STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION

K973734 · Welcon, Inc. · JOL · Feb 5, 1998 · General Hospital

Device Facts

• Record ID: K973734
• Device Name: STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION
• Applicant: Welcon, Inc.
• Product Code: JOL · General Hospital
• Decision Date: Feb 5, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6740
• Device Class: Class 2

Indications for Use

The Welcon Sterile Water for Irrigation and Sterile 0.9% Normal Saline for irrigation are indicated for use in device irrigation procedures. The sterile water and saline are not indicated for injection.

Device Story

Welcon Sterile Water and Sterile 0.9% Normal Saline are single-use 4 oz. (120 ml.) plastic cups containing irrigation fluid; sealed with adhesive-backed foil lid. Intended for device irrigation; not for injection. Used in clinical settings to facilitate device cleaning or maintenance. No active components, electronics, or software.

Clinical Evidence

No clinical data. Bench testing only; USP bacterial endotoxin testing performed to verify conformance with USP requirements.

Technological Characteristics

Single-use 120 ml plastic cup with heat-sealed, adhesive-backed foil lid. Contains sterile water or 0.9% normal saline. No energy source, electronics, or software.

Indications for Use

Indicated for device irrigation procedures. Not indicated for injection. Patient population not specified.

Regulatory Classification

Identification

A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.

Predicate Devices

• Sterile Water for Irrigation (Catalog #5575) (K842166)
• Sterile 0.9% Saline for Irrigation (Catalog #5565) (K842166)

Submission Summary (Full Text)

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K973734

Sterile Water/Saline for

# 510(k) Summary

Pursuant to 512(i)(3)(A) of the Food, Drug and Cosmetic Act, Welcon, Inc. is required to submit with this Premarket Notification either an "... adequate summary of any information respecting safety and effectiveness or state that information will be made available upon request of any person." Welcon chooses to submit a summary of the safety and cffectiveness information. The summary is as follows:

| Trade Name: | Welcon Sterile Water for Device Irrigation<br>Welcon Sterile 0.9% Normal Saline for Device Irrigation |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Owner/Operator: | Welcon, Inc.<br>99 Hartford Avenue<br>Providence, RI 02909 |
| Distributed by: | Welcon, Inc.<br>303 Main Street, Suite 300<br>Fort Worth, TX 76102 |
| Manufacturing Site: | Intermed, Inc.<br>15 White Lake Road<br>Sparta, NJ 07871 |
| Device Generic Name: | Sterile water/sterile saline for device irrigation |
| Classification: | According to Section 513 of the Federal Food, Drug, and<br>Cosmetic Act, the device classification is Class II, Performance Standard<br>(79LWD). |
| Predicate Devices: | Sterile Water for Irrigation (Catalog #5575)<br>Intermed, Inc.<br>Sparta, New Jersey 07871<br>K842166<br>Sterile 0.9% Saline for Irrigation (Catalog #5565)<br>Intermed, Inc.<br>Sparta, New Jersey 07871<br>K842166 |

### Product Description:

The Welcon Sterile Water and Sterile 0.9% Normal Saline for Device Irrigation are individual, single-use 4 oz. (120 ml.) cups of fluid intended to be used for irrigation. The individual container consists of a plastic cup with a heat-sealed, adhesive-backed foil lid.

### Indications for Use:

The sterile water and sterile saline are indicated for device irrigation only.

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## Safety and Performance:

Substantial equivalence for these devices was based solely on design characteristics; no performance or safety data was included in this premarket notification. The materials, performance specifications and essential design characteristics of the Welcon devices are identical to those of the Intermed predicate devices. USP bacterial endotoxin testing was performed to verify that the sterile water and saline solutions conform with USP requirements.

### Conclusion:

Based on the indications for use, tochnological characteristics, and comparison to predicate devices, the Welcon Sterile Water and Sterile 0.9% Normal Saline for Device Irrigation have been shown to be safe and effective for its intended use.

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Image /page/2/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 its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 5 1998

Ms. Pamela Papineau C/O Delphi Medical Device Consulting Welcon, Incorporated 99 Hartford Avenue 02909 Providence, Rhode Island

K973734 Re : Sterile Water for Device Irrigation/Sterile Trade Name: 0.9% Saline for Device Irrigation Requlatory Class: II Product Code: JOL Dated: January 16, 1998 January 20, 1998 Received:

Dear Ms. Papineau:

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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 Reqister. Please note: this response to your premarket notification submission does

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Page 2 - Ms. Papineau

not affect any obligation you might have under sections 531 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 requlation (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.fdf.gov/cdrh/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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510(k) Number (if known):

Sterile Water for Irrigation/Sterile 0.9% Normal Saline for Device Name: Device Irrigation

Indications for Use:

The Welcon Sterile Water for Irrigation and Sterile 0.9% Normal Saline for irrigation are indicated for use in device irrigation procedures. The sterile water and saline are not indicated for injection.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Aner Nariani for PLC

(Division Sie Division of Den and Gene sral He 510(k) Number

Prescription Use (Per 21 CFR 801.109)

OR

Over-the -Counter Use ________________________________________________________________________________________________________________________________________________________

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