← Product Code [FPA](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA) · K961928 # BIOMEDIX I.V. EXTENSION LINE W/ STOPCOCK MODEL B50-102/B51-102 (K961928) _Biomedix, Inc. · FPA · Sep 16, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K961928 ## Device Facts - **Applicant:** Biomedix, Inc. - **Product Code:** [FPA](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA.md) - **Decision Date:** Sep 16, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5440 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Therapeutic ## Indications for Use This product would be used by Nurses and Paramedics in prehospital, emergency room and field situations. ## Device Story I.V. Extension with Stopcock facilitates intravenous fluid/drug administration; provides extra length between I.V. supply and patient; includes four-way stopcock for fluid source selection; features slip-type clamp to prevent backflow/dilution. Used by nurses and paramedics in prehospital, emergency room, and field settings. Available in two models: standard needle-type injection site or blunt cannula (needleless) injection site. Device connects to primary I.V. set to allow direct injection at patient catheter site. ## Clinical Evidence No clinical data. Bench testing only. ## Technological Characteristics I.V. extension line assembly with four-way stopcock. Features include threaded and/or slip luer connections, 3.75 mL capacity, and 0.114" I.D. tubing. Available with needle-type or blunt cannula (needleless) injection sites. Includes slip-type tubing clamp. Construction utilizes commercially available components similar to existing I.V. sets. ## Regulatory Identification An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container. ## Special Controls *Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9. ## Predicate Devices - Baxter PHARMASEAL K52 NOVEX Three-Way Stopcock with Extension Tube (K52) - Medex Extension Set - McGaw G0719 I.V. Extension Set - McGaw G0726 I.V. Extension Set - McGaw G0716 I.V. Extension Set ## 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} BIOMEDIX quality medical products K961928 SEP 16 1996 TO: Food and Drug Administration Center for Devices and Radiological Health (HFZ-401) 9200 Corporate Blvd. Rockville, MD 20850 FROM: Daniel J. Dyar, President DATE: May 17, 1996 (Revised June 11, 1996) SUBJECT: 510 K Summary TRADE NAME: I.V. Extension with Stopcock. COMMON NAME: I.V. Extension CLASSIFICATION NAME: [ 880.5440 ] Intravascular Administration Set SUBSTANTIALLY EQUIVALENT TO: Biomedix, Inc. claims substantial equivalence regarding this design of the I.V. Extension Line Assembly with Stopcock as follows: Products currently on the market include: Baxter PHARMASEAL K52 NOVEX Three-Way Stopcock with Extension Tube. ( Sterile, For Single Use Only, Capacity 2.3 mL, Length 50.8 cm. Blue Protector covers Male Adapter. ) Medex Extension Set - 12" Extension with "Y" Injection Site. McGaw - G0719 I.V. Extension Set, Female and Needle Adapter, Vol. 3 mL., Length 21" G0726 I.V. Extension Set with (2) Injection Sites, Vol. 6 mL., Length 33" G0716 I.V. Extension Set with (2) Injection Sites with check valve and flashtube., Vol. 6 mL., Length 34" PAGE 15 45 South Main Street P.O. Box 231 Spencer, Indiana 47460 800-627-2765 812-829-9667 FAX: 812-829-9650 {1} 510 K SUMMARY ( CONTINUED ) DESIGN COMPARISONS: | COMPONENT | BIOMEDIX | BAXTER K52 | MEDEX EXTENSION SET | | --- | --- | --- | --- | | Stopcock | All 3 ports include both threaded and / or slip luer connections. | ( 1 ) Port has removeable needle injection site. ( 2 ) remaining ports have slip luer conn. only. | ( 1 ) Y - Port for Sharps Devices. | | Capacity | 3.75 ml. | 2.3 ml. | N/A | | Tubing | .114 +/- .002" I.D. | .088-.090" I.D. | N/A | | Connections | Choice of Needle or Blunt Cannula Y-Site with Male Slip Luer Connector. | Male Slip Luer Connector Only. | Male Slip Luer Connector Only. | The Biomedix design allows injection of solutions directly at the Patient I.V. Catheter. A slip-type clamp on the tubing portion of the I.V. Extension Line allows the line to be shut-off preventing backflow and/or dilution of administered fluids away from the patient. DESCRIPTION: The I.V. Extension Line Assembly with Stopcock is attached to the Primary I.V. to facilitate two advantages. One, is to add extra length between the I.V. Supply and the Patient. A second, is to provide additional supply ports for the administration of alternate solutions and special drugs that are administered intravenously. A four-way stopcock offers selection of the fluid types and sources. Biomedix is offering two models, one with a standard Needle-Type Injection Site at the Outlet and a second with a Blunt Cannula (Needleless) Type Injection Site at the outlet. INTENDED USE: This product would be used by Nurses and Paramedics in prehospital, emergency room and field situations. PAGE 16 {2} 510 K SUMMARY ( CONTINUED ) ## SUMMARY OF DEVICE COMPARISONS: Basic construction of both Biomedix and Competitive Products of this type are of commercially available components. Biomedix already employs a process and construction similar to this in their existing Selec-3 Primary I.V. Set. Sincerely, ![img-0.jpeg](img-0.jpeg) Daniel J. Dyar President Biomedix, Inc. PAGE 16a --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K961928](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K961928) **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