(229 days)
No
The summary describes a standard spirometer and lung volume measurement device. There is no mention of AI, ML, or any algorithms that would typically fall under those categories. The performance studies focus on correlation with a gold standard, not on the performance of an AI/ML model.
No
The device measures lung function for diagnostic purposes, it does not provide therapy.
Yes
Explanation: The device is intended to measure lung function (spirometry and lung volumes) and resistance/compliance parameters in adult patients, and the results are used to evaluate lung health. This measurement of physiological parameters for evaluation and detection of conditions falls under the definition of a diagnostic device.
No
The device description explicitly states it is a "handheld spirometer" and a "pulmonary function testing device" that is "battery operated," indicating it is a physical hardware device that measures lung function. While it uses software/App to display results, the core measurement is performed by the hardware.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The STS device measures lung function directly in the patient by having them breathe into a mouthpiece. It is not analyzing a biological sample like blood, urine, or tissue.
- The intended use and device description clearly state it measures lung function in adult patients while at rest. This is a direct physiological measurement, not an analysis of a sample.
- The device description mentions a disposable mouthpiece with a filter. This is for hygiene and protection, not for collecting a sample for analysis.
Therefore, the STS device falls under the category of a medical device that performs a physiological measurement, but it is not an IVD.
N/A
Intended Use / 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.
Product codes
BZC
Device Description
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 viral-bacterial filter protecting the patient from the internal components of the device. It 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lung
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Physician, respiratory therapist, or technician. Professional healthcare environment.
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
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.
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.
Key Metrics
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.
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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"
1
(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).
2
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
3
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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.
5
| 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% and | |
| 75% 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
6
| 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.
7
| 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 data | |||
| calculator | 868.1880 - Pulmonary-function data | |||
| calculator | 868.1840 - Diagnostic spirometer | Same as primary predicate | ||
| Classification Panel | Anesthesiology | Anesthesiology | Anesthesiology | Same |
| Indications For Use | The STS is 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 | ||||
| intended to be used in a professional | ||||
| healthcare environment. | The PulmOne MiniBox+is intended to | |||
| measure lung function in adult and | ||||
| pediatric patients while at rest | ||||
| (including spirometry and lung | ||||
| volumes). The PulmOne MiniBox+is to | ||||
| be used by either a physician, | ||||
| respiratory therapist, or technician. | The Resmon PRO FULL is | |||
| intended to measure respiratory | ||||
| system impedance using the | ||||
| Forced Oscillation Technique | ||||
| (FOT). Resmon PRO FULL is | ||||
| intended for use with pediatric and | ||||
| adult patients 4 years of age or | ||||
| older. The device is designed to be | ||||
| used by pulmonologists, general | ||||
| practitioners, nurses, respiratory | ||||
| therapists, laboratory technologists, | ||||
| medical researchers and similarly | ||||
| trained personnel in hospitals, | ||||
| clinics, and private physician | ||||
| offices. | Similar to the primary predicate; | |||
| The STS device has a narrower | ||||
| patient population | ||||
| Basic Operating | ||||
| Principle | Uses pressure data measured at the | |||
| mouth to calculate TLC | Uses pressure and flow data measured at | |||
| the 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 to | |
| electricity while the STS has a | ||||
| rechargeable battery. | ||||
| Built in screen | No | Yes | Yes | The STS data is transferred via |
| Bluetooth to the user PC and is | ||||
| displayed there. | ||||
| Physical properties | Small handheld device; 70x200x85 mm | |||
| and weighs 400 gr. | Larger desktop device; 510x470x310 | |||
| mm and weighs 8 kgs. | 310X290X260 mm; 4.3 Kg | The STS device is a small | ||
| handheld device that incorporates | ||||
| the same functionalities as the | ||||
| predicate. | ||||
| Procedure duration | ~15 minutes | 15-20 minutes | A few minutes | Same |
| Sterilization/cleaning | Nonsterile device intended to be cleaned | |||
| between uses | Nonsterile device intended to be cleaned | |||
| between uses | Nonsterile device intended to be | |||
| cleaned between uses | Same |
8
| 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 a | |||
| limited ( |