(139 days)
This solution is indicated for use as a tracheal lavage, nasal irrigation solution or as an irrigation solution for flushing a body cavity.
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.
The provided text is a 510(k) summary for a medical device called "Sterile Water and Saline Bottle for Irrigation." This document primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than presenting a study with specific acceptance criteria and detailed performance data on a new, unproven device.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not available in this document. The 510(k) process for this type of device typically relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring novel clinical studies with extensive performance metrics.
Here's an analysis based on the provided text, highlighting what can be inferred or what is explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. For a product like a sterile saline solution and bottle for irrigation, acceptance criteria would typically revolve around sterility, purity of ingredients, container integrity, and potentially biological safety (e.g., non-pyrogenic). However, the specific quantitative criteria and detailed performance results against those criteria are not detailed in this 510(k) summary.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. The document does not describe a clinical study or a specific test set. The focus is on the long-standing use and known properties of the product.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided. No expert review or ground truth establishment process for a test set is described.
4. Adjudication Method for the Test Set
This information is not provided. No test set or adjudication process is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not conducted or reported in this document. This type of study is more common for diagnostic imaging devices where human interpretation is crucial, not for a sterile irrigation solution and bottle.
6. Standalone Performance Study
A standalone performance study (algorithm only without human-in-the-loop) was not conducted or reported. This concept is not applicable to this type of medical device (a sterile solution and bottle).
7. Type of Ground Truth Used
The "ground truth" for this type of device is inherent in its composition and long history of use. The document states: "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."
Therefore, the "ground truth" or basis for safety and effectiveness relies on:
- Historical clinical use/Outcomes data: The long-standing safe use of such products.
- Chemical and material properties: The known safety and inertness of the ingredients (sterile water, sodium chloride) and the container material (100% virgin low density polyethylene).
- Manufacturing processes: Aseptic filling and hermetic sealing ensure sterility.
8. Sample Size for the Training Set
This information is not provided. There is no "training set" in the context of this device's approval process. The device is not a learning algorithm or AI.
9. How the Ground Truth for the Training Set Was Established
This information is not provided. As no training set exists, no ground truth needed to be established for it.
In summary, the provided 510(k) summary is for a relatively simple, well-understood medical device (sterile irrigation solution and bottle). Its approval hinges on demonstrating substantial equivalence to a predicate device, relying on the known safety of its components and manufacturing processes, rather than on detailed clinical studies with the kind of metrics requested for devices like AI algorithms or complex diagnostic tools.
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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 ●
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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.
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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
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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_
§ 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.