(110 days)
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No
The device description and intended use focus on mechanical components for accessing vials and bags, with no mention of AI or ML capabilities.
No.
The device description and intended use indicate it is an accessory for accessing vials and bags, primarily for medication aspiration/injection and reducing needle stick injuries, rather than directly treating a medical condition or disease.
No
This device is described as an access pin for vials and bags, facilitating the aspiration or injection of medical contents. Its primary function is to prevent needle stick injuries and allow access to medication, not to diagnose medical conditions or analyze patient data.
No
The device description clearly describes a physical adapter (pins) that pierce vials and bags, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for accessing and transferring medical substances from vials and bags, primarily for injection or aspiration. This is a function related to drug delivery and patient care, not the examination of specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a mechanical adapter for piercing vials and bags, with features like luer connections and an air vent. These are components related to fluid handling and access, not diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The device's function is purely mechanical access and transfer.
- Predicate Device: The predicate device listed is a "Needle-Free Dispensing Pin," which aligns with the described function of accessing and dispensing substances, not performing in vitro diagnostic tests.
In summary, the device's purpose and design are focused on accessing and handling medical substances for patient treatment, not on performing diagnostic tests on biological specimens.
N/A
Intended Use / Indications for Use
- 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 C. therapy.
- For use with standard luer taper connections.
- For singe patient use.
Product codes
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Device 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 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.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Needle-Free Dispensing Pin, Burron Medical Inc.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
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
・・。
نير .. . . . .
| 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) 32 I-NIMA · · Phone (7 1 4) 257-2 1 97 · · Fax (800) 299-4849
1
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.