(233 days)
The ESPRIT ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. It is intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support for adult and pediatric patients as prescribed by a physician. The ESPRIT Ventilator is intended for use in either invasive or non-invasive applications.
The ESPRIT ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. The specific features of the product include:
- . Breathing system under microprocessor control.
- · User interface under microprocessor control. Uses "hyman interface" features associated with touch screen and graphical user interface technology. The specifics of the particular touch screen technology and its suitability to medical applications is covered in more detail in the principle of operation section.
- · Integral air source is built into the ventilator, eliminating the requirement for a central compressor and piped, medical grade wall air and/or an individual, stand alone compressor for each ventilator. The product will also be offered in a configuration without the blower in which case it will operate from a wall air supply.
- · Ability to provide variable oxygen concentrations (21% to 100% O2) from a 35 to 80 PSIG medical grade, oxygen gas source, including medical grade gas cylinders with suitable regulators.
- · Ability to operate on a re-chargeable primary battery for 30 minutes (nominal).
- · Ability to be powered by a secondary DC power source (24 VDC) for up to 3 hours.
- · Provide high product quality and reliability. ESPRIT has been designed using Highly Accelerated Life Testing (HALT), coupled with Environment Stress Screening (ESS) during manufacturing. Studies have shown that these techniques greatly eliminate reliability problems and are integral to the reliability of the product.
The Esprit Critical Care Ventilator (K981072) demonstrates substantial equivalence to predicate devices through a series of environmental and performance tests. The provided documentation does not detail specific acceptance criteria in numerical thresholds for clinical performance or any associated study proving the device meets those criteria with statistical significance. Instead, the focus is on engineering performance and safety standards.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily based on complying with various environmental and electrical safety standards, as well as meeting performance characteristics comparable to legally marketed predicate devices. The document does not provide specific numerical performance metrics but asserts that the device meets the requirements of the referenced standards and produces the flows and pressures detailed in the comparative analysis.
| Test / Criterion | Basis / Standard | Reported Device Performance |
|---|---|---|
| Dielectric Strength | IEC 601-1, Clause 20 | Not specified, but implied compliance through testing. |
| Leakage Current | IEC 601-1, Clause 19 | Not specified, but implied compliance through testing. |
| Radiated and Conducted Electromagnetic Emissions | CISPR 11 | Not specified, but implied compliance through testing. |
| Magnetic Field Emissions | RE101 of MIL-STD 461D at 7 cm | Not specified, but implied compliance through testing. |
| Electrostatic Discharge | IEC 801-2 | Not specified, but implied compliance through testing. |
| Radiated Electromagnetic Fields Susceptibility | IEC 801-3 | Not specified, but implied compliance through testing. |
| AC Voltage Fluctuation: Steady State, Dropout, Slow Sags and Surges | IEC 801-11 | Not specified, but implied compliance through testing. |
| AC Voltage Fluctuation: Fast Transient Bursts | IEC 801-4 | Not specified, but implied compliance through testing. |
| AC Voltage Fluctuation: Fast Surges | IEC 801-5 | Not specified, but implied compliance through testing. |
| Conducted Electromagnetic Energy Susceptibility | MIL-STD-461D, CS114 | Not specified, but implied compliance through testing. |
| Magnetic Fields Susceptibility | RS101 (Army) of MIL-STD-461D | Not specified, but implied compliance through testing. |
| Quasi-static Electric Fields Susceptibility | Reviewer Guidance for Premarket Notification Submissions, November, 1993 | Not specified, but implied compliance through testing. |
| Random Vibration | Reviewer Guidance for Premarket Notification, Submissions, November, 1993 | Not specified, but implied compliance through testing. |
| Shock | Test conditions based on IEC 68-2-27 | Not specified, but implied compliance through testing. |
| Ingress of Liquids | IEC 601-1, Clause 44.6, and IEC 529 | Not specified, but implied compliance through testing. |
| Temperature/Humidity | Reviewer Guidance for Premarket Notification Submissions, November, 1993 | Not specified, but implied compliance through testing. |
| Surface Temperature | Reviewer Guidance for Premarket Notification Submissions, November, 1993 | Not specified, but implied compliance through testing. |
| Ventilator Requirements | "Draft Reviewer Guidance for Ventilators, July, 1995" | Device meets the requirements (details in Section 7). |
| Performance Characteristics (Flows and Pressures) | Comparative Analysis to Predicate Devices (Section 8) | Device produces the flows and pressures (details in Section 8). |
| Waveform Performance | Comparative Analysis to Predicate Devices (Section 8.3) | Compared to 7200 Ventilator predicate device (details in Section 8.3). |
2. Sample Size Used for the Test Set and Data Provenance
The document describes environmental and lab testing for the device. It does not refer to a "test set" in the context of patient data or clinical trials for evaluating diagnostic or predictive performance. The testing appears to be primarily engineering validation. Therefore, information on sample size for a test set, data provenance (country of origin, retrospective/prospective), is not applicable in the typical sense for AI/diagnostic devices. The testing is likely conducted on various units of the Esprit ventilator itself to ensure adherence to specified standards.
3. Number of Experts and Qualifications for Ground Truth
This information is not applicable as the studies described are engineering and performance validation tests, not clinical evaluations requiring expert consensus for ground truth establishment.
4. Adjudication Method
This information is not applicable for the type of testing described (environmental and performance validation). There is no mention of human adjudication for defining a ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC study was not performed or described. The submission focuses on device equivalence through engineering and performance comparisons, not on comparing human reader performance with or without AI assistance.
6. Standalone Performance
The device itself is a standalone mechanical ventilator. The described testing (environmental, performance, and comparison to predicate devices) effectively assesses the standalone performance of the ventilator in terms of its engineering and functional characteristics. There is no mention of an algorithm 'only' performance in the context of a diagnostic AI.
7. Type of Ground Truth Used
The "ground truth" in this context is adherence to established engineering standards, regulatory guidance for ventilators, and the performance characteristics of legally marketed predicate devices. This is based on objective measurements and comparisons against these defined benchmarks. There is no mention of expert consensus, pathology, or outcomes data as "ground truth" for the declared studies.
8. Sample Size for the Training Set
This information is not applicable. The Esprit Ventilator is a mechanical device, not an AI or machine learning algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
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NOV 1 2 1998
2. 510(k) Summary
This 510/k) is being submitted by: Respironics. 1261 Liberty Way Vista CA., 92083. Phone number : 760-727-3500 FAX number: 760-727-8349
The contact personnel for this submittal are:
Paul L. Woodring, primary contact 760-734-3202
Kathy E. Moore, secondary contact 760-734-3221
This summary was prepared on March 23, 1998.
This 510(k) is for the Esprit critical care ventilator, product code (21CFR 868.5895, 73 CBK) The legally marketed predicate devices are the 7200 ventilator offered for sale by Nellcor-Puritan-Bennett; the BIRD Tbird offered for sale by BIRD Medical Products; and the Siemens SV300 offered for sale by Siemens-Elema AB, Electromedical Systems Division. The 7200 ventilator is currently used in both invasive and noninvasive applications. A comparison is also made to the Quantum non-invasive ventilator offered for sale by Healthdyne Technologies (now part of Respironics). Detailed comparisons of the devices can be found in Section 8- Comparative Analysis to Predicate Devices.
The ESPRIT ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. The specific features of the product include:
- . Breathing system under microprocessor control.
- · User interface under microprocessor control. Uses "hyman interface" features associated with touch screen and graphical user interface technology. The specifics of the particular touch screen technology and its suitability to medical applications is covered in more detail in the principle of operation section.
- · Integral air source is built into the ventilator, eliminating the requirement for a central compressor and piped, medical grade wall air and/or an individual, stand alone compressor for each ventilator. The product will also be offered in a configuration without the blower in which case it will operate from a wall air supply.
- · Ability to provide variable oxygen concentrations (21% to 100% O2) from a 35 to 80 PSIG medical grade, oxygen gas source, including medical grade gas cylinders with suitable regulators.
- · Ability to operate on a re-chargeable primary battery for 30 minutes (nominal).
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K981072 2. 510(k) Summary
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- · Ability to be powered by a secondary DC power source (24 VDC) for up to 3 hours.
- · Provide high product quality and reliability. ESPRIT has been designed using Highly Accelerated Life Testing (HALT), coupled with Environment Stress Screening (ESS) during manufacturing. Studies have shown that these techniques greatly eliminate reliability problems and are integral to the reliability of the product.
The Esprit Ventilator is intended for use by aualified medical personnel in providing continuous or intermittent ventilatory support for adult and pediatric patients as prescribed by a physician. The ESPRIT Ventilator is intended for use in either invasive or non-invasive applications.
The ESPRIT ventilator is intended to be marketed worldwide as a new ventilator that shall address the needs of low and moderate acuity subacute facilities in the US, surgical recovery units in hospitals, in ICU applications where more expensive options such as trending and waveforms are not required, in stand alone surgery centers in the US and international markets, as well as high acuity intensive care units (ICUs) in undeveloped and emerging nation, rest-of-world (ROW) markets. No medical claims are made regarding the ventilator. It produces the flows and pressures detailed in Section 8 - Comparative Analysis to Predicate Devices. These performance characteristics have been validated with the testing that is summarized in Sections 7 -Table Of Ventilator Requirements, 8 - Comparative Analysis to Predicate Devices and 10 - Environmental Testing.
The determination of equivalence is also based on environmental and lab testina. The ventilator has been tested according to the following environmental standards:
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| TEST | BASIS |
|---|---|
| Dielectric Strength | IEC 601-1, Clause 20 |
| Leakage Current | IEC 601-1, Clause 19 |
| Radiated and ConductedElectromagnetic Emissions | CISPR 11 |
| Magnetic Field Emissions | RE101 of MIL-STD 461D at 7 cm |
| Electrostatic Discharge | IEC 801-2 |
| Radiated Electromagnetic FieldsSusceptibility | IEC 801-3 |
| AC Voltage Fluctuation: Steady State,Dropout, Slow Sags and Surges | IEC 801-11 |
| AC Voltage Fluctuation: Fast TransientBursts | IEC 801-4 |
| AC Voltage Fluctuation: Fast Surges | IEC 801-5 |
| Conducted Electromagnetic EnergySusceptibility | MIL-STD-461D, CS114 |
| Magnetic Fields Susceptibility | RS101 (Army) of MIL-STD-461D |
| Quasi-static Electric Fields Susceptibility | Reviewer Guidance for PremarketNotification Submissions, November,1993 |
| Random Vibration | Reviewer Guidance for PremarketNotification, Submissions,November, 1993 |
| Shock | Test conditions based on IEC 68-2-27 |
| Ingress of Liquids | IEC 601-1, Clause 44.6, and IEC 529 |
| Temperature/Humidity | Reviewer Guidance for PremarketNotification Submissions, November,1993. |
| Surface Temperature | Reviewer Guidance for PremarketNotification Submissions, November,1993 |
Table 1 - Environmental Standards
Section 7 - Table Of Ventilator Requirements includes a table demonstrating how the Esprit ventilator meets the requirements called out in the "Draft Reviewer Guidance for Ventilators, July, 1995" Finally, Section 8 - Comparative Analysis to Predicate Devices includes a summary of performance testing comparing the Esprit ventilator to the 7200 predicate device.
A description of waveform performance is covered in 8.3 - Waveform Comparisons to 7200 Ventilator predicate device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 2 1998
Mr. Paul L. Woodring Respironics Inc. 1261 Liberty Way Vista, Ca. 92083
Re: K981072 Esprit Ventilator Requlatory Class: II (two) Product Code: 73 CBK Dated: August 14, 1998 Received: August 18, 1998
Dear Mr. Woodring:
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 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 (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 regulatory 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. Paul L. Woodring
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 regulation (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 regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other qeneral 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.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callehan
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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510(K) Number (if known): K981072
Device Name: Esprit Ventilator
Indications for Use:
The ESPRIT ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. It is intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support for adult and pediatric patients as prescribed by a physician. The ESPRIT Ventilator is intended for use in either invasive or non-invasive applications.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kramer
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 1981072 510(k) Number _
prescriptions use
OTC
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).