CERTODYN RAECG UNIVERSAL ADAPTER

K973371 · B.Braun Medical, Inc. · DQY · Nov 24, 1997 · Cardiovascular

Device Facts

• Record ID: K973371
• Device Name: CERTODYN RAECG UNIVERSAL ADAPTER
• Applicant: B.Braun Medical, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Nov 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

in the accurate placement of central venous catheters using the RAECG technique

Device Story

The Certodyn RAECG Universal Adapter is a device designed to aid in the accurate placement of central venous catheters. It utilizes the RAECG (Right Atrial Electrocardiogram) technique to assist clinicians during catheter insertion. The device acts as an interface to facilitate the monitoring of ECG signals during the procedure, allowing the healthcare provider to confirm the catheter tip position. It is intended for use in a clinical setting by trained medical professionals.

Clinical Evidence

No clinical data provided; bench testing only. Finished products undergo physical testing and visual examination in accordance with Quality Control Test Procedure documents and GMP requirements.

Technological Characteristics

The device is an adapter for RAECG catheter placement. Materials have been tested in accordance with Tripartite Guidance for Plastics. The device is a passive electrical interface component.

Indications for Use

Indicated for use in the accurate placement of central venous catheters using the RAECG technique.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Arrow-Johans ECG Adaptor (K843263)

Submission Summary (Full Text)

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K973371

NOV 2 4 1997

# II. 510(k) SUMMARY of SAFETY and EFFECTIVENESS in ACCORDANCE with SMDA'90

B. Braun Medical, Inc 1997 824 Twelfth Avenue Bethlehem, PA 18018 [phone]

Contact: Mark S. Alsberge, Regulatory Affairs Director

Product Name: Epidural Catheter Connector

Trade Name: Conduction Anesthesia Kit

#### Classification Name:

Cardiovascular Class II, 74 DQY, Percutaneous Catheter 21 CFR 870.1250

# Substantial Equivalence to:

| 510(k) number | Name | Applicant |
|---------------|--------------------------|---------------------------|
| K843263 | Arrow-Johans ECG Adaptor | Arrow International, Inc. |

#### 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 the Certodyn® RAECG Universal Adapter. The Adapter is designed to aid in the accurate placement of central venous catheters using the RAECG technique.

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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### Materials:

The Certodyn® RAECG Universal Adapter is composed of materials that have been tested in accordance with Tripartite Guidance for Plastics and determined to be suitable for the intended use of this product.

#### Substantial Equivalence:

The Certodyn® RAECG Universal Adapter is equivalent in materials, form, and intended use to our the Arrow-Johans ECG Adaptor currently marketed under K843263 by Arrow International, Inc. There are no new issues of safety or effectiveness raised by the Certodyn® RAECG Universal Adapter.

### 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.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

NOV 2 4 1997

Mr.. Mark S. Alsberge Director, Regulatory Affairs B. Braun Medical, Inc. 824 12th Avenue Bethlehem, PA 18018-0027

Re: K973371 Trade Name: Certodyn RAECG Universal Adapter Regulatory Class: II ... Product Code: DOY Dated: September 3, 1997 Received: September 8, 1997

Dear Mr. Alsberge:

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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.

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Page 2 - Mr. Mark S. Alsberge

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation 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 [phone] or [phone] or at its internet address "[e-mail]".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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- K923321 - -510(k) Number (if known):

Device Name: Certody n RAEC G Universal Adapter

Indications For Use:

in the accurate placement of central aid ﺍﻟﻤ catheters using the RAECG technique Venous

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular,
and Neurological Devices
510(k) Number K973371

Prescription Use X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use

(Optional Format 1-2-96)