(90 days)
Not Found
No
The device description and other sections do not mention any AI or ML components; it is a simple saline solution for inhalation.
No
The device, Steri-Neb Saline, is described as a solution for respiratory therapy and tracheal lavage, specifically for dilution of solutions used in nebulizers. While it's used in conjunction with respiratory therapy, it's a sterile saline solution and not a therapeutic device itself, but rather a diluent or for lavage.
No
Explanation: The "Intended Use / Indications for Use" section states "For respiratory therapy and tracheal lavage," which are therapeutic applications, not diagnostic ones. The device description also focuses on its composition and use for dilution or lavage, without any mention of identifying, detecting, or monitoring medical conditions.
No
The device description clearly states it is a 3 mL solution of Sodium Chloride, which is a physical substance, 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 "respiratory therapy and tracheal lavage." This involves direct application to the patient's respiratory system, not the examination of specimens taken from the body.
- Device Description: The description details a sterile saline solution for inhalation and lavage. This is a therapeutic or procedural product, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting substances, or providing information about a patient's health status based on in vitro testing.
IVDs are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
For respiratory therapy and tracheal lavage
Product codes (comma separated list FDA assigned to the subject device)
73 CAF
Device Description
The subject device is 3 mL Steri-Neb Saline, 0.9% "/v Sodium Chioride Inhalation Solution USP. Steri-Neb Saline is used for respiratory therapy and tracheal lavage. For respiratory therapy, Steri-Neb Saline is used for dilution of solutions used in nebulizers. Steri-Neb Saline is a unit dose low density polyethylene vial containing sterile, preservative-free, clear, colourless, aqueous solution. The Steri-Neb Saline product contains 0.9% w/v Sodium Chloride USP in Water for Injection USP. The formulation contains no additives.
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): 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
Image /page/0/Picture/0 description: The image shows the text "JUN 2 1998" on the left side of the image. To the right of the date is the word "Steripak" in a large, bold font. Below the word "Steripak" is the text "510(k) Summary".
"This summary of 510 (k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92".
"The assigned 510 (k) number is 1980 929 11
1. Submitter Information
Steripak Limited Goddard Road, Astmoor Runcorn , Cheshire WA7 1QF England
Contact Person: Steve Forrester-Coles Site Operations Director
Phone: 44-1-928-579110 44-1-928-579540 FAX:
2. Name of Device
| Trade/Proprietary Name: | 3mL Steri-Neb Saline, 0.9% w/v Sodium Chloride
Inhalation Solution USP |
|-------------------------|----------------------------------------------------------------------------------------------|
| Common/Usual Name: | Pre-filled Vial for Respiratory Therapy, 0.9% w/v
Sodium Chloride Inhalation Solution USP |
| Classified Name: | Accessory for Nebulizer, Direct Patient Interface |
3. Predicate Device
The predicate device identified for the substantial equivalence claim is Dey's 3 mL 0.9% Sodium Chloride Inhalation Solution USP. This product is distributed by Dey under Automatic Liquid Packaging, Incorporated's 510 (k) K840943, Pre-filled Respiratory Therapy Vial, cleared on April 24, 1983. Dey's Sodium Chloride Inhalation Solution USP 0.9% product is a plastic single-use vial containing sterile preservative-free solution for respiratory therapy and tracheal lavage.
Description of the Subject Device 4.
The subject device is 3 mL Steri-Neb Saline, 0.9% "/v Sodium Chioride Inhalation Solution USP. Steri-Neb Saline is used for respiratory therapy and tracheal lavage. For respiratory therapy, Steri-Neb Saline is used for dilution of solutions used in nebulizers. Steri-Neb Saline is a unit dose low density polyethylene vial containing sterile, preservative-free, clear, colourless, aqueous solution. The Steri-Neb Saline product contains 0.9% w/v Sodium Chloride USP in Water for Injection USP. The formulation contains no additives.
1
Intended Use of the Subject Device
The Steri-Neb Saline product is 0.9% Sodium Chloride Inhalation Solution USP in a plastic unit-dose vial. The Steri-Neb Saline plastic unit-dose vial is first separated from the strip of vials and then opened by twisting off the top of the vial. The Steri-Neb Saline is used for respiratory therapy and tracheal lavage. For respiratory therapy, the Steri-Neb Saline vial is emptied into the nebulizer reservoir by squeezing the solution from the opened vial. The Steri-Neb Saline product is a sterile single use product. Any solution remaining in the plastic unit-dose vial should be discarded.
Technological Characteristics of the Subject Device Compared to the Predicate ર. Device
The predicate device identified for the substantial equivalence claim is Dey's 3 mL 0.9% w/v Sodium Chloride Inhalation Solution USP. Dey's product is substantially equivalent to the Steri-Neb Saline product in that both products are plastic unitdose vials containing 0.9% Sodium Chloride Inhalation Solution USP for single-use in respiratory therapy and tracheal lavage. The solution for both the predicate and subject device is sterile and preservative-free. Comparison of the predicate device and the subject device indicate that there are no technological differences between the two products that raise new questions of safety and effectiveness. Details of the substantial equivalence claim are included in Attachments 3 through 8.
7. Signature of Applicant
Steripak Limited,
John William Holloway BSc. CChem MRSC MBIRA Head of Product Development and Regulatory Affairs
Signature
03/03/98
Date
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 1998
Mr. Jason A. Gross Zenith Goldline Pharmaceuticals Inc. 140 Legrand Avenue Northvale, NY 07647
Re : K980829 0.9% w/v Sodium Chloride Inhalation Solution USP Regulatory Class: II (two) Product Code: 73 CAF March 3, 1998 Dated: Received: March 4, 1998
Dear Mr. Gross:
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 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 requlations 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 (QS) (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in In addition, FDA may publish further announcements regulatory action. 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.
3
Page 2 - Mr. Jason A. Gross
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/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
4
510 (K) Notification 3rd March 1998
Indications For Use Statement
1980829 510(k) Number (if known): J
Device Name : ___ 0.9%w/v Sodium Chloride Inhalation Solution USP
Indications For Use:
For respiratory therapy and tracheal lavage
(Please Do Not Write Below This Line - Continue On another Page If Needed)
Concurrence of CDRH, Office of Device Evaluation
==============================================================================================================================================================================
- M. Singh -
(Division Sign-Off) Division of Cardiova and Neurological De 510(k) Number
Prescription Use
Over-The-Counter Use_
(Per 21 CFR § 801.109)