← Product Code [LHI](/productcode/LHI) · K964989 # CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5) (K964989) _Critical Device Corp. · LHI · Apr 2, 1997 · General Hospital · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K964989 ## Device Facts - **Applicant:** Critical Device Corp. - **Product Code:** [LHI](/productcode/LHI.md) - **Decision Date:** Apr 2, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5440 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## Indications for Use a. For aspiration or injection of medical from inverted multidose vials and bags b. For use as part of a program to reduce the occurrence of needle stick injuries and the associated transmission of blood borne pathogens such as HIV and HBV. c. For use up to 24 hours, or in accordance with current guidelines of IV therapy. d. For use with standard luer taper connections. e. For single patient use. ## Device Story CDC Vial and Bag Access Pins are needle-free adapters designed to pierce rubber stoppers of drug vials or bags. Devices feature spikes (1.5" or 2.5"), female luer locks, 0.45-micron filtered vents, and optional two-way check valves or extension lines. Operated by clinicians to aspirate or inject medication from inverted containers. Vents remove air/particulates; check valves/extension lines prevent medication loss. Used to minimize needle stick injuries and blood-borne pathogen transmission (HIV/HBV). Provided sterile and non-pyrogenic for single-patient use. ## Clinical Evidence Bench testing only. Biocompatibility testing performed; C3a levels were statistically higher than untreated plasma control but below positive control and showed no statistical difference compared to a similar marketed IV set. ## Technological Characteristics Spike-based access adapters with female luer locks. Features include 0.45-micron filtered vents, two-way check valves, and extension lines. Materials consistent with predicate device. Sterile, non-pyrogenic, single-use. ## 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 - Needle-Free Dispensing Pin, Burron Medical Inc. ## 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} K 964989 499 Nibus Street • Brea • CA • 92821 APR - 2 1997 # 510(k) Summary 1. Submitter: Critical Device Corporation 499 Nibus Street Brea, CA 92821 Tel: 714-257-2197 or 800-321-6462 Fax: 800-299-4849 2. Contact: Dan Hyun, President Critical Device Corporation 3. Date prepared: December 10, 1996 4. Device trade name: CDC Vial and Bag Access Pins Model numbers: CDC-P-1 1½" spike with female luer lock and 0.45 micron filtered vent CDC-P-2 1½" spike with female luer lock, two-way check valve, and 0.45 micron filtered vent CDC-P-3 2½" spike with female luer lock and 0.45 micron filtered vent CDC-P-4 2½" spike with female luer lock, two-way check valve, and 0.45 micron filtered vent CDC-P-5 2½" spike with extension line, female luer lock, and 0.45 micron filtered vent Common name: Intravenous (IV) Sets Accessory 5. Predicate device: Needle-Free Dispensing Pin, Burron Medical Inc. | CDC catalog number | corresponding BMI product number | | --- | --- | | CDC-P-1 | DP -1000 | | CDC-P-2 | DP -1500 | | CDC-P-3 | DP -2001 | | CDC-P-4 | DP -2500 | | CDC-P-5 | DPL-2500 | 6. Description: The CDC Vial and Bag Access Pin are adapters which pierce a rubber stoppered drug vial and/or bag and allows access to the contents. The CDC Vial and Bag Access Pins will be available with and without a 2-way luer activated check valve or with an extension line. The luer activated check valve or Toll Free (800) 321-NIMA • Phone (714) 257-2197 • Fax (800) 299-4849 {1} Critical Device Corporation 510(k) Summary Page 2 of 2 extension line is used to prevent loss of medication during aspiration or injection from inverted vials or bags. The 0.45 micron air vent is used to eliminate air and particulates in the vial or bag contents during aspiration. The CDC Vial and Bag Access Pin are provided sterile and non-pyrogenic in sealed single unit pouches. 7. Intended Use: a. For aspiration or injection of medical from inverted multidose vials and bags b. For use as part of a program to reduce the occurrence of needle stick injuries and the associated transmission of blood borne pathogens such as HIV and HBV. c. For use up to 24 hours, or in accordance with current guidelines of IV therapy. d. For use with standard luer taper connections. e. For single patient use. 8. Technological Comparison to predicate device: The CDC Vial and Bag Access Pin design has essentially the same component materials and material source as the predicate Burron Medical Dispensing Pin. The non-shared assembly process and components of the protective end caps, tubing, and packaging are all currently qualified for product of other Critical Device Corporation product. 9. Nonclinical test summary: Biocompatibility testing demonstrated compatibility with guidance standards except a statistically significant C3a compared to the untreated plasma control, though well below the activation of the positive control. The observed level of C3a is considered typical of this type of device (IV sets). There was however no statistical difference of C3a when evaluated against a similar marketed IV set. 10. Conclusion: The CDC Vial and Bag Access Pins have demonstrated safety and effectiveness and are substantially equivalent to the legally marketed predicate device. 2-4 --- **Source:** [https://fda-staging.innolitics.com/device/K964989](https://fda-staging.innolitics.com/device/K964989) **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