MODIFICATION TO: TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM, ULTRASAFE PASSIVE DELIVERY SYSTEM (X-SERIES)

K060743 · Safety Syringes, Inc. · MEG · Apr 28, 2006 · General Hospital

Device Facts

• Record ID: K060743
• Device Name: MODIFICATION TO: TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM, ULTRASAFE PASSIVE DELIVERY SYSTEM (X-SERIES)
• Applicant: Safety Syringes, Inc.
• Product Code: MEG · General Hospital
• Decision Date: Apr 28, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Single use devices that are indicated for use as an accessory with prefilled ISO Standard glass syringes to aid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications, and individuals that assist self-injecting patients, from accidental needlesticks. The intended patient population is unrestricted and may include children and adults, and parenteral methods of administration.

Device Story

Antineedlestick accessory for pre-filled ISO Standard glass syringes (0.5 mL to 5.0 mL); passive needle guard mechanism; protects users from accidental needlesticks. Used by healthcare professionals, patients, and caregivers in clinical or home settings. No changes to design, materials, or technology from predicate; modification limited to expanded indications for use. Device provides safety benefits to non-healthcare professional users; usability testing confirms non-healthcare users can follow instructions.

Clinical Evidence

No clinical data. Usability testing performed to evaluate the ability of non-healthcare personnel to understand and follow the Instructions for Use, confirming the device performs as intended for the expanded user population.

Technological Characteristics

Passive needle guard accessory for ISO Standard glass syringes. Fits syringe sizes 0.5 mL, 1.0 mL, 1.0 mL long, 1.5 mL, 2.25 mL, 3.00 mL, and 5.0 mL. Mechanical design; no energy source or software.

Indications for Use

Indicated for healthcare professionals, patients self-injecting doctor-prescribed medications, and caregivers assisting self-injecting patients. Unrestricted patient population (children and adults) requiring parenteral administration.

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

• Tamper Evident UltraSafe® Passive™ Delivery System
• UltraSafe® Passive™ Delivery System (X-Series)

Submission Summary (Full Text)

{0}------------------------------------------------

#### 510(k) Summary

# Special 510 (k) Summary of Safety and Effectiveness

#### Company and Contact Information

Safety Svringes, Inc. 1939 Palomar Oaks Way, Suite A Carlsbad, CA 92011

Voice 760.918.9908 Fax [phone]

Thomas L. Hall Sr. Director, Regulatory Affairs & Quality Assurance

### Device Identification

Trade Names:

- 1. Tamper Evident UltraSafe® Passive™ Delivery System
2. UltraSafe® Passive™ Delivery System (X-Series) Regulation Number - 21 CFR 880.5860 Regulation Name - Syringe, Piston (accessory) Classification - Class II Product Code - MEG

### Predicate Devices

- 1. Tamper Evident UltraSafe® Passive™ Delivery System
- 2. UltraSafe® Passive™ Delivery System (X-Series) (Subsequent to the submission of the premarket notification for this device, the trade name was changed from UltraSafe® Passive™ X-Series Needle Guard)

### Description of Modified Devices

The Safety Syringes UltraSafe Delivery System/Needle Guard devices are antineedlestick accessories for pre-filled ISO Standard glass syringes. ISO Standard glass syringes are supplied in multiple sizes. These devices are designed to fit syringe sizes 0.5 mL, 1.0 mL, 1.0 mL long, 1.5 mL, 2.25 mL, 3.00 mL, and 5.0 mL.

The only change from the currently legally marketed devices, and the subject of this premarket notification is the expansion of the Indications for Use, that is currently limited to healthcare professionals, to include physician prescribed medication selfinjecting patients and individuals who assist self-injecting patients. There are no changes to the design of these devices, materials used to produce these devices, or to their fundamental technology.

{1}------------------------------------------------

## Indications for Use

Single use devices that are indicated for use as an accessory with prefilled ISO Standard glass syringes to aid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications, and individuals that assist selfiniecting patients, from accidental needlesticks.

The intended patient population is unrestricted and may include children and adults, and parenteral methods of administration.

### Compliance with Design Controls

Design Control activities for this device have been performed in conformance with the design control procedure requirements as specified in 21 CFR part 820.30.

## Risk Management

Risks associated with each product family have been identified, evaluated and, after mitigation, the risks fall into the "Broadly Acceptable Region" following ISO 14971.

## Conclusion

The expansion of the indications for use to include patients who self-inject doctor prescribed medications and individuals who assist self-injecting patients provides needed protection to an expanding population of users who can benefit with the use of anti-needlestick devices. The ability of non-healthcare personnel to understand and follow the Instructions for Use has been tested and the results of that testing indicates that the devices will perform as intended in the hands of typical nonhealthcare users.

This labeling change brings the safety benefits to a new user group. No issues have arisen to indicate that this labeling change poses unreasonable risks to nonhealthcare professional users.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three wing-like shapes, representing health, services, and people. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

APR 2 8 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Thomas L. Hall Senior Director, Regulatory Affairs and Quality Assurance Safety Syringes, Incorporated 1939 Palomar Oaks Way, Suite A Carlsbad, California 92011

Re: K060743

Trade/Device Name: Tamper Evident UltraSafe® Passive™ Delivery System UltraSafe® Passive™ Delivery System (X-Series) Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: April 12, 2006 Received: April 14, 2006

Dear Mr. Hall:

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 Federa! Register.

{3}------------------------------------------------

Page 2 - Mr. Hall

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.

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

{4}------------------------------------------------

# Indications for Use

510(k) Number:

K060743

Device Name:

UltraSafe® Passive™ Delivery System

Indications for Use:

Single use devices that are indicated for use as an accessory with prefilled ISO Standard glass syringes to aid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications, and individuals that assist self-injecting patients, from accidental needlesticks.

The intended patient population is unrestricted and may include children and adults, and parenteral methods of administration.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Antony D. ins

Ancolliesiology, General Hospital, : Connol Dental Devices

大46φ743

000 03

{5}------------------------------------------------

# Indications for Use

510(k) Number:

#### K060743 .

Device Name:

Tamper Evident UltraSafe® Passive™ Delivery System

Indications for Use:

Single use devices that are indicated for use as an accessory with prefilled ISO Standard glass syringes to aid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications, and individuals that assist self-injecting patients, from accidental needlesticks.

The intended patient population is unrestricted and may include children and adults, and parenteral methods of administration.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

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

#### Concurrence of CDRH, Office of Device Evaluation (ODE)

Ching veng

ാത്രം (1) അടിമൃത്രം (General Hospital) In Com.of Dental Devices

K06243

000 02