(93 days)
Not Found
No
The device description and performance studies focus on mechanical function and physical dimensions, with no mention of AI/ML terms or data processing.
No.
The device is intended to prevent needlestick injuries, not to treat a medical condition.
No
The device is described as a needle recapper used to minimize needlesticks after an injection procedure, not to diagnose any condition or disease.
No
The device description clearly states it is made of ABS plastic and has physical dimensions and weight, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to safely recap conventional needles after an injection procedure to prevent needlesticks. This is a physical safety device used in the handling of medical waste, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a physical plastic device with apertures for needles and caps. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. There are no reagents, test strips, or analytical components described.
The device's function is purely mechanical and related to safety in handling used needles. This falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Recap-1 is used following OSHA guidelines to safely recap conventional needles prior to transport to an authorized sharps container in order to minimize the possibility of accidental needlesticks from occurring, after the injection procedure has been completed.
The device would be used in all healthcare environments to protect healthcare workers and patients from needlesticks after the injection process has taken place.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
Recap-1 is 3"x4"x4.5" made of red pigmented ABS plastic weighing 6.5 ounces. The faceplate has 5 precise apertures to accommodate a majority of needles and their corresponding caps that are in the healthcare market today. It is labeled Recap-1, onehanded needle recapper. The five apertures identify by name the different types of needles that can be resheathed. Below the apertures it is stated "Do Not Use 2 Hands" thus conforming with OSHA guidelines and 29 CFR Part 1910.1030.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare environments
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Bench Testing was performed evaluating 10 needles of each cap size as defined in the enclosed Needle Cap Fit Guide.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing was performed evaluating 10 needles of each cap size as defined in the enclosed Needle Cap Fit Guide. Tests included (1) if the cap was sticking in the device during the one handed needle recapping procedure and (2) if there was a problem removing the recapped needle from the device. The test results demonstrate no problems or failures were encountered when recapping the needles or removing the recapped needle from the Recap-1 Device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Cap Sticking in Device: None, Problem Removing Recapped Needle: None
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.
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
§ 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
Image /page/0/Picture/0 description: The image shows the word "MedScience" in a stylized font. The letters are all connected and in bold. There is a trademark symbol after the word.
MAN 1 7 1996 510K Summary
Autumn Kliskey, President MedScience, Inc. 8803 Brecksville Road, Suite 5 Cleveland, Ohio 44141-1933 Phone: 216-546-0990 Fax: 216-546-1856
Q.M. Welch
February 13 1996
1
| Trade Name - | Recap-1 |
|---|---|
| Common Name - | Needle Recapping Device |
| Classification Name - | Hypodermic Single Lumen Needle (Accessory) |
Needlesafe I]
Manufactured by Ingenious Technologies Corp. Substantial Equivalent: 510K # K936235
2
Description of Recap-1
Recap-1 is 3"x4"x4.5" made of red pigmented ABS plastic weighing 6.5 ounces. The faceplate has 5 precise apertures to accommodate a majority of needles and their corresponding caps that are in the healthcare market today. It is labeled Recap-1, onehanded needle recapper. The five apertures identify by name the different types of needles that can be resheathed. Below the apertures it is stated "Do Not Use 2 Hands" thus conforming with OSHA guidelines and 29 CFR Part 1910.1030.
3
Intended Use of Recap-1
Recap-1 is used following OSHA guidelines to safely recap conventional needles prior to transport to an authorized sharps container in order to minimize the possibility of accidental needlesticks from occurring, after the injection procedure has been completed.
The device would be used in all healthcare environments to protect healthcare workers and patients from needlesticks after the injection process has taken place.
Remove the cap from the sterile needle by pulling back with a straight motion to avoid needle point damage. The needle cap is then placed in the appropriate aperture on the faceplate. After the injection procedure, the needle is placed into the cap with one hand only. Push down until you feel or hear the cap lock into place. The entire recapped needle is then removed from Recap-1 with one hand and transported safely to an authorized sharps container for disposal.
4
Technological Characteristic Comparison Between Recap-1 and Needlesafe II
Three basic technological differences are noted between Recap-1 and Needlesafe II.
-
- Recap-1 is larger than Needlesafe II.
- Recap-1 has 5 apertures. Needlesafe II has only one aperture. Recap-1 2. allows for various sized needles and corresponding caps to be used.
-
- Recap-1 has non-skid EDPM rubber extruded "feet" for stability. Needlesafe II has an independent base for possible adherence to a surface.
The difference in the technological characteristics noted above do not affect the safety and effectiveness of Recap-1 with regards to Substantial Equivalence.
Non-clinical testing of both devices actually presented an easier recapping procedure with Recap-1. In testing, removing the caps and placing them in Needlesafe II, it became apparent the caps could stick due to the single size aperture. Recap-1 had no sticking or failures whatsoever. This is attributed to the fact that Recap-1 has 5 different apertures allowing for a larger variety of car sizes to be used, as well as possessing clear, unrestricted openings where the caps rest.
5
BENCH TESTING OF RECAP-1
Bench Testing was performed evaluating 10 needles of each cap size as defined in the enclosed Needle Cap Fit Guide. Tests included (1) if the cap was sticking in the device during the one handed needle recapping procedure and (2) if there was a problem removing the recapped needle from the device.
| Cap Size | Cap Sticking
in Device | Problem
Removing
Recapped Needle |
|----------------------------------------------------|---------------------------|----------------------------------------|
| Terumo B-D 1/4" Round | None | None |
| B-D 1/4" Round | None | None |
| Novalon 7/16" Hexagon
16, 18, 20, 22 Gauge | None | None |
| Monoject 7/32" Square
250 E Series | None | None |
| Monoject 5/16" Square
250, 200, 205, 220 Series | None | None |
| Accuderm 9/32" Square | None | None |
| B-D 9/32" Square | None | None |
| MPL 9/32" Square | None | None |
The above test results demonstrate no problems or failures were encountered when recapping the needles or removing the recapped needle from the Recap-1 Device.
6
:
| ramber Cherabini of and states waters and the f | |||
|---|---|---|---|
| Securely grips needle caps, phiebotomy and intravenous | |||
| catheter caps. | |||
| · Complies fully with the newest OSHA standards. | |||
| Can be mounted wherever syringes are used. Base can be | |||
| adhered to any clean smooth surface. | |||
| Reusable - The top portion of the unit can be removed from the | |||
| base and steam autoclaved, gas sterilized, or disinfected by | |||
| wiping with or soaking in alcohol. | |||
| · Can also be used as a syringe holder. | NaegleSale | ||
| · Unit measures 2 1/2"W x 3"H. | |||
| eedle Resheather & Needle Cap & Blood Tube Holder | |||
| 8 7 | |||
| Description | |||
| 7375 Needle Resheather | |||
| Needle Cap Holder | |||
| 1379 Blood Tube Holder State | |||
| D 7373 Needle Cap & Blood Tube Holder Stand 10 |