VOLUME CONTROL SYRINGE MODEL VCD-SYR-10

K962141 · B.Braun Medical, Inc. · DXT · Mar 19, 1997 · Cardiovascular

Device Facts

• Record ID: K962141
• Device Name: VOLUME CONTROL SYRINGE MODEL VCD-SYR-10
• Applicant: B.Braun Medical, Inc.
• Product Code: DXT · Cardiovascular
• Decision Date: Mar 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Volume Control Delivery Syringe is used for the controlled inflation of balloon catheters during angioplasty procedures.

Device Story

Volume Control Delivery Syringe; manual device for controlled inflation of balloon catheters during angioplasty. Used in clinical settings by physicians. Device provides precise volume control for balloon expansion; facilitates angioplasty procedure; ensures patient safety through controlled inflation. No complex electronics or software.

Clinical Evidence

Bench testing only. Finished products must meet release specifications including physical testing and visual examination per established Quality Control Test Procedures and GMP standards.

Technological Characteristics

Materials tested per ISO 10993. Manual syringe form factor for balloon catheter inflation. No software or electronic components.

Indications for Use

Indicated for patients undergoing angioplasty procedures requiring controlled inflation of balloon catheters.

Regulatory Classification

Special Controls

*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.

Predicate Devices

• Angiographic Injector Syringe (K902377)

Submission Summary (Full Text)

{0}

MAR-12-97 WED 12:39 PM B BRAUN-REGULATORY AFF Q FAX NO. 6106917906 P. 4

# II 510(k) Summary of Safety and Effectiveness in Accordance with SMDA'90

K902141

March 12, 1997

MAR 19 1997

B. Braun Medical, Inc
824 Twelfth Avenue
Bethlehem, PA 18018
[phone]

Contact: Mark S. Alsberge, Regulatory Affairs Manager

Product Name: Volume Control Delivery Syringe

Trade Name: Angiographic Injector Syringe

Classification name:

Cardiovascular
Class II, 74DXT
21 CFR 870.1650

## SUBSTANTIAL EQUIVALENCE¹ TO:

| Name | 510(k) number | Applicant |
| --- | --- | --- |
| Angiographic Injector Syringe | K902377 | Angeion |

## 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.

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MAR-12-97 WED 12:39 PM B BRAUN-REGULATORY AFF Q FAX NO. 51759.7905 P. 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.