(295 days)
Not Found
No
The device description details standard signal processing and calculation methods (calibration polynomial algorithm, integration) for spirometry data. There is no mention of AI or ML techniques for data analysis, interpretation, or diagnosis.
No.
Explanation: The device is used to evaluate pulmonary function and monitor the effects of disease and interventions, but it does not directly provide therapy. It is a diagnostic and monitoring tool.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is used to "evaluate pulmonary function" and that "These measures are used in the diagnosis and monitoring of lung diseases". The "Device Description" also refers to the software as running the "diagnostic spirometer application".
No
The device description clearly outlines hardware components including a handheld spirometer with a pressure transducer, analog to digital converter, USB microcontroller, flow sensor, and mouthpiece. While software is used for data processing and display, it is dependent on and integrated with these physical components.
Based on the provided text, the Spiro-Master PC-10 Spirometry System is an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use explicitly states that the measures acquired are "used in the diagnosis and monitoring of lung diseases and interventions for the treatment of certain lung diseases." This directly aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. While the device measures exhaled breath (a specimen from the body), the key is that the information derived from this measurement is used for diagnostic and monitoring purposes.
- Evaluation of Pulmonary Function: The device is intended to "evaluate pulmonary function," which is a key aspect of diagnosing and monitoring respiratory conditions.
- Specific Indications for Use: The detailed list of indications for use further supports its IVD nature, as it outlines how the device's output is used to assess symptoms, effects of disease, risk factors, treatment responses, and the course of disease.
While the device itself is a physical instrument that measures airflow, the crucial factor is how the data it collects is used in a clinical context. The intended use and indications clearly demonstrate that the Spiro-Master PC-10 Spirometry System provides information that is directly utilized for diagnostic and monitoring purposes related to lung diseases, which falls under the scope of IVD devices.
N/A
Intended Use / Indications for Use
The Spiro-Master PC-10 Spirometry System is intended to acquire, view, store and print measures and waveforms of the exhaled breath of a person and evaluate pulmonary function These measures are used in the diagnosis and monitoring of lung diseases and interventions for the treatment of certain lung diseases The spirometer should only be used with pattents able to understand the instructions for performing the test
The Spiro-Master PC-10 Spirometry System is indicated for use with people of all ages, of either gender, excluding infants and neonates, to acquire, view, store and print measures and waveforms of the exhaled breath of a person and evaluate, access, describe, measure, or monitor
- Symptoms, signs, or abnormal laboratory tests 1
- Effects of disease on pulmonary function 2
- 3 Individuals at risk for pulmonary disease
- 4 Preoperative risk
- 5 Post-surgical prognosis
- ર્ભ Pre-treatment health status
- 7 Therapeutic interventions
- 8 The course of disease affecting lung function
- 9 Persons exposed to pollutants
- Adverse reactions to drugs with known pulmonary toxicity 10
- Rehabilitation programs 11
- Risks as part of an insurance evaluation 12
- Individuals for legal reasons 13
- 14 Epidemiological surveys
- Derivation of reference equations । રે
Product codes (comma separated list FDA assigned to the subject device)
BZG
Device Description
The "Spiro-Master PC-10 Spirometry System" is a handheld spirometer that connects to a Personal Computer (PC) via a Universal Serial Bus (USB 11 and 20) cable Windows 10-based software on the PC runs the diagnostic spirometer application.
The device consists of a plastic handle which houses the amplified pressure transducer, analog to digital converter. USB microcontroller and connection via a USB cable The electronics in the handle are powered by the 5 volts DC of the PC USB port The top of the handle has a connection for the flow sensor, which connects to the mouthpiece.
A Pneumotach sensor is incorporated into the Spiro-Master PC-10 Spirometry System to detect arrilow The flow sensor consists of two flow tubes that connect to each other around a sensor mesh ring which provides flow resistance A differential pressure across the mesh is generated depending on the inhalation/exhalation strength of the person being tested Inside the flow tube, the front and back of the mesh is connected to a pressure sensor through pressure outlet ports and tubes This differential pressure transducer measures the pressure difference across the flow sensor (mesh ring) as the air-stream passes through it The resulting pressure change is converted to a signal proportional to the airflow rate.
The patient places their mouth on the mouthpiece, which is connected to a bacterial filter (KoKo Moe White Filter) between the mouthpiece and the sensor The mouthpiece is a single-use, disposable component.
The patient breathes as instructed through the mouthpiece The pressure transducer in the handle continuously transmits the differential pressure in the flow tube to the analog to digital converter The digitized 12 bit data is sent to the PC via the USB cable at 12 bit samples per second The Spiro-Master PC-10 Spirometry System application software (which requires Windows 98 or later), calculates the flow and integrates the flow to calculate volume The flows are calculated from the 12 bit data stream by applying a calıbration polynomial algorithm All flow and volume data are calculated in real tıme for the flow-volume measurements which includes Peak Flow, Forced Vital Capacity, Forced Expiratory Flows Forced Inspiratory Vital Capacity as well as FEF and FIVC.
The spirometer technician/operator uses the software on the PC to perform the tests The software includes a number of screens and 'buttons' that assust to logically perform the tests in the correct order The tests can be saved to the PC hard drive, printed (report format) and recalled for later review There are various parameters that are displayed to assust the technician in the quality control of the test procedure per the ATS 1994 update and the ATS 2005 standards The system calıbration procedure requires sıx (6) varyıng strokes from a three (3) liter syringe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
all ages, of either gender, excluding infants and neonates
Intended User / Care Setting
qualified cluncian desires to take lung function measurement such as in hospitals, clinics, physicians' offices, laboratories and industrial health screenings
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.1840 Diagnostic spirometer.
(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).
0
510(k) Summary
a. Owner/Company name, address CHEST MI , INC
3-6-10 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan
Mr Norıo Suzukı Quality Assurance Specialist Phone 011-81-3-3812-7271 Fax 011-81-3-3812-7496 Email bck04184@nifty com
b. Contact/Application Correspondent
Fumıakı Kanaı, Ph D President and CEO MIC International 4-1-17 Hongo, Bunkyo-ku Tokyo, 113-0033, Japan
011-81-3-3818-8577 Phone Fax 011-81-3-3818-8577 Email fkanaı@micinternational com
c. Date prepared
January 14, 2008
d. Name of device
| Trade Name | Spiro-Master PC-10 Spirometry System |
|---|---|
| Common Name | Diagnostic spirometer |
| Classification Name | Diagnostic spirometer |
| Classification Regulation | 21 CFR 868 1840 |
e. Predicate devices
The Spiro-Master PC-10 Sprometry System is substantially equivalent to the following legally marketed devices
| 510(k) | K020102 |
|---|---|
| Trade name | IQTeQ Spirometer 2001 |
| Product code | BZG |
| 510(k) | K002499 |
| Trade name | Brentwood IQMarkTM Digital Spirometer |
| Product code | BZG |
SPIRO-MASTER PC-10 SPIROMETRY SYSTEM (K080921)
JAN 2 1 2009
1
SPIRO-MASTER PC-10 SPIROMETRY SYSTEM PREMARKET NOTIFICATION 510(k)
f. Description of the device
The "Spiro-Master PC-10 Spirometry System" is a handheld spirometer that connects to a Personal Computer (PC) via a Universal Serial Bus (USB 11 and 20) cable Windows 10-based software on the PC runs the diagnostic spirometer application
The device consists of a plastic handle which houses the amplified pressure transducer, analog to digital converter. USB microcontroller and connection via a USB cable The electronics in the handle are powered by the 5 volts DC of the PC USB port The top of the handle has a connection for the flow sensor, which connects to the mouthpiece
Image /page/1/Picture/5 description: The image shows a laptop computer next to a piece of equipment. The equipment has a cylindrical component at the top, which is connected to a rectangular base by an arm. A cable is connected to the base of the equipment. The laptop is open and the screen is visible.
Spiro-Master PC-10 Spirometry System Figure 1
A Pneumotach sensor is incorporated into the Spiro-Master PC-10 Spirometry System to detect arrilow The flow sensor consists of two flow tubes that connect to each other around a sensor mesh ring which provides flow resistance A differential pressure across the mesh is generated depending on the inhalation/exhalation strength of the person being tested Inside the flow tube, the front and back of the mesh is connected to a pressure sensor through pressure outlet ports and tubes This differential pressure transducer measures the pressure difference across the flow sensor (mesh ring) as the air-stream passes through it The resulting pressure change is converted to a signal proportional to the airflow rate
Image /page/1/Figure/8 description: The image shows a diagram of a flow sensor. The air flows through a pipe, and a flow sensor mesh ring is placed in the middle of the pipe. The pressure difference (ΔP) is measured, and the data is sent to a processor, which outputs measurement values.
Figure 2 Block diagram of air flow detection circuit
2
The patient places their mouth on the mouthpiece, which is connected to a bacterial filter (KoKo Moe White Filter) between the mouthpiece and the sensor The mouthpiece is a single-use, disposable component.
Image /page/2/Figure/3 description: The image shows a diagram of a device with several components. The components are labeled as "Mouthpiece", "Bacterial filter", and "Sensor". An arrow shows the direction of flow from the mouthpiece to the bacterial filter and then to the sensor. A note says, "Check to be sure that the sensor is connected in the correct direction".
Figure 3 Patient connection components
The patient breathes as instructed through the mouthpiece The pressure transducer in the handle continuously transmits the differential pressure in the flow tube to the analog to digital converter The digitized 12 bit data is sent to the PC via the USB cable at 12 bit samples per second The Spiro-Master PC-10 Spirometry System application software (which requires Windows 98 or later), calculates the flow and integrates the flow to calculate volume The flows are calculated from the 12 bit data stream by applying a calıbration polynomial algorithm All flow and volume data are calculated in real tıme for the flow-volume measurements which includes Peak Flow, Forced Vital Capacity, Forced Expiratory Flows Forced Inspiratory Vital Capacity as well as FEF and FIVC
The spirometer technician/operator uses the software on the PC to perform the tests The software includes a number of screens and 'buttons' that assust to logically perform the tests in the correct order The tests can be saved to the PC hard drive, printed (report format) and recalled for later review There are various parameters that are displayed to assust the technician in the quality control of the test procedure per the ATS 1994 update and the ATS 2005 standards The system calıbration procedure requires sıx (6) varyıng strokes from a three (3) liter syringe
3
Image /page/3/Picture/35 description: The image shows a simple line drawing of a cube. The cube is drawn in a way that emphasizes its three-dimensional form. The lines are thin and black, and the background is white.
g. Intended Use, Indications for Use, and Environment
Intended Use
The Spiro-Master PC-10 Spirometry System is intended to acquire, view, store and print measures and waveforms of the exhaled breath of a person and evaluate pulmonary function These measures are used in the diagnosis and monitoring of lung diseases and interventions for the treatment of certain lung diseases The spirometer should only be used with pattents able to understand the instructions for performing the test
Indication for Use
The Spiro-Master PC-10 Spirometry System is indicated for use with people of all ages, of either gender, excluding infants and neonates, to acquire, view, store and print measures and waveforms of the exhaled breath of a person and evaluate, access, describe, measure, or monitor
- Symptoms, signs, or abnormal laboratory tests 1
- Effects of disease on pulmonary function 2
- 3 Individuals at risk for pulmonary disease
- 4 Preoperative risk
- 5 Post-surgical prognosis
- ર્ભ Pre-treatment health status
- 7 Therapeutic interventions
- 8 The course of disease affecting lung function
- 9 Persons exposed to pollutants
- Adverse reactions to drugs with known pulmonary toxicity 10
- Rehabilitation programs 11
- Risks as part of an insurance evaluation 12
- Individuals for legal reasons 13
- 14 Epidemiological surveys
- Derivation of reference equations । રે
Environment of Use
Places where a qualified cluncian desires to take lung function measurement such as in hospitals, clinics, physicians' offices, laboratories and industrial health screenings
h. Statement of substantial equivalence
The characteristics of the Spiro-Master PC-10 Spirometry System are similar to those of the predicates described in Item e above The similarities are
- . same intended use
- . same operating principle
- same spirometry parameters �
- same algorithms for spirometry parameters calculation .
- same physical aspect (shape, size and weight) 0
There are no differences regarding safety or effectiveness Refer to Table 1 "Companson Table" on the following two pages for a complete assessment
4
SPIRO-MASTER PC-10 SPIROMETRY SYSTEM
PREMARKET NOTIFICATION 510(k)
m
| Table 1 Comparison Table | ||||
|---|---|---|---|---|
| Characteristic | IQTEQ Spirometer 2001 | Predicate Devices | ||
| Brentwood IQmark™ Digital Spirometer | Spiro-Master PC-10 Spirometry System | |||
| 1 | PC Based | Yes | Yes | Yes |
| 2 | Physical | |||
| configuration | The IQTEQ Spirometer2001 is a handheld | |||
| spirometer that connects to a Personal | ||||
| Computer (PC) via a Universal Serial Bus | ||||
| (USB) port cable connection Windows | ||||
| based software on the PC runs the | ||||
| diagnostic spirometer application | Disposable Pneumotach Mouthpiece with | |||
| handle (containing electronics) that | ||||
| connects directly to PC serial port via | ||||
| cable system software disk for PC | ||||
| installation | Spiro-Master PC-10 is a handheld | |||
| spirometer that connects to a Personal | ||||
| Computer (PC) via a Universal Serial | ||||
| Bus (USB) port cable connection | ||||
| Windows based software on the PC | ||||
| runs the diagnostic spirometer | ||||
| application | ||||
| 3 | Minimum PC | |||
| requirements | Pentium II with USB port, 128mb RAM, | |||
| Windows 98 Second Edition, CD-ROM | ||||
| drive, mouse, and 800X600 screen | ||||
| resolution | Pentium 100 MHz Processor, 16MB RAM | |||
| (Windows 95&98), 32MB RAM | ||||
| (Windows NT), 64MB RAM (Windows | ||||
| 2000 Professional), 10MB HD space, | ||||
| Windows compatible printer | Windows 98, 2000, XP, Vista | |||
| Keyboard, mouse, and a CD-Rom | ||||
| drive | ||||
| VGA display accommodating | ||||
| 1024x786, 1280x1024, or higher | ||||
| resolution | ||||
| At least one USB port | ||||
| 4 | Power source | Power derived from USB port | Disposable Pneumotach Mouthpiece with | |
| handle two series AAA batteries (1 5v) | ||||
| inside handle | Power derived from USB port | |||
| 5 | ATS Spirometry | |||
| performance | ||||
| recommendations | Complies (1994 Update) | Complies (1994 Update) | Complies (1994 Update) | |
| Complies (2005) | ||||
| 6 | Cross | |||
| contamination | ||||
| control | Disposable mouth piece & bacterial filter | Disposable mouth piece & bacterial filter | Disposable mouth piece & bacterial | |
| filter | ||||
| 7 | Flow detection | |||
| principle | Differential pressure Laminar flow | |||
| resistance element | Disposable bi-directional pressure | |||
| differential measuring pneumotach | ||||
| mouthpieces for expiratory/inspiratory | ||||
| testing | Reusable pressure differential | |||
| measuring pneumotach | ||||
| 8 | Flowmeter | |||
| calibration method | Injection of known fixed volume from | |||
| calibrated syringe | Injection of known fixed volume from | |||
| calibrated syringe | Injection of known fixed volume from | |||
| calibrated syringe | ||||
| 9 | Display & printer | |||
| used | PC monitor screen (LCD/CRT) and PC | |||
| printer | PC monitor screen (CRT), alphanumerics | |||
| and graphics | PC monitor screen (LCD/CRT) and PC | |||
| printer |
CONFIDENTIAL
5
| Table 1 Comparison Table (continued) | ||||||
|---|---|---|---|---|---|---|
| Predicate Devices | ||||||
| Characteristic | IQTEQ Spirometer 2001 | Brentwood IQmark Digital Spirometer | Spiro-Master PC-10 | |||
| 10 Graphic output | Flow-Volume loop, | |||||
| Volume/Time graph, | ||||||
| predicted curve | Flow-Volume loop, Volume-Time curve, | |||||
| predicted curve, pre & post bronchodilator | ||||||
| comparison | Flow-Volume loop, Volume/Time | |||||
| graph, predicted curve, pre & post | ||||||
| bronchodilator comparison, | ||||||
| bronchodilator-challenge | ||||||
| 11 Tests performed | FVC, FIVC, PRE/POST Bronchodilator, | |||||
| Flow/Volume Loop, Volume/Time graph, | ||||||
| SVC | FVC, F-V loop, MVV, VC(SVC), IVC, | |||||
| respiratory pattern, PRE/POST | ||||||
| comparisons, bronchodilator-challenge | FVC, MVV, MV, VC(SVC), | |||||
| respiratory pattern, pre/post | ||||||
| comparisons, broncho-challenge | ||||||
| 12 Indices calculated | ||||||
| (bold text indicates | ||||||
| that an index used | ||||||
| by Brentwood | ||||||
| spirometer is also | ||||||
| used by a listed | ||||||
| predicate) | FVC, FEV1, FEV3, FEV6, FEV1/FVC, | |||||
| FEV1/FEV6, PEFR, FEF25%, FEF50%, | ||||||
| FEF75%, FEF25-75, FEF75-85, FIVC, PIFR, | ||||||
| FIV0.5, FIV1, FIV3, FIV1/FIVC, FIF50%, | ||||||
| FET100%, SVC Extrapolated V%, and | ||||||
| V(L), Peak risk time | FVC, FEV0.5, FEV10, FEV30, | |||||
| FEV1/FVC; FEF25-75, FEF75-85, FEF25, | ||||||
| FEF50, FEF75, FEF200-1200, PEF, FIVC, | ||||||
| FIF50, FEF50/FIF50, PIF, MVV, VC, VT, | ||||||
| ERV, RR, tE, Vext, FIV0.5, FIV0.5/FIV0.5, | ||||||
| MVT, IRV | SVC (VC), TV, FVC, FEV0.5, FEV10, | |||||
| FEV30, FEV60, FEV1/FVC, | ||||||
| FEV1/SVC, MMEF, PEF, FEF25, | ||||||
| FEF50, FEF75, FEF25-75, FEF200-1200, | ||||||
| FET, FIVC, FIV0.5, FIV10, PIF, FIF50, | ||||||
| FEF50/FIF50, FIF50/FEF50, MVV, RR, | ||||||
| MV | ||||||
| 13 Predictive models | ||||||
| used (bold text | ||||||
| indicates | ||||||
| predicated model | ||||||
| used by Brentwood | ||||||
| spirometer also | ||||||
| used by predicate) | Crapo, ECCS, Chernisk, Morris, | |||||
| Knudoson1983, Hsu, Schoenberg, | ||||||
| NHANES III 1999 (Hankınson), Plogar | ||||||
| 79 | Adult Kundson 76 & 83, Crapo(ITS), | |||||
| ECCS 93 | ||||||
| Pediatric Plogar 71 and Knudson 76 & | ||||||
| 83u | Crapo-Hsu, ECCS, ITS, Knudson, | |||||
| Morrıs, Polgar, NHANES III 1999 | ||||||
| (Hankınson) |
SPIRO-MASTER PC-10 SPIROMETRY SYSTEM
(K080921)
ATTACHMENT 4
4-6 OF 4-6 OF 4-7
CONFIDENTIAI
SPIRO-MASTER PC-10 SPIROMETRY SYSTEM
PREMARKET NOTIFICATION 510(k)
6
SPIRO-MASTER PC-10 SPIROMETRY SYSTEM PREMARKET NOTIFICATION 510(k)
As with the predicate devices, the Spiro-Master PC-10 Spirometry System has been tested for compliance to the ATS1994 (Update), IEC60601-1 and IEC60601-2 standards In addition the Spiro-Master PC-10 Spirometry System also complies with the ATS2005 standard
Therefore CHEST MI, INC believes that the Spiro-Master PC-10 Spirometry System is substantially equivalent to the predicate devices and does not raise any new questions regarding safety or effectiveness
Conclusion i.
Based on the above discussion and enclosed sections regarding substantial equivalence to predicate devices. CHEST MI. INC concludes that the Spiro-Master PC-10 Spirometry System is substantially equivalent to the IQTeQ Spirometer 2001 (K020102) and the Brentwood IQMark" Digital Spirometer (K002499) and does not raise any new questions regarding safety or effectiveness
7
Image /page/7/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized caduceus, a symbol of medicine and health. The caduceus consists of a staff with two snakes coiled around it, and a pair of wings at the top.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Chest M I , Incorporated C/O Fumiakı Kanaı, Ph D President and Chief Executive Officer MIC International 4-1-17 Hongo Bunkyo-ku Tokyo JAPAN 113-0033
JAN 2 1 2009
Re K080921
Trade/Device Name Spiro-Master PC-10 Spirometry System Regulation Number 21 CFR 868 1840 Regulation Name Diagnostic Spirometer Regulatory Class II Product Code BZG Dated January 14, 2009 Received January 16, 2009
Dear Dr Kanaı
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 affectung 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
8
Page 2 - Dr Kanaı
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 requrements, including, but not hmited to registration and listing (21 CFR Part 807), labeling (21 CFR Part 801), good manufacturing practice requirements as set forth in the quality systems (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807 97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474 For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464 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 (240) 276-3150 or at its Internet address http //www fda gov/cdrh/industry/support/index html
Sincerely yours,
Anthony V. Arintor for
Ginette Michaud, M D Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
Indications for Use
510(k) Number (If known) K080921
Device Name Spiro-Master PC-10 Spirometry System
Intended Use
The Spiro-Master PC-10 Spirometry System is intended to acquire, view, store and print measures and waveforms of the exhaled breath of a person and evaluate pulmonary function These measures are used in the dragnosis and monitoring of lung diseases and interventions for the treatment of certain lung diseases The spirometer should only be used with patients able to understand the instructions for performing the test
Indication for Use
The Spiro-Master PC-10 Spirometry System is indicated for use with people of all ages, of either gender, excluding infants and neonates, to acquire, view, store and print measures and waveforms of the exhaled breath of a person and evaluate, access, describe, measure, or monitor
- Symptoms, signs, or abnormal laboratory tests 1
- 2 Effects of disease on pulmonary function
- 3 Individuals at risk for pulmonary disease
- 4 Preoperative risk
- 5 Post-surgical prognosis
- Pre-treatment health status 6
- 7 Therapeutic interventions
- 8 The course of disease affecting lung function
- 9 Persons exposed to pollutants
- 10 Adverse reactions to drugs with known pulmonary toxicity
- Rehabilitation programs l I
- 12 Risks as part of an insurance evaluation
- 13 Individuals for legal reasons
- 14 Epidemiological surveys
- ા ર Derivation of reference equations
Environment of Use
Places where a qualified clinician desires to take lung function measurement such as in hospitals, clinics, physicians' offices, laboratories and industrial health screenings
Image /page/9/Picture/24 description: The image shows the words "Prescription Use" followed by the text "(Per 21 CFR 801 Subpart D)". There is a large "X" marked over the words "Prescription Use". The text is in black font and is on a white background.
AND/OR
Over-the Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
A
(P
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number K080921