(78 days)
Not Found
Not Found
No
The device is sterile water and saline for irrigation, with no mention of AI/ML in the description or intended use.
No.
The device is indicated for irrigation and flushing of medical devices, not for therapeutic intervention in patients.
No
Explanation: The device is described as "Sterile Water for Device Care and Sterile Saline for Device Care" indicated for "irrigation and flushing of medical devices." This function is for device maintenance, not for diagnosing medical conditions.
No
The device description clearly states it is "Sterile Water for Device Care and Sterile Saline for Device Care in 250 mL plastic containers," indicating a physical product (liquids in containers), not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "irrigation and flushing of medical devices." This is an external application to devices, not for testing samples taken from the human body.
- Device Description: The description confirms it's sterile water and saline in containers for single use, consistent with irrigation solutions.
- Lack of IVD Characteristics: The provided text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health
- Using reagents or assays
Therefore, based on the information given, this device falls under the category of a medical device used for device care, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JOL
Device Description
Sterile Water for Device Care and Sterile Saline for Device Care in 250 mL plastic containers for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
Image /page/1/Picture/1 description: The image shows a logo with a circular border containing text, though the text is too blurry to read. Inside the circle is a stylized symbol resembling three curved lines stacked vertically, possibly representing a bird or a similar abstract design. The logo is in black and white.
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.
2
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
3
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
Page 1 of 1 __________________________________________________________________________________________________________________________________________________________________
510(k) Number: