OTTER SAFETY SYRINGE

K040545 · Otter (China) Technology Co., Ltd. · MEG · Apr 22, 2004 · General Hospital

Device Facts

• Record ID: K040545
• Device Name: OTTER SAFETY SYRINGE
• Applicant: Otter (China) Technology Co., Ltd.
• Product Code: MEG · General Hospital
• Decision Date: Apr 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Otter Safety Syringe is a sterile, single-use, disposable and non-reusable, manual retractable safety syringe intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.

Device Story

Otter Safety Syringe is a manual retractable safety syringe; integrated needle and piston design. Operation: standard injection technique; user withdraws plunger completely into barrel; forward compression of plunger crushes needle within puncture-resistant barrel. Output: crushed, unusable needle; prevents accidental needlesticks and syringe reuse. Used in clinical settings by healthcare professionals. Benefits: reduces sharps injury risk; prevents reuse.

Clinical Evidence

Clinical testing conducted in China and simulated use testing performed by qualified healthcare professionals. Results confirmed the device performs reliably and meets safety syringe performance standards.

Technological Characteristics

Integrated needle and piston syringe; manual retraction mechanism; puncture-resistant barrel. Materials and performance meet internationally recognized standards for syringe performance. Non-powered, manual operation.

Indications for Use

Indicated for patients requiring fluid injection; intended for use by healthcare professionals to reduce sharps injuries and prevent syringe reuse.

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

• Duopro Safety Syringe
• SecureGard
• SEZ Safety Syringe
• Nipro hypodermic needle

Submission Summary (Full Text)

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K 040545

# APR 2 2 2004 510(k) Summary

#### Submitted on behalf of:

#### Otter (China) Technology, Co. Ltd.

7F Zhaofeng Universe Building 1800 Zhongshan West Road Shanghai, 200233, China 86-21-64401779 Telephone: [phone] Fax:

by:

Elaine Duncan, M.S.M.E., RAC President, Paladin Medical, Inc. PO Box 560 Stillwater, MN 55082 715-549-6035 715-549-5380

Telephone: Fax:

CONTACT PERSON:

Elaine Duncan

| DATE PREPARED: | February 27, 2003, revised April 16, 2004 |
|----------------|-------------------------------------------|
|----------------|-------------------------------------------|

| TRADE NAME: | Otter Safety Syringe |
|--------------|----------------------|
| COMMON NAME: | Safety Syringe |

#### SUBSTANTIALLY EQUIVALENT TO:

The Otter Safety Syringe is substantially equivalent to the Duopro Safety Syringe and the SecureGard The otter barety Byringe because these devices also retract the needle into the barrel of the syringe and the SEZ Safety Syringe which also crumples the needle. The Nipro hypodermic needle is a predicate for the Otter Syringe as these are the same as the needles used on the Otter Syringe.

### DESCRIPTION of the DEVICE:

The Otter Safety Syringe is an integrated needle and piston syringe with an innovative anti-needlestick mechanism. The design incorporates the ideal features desired in a safety syringe. No special techniques meenanism. "The atternechanism. The mechanism allows clear visualization of the injection site at all times. The mechanism clearly shows that the needle has been crushed within the syringe barrel. After standard techniques for injection, the plunger is withdrawn completely into the barrel. A forward compression of the plunger again and the needle is crushed within the puncture-resistant barrel. This renders the needle unusable and safe from accidental needle sticks.

#### INDICATIONS FOR USE:

The Otter Safety Syringe is a sterile, single-use, disposable and non-reusable, manual retractable safety syringe intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.

#### SUMMARY of TESTING:

The Otter Safety Syringe has been shown to meet internationally recognized standards for syringe performance and labeling characteristics. In addition, clinical testing in China and simulated use testing in per remails by qualified healthcare professionals proved the Otter Safety Syringe performs reliably and in accordance with the high expectations for safety syringes set by FDA and healthcare organizations.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a series of flowing lines, possibly representing the interconnectedness of health and human services.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 2 2 2004

Otter (CHINA) Technology Company Limited C/O Ms. Elaine Duncan Paladin Medical, Incorporated P.O. Box 560 Stillwater, Minnesota 55082

Re: K040545

Trade/Device Name: Otter Safety Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: February 27, 2004 Received: March 2, 2004

Dear Ms. Duncan:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reveal 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 Interstate commerco prior to 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 approvin application () { } }) } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } controls provided or an al 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 If your device is chassinod (500 as 10) in a controls. Existing major regulations affecting (1 Mrx), it may be subject to back adala f Federal Regulations, Title 21, Parts 800 to 898. In your device ean be found in ther announcements concerning your device in the Federal Register.

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Page 2 - Ms. Duncan

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 mean that IDA has made a deceminations administered by other Federal agencies. of the Act of ally I oderal bata separements, including, but not limited to: registration You must comply with an the Act 5 requirements and 801); good manufacturing practice and listing (21 CFR Part 867), labelity systems (QS) regulation (21 CFR Part 820); and if requirents as set forth in the quality is a 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) This letter will anow you to begin maintaing of substantial equivalence of your device to a prematication. The PDF intents 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), If you ucsile specific advice for your 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 Inay obtain other general micromational 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 yours,

Chiu Lin, Ph.D.

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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K 040545

## Indications for Use

510(k) Number (if known): ___K040545

Device Name: _Otter Safety Syringe

Indications For Use:

The Otter Safety Syringe is a sterile, single-use, disposable and non-reusable, The Otter Galety Cyringe intended for injection of fluids into the body, manual rotractable cally of sharps injuries and the potential for syringe reuse.

AND/OR Prescription Use __ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (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)

Irene Hansen for ADu Hr/o 4

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

510(k) Number ..

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