(104 days)
The FlowScreen / FlowScreen ECG is a diagnostic system for recording and assessing inspiratory and expiratory pulmonary function (spirometry).
In addition it is intended for measuring a 3/6- or 12-channel surface electrocardiogram (ECG) of a patient. The acquired ECG can be recorded and displayed on a screen or printed on paper. 12channel ECGs are analysed automatically and suggestions for the interpretation of the 12-channel ECG can be made by the software.
FlowScreen / FlowScreen ECG can be used for non interpretive applications for patients with an age of 4 years and older and a weight of 20 kg or higher. FlowScreen / FlowScreen ECG is intended for use in routine ECG recording by trained physicians in the office or hospital. FlowScreen ECG is not intended for intracardial use. Automatic interpretation of the ECG is not possible for pediatric patients with an age below 16 years and for pacemaker patients.
FlowScreen CT (Clinical Trial version) incorporates the identical measurements, but individual access rights are defined for different user roles (e.g. Investigator, study nurse, trainer and service personnel).
The interpretation software is intended to support the physician in evaluation the ECG in terms of morphology and rhythm.
A qualified physician has to reassess all FlowScreen measurements. An interpretation by FlowScreen is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the FlowScreen represent partial qualitative and quantitative information on the patient's cardiovascular condition and no therapy or drugs can be administered based solely on the interpretation statements.
The FlowScreen is powered from 100 - 240V / 50 - 60Hz wall outlets. No energy is transferred to the patient.
Federal U.S. law restricts this device to sale by or on the order of a physician.
FlowScreen is an active medical device providing following characteristics:
Mains operation Colour LCD display for user interface Alphanumerical keyboard Colour ink-printer for printout of reports in US-letter and DIN A4 size Patient information and measurements are stored in an internal database Data can be stored on an SD memory card
a) pulmonary functions
Measurement with ultrasonic handle or pneumotach handle .
Slow spirometry (VCin, VCex, VCmax, ERV, IC, VT, IRV, MV, BF, TI, TE, ... )
Forced spirometry (FVCin, FVC, FEV1, PEF, FEV1/FVC, FEF 50, FEF 75, . PIF, ... )
Flow-Volume and Volume-Time Loop, pre/post tests .
MVV measurement
Trending capabilities
Patient Incentive animations
Interpretation modules .
b) ECG functions
. Simultaneous acquisition of the 12 standard leads
Storage of 10 seconds of acquired ECG signal .
Digital filters for base-line drift and mains interference suppression
Interpretation program Hanover ECG System (HES) providing the following . additional information:
Representatives templates of each lead including markers on fiducial O points
Summary of mean measurements O
Rhythm Analysis statements O
Signal noise detection and information O
Specific findings on QRS complex
Conduction statements O
QRS T diagnostic statements O
Arrhythmia monitoring detection o
Heart Rate Variability 0
The provided document (K080734) is a 510(k) premarket notification for a medical device called FlowScreen / FlowScreen ECG / FlowScreen CT. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving efficacy through clinical trials with specific acceptance criteria and performance metrics in the way a PMA (Premarket Approval) submission would.
Therefore, the study design elements typically found in a PMA (like sample sizes for test sets, data provenance for clinical trials, number/qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types for training sets) are not present in this 510(k) submission.
The "acceptance criteria" in this context are primarily related to meeting the performance characteristics of the predicate devices and demonstrating compliance with relevant standards and risk analysis. The "study" refers to non-clinical performance tests and comparisons to predicate devices to establish substantial equivalence.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this 510(k) submission are implied by the comparison to predicate devices and compliance with relevant standards. The performance is reported in terms of being "identical" to the predicate devices across various parameters.
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance (FlowScreen / FlowScreen ECG) | Result |
|---|---|---|---|
| Pulmonary Function | Identical to FlowScreen K062011 | Identical across all listed parameters | Met |
| Intended Use | Diagnostic Spirometry (VCin, VCex, etc.) | Diagnostic Spirometry (VCin, VCex, etc.) | Identical |
| Patient population | Screening device for pulmonary function disorders | Screening device for pulmonary function disorders | Identical |
| Performance | Slow Spirometry, Forced Spirometry, Flow-Volume, MVV, Pre/Post Tests, Trending, Interpretation modules | Slow Spirometry, Forced Spirometry, Flow-Volume, MVV, Pre/Post Tests, Trending, Interpretation modules | Identical |
| Patient user interface | Ultrasonic handle or pneumotach handle | Ultrasonic handle or pneumotach handle | Identical |
| Material of patient user interface | Matches predicate device (Ultem 1010R, Romira ABS 1001 FRVO, Polypropylene RG835MO, Luran S778 TE, HDPE Eraclene MS 80U) | Matches predicate device | Identical |
| Patient contacting accessories | Mouthpiece, Nose clip, Nose pads | Mouthpiece, Nose clip, Nose pads | Identical |
| Material of patient contacting accessories | Nose clip: Polyacetal, Nose pads: Ethylene Vinyl Acetate | Nose clip: Polyacetal, Nose pads: Ethylene Vinyl Acetate | Identical |
| Dimensional specification | 455 x 280 x 380 (W x H x D) | 455 x 280 x 380 (W x H x D) | Identical |
| Software | Data acquisition, calculation, predicted values, analysis, interpretation, storage, output, input | Data acquisition, calculation, predicted values, analysis, interpretation, storage, output, input | Identical |
| ECG Function | Identical to CorScreen K070614 | Identical across all listed parameters | Met |
| Intended Use | 3/6- or 12-channel surface ECG recording device | 3/6- or 12-channel surface ECG recording device | Identical |
| Input dynamic range | +/- 300mV @ DC | +/- 300mV @ DC | Identical |
| Frequency response Bandwidth | 0.05 - 150 Hz / According to EC11 and IEC 60601-2-51 | 0.05 - 150 Hz / According to EC11 and IEC 60601-2-51 | Identical |
| A/D conversion | 24 bits | 24 bits | Identical |
| Leads | 12 Standard | 12 Standard | Identical |
| Paper Speed | 25-50 mm/s +/-5% According to EC11 | 25-50 mm/s +/-5% According to EC11 | Identical |
| Recorder Sensitivity | 5, 10, 20 mm/s According to EC11 | 5, 10, 20 mm/s According to EC11 | Identical |
| Writing System | Ink-printer US-letter and DIN-A4 size | Ink-printer US-letter and DIN-A4 size | Identical |
| Printed Channels | 1/2/6/12 | 1/2/6/12 | Identical |
| Paper | US-Letter and DIN-A4 | US-Letter and DIN-A4 | Identical |
| Mode of operation | Manual | Manual | Identical |
| Input/output | SD Memory card | SD Memory card | Identical |
| Display Size | 320 x 240 pixels | 320 x 240 pixels | Identical |
| No. of displayed channels | 1/3/6/12 | 1/3/6/12 | Identical |
| Trace speeds | 5, 10, 25, 50 mm/s | 5, 10, 25, 50 mm/s | Identical |
| Sensitivity | 5, 10, 20, 40 mm/mV | 5, 10, 20, 40 mm/mV | Identical |
| Hardware/Software Platform | Identical to predicate device components | Identical across all listed components | Met |
2. Sample size used for the test set and the data provenance
Not applicable in this 510(k) submission as it relies on substantial equivalence to predicate devices and non-clinical performance and safety testing. There is no mention of a clinical "test set" with patient data in the context you would expect for an AI/CADe device. The document mentions "validation test script" and "validation test log" for non-clinical performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not mentioned as part of the 510(k) submission. For ECG interpretation, the device includes an "interpretation program Hanover ECG System (HES)" which provides "suggestions for the interpretation." The document explicitly states: "A qualified physician has to reassess all FlowScreen measurements. An interpretation by FlowScreen is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the FlowScreen represent partial qualitative and quantitative information on the patient's cardiovascular condition and no therapy or drugs can be administered based solely on the interpretation statements." This indicates the device is a diagnostic aid, and expert human review is mandated, rather than relying on an expert consensus for algorithmic ground truth.
4. Adjudication method for the test set
Not applicable. No clinical test set with human expert review and adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. No MRMC study or assessment of human reader improvement with AI assistance is mentioned. The device's ECG interpretation software is described as providing "suggestions" to "support the physician," implying it's an aid, but no comparative effectiveness study is presented.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device does perform "automatic analysis" and "suggestions for the interpretation" for 12-channel ECGs. However, the regulatory submission does not provide specific standalone performance metrics (e.g., sensitivity, specificity) for this automatic analysis compared to a ground truth established by experts. Instead, it relies on the substantial equivalence of the ECG module to the predicate CorScreen K070614, which presumably had its performance validated earlier. Critically, the device explicitly states that a "qualified physician has to reassess all FlowScreen measurements," meaning it's not approved for standalone interpretation without human oversight.
7. The type of ground truth used
For the non-clinical performance tests ("validation test script" and "validation test log"), the ground truth would be against engineering specifications and industry standards (e.g., IEC 60601-1, IEC60601-2-25, EN60601-2 for safety and EMC, and EC11 for ECG paper speed and sensitivity). For the inherent 'intelligence' (like the HES interpretation program), the ground truth and its establishment are not detailed in this submission; it's assumed to be part of the predicate device's prior approvals or an established algorithm.
8. The sample size for the training set
Not applicable. This 510(k) submission does not provide information about a training set for an AI algorithm. The predicate HES interpretation program's training data (if any) is not discussed here.
9. How the ground truth for the training set was established
Not applicable. As no training set information is provided, how its ground truth was established is also not detailed.
{0}------------------------------------------------
GENERAL INFORMATION
JUN 2 6 2008
| 1. Applicant | |
|---|---|
| Date: | May 05th, 2008 |
| Name: | VIASYS Healthcare GmbH (owned by Cardinal Health) |
| Address: | Leibnizstrasse 7D-97204 HoechbergGermany |
| Contact person in Germany:(Official Correspondent) | |
| Address | Thomas RustVIASYS Healthcare GmbHLeibnizstrasse 7, 97204 HoechbergGermany |
| Phone: | +49 931 4972 - 383 |
| FAX: | +49 931 4972 - 62383 |
| Thomas.Rust@viasyshc.comor at: Thomas.Rust@cardinalhealth.com | |
| Contact person in USA: |
| (US Agent) | Yvette Lloyd |
|---|---|
| Address | Cardinal Health |
| 22745 Savi Ranch Parkway | |
| Yorba Linda, CA 92887 | |
| Phone/Fax: | (714) - 919 - 3247 |
| Yvette.Lloyd@cardinalhealth.com |
2. Trade Name
FlowScreen FlowScreen ECG FlowScreen CT
3. Classification Name
Pulmonary calculator (21 CFR 868.1890, Product Code BTY) Electrocardiograph (21 CFR 870.2340, Product Code DPS)
-
- Establishment Registration Number 9615102
5. Facility Address
VIASYS Healthcare GmbH Leibnizstrasse 7 D-97204 Hoechberg Germany
{1}------------------------------------------------
KC80734
Section 513 Device Classification 6.
6.1 Classification
This is a Class II device
6.2 Classification Panel
Panel 73, Anesthesiology Code BTY Panel 74, Circular System Devices, ECG Code DPS
Reason for Premarket Notification 7. New option for FlowScreen K062011 (Combination of two VIASYS devices, K062011 + K070614)
Predicate Devices Descriptions 8.
-
8.1 Name
a) FlowScreen b) CorScreen -
8.2 Predicate Device Company Viasys Healthcare GmbH
Device Description க்
FlowScreen is an active medical device providing following characteristics:
Mains operation Colour LCD display for user interface Alphanumerical keyboard Colour ink-printer for printout of reports in US-letter and DIN A4 size Patient information and measurements are stored in an internal database Data can be stored on an SD memory card
a) pulmonary functions
- Measurement with ultrasonic handle or pneumotach handle .
- Slow spirometry (VCin, VCex, VCmax, ERV, IC, VT, IRV, MV, BF, TI, TE, ... ) �
- Forced spirometry (FVCin, FVC, FEV1, PEF, FEV1/FVC, FEF 50, FEF 75, . PIF, ... )
- Flow-Volume and Volume-Time Loop, pre/post tests .
- MVV measurement �
- Trending capabilities �
- Patient Incentive animations �
- Interpretation modules .
{2}------------------------------------------------
b) ECG functions
- . Simultaneous acquisition of the 12 standard leads
- Storage of 10 seconds of acquired ECG signal .
- Digital filters for base-line drift and mains interference suppression �
- Interpretation program Hanover ECG System (HES) providing the following . additional information:
- Representatives templates of each lead including markers on fiducial O points
- Summary of mean measurements O
- Rhythm Analysis statements O
- Signal noise detection and information O
- Specific findings on QRS complex ಂ
- Conduction statements O
- QRS T diagnostic statements O
- Arrhythmia monitoring detection o
- Heart Rate Variability 0
10. Intended Use Statement
The FlowScreen / FlowScreen ECG is a diagnostic system for recording and assessing inspiratory and expiratory pulmonary function (spirometry).
In addition it is intended for measuring a 3/6- or 12-channel surface electrocardiogram (ECG) of a patient. The acquired ECG can be recorded and displayed on a screen or printed on paper. 12-channel ECGs are analysed automatically and suggestions for the interpretation of the 12-channel ECG can be made by the software.
FlowScreen / FlowScreen ECG can be used for non interpretive applications for patients with an age of 4 vears and older and a weight of 20 kg or higher. FlowScreen ECG is intended for use in routine ECG recording by trained physicians in the office or hospital. FlowScreen ECG is not intended for intracardial use. Automatic interpretation of the ECG is not possible for pediatric patients with an age below 16 years and for pacemaker patients.
FlowScreen CT (Clinical Trial version) incorporates the identical measurements, but individual access rights are defined for different user roles (e.g. Investigator, study nurse, trainer and service personnel).
The interpretation software is intended to support the physician in evaluation the ECG in terms of morphology and rhythm.
A qualified physician has to reassess all FlowScreen measurements. An interpretation by FlowScreen is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the FlowScreen represent partial qualitative information on the patient's cardiovascular condition and no therapy or drugs can be administered based solely on the interpretation statements.
The FlowScreen is powered from 100 - 240V / 50 - 60Hz wall outlets. No energy is transferred to the patient.
Federal U.S. law restricts this device to sale by or on the order of a physician.
11. Required Components
FlowScreen - monitor Ultrasonic handle or pneumotach handle ECG-amplifier Disposable ECG-electrodes User manual
{3}------------------------------------------------
:
12. Summary table of comparison
| Pulmonary Function | ||||
|---|---|---|---|---|
| # | Parameter | New Device:FlowScreen | Predicate Device:FlowScreen K062011 | Result |
| 1 | Intended Use | Diagnostic Spirometry(VCin, VCex, etc.) | Diagnostic Spirometry(VCin, VCex, etc.) | identical |
| 2 | Patient population | To be used as ascreening device todetermine whether ornot a patient requiresfurther diagnosis forpulmonary functiondisorders | To be used as ascreening device todetermine whether ornot a patient requiresfurther diagnosis forpulmonary functiondisorders | identical |
| 3 | Performance | Slow SpiormetryForced SpiormetryFlow-VolumeMVVPre/Post TestsTrending capabilitiesInterpretation modules | Slow SpiormetryForced SpiormetryFlow-VolumeMVVPre/Post TestsTrending capabilitiesInterpretation modules | identical |
| 4 | Patient userinterface | Ultrasonic handle orpneumotach handle | Ultrasonic handle orpneumotach handle | identical |
| 5 | Material ofpatient userinterface | Pneumotach handle:Pneumotach (Ultem1010R, handle (RomiraABS 1001 FRVO),mouthpiece(PolypropyleneRG835MO)Ultrasonic handle:handle (Luran S778 TE),mouthpiece (HDPEEraclene MS 80U) | Pneumotach handle:Pneumotach (Ultem1010R, handle (RomiraABS 1001 FRVO),mouthpiece(PolypropyleneRG835MO)Ultrasonic handle:handle (Luran S778 TE),mouthpiece (HDPEEraclene MS 80U) | identical |
| 6 | Patientcontactingaccessories | MouthpieceNose clipNose pads | MouthpieceNose clipNose pads | identical |
| 7 | Material ofpatientcontactingaccessories | Nose clip: PolyacetalNose pads: EthyleneVinyl Acetate | Nose clip: PolyacetalNose pads: EthyleneVinyl Acetate | identical |
| 8 | Dimensionalspecification | 455 x 280 x 380 (W x Hx D) | 455 x 280 x 380 (W x Hx D) | Identical |
| 9 | Software | Data acquisitionData calculationCalc. of predicted valuesData analysisData interpretationData storageData outputData input | Data acquisitionData calculationCalc. of predicted valuesData analysisData interpretationData storageData outputData input | Identical |
{4}------------------------------------------------
| ECG Function | ||||
|---|---|---|---|---|
| # | Parameter | New Device:FlowScreen | Predicate Device:CorScreen K070614 | Result |
| 1 | Intended Use | 3/6- or 12-channelsurface ECG recordingdevice | 3/6- or 12-channelsurface ECG recordingdevice | identical |
| 2 | Input dynamicrange | +/- 300mV @ DC | +/- 300mV @ DC | identical |
| 3 | FrequencyresponseBandwidth | 0,05 - 150 Hz /According to EC11 andIEC 60601-2-51 | 0,05 - 150 Hz /According to EC11 andIEC 60601-2-51 | identical |
| 4 | A/D conversion | 24 bits | 24 bits | identical |
| 5 | Leads | 12 Standard | 12 Standard | identical |
| 6 | Paper Speed | 25 50 mm/s +/-5%According to EC11 | 25 50 mm/s +/-5%According to EC11 | identical |
| 7 | RecorderSensitivity | 5 10 20 mm/sAccording to EC11 | 5 10 20 mm/sAccording to EC11 | identical |
| 8 | Writing System | Ink-printer US-letter andDIN-A4 size | Ink-printer US-letter andDIN-A4 size | Identical |
| 9 | PrintedChannels | 1/2/6/12 | 1/2/6/12 | Identical |
| 10 | Paper | US-Letter and DIN-A4 | US-Letter and DIN-A4 | Identical |
| 11 | Mode ofoperation | Manual | Manual | Identical |
| 12 | Input/output | SD Memory card | SD Memory card | Identical |
| 13 | Display | |||
| 14 | Size | 320 x 240 pixels | 320 x 240 pixels | Identical |
| 15 | No. of displayedchannels | 1/3/6/12 | 1/3/6/12 | Identical |
| 16 | Trace speeds | 5 10 25 50 mm/s | 5 10 25 50 mm/s | Identical |
| 17 | Sensitivity | 5 10 20 40 mm/mV | 5 10 20 40 mm/mV | Identical |
.
KOBA
{5}------------------------------------------------
| Hardware platform | ||
|---|---|---|
| FlowScreen | FlowScreen K062011 | CorScreen K070614 |
| Power supply | Identical | Identical |
| Mainboard | Identical | Identical |
| Connector board | Identical | Identical |
| Interfaces | Identical | Identical |
| Color printer | Identical | Identical |
| Keyboard | Identical | Identical |
| Color display | Identical | Identical |
| Enclosure | Identical | Identical |
| Hardware patient user interfaces | ||
| Patient user interface pneumotach handle | Identical | ---------- |
| Patient user interface USS-handle | Identical | ---------- |
| ECG Amplifier | ---------- | Identical |
| Accessories | ||
| Mouthpiece | Identical | ---------- |
| Nose clip | Identical | ---------- |
| ECG electrodes | ---------- | Identical |
| Software / Firmware / Operating System | ||
| Boot loader (u-boot) | Identical | Identical |
| Operating system (Linux) | Identical | Identical |
| Firmware: | ||
| Base module | Identical | Identical |
| Spirometry module | Identical | ---------- |
| ECG module | ---------- | Identical |
{6}------------------------------------------------
13. Summary of non-clinical performance tests
The following practices were followed and monitored for development of the FlowScreen / FlowScreen ECG / FlowScreen CT:
The risk analysis method used to assess the impact of the FlowScreen with the new option ECG was a Failure Modes and Effects Analysis (FMEA). The risk analysis and risk control document number is 651003 17.
The design validation tests that were performed as a result of this risk analysis assessment and functional specifications are documented in document "Validation test script" and "validation test log" with document number 671003 32 (Test Script), 671003 33 (Test Log), 671003 40 (Test Script Workflow ECG) and 671003 41 (Test Log Workflow ECG).
The safety test procedures demonstrate satisfaction of all safety requirements and mitigation of all identified hazards. The document numbers for the performed safety tests according IEC 60601-1 are 407.267.2 and 71320123. The document number according IEC60601-2-25 is 407.267.3.
The EMC testing was performed according EN60601-2 with the document numbers 266.182 and 267.281.
Conclusion:
Based on the above, VIASYS HEALTHCARE GMBH concludes, that FlowScreen is determined substantially equivalent to the legally marketed predicate VIASYS devices and is safe and effective for its intended use, and performs at least as well as the predicate devices. The FlowScreen / FlowScreen ECG / FlowScreen CT is a combination of FlowScreen K062011 and CorScreen K070614 on the identical hardware base.
{7}------------------------------------------------
Image /page/7/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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines or strokes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 6 2008
Mr. Thomas Rust Regulatory Affairs Manager VIASYS Healthcare GmbH Leibnizstrasse 7 D-97204 Hoechberg GERMANY
Re: K080734
Trade/Device Name: FlowScreen FlowScreen ECG FlowScreen CT
Regulation Number: 21 CFR 868.1890
Regulation Name: Predictive Pulmonary Function Value Calculator Regulatory Class: II Product Code: BTY,DPS Dated: May 7, 2008 Received: May 12, 2008
Dear Mr. Rust:
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.
{8}------------------------------------------------
Page 2 - Mr. Rust
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 (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 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,
Clare
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
{9}------------------------------------------------
510(k) Number (if known): K080734
Device Name:
FlowScreen FlowScreen ECG FlowScreen CT
Indications for Use:
The FlowScreen / FlowScreen ECG is a diagnostic system for recording and assessing inspiratory and expiratory pulmonary function (spirometry).
In addition it is intended for measuring a 3/6- or 12-channel surface electrocardiogram (ECG) of a patient. The acquired ECG can be recorded and displayed on a screen or printed on paper. 12channel ECGs are analysed automatically and suggestions for the interpretation of the 12-channel ECG can be made by the software.
FlowScreen / FlowScreen ECG can be used for non interpretive applications for patients with an age of 4 years and older and a weight of 20 kg or higher. FlowScreen / FlowScreen ECG is intended for use in routine ECG recording by trained physicians in the office or hospital. FlowScreen ECG is not intended for intracardial use. Automatic interpretation of the ECG is not possible for pediatric patients with an age below 16 years and for pacemaker patients.
FlowScreen CT (Clinical Trial version) incorporates the identical measurements, but individual access rights are defined for different user roles (e.g. Investigator, study nurse, trainer and service personnel).
The interpretation software is intended to support the physician in evaluation the ECG in terms of morphology and rhythm.
A qualified physician has to reassess all FlowScreen measurements. An interpretation by FlowScreen is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the FlowScreen represent partial qualitative and quantitative information on the patient's cardiovascular condition and no therapy or drugs can be administered based solely on the interpretation statements.
The FlowScreen is powered from 100 - 240V / 50 - 60Hz wall outlets. No energy is transferred to the patient.
Federal U.S. law restricts this device to sale by or on the order of a physician.
Prescription Use X (Part 21 CFR 801 Subpart D)
NEEDED)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K080734
Page 1 of
§ 868.1890 Predictive pulmonary-function value calculator.
(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).