(150 days)
Not Found
No
The description focuses on the mechanical operation (venturi principle), materials, and standard accessories of a pneumatic nebulizer, with no mention of AI or ML.
Yes.
The device nebulizes specific drugs for inhalation by a patient, which directly implies a therapeutic function.
No
Explanation: The device is a nebulizer designed to deliver medication in aerosol form for inhalation, not to diagnose a medical condition.
No
The device description clearly states it is a pneumatic nebulizer made from acrylic and polypropylene plastics, indicating it is a physical hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "nebulize specific drugs for inhalation by a patient." This describes a device used to deliver medication directly to the patient's respiratory system.
- Device Description: The description focuses on the mechanical function of the nebulizer (spraying liquids in aerosol form into gasses for breathing) and its components.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (on or in the body) to administer medication.
N/A
Intended Use / Indications for Use
The GaleMed Neb-Easy Nebulizer is a pneumatic nebulizer which nebulizes specific drugs for inhalation by a patient. It is for adult and pediatric patients.
Product codes (comma separated list FDA assigned to the subject device)
CAF
Device Description
The nebulizer is a device intended to spray liquids in aerosol form into gasses that are delivered directly to the patient for breathing. It is a Class II device, requlation number: 868.5630. This device operates on the venturi principle and is refillable. The device is called the GaleMed Neb-Easy Nebulizer. It is made from acrylic and polypropylene plastics, is injection molded and is intended for single patient use for up to 28 days. These material types are used in other predicate devices, such as the Salter Labs and Allegiance Airlife product lines. The specific materials have been tested for biocompatibility to ISO 10993 and results showed them to be non-reactive. All testing requirements contained in the "Reviewer Guidance: Nebulizers, Metered Dose Inhalers, Spacers and Actuators, 10/01/93" have been completed and were submitted by GaleMed for FDA review in their premarket notification submission. Comparative testing data to the predicate device (Allegiance Airlife Misty-Neb, K883964) was also performed at a third party independent test laboratory to the requirements of the "Reviewers Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators, 10/01/93." The Neb-Easy Nebulizer has several attachments that are used with it during the nebulization process. These include a Tee Connector, which connects to the top of the nebulizer; a mouthpiece and a 6 inch corrugated tube, which connects to the side of the Tee connector opposite the mouthpiece. These are standard accessories to class 1 oxygen masks and breathing circuits as well as being considered standard accessories to a nebulizer devices. A standard oxygen tube connects to the bottom of the Neb-Easy Nebulizer and serves to connect the nebulizer to a pressurized gas source. This gas source is used to create the venturi and high flow conditions inside of the Neb-Easy that are used to create respirable aerosols. Flow rates are determined by the physician, but are typically between 5 lpm and 9 lpm. The accessories, attachments, principles of operation and materials are all essentially equivalent to predicate devices already cleared by FDA.
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
Not Found
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)
Not Found
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
OCT 2 5 2002
12. GaleMed Neb-Easy Nebulizer 510(k) Summary:
In accordance with 21 CFR section 807.92 GaleMed is submitting the following safety and effectiveness summary.
- Submitter Information
Gary Lee President, GaleMed 87. Li-gong 2nd Road Wu-Jia, I-Lan 268 Taiwan
Telephone: 886-3-9908-618 886-3-9908-245 FAX:
-
- Name of Device
Proprietary Name: Neb-Easy Nebulizer Common Name is Nebulizer Classification Name: Nebulizer
- Name of Device
-
- Substantially equivalent to: Allegiance Misty-Neb Nebulizer (K883968).
-
- Device Description and System Overview:
General Description of the Device:
The nebulizer is a device intended to spray liquids in aerosol form into gasses that are delivered directly to the patient for breathing. It is a Class II device, requlation number: 868.5630.
This device operates on the venturi principle and is refillable. The device is called the GaleMed Neb-Easy Nebulizer. It is made from acrylic and polypropylene plastics, is injection molded and is intended for single patient use for up to 28 days. These material types are used in other predicate devices, such as the Salter Labs and Allegiance Airlife product lines. The specific materials have been tested for biocompatibility to ISO 10993 and results showed them to be non-reactive. All testing requirements contained in the "Reviewer Guidance: Nebulizers, Metered Dose Inhalers, Spacers and Actuators, 10/01/93" have been completed and were submitted by GaleMed for FDA review in their premarket notification submission. Comparative testing data to the predicate device (Allegiance Airlife Misty-Neb, K883964) was also performed at a third party independent test laboratory to the requirements of the "Reviewers Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators, 10/01/93."
The Neb-Easy Nebulizer has several attachments that are used with it during the nebulization process. These include a Tee Connector, which connects to the top of the nebulizer; a mouthpiece and a 6 inch corrugated tube, which connects to the side of the Tee connector opposite the
1
opposite the mouthpiece. These are standard accessories to class 1 oxygen masks and breathing circuits as well as being considered standard accessories to a nebulizer devices.
| Accessory | Part # | Manufacturer | Regulatory Status |
|---|---|---|---|
| Mouth Piece | 3394-B | GaleMed Corp. | Class 1 device exempt from pre-market notification |
| Tee Connector | TZ-3393 | GaleMed Corp. | Class 1 device exempt from pre-market notification |
| 6" Corrugated Tubing | 740-01 | GaleMed Corp. | Class 1 device exempt from pre-market notification |
| Oxygen Supply Tubing | 34502-YY | GaleMed Corp. | Class 1 device exempt from pre-market notification |
Table 1a: List of Accessories and Regulatory Status.
A standard oxygen tube connects to the bottom of the Neb-Easy Nebulizer and serves to connect the nebulizer to a pressurized gas source. This gas source is used to create the venturi and high flow conditions inside of the Neb-Easy that are used to create respirable aerosols. Flow rates are determined by the physician, but are typically between 5 lpm and 9 lpm.
The accessories, attachments, principles of operation and materials are all essentially equivalent to predicate devices already cleared by FDA.
The GaleMed Design System
GaleMed has in place a fully operational quality system that conforms to ISO 9001:1994, EN 46001:1996, the QSR and required elements of the Medical Device Directive. All new products are processed according to the requirements of 21 CFR Part 820.30. Design History Files are maintained for all new development projects and the products are tested in the United States by MDVentures prior to the submission process.
| Table 1: Comparison of Neb-Easy Materials to predicate Allegiance Misty Neb Nebulizer | |||
|---|---|---|---|
| Nebulizer Component: | GaleMed Neb-Easy | ||
| Nebulizer | Allegiance MistyNeb | ||
| (883964) | |||
| Cup: material and GaleMed | |||
| component material | |||
| specification #: | Acrylic, Cyro 20G-Hiflow | ||
| part #001-0129-01 | |||
| (equivalent to polystyrene) | Polystyrene, supplier | ||
| unknown | |||
| Top Cap: material and | |||
| GaleMed component | |||
| material specification #: | Polypropylene, Basell Profax | ||
| 549M or Fina 7235, | |||
| GaleMed part #001-0126-01 | Polystyrene, supplier | ||
| unknown | |||
| Cone Insert: material and | |||
| GaleMed component | |||
| material specification #: | Acrylic, Cyro 20G-Hiflow, | ||
| GaleMed part #001-0128-01 | Polystyrene, supplier | ||
| unknown |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 5 2002
GaleMed Corporation C/O Mr. Thomas Shanks MDVentures 29201 Via Norte Temecula, California 92591
Re: K021742
Trade Name: Gale-Med Neb-Easy Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: 73 CAF Dated: September 4, 2002 Received: September 10, 2002
Dear Mr. Shanks:
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 l'ederal statutes and regulations administered by other Federal agencies.
3
Page 2 – Mr. Tom Shanks
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,
[signature]
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
- Indications for Use
510(k) Number: K021742
Device Name: Neb-Easy Nebulizer
Indications for Use:
The GaleMed Neb-Easy Nebulizer is a pneumatic nebulizer which nebulizes specific drugs for inhalation by a patient. It is for adult and pediatric patients.
X Prescription
use
510(k) Submission for the GaleMed Neb-Easy Nebulizer
Revised 09-04-02
-
- Over-the-
- under- over
R.K.W.L.A.T.L.
(Division Sign-Off) Division of Anesthesiology, General Hospital, Enteren of Anesthesion Control, Dental Devices
510(k) Number.
KOZI 74222