← Product Code [FOZ](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOZ) · K984590 # 0.9% SODIUM CHLORIDE FLUSH SYRINGE (K984590) _Baxter Healthcare Corp · FOZ · Oct 7, 1999 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOZ/K984590 ## Device Facts - **Applicant:** Baxter Healthcare Corp - **Product Code:** [FOZ](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOZ.md) - **Decision Date:** Oct 7, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5200 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## Indications for Use The device is intended for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices. ## Device Story Device consists of plastic syringes aseptically filled with sterile 0.9% sodium chloride solution. Used by clinicians to flush compatible intravenous tubing systems and indwelling intravascular access devices. Provides a ready-to-use sterile saline delivery system to maintain patency of vascular access devices. ## Clinical Evidence Bench testing only. Stability and container/closure suitability testing performed. Results indicate device meets or exceeds all functional requirements. ## Technological Characteristics Plastic syringe containing sterile 0.9% sodium chloride solution. Aseptically filled. Various sizes and fill volumes. ## Regulatory Identification An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials. ## Predicate Devices - Abbott prefilled syringe with 0.9% sodium chloride solution ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 984590 OCT 7 1999 510(k) Premarket Notification 0.9% Sodium Chloride Flush Syringe # 510(k) SUMMARY ## Submitted by: Marcia Marconi Baxter Healthcare Corporation I.V. Systems Division Rte. 120 and Wilson Road Round Lake, IL 60073 Date Prepared: December 24, 1998 ## Proposed Device: The proposed device consists of various sizes and fill volumes of plastic syringes aseptically filled with sterile 0.9% sodium chloride solution. ### Predicate Device: The predicate device is the Abbott prefilled syringe with 0.9% sodium chloride solution. ### Proposed Device Description: The proposed device consists of various sizes and fill volumes of plastic syringes aseptically filled with sterile 0.9% sodium chloride solution. ### Statement of Intended Use: The device is intended for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices. ## Summary of Technological Characteristics of New Device Compared to Predicate Devices The proposed device has the same technological characteristics as the predicate device. Both consist of plastic syringes containing sterile 0.9% sodium chloride solution. ### Discussion of Nonclinical Tests; Conclusions Drawn from Nonclinical Tests Test data have been generated for stability and container/closure suitability. Performance testing indicates that the proposed device meets or exceeds all functional requirements and supports its suitability for use. DEC 2 4 1998 {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract human profiles facing to the right, stacked on top of each other. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 7 1999 Ms. Marcia Marconi Vice President, Regulatory Affairs I.V. Systems Division Regulatory Affairs Baxter Healthcare Corporation Route 120 & Wilson Road Round Lake, Illinois 60073-0490 Re : K984590 0.9% Sodium Chloride Flush Syringe Trade Name: Regulatory Class: II Product Code: FOZ Dated: July 29, 1999 Received: August 2, 1999 Dear Ms. Marconi: 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, Druq, and Cosmetic Act (Act). 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, qood 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any {2}------------------------------------------------ Page 2 - Ms. Marconi 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 regulations. 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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.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 Radiological Health Enclosure {3}------------------------------------------------ 510(k) Premarket Notification 0.9% Sodium Chloride Flush Syringe Not Available 510(k) Number: 0.9% Sodium Chloride Flush Syringe Device Name: Indication for Use: The 0.9% Sodium Chloride Flush Syringe is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices. Palucca Crescent Prescription USE ✓ (Per 21 CFR 801.109) DEC 2 4 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOZ/K984590](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOZ/K984590) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com