JACKSON-PRATT GOLD WOUND DRAINS WITH DURAFLO II COATING

K960955 · Baxter Healthcare Corp · GBX · May 22, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K960955
• Device Name: JACKSON-PRATT GOLD WOUND DRAINS WITH DURAFLO II COATING
• Applicant: Baxter Healthcare Corp
• Product Code: GBX · General, Plastic Surgery
• Decision Date: May 22, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

These drains are used in conjunction with non-powered single patient, portable suction apparatus. The drains provide a means to conduct fluids from a surgical wound via suction drainage.

Device Story

Jackson-Pratt Gold™ Wound Drains; passive suction drainage system. Input: surgical wound fluid. Mechanism: suction via non-powered portable apparatus. Output: fluid removal from wound site. Used in clinical settings by physicians/nurses. Benefits: facilitates wound healing by preventing fluid accumulation.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: polyvinyl chloride or silicone. Form factor: various sizes. Energy source: non-powered (passive suction). Sterilization: sterile.

Indications for Use

Indicated for patients requiring surgical wound fluid drainage via non-powered, single-patient, portable suction apparatus.

Regulatory Classification

Identification

An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.

Predicate Devices

• Jackson-Pratt® Wound Drains
• Atrium PDR™ Thoracic Catheter

Submission Summary (Full Text)

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MAY 14 '96 11:02AM QARA SURGICAL P.7/13
K960955

# XIII. SUMMARY OF SAFETY AND EFFECTIVENESS

## Baxter
MAY 22 1996

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Jackson-Pratt Gold™ Wound Drains

**Manufacturer:** Baxter Healthcare Corporation of Puerto Rico Surgical Group
State Road 402, Km 1.2
Añasco, Puerto Rico 00610

**Regulatory Affairs Contact:** Ingrid M. Hoos
Surgical Group
1500 Waukegan Road, Bldg. K
McGaw Park, IL 60085

**Telephone:** [phone]

**Date Summary Prepared:** January, 1996

**Product Trade Name:** Jackson-Pratt Gold™ Wound Drains

**Common Name:** Surgical Wound Drain

**Classification:** Apparatus, Suction, Single Patient Use, Non-Powered

**Predicate Devices:** Jackson-Pratt® Wound Drains
Atrium PDR™ Thoracic Catheter

**Description:** The Jackson-Pratt Gold™ Wound Drains are made of polyvinyl chloride or silicone in a variety of sizes and are offered sterile.

**Intended Use:** These drains are used in conjunction with non-powered single patient, portable suction apparatus. The drains provide a means to conduct fluids from a surgical wound via suction drainage.

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