(56 days)
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No
The device description details a purely mechanical accessory for infusion stands, with no mention of software, data processing, or any computational elements that would suggest AI/ML.
No.
The device is an accessory for storing electric cords and needle covers on an infusion stand, and does not directly treat or diagnose any medical condition.
No
The device is an accessory designed to store electric cords and provide a needle resheather for infusion stands. It does not perform any diagnostic functions like analyzing patient data, taking measurements, or identifying medical conditions.
No
The device description clearly details physical components made of ABS resin and stainless steel, and describes a mechanical function (coiling cords, clamping to a pole, holding needle covers). There is no mention of software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as an "accessory to Infusion Stands" for storing electric cords and providing a needle resheather. This function is related to the delivery of fluids to a patient, not the examination of specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a physical accessory for an infusion stand, made of plastic and metal, designed for cord management and needle handling. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other bodily fluids.
- Detecting specific analytes (e.g., glucose, antibodies, DNA).
- Providing diagnostic results or information.
- Using reagents or assays.
The device is clearly a physical accessory for medical equipment used in patient care, not a diagnostic tool.
N/A
Intended Use / Indications for Use
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Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Cord Wrap with Needle Resheather comprises a reel for storing electric cords at a pole-type infusion stand. The stand provides a pole stanchion that extends a number of feet and supports an infusion pump and/or bags or bottles of liquid infusants. The Cord Wrap is constructed to conveniently store the electric cord of the infusion pump at the pole during and between use. The cord is coiled about an elongated spool which is retained on the pole via a clamp assembly. The clamp assembly includes a hand wheel and threaded hook arm. The hook arm mounts about the pole, and upon tightening of the hand wheel the hook arm is drawn tight to the infusion stand. Two protrusions are aligned to the hook arm and form a channel space where the infusion stand can nest. The Cord Wrap with Needle Resheather is thereby prevented from rotating about the pole. The position of the Cord Wrap with Needle Resheather along the infusion stand can be varied by loosening the hand wheel and moving the Cord Wrap with Needle Resheather either up or down the infusion stand and retightening the hand wheel. Protruding from the Cord Wrap with Needle Resheather is a needle holder which contains five cavities to receive and retain several cover pieces of needle storage containers. The Cord Wrap with Needle Resheather is NOT a SHARPS RECEPTACLE. Each infusion line set typically requires an infusion needle which is stored in a two-piece container Each container includes a cover and a needle body. The five cavities are constructed to receive and hold the cover piece. This permits the staff member to de-couple the needle body from the cover with a single hand. The Cord Wrap, hand wheel, and Needle Resheather are molded from a resin Acrylonitrile-Butadiene-Styrene (ABS). The Needle Resheather is glued to the Cord Wrap with Loctite® 494 adhesive. The threaded hook arm is made of stainless steel. The Cord Wrap with Needle Resheather is packaged assembled in polyethylene bags. Twenty-eight Cord Wrap with Needle Resheathers are shipped in standard shipping containers.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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).
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§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).
0
MAY -6 1996
B. Summary
The Cord Wrap with Needle Resheather (Model CN-34) is an accessory to Infusion Stands, Classification (80 FOX).
As an accessory, it is substantially equivalent to the Ferguson Medical I.V. Hanger Bag or Holder. The 510(k) number for the Ferguson I.V. Hanger Bag or Holder is K883133.
Both the Ferguson Hanger Bag (K883133) and the Osborn Medical Corporation Cord Wrap with Needle Resheather are accessories to Infusion Stands.
Submitter:
Osborn Medical Corporation 100 West Main Utica, MN 55979
Contact Person:
Bill D. Davis
Trade Name:
Cord Wrap with Needle Resheather
Common Name:
Infusion Stand Accessory
Substantially Equivalent to:
Ferguson Medical I.V. Hanger Bag or Holder
Description of Device:
The Cord Wrap with Needle Resheather comprises a reel for storing electric cords at a pole-type infusion stand. The stand provides a pole stanchion that extends a number of feet and supports an infusion pump and/or bags or bottles of liquid infusants.
1
Depending on the infusion pump, electric cords extend from the pole. Storage and containment can present difficulties during and between use of the equipment.
The Cord Wrap is constructed to conveniently store the electric cord of the infusion pump at the pole during and between use.
(Photographs in Section E, and drawings in Section F. depict the Cord Wrap with Needle Resheather.)
The cord is coiled about an elongated spool which is retained on the pole via a clamp assembly. The clamp assembly includes a hand wheel and threaded hook arm. The hook arm mounts about the pole, and upon tightening of the hand wheel the hook arm is drawn tight to the infusion stand.
Two protrusions are aligned to the hook arm and form a channel space where the infusion stand can nest. The Cord Wrap with Needle Resheather is thereby prevented from rotating about the pole.
The position of the Cord Wrap with Needle Resheather along the infusion stand can be varied by loosening the hand wheel and moving the Cord Wrap with Needle Resheather either up or down the infusion stand and retightening the hand wheel.
Protruding from the Cord Wrap with Needle Resheather is a needle holder which contains five cavities to receive and retain several cover pieces of needle storage containers.
The Cord Wrap with Needle Resheather is NOT a SHARPS RECEPTACLE. Each infusion line set typically requires an infusion needle which is stored in a twopiece container Each container includes a cover and a needle body.
The five cavities are constructed to receive and hold the cover piece. This permits the staff member to de-couple the needle body from the cover with a single hand.
The Cord Wrap, hand wheel, and Needle Resheather are molded from a resin Acrylonitrile-Butadiene-Styrene (ABS).
The Needle Resheather is glued to the Cord Wrap with Loctite® 494 adhesive.
The threaded hook arm is made of stainless steel.
2
The Cord Wrap with Needle Resheather is packaged assembled in polyethylene bags.
Twenty-eight Cord Wrap with Needle Resheathers are shipped in standard shipping containers.
Statement of Substantial Equivalence:
Osborn Medical Corporation considers the Cord Wrap with Needle Resheather to be substantially equivalent to the Ferguson Medical I.V. Hanger Bag or Holder.