(93 days)
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.
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.
The provided text describes a 510(k) summary for the Recap-1 device, a one-handed needle recapper. The document focuses on demonstrating substantial equivalence to a predicate device, Needlesafe II, and ensuring compliance with OSHA guidelines regarding needle recapping.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
Based on the provided Bench Testing section, the acceptance criteria are implicitly related to the absence of problems during the recapping and removal process.
| Acceptance Criteria | Reported Device Performance (Recap-1) |
|---|---|
| No cap sticking in the device during one-handed needle recapping procedure. | None reported for any of the 8 tested cap sizes. |
| No problem removing the recapped needle from the device. | None reported for any of the 8 tested cap sizes. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: "10 needles of each cap size as defined in the enclosed Needle Cap Fit Guide." There are 8 distinct cap sizes listed in the table, meaning a total of 80 needles were tested (10 needles * 8 cap sizes).
- Data Provenance: Not explicitly stated. The tests were "Bench Testing," suggesting they were conducted in a laboratory or controlled environment by the manufacturer (MedScience, Inc. in Cleveland, Ohio). It is a prospective test designed to evaluate the new device. No country of origin for the data is specified beyond the manufacturer's location.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- The document does not mention the use of experts to establish ground truth for this bench testing. The evaluation criteria ("Cap Sticking in Device" and "Problem Removing Recapped Needle") seem to be objective and directly observable from the device's mechanical function.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- None specified. The testing appears to be a direct observation of device function against a simple pass/fail criterion (presence or absence of sticking/problems). There is no indication of multiple reviewers or an adjudication process.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. This document describes a mechanical device for recapping needles, not an AI-assisted diagnostic or interpretative tool. The study focuses on the device's physical function rather than human interpretation or performance with AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance test was done. The "Bench Testing of Recap-1" evaluates the device's functional performance (recapping and removal) independently. There is no human interaction that influences the core mechanical performance being measured. The human operator is simply using the device as intended.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth used is based on direct observation of functional performance during bench testing. For "Cap Sticking in Device," the ground truth is simply whether the cap physically stuck or not. For "Problem Removing Recapped Needle," it's whether the recapped needle could be freely removed or not. These are objective, observable physical events.
8. The sample size for the training set
- The document does not mention a training set. This is a physical device, and the testing described is a functional validation, not a machine learning model that requires training data.
9. How the ground truth for the training set was established
- Not applicable, as no training set is mentioned for this device.
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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
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| 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
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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.
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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.
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- 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.
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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 Stickingin Device | ProblemRemovingRecapped Needle |
|---|---|---|
| Terumo B-D 1/4" Round | None | None |
| B-D 1/4" Round | None | None |
| Novalon 7/16" Hexagon16, 18, 20, 22 Gauge | None | None |
| Monoject 7/32" Square250 E Series | None | None |
| Monoject 5/16" Square250, 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.
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:
| ramber Cherabini of and states waters and the f | |||
|---|---|---|---|
| Securely grips needle caps, phiebotomy and intravenouscatheter caps. | |||
| · Complies fully with the newest OSHA standards. | |||
| Can be mounted wherever syringes are used. Base can beadhered to any clean smooth surface. | |||
| Reusable - The top portion of the unit can be removed from thebase and steam autoclaved, gas sterilized, or disinfected bywiping 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 |
§ 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).