(65 days)
Not Found
No
The summary describes saline solutions and their use with a nebulizer, with no mention of AI or ML technology.
No.
The device is an inhaled saline solution used to induce sputum production for specimen collection, not to treat a disease or condition.
No
Explanation: The device is described as inhaled saline solutions used for the induction of sputum production, which is a method for collecting a specimen. It is not described as analyzing or diagnosing any condition.
No
The device description explicitly states the device is "inhaled saline solutions" packaged in "vials," which are physical components, 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 to induce sputum production for specimen collection. This is a method of obtaining a biological sample, not a test performed on a biological sample to diagnose or monitor a condition.
- Device Description: The device is a saline solution used in conjunction with a nebulizer. This is a therapeutic or procedural aid, not a diagnostic reagent or instrument.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze or test the collected sputum. The device's function ends with the collection of the sample.
IVD devices are specifically designed to be used in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device facilitates the collection of a specimen, but it does not perform any diagnostic testing on that specimen.
N/A
Intended Use / Indications for Use
Used in conjunction with a nebulizer for induction of sputum production where specimen collection is indicated.
Product codes
CAF
Device Description
The proposed inhaled saline solutions are in 3.5%, 6% and 7% concentrations. They are packaged sterile in 4 ml vials for use as indicated.
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
Any patient population
Intended User / Care Setting
Hospital, sub-acute care or home
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)
None applicable
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
DEY Laboratories – K972778
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
....
Non-Confidential Summary of Safety and Effectiveness
Page 1 of 2 26-Apr-07
| PARI Innovative Manufacturers, Inc.
2943 Oak Lake Blvd.
| Midlothian, VA 23112 | APR 26 2007 |
|---|---|
| Tel - (804) 253-7274 | |
| Fax - (804) 639-7244 | |
| Official Contact: | Mike Judge - RA |
| Proprietary or Trade Name: | Hyper Sal |
| Common/Usual Name: | Saline solution |
| Classification Name: | CAF – Nebulizer (Direct Patient Interface) |
| Device: | Inhaled saline solutions – 3.5%, 6% and 7% |
| Predicate Devices: | DEY Laboratories – K972778 |
| Device Description: |
The proposed inhaled saline solutions are in 3.5%, 6% and 7% concentrations. They are packaged sterile in 4 ml vials for use as indicated.
| Indications for Use: | |
|---|---|
| Indicated Use -- | Used in conjunction with a nebulizer for induction of sputum production where specimen collection is indicated.. |
| Patient Population -- | Any patient population |
| Environment of Use -- | Hospital, sub-acute care or home |
| Contraindications -- | None |
1
Premarket Notification 510(k) K070498
. .
Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 26-Apr-07
| Attributes | |
|---|---|
| Intended use | Used in conjunction with a nebulizer for induction of |
| sputum production where specimen collection is | |
| indicated. | |
| Environments of use | Hospital, sub-acute care or home |
| Patient Population | Any |
| Contraindications | None |
| Prescription | Yes |
| Design | USP sodium chloride solutions of 3.5%, 6% and 7% |
| Performance | None applicable |
| USP monograph |
Differences between Other Legally Marketed Predicate Devices
The proposed inhale saline solutions are viewed as substantially equivalent to the following predicate device – DEY K972778.
There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate device.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pari Innovative Manufacturers, Incorporated C/O Mr. Paul Dryden President ProMedic, Incorporated 3460 Pointe Creek Court #102 Bonita Springs, Florida 34134
APR 2 6 2007
Re: K070498
Trade/Device Name: Inhaled Saline Solutions 3.5%, 6%, and 7% Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: February 14, 2007 Received: February 20, 2007
Dear Mr. Dryden:
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 - Mr. Dryden -
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 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours.
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Premarket Notification 510(k) Section 4 - Indications for Use Statement
Indications for Use Statement 4
Page 1 of 1
| 510(k) Number: | K070498 (To be assigned) |
|---|---|
| Device Name: | Inhaled saline solutions 3.5%, 6%, and 7% |
| Indications for Use: | Used in conjunction with a nebulizer for induction of sputum production where specimen collection is indicated. |
Prescription Use XX (Part 21 CFR 801 Subpart D) or Over-the-counter use __ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
and the comments of the country of
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chlotte
.k) Number
. . . . .
:
:
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.