(257 days)
Not Found
No
The summary describes a standard syringe with a magnifier and mentions only physical and visual testing, with no indication of AI/ML technology.
No.
The syringe is used for injection, which is a delivery method, not a therapeutic action itself. Its predicate device, an insulin syringe, further supports its role as a delivery tool for medication rather than a therapeutic device.
No
Explanation: The device is described as a syringe for subcutaneous injection, which is a therapeutic rather than a diagnostic function. The "Intended Use" section explicitly states its purpose is for "subcutaneous, injection," and there is no mention of it being used to gather information about a patient's health condition.
No
The device description clearly states it is a physical syringe made of plastic materials and includes a magnifier, indicating it is a hardware device.
Based on the provided information, the Omnican Syringe is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "for subcutaneous, injection." This describes a device used to administer substances directly into the body, not to test samples taken from the body.
- Device Description: The description focuses on the physical components and materials of the syringe, consistent with a device for injection.
- Lack of IVD Characteristics: There is no mention of testing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a condition based on in vitro analysis.
- Predicate Device: The predicate device is an "Insulin Syringe," which is also a device for administering medication, not for in vitro diagnostics.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Omnican Syringe's function is to deliver substances into the body, which is a different category of medical device.
N/A
Intended Use / Indications for Use
The Omnican Syringe is designed to be used for subcutaneous, injection.
Product codes
FMF
Device Description
In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce Omnican Syringe. The Omnican Syringe is designed to be used for subcutaneous, injection. The syringes are packaged in boxes of 100 each. Each box contains a magnifier to assist in reading the scale on the syringe barrel. The following is a list of article numbers that we intend to market after the clearance of this device:
| Article Number | Name | Description |
|---|---|---|
| 09151150 | Omnican 100 | 1 ml for insulin 100 I.U./1 ml, integral needle |
| 09151168 | Omnican 50 | 0.5 ml for insulin 100 I.U./1 ml, integral needle |
| 09151176 | Omnican 30 | 0.3 ml for insulin 100 |
The Omnican Syringe is composed of materials that have been tested in accordance with ISO 10993 for plastics and determined to be sultable for the intended use of this product.
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)
All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to; physical teating, visual examination (in process and finished product).
The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications.
The testing instruction records for each of the individually required procedures are approved, released, distributed and revised in accordance with document control GMP"s.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
0
FEB | 0 |997
II 510(k) Summary of Safety and Effectiveness in Accordance with SMDA'90
January 21, 1997
B. Braun Medical, Inc 824 Twelfth Avenue Bethlehem, PA 18018 (610)691-5400
Mark S. Alsberge, Regulatory Affairs Manager CONTACT:
PRODUCT NAME: Omnican Syringe TRADE NAME: Piston Syringe
CLASSIFICATION NAME:
General Hospital Class II, 80 FMF 21 CFR 880.5860
SUBSTANTIAL EQUIVALENCE, TO:
| 510 (k) number | Name | Applicant |
|---|---|---|
| K941657 | Insulin Syringe | Becton Dickinson |
DEVICE DESCRIPTION:
In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce Omnican Syringe. The Omnican Syringe is designed to be used for subcutaneous, The syringes are packaged in boxes of 100 each. injection. Each box contains a magnifier to assist in reading the scale on the syringe barrel. The following is a list of article numbers that we intend to market after the clearance of this device:
| Article Number | Name | Description |
|---|---|---|
| 09151150 | Omnican 100 | 1 ml for insulin 100 |
| I.U./1 ml, integral | ||
| needle | ||
| 09151168 | Omnican 50 | 0.5 ml for insulin 100 |
| I.U./1 ml, integral | ||
| needle | ||
| 09151176 | Omnican 30 | 0.3 ml for insulin 100 |
1
² The term "substantially equivalent" as use herein is intended to be a determination of subetantial equivalence from an FDA -regulatory point of view under the Federal Food, Drug, and Cosmetic Act and relates to the fact that the product can be marketed without premarket approval or reclassification. These products may be considered distinct from a patent point of view. The term "substantially equivalent" is not applicable to and does not diminish any patent claims related to this product or the technology used to manufacture the product.
MATERIAL :
The Omnican Syringe is composed of materials that have been tested in accordance with ISO 10993 for plastics and determined to be sultable for the intended use of this product.
SUBSTANTIAL EQUIVALENCE :
The Omnican Syringe is identical in materials, form, and intended use to the Insulin Syringe currently marketed by Becton Dickinson. There are no new issues of safety or effectiveness raised by Omnican Syringe.
SAFETY AND EFFECTIVENESS:
All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to; physical teating, visual examination (in process and finished product).
The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications.
The testing instruction records for each of the individually required procedures are approved, released, distributed and revised in accordance with document control GMP"s.
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