(257 days)
The Omnican Syringe is designed to be used for subcutaneous, injection.
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. 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 provided text is a 510(k) summary for a medical device (Omnican Syringe) from 1997. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study data with specific acceptance criteria, performance metrics, and sophisticated statistical analyses typical of modern AI/ML device submissions.
Therefore, many of the requested elements for describing acceptance criteria and a study proving "device meets acceptance criteria" are not applicable or cannot be extracted from this document, as the regulatory framework and expectations were different at that time.
Here's an attempt to address your points based on the available information, noting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for a syringe, the "acceptance criteria" are primarily related to general safety, effectiveness, and manufacturing quality, rather than specific performance metrics (like accuracy, sensitivity, specificity) that would be relevant for an AI/ML device.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Material Biocompatibility | Materials tested in accordance with ISO 10993 for plastics and determined to be suitable for the intended use. |
| Physical Performance / Functional Equivalence | "The Omnican Syringe is identical in materials, form, and intended use to the Insulin Syringe currently marketed by Becton Dickinson." This implies that its physical performance (e.g., fluid delivery, ease of use, scale readability) is equivalent to the predicate device. Specific quantitative metrics are not provided. |
| Manufacturing Quality / Release Specifications | "All finished products are tested and must meet all required release specifications before distribution." This includes physical testing and visual examination (in-process and finished product) defined by Quality Control Test Procedure documents and conforming to product design specifications. Specific quantitative acceptance criteria (e.g., sterility rate, dimensional tolerances, leakage rates) are not detailed but are implied by adherence to "established testing procedures and parameters." |
| No New Issues of Safety or Effectiveness | "There are no new issues of safety or effectiveness raised by Omnican Syringe." This is a core finding for 510(k) clearance based on substantial equivalence. |
| Intended Use (Subcutaneous injection for insulin 100 IU/1ml) | Device is designed and marketed for subcutaneous injection of insulin 100 IU/1 ml, with various sizes (1ml, 0.5ml, 0.3ml) specified. The magnifier in each box assists in reading the scale. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The submission relies on demonstrating substantial equivalence to a predicate device and adherence to internal manufacturing quality control, rather than a clinical study with a "test set" in the context of AI/ML performance evaluation. The "tests" mentioned are product release tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable/provided. There was no "ground truth" establishment in the context of expert consensus for a test set, as this is a physical medical device (syringe), not an AI/ML diagnostic tool.
4. Adjudication Method for the Test Set
This information is not applicable/provided. No adjudication method was mentioned as there was no test set requiring expert interpretation or consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
This information is not applicable/provided. The device is a physical syringe, not an AI-assisted diagnostic tool, so an MRMC study is irrelevant to its evaluation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is not applicable/provided. The device is a physical syringe; there is no algorithm or AI component.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically discussed for AI/ML devices (e.g., pathology, outcomes data) is not directly applicable here. The "truth" for this device's safety and effectiveness relies on:
- Material properties: Conformance to ISO 10993 standards.
- Manufacturing specifications: Adherence to established physical and visual inspection criteria.
- Functional equivalence: Comparison to a legally marketed predicate device (Becton Dickinson Insulin Syringe) regarding materials, form, and intended use.
8. The Sample Size for the Training Set
This information is not applicable/provided. There is no "training set" as the device is a physical product and does not involve AI/ML.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided. As there is no AI/ML component, there's no training set or associated ground truth.
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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 100I.U./1 ml, integralneedle |
| 09151168 | Omnican 50 | 0.5 ml for insulin 100I.U./1 ml, integralneedle |
| 09151176 | Omnican 30 | 0.3 ml for insulin 100 |
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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.
職
§ 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).