(229 days)
The STS device is intended to measure lung function in adult patients while at rest (including spirometry and lung volumes). The STS device is to be used by either a physician, respiratory therapist, or technician. The STS device is intended to be used in a professional healthcare environment.
The STS is a handheld spirometer intended to measure lung function in adult patients while at rest (including spirometry and lung volumes). The STS is to be used by either a physician, respiratory therapist, or technician. The STS device is pulmonary function testing device that measures both flow/volume (spirometry), lung volume and resistance/compliance parameters. It is a multi-use device that should be used with a compatible single-use, disposable mouthpiece which incorporates a viralbacterial filter protecting the patient from the internal components of the device is battery operated allowing for approximately 40 operating hours between charges. The measurement results, which are transmitted via Bluetooth, are displayed on the physician's computer via the STS software/App.
The provided text is a 510(k) summary for the STS device, a pulmonary function data calculator. While it mentions a clinical study, the details provided are limited and do not fully address all requested points regarding acceptance criteria and study specifics for proving the device meets those criteria.
Based on the provided document, here's what can be extracted and what remains unknown:
1. Table of acceptance criteria and reported device performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating acceptance criteria values for performance. However, an implicit acceptance criterion is a "high correlation" and specific statistical thresholds mentioned in the clinical study summary.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| High correlation between STS and Body Plethysmography (BP) for resistance and compliance parameters | Correlation coefficients between 0.75 and 0.97 |
| P-value not to exceed a certain threshold (implied to be low for significance) | P-value did not exceed 3% |
| Repeatability coefficients below a certain threshold | Repeatability coefficients less than 0.3L |
| Within-subject standard deviation below a certain threshold | Within-subject standard deviation values less than 0.15L |
2. Sample size used for the test set and the data provenance:
- Sample Size: 161 subjects (61 females, 100 males, implicitly). This test set was used for the clinical study comparing STS to Body Plethysmography.
- Data Provenance: Not explicitly stated (e.g., country of origin). It is a prospective study as subjects were "enrolled" and "tested by both STS and BP," suggesting data was collected specifically for this study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document states that Body Plethysmography (BP) is considered the "gold standard" for measuring lung volumes. Therefore, the BP measurements served as the ground truth.
- It does not specify the number of experts or their qualifications involved in performing or interpreting the Body Plethysmography tests. It's implied that standard clinical practice for BP was followed, which would involve trained medical professionals, but this is not detailed.
4. Adjudication method for the test set:
- No information on adjudication methods is provided. The comparison is directly between the STS device measurements and the "gold standard" Body Plethysmography measurements.
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:
- No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done or reported. This device is a pulmonary function data calculator and not an AI-assisted diagnostic imaging tool where human reader performance with and without AI assistance would typically be evaluated. The study focuses on the device's accuracy in measuring physiological parameters when compared to a gold standard.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The clinical study described evaluates the "performance of STS technique in calculating resistance and compliance parameters" by comparing it with Body Plethysmography.
- The STS device itself is a "pulmonary function testing device that measures both flow/volume (spirometry), lung volume and resistance/compliance parameters." This implies a standalone performance evaluation of the device's measurements against the gold standard. However, the device "is to be used by either a physician, respiratory therapist, or technician" and its results are "displayed on the physician's computer via the STS software/App," indicating there's a human-in-the-loop for operation and interpretation. The study evaluates the measurement accuracy, which can be seen as a form of standalone performance for the measurement part of the device.
7. The type of ground truth used:
- The ground truth used was "gold standard" Body Plethysmography (BP) measurements of lung volumes. While BP is a clinical measurement, it serves as the established reference standard in this context.
8. The sample size for the training set:
- The document does not provide any information about the sample size used for the training set. This is a 510(k) submission, and often, proprietary training data details are not included in the public summary.
9. How the ground truth for the training set was established:
- The document does not provide any information on how the ground truth for the training set was established, as details about the training set itself are absent.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 17, 2024
TechnoPulm, Ltd. % Bosmat Friedman Regulatory Consultant ProMedoss. Inc. 3521 Hatwynn Rd. Charlotte, North Carolina 28269
Re: K240293
Trade/Device Name: STS Regulation Number: 21 CFR 868.1880 Regulation Name: Pulmonary-Function Data Calculator Regulatory Class: Class II Product Code: BZC Dated: August 13, 2024 Received: August 13, 2024
Dear Bosmat Friedman:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Sincerely,
Rachana Visaria -S
Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
STS
Indications for Use (Describe)
The STS device is intended to measure lung function in adult patients while at rest (including spirometry and lung volumes). The STS device is to be used by either a physician, respiratory therapist, or technician. The STS device is intended to be used in a professional healthcare environment.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the logo for "TechnoPulm". The logo consists of a black symbol resembling a stylized letter or character on the left, followed by the word "TechnoPulm" in a sans-serif font. The word "Techno" is in a bright blue color, while "Pulm" is in black.
STS Device Traditional 510(k)
510(k) Summary
510(k) Summary [Traditional 510(k)] STS 510(k) Number K240293
1. SUBMITTER
Applicant's Name:
TechnoPulm Ltd. 6 Ovadya St. Yad Benyamin Israel
Primary Contact:
Bosmat Friedman Regulatory Affairs Consultant 6026 Beech Cove Ln. Charlotte, NC 28269 Phone: 980-308-1636 bosmat.f(@promedoss.com
Date Prepared: September 17, 2024
DEVICE 2. Trade Name: STS
| Classification Code: | Device: calculator, pulmonary function data |
|---|---|
| Product Code: BZC | |
| Regulation No: 868.1880 | |
| Class: 2 | |
| Review Panel: Anesthesiology |
3. PREDICATE DEVICE
Primary Predicate:
- MiniBox +, by PulmOne Advanced Medical Devices, Ltd., Product code BZC/BZG, ● cleared Under: K161295.
Reference Device:
- Resmon PRO FULL, by Medical Graphics Corporation, product code PNV/BZC, cleared . under: K152585.
DEVICE DESCRIPTION 4.
The STS is a handheld spirometer intended to measure lung function in adult patients while at rest (including spirometry and lung volumes). The STS is to be used by either a physician, respiratory therapist, or technician.
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| STS Device | ||
|---|---|---|
| Image: TechnoPulm logo | Traditional 510(k) | 510(k) Summary |
The STS device is pulmonary function testing device that measures both flow/volume (spirometry), lung volume and resistance/compliance parameters. It is a multi-use device that should be used with a compatible single-use, disposable mouthpiece which incorporates a viralbacterial filter protecting the patient from the internal components of the device is battery operated allowing for approximately 40 operating hours between charges. The measurement results, which are transmitted via Bluetooth, are displayed on the physician's computer via the STS software/App.
The STS has the following measurement capabilities:
| Lung Volume Parameters: | |
|---|---|
| Total lung capacity | (TLC) L |
| Thoracic Gas Volume | (TGV) L |
| Residual volume | (RV) L |
| Ratio of TGV to TLC | (TGV/TLC) % |
| Ratio of RV to TLC | (RV/TLC) % |
| Flow/Volume (Spirometry) Parameters: | |
| Forced vital capacity | (FVC) L |
| Forced expiratory volume in 1second | (FEV 1) L |
| Ratio of FEVI to FVC | (FEV1/FVC) % |
| Forced expiratory volume in 6 seconds | (FEV6) L |
| Forced expiratory volume in 3 seconds | (FEV3) L |
| Ratio of FEV3 to FVC | (FEV3/FVC) % |
| Peak expiratory flow | (PEF) L/s |
| Forced expiratory flow between 25% and75% of force vital capacity | (FEF 25-75) L/s |
| Vital capacity | (VC) L |
| Inspiratory vital capacity | (IVC) L |
| Peak inspiratory flow | (PIF) L/s |
| Resistance/Compliance Parameters: | |
| Airway resistance | (RAW) kPa*s/L |
| Lung compliance | (CL) L/kPa |
5. INDICATIONS FOR USE
The STS device is intended to measure lung function in adult patients while at rest (including spirometry and lung volumes). The STS device is to be used by either a physician. respiratory therapist, or technician. The STS device is intended to be used in a professional healthcare environment.
6. SUBSTANTIAL EQUIVALENCE
The STS is substantially equivalent to the predicate device based on the following:
Intended Use
The intended use of the proposed device is the same as that of the cleared device. The only difference in the indication for use statement is the narrowing of the STS population to include only adult patients. This difference is due to the fact that the STS device has not been tested in a
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| Image: Pi symbol | TechnoPulm |
|---|---|
| ------------------ | ------------ |
pediatric population. The narrowing of the indication does not raise new questions of safety and effectiveness.
Technology
Both the STS and Minibox are used to measure lung function in adult patients. Both devices are used with an off-the-shelf FDA cleared biological filter. The predicate is to be used with 2800 PFT FILTER by Air Safety Ltd. (K051712) and the STS can be used with MicroGard by CareFusion Germany 234 GmbH (K111408).
In both devices, the test is performed by having the seated patient use a nose clip and blow through the mouthpiece filter. In both, the operator navigates through the software and is required to initiate the test prior to the patient exhaling in the device. In the STS, the patient is required to "blast" exhale into the mouthpiece; 3 successful tests are required in order to receive an output report. The Minibox procedure is slightly different; the patient first preforms 2-3 tidal breaths followed by "blast" exhale. In the Minibox, three tests are also required in order to obtain comprehensive results. Both devices require a relatively short procedure duration (approximately 15 minutes to perform 3 successful breath tests).
With respect to device design, the Minibox is a standalone unit incorporating the handheld device which is wired to the desktop unit. The desktop unit incorporates a touch screen that allows for software navigation to operate the system, control the test, input patient data, commence testing, etc.
When compared to predicate, the STS is more compact and connects via Bluetooth to the user's PC on which the STS software is installed. Additionally, while the majority of lung test parameters are the same between the two devices, some parameters are only available on one device and not the other, this difference does not raise new safety and effectiveness concerns as the obtained parameters for both devices are sufficient to perform a lung function assessment.
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| Attribute | Subject Device | Primary Predicate | Reference Device | Comparison |
|---|---|---|---|---|
| Trade Name | STS | MiniBox + | Resmon PRO FULL | |
| 510(k) Number | K240293 | K161295 | K152585 | |
| Classification | Class II, BZC, BZG | Class II, BZC, BZG | Class II, PNV, BZC | Same as primary predicate |
| Regulation | Calculator, Pulmonary Function Data | Calculator, Pulmonary Function Data | Diagnostic spirometer | Same as primary predicate |
| Description | ||||
| Regulation Number | 868.1880 - Pulmonary-function datacalculator | 868.1880 - Pulmonary-function datacalculator | 868.1840 - Diagnostic spirometer | Same as primary predicate |
| Classification Panel | Anesthesiology | Anesthesiology | Anesthesiology | Same |
| Indications For Use | The STS is intended to measure lungfunction in adult patients while at rest(including spirometry and lungvolumes). The STS is to be used byeither a physician, respiratory therapist,or technician. The STS device isintended to be used in a professionalhealthcare environment. | The PulmOne MiniBox+is intended tomeasure lung function in adult andpediatric patients while at rest(including spirometry and lungvolumes). The PulmOne MiniBox+is tobe used by either a physician,respiratory therapist, or technician. | The Resmon PRO FULL isintended to measure respiratorysystem impedance using theForced Oscillation Technique(FOT). Resmon PRO FULL isintended for use with pediatric andadult patients 4 years of age orolder. The device is designed to beused by pulmonologists, generalpractitioners, nurses, respiratorytherapists, laboratory technologists,medical researchers and similarlytrained personnel in hospitals,clinics, and private physicianoffices. | Similar to the primary predicate;The STS device has a narrowerpatient population |
| Basic OperatingPrinciple | Uses pressure data measured at themouth to calculate TLC | Uses pressure and flow data measured atthe mouth to calculate TLC | Forced Oscillation Technique(FOT) | Similar to the primary predicate |
| Power Source | Rechargeable Lithium Ion Battery(3.7V, 3500mAh) | 100-240VAC,50-60Hz | 100-240 V / 50-60Hz | The Minibox+ is connected toelectricity while the STS has arechargeable battery. |
| Built in screen | No | Yes | Yes | The STS data is transferred viaBluetooth to the user PC and isdisplayed there. |
| Physical properties | Small handheld device; 70x200x85 mmand weighs 400 gr. | Larger desktop device; 510x470x310mm and weighs 8 kgs. | 310X290X260 mm; 4.3 Kg | The STS device is a smallhandheld device that incorporatesthe same functionalities as thepredicate. |
| Procedure duration | ~15 minutes | 15-20 minutes | A few minutes | Same |
| Sterilization/cleaning | Nonsterile device intended to be cleanedbetween uses | Nonsterile device intended to be cleanedbetween uses | Nonsterile device intended to becleaned between uses | Same |
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| Image: TechnoPulm logo | STS Device | |
|---|---|---|
| Image: TechnoPulm text | Traditional 510(k) | 510(k) Summary |
| Attribute | Subject Device | Primary Predicate | Reference Device | Comparison |
|---|---|---|---|---|
| Trade Name | STS | MiniBox + | Resmon PRO FULL | |
| 510(k) Number | K240293 | K161295 | K152585 | |
| Biocompatibility | Externally communicating device with alimited (< 24 hours) duration of patientcontact due to its indirect contact withpatient respiratory tissues involvinginspiratory and exhalatory maneuvers | Externally communicating device with alimited (< 24 hours) duration of patientcontact due to its indirect contact withpatient respiratory tissues involvinginspiratory and exhalatory maneuvers | Externally communicating devicewith a limited (< 24 hours)duration of patient contact due toits indirect contact with patientrespiratory tissues involvinginspiratory and exhalatorymaneuvers | Same |
| Bacterial filter | To be used with compatible filter(MicroGard by CareFusion Germany234 GmbH (K111408) | Used with FDA cleared compatible filter(K051712) | Used with designated disposablefilter | Similar to the primary predicate |
| Single Use/reusable | Handheld device is reusable; to be usedwith single use compatible filter | Desktop device is reusable; to be usedwith single use compatible filter | Desktop device is reusable; to beused with single use compatiblefilter | Same |
| Measuredparameters | The following parameters are displayedin the results report:TLC, TGV, RV, TGV/TLC, RV/TLC,FVC, FEV1, FEV1/FVC, FEV6, FEV3,FEV3/FVC, PEF, FEF 25-75, VC, IVC,PIF, RAW (kPa*s/L), CL (L/kPa) | The following parameters are displayedin the results report: FAV1/FVC, FVC,FEV1, FEF 25-75, Lung age,FEV1/SVC, FEV1/VC, FEV6,FEV1/FEG6, PEF, FEV3, FEV3/FVC,FET, FEF 25, FEF 50, FEF 75, Evol,FIVC, FIV1, FIV1/FIVC, PIF, PEF m,RV, TLC, RV/TLC, IC/TLC, TGV, VC,SVC(LVM), IC(LVM), ERV(LVM),DLco, VA, DLco/VA, BHT, VI, TLco,TLco/VA, TLcp/VA-c | Calculated impedance parameters:Total Resistance (Rtot) InspiratoryResistance (Rinsp) ExpiratoryResistance (Rexp) Total Reactance(Xtot) Inspiratory Reactance(Xinsp) Expiratory Reactance(Xexp) deltaXrs R5-R19Calculated Breathing PatternParameters: Tidal Volume (Vt)Inspiratory Time (Ti) ExpiratoryTime (Te) Respiratory Duty Cycle(Ti/Ttot) Respiratory Rate (RR)Mean Inspiratory Flow (Vt/Ti)Mean Expiratory Flow (Vt/Te)Ventilation (Ve) | Similar; while some variations indisplayed parameters exist, themajority of displayed parametersare the same as the primarypredicate. The reference device hasbeen introduced to include lungcompliance parameter (Rexp).Lung compliance measured bySTS is a function of the RAWresistance which is measured bothby STS and reference device. |
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Discussion
T ТеснпоPulm
Based on the comparison presented in our submission, the STS shares the same indications for use as the primary predicate, as both are intended to measure lung function in adult patients while at rest. Additionally, while some technological differences do exist between the STS and its predicate, comprehensive testing including bench, and clinical studies have demonstrated that the device is substantially equivalent to its predicate and that the technological differences do not raise new safety and effectiveness concerns and support the company's substantial equivalency claim.
7. UTILIZATION OF STANDARDS
The following standards were used in whole or in part in the evaluation of the device's safety and effectiveness:
- AAMI ST98:2022 Cleaning validation of health care products Requirements for । development and validation of a cleaning process for medical devices.
- ATS Standardization of Spirometry (2019 Update) -
- ISO 17664-2: 2021: Processing of health care products- Information to be provided for the processing of medical devices- Part 2: Non-critical medical devices.
- IEC 60601-1:2005. AMD1:2012. AMD2:2020 Medical electrical equipment Part 1: General requirements for basic safety and essential performance Edition 3.2
- IEC 60601-1-2:2014, IEC 60601-1+2:2014/AMD1:2020 Medical Electrical Equipment Part -1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests Edition 4.1
- ISO 26782 Anaesthetic and respiratory equipment Spirometers intended for the measurement of time forced expired volumes in humans
- ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and -Systems
- ASTM D4332-22 Standard Practice for Conditioning Containers, Packaging -Components for Testing
- ISO 10993-1:2018 Biological Evaluation of Medical devices Part 1: Evaluation and testing within a risk management process
- -ISO 18562-1:2024 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
- ISO 23747:2015 Anaesthetic and respiratory equipment Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans
-
8. PERFORMANCE DATA
Bench tests summary of nonclinical performance data:
The STS underwent nonclinical bench tests to establish substantially equivalent performance including biocompatibility testing, cleaning validation, EMC and electrical safety per IEC 60601-1 and IEC 60601-1-2, software validation, cybersecurity and environmental testing.
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| STS Device | |||
|---|---|---|---|
| ГеснпоРulmﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ | Traditional 510(k) | 510(k) Summary |
In addition, simulator bench testing per ISO 26782 were conducted to verify the STS accurate performance. The results of the bench testing support the safety profile of the device and demonstrate that the device functions as intended.
Clinical Study:
The main goal of the study was to evaluate the performance of STS technique in calculating resistance and compliance parameters. The accuracy of the STS device was examined by comparing with Body plethysmography (BP), which is considered as the "gold standard" for measuring lung volumes.
161 subjects including 61 females enrolled in the study, to be tested by both STS and BP. The subject population included 63 healthy subjects (39.1%), 40 (24.9%) obstructive patients and 58 (36.0%) restrictive patients. The age of enrolled subjects was 53.5±31.5 years.
The comparison results demonstrated a high correlation between the two devices. Correlation coefficients were in the range between 0.75 and 0.97, the P-value did not exceed 3%, repeatability coefficients were less than 0.3L and within-subject standard deviation values were less than 0.15L.
9. CONCLUSION
The STS has similar intended use, technological characteristics, and principles of operation as the predicate. Any differences between the subject and predicate device were evaluated through design verification and validation testing and comparative testing which demonstrated device performance and safety, and do not raise any new questions of safety and effectiveness.
Based on the information submitted in this 510(k), the STS is substantially equivalent to the currently marketed predicate Minibox+.
§ 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).