test set. The performance claims are primarily based on:

Engineering and bench testing against recognized standards.
Comparison to predicate devices.
Comparison to "published American Thoracic operating conditions requirements."
"Gas exchange was tested against a simulation system."

There is no mention of a ground truth established by a panel of experts for the technical performance tests. The clinical performance statement refers to safe and effective use by "patients and clinicians" in Europe, implying general clinical acceptance rather than a specific expert-driven ground truth assessment for this submission.

4. Adjudication Method for the Test Set

Not applicable. As described above, there's no patient-based test set with ground truth established by experts that would require an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. The document makes no mention of an MRMC study comparing human readers with and without AI assistance. The ZAN Lung-Function Lab is a diagnostic measurement device for pulmonary function, not an AI-assisted interpretation tool for images or other complex data that would typically involve an MRMC study.

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

The device itself is a measurement system that provides quantitative pulmonary function data. Its performance, as described, is inherently "standalone" in the sense that the sensors and analyzers produce the measurements. There isn't an "algorithm only" performance being evaluated separate from the physical device taking measurements, as it is a complete system. The measurements are then used by clinicians.

7. The Type of Ground Truth Used

The ground truth for the performance claims appears to be:

For Safety and Effectiveness: Recognized international consensus standards (e.g., EN 60601-1) and "published American Thoracic operating conditions requirements," as well as "test gases of known compositions" and "simulation system" for gas exchange analysis.
For Equivalence: The performance characteristics and technologies of the predicate devices (SensorMedics Vmax and Collins CPL).
For Clinical Use: "Years of successful operation in Europe" implying real-world clinical outcomes and acceptance.

8. The Sample Size for the Training Set

Not applicable. This device is a measurement instrument, not an AI/machine learning model that undergoes a "training set" for classification or prediction. Its operation is based on established physical and chemical principles and algorithms for calculating pulmonary function parameters from measured values.

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

Not applicable, as there is no "training set" in the context of machine learning. The device's underlying principles and calibration would be based on fundamental scientific understanding and established clinical standards (e.g., American Thoracic Society guidelines).

Summary

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DEC 2 2 2005

510(k) Number K052328

Date 12/12/05

ZAN Lung-Function Lab 510(k) Summary

Submitter
Company:	ZAN Messgeräte GmbHSchlimpfhofer Strasse 14, D-97723 Oberthulba, GermanyTel +49 97 36 81810, Fax +49 97 36 818120
Contact:	Jim LewisFerraris Respiratory Inc, 908 Main Street, Louisville CO 80027, USATel 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 .

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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.

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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

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 <5 ml <1 ml/s FlowSensor Type 2a

Mouth/Nasal pressure sensing:
Semiconductor; 0 to 7 kPa; 0.1% accuracy
Pressure transducer: Type of applied part: BF (subject floating) .
Enclosure rating: IPX1 .
Power supply: 12 VDC, 950 mA 4

FlowSensor Type 2a

POM (polyoxymethylene) . Material:
Matehal: t
Range:0 to 15 l/s, bi-directional .
2.5% Max linearity error (corrected): ●
Flow resistance: <0.03 kPa/l/s .
Effective dead space: <50 ml .

Shutter valve for mouth/nasal pressure reading

Dimensions: 140x55x50 mm .
<30 ml Additional dead space: .
Power supply: 12 VDC, 1.6 A .

Diffusion-gas analyzer

Module

Dimensions: 160x60x200 mm .
Weight: 250 d .
Case material: ABS .
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Power: .
IPX0 Enclosure rating: .

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CO analyzer

Infrared absorption Technology: .
Measurement range: 0 to 3000 ppm t
<1% Accuracy: .
<2% per week Neutral point drifft: .
<1% Linearity: .

CH4 analyzer

Infrared absorption Technology: .
Measurement range: 0 to 3000 ppm t
Accuracy: 1% t
<2% per week Neutral point drift: .
<1% Linearity: ●

Test gas

0.2% CO, 0.3% CH4, 99.5% synthetic air

Gas-exchange analyzer

Module

24 VDC, 3 A max . Power:
IPX0 Enclosure rating: .

O2 analyzer

Optical spectrometer Technology: .
Measurement range: 0 to 100% .
0.1% . Accuracy:
0.1% Resolution: .
0.2% Linearity: .

CO2 analyzer

Infrared absorption Technology: .
Measurement range: 0 to 10% ●
0.1% . Resolution:
0.1% Accuracy: .
0.1% Linearity: .

Body Plethysmograph

. Power:
12 VDC, 5 A & 24 VDC, 3 A max
Pressure transducer: Semiconductor; ±0.25 kPa;0.05% accuracy . .
- Security glass and aluminum Case materials:

Adult enclosure

71x87x174 cm Dimensions: .
980 L Volume: .
145 kg Weight: .

Child enclosure

Dimensions: 58x63x130 cm .
380 L Volume: .
85 kg Weight: .

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Summary of Non-Clinical Performance Data

Safety

Proprietary components of the LFL have been examined and bench tested by third-party Propretary components of the EFE have boor oxaminored international consensus standards.
examiners to demonstrate conformance to three recognized international device of the examiners to definonstrate conformance to the counce a medical-device safety, EN
for safety of medical electrical equipment: EN 60601-1 for generation compatibility for saley of medical electrical equipmont. EN 60601-1-2 for electromagnetic compatibility.

Effectiveness

In-house and third-party testing demonstrate that the LFL measurement performance meets or In-flouse and thiru-party tosting domonotic the the warments and the claimed performance exceeded published American Thoracle operating conditions. Cardiopulmonary testing was requirements under stated and annolpated operating contailed measure) and competing units. Gas exchange was tested against a simulation system as well.

Summary of Clinical Performance Data

CE marking and years of successful operation in Europe demonstrate that patients and CE mainling and years of Successful operation in Edrope conditions and that the users
clinicians can safely and effectively use the LFL under actual-use condition LFL evetsma clifficians can salely and encothory aco the him an-factor characteristics of the LFL system are appropriate for the product's intended use.

Equivalence to Predicate Devices

The LFL design uses similar technologies and design principles as its predicate vices. The The LFL design uses similar to the SensorMedics Vmax and the Collins CPL: using similar System is substantially equivalorition, material, and energy source; and meeting the same measurement principies, bonotraction, thatened, the LFL adds a few more calculated features, performance characteristics and intonecolor output, and reports a slightly different list Such as the Indiced Frok I mollo for implied carated the CPL. However, these calculations of spiromethe and productou falses if forms and parameters for presenting pulmonary and reports are recognized allemate formed and participants or new claims or uses.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 2 2005

Zan Messgerate GMBH C/O Mr. Jim Lewis Ferraris Respiratory, Incorporated 908 Main Street Louisville, Colorado 80027 ·

Re: K052328

Trade/Device Name: ZAN LUNG-FUNCTION LAB Regulation Number: 868.1880 Regulation Name: Pulmonary-Function Date Calculator Regulatory Class: II Product Code: BZC and BZG Dated: December 1, 2005 Received: December 2, 2005

Dear Mr. Lewis:

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.

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Page 2 - Mr. Lewis

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.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/cdrh/industry/support/index.html.

Sincerely yours,

Shula M. Murghy, MD, FACOG
12/22/

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

K052328

Device Name: ZAN Lung-Function Lab

Indications for Use:

ZAN Lung-Function Lab is used to measure or monitor pulmonary function in adult and pediatric ZAN Lung-1 ancilon East is about to moders of raining, and stress testing) or while at rest subjects during excroloo (increating chasmass diffusion capacity, body (including Spiromotify, andrey, on shipment, and indirect cardiac output) for diagnosis, pictrySmography, nathleneement, and other related activities.

Prescription Use __ V (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Division of Anesthoology, Infection Control, Devices

510(k) Number: "

ZAN Lung-Function Lab --------------------------------------------------------------------------------------------------------------------------------------------------------

Intended Use

4.1

Regulation Number and Section

§ 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).