(110 days)
- For aspiration or iniection of medical from inverted multidose vials and bags
- For use as part of a program to reduce the occurrence of needle stick injuries and the associated transmission of blood bome pathogens such as HIV and HBV.
- For use up to 24 hours, or in accordance with current guidelines of IV therapy.
- For use with standard luer taper connections.
- For singe patient use.
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 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.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or a study that employs AI or machine learning.
The document describes a medical device called "CDC Vial and Bag Access Pins," its features, intended use, and a nonclinical test summary concerning biocompatibility. It concludes by stating the device's safety, effectiveness, and substantial equivalence to a legally marketed predicate device.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving a device meets them, especially with components related to AI, machine learning, expert reviews, or comparative effectiveness studies.
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Image /page/0/Picture/1 description: The image shows the logo for Critical Device Corporation. The logo includes the company name in a bold, sans-serif font, with the words stacked on top of each other. Below the logo is the company's address, which is 499 Nibus Street, Brea, CA 92821.
APR - 2 1997
510(k) Summary
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نير .. . . . .
| 1. Submitter: | Critical Device Corporation499 Nibus StreetBrea, CA 92821Tel: 714-257-2197 or 800-321-6462Fax: 800-299-4849 |
|---|---|
| 2. Contact: | Dan Hyun, PresidentCritical 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) 32 I-NIMA · · Phone (7 1 4) 257-2 1 97 · · Fax (800) 299-4849
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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:
- For aspiration or iniection of medical from inverted multidose vials ਰ. and bags
- b. For use as part of a program to reduce the occurrence of needle stick injuries and the associated transmission of blood bome pathogens such as HIV and HBV.
- For use up to 24 hours, or in accordance with current guidelines of IV C. therapy.
- For use with standard luer taper connections. ರ
- e. For singe patient use.
- க். 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.
ക് 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.
§ 880.5440 Intravascular administration set.
(a)
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.(b)
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.