(90 days)
Not Found
No
The document describes a mechanical device for needle extraction and does not mention any AI or ML components or functionalities.
No
Explanation: The device is intended for the mechanical removal of needles, not for treating or diagnosing a disease or condition.
No
The device is described as a needle extractor, an accessory for removing needles from IV ports. Its function is to facilitate a physical action (extraction), not to diagnose or detect medical conditions or disease.
No
The device description explicitly states it is manufactured from polypropylene and provides a physical mechanism for needle extraction, indicating it is a hardware device.
Based on the provided text, the Doyle Extractor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for removing needles from implanted IV ports, which is a procedure performed on a patient, not on a sample of bodily fluid or tissue outside the body for diagnostic purposes.
- Device Description: The description reinforces its function as a tool for physical extraction, not for analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring biomarkers
The device is an accessory used in a clinical procedure, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Doyle Extractor is a needle extractor intended for use as an accessory to IV administration sets. Specifically, the Doyle Extractor is intended for use during the removal of right-angle needles from implanted IV ports.
Product codes
80 FPA
Device Description
The Doyle Extractor is manufactured from polypropylene and provides a suitable leverage for extraction of right-angle needles from the skin and implanted IV port. The device contains a slot on the top blade to secure the IV tubing prior to removal of the needle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin, implanted IV port
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was designed to determine the force required to withdraw a right-angle needle from the skin and injection port, as well as to determine that the material and design characteristics of the device were adequate to meet\provide that required force. Testing results confirmed the suitability of the device material and design for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
LQKSX(S
955748
MAR 1 4 1996
510(k) Summary for
Safetech International Inc.'s Doyle Extractor
1. DATE PREPARED
December 14, 1995
2. SPONSOR INFORMATION
| Address: | Safetech International, Inc. |
|---|---|
| 511 W. Grove Street, Suite 202 | |
| Middleboro, MA 02346 |
Telephone: 508-946-0096
Contact: Patricia A. Doyle
3. DEVICE NAME
| Proprietary Name: | Doyle Extractor |
|---|---|
| Common/Usual Name: | Needle Extractor |
| Classification Name: | IV Administration Set/Accessory |
| (21 CFR 880.5440, Product Code: 80 FPA) |
4. DEVICE DESCRIPTION AND INTENDED USE
The Doyle Extractor is a needle extractor intended for use as an accessory to IV administration sets. Specifically, the Doyle Extractor is intended for use during the removal of right-angle needles from implanted IV ports. It is manufactured from polypropylene and provides a suitable leverage for extraction of right-angle needles from the skin and implanted IV port. The device contains a slot on the top blade to secure the IV tubing prior to removal of the needle.
12/14/95
1
5. PREDICATE DEVICES
The Doyle Extractor is similar in design, function, and intended use to accessories for other temporary or removable devices. Examples include the AutoSuture skin staple remover (K810187, K914130)--a disposable staple remover which is similar in design, appearance, and function to the Doyle Extractor, as well as the Ethicon skin staple extractor (K760733). Skin staple removers utilize the principle of a simple lever to apply adequate force for removal of the skin staple; the Doyle Extractor utilizes this same principle for removal of the right angle infusion needle from an implanted port. The devices are very similar in design, shape, and even intended use, since all are intended to remove items which are puncturing the skin.
6. DEVICE TESTING
Testing was designed to determine the force required to withdraw a right-angle needle from the skin and injection port, as well as to determine that the material and design characteristics of the device were adequate to meet\provide that required force. Testing results confirmed the suitability of the device material and design for its intended use.