1BD SOLOSHOT IX SYRINGE

K042934 · Becton, Dickinson & CO · FMF · Oct 28, 2004 · General Hospital

Device Facts

• Record ID: K042934
• Device Name: 1BD SOLOSHOT IX SYRINGE
• Applicant: Becton, Dickinson & CO
• Product Code: FMF · General Hospital
• Decision Date: Oct 28, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic, Expedited Review

Intended Use

The BD SoloShot™ IX Syringes are intended for the aspiration and injection of fluids.

Device Story

BD SoloShot IX is a 2-piece piston syringe consisting of a barrel and a one-piece plunger rod. It features a permanently attached needle and an auto-disable mechanism that locks the plunger rod after injection to prevent reuse. It is used for the aspiration and injection of fluids. The device is intended for clinical use. It replaces the 3-piece predicate design (which included a rubber stopper) with a simplified 2-piece construction. The device is supplied sterile.

Clinical Evidence

Bench testing only. Design verification tests were performed based on risk analysis to demonstrate that the modified device performs in an equivalent manner to the predicate.

Technological Characteristics

2-piece piston syringe (barrel and one-piece plunger rod). Materials are identical to the predicate. Features a permanently attached needle and an auto-disable mechanism. Sterilization method is ETO to SAL 10^-6.

Indications for Use

Indicated for the aspiration and injection of fluids. No specific patient population, age, or gender restrictions are defined.

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 Single-Fil Syringe (K883955)

Submission Summary (Full Text)

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K042934

# 510K SUMMARY OF SAFETY AND EFFECTIVENESS

## 1. Submitted By:

Peter Zurlo Manager, Regulatory Affairs

BD Medical Surgical 1 Becton Drive Franklin Lakes, NJ 07417-1883

Phone: [phone] Fax:

- 2. Device Name:
BD SoloShot IX Syringe Trade Name:

Piston Syringe Common Name:

Syringe, Piston Classification Name:

### Predicate Device:

## BD Single-Fil Syringe

### Manufactured by: Becton Dickinson and Company

## 3. Device Description:

The Predicate Device, the BD Single-Fil™ Syringe (K883955) is a standard 3-piece piston syringe with a permanently attached needle and with an auto-disable feature that prevents reuse of the syringe after aspiration and injection by locking the plunger rod in place after injection. The syringe consists of the syringe barrel with permanently attached needle, a plunger rod and non-latex rubber stopper. The syringe is individually blister packaged and Gamma Irradiation sterilized to SAL of 104. This syringe is intended for aspiration and injection of fluids.

The Modified Device, the subject of this 510(k), the BD SoloShot™ IX Syringe has been modified from the Predicate Device by changing to a 2-piece piston syringe. The syringe consists of a syringe barrel and one-piece plunger rod without the rubber stopper. The SoloShot™ IX Syringe has an identical permanently attached needle and identical autodisable feature. This syringe is individually blister packaged and ETO sterilized to SAL

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of 10". The intended use of the modified device remains the same as the predicate; for aspiration and injection of fluids.

#### Intended Use: રું.

## Same intended use as the Predicate Device.

The BD SoloShot™ IX Syringe is intended for the Aspiration and Injection of fluids

## Technological Charactcristics:

The Modified Device, the subject of this 510(1), The BD SoloShot™ IX Syringe Was modified by changing the plunger rod and removing the rubber plunger stopper making the syringe a 2-piece syringe ( barrel and plunger rod).

The Modified Device is manufactured of the same materials, has the same intended use and SAL of 10t as the Predicate Device.

#### Performance: ર.

Design Verification tests were performed based on the risk analysis performed and the results of these tests demonstrate that the BD SoloShot™ IX Syringe performed in an equivalent manner to the predicate device and is safe and effective when used as intended

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wing-like shapes, representing the department's mission to protect the health of all Americans and provide essential human services.

OCT 2 8 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Peter Zurlo Manager, Regulatory Affairs Becton Dickinson Medical Surgical 1 Becton Drive Franklin Lakes, New Jersey 07417

Re: K042934

Trade/Device Name: SoloShot™ IX Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: October 22, 2004 Received: October 25, 2004

Dear Mr. Zurlo:

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. Zurlo

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 yours,

Olu 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 Statement

| 510(k)<br>Number<br>(if known) | K442934 |
|--------------------------------|---------------------------------------------------------------------------------------|
| Device Name | BD SoloShot™ IX Syringe |
| Indications for Use | The BD SoloShot™ IX Syringes are intended for the aspiration and injection of fluids. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE) OR Over-The-Counter Use Prescription Use______________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801. 109) le n (Division Sign-Off)

Division of Anesthesinlogy, General Hospital, Infection Control, Dental Devices

510(k) Number: X042934

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