(72 days)
No
The summary explicitly states that the device description is exactly the same as the predicate device except for the material and coating, and there are no mentions of AI, DNN, or ML.
Yes
The device is described as a "Nebulizer Cap" used for "inhalation therapy," indicating its role in administering therapeutic respiratory treatments.
No
Explanation: The "Intended Use / Indications for Use" section states the device is "for inhalation therapy only." There is no mention of diagnosing conditions or diseases.
No
The device description explicitly states it is a physical component (Nebulizer Cap) made of aluminum alloy with a coating, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "inhalation therapy only" with sterile water. This is a therapeutic application, not a diagnostic one.
- Device Description: The description focuses on the physical components and materials of a nebulizer cap, which is a delivery device for inhalation.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This nebulizer cap does not fit that description.
N/A
Intended Use / Indications for Use
The Baxter Healthcare Corporation's Nebulizer Cap is for use with Sterile Water for Inhalation, USP, in 500 ml, 1000 ml, and 1500 ml plastic bottles, for inhalation therapy only.
Product codes
Not Found
Device Description
All blueprints dimension and specifications are exactly the same in this device as found in the predicate device. The only change is the aluminum alloy and the coating. The rest of the device remains the same as currently marketed.
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
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)
Baxter Healthcare Corporation K780406
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
510(K) SUMMARY (as required by 807.92(c))
K 962161
| Submitter of 510(k): | Tamima Itani, Ph.D.
Baxter Healthcare Corp.
I.V. Systems Division
Route 120 & Wilson Rd.
Round Lake, IL 60073 |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Regulatory & Marketing Services, Inc. (RMS)
40178 U.S. 19 North
Tarpon Springs, FL 34689 |
| | Phone: 813-942-3908
Fax: 813-942-3828 |
| Contact Person: | Ed Ransom |
| Date of Summary: | 04/26/96 |
| Trade Name: | Baxter Nebulizer Cap |
| Classification Name: | Nebulizer Cap |
| Predicate Device: | Baxter Healthcare Corporation K780406 |
| Device Description/Comparison: | All blueprints dimension and specifications are exactly
the same in this device as found in the predicate
device. The only change is the aluminum alloy and
the coating. The rest of the device remains the same
as currently marketed. |
| Intended Use: | The Baxter Healthcare Corporation's Nebulizer Cap is
for use with Sterile Water for Inhalation, USP, in 500
ml, 1000 ml, and 1500 ml plastic bottles, for inhalation
therapy only. |
MAY 30 1996