ZAN LUNG-FUNCTION LAB

{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<br>Schlimpfhofer Strasse 14, D-97723 Oberthulba, Germany<br>Tel +49 97 36 81810, Fax +49 97 36 818120 | | Contact: | Jim Lewis<br>Ferraris Respiratory Inc, 908 Main Street, Louisville CO 80027, USA<br>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 <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: . {3}------------------------------------------------ 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: . {4}------------------------------------------------ ### 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. {5}------------------------------------------------ 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. {6}------------------------------------------------ #### 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 {7}------------------------------------------------ # 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