(71 days)
K924123,K914152B
K924123, K914152B
No
The summary describes a simple mechanical nebulizer and explicitly states that it does not mention AI, DNN, or ML.
No
A nebulizer is a drug delivery device that turns liquid medicine into a mist to be inhaled. It is a drug delivery device, not a therapeutic device itself.
No
This device is a nebulizer designed to deliver aerosolized medications, not to diagnose medical conditions. Its intended use is for drug delivery, not for detecting, monitoring, or identifying diseases.
No
The device description clearly states it is a hand-held nebulizer made of physical components (top, baffle, base) and materials (polypropylene), indicating it is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to aerosolize liquid drugs for inhalation by patients. This is a therapeutic delivery method, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a nebulizer, which is a device used to administer medication. It does not describe a device used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This nebulizer does not fit that description.
N/A
Intended Use / Indications for Use
A hand-held nebulizer to aerosolize commonly prescribed liquid drugs (except pentamadine) for inhalation by patients in the Home, Hospital and Nursing Home settings - anywhere aerosolized drug delivery is utilized.
Product codes
73 CAF
Device Description
The Inspired Medical Products Sidestream Nebulizer is identical to the Medic-Aid Sidestream Nebulizer cleared under K924123.
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
Not Found
Intended User / Care Setting
Home, Hospital and Nursing Home settings - anywhere aerosolized drug delivery is utilized.
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)
There are no differences in performance, safety, or efficacy between the intended device and the predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Medic-Aid - Sidestream Nebulizer - K924123, Medic-Aid - Sidestream Nebulizer - K914152B
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
Inspired Medical Products, Ltd. Heath Place Bognor Regis, West Sussex PO22 9SL United Kingdom
Fax - 011-44-1243-846100 Tel - 011-44-1243-840888
Non-Confidential Summary of Safety and Effectiveness
page 1 of 3 May 19, 1999
Inspired Medical Products, Ltd.
Heath Place
Bognor Regis, West Sussex PO22 9SL
United Kingdom
| Tel - 011-44-1243-840888 | Fax - 011-44-1243-846100 |
|---|---|
| Official Contact: | Ed Walters, Quality Manager |
| Proprietary or Trade Name: | Sidestream Drug Nebulizer |
| Common/Usual Name: | Nebulizer |
| Classification Name: | Nebulizer, Medicinal, Non-ventilatory (atomizer) |
| Predicate Devices: | Medic-Aid - Sidestream Nebulizer - K924123 |
| Medic-Aid - Sidestream Nebulizer - K914152B |
Device Description: 2011 - 11 - 11 - 11
The Inspired Medical Products Sidestream Nebulizer is identical to the Medic-Aid Sidestream Nebulizer cleared under K924123.
| 1. Intended use - | Aerosolization of commonly prescribed liquid drugs (except pentamadine) for inhalation by the patient. |
|---|---|
| 2. Environment of Use - | Single patient use for the Home, Hospital and Nursing Home settings - anywhere aerosolized drug delivery is utilized. |
| 3. Patient Population - | Patients requiring nebulized drug delivery. |
1
Non-Confidential Summary of Safety and Effectiveness
page 2 of 3
May 19, 1999
Comparison to Other Legally Marketed Predicate Devices
The following comparison table details the primary attributes of the intended device and legally marketed predicate devices. The most significant attributes have been listed.
| DILE FREELLE CORRENCE CONCELMALE CONSUMERAL | ||||
|---|---|---|---|---|
| SALES CALL COLLECTION CONSULTION CONSULTION CONTRACTION CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CARACT CARACT CARAC | September 1978 - 1998 - 1998 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 199 | |||
| CHANDED AND STORE AND CONSULTION | ||||
| A STORES OF COURTES CONSULTION CALL COLLECTION CALL COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION CONSTITUTION CANADA CONSTITUTION C | ||||
| and and the country of the more of the state of the state of the such | ||||
| 11 25 25 25 25 25 25 25 | a managar managar mana mana mana mana mana mana mana mana mara mara mara mara mara mara mara mara mara mara mara marka marka marka marka marka mara mara mara mara mara mara m | |||
| 1 | ||||
| 1. 802-10-10-10. | ||||
| 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 | Comments of the comments of the first of the first of the first of the first of the first of the first of the first of the first of the first of the first and | |||
| 12225 535 | ||||
| a market and the products of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of t | ||||
| Use | |||
|---|---|---|---|
| Intended to nebulize drugs | Yes | Yes | Yes |
| Utilizes Sidestream jet system | |||
| to nebulize drug | Yes | Yes | Yes |
| Used in hospitals, home care, | |||
| nursing home settings - anywhere | |||
| aerosolized drug delivery is utilized | Yes | Yes | Yes |
| Single Patient Use | Yes | Yes | Yes |
| Design | |||
| Utilizes same technology | |||
| to atomize drugs | Yes | Yes | Yes |
| Gas Source - Compressed Air | Yes | Yes | Yes |
| Made of three components - | |||
| top, baffle, base | Yes | Yes | Yes |
2
Non-Confidential Summary of Safety and Effectiveness
page 3 of 3 May 19, 1999
| Attribute | Inspired Med.
Sidestream
Nebulizer
disposable | Medic-Aid
Sidestream
Nebulizer
disposable
K924123 | Medic-Aid
Sidestream
nebulizer
K914152B |
|--------------------------------------------------------------|--------------------------------------------------------|---------------------------------------------------------------|--------------------------------------------------|
| Materials | | | |
| Materials in contact with
patient - polypropylene | Yes | Yes | Yes |
| Packaging | | | |
| Provided clean, non-sterile | Yes | Yes | Yes |
| Performance Standards / Specifications | | | |
| None applicable under Section 514 | Yes | Yes | Yes |
| Differences Between Other Legally Marketed Predicate Devices | | | |
There are no differences in performance, safety, or efficacy between the intended device and the predicates.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the circumference. Inside the circle is a stylized symbol resembling an abstract caduceus or a series of flowing lines, possibly representing human figures or a stylized representation of health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 30 1999
Mr. Paul Dryden Inspired Medical Product, Ltd. c/o ProMedic, Inc. 6329 W. Waterview Court McCordsville, IN 46055-9501
Re: K991725 Sidestream Drug Nebulizer Requlatory Class: II (two) Product Code: 73 CAF Dated: May 19, 1999 Received: May 20, 1999
Dear Mr. Dryden:
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 A substantially equivalent determination assumes compliance to 895. 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 Failure to comply with the GMP regulation may result in assumptions. regulatory 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. Paul Dryden
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) 594-4648. 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,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE AND
Page 1 of 1
Pursuant to the Notice of February 6, 1996 regarding listing of Indications for Use on a separate sheet, the following is per that request.
510(k) Number: K991725 (To be assigned)
Device Name: Sidestream nebulizer
Intended Use : A hand-held nebulizer to aerosolize commonly prescribed
liquid drugs (except pentamadine) for inhalation by
patients in the Home, Hospital and Nursing Home settings -
anywhere aerosolized drug delivery is utilized.
Concurrence of CDRH, Office of Device Evaluation (ODE)
toth Westerhausen 7.30.99
of Cardiovascular. d Neurological Devices 10(k) Number
Prescription Use (Per CFR 801.109)
or
Over-the-counter use ___