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 Description

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

AI/ML Overview

The provided document, K051370, is a 510(k) premarket notification for "Sterile Water for Device Care" and "Sterile Saline for Device Care." This is a regulatory submission for medical devices, specifically for irrigation and flushing solutions. As such, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of AI/software performance metrics (like accuracy, sensitivity, specificity) is not applicable here.

Instead, the "acceptance criteria" for such a device are related to demonstrating substantial equivalence to a legally marketed predicate device, focusing on material composition, manufacturing processes, sterility, and intended use. The "study" that proves the device meets these criteria is typically a demonstration of equivalence through non-clinical tests (e.g., biocompatibility testing, stability testing, sterility testing, chemical characterization), rather than a clinical trial or a performance study with human readers or AI algorithms.

Here's a breakdown of the relevant information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

As this is not a performance study for an AI or diagnostic device, a direct table of statistical acceptance criteria and reported device performance (e.g., sensitivity, specificity) is not relevant. Instead, the "acceptance criteria" revolve around demonstrating equivalence to predicate devices in terms of:

Acceptance Criterion	Reported Performance / Equivalence Justification
Intended Use	Indicated for irrigation and flushing of medical devices, identical to predicate devices.
Technological Characteristics	Sterile Saline for Device Care is the existing Baxter Sterile Saline for Catheter Care with only a name change. Sterile Water for Device Care is the same as Sterile Saline for Catheter Care except for the solution (sterile water instead of saline). The container-closure system, plastic materials, and sterilization are identical to marketed Baxter Sterile Saline for Catheter Care products.
Safety and Effectiveness	"There are no new issues of safety or effectiveness" compared to the predicate devices.
Sterility	Implied by the name "Sterile Water/Saline" and the identical sterilization process to the predicate. Specific sterility test results are not detailed in this summary but would be part of the full submission.
Biocompatibility	Implied by the use of existing materials and container systems from the predicate device. Specific biocompatibility test results are not detailed but would be part of the full submission.

2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This device is a sterile solution, not an AI or diagnostic device that uses a "test set" of data for performance evaluation in the traditional sense.

3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Ground truth in the context of AI or diagnostic imaging is irrelevant for this type of device.

4. Adjudication Method for the Test Set
Not applicable.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a diagnostic device or a device involving human interpretation, so MRMC studies are irrelevant.

6. Standalone (Algorithm only without human-in-the-loop performance) Study
Not applicable. This is not an algorithm or AI device.

7. Type of Ground Truth Used
Not applicable.

8. Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device.

9. How the Ground Truth for the Training Set was Established
Not applicable.

Study Proving Device Meets Acceptance Criteria:

The "study" in this context is the 510(k) Premarket Notification process itself, which involves providing documentation demonstrating substantial equivalence to predicate devices.

The document states:

"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."
"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."
"There are no new issues of safety or effectiveness."

These statements constitute the manufacturer's rationale and evidence that the proposed devices are substantially equivalent to the predicate devices and therefore meet the safety and effectiveness requirements. The FDA's issuance of the 510(k) clearance signifies their agreement with this assessment, based on the nonclinical tests and data submitted (which are not fully detailed in this summary document but would have been part of the complete submission).

In summary, for this type of device, the "acceptance criteria" are regulatory benchmarks for substantial equivalence and the "study" is the comprehensive documentation and testing (non-clinical) provided to the FDA to demonstrate that equivalence.

Summary

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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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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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510(k) Number: < 4 \ 1 ? = 16

Baxter Confidential

Regulation Number and Section

§ 880.6740 Vacuum-powered body fluid suction apparatus.

(a)
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).(b)
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.