VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES

K031748 · Vitalcare Group, Inc. · EZL · Aug 27, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K031748
• Device Name: VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES
• Applicant: Vitalcare Group, Inc.
• Product Code: EZL · Gastroenterology, Urology
• Decision Date: Aug 27, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2

Indications for Use

Sterile water and 0.9% Sodium Chloride pre-filled syringes are intended to be used for catheter balloon inflation. The devices are not intended to be used for wound irrigation or IV administration.

Device Story

Pre-filled inflation syringes containing sterile water or 0.9% sodium chloride; used for catheter balloon inflation. Syringes manufactured from medical-grade polypropylene with Santoprene rubber; gamma-irradiated for single use. No preservatives or additives. Operated by clinicians in hospital settings. Device provides controlled volume for balloon inflation; ensures sterility and convenience compared to manual filling. Not for injection or irrigation.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: 100% medical-grade polypropylene, Santoprene rubber. Form factor: 10cc and 30cc pre-filled syringes. Sterilization: Gamma irradiation. Single-use. No preservatives or additives.

Indications for Use

Indicated for catheter balloon inflation. Not for wound irrigation, injection, or IV administration.

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

• Orion Life Systems- Sterile Water and 0.9% 10cc pre-filled inflation syringes

Submission Summary (Full Text)

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AUG 2 7 2003

K031748

### 510(k) Summary

Submitter:

VitalCare Group Inc. 8935 NW 27th Street Miami Fl. 33172

Contact:

Michael McAvenia Director of Quality Assurance [phone] Fax: [phone] Internet: [e-mail]

Name of Device: VitalCare Sterile Water and .09% Saline 10cc, 30cc pre-filled inflation syringes.

Predicate Device: Orion Life Systems- Sterile Water and 0.9% 10cc pre-filled inflation syringes.

Description of the New Device: Sterile Water and 0.9% Sodium Chloride are products that have been used in the medical community for decades, the only ingredient in the two solutions other than water is Sodium Chloride; there are no preservatives or stabilizers. The syringes are manufactured from 100% medical grade polypropylene and contain no color or preservatives or additives.

The containers are filled with distilled water and distilled saline solution, sealed, capped and gamma irradiated for single use only.

The Sterile Water and Saline Solutions pre-filled syringes are substantially equivalent to Orion Life Systems. Sterile Water and Saline Solutions pre-filled syringes in that:

- The intended use is the same -
- -The performance attributes are the same

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#### Intended Use of the New Device:

Sterile water and 0.9% Sodium Chloride pre-filled syringes are intended to be used for catheter balloon inflation. The devices are not intended to be used for wound irrigation or IV administration.

#### Comparison of the Technological Features of the New Device and Predicate Device:

The new device features and predicate device features are similar. The components and contents of the containers are similar.

| Feature\Claim | VitalCare Group Inc. Sterile<br>Water - 0.9% Saline Solution | Orion Life Systems Sterile Water -<br>0.9% Saline Solution |
|---------------|-----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Contents | Sterile Water\0.9% Sodium<br>Chloride. | Similar |
| Labeling | Sterile Water\Saline 10cc\30cc<br>syringes. For Balloon Inflation.<br>Not for injection. No antimicrobial<br>or other substances added. | Similar |
| Materials | Polypropylene, Santoprene rubber | Similar |

### Device Common and Classification Name(s):

Inflation Syringe. Common Name: Classification Name: Syringe, Balloon Inflation

# Classification Information:

| Class: | Class II |
|---------------|------------------|
| Panel: | General Hospital |
| Product Code: | JOL |
| Cite: | 880 |

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a bird or a stylized human figure with outstretched arms. The symbol is composed of three curved lines that converge at the center.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 7 2003

Mr. Michael Mcavenia Director of Quality Assurance VitalCare Group, Incorporation 8935 N.W. 27th Street Miami, Florida 33172

Re: K031748

Trade/Device Name: VitalCare Sterile Water and 0.9% Saline 10cc, 30cc Pre-Filled Inflation Syringe Regulation Number: 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZL Dated: April 16, 2003 Received: June 13, 2003

Dear Mr. Mcavenia:

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 vour 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. Mcavenia

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 vours.

Suser Kunne

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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## INDICATIONS FOR USE

510(k) Number: K031748

Device Name:

Indications for Use:

VitalCare Sterile Water and 0.9% Sodium Chloride Pre-Filled Syringes.

VitalCare Sterile Water and 0.9% Sodium Chloride. The10cc/30cc syringes are used for balloon inflation. Devices are not intended for wound irrigation, injection or IV Administration.

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

or Over-The Counter Use

Petrea Cucurite
(Division Sign Off)

ion of Anesthesiology, General Hospital, Infection Control. Dental Devices

**510(k) Number:** K031748