(16 days)
K00334, K86262
Not Found
No
The description focuses on the mechanical components (compressor type) and intended use (nebulization) without mentioning any AI/ML capabilities or data processing.
Yes
The device is used in conjunction with a pneumatic nebulizer to produce a fine aerosol mist of medication for respiratory therapy. This shows it is used for the treatment of respiratory disorders, which is a therapeutic purpose.
No
Explanation: The device is described as providing compressed air for pneumatic nebulizers to deliver medication. It does not mention any function for diagnosing medical conditions.
No
The device description explicitly states it is a "Nebulizer Device" and mentions a "membrane rather than a piston compressor," indicating it is a hardware device that produces compressed air.
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 compressed air for medical purposes, specifically for use with a pneumatic nebulizer to deliver medication for respiratory therapy. This is a therapeutic application, not a diagnostic one.
- Device Description: The description focuses on the compressor mechanism and its similarity to other nebulizer devices. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is clearly intended to deliver medication, which falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Medical Depot is intended to provide a source of compressed air for medical purposes for use in home health care. This device is used in conjunction with a pneumatic nebulizer to produce a fine aerosol mist of medication for respiratory therapy, for both children and adults suffering from respiratory disorders.
Product codes
73 CAF
Device Description
The Medical Depot Nebulizer Device is the same as our Power Neb II except with a membrane rather than a piston compressor. It is also the same as the Graham - Field Mini-Mist II which was originally cleared by John Bunn Company and has the same compressor as this device.
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
for both children and adults
Intended User / Care Setting
home health care
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)
K00334, K86262
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
K012006
JUL 1 3 2001
510(K) SUMMARY (as required by 807.92(c))
| Submitter of 510(k): | Medical Depot, Inc.
55 Sea Lane
Farmingdale, NY 11735 | |
|----------------------|-------------------------------------------------------------------------|------------------------------|
| | Phone:
Fax: | 631-420-4134
631-420-4168 |
| Contact Person: | Harvey Diamond | |
| Date of Summary: | May 1, 2001 | |
| Trade Name: | Medical Depot Power Neb I | |
| Classification Name: | Nebulizer | |
| Predicate Device: | Medical Depot Power Neb II
John Bunn Model 510 Medication Compressor | K00334
K86262 |
Device Comparison/Description:
The Medical Depot Nebulizer Device is the same as our Power Neb II except with a membrane rather than a piston compressor. It is also the same as the Graham - Field Mini-Mist II which was originally cleared by John Bunn Company and has the same compressor as this device.
Intended Use:
The Medical Depot is intended to provide a source of compressed air for medical purposes for use in home health care. This device is used in conjunction with a pneumatic nebulizer to produce a fine aerosol mist of medication for respiratory therapy, for both children and adults suffering from respiratory disorders.
1
Image /page/1/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 a symbol consisting of three stylized, wavy lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 3 2001
Medical Depot, Inc. c/o Art Ward Regulatory and Marketing Services, Inc. 962 Allegro Lane Apollo Beach, FL 33572
Re: K012006
Medical Depot Power Neb I Regulation Number: 868.5630 Regulatory Class: II (two) Product Code: 73 CAF Dated: May 1, 2001 Received: June 27, 2001
Dear Mr. Ward:
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 OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this
2
Page 2 - Mr. Art Ward
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.
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 regulation (21 CFR Part 801 and additionally 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 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,
Arth A. CarhartL.
Yr James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K012006
Device Name: Medical Depot Power Neb I
Indications For Use:
The Medical Depot is intended to provide a source of compressed air for medical purposes for use in home health care. This device is used in conjunction with a pneumatic nebulizer to produce a fine aerosol mist of medication for respiratory therapy, for both children and adults suffering from respiratory disorders.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
- Aoh A. Cia U. fr. IED
Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)