(23 days)
Not Found
No
The document describes a software enhancement for a ventilator that provides additional flow based on patient demand, which is a rule-based or algorithmic function, not explicitly AI/ML. There are no mentions of AI, ML, DNN, or training/test sets.
Yes
The device is a mechanical ventilator intended to provide ventilatory support to patients, which directly treats or alleviates a medical condition.
No
The device is a mechanical ventilator used for respiratory support, not for diagnosing medical conditions. Its function is to deliver air to patients, not to identify diseases or pathological states.
No
The device is described as a software option for a mechanical ventilator, which is a hardware device. While the option itself is software, it functions as part of a larger hardware system and is not a standalone software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a mechanical ventilator providing ventilatory support to patients. This is a life-support device that interacts directly with the patient's respiratory system.
- Device Description: The description reinforces that it's a software option for a ventilator, enhancing its ability to deliver air to the patient.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological samples.
Therefore, the Esprit Ventilator with VCV Demand Flow Option falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
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 and BZG
Device Description
The VCV Demand Flow Option is a software option for the currently marketed Esprit Ventilator. It represents an enhancement intended to provide additional flow/volume to patients when operator settings do not satisfy patient demand. VCV Demand Flow is available only in volume controlled mandatory and assist breaths. Once the software is enabled, the VCV Demand Flow feature is always available.
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 VCV Demand Flow 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.
Esprit Ventilator (K023350/K981072), Bear 1000 Ventilator (K912619/A), Servoi Ventilator System (K022132)
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
Image /page/0/Picture/1 description: The image shows a handwritten text that appears to be a combination of letters and numbers. The text includes "KO34O4O" and the word "2pasis" written below it. The writing is in black ink and is slightly tilted on the page.
ದ
ESPRIT VENTILATOR WITH VCV DEMAND FLOW SPECIAL 510(k): Device Modification
510(k) SUMMARY
JAN 2 1 2004
| Company: | Respironics California, Inc. |
|---|---|
| Address: | 2271 Cosmos Court |
| Carlsbad, CA-92009 | |
| Contact: | Anil Bhalani |
| Manager, QA/RA | |
| Date prepared: | December 26, 2003 |
| Product Common Name: | Continuous Ventilator |
| Product Proprietary Name: | Esprit Ventilator |
| Model Number: V1000 | |
| Device Classification: | Class II (Special Controls) and 840 |
| Continuous Ventilator per 21 CFR 868.5895 and | |
| Diagnostic Spirometer per 21 CFR 868.1 | |
| Procode: CBK and BZG | |
| Predicate Devices: | Esprit Ventilator (K023350/K981072) |
| Bear 1000 Ventilator (K912619/A) | |
| Servoi Ventilator System (K022132) |
Description of Device Modification:
The VCV Demand Flow Option is a software option for the currently marketed Esprit Ventilator. It represents an enhancement intended to provide additional flow/volume to patients when operator settings do not satisfy patient demand. VCV Demand Flow is available only in volume controlled mandatory and assist breaths. Once the software is enabled, the VCV Demand Flow feature is always available.
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 the VCV Demand Flow option.
1
KB4040
ESPRIT VENTILATOR WITH VCV DEMAND FLOW SPECIAL 510(k): Device Modification
Determination of Substantial Equivalence:
The Esprit Ventilator with the VCV Demand Flow option has similar performance characteristics, the same intended use, the same environment of use and patient populations as 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 and 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 VCV Demand Flow have been met.
Conclusion:
The technological characteristics of the Esprit ventilator with the VCV Demand Flow 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
Image /page/2/Picture/1 description: The image is a seal for the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized caduceus, a symbol of medicine and health, with a double helix representing DNA. The caduceus is composed of three wavy lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 1 2004
Mr. Anil Bhalani Manager of QA/RA Respironics, Incorporated 2271 Cosmos Court Carlsbad, CA 92009-1517
Rc: K034040
Trade/Device Name: Esprit Ventilator, Model V1000 Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: December 26, 2003 Received: December 29, 2003
Dear Mr. Bhalani:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your became of 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 interstate conmisive prior to tray been reclassified in accordance with the provisions of Amendinens, of to devroos and nave ooch (Act) that do not require approval of a premarket the rederal Food, Drag, and Commens , therefore, market the device, subject to the general approval appreation (1 Million). The general controls provisions of the Act include controls 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 (FMA), it may be subject to sace of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Cours nouncements concerning your device in the Federal Register.
3
Page 2 - Mr. Bhalani
Please be advised that I DA's issuance of a substantial equivalence determination does not Fleast be advisod that I Dr. determination that your device complies with other requirements mean that I Dr mai maal statutes and regulations administered by other Federal agencies. of the Act of ally I ederal babet's requirements, including, but not limited to: registration 1 our must comply with and are reveling (21 CFR Part 801); good manufacturing practice and fisting (21 CF A real of 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) This letter will are .. The FDA finding of substantial equivalence of your device to a premaired 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 desire spleetive at Compliance at (301) 594-4646. 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 Inter 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,
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
ESPRIT VENTILATOR WITH VCV DEMAND FLOW SPECIAL 510(k): Device Modification
Indications for Use
510(k) Number (if known): K034040
Esprit Ventilator with VCV Demand Flow Option Device Name:
Indications for Use:
The Esprit Ventilator with VCV Demand Flow Option is a microprocessor controlled, The Espit Pennancel was 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.
MB 20/04
| Prescription Use
| (Per 21 CFR 801.109) | OR Over-The-Counter Use |
|---|---|
| ------------------------------------------ | ------------------------- |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
BHWunderhauer
on Sign-C of Anesthesiology, General Hospital,
510(k) Number: K034040
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