(53 days)
No
The summary describes a software modification for a ventilator that enables neonatal ventilation modes. There is no mention of AI, ML, or any related concepts in the description of the device's functionality or performance testing.
Yes
The device is a ventilator, which provides ventilatory support for patients, squarely placing it in the category of therapeutic devices.
No
The device is a ventilator used for providing ventilatory support, not for diagnosing conditions.
No
The device is described as a "software modification to the currently marketed Esprit Ventilator," indicating it is an addition to existing hardware, not a standalone software device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mechanical ventilatory support to patients. This is a life-support function performed directly on the patient, not a test performed on a sample taken from the patient.
- Device Description: The device is a ventilator with a software modification. It provides different modes of breathing support. This is consistent with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The currently marketed Esprit ventilator is intended for use by qualified medical rne ourrelity many many or intermittent ventilatory support for adult and performer and prescribed by a physician. It is intended for use in either invasive or non-invasive applications.
With the Neonatal Option, the intended patient population is expanded to include intubated neonatal patients with an ideal body weight range from 0.5 kg to 6.5 kg and an endotracheal tube I.D. range from 2.5 - 4.0 mm.
The Esprit Ventilator is not intended for use as an emergency transport ventilator. It is not intended for use in the presence of flammable anæsthetics. PLVC is a prescription use device that is intended for sale by or on the order of a physician.
The intended use of the Esprit Ventilator Neonatal Option is to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
The intended patient population includes intubated neonatal patients with an ideal body weight range from 0.5 kg to 6.5 kg and an endotracheal tube I.D. range from 2.5 – 4.0 mm.
Product codes
CBK
Device Description
The Neonatal Option is a software modification to the currently marketed Esprit Ventilator. Once the software is enabled and the neonatal patient type is selected on the Esprit, it provides the following types of ventilatory support to neonatal patients in invasive applications only:
- Assist/Control, Spontaneous Intermittent Mandatory Ventilation (SIMV) or . Continuous Positive Airway Pressure (CPAP) modes of ventilation.
- Pressure-Controlled (PC). Available in A/C and SIMV. .
- Pressure Support (PS). Available in SIMV and SPONT. .
- . Apnea Ventilation
Note: certain features of the currently marketed Esprit are not available to neonatal patient types. Refer to the Neonatal Option instructional information for details.
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
neonatal patients
Intended User / Care Setting
qualified medical rne ourrelity many many or intermittent ventilatory support for adult and performer and prescribed by a physician.
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 verification and validation testing was performed per FDA's Guidance for the Content of Premarket Submissions for Software contained in Medical Devices (1998). Performance testing was successfully completed demonstrating that all design and system level requirements for the Esprit Ventilator with Neonatal Option have been met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
P-B 840 Ventilator NeoMode Option K001646 Event Medical Inspiration Ventilator K021112 Siemens Servo 300 Ventilator K970839 Dräger Evita 4 Ventilator NeoFlow Option K983219
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JUL. - 8 2005
Modification to the Esprit Ventilator 510(k) Premarket Notification for the Neonatal Option
510(k) SUMMARY 16
| Company
Information: | Respironics, California Inc.
2271 Cosmos Court
Carlsbad, CA. 92009 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact
Information: | Mary Funk
Regulatory Affairs Project Manager |
| | Phone Number: (760) 918-7328
Fax Number: (760) 918-0169 |
| Date Prepared: | May 12, 2005 |
| Product Name: | Esprit Ventilator Neonatal Option |
| Common Name: | Ventilator |
| Classification: | Class II
Continuous Ventilator (per 21 CFR 868.5895) |
| Predicate
Devices: | P-B 840 Ventilator NeoMode Option K001646 Event Medical Inspiration Ventilator K021112 Siemens Servo 300 Ventilator K970839 Dräger Evita 4 Ventilator NeoFlow Option K983219 |
16.1 Device Description:
The Neonatal Option is a software modification to the currently marketed Esprit Ventilator. Once the software is enabled and the neonatal patient type is selected on the Esprit, it provides the following types of ventilatory support to neonatal patients in invasive applications only:
- Assist/Control, Spontaneous Intermittent Mandatory Ventilation (SIMV) or . Continuous Positive Airway Pressure (CPAP) modes of ventilation.
- Pressure-Controlled (PC). Available in A/C and SIMV. .
- Pressure Support (PS). Available in SIMV and SPONT. .
- . Apnea Ventilation
Note: certain features of the currently marketed Esprit are not available to neonatal patient types. Refer to the Neonatal Option instructional information for details.
1
Intended Use: 16.2
The currently marketed Esprit ventilator is intended for use by qualified medical rne ourrelity many many or intermittent ventilatory support for adult and performer and prescribed by a physician. It is intended for use in either invasive or non-invasive applications.
With the Neonatal Option, the intended patient population is expanded to include intubated neonatal patients with an ideal body weight range from 0.5 kg to 6.5 kg and an endotracheal tube I.D. range from 2.5 - 4.0 mm.
The Esprit Ventilator is not intended for use as an emergency transport ventilator. It is not intended for use in the presence of flammable anæsthetics. PLVC is a prescription use device that is intended for sale by or on the order of a physician.
Technological Characteristics: 16.3
The addition of the Neonatal Option to the currently marketed Esprit does not result in the use of any new technological characteristics. Breath delivery is controlled by software algorithms that are equivalent to those used on the currently marketed Respironics Esprit ventilator (reference K981072).
Determination of Substantial Equivalence: 16.4
The modes/types of ventilation on the Esprit Ventilator with Neonatal Option are similar to those on other currently marketed continuous ventilators. The modified Esprit has similar performance characteristics, similar intended use and similar patient populations to the predicate devices. The addition of the Neonatal Option does not raise new questions of safety or effectiveness. The labeling and instructional information for the Neonatal Option is similar to that of the predicate devices.
16.5 Summary of Performance Testing:
Software verification and validation testing was performed per FDA's Guidance for the Content of Premarket Submissions for Software contained in Medical Devices (1998). Performance testing was successfully completed demonstrating that all design and system level requirements for the Esprit Ventilator with Neonatal Option have been met.
16.6 Conclusion:
The addition of the Neonatal Option to the Esprit Ventilator does not raise new questions of safety and effectiveness when compared to the legally marketed predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human figures connected by flowing lines, representing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 8 2005
Ms. Mary Funk Regulatory Affairs Project Manager Respironics California, Incorporated 2271 Cosmos Court Carlsbad, California 92009
Re: K051262
Trade/Device Name: Esprit Ventilator with Neonatal Option Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: May 12, 2005 Received: May 16, 2005
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.
3
Page 2 – Ms. Funk
Please be advised that FDA's issuance of a substantial equivalence determination does not I Tease be advisod that 12 a determination that your device complies with other requirements mean that I DA mas made statutes and regulations administered by other Federal agencies. or the Fet of all , a vary - eath s requirements, including, but not limited to: registration 1 ou intiles comprise to Part 807); labeling (21 CFR Part 801); good manufacturing practice and ifsung (21 es reas of the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quartify tion 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) This letter will and if your even 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), If you desite of the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may of any 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/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Modification to the Esprit Ventilator Mountcation to the Esphe For the Neonatal Option
INDICATIONS FOR USE STATEMENT
| Applicant: | Respironics California, Inc.
2271 Cosmos Court
Carlsbad, CA 92009
USA |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number: | K051262 |
| Device Name: | Esprit Ventilator with Neonatal Option |
| Indications for use: | The intended use of the Esprit Ventilator Neonatal Option is to provide
continuous or intermittent ventilatory support for the care of individuals
who require mechanical ventilation.
The intended patient population includes intubated neonatal patients
with an ideal body weight range from 0.5 kg to 6.5 kg and an
endotracheal tube I.D. range from 2.5 – 4.0 mm. |
| 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)
Oeen Sulam K051262
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital,
Division of Anesthesiology, General Devices Division of Anesthesion Control, Devices
510(k) Number -