RECAP-1

K960641 · Medscience, Inc. · FMI · May 17, 1996 · General Hospital

Device Facts

• Record ID: K960641
• Device Name: RECAP-1
• Applicant: Medscience, Inc.
• Product Code: FMI · General Hospital
• Decision Date: May 17, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended 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.

Device Story

Recap-1 is a needle recapping device; 3"x4"x4.5" red ABS plastic housing; 5 precise apertures for various needle/cap sizes. Operation: user places needle cap into appropriate aperture; after injection, user inserts needle into cap using one hand; cap locks into place; user removes recapped needle for disposal in sharps container. Used in healthcare environments by clinicians to prevent accidental needlesticks. Provides stable, one-handed recapping; non-skid EDPM rubber feet for surface stability. Benefits: minimizes needlestick risk; complies with OSHA guidelines (29 CFR Part 1910.1030).

Clinical Evidence

Bench testing only. Evaluated 10 needles per cap size across 8 different cap types. Endpoints: cap sticking in device and difficulty removing recapped needle. Results: 0 failures or sticking incidents reported across all tested configurations.

Technological Characteristics

Materials: red pigmented ABS plastic, EDPM rubber feet. Dimensions: 3"x4"x4.5". Design: 5-aperture faceplate for multi-size needle cap accommodation. Mechanical operation: passive, non-powered, one-handed recapping mechanism. Sterilization: reusable; top portion removable for steam autoclaving, gas sterilization, or alcohol disinfection.

Indications for Use

Indicated for use by healthcare workers in all healthcare environments to safely recap conventional needles post-injection to prevent accidental needlesticks.

Regulatory Classification

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.

Predicate Devices

• Needlesafe II (K93-5235)

Submission Summary (Full Text)

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MedScience™

K 960641

510K Summary MAY 17 1996

Autumn Kliskey, President
MedScience, Inc.
8803 Brecksville Road, Suite 5
Cleveland, Ohio 44141-1933
Phone: [phone]
Fax: [phone]


February 13 1996

MedScience Inc. • 8803 Brecksville Road • Suite 5 • Cleveland, Ohio 44141-1933 • [phone] • Fax [phone]

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Trade Name – Recap-1

Common Name – Needle Recapping Device

Classification Name – Hypodermic Single Lumen Needle (Accessory)

Substantial Equivalent: Needlesafe II
Manufactured by Ingenious Technologies Corp.
510K # K93-5235

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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, one-handed 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.

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# 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.

1. Recap-1 is larger than Needlesafe II.
2. Recap-1 has 5 apertures. Needlesafe II has only one aperture. Recap-1 allows for various sized needles and corresponding caps to be used.
3. 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 cap 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 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.

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# Needle Resheather

All materials must be in accordance with the manufacturer's instructions.

- Securely grips needle caps, phlebotomy 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.
- Unit measures 2 1/2"W x 3"H.

NeedleSafe II™ is a trademark of Ingenious Technologies Corporation.

Needle Resheather & Needle Cap & Blood Tube Holder

| HCL No. | Description | Price Each |
| --- | --- | --- |
| A 7375 | Needle Resheather | $14.50 |
| B 7377 | Needle Cap Holder | 32.60 |
| C 7379 | Blood Tube Holder | 32.60 |
| D 7373 | Needle Cap & Blood Tube Holder Stand | 10.30 |

The Needle Cap & Blood