SHARPSAWAY II LOCKING DISPOSABLE CUP

K041153 · Arrow Intl., Inc. · FMI · Jul 12, 2004 · General Hospital

Device Facts

• Record ID: K041153
• Device Name: SHARPSAWAY II LOCKING DISPOSABLE CUP
• Applicant: Arrow Intl., Inc.
• Product Code: FMI · General Hospital
• Decision Date: Jul 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

The Arrow SharpsAway II™ Locking Disposal Cup is intended as a single use needle protection device, which covers the end of needles after use to minimize the risk of needle sticks. This device is designed for use with 15 Ga. to 30 Ga. needles for various clinical procedures.

Device Story

SharpsAway II™ Locking Disposal Cup is a single-use accessory designed to prevent needle sticks during clinical procedures. It functions as a temporary receptacle for used needles, allowing clinicians to safely cover the needle tip after use before transferring the sharp to a final disposal container. The device is used in clinical settings by healthcare professionals. By providing a secure, locking mechanism to shield the needle point, it reduces the risk of accidental injury to the user during the transition from the procedure site to the sharps container.

Clinical Evidence

No clinical data. Substantial equivalence was demonstrated through bench testing, including simulated use studies, puncture resistance testing, gripping mechanism functionality testing, and water leak testing.

Technological Characteristics

Single-use needle protection cup designed for 15 Ga. to 30 Ga. needles. Features a locking mechanism to secure needle tips. Technological characteristics are stated to be unchanged from the predicate device.

Indications for Use

Indicated for use as a single-use needle protection device to cover the tips of 15 Ga. to 30 Ga. needles following clinical procedures to minimize the risk of accidental needle sticks.

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

• Devon Industries - Point-Lok® Needle Protection Device (K946289)

Submission Summary (Full Text)

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JUL 1 2 2004 510(k) Summary:

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K04 1153

## SharpsAway II™ Locking Disposal Cup

| Submitter: | Arrow International Inc.<br>2400 Bernville Road<br>Reading, PA 19605 |
|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Elizabeth Price<br>Regulatory Associate |
| | Phone: [phone] Ext. 3220<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date summary prepared: | April 30, 2004 |
| Date summary revised: | July 6, 2004 |
| Device trade name: | SharpsAway II™ Locking Disposal Cup |
| Device common name: | Accessory to a Needle, Hypodermic, Single Lumen |
| Device classification<br>name: | Needle, Hypodermic, Single Lumen |
| Legally marketed devices<br>to which the device is<br>substantially equivalent | Devon Industries - Point-Lok® Neeedle Protection Device<br>(K946289) |
| Description of device: | The proposed SharpsAway II™ Locking Disposal Cup was<br>created to help prevent needle sticks by providing a means of<br>moving used sharps from procedure to sharps container. |
| Intended use of the<br>device: | The Arrow SharpsAway II™ Locking Disposal Cup is intended<br>as a single use needle protection device, which covers the<br>end of needles after use to minimize the risk of needle sticks.<br>This device is designed for use with 15 Ga. to 30 Ga. needles<br>for various clinical procedures. |
| Technological<br>characteristics: | The technological characteristics are unchanged from the<br>predicate device. |

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## 510(k) Summary:

## SharpsAway II™ Locking Disposal Cup

| Performance tests: | The following tests were performed to demonstrate substantial<br>equivalence:<br>• Simulated Use Study<br>• Puncture Resistance<br>• Gripping Mechanism Functionality Test<br>• Water Leak |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusions: | The results of the performance tests demonstrate that the<br>device is substantially equivalent to the legally marketed<br>predicate device. |

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 2 2004

Ms. Elizabeth Price Regulatory Affairs Arrow International 2400 Bernville Road Reading, Pennsylvania 19605

Re: K041153

Trade/Device Name: SharpsAway II TM Locking Disposable Cup Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: April 30, 2004 Received: May 3, 2004

Dear Ms. Price:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number: K041153

Device Name: SharpsAway IITM Locking Disposal Cup

Indications For Use:

The Arrow SharpsAway II™ Locking Disposal Cup is intended as a single use needle protection device, which covers the end of needles after use to minimize the risk of needle sticks. This device is designed for use with 15 Ga. to 30 Ga. needles for various clinical procedures.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aton Dm

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K441153