DUPLOJECT (0.5/1.0 ML, 2.0 ML, 5.0 ML)

K973510 · Immuno-U.S., Inc. · FMF · Dec 8, 1997 · General Hospital

Device Facts

• Record ID: K973510
• Device Name: DUPLOJECT (0.5/1.0 ML, 2.0 ML, 5.0 ML)
• Applicant: Immuno-U.S., Inc.
• Product Code: FMF · General Hospital
• Decision Date: Dec 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Duploject® is intended for use in the simultaneous delivery of two non-homogenous fluids or solutions onto a surgical site. The Duploject® is equipped with syringe holder, which assures controlled, accurate dispensing, and a needle holder, which allows the contents of the syringes to mix prior to dispensing.

Device Story

Duploject is a single-use, disposable syringe system for simultaneous delivery and mixing of two non-homogenous fluids at a surgical site. System includes two syringes, withdrawal needles for reconstitution, a clip with a common plunger to join syringes, and a common joining piece (needle holder) for mixing prior to dispensing. Operated by clinicians in surgical settings. The common plunger ensures equal volumes are dispensed from both syringes. Benefits include controlled, accurate delivery of two-component surgical solutions.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Single-use, disposable syringe system. Materials: unspecified plastic components. Principle: mechanical dual-syringe coupling with common plunger and mixing tip. Sterilization: EtO (10^6). Volumes: 0.5/1.0 ml, 2 ml, 5 ml. No software or electronic components.

Indications for Use

Indicated for the simultaneous delivery of two non-homogenous fluids or solutions onto a surgical site. Intended for prescription use.

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

• Duoflo Dispenser (K872565)
• RMI Dual Fluid Irrigating Syringe (K964833)
• Surgical Sealant Dispenser (SSD) (K881020)

Submission Summary (Full Text)

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K9 73510

DEC - 8 1997

# 510(k) Summary of Safety and Effectiveness Duploject®

# Submitter

Immuno- US, Inc. Ron Vallencourt, DVM Vice President Regulatory Affairs 1200 Parkdale Road Rochester, Michigan Tel: [phone] Fax: [phone]

#### Date summary was prepared

Spetember 16, 1997

#### Name(s) of the device

Duploject®

#### Identification of predicate device(s)

Duoflo Dispenser K872565 Manufactured by Hemaedics, Inc.

RMI Dual Fluid Irrigating Syringe K964833 Manufactured by Research Medical, Inc.

Surgical Sealant Dispenser (SSD) K881020 Micromedics, Inc.

### Description of the device

The Duploject® is a single-use, disposable syringe, which is used in the application of two nonhomogenous fluids or solutions onto a surgical site. The Duploject® consists of two disposable syringes and withdrawal needles for reconstitution of the solutions. It also contains the following components for use in the simultaneous application of the two solutions: a clip, with a common plunger, is used to join the two identical disposable syringes together and ensures that equal volumes of the two components are fed through a common joining piece and mixed prior to dispensing. Three extra application needles and one extra joining piece are included in the package to use as replacements, if needed. The Duploject® is sterile and non-pyrogenic.

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# Intended Use

The Duploject® is intended for use in the simultaneous delivery of two non-homogenous fluids or solutions onto a surgical site. The Duploject® is equipped with syringe holder, which assures controlled, accurate dispensing, and a needle holder, which allows the contents of the syringes to mix prior to dispensing.

| Characteristic | Duploject® | Predicate Devices |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Principle of<br>Operation | A joining piece, with a common<br>plunger, connects two disposable<br>syringes, and the contents are mixed in<br>a common tip prior to dispensing. | Same |
| Volume | 0.5/1.0 ml, 2 ml,5 ml | Same |
| Delivery<br>Accuracy | The slide bar on the syringe holder<br>ensures delivery of equal amounts of<br>the contents of the syringes. | Same |
| Reuse | Disposable | Same |
| Sterilization | EtO (106) | Same |

# Comparison of device characteristics to predicate

# Conclusion

The intended use, design, materials of fabrication, and performance of the Duploject® are the predicate devices. Therefore, the Duploject® is substantially equivalent to piston syringes marketed in interstate commerce prior to May 28,1 976.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the logo is an abstract symbol that resembles a stylized human figure or a bird in flight.

DEC - 8 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

David West, Ph.D. Senior Technical Advisor Immuno-U.S., Incorporated C/O Medical Technology Consultants 15825 Shady Grove Road, Suite 90 Rockville, Maryland 20850

Re : K973510 Duploject (0.5/1.0 ML, 5.0 ML) Trade Name: Regulatory Class: II Product Code: FMF Dated: September 16, 1997 Received: September 16, 1997

Dear Dr. West:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Dr. West

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Tim Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K973510

#### INDICATIONS FOR USE 5.0

The Duploject® is intended for use in the simultaneous delivery of two non-homogenous fluids or solutions onto a surgical site. The Duploject® is equipped with a syringe holder, which assures controlled, accurate dispensing, and a needle holder, which allows the contents of the syringes to mix prior to dispensing.

Patrici Cuscenti

510k)

Prescription Use. ✓
(Per 21 CFR 801.109)

September 17, 1997 Immuno-Duploject®