(139 days)
Not Found
Not Found
No
The device description focuses on the composition and packaging of sterile water and saline solutions, with no mention of AI or ML technology.
No
The device is described as an irrigation solution for flushing body cavities, not for treating a disease or condition, which is the primary characteristic of a therapeutic device.
No
Explanation: The "Intended Use / Indications for Use" section describes the product as an irrigation solution for lavage, nasal irrigation, or flushing body cavities. This function does not involve diagnosing conditions, but rather cleaning or rinsing.
No
The device description clearly states it is a sterile water and saline solution packaged in a polyethylene bottle, indicating it is a physical product, 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 irrigation purposes (tracheal lavage, nasal irrigation, flushing body cavities). This involves applying the solution directly to or within the body for cleaning or flushing, not for analyzing a sample taken from the body to diagnose a condition.
- Device Description: The description focuses on the composition of the solution (sterile water and saline) and the packaging. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely for irrigation.
N/A
Intended Use / Indications for Use
The intended use of the Sterile Water and Saline Irrigation Bottle is to irrigate:
- Nasal suctioning and tracheostomy catheters to lubricate these and aid . in their use
- Body cavities ●
This solution is indicated for use as a tracheal lavage, nasal irrigation solution or as an irrigation solution for flushing a body cavity.
Product codes
JOH
Device Description
Automatic Liquid Packaging, Inc. Sterile Water and Saline Solutions are products that have been used in the medical community for decades. These products have not experienced or been associated with toxic or undesirable effects that relate to the ingredients used in their production. The only ingredient in the two solutions other than water is Sodium Chloride; there are no preservatives or stabilizers.
The irrigation bottle is manufactured of 100% virgin low density polyethylene (LDPE) and contains no regrind, color or chemical additives.
The two solutions are sterile, aseptically filled, and are hermetically sealed for Single Use Only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body cavities, Tracheal, Nasal
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)
ALP's Prefilled Saline Solution for Irrigation USP
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5800 Tracheostomy tube and tube cuff.
(a)
Identification. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.(b)
Classification. Class II.
0
510(k) Summary Automatic Liquid Packaging Inc. Sterile Water and Saline Bottle for Irrigation
FEB 2 3 1998
Submitter:
Automatic Liquid Packaging Inc. 2200 W. Lake Shore Drive Woodstock, IL 60098
Device Name:
- Common Name: Sterile Water and Saline Bottle for Irrigation .
- Classification Name: Unclassified ●
Predicate Device:
ALP's Prefilled Saline Solution for Irrigation USP
Description of the Device:
Automatic Liquid Packaging, Inc. Sterile Water and Saline Solutions are products that have been used in the medical community for decades. These products have not experienced or been associated with toxic or undesirable effects that relate to the ingredients used in their production. The only ingredient in the two solutions other than water is Sodium Chloride; there are no preservatives or stabilizers.
The irrigation bottle is manufactured of 100% virgin low density polyethylene (LDPE) and contains no regrind, color or chemical additives.
The two solutions are sterile, aseptically filled, and are hermetically sealed for Single Use Only.
Intended Use:
The intended use of the Sterile Water and Saline Irrigation Bottle is to irrigate:
- Nasal suctioning and tracheostomy catheters to lubricate these and aid . in their use
- Body cavities ●
1
. . . . . .
Image /page/1/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three wing segments, positioned to the right of the text. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the left side and "USA" on the top right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Automatic Liquid Packaging, Inc. c/o Mr. Eduardo March Senior Consultant AAC Consultant Group 7475 Wisconsin Avenue, Suite 850 20814 Bethesda, MD
FEB 2 3 1998
Re : K973829 Irrigation Bottle Regulatory Class: II (Two) 73 JOH Product Code: Dated: January 21, 1998 Received: January 23, 1998
Dear Mr. March:
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 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 Requlation (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 assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. this response to your premarket notification Please note: 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 requlations.
2
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. Callehan
Thomas J. Callahan, Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page l of of loss.
K973829 510(k) Number (if known):
Sterile Water and Saline Solution Irrigation Bottle Device Name:
Indications for Use:
This solution is indicated for use as a tracheal lavage, nasal irrigation solution or as an irrigation solution for flushing a body cavity.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONIINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use:
Use:
(Per 21 CFR 80.109) ✓
OR
Over-the-Counter
M. Puac̃
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number_