(184 days)
Not Found
No
The device description explicitly states it is controlled by a mechanical timer and uses a piezoelectric crystal to generate ultrasonic waves. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is an ultrasonic nebulizer intended to deliver aerosol medications to mechanically-ventilated patients, which directly functions to provide a therapeutic effect.
No
Explanation: The device is an ultrasonic nebulizer designed to deliver aerosol medications. Its stated intended use is for medication delivery, not for diagnosing medical conditions or diseases.
No
The device description explicitly states it is an ultrasonic nebulizer with physical components like a power supply, mechanical timer, piezoelectric crystal, and medication cup. It is a hardware device.
Based on the provided text, the 800 Series EasyNeb is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is designed to "deliver aerosol medications to mechanically-ventilated patients." This is a therapeutic function, not a diagnostic one.
- Device Description: The description details how the device converts liquid medication into an aerosol for delivery to the patient. This aligns with a therapeutic device.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (blood, urine, tissue, etc.) or to provide information for the diagnosis of a disease or condition.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The 800 Series EasyNeb's function is to administer medication, which is a treatment, not a diagnostic process.
N/A
Intended Use / Indications for Use
The 800 Series EasyNeb is designed to deliver aerosol medications to mechanically-ventilated patients. It is intended for use with the Puritan Bennett Model 840 Ventilator System operating in continuous mode in ventilation (not anesthetic) breathing circuits only.
The intended patient population includes neonatal, pediatric and adult patients (tidal volume 0.005 - 2 L) who require continuous respiratory support and nebulized medication.
The 800 Series EasyNeb is intended for use in hospitals and institutions that provide care for patients requiring respiratory support. The Model 840 Ventilator System may be used for transport within the hospital or other facility. It s intended for sale by or on the order of a physician, intended for operation by qualified clinicians only, and not to be used in the presence of flammable anesthetics.
The 800 Series EasyNeb is intended to serve as an accessory to the Puritan Bennett Model 840 Ventilator to provide nebulization of medications.
Product codes
CAF
Device Description
The 800 Series EasyNeb is an ultrasonic nebulizer that is designed to deliver aerosol medications to patients being mechanically ventilated. It is powered by a 24V DC power supply and controlled by a mechanical timer. It contains a piezoelectric crystal that generates ultrasonic waves which are transmitted through buffer water to a medication cup and which convert the liquid medication into an aerosol. The nebulizer medication cup is designed for single-patient use 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
neonatal, pediatric and adult patients (tidal volume 0.005 - 2 L)
Intended User / Care Setting
qualified clinicians only / hospitals and institutions that provide care for patients requiring respiratory support.
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
Environmental testing was conducted per internal company requirements using FDA's Reviewer Guidance for Premarket Notification Submissions, Nov. 1993 draft as a guideline. The 800 Series EasyNeb device design and testing are also compliant with various voluntary, international standards including: EN60601-1:1990, EN 60601-1-2:1993, preliminary EN 13544-1 Respiratory therapy equipment - Part 1: Nebulizing systems and their components, and 93/42/EEC Medical Device Directive.
The combined testing and analysis of results provide assurance that the device meets its specifications and is safe and effective for its intended use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
AUG 0 7 2002
510(k) SUMMARY: K020357
| SUBMITTED BY: | Puritan-Bennett Corporation
(a subsidiary of Mallinckrodt Inc.,
a Division of Tyco Healthcare Group, LP)
4280 Hacienda Drive
Pleasanton, CA 94588 |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DATE: | August 5, 2002 |
| COMMON NAME: | Nebulizer |
| PROPRIETARY NAME: | 800 Series EasyNeb |
| CONTACT: | Gina To
Senior Regulatory Affairs Project Manager
Puritan-Bennett Corporation
4280 Hacienda Drive
Pleasanton, CA 94588
Phone: (925) 463-4427, Fax: (925) 463-4020
email: gina.to@tycohealthcare.com |
| CLASSIFICATION: | Class II (per 21 CFR 868.5630)
Nebulizer |
PREDICATE DEVICE:
Puritan-Bennett is claiming substantial equivalence to the 700 Series Ventilator incorporating the EasyNeb Nebulizer, K990897.
DEVICE DESCRIPTION:
The 800 Series EasyNeb is an ultrasonic nebulizer that is designed to deliver aerosol medications to patients being mechanically ventilated. It is powered by a 24V DC power supply and controlled by a mechanical timer. It contains a piezoelectric crystal that generates ultrasonic waves which are transmitted through buffer water to a medication cup and which convert the liquid medication into an aerosol. The nebulizer medication cup is designed for single-patient use and holds up to 10 mL of medication.
1
510(k) SUMMARY: K020357
(Continued)
INTENDED USE:
The 800 Series EasyNeb is designed to deliver aerosol medications to mechanically-ventilated patients. It is intended for use with the Puritan Bennett Model 840 Ventilator System operating in continuous mode in ventilation (not anesthetic) breathing circuits only.
The intended patient population includes neonatal, pediatric and adult patients (tidal volume 0.005 - 2 L) who require continuous respiratory support and nebulized medication.
The 800 Series EasyNeb is intended for use in hospitals and institutions that provide care for patients requiring respiratory support. The Model 840 Ventilator System may be used for transport within the hospital or other facility. It s intended for sale by or on the order of a physician, intended for operation by qualified clinicians only, and not to be used in the presence of flammable anesthetics.
SUBSTANTIAL EQUIVALENCE:
The 800 Series EasyNeb is identical to the EasyNeb nebulizer that was cleared for use with the Puritan-Bennett 700 Series Ventilator under 510(k) #K990897. The only modifications are the addition of an external timer, an external power supply, and a mounting bracket.
Information provided in the 510(k) supports the determination of substantial equivalence. Environmental testing was conducted per internal company requirements using FDA's Reviewer Guidance for Premarket Notification Submissions, Nov. 1993 draft as a guideline. The 800 Series EasyNeb device design and testing are also compliant with various voluntary, international standards including: EN60601-1:1990, EN 60601-1-2:1993, preliminary EN 13544-1 Respiratory therapy equipment - Part 1: Nebulizing systems and their components, and 93/42/EEC Medical Device Directive.
The combined testing and analysis of results provide assurance that the device meets its specifications and is safe and effective for its intended use. This device is substantially equivalent to the currently marketed EasyNeb Nebulizer that was previously cleared by FDA for marketing.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, resembling an abstract bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 0 7 2002
Ms. Gina To Senior Regulatory Affairs project Manager Nellcor Puritan-Bennett, Incorporated 4280 Hacienda Drive Pleasanton, California 94588
Re: K020357
Trade/Device Name: 800 Series EasyNeb Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: June 4, 2002 Received: June 5, 2002
Dear Ms. To:
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. To
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. 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.qov/cdrh/dgma/dsmamain.html
Sincerely,
Timothy A. Ulatowski
Timothy A Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K020357 510(k) Number (if known):
Puritan Bennett 800 Series EasyNeb Nebulizer Device Name:
Indications For Use:
The 800 Series EasyNeb is intended to serve as an accessory to the Puritan Bennett Model 840 Ventilator to provide nebulization of medications.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
X Prescription
use
CA Westrash
(Division Sign-Off Division of Anesth siology, General Hos Infection Control, De
510(k) Number: K020357
-
or -
-
Over-the-counter
use
(Optional Format 3-10-98)
CONFIDENTIAL