(72 days)
Jackson-Pratt® Wound Drains, Atrium PDR™ Thoracic Catheter
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No
The summary describes a simple wound drain and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device, Jackson-Pratt Gold™ Wound Drains, is intended to conduct fluids from a surgical wound via suction drainage. While it aids in post-surgical recovery, it does not actively treat a disease or condition in a therapeutic manner such as drug delivery, energy delivery, or biological intervention. It is a passive drainage system.
No
The device description clearly states its purpose is to "conduct fluids from a surgical wound via suction drainage," which is a treatment or management function, not a diagnostic one.
No
The device description explicitly states the drains are made of polyvinyl chloride or silicone, indicating a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used to "conduct fluids from a surgical wound via suction drainage." This is a mechanical function performed on the patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description focuses on the physical materials and form of the drains, which are used for drainage, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely for drainage.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Jackson-Pratt Gold™Wound Drains are made of polyvinyl chloride or silicone in a variety of sizes and are offered sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
surgical wound
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Jackson-Pratt® Wound Drains, Atrium PDR™ Thoracic Catheter
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/2 description: The image shows a sequence of handwritten alphanumeric characters. The sequence starts with the letter 'K', followed by the numbers '960955'. The characters are written in a bold, cursive style, with the numbers appearing slightly larger than the letter.
XIII. SUMMARY OF SAFETY AND EFFECTIVENESS
ເ
Baxter
HAY 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: | (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 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. |