REDYROB-CLOSED WOUND DRAINAGE SYSTEM

K972703 · B.Braun Medical, Inc. · GCY · Oct 1, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K972703
• Device Name: REDYROB-CLOSED WOUND DRAINAGE SYSTEM
• Applicant: B.Braun Medical, Inc.
• Product Code: GCY · General, Plastic Surgery
• Decision Date: Oct 1, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4680
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The intended use of Redyrob is as a vacuum source / waste container utilized for post operative wound drainage. The indications for use for the device are to drain blood and secretions from wounds and body cavities for hematoma and surtma prophylaxes and for the removal of serosanguineous fluid and other harmful liquids.

Device Story

REDYROB is a portable, non-powered, single-patient-use suction apparatus; functions as a vacuum source and waste container for post-operative wound drainage. Device collects blood, secretions, and serosanguineous fluids from wounds and body cavities; aids in hematoma and seroma prophylaxis. Used in clinical settings; operated by healthcare professionals. Output is the physical collection of wound exudate; assists clinicians in managing post-operative sites and promotes patient healing by removing harmful fluids.

Clinical Evidence

Bench testing only. Finished products undergo physical testing and visual examination in accordance with established Quality Control Test Procedures and CGMP requirements to ensure conformance to design specifications.

Technological Characteristics

Portable, non-powered suction apparatus. Materials tested per ISO 10993. Device functions as a vacuum source and waste container. Mechanical operation.

Indications for Use

Indicated for patients requiring post-operative wound drainage to remove blood, secretions, serosanguineous fluid, and other liquids from wounds and body cavities for hematoma and seroma prophylaxis.

Regulatory Classification

Identification

A nonpowered, single patient, portable suction apparatus is a device that consists of a manually operated plastic, disposable evacuation system intended to provide a vacuum for suction drainage of surgical wounds.

Predicate Devices

• Varidyne Model 250 Suction Drainage System (K883582)

Submission Summary (Full Text)

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K972703

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

OCT - 1 1997

July 10, 1997

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

Mark S. Alsberge, Requlatory Affairs Manager Contact:

REDYROB ® Closed Wound Drainage System Product Name:

Apparatus, Suction, Single Patient Use, Portable, Nonpowered Trade Name:

Classification name:

General Hospital and Plastic Surgery Class :1. - 79 GCY 21 CRF 878.4680

# SUBSTANTIAL EQUIVALENCE1 TO:

| 510(k) number | Name | Applicant |
|---------------|-----------------------------------------------|-----------|
| K883582 | Varidyne Model 250 Suction<br>Drainage System | Surgidyne |

## 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 REDYROB ®, Closed Wound Drainage System. REDYROB ® is a vacuum source/waste container utilized for postoperative wound drainage.

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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### Material:

REDYROB ® 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:

REDYROB ® is similar in intended use to the Varidyne Model 250 Suction Drainage System manufactured by Surgidyne. There are no new issues of safety or effectiveness raised by REDYROB ® Closed Wound Drainage System.

#### 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 approve', released, distributed and revised in accordance with document control CGMP's.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

OCT - 1 1997

Mr. Mark S. Alsberge .Regulatory Affairs Director B. Braun Medical, Inc. 824 Twelfth Avenue Bethlehem, Pennsylvania 18018-0027

Re: K972703

> Trade Name: REDYROB® Closed Wound Drainage System Regulatory Class: I Product Code: GCY Dated: July 17, 1997 Received: July 18, 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 current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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 "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

palla

lia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ Dramage Redyrob - Closed Woung Device Name: oum Indications For Use:

The intended use of Redyrob is
as a vacuum source / waste container
utilized for post operative wound
drainage. The indications for use
for the device are to drain blood
and secretions from wounds and
body cavities for hematoma and
surtma prophylaxes and for the
removal of serosanguineous fluid
and other harmful liquids.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

loach

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number
K972703

Prescription Use (Pcr 21 CFR 801.109)

OR

Over-The-Counter Use .

(Optional Forrant 1-2-96)