(30 days)
Not Found
No
The description focuses on standard microprocessor control and calculation of respiratory mechanics parameters, with no mention of AI or ML techniques.
Yes
The device is a ventilator, which provides ventilatory support for patients, directly treating a physiological function.
Yes
The Device Description explicitly states: "Esprit Respiratory Mechanics is a diagnostic tool that enables a clinician to take dynamic and static measurements of a patient's lung parameters." It further details specific diagnostic maneuvers and calculations related to respiratory status monitoring.
No
The device is described as a "microprocessor controlled, electrically powered, mechanical ventilator," which clearly indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided text, the Esprit ventilator with Respiratory Mechanics is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Esprit ventilator function: The description clearly states that the Esprit ventilator is a mechanical ventilator used for providing ventilatory support to patients. The Respiratory Mechanics feature is a diagnostic tool that measures lung parameters directly from the patient's respiratory system (in vivo), not from a sample taken from the body (in vitro).
The Respiratory Mechanics feature is a diagnostic tool, but it operates in vivo by measuring physiological parameters within the patient's lungs, not in vitro by analyzing samples outside the body.
N/A
Intended Use / 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 to adult and pediatric patients as prescribed by a physician. The Esprit Ventilator is intended for use in either invasive or non-invasive applications.
Esprit is not intended for use in the presence of flammable anesthetics. Esprit is a prescription use device that is intended for sale by or on the order of a physician.
Product codes (comma separated list FDA assigned to the subject device)
CBK, BZG
Device Description
Esprit Respiratory Mechanics is a diagnostic tool that enables a clinician to take dynamic and static measurements of a patient's lung parameters. The following maneuvers can be performed using Esprit Respiratory Mechanics:
- Vital Capacity .
- . Maximum Inspiratory Pressure
- PO.1 (Pressure change after the first 100 milliseconds of inspiratory effort) .
- Static Compliance and Resistance .
These tools are used by clinicians to monitor a patient's respiratory status and are displayed on the Esprit User Interface both graphically and in text format. Respiratory Mechanics also calculates the following:
- . Ti/Ttot
- Peak Lung Flow
- Dynamic Compliance and Resistance .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult and pediatric patients.
Intended User / Care Setting
Qualified medical personnel
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Software validation testing was performed in accordance with FDA's Guidance for the Content of Premarket Submissions for Software contained in Medical Devices (1998). The results of all verification and validation testing demonstrate that all design and system requirements for the Esprit ventilator with Respiratory Mechanics have been met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K902506, K970460, K905272, K961687, K982454
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
6 510(k) SUMMARY
| Company
Information: | Respironics, California Inc.
2271 Cosmos Court
Carlsbad, CA. 92009 | |
|-------------------------|--------------------------------------------------------------------------------------------------------|---------|
| Contact: | Mary Funk
Regulatory Affairs Project Manager | |
| | Phone Number: (760) 918-7328
Fax Number: (760) 918-0169 | |
| Date Prepared: | November 5, 2002 | |
| Product Name: | Esprit Ventilator with Respiratory Mechanics | |
| Classification: | Class II
Continuous Ventilator (per 21 CFR 868.5895)
Diagnostic Spirometer (per 21 CFR 868.1840) | |
| Predicate
Devices: | Puritan-Bennett 7200a Ventilator | K902506 |
| | Puritan-Bennett 840 Ventilator | K970460 |
| | Infrasonics Adult Star Ventilator | K905272 |
| | Dräger Evita 4 Ventilator | K961687 |
| | Respironics BiPAP Vision | K982454 |
Description of Device Modification:
Esprit Respiratory Mechanics is a diagnostic tool that enables a clinician to take dynamic and static measurements of a patient's lung parameters. The following maneuvers can be performed using Esprit Respiratory Mechanics:
- Vital Capacity .
- . Maximum Inspiratory Pressure
- PO.1 (Pressure change after the first 100 milliseconds of inspiratory effort) .
- Static Compliance and Resistance .
These tools are used by clinicians to monitor a patient's respiratory status and are displayed on the Esprit User Interface both graphically and in text format. Respiratory Mechanics also calculates the following:
- . Ti/Ttot
- Peak Lung Flow
- Dynamic Compliance and Resistance .
1
Intended 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 to adult and pediatric patients as prescribed by a physician. The Esprit Ventilator is intended for use in either invasive or non-invasive applications.
Esprit is not intended for use in the presence of flammable anesthetics. Esprit is a prescription use device that is intended for sale by or on the order of a physician.
Technological Characteristics:
The Esprit ventilator does not incorporate any new technological characteristics with the addition of Respiratory Mechanics.
Determination of Substantial Equivalence:
The Esprit Ventilator with Respiratory Mechanics has similar performance characteristics, the same intended use, the same environment of use and patient populations as the currently marketed predicate devices. The labeling and instructional information, including warning and caution statements, is similar to that of the predicate devices. The addition of this new feature does not raise new questions of safety or effectiveness for the Esprit.
Summary of Performance Testing:
Software validation testing was performed in accordance with FDA's Guidance for the Content of Premarket Submissions for Software contained in Medical Devices (1998). The results of all verification and validation testing demonstrate that all design and system requirements for the Esprit ventilator with Respiratory Mechanics have been met.
Conclusion:
The technological characteristics of the Esprit ventilator with Respiratory Mechanics and the results of the performance testing do not raise new questions of safety and effectiveness when compared to the legally marketed predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Mary Funk Regulatory Affairs Project Manager Respironics California, Incorporated Hospital Division 2271 Cosmos Court Carlsbad, California 92009
Re: K023350
Trade/Device Name: Esprit Ventilator with Respiratory Mechanics Regulation Number: 21 CFR 868.5895 and 21 CFR 868.1840 Regulation Name: Continuous Ventilator and Diagnostic Spirometer Regulatory Class: II Product Code: CBK and BZG Dated: October 4, 2002 Received: October 7, 2002
Dear Ms. Funk:
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.
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.
3
Page 2 - Ms. Funk
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 (QS) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646 . 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski
Timot Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Special 510(k): Device Modification Esprit Ventilator with Respiratory Mechanics
.
11 - 11 - 11
.
.
.
STATEMENT OF INDICATIONS FOR USE 8
| Applicant: | Respironics California, Inc. |
|---|---|
| 510(k) Number: | K023350 |
| Device Name: | Esprit Ventilator with Respiratory Mechanics |
| 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. |
| Prescription Use: | Yes (Per 21 CFR 801.109) |
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109) (Optional Format 1-2-96)
(
v. General Hospital,
510(k) Number
Prescription Use √
or
OTC Use