NEEDLE-TRAP/NEEDLE SAFETY LABEL

K073206 · Schreiner Medipharm · MEG · Jan 16, 2008 · General Hospital

Device Facts

• Record ID: K073206
• Device Name: NEEDLE-TRAP/NEEDLE SAFETY LABEL
• Applicant: Schreiner Medipharm
• Product Code: MEG · General Hospital
• Decision Date: Jan 16, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2

Intended Use

The Needle-Trap™ contains a mechanism that is used to cover the needle point after use of the syringe and needle for their intended functions. In the activated position the Needle-Trap™ guards against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.

Device Story

Needle-Trap™ is a syringe anti-needle stick accessory; functions as a safety mechanism integrated into a label or housing to cover needle points post-injection. Device is manually activated by the user after syringe use; provides a physical guard over the needle tip to reduce risk of accidental needle sticks during disposal and handling. Used in clinical or home settings by healthcare professionals or patients. Benefits include enhanced safety for personnel handling sharps by mitigating exposure to contaminated needles.

Clinical Evidence

Bench testing only; no clinical data provided. Verification and validation testing confirmed the product meets specifications.

Technological Characteristics

Syringe anti-needle stick accessory; mechanical safety guard; manual activation; class II device; product code MEG.

Indications for Use

Indicated for use as a protective mechanism to cover needle points following syringe use to prevent accidental needle sticks during handling and disposal of used needle/syringe combinations.

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Predicate Devices

• BD SafetyGlide™ Needle (K951254)
• Portex® Needle-Pro® EDGE™ Safety Device with Syringe (K061194)
• BD Eclipse™ Hypodermic Needle (K010188)

Submission Summary (Full Text)

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- 9. 510(K) SUMMARY
Submitted By:

JAN 16 2008 Date Prepared: November 05, 2007

SUMMARY OF SAFETY AND EFFECTIVENESS

Robert Licha Director Product and Process Management Schreiner MediPharm

- Needle Trap™ / Needle Safety Label 9.1 Trade/Proprietary Name:
- 9.2 Common/Usual Name Syringe Anti-Needle Stick Accessory
- 9.3 Classification Name Antistick Syringe
- 9.4 Substantial Equivalence The Needle Trap™ Needle Safety devices are substantially equivalent to the BD SafetyGlide™ Needle (K951254), Portex® Needle-Pro® EDGE™ Safety Device with Syringe (K061194) and/or the BD Eclipse™ Hypodermic Needle (K010188)
- 0.5 Classification: Class II Panel: 80 Product Code: 80MEG Cite: 21CFR 880.5860 Piston syringe FMF - Piston Syringe MEG - Antistick Syringe FMI - Hypodermic Single Lumen Needle
- 9.6 Technological Characteristics The technological characteristics of the Needle Safety devices are similar to the current marketed products
- 9.7 Performance Data Verification and Validation testing confirmed the products meet their specifications.
- ರಿ.8 Conclusion Schreiner MediPharm concludes based on the information presented that the new products lines are substantially equivalent to products currently legally marketed in the USA

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract design of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 6 2008

Schreiner MediPharm C/O Mr. Lee Leichter President P/L Biomedical 7609 Cameron Circle Fort Myers, Florida 33912

Re: K073206

Trade/Device Name: Needle-Trap™ Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: November 8, 2007 Received: November 13, 2007

Dear Mr. Leichter:

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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Page 2 -- Mr. Leichter

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/industry/support/index.html.

Sincerely vours.

Clrs

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:

## HO73206

Device Name: Indications for Use: Needle-Trap™

The Needle-Trap™ contains a mechanism that is used to cover the needle point after use of the syringe and needle for their intended functions. In the activated position the Needle-Trap™ guards against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.

Concurrence of CDRH, Office of Device Evaluation (ODE)

1 Prescription Use (Per 21 CFR 801.109)

or

**Over-the-Counter Use**

Charles Zink for A.W.
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: k073206