(363 days)
Not Found
No
The summary describes a ventilator system with nebulization functionality controlled by software. There is no mention of AI, ML, or any related concepts in the device description, intended use, or performance studies.
Yes
The device is a ventilator system that provides continuous ventilation to patients requiring respiratory support, which is a therapeutic intervention. Additionally, it has a nebulization functionality to deliver aerosol medications, further indicating its therapeutic purpose.
No
This device is a ventilator, which is a therapeutic device used to provide continuous ventilation and nebulization. It does not perform any diagnostic functions.
No
The device is a ventilator system which includes both hardware (the ventilator itself and the optional nebulizer accessory) and software. While the software controls the nebulizer, the device is not solely software.
Based on the provided text, the 700 Series Ventilator System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to provide continuous ventilation to patients requiring respiratory support. This is a life support function directly applied to the patient's respiratory system.
- Device Description: The device is a ventilator, a machine that assists or replaces breathing. It also includes an optional nebulizer for delivering aerosol medications directly to the patient's lungs.
- 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. The 700 Series Ventilator does not perform any such analysis of bodily specimens.
The device is clearly a therapeutic device used for direct patient care, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The 700 Series Ventilator System is used to provide continuous ventilation to patients requiring respiratory support. This device is used for a wide range of patients from pediatric to adult and for a wide variety of clinical conditions. It also has the capability to provide nebulization through use of an optional accessory, the EasyNeb Nebulizer.
Product codes (comma separated list FDA assigned to the subject device)
CAF, CBK
Device Description
The device is a low-cost, critical care ventilator intended to provide continuous ventilation for pediatric and adult patients, with the provision of nebulization functionality, through use of an optional accessory, the EasyNeb Nebulizer. The nebulization functionality is implemented by: a) modifying the 700 Series software to activate a nebulizer interface which directly controls the power and operation of the EasyNeb Nebulizer and b) the provision of an external nebulizer, the EasyNeb Nebulizer, as an optional accessory. which is intended to be used solely with the 740 and 760 ventilators. The modification to the ventilator is the activation through software of the nebulizer port on an existing Communications interface option. This nebulizer port facilitates electrical connection of the EasyNeb Nebulizer to the ventilator, the operation of which is controlled completely by ventilator software. The ventilator modification in essence then is a software modification which allows control of the nebulizer power on/off, the nebulization period and mode of operation. The EasyNeb Nebulizer is an ultrasonic nebulizer which is designed to deliver aerosol medications to the patient without affecting ventilator performance or patient data. It is powered and controlled by a 700 Series Ventilator, with the Communications Option installed. It contains a piezoelectric crystal that generates ultrasonic waves. The crystal's vibrations are transmitted through buffer water to a medication cup and convert the liquid medication into fine particles. The nebulizer medication cup is designed for single-patient use only, and holds up to 10 mL of medication.
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
pediatric to adult
Intended User / Care Setting
Intended environment of use: The 700 Series Ventilator is intended for use in hospitals and hospital type facilities which provide respiratory care for patients requiring respiratory support. The 700 Series Ventilator may be used during hospital and hospital type facility transport. The 700 Series Ventilator is not to be used in the presence of flammable anesthetics. The 700 Series Ventilator is intended for sale by or on the order of a physician only. This product is intended for operation by trained and qualified clinicians only.
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)
The combined testing and analysis of results provides assurance that the device meets its specifications and is safe and effective for its intended use. In summary Puritan-Bennett Corp. has demonstrated the 700 Series Ventilator, incorporating the EasyNeb Nebulizer as an optional accessory, to be safe and effective.
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.
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
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
SUMMARY OF SAFETY AND EFFECTIVENESS
| SUBMITTER: | Nellcor Puritan Bennett Ireland,
a subsidiary of Mallinckrodt Inc., |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| on behalf of: | Puritan-Bennett Corp.,
a subsidiary of Mallinckrodt Inc. |
| DATE: | 16 March 1999 |
| COMMON NAME: | Continuous Ventilator |
| PROPRIETARY NAME: | 700 Series Ventilator |
| CONTACT: | Robbie Walsh, Regulatory Affairs Manager
Nellcor Puritan Bennett Ireland,
Mervue,
Galway.
Ireland.
Tel: + 353 91 753771
Fax: + 353 91 770156 |
| CLASSIFICATION: | Class II per 21 CFR 868.5895
Continuous Ventilator |
PREDICATE DEVICES:
Puritan-Bennett Corp. is claiming substantial equivalence to the following two predicate medical devices:
| Predicate Device | 510(k) Number | Classification |
|---|---|---|
| Siemens Servo | ||
| Ventilator 300 | K902859 | Class II, |
| Continuous Ventilator | ||
| per 21 CFR 868.5895 | ||
| Siemens Servo Ultra | ||
| Nebulizer 345 | K960854 | Class II, |
| Nebulizer | ||
| per 21 CFR 868.5630 |
1
A Device Description:
The device is a low-cost, critical care ventilator intended to provide continuous ventilation for pediatric and adult patients, with the provision of nebulization functionality, through use of an optional accessory, the EasyNeb Nebulizer.
The nebulization functionality is implemented by:
a) modifying the 700 Series software to activate a nebulizer interface which directly controls the power and operation of the EasyNeb Nebulizer and b) the provision of an external nebulizer, the EasyNeb Nebulizer, as an optional accessory. which is intended to be used solely with the 740 and 760 ventilators.
The modification to the ventilator is the activation through software of the nebulizer port on an existing Communications interface option. This nebulizer port facilitates electrical connection of the EasyNeb Nebulizer to the ventilator, the operation of which is controlled completely by ventilator software. The ventilator modification in essence then is a software modification which allows control of the nebulizer power on/off, the nebulization period and mode of operation.
The EasyNeb Nebulizer is an ultrasonic nebulizer which is designed to deliver aerosol medications to the patient without affecting ventilator performance or patient data. It is powered and controlled by a 700 Series Ventilator, with the Communications Option installed. It contains a piezoelectric crystal that generates ultrasonic waves. The crystal's vibrations are transmitted through buffer water to a medication cup and convert the liquid medication into fine particles. The nebulizer medication cup is designed for single-patient use only, and holds up to 10 mL of medication.
Intended Use: B
The intended use is provided below;
Purpose and function of device:
- · The 700 Series Ventilator is intended to provide continuous ventilation to patients requiring respiratory support.
- · It offers nebulization functionality through use of an optional accessory, the EasyNeb Nebulizer
- This product is intended for a wide range of patients from pediatric to adult and for a wide variety of clinical conditions.
Intended patient population:
- · The intended patient population includes pediatric and adult patients (tidal volume 0.04 - 2 L) who require continuous respiratory support.
- Intended for patients who require either invasive or non-invasive . ventilation.
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Intended environment of use:
- · The 700 Series Ventilator is intended for use in hospitals and hospital type facilities which provide respiratory care for patients requiring respiratory support.
- · The 700 Series Ventilator may be used during hospital and hospital type facility transport
- · The 700 Series Ventilator is not to be used in the presence of flammable anesthetics
- · The 700 Series Ventilator is intended for sale by or on the order of a physician only.
- · This product is intended for operation by trained and qualified clinicians only.
C Substantial Equivalence
The intended use of the 700 Series Ventilator, incorporating the EasyNeb Nebulizer as an optional accessory, is the same as that for a standard, currently marketed critical care ventilator. The materials and design of these device are similar to those of the predicate devices. The technical characteristics of the 700 Series Ventilator do not introduce new questions regarding safety or effectiveness of critical care ventilators. Furthermore, the labeling associated with the 700 Series Ventilator and EasyNeb Nebulizer provides similar information as the predicate devices.
Information provided in the 510(k) submission supports the determination of substantial equivalence. Software design and development, (including verification and validation testing. test and software quality procedures) was conducted using FDA's Guidance for the Content of Premarket Submissions for Software contained in medical devices, dated May 29 1998, as a guidance and per internal company requirements. Environmental testing was conducted using FDA's Reviewers Guidance for Premarket Notification Submissions, Nov. 1993 draft as a guideline and per internal company requirements. The 700 Series Ventilator and EasyNeb Nebulizer device design and testing are also compliant with various voluntary, international standards including: EN60601-1:1990, EN 60601-1-2:1993, CAN/CSA C22.2 No. 601-1M90:1994, UL 2601-1:1994 and 93/42/EEC Medical Device Directive.
The combined testing and analysis of results provides assurance that the device meets its specifications and is safe and effective for its intended use.
In summary Puritan-Bennett Corp. has demonstrated the 700 Series Ventilator, incorporating the EasyNeb Nebulizer as an optional accessory, to be safe and effective. This device is considered to be substantially equivalent to currently marketed devices which have been previously cleared by FDA.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem that resembles a stylized bird or eagle with three wing-like shapes.
Public Health Service
MAR 1 5 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robbie Walsh Nellcor Puritan Bennett Ireland Mervue Galway Ireland
Re: K990897 700 Series Ventilator incorporating EasyNeb Nebulizer Regulatory Class: II (two) Product Code: CAF, CBK December 10, 1999 Dated: December 16, 1999 Received:
Dear Mr. Walsh:
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 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.
4
Page 2 - Mr. Robbie Walsh
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 regulation 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.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
James E. Dillard III Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATION FOR USE
| 510(k) Number: | K990897 |
|---|---|
| Device Name: | 700 Series Ventilator System (incorporating the EasyNeb |
| Nebulizer as an optional accessory) | |
| Indication for Use: | The 700 Series Ventilator System is used to provide |
| continuous ventilation to patients requiring respiratory support. | |
| This device is used for a wide range of patients from pediatric | |
| to adult and for a wide variety of clinical conditions. It also has | |
| the capability to provide nebulization through use of an optional | |
| accessory, the EasyNeb Nebulizer. |
Prescription Use: Yes (Per 21 CFR 801.109)
L.A.Ketron
(Division Sign-off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number