(86 days)
Not Found
No
The document describes a simple, single-use container for inhalation solutions and makes no mention of AI or ML technology.
No
The device is described as an accessory to existing therapeutic devices (nebulizers) and for procedures (tracheal irrigation/lavage), not a therapeutic device itself.
No
Explanation: The device is described as an "accessory to medicinal non-ventilatory nebulizers" for "respiratory therapy or for tracheal irrigation or lavage." Its purpose is to deliver liquid contents for inhalation therapy, not to diagnose a condition.
No
The device description clearly states it is a "single-use device is in a color-coded unit blow-fill-sealed container with liquid contents" and mentions "physical-chemical characteristics (solution properties; unit configuration)", indicating it is a physical device with liquid contents, not software.
Based on the provided text, 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, not a diagnostic one.
- Device Description: The description focuses on the physical characteristics of the container and its contents (sterile liquid for inhalation), which aligns with a therapeutic device.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information for the diagnosis of a disease or condition.
Therefore, based on the information provided, this device falls under the category of a medical device used for respiratory therapy, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of this sterile device is as accessory to medicinal nonventilatory nebulizers; in respiratory therapy; 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 respiratory therapy accessories and for inhalation therapy is well-established. 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 CAF
Device Description
The single-use device is in a color-coded unit blow-fill-sealed container with liquid contents as labeled for inhalation therapy. The device contains no preservative and is sterile and pyrogen-free. 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.
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
order of physician or licensed practitioner
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)
Non-Clinical and Clinical Testing: The component materials of the accessory device container have each been substantiated to meet criteria for direct food and drug contact or additive respectively and to comply with USP container testing. 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 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
| Holopack | 510(k) Notification | October, 1997 |
|---|---|---|
| ---------- | --------------------- | --------------- |
Section 2: 510(k) Summary
- Applicant Name & Address: 1.
Holopack International, LP Carolina Research Park 1 Technology Circle Columbia, SC 29203
JAN 2 | 1998
Contact Persons:
Walter Zahn President 803-806-3300 Phone: 803-806-3301 Fax:
Marianna Cronrath Regulatory Agent Phone: 732-888-6278 Fax: 732-888-2917
This 510(k) premarket notification summary was prepared October, 1997 in conjunction with the notification.
-
- Device Name and Classification:
- . Trade Name of Device:
- 2.1 0.9% Sodium Chloride Inhalation Solution, USP [labeled concentration at 0.9%]
- Common Name of the Device: .
- 2.2 0.9% Sodium Chloride Inhalation Solution
- Classification: Class II, Anesthesiology . 514 Compliance: Standard
- 2.3 Class Code: 73 CAF
1
| 1000 | |
|---|---|
Section 2: 510(k) Summary
The Predicate Devices to which Equivalence is Claimed 3.
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 in 3, 5 and 15mL containers | |
| 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 Inhalation Solution Dey Laboratories, Inc. Concord, CA 94518
- Description of the Devices 4.
The single-use device is in a color-coded unit blow-fill-sealed container with liquid contents as labeled for inhalation therapy. The device contains no preservative and is sterile and pyrogen-free.
| CONTENTS | VOLUME | CONTAINER |
|---|---|---|
| 0.9% Sodium Chloride Inhalation Solution, USP | 15mL fill | Pink |
| Embossed label |
2
Section 2: 510(k) Summary
5. Intended Use
The intended use of this sterile device is as accessory to medicinal nonventilatory nebulizers; in respiratory therapy; 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 respiratory therapy accessories and 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 is on order of physician or licensed practitioner.
- Technological Characteristics of the Device and the Predicate Devices
The subject unit dose device containers of this premarket notification are formed of polyethylene resins meeting the direct food and drug contact criteria. The formed units likewise meet the criteria for direct food and drug contact as prefilled unit containers. The solution component at the stated concentration in Sodium Chloride Inhalation Solution meets the current 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, LP in the production of these devices for inhalation therapy utilize dark-side/white-side machine technology. The blowfill-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.
3
Holopack
| 510(k) Notification | October, 1997 |
|---|---|
| Section 2: 510(k) Summary |
7. Non-Clinical and Clinical Testing
The component materials of the accessory device container have each been substantiated to meet criteria for direct food and drug contact or additive respectively and to comply with USP container testing. 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 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
The subject device:
0.9% Sodium Chloride Inhalation Solution. USP
as manufactured by Holopack International, LP of Columbia, SC claims 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.
This device is designed to meet the current USP specifications. The device containers have embossed unit identification and shelf carton labeling.
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/whiteside blow-fill-seal technology on rommeLag® machines specifically designed for aseptic filling operations. These manufacturing systems represent a technological advance for the production of this type of device. The details of the aseptic manufacturing processes and environment are referenced under confidentiality.
9
4
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 1 1998
Mr. Walter Zahn Holopack International, L.P. Carolina Research Park 1 Technology Circle Columbia, SC 29203
Re : K974056 0.9% Sodium Chloride Solution for Inhalation, USP Requlatory Class: II (two) Product Code: 73 CAF October 20, 1997 Dated: Received: October 27, 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.
5
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 requlation 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. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
| Holopack | |
|---|---|
| 1 23 40 | |
| Parcellinously & |
510(k) Notification
October, 1997
STATEMENT OF INTENDED USE
Sodium Chloride Inhalation Solution, USP Devices: [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 wellestablished.
Limitations
These devices are not for parenteral use nor for preparations intended for parenteral use.
The use of these devices is on order of physician or licensed practictioner.
Prescription Device 1
M. Ruyc
(Division Sign-Off) Division of Cardiovascular and Neurological Devices 510(k) Number