(198 days)
The indications for use are the same as the Vmax Series to which this product is an option. Quotation from the Indications for Use section of the Vmax premarket notification: "Basically, this involves performing physicianprescribed pulmonary function and metabolic testing. More-specific intended uses are shown in the table below, along with the predicate SensorMedics product model with the same intended-use labeling."
The Static and Dynamic Compliance option is indicated specifically for Evaluation of medication effects, Pulmonary Function testing in adults & children, Pulmonary disability evaluation, Industrial surveillance and Bedside lung function.
The Static and Dynamic Compliance software product option is identical in safety and effectiveness to the predicate devices listed in the last section. The technique of placing an esophageal balloon and derived measurements are also the same as the predicate devices.
Static and dynamic compliance are measurements of pulmonary function. also commonly referred to as Respiratory Mechanics. The mechanical properties of the respiratory system are important to breathing effectively. In healthy people, the elastic recoil and compliance of the lung are easily managed by the respiratory muscles allowing normal breathing. In some common respiratory diseases, there are changes in recoil and compliance. Static and dynamic compliance are easily measured and can be valuable in determining the effects of lung disease on breathing.
Static and dynamic compliance are performed by having the patient swallow an esophageal balloon that is connected to a calibrated pressure transducer, The patient breathes quietly on a mouthpiece connected to a flow meter. while mouth pressure, esophageal pressure, flow rate and volume changes are measured. The balloon is placed in the esophagus just above the diaphragm. This position is determined by having the patient breath through a flow meter, while the operator views a display of esophageal pressure, inspiratory flow and expiratory flow on a computer monitor. The operator looks for a negative pressure-tracing concomitant to a positive flow tracing. If the pressure tracing is positive, the balloon has passed the level of the diaphragm and needs to be pulled back until a positive tracing is displayed.
When measurements are made under no-airflow conditions, Static Compliance is calculated. When the measurements are made under flow conditions, Dynamic Compliance is calculated.
The provided text describes the Static and Dynamic Compliance software product option and states it is "identical in safety and effectiveness to the predicate devices listed in the last section." It also notes that "The technique of placing an esophageal balloon and derived measurements are also the same as the predicate devices."
However, the document does not describe a study to prove the device meets acceptance criteria. Instead, it relies on substantial equivalence to predicate devices. Therefore, I cannot generate a table of acceptance criteria with reported device performance or information about a specific study for this device.
Here's what I can extract based on the provided text, highlighting the absence of a study and related details:
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A table of acceptance criteria and the reported device performance: Not available. The document asserts identity to predicate devices rather than presenting specific acceptance criteria and performance data for the device itself.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No new study testing the device's performance is described.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. No new study testing the device's performance is described.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No new study testing the device's performance is described.
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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. This device is not an AI-assisted diagnostic tool; it's software for pulmonary function measurements. No MRMC study is mentioned.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No standalone performance study details are provided.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No new study testing the device's performance is described.
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The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set in the conventional sense. Its functionality is based on established physiological measurements and calculations.
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How the ground truth for the training set was established: Not applicable.
In summary, the document does not contain details of a de novo study or performance data for this specific device. It establishes substantial equivalence to predicate devices, inferring that its performance matches those established devices.
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Image /page/0/Picture/0 description: The image shows a series of handwritten digits and a letter. The characters are K981366. The numbers are written in a dark ink and are slightly distorted. The image appears to be a close-up of the handwritten characters.
Section 8. Summary of Safety and Effectiveness.
The Static and Dynamic Compliance software product option is identical in safety and effectiveness to the predicate devices listed in the last section. The technique of placing an esophageal balloon and derived measurements are also the same as the predicate devices.
Static and dynamic compliance are measurements of pulmonary function. also commonly referred to as Respiratory Mechanics. The mechanical properties of the respiratory system are important to breathing effectively. In healthy people, the elastic recoil and compliance of the lung are easily managed by the respiratory muscles allowing normal breathing. In some common respiratory diseases, there are changes in recoil and compliance. Static and dynamic compliance are easily measured and can be valuable in determining the effects of lung disease on breathing.
Static and dynamic compliance are performed by having the patient swallow an esophageal balloon that is connected to a calibrated pressure transducer, The patient breathes quietly on a mouthpiece connected to a flow meter. while mouth pressure, esophageal pressure, flow rate and volume changes are measured. The balloon is placed in the esophagus just above the diaphragm. This position is determined by having the patient breath through a flow meter, while the operator views a display of esophageal pressure, inspiratory flow and expiratory flow on a computer monitor. The operator looks for a negative pressure-tracing concomitant to a positive flow tracing. If the pressure tracing is positive, the balloon has passed the level of the diaphragm and needs to be pulled back until a positive tracing is displayed.
When measurements are made under no-airflow conditions, Static Compliance is calculated. When the measurements are made under flow conditions, Dynamic Compliance is calculated.
| Cst | L/kPa | Static Compliance | The change in volume/Trans-pulmonary pressure measuredfrom FRC + 500 mls to FRCagainst a closed breathing valve |
|---|---|---|---|
| Ptp | CmH2O | Trans-pulmonary Pressure | Mouth Pressure - EsophagealPressure |
| Cdyn | L/kPa | Dynamic Compliance | Change in Volume/Trans-pulmonary pressure measuredduring quiet breathing |
| f | /min | Breathing Frequency | Breaths/minute |
| Vt | Mls | Tidal Volume | Inspiration or Expiration at Rest |
| MV | Min | Minute Ventilation | Vt * f |
Calculated Parameters are as follows.
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Normal Ranges for Compliance.
| Males | $Cst = 0.0024 *Age + .00516 * Height - 0.677$ |
|---|---|
| Females | $Cst = 0.0019 *Age + .0039 *Height - 0.471$ |
| Reference: Begin, et. al. Flow and age dependence of airway closure and | |
| dynamic compliance. J. Appl. Physio. 38:199, 1975 |
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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 3 0 1998
Mr. Larry Murdock SensorMedicss Corporation 22705 Savi Ranch Parkway Yorba Linda, CA 92887
Re: K981366 Static and Dynamic Compliance Regulatory Class: II (two) Product Code: 73 BTY August 8, 1998 Dated: Received: August 10, 1998
Dear Mr. Murdock:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the qeneral 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Larry Murdock
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 9. Indications for Use.
The indications for use are the same as the Vmax Series to which this product is an option. Quotation from the Indications for Use section of the Vmax premarket notification: "Basically, this involves performing physicianprescribed pulmonary function and metabolic testing. More-specific intended uses are shown in the table below, along with the predicate SensorMedics product model with the same intended-use labeling."
| (This table is from the Vmax premarket notification) | |||
|---|---|---|---|
| Intended Use | SameAs | SimilarTo | DifferentFrom |
| Differential diagnosis (heart/lungs) | 2900 | ||
| Disability assessment | 2900 | ||
| Rehabilitative evaluation | 2900 | ||
| Exercise prescription | 2900 | ||
| Sports medicine/research | 2900 | ||
| Energy assessment, substrateutilization | 2900 | ||
| Assessment or supplemental 02requirement | 2900 | ||
| Evaluation of medication effects | 2900 | ||
| Pulmonary Function testing foradults & children | 2200 | ||
| Document effectiveness ofbronchodilator therapy | 2200 | ||
| Pulmonary disability evaluation | 2200 | ||
| Industrial surveillance | 2200 | ||
| Broncho-challenge testing | 2200 | ||
| Exercise induced bronchospasm | 2200 | ||
| Pre-surgical risk evaluation | 2200 | ||
| Bedside lung function | 2200 |
(This table is from the Vmax premarket notification)
The Static and Dynamic Compliance option is indicated specifically for Evaluation of medication effects, Pulmonary Function testing in adults & children, Pulmonary disability evaluation, Industrial surveillance and Bedside lung function.
- Prescription
Last mda 10-29-58
(Division Sign-Off) Division of Cardiovascular, Respiratory, Page Neurological Devices
510(k) Number
§ 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).