(72 days)
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.
The Jackson-Pratt Gold™Wound Drains are made of polyvinyl chloride or silicone in a variety of sizes and are offered sterile.
I am sorry, but after carefully reviewing the provided document, I could not find information about "acceptance criteria and the study that proves the device meets the acceptance criteria". The document focuses on providing general information about the Jackson-Pratt Gold™ Wound Drains, including its manufacturer, regulatory contact, trade name, classification, predicate devices, description, and intended use. It does not contain details about specific studies, performance metrics, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.
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XIII. SUMMARY OF SAFETY AND EFFECTIVENESS
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Baxter
HAY 22 1996
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Jackson-Pratt Gold™ Wound Drains
| Manufacturer: | Baxter Healthcare Corporation of Puerto RicoSurgical GroupState Road 402, Km 1.2Añasco, Puerto Rico 00610 |
|---|---|
| Regulatory Affairs Contact: | Ingrid M. HoosSurgical Group1500 Waukegan Road, Bldg. KMcGaw Park, IL 60085 |
| Telephone: | (847) 785-3312 |
| 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 DrainsAtrium PDR™ Thoracic Catheter |
| Description: | The Jackson-Pratt Gold™Wound Drains are made of polyvinylchloride 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 froma surgical wound via suction drainage. |
§ 878.4200 Introduction/drainage catheter and accessories.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.