(289 days)
Not Found
No
The description focuses on a mechanical syringe for controlled inflation and does not mention any computational or data-driven features indicative of AI/ML.
No.
The device is a syringe used for controlled inflation of balloon catheters during angioplasty procedures, which is an accessory to a therapeutic procedure rather than a therapeutic device itself.
No
Explanation: The device is described as a "Volume Control Delivery Syringe" used for the "controlled inflation of balloon catheters during angioplasty procedures." This indicates it is an interventional or procedural device, not one designed for diagnosis.
No
The device description explicitly states it is a "Volume Control Delivery Syringe," which is a physical hardware device used for controlled inflation. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the controlled inflation of balloon catheters during angioplasty procedures." This is a procedure performed on a patient, not a test performed on a sample taken from a patient.
- Device Description: The description reiterates the intended use during angioplasty procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely mechanical and procedural, not diagnostic.
N/A
Intended Use / Indications for Use
The Volume Control Delivery Syringe is used for the controlled inflation of balloon catheters during angioplasty procedures.
Product codes
DXT
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 a Volume Control Delivery Syringe. The Volume Control Delivery Syringe is used for the controlled inflation of balloon catheters during angioplasty procedures.
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
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 testing, 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
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
= 16
II 510(k) Summary of Safety and Effectiveness in Accordance with SMDA'90
March 12, 1997
MAR 1 9 1997
P. 4
B. Braun Medical, Inc 824 Twelfth Avenue Bethlehem, PA 18018 (610)691-5400
Contact: Mark S. Alsberge, Regulatory Affairs Manager
Product Name: Volume Control Delivery Syringe
Angiographic Injector Syringe Trade Name:
Classification name:
Cardiovascular Class II, 74DXT 21 CFR 870.1650
SUBSTANTIAL EQUIVALENCE1 TO:
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ARRING REPERTER PRODUCT STATES CONSTITUTION ASSESS OF CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULT
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|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Anolographic Iniector Syringe | 1007277 | Angelor |
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 a Volume Control Delivery Syringe. The Volume Control Delivery Syringe is used for the controlled inflation of balloon catheters during angioplasty procedures.
1 The term "substantially equivalent" as use herein is intended to be a determination of substantial 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.
1
. : 5
Material:
The Volume Control Delivery Syringe is composed of materials that have been tested in accordance with the ISO Standard 10993 and have been determined to be suitable for the intended use of this product.
Substantial equivalence:
The Volume Control Delivery Syringe is similar in materials, form, and intended use to the Angiographic Injector Syringe cleared by Angeion and marketed by B. Braun Medical Cardiovascular Division. There are no new issues of safety or effectiveness raised by the Volume Control Delivery 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 testing, 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.