STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014

K051370 · Baxter Healthcare Corp · JOL · Aug 12, 2005 · General Hospital

Device Facts

• Record ID: K051370
• Device Name: STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014
• Applicant: Baxter Healthcare Corp
• Product Code: JOL · General Hospital
• Decision Date: Aug 12, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6740
• Device Class: Class 2

Indications for Use

Baxter Sterile Water for Device Care and Sterile Saline for Device Care are indicated for irrigation and flushing of medical devices. Baxter Sterile Water for Device Care and Sterile Saline for Device Care are not indicated for intravascular injection.

Device Story

Sterile Water for Device Care and Sterile Saline for Device Care are single-use, 250 mL plastic containers containing sterile water or sterile saline. Used for irrigation and flushing of medical devices. Intended for prescription use. The device provides a sterile medium for cleaning or clearing medical devices; it does not involve complex processing, algorithms, or software.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Single-use 250 mL plastic containers. Sterile water or sterile saline solution. Sterilization method consistent with existing marketed Baxter products. No software, electronics, or complex sensing mechanisms.

Indications for Use

Indicated for irrigation and flushing of medical devices. Not indicated for intravascular injection.

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

• Baxter Sterile Saline for Catheter Care
• Welcon Sterile Water for Device Irrigation

Submission Summary (Full Text)

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K051370

510(k) Premarket Notification Sterile Water for Device Care Sterile Saline for Device Care

AUG 1 2 2005

### 510(k) SUMMARY

#### Submitted by:

Nanette Hedden Project Manager, Global Regulatory Affairs Baxter Healthcare Corporation 1620 Waukegan Road McGaw Park, IL 60085

Date Prepared: May 23, 2005

Proposed Device: Sterile Water for Device Care Sterile Saline for Device Care

## Predicate Device:

Baxter Sterile Saline for Catheter Care, Welcon Sterile Water for Device Irrigation.

#### Proposed Device Description:

Sterile Water for Device Care and Sterile Saline for Device Care in 250 mL plastic containers for single use.

#### Indication for Use:

Baxter Sterile Water for Device Care and Sterile Saline for Device Care are indicated for irrigation and flushing of medical devices.

#### Summary of Technological Characteristics of New Device to Predicate Devices

The proposed Sterile Saline for Device Care is the existing Baxter Sterile Saline for Catheter Care. Only the name is changed. The Sterile Water for Device Care is the same as Sterile Saline for Catheter Care except for the solution, which is sterile water instead of saline. The container-closure system, plastic materials, and sterilization are the same as those used in marketed Baxter Sterile Saline for Catheter Care products.

#### Discussion of Nonclinical Tests; Conclusions Drawn from Nonclinical Tests

The subjects of this submission are a name change for a previously cleared medical device and the addition of Sterile Water for Device Care to the product line. There are no new issues of safety or effectiveness.

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AUG 1 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Nanette Hedden Project Manager, Global Regulatory Affairs Baxter Healthcare Corporation 1620 Waukegan Road, MPGR-AL McGaw Park, Illinois 60085

Re: K051370

Trade/Device Name: Sterile Saline for Device Care, Sterile Water for Device Care Regulation Number: 21 CFR 880.6740 Regulation Name: Catheter And Tip Suction Regulatory Class: II Product Code: JOL Dated: May 24, 2005 Received: May 26, 2005

Dear Ms. Hedden:

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 - Ms. Hedden

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 and insting (2) 22 x 1 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,

Sapitte y. Michael Davis

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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510(k) Premarket Notification Sterile Water for Device Care Sterile Saline for Device Carc

# Indications for Use

510(k) Number (if known): K051370

Device Name: Sterile Water for Device Care, Sterile Saline for Device Care

Indications For Use: Baxter Sterile Water for Device Care and Sterile Saline for Device Care are indicated for irrigation and flushing of medical devices.

Baxter Sterile Water for Device Care and Sterile Saline for Device Care are not indicated for intravascular injection.

Over-The-Counter Use _______ (Part AND/OR Prescription Use X 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chis

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

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