ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICE

K043249 · Atrion Medical Products, Inc. · FMI · May 25, 2005 · General Hospital

Device Facts

• Record ID: K043249
• Device Name: ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICE
• Applicant: Atrion Medical Products, Inc.
• Product Code: FMI · General Hospital
• Decision Date: May 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

The Atrion NeedleVISE™ Large-Bore Sharps Securing Device is intended for use in various clinical procedures as a sharps securing device for contaminated needles that do not have integral engineered sharps safety systems.

Device Story

Single-patient, disposable device for securing contaminated large-bore needles. Operated by healthcare professionals using one hand to render sharps harmless. Device utilizes a plastic housing containing a metal retaining clip to lock used needles in place. Used in clinical settings where sharps containers are not immediately available or accessible. Benefits include reduced risk of accidental needlestick injuries by providing a secure, passive containment mechanism for needles lacking built-in safety features.

Clinical Evidence

Bench testing included mechanical property assessments for puncture resistance and pull-out force. Field trials were conducted to assess ease of use. No clinical patient data was required or presented.

Technological Characteristics

Disposable, single-patient use device. Construction consists of a plastic housing and a metal retaining clip. Operates via mechanical locking mechanism to secure needles. No energy source or software components.

Indications for Use

Indicated for use by healthcare professionals as a sharps securing device for contaminated needles lacking integral engineered safety systems during clinical procedures.

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, Inc. Point-Lok® Needle Protection Device (K946289)

Submission Summary (Full Text)

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MAY 2 5 2005

K043249

Atrion Medical Products, Inc. 1426 Curt Francis Road Post Office Box 564 Arab, AL 35016 Tel [phone] Fax [phone]

Image /page/0/Picture/3 description: The image shows the logo for Atrion Medical. The logo is black and white and features the word "Atrion" in a bold, sans-serif font. A stylized graphic element, resembling a swoosh or a stylized "A", is placed to the left of the word "Atrion". Below the word "Atrion" is the word "Medical" in a smaller, less bold font.

### 11. 510(k) SUMMARY

| Date of Preparation: | April 30, 2005 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Names: | Atrion NeedleVISE™ Large-Bore Sharps Securing Device |
| Common Name: | Accessory to a Needle, Hypodermic, Single Lumen |
| Classification Name: | Accessory to single lumen hypodermic needle<br>21 CFR 880.5570, ProCode 80 FMI |
| Manufacturer: | Atrion Medical Products, Inc.<br>1426 Curt Francis Road<br>Arab, AL 35016 |
| Contact: | Mr. Dan Clark,<br>Atrion Medical Products, Inc.<br>1426 Curt Francis Road<br>Arab, AL 35016<br>Telephone: [phone], Fax: [phone] |
| Predicates: | Devon Industries, Inc. Point-Lok® Needle Protection Device<br>(K946289) |

#### Device Description:

The NeedleVISE™ Large-Bore Sharps Securing Device is a single patient procedure use, disposable device used for securing needles.

The healthcare professional using only one hand can render the sharps harmless. The purpose The neathedie profoseional asing Securing Device is to provide a means to make of the Needle TOL - Eargo Boro ion available for all instances in which introduction of contaminated sharps containers is not acceptable.

### Intended Use:

The Atrion NeedleVISE™ Large-Bore Sharps Securing Device is intended for use in various The Attrion Necule Froz - as a sharps securing device for contaminated needles that do not have integral engineered sharps safety systems.

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KC.43249

Atrion Medical Products, Inc. 1426 Curt Francis Road Post Office Box 564 Arab, AL 35016 Tel [phone] Fax [phone]

Image /page/1/Picture/2 description: The image shows the logo for Atrion Medical. The word "Atrion" is in a bold, sans-serif font, with a stylized swoosh extending from the left side of the "A". Below "Atrion" and slightly to the right, the word "Medical" is written in a smaller, sans-serif font.

### Technological Characteristics:

The NeedleVISE™ Large-Bore Sharps Securing Device has similar materials as the predicate The NeculeVTOL - Earge Berb States tics are unchanged from the predicate device, as they both lock the used sharps into a metal retaining clip contained within a plastic housing.

## Summary of Testing:

The NeedleVISE™ Large-Bore Sharps Securing Device tests included mechanical property The Nedalovice - Earge puncture resistance and pull out force. The results showed the testing to assoco impact, panears Securing Device to be substantially equivalent to the Needicate device. Earge Belleted in field trials designed to assess ease of use.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged in a circular pattern around the symbol. The caduceus symbol is composed of three curved lines that resemble the wings of a bird or the leaves of a plant. The text is in a simple, sans-serif font.

#### Public Health Service

MAY 2 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Dan Clark Vice President Atrion Medical Products, Incorporated 1426 Curt Francis Road P.O. Box 564 Arab, Alabama 35016

Re: K043249

18045247
Trade/Device Name: Atrion NeedleVISE™ Large-Bore Sharps Securing Device Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: April 30, 2005 Received: May 2, 2005

.

Dear Mr. Clark:

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 approvisions 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 (1 wr 1) is a 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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#### Page 2 - Mr. Clark

Please be advised that FDA's issuance of a substantial equivalence determination does not r lease be act for a made a determination that your device complies with other requirements mount that I DIT has made statutes and regulations administered by other Federal agencies. or the Fet of any 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 and ibsing (= = = set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as as electronic product radiation control provisions 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) rins reter 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), 11 you debite bythe 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 Inter 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/industry/support/index.html.

Sincerely yours,

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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## 12. INDICATIONS FOR USE STATEMENTS

b. NeedleVISE Large-Bore Sharps Securing Device

# Indications for Use

510(k) Number (if known): KONGORAS

Device Names: Atrion NeedleVISE™ Large-Bore Sharps Securing Device

Indications For Use:

The NeedleVISE™ Large-Bore Sharps Securing Device is intended for use in various clinical The NeedleVISE™ Large-Bore Shaps Gecuring Device is increase to:
procedures as a sharps securing device for contaminated needles that do not have integral engineered sharps safety systems.

Prescription Use × (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGEIFNEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

Susan Evans

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

510(k) Number: