(58 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of the saline solution and its container, with no mention of AI or ML.
Yes
The device is described as an "accessory to medicinal non-ventilatory nebulizers in respiratory therapy" and contains solutions for "inhalation therapy." This indicates its role in treating or managing respiratory conditions, fitting the definition of a therapeutic device.
No
The device is described as an accessory to non-ventilatory nebulizers for respiratory therapy or for tracheal irrigation or lavage, and contains solutions for inhalation. Its purpose is therapeutic (delivery of medication/solution for treatment), not to diagnose a condition.
No
The device description clearly states it is a "single-use device" consisting of "color-coded unit blow-fill-sealed containers with liquid contents." This describes 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 clearly stated as "accessories to medicinal non-ventilatory nebulizers in respiratory therapy or for tracheal irrigation or lavage." This describes a therapeutic or procedural use within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device contains solutions for inhalation, which are administered to the patient for therapeutic or procedural purposes. IVDs typically contain reagents or materials used to analyze biological samples.
- Lack of Diagnostic Function: There is no mention of the device being used to detect, measure, or analyze any substance or characteristic in a biological sample for the purpose of diagnosis, monitoring, or screening.
The device is intended for direct use in respiratory therapy and procedures, which falls under the category of medical devices used for treatment or intervention, not in vitro diagnosis.
N/A
Intended Use / Indications for Use
The intended use of these sterile single use devices is as accessories to medicinal non-ventilatory nebulizers in respiratory therapy or for tracheal irrigation or lavage.
The intended use indication is identical to those devices to which substantial equivalence is claimed. The use of these devices for inhalation therapy is well-established.
Product codes (comma separated list FDA assigned to the subject device)
73 CCQ, 73 CAF, 73 BTT
Device Description
The single-use devices are color-coded unit blow-fill-sealed containers with liquid contents as labeled for inhalation therapy. The devices contain no preservative. They are sterile and pyrogen-free.
| CONTENTS | VOLUME | CONTAINER |
|---|---|---|
| 0.45% Sodium Chloride Inhalation Solution, USP | 3mL fill | Green / Embossed label |
| 0.45% Sodium Chloride Inhalation Solution, USP | 5mL fill | Green / Embossed label |
| 0.9% Sodium Chloride Inhalation Solution, USP | 3mL fill | Pink / Embossed label |
| 0.9% Sodium Chloride Inhalation Solution, USP | 5mL fill | Pink / Embossed label |
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)
The component materials of the accessory device container have been substantiated to each meet criteria for direct food and drug contact or additive respectively. The formulation components of the filled device solution have been substantiated to each meet their respective USP monograph criteria. Each of the finished devices undergoes testing to meet the stated USP monograph and container criteria.
Clinical testing is not necessary to show substantial equivalence for either safety or efficacy of intended use to the predicate devices as there are several various in vitro analytical methods (assay; fill uniformity; sterility; container integrity) and physical-chemical characteristics (solution properties; unit configuration) available which demonstrate this equivalence.
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
olopack
510(k) Notification
June, 1997
2-100
Section 2: 510(k) Summary
AUG 7 7 7 SUMMARY CONTENTS
Sodium Chloride Inhalation Solutions, USP 0.45% ; 0.9%
- Applicants Name 1. Address Contact Person Date of Submission
-
- Device Name and Classification
- The Predicate Devices to which Equivalence is Claimed 3.
- Description of the Device 4.
-
- Intended Use
- Technological Characteristics of the Device and the Predicate Device 6.
- Non-Clinical and Clinical Testing 7.
- Summary Conclusion 8.
This 510(k) Premarket Notification summary information following is provided with respect to requests for information on this submission under Freedom of Information. Copy of this summary, which excludes Confidential Information, will be made available on request as required under Freedom of Information.
1
510(k) Notification
Section 2: 510(k) Summary
- Applicant Name & Address: 1.
Holopack International, LP Carolina Research Park 1 Technology Circle Columbia, SC 29203
Contact Persons:
Walter Zahn President Phone: 803-806-3300 803-806-3301 Fax:
Marianna Cronrath Regulatory Agent Phone: 732-888-6278 732-888-2917 Fax:
This 510(k) premarket notification summary was prepared June, 1997 in conjunction with the notification.
-
- Device Name and Classification:
- . Trade Name of Devices:
- Sodium Chloride Inhalation Solution, USP 2.1 [labeled concentration at ] 0.45% and 0.9%
- . Common Name of the Devices:
- Sodium Chloride Inhalation Solution 2.2 0.45% and 0.9%
- Class II, Anesthesiology . Classification: 514 Compliance: Standard
- 2.3 73 CCQ Class Code: 73 BTT Accessory to medicinal non-ventilatory nebulizer
Class Code: 73 CAF Nebulizer accessory
6
2
| Holopack |
|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| 15 - hoursehold L.P. |
510(k) Notification
Section 2: 510(k) Summary
- The Predicate Devices to which Equivalence is Claimed
There are several comparable devices manufactured prior to 1976 and/or those to which Substantial Equivalence is claimed.
K884359 Unit Dose 0.45%; 0.9% ; 3% Sodium Chloride Solution for Inhalation K870332 Automatic Liquid Packaging, Inc. 2200 W. Lake Shore Drive Woodstock, IL 60096
K8703320 Travenol Laboratories ( pre-1976) Wyeth Laboratories, Inc. (pre-1976) Respiratory Therapy Vials
Sodium Chloride Solution for Inhalation Dey Laboratories, Inc. Concord, CA 94518
4. Description of the Devices
The single-use devices are color-coded unit blow-fill-sealed containers with liquid contents as labeled for inhalation therapy. The devices contain no preservative. They are sterile and pyrogen-free.
| CONTENTS | VOLUME | CONTAINER |
|---|---|---|
| 0.45% Sodium Chloride Inhalation Solution, USP | 3mL fill | Green / Embossed label |
| 0.45% Sodium Chloride Inhalation Solution, USP | 5mL fill | Green / Embossed label |
| 0.9% Sodium Chloride Inhalation Solution, USP | 3mL fill | Pink / Embossed label |
| 0.9% Sodium Chloride Inhalation Solution, USP | 5mL fill | Pink / Embossed label |
3
Section 2: 510(k) Summary
ട. Intended Use
The intended use of these sterile devices is as accessories to medicinal non-ventilatory nebulizers in respiratory therapy or for tracheal irrigation or lavage.
The intended use indication is identical to those devices to which substantial equivalence is claimed. The use of these devices as accessories for inhalation therapy is well-established.
5.1 Limitations
These devices are not for parenteral use nor for preparations intended for parenteral use. The use of these devices requires prescription.
6. Technological Characteristics of the Device and the Predicate Devices
The subject unit dose devices of this premarket notification are formed of polyethylene resins meeting the direct food and drug contact criteria. The formed units meet the criteria for direct food and drug contact as prefilled unit containers. The solutions component , at the stated concentration of Sodium Chloride Inhalation Solution, meet the USP monograph requirements.
The single-use containers are embossed with identifying product text and level markings.
The finished device product configuration characteristics of these inhalation devices are similar to those of the predicate devices.
The technological improvements relate to the method of manufacture of the devices which are the subject of this premarket notification. The blow-fill-seal systems used by Holopack International, L.P in the production of these devices for inhalation therapy utilize dark-side/white-side machine technology. The blow-fill-seal systems on which the devices are manufactured represent technological advances in this type of production and in the control of the manufacturing environment. The devices are manufactured under conditions of current Good Manufacturing Practices (cGMP).
Performance characteristics of the devices that are the subject of this notification are identical or better than the predicate devices.
Proprietary details of the aseptic manufacturing environment and blow-fill-seal technology are referenced under confidentiality.
4
| Holopack |
|---|
| Business and the designation for the designed to and |
Section 2: 510(k) Summary
7. Non-Clinical and Clinical Testing
The component materials of the accessory device container have been substantiated to each meet criteria for direct food and drug contact or additive respectively. The formulation components of the filled device solution have been substantiated to each meet their respective USP monograph criteria. Each of the finished devices undergoes testing to meet the stated USP monograph and container criteria.
Clinical testing is not necessary to show substantial equivalence for either safety or efficacy of intended use to the predicate devices as there are several various in vitro analytical methods (assay; fill uniformity; sterility; container integrity) and physical-chemical characteristics (solution properties; unit configuration) available which demonstrate this equivalence.
Summary Conclusions 8.
The subject devices:
0.45% and 0.9% Sodium Chloride Inhalation Solution, USP
as manufactured by Holopack International, LP of Columbia, SC claim substantial equivalence, with the same intended use, to several devices which were manufactured prior to 1976 or which have received market clearance through established equivalence.
These devices are designed to meet the current USP specifications. The device containers have embossed unit identification and shelf carton labeling so that label requirements are met.
Analytical testing to the stated specifications demonstrates that these devices will have comparable safety and efficacy in use.
The devices, as manufactured by Holopack, are produced using dark-side/white-side blow-fill-seal technology on rommeLag® machines specifically designed for aseptic filling operations. These manufacturing systems represent a technological advance for the production of these types of devices. The details of the aseptic manufacturing processes and environment are referenced under confidentiality.
••
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
AUG 28 1997
Mr. Walter Zahn Holopack International, LP Carolina Research Park 1 Technology Circle Columbia, South Carolina 29203
K972466 Re : Prefilled Units containing Sodium Chloride Inhalation Solutions, USP Regulatory Class: II (two) Product Code: 73 CAF Dated: June 30, 1997 Received: July 1, 1997
Dear Mr. Zahn:
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 Regulation (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 regulation may result in regulatory action. In addition, FDA may publish further announcements 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.
6
Page 2 - Mr. Walter Zahn
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, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
lolopaci
510(k) Notification
June, 1997
STATEMENT OF INTENDED USE
Sodium Chloride Inhalation Solution, USP Devices: [labeled concentration at] 0.45% [labeled concentration at] 0.9%
Intended Use
The intended use of these sterile single use devices is as accessories to medicinal non-ventilatory nebulizers in respiratory therapy or for tracheal irrigation or lavage.
The intended use indication is identical to those devices to which substantial equivalence is claimed. The use of these devices for inhalation therapy is well-established.
Limitations
These devices are not for parenteral use nor for preparations intended for parenteral use.
The use of these devices requires physician order (prescription). Sale of the device is restricted by or on the order of a physician.
Prescription Device
A. Cirlousli.
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number