POWRSYRINGE INJECTOR

K072318 · Pinyons Medical Technology, Inc. · FMF · Sep 21, 2007 · General Hospital

Device Facts

• Record ID: K072318
• Device Name: POWRSYRINGE INJECTOR
• Applicant: Pinyons Medical Technology, Inc.
• Product Code: FMF · General Hospital
• Decision Date: Sep 21, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The PowrSyringe Injector is a piston syringe to inject fluids into, or aspirate fluids from, the body including use in angiography.

Device Story

PowrSyringe Injector is a single-use, manual, hand-held piston syringe designed for fluid injection or aspiration, including angiography. Device features a barrel and plunger mechanism operated by integrated handles; squeezing handles advances plunger for injection; opening handles retracts plunger for aspiration. Clear barrel allows visualization of air bubbles; handle design prevents plunger detachment during aspiration; minimal dead space design. Used by clinicians in clinical settings. Provides manual control of fluid delivery/aspiration; aids in angiography procedures by facilitating precise fluid management.

Clinical Evidence

No clinical data. Bench and animal performance testing conducted to confirm functionality and equivalence to predicate devices.

Technological Characteristics

Manual hand-held piston syringe. Features: clear barrel, integrated handles, minimal dead space design, anti-detachment mechanism. Single-use. Materials and sterilization methods not specified.

Indications for Use

Indicated for injection of fluids into or aspiration of fluids from the body, including angiography procedures. No specific patient population, age, or gender restrictions provided.

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.

Submission Summary (Full Text)

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# 5. 510(k) Summary

SEP 2 1 2007

In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title of the Code of Federal Regulations Part 807 (21 CFR §807), and in particular §807.92, the following summary of safety and effectiveness information is provided.

# Device Information

| Trade Name: | PowrSyringe Injector |
|----------------------|----------------------|
| Common Name: | Piston Syringe |
| Classification Name: | FMF Syringe, Piston |

#### Predicate Devices

The PowrSyringe Injector is substantially equivalent to multiple previous cleared piston syringes and angiographic syringes.

#### Device Description

The PowrSyringe Injector is a single use manual hand-held piston syringe with handles to inject fluids into, or aspirate fluid from, the body including use in angiography. The PowrSyringe Injector handles allow the user to push the blunger into the barrel when the user squeezes the handles. Users may open the PowrSyringe Injector's handles to aspirate fluid back into the barrel.

The PowrSyringe Injector safety features include:

- Clear barrel for visualization of air bubbles. a
- I Minimum dead space between the plunger and barrel with the handles are fully squeezed.
- 트 Handle design to prevent the plunger from being pulled out of the barrel during aspiration.

## Intended Use

The PowrSyringe Injector is a piston syringe to inject fluids into, or aspirate fluids from, the body including use in angiography.

## Comparison to Predicate Devices

Data is provided to demonstrate the PowrSyringe Injector is substantially equivalent to previous cleared devices and does not introduce any new safety risks. Substantial equivalence is based on equivalence in indications for use, intended use, patient contact, materials, design, function, performance, sterilization, and safety.

#### Non-Clinical Testing

Bench and animal performance testing to confirm functionality in the intended use and equivalence to predicate device is included.

## Clinical testing

Not applicable.

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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 stylized eagle with three stripes forming its body and wing. The eagle faces right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

SEP 2 1 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Pinyons Medical Technology, Incorporated C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street North West Buffalo, Minnesota 55313

Re: K072318

Trade/Device Name: PowrSyringe Injector Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: September 5, 2007 Received: September 6, 2007

Dear Mr. Job:

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. Job

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 yours.

Snute Y. Michine Ound.

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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# 4. Indication for Use Statement

510(k) Number:

K472318

Device Name:

PowrSyringe Injector

Indications for Use:

The PowrSyringe Injector is a piston syringe to inject fluids into, or aspirate fluids from, the body including use in angiography.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

Chas V. m

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: _ Kanall