PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND

K030813 · Primary Care Solutions, Inc. · EZL · May 30, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K030813
• Device Name: PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND
• Applicant: Primary Care Solutions, Inc.
• Product Code: EZL · Gastroenterology, Urology
• Decision Date: May 30, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2

Indications for Use

The 10cc and 30cc pre-filled syringes are intended to be used for foley catheter balloon inflation. The intended use of the device is identical to that of the predicate device and other similar devices in the market. The syringe is employed by connecting the syringe tip to the valve on the side arm of foley catheter and forcing sterile water through a lumen into the balloon for inflation.

Device Story

Device consists of 10cc or 30cc syringe pre-filled with USP purified water; gamma irradiated. Used by clinicians to inflate foley catheter balloons by connecting syringe tip to catheter side-arm valve and injecting sterile water. Facilitates secure catheter placement. Simple manual operation; no electronic or automated components.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Materials: Polypropylene (barrel/plunger), pharmaceutical grade latex-free rubber (gasket/tip cover). Contents: USP purified water. Sterilization: Gamma irradiation. Form factor: 10cc and 30cc manual syringes. No energy source, software, or connectivity.

Indications for Use

Indicated for inflation of foley catheter balloons in patients requiring catheterization.

Regulatory Classification

Identification

A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

Predicate Devices

• Pre-Filled 10cc Inflation Syringe with Sterile Water (K943836)

Submission Summary (Full Text)

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## 人030813

,

## MAY 3 0 2003

## PRIMARY CARE SOLUTIONS, INC 510(K) SUMMARY

| Applicant Name/Address | PRIMARY CARE SOLUTIONS, INC.<br>40420 Free Fall Ave.<br>Zephyrhills, FL 33542 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Ron Maddix<br>Vice President, Marketing & Sales |
| Phone:<br>Fax: | 813-779-7226<br>813-715-4084 |
| Trade Name: | Primary Care Solutions Prefilled 10cc and Prefilled 30cc<br>Inflation Syringes with Sterile Water<br>Catalog numbers 1010 and 1030 respectively |
| Establishment Reg. No. | 1066336 |
| Manufacturing Facility: | PRIMARY CARE SOLUTIONS, INC<br>40420 Free Fall Ave.<br>Zephyrhills, FL 33542 |
| Sterilization Facility: | FOOD TECHnology Service, Inc.<br>502 Prairie Mine Road<br>Mulberry, FL 33860 |
| Classification Name: | Syringe, Balloon Inflation |
| Class: | II |
| Reason for Application: | New Devices to Primary Care Solutions, Inc. |
| Predicate Devices: | K943836 - Pre-Filled 10cc Inflation Syringe with Sterile<br>Water<br>Orion Medical Products, Inc.<br>Wheeling, IL 60090 |
| Device Description | The device is a 10cc and 30cc syringe pre-filled with<br>USP purified water and gamma irradiated. The syringe<br>is produced using polypropylene for the device barrel<br>and plunger and pharmaceutical grade latex free rubber for<br>both the plunger gasket and syringe tip cover. |
| Intended Device Use: | The 10cc and 30cc pre-filled syringes are intended to be<br>used for foley catheter balloon inflation. The intended use<br>of the device is identical to that of the predicate device and<br>other similar devices in the market. The syringe is employed<br>by connecting the syringe tip to the valve on the side arm of<br>foley catheter and forcing sterile water through a lumen into<br>the balloon for inflation. |

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Material Comparison to Predicate Device: The predicate device contains exactly the same material components as the pre-market notice subject device as indicated in the device description summary above. :

Compliance with special controls: No applicable mandatory performance standards or special controls exist for these devices.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 3 0 2003

Mr. Ron Maddix Vice President, Marketing & Sales Primary Care Solutions, Incorporated 40420 Free Fall Avenue Zephyrhills, Florida 33542

Re: K030813

Trade/Device Name: Primary Care Solutions Pre-Filled 10cc and Pre-Filled 30cc Balloon Inflation Syringe with Sterile Water Regulation Number: 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZL Dated: March 4, 2003 Received: March 14, 2003

Dear Mr. Maddix:

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. Maddix

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 (OS) 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,

Susan Rusine

Susan Runner, DDS, MA Interim 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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Page_ of

510(K) Number: K030813

Device Name: Primary Care Solutions Pre-Filled 10cc and Pre-Filled 30cc Balloon Inflation Syringe with Sterile Water

Indications For Use: A sterile water pre-filled syringe for use in inflating foley catheter balloon

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

Evaluation (ODE)

Concurrence of CDRH, Office of Device

.

Patua Cucurite

Infecti

510(k) Number. *K050813*