(81 days)
Not Found
No
The document describes a mechanical device for accessing medication vials and does not mention any AI or ML components or functionalities.
No
The device is described as an access device for reconstituting or dispensing medication, rather than a device used for therapeutic treatment of a patient.
No
The device description states it is for reconstitution or dispensing of medications and does not mention any diagnostic capabilities.
No
The device description clearly states it is a "stand-alone, single use, multiple-dose device" with physical components like a valve and filter, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the reconstitution or dispensing of medication from vials. This is a process related to drug preparation and administration, not the diagnosis of a disease or condition using in vitro methods.
- Device Description: The description focuses on features for accessing vials and venting air, which are relevant to medication handling, not diagnostic testing.
- Lack of Diagnostic Language: The text does not mention any terms related to diagnostic testing, analyzing biological samples, or providing information for diagnosis.
IVD devices are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is entirely focused on the handling of medications.
N/A
Intended Use / Indications for Use
The SmartSite® Vented Vial Access Device is intended for use by healthcarc professionals in a wide variety of healthcare environments including hospitals, healthcare facilities, and pharmacies for reconstitution or dispensing of medication. The SmartSite® Vented Vial Access Device is indicated for use with rubber-stopper medication vials for reconstitution or dispensing of medications, including chemotherapy agents.
Product codes
LHI
Device Description
The SmartSite® Vented Vial Access Device (Vented VAD) is a stand-alone, single use, multiple-dose device with a SmartSite® Needle Free Valve and a 0.2 micron hydrophobic air-venting filter for use with rubber-stopper vials. The device is intended for use when reconstituting Ivophilized drugs and/or when dispensing medications, particularly hazardous drugs such as chemotherapeuties.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals in a wide variety of healthcare environments including hospitals, healthcare facilities, and pharmacies
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance data indicate that the SmartSite® Vented Vial Access Device meets specified requirements and is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
K052790
CARDINAL HEALTH, ALARIS PRODUCTS
DEC 2 3 2005 SUMMARY OF SAFETY AND EFFECTIVENESS Cardinal Health, Alaris Products® VENTED VIAL ACCESS DEVICE
SUBMITTER INFORMATION
| A. | Company Name: | Cardinal Health, Alaris Products |
|---|---|---|
| B. | Company Address: | 10221 Wateridge Circle |
| San Diego, CA 92121-2733 | ||
| C. | Company Phone: | |
| Company Fax: | (858) 458-7830 | |
| (858) 458-6114 | ||
| D. | Contact Person: | Stacy L. Lewis |
| Sr. Regulatory Affairs Specialist | ||
| Cardinal Health, Alaris Products | ||
| E. | Date Summary Prepared: | September 30, 2005 |
DEVICE IDENTIFICATION
| A. | Generic Device Name: | IV Fluid Transfer Pin |
|---|---|---|
| B. | Trade/Proprietary Name: | SmartSite® Vented Vial Access Device |
| C. | Classification: | Class II |
| D. | Product Code: | LHI |
DEVICE DESCRIPTION
The SmartSite® Vented Vial Access Device (Vented VAD) is a stand-alone, single use, multiple-dose device with a SmartSite® Needle Free Valve and a 0.2 micron hydrophobic air-venting filter for use with rubber-stopper vials. The device is intended for use when reconstituting Ivophilized drugs and/or when dispensing medications, particularly hazardous drugs such as chemotherapeuties.
1
CARDINAL HEALTH, ALARIS PRODUCT
Kosaэro
ORIGINAI
SUMMARY OF SAFETY AND EFFECTIVENESS Cardinal Health, Alaris Products® SmartSite® Vented Vial Access Device Page 2 of 2
SUBSTANTIAL EQUIVALENCE
The SmartSite® Vented Vial Access Device is of comparable type and is substantially
equivalent to the following predicate devices:
| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|---|---|---|---|
| Chemo Dispensing Pin | B. Braun | K983794 | 3/23/99 |
| SmartSite® Access Pin | Cardinal Health, Alaris | ||
| Products* | K970485 | 4/21/97 |
- Originally submitted by IVAC Holdings. Cardinal Health, Alaris Products was previously known as Alaris Medical Systems, which was the result of the merger of IVAC and IMEI) Corporation.
INTENDED USE
The SmartSite® Vented Vial Access Device is intended for use by healthcare professionals in a wide variety of healthcare environments including hospitals, healthcare facilities, and pharmacics when reconstituting lyophilized drugs and/or dispensing of medication, particularly hazardous drugs such as chemotherapeutics.
TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the SmartSite® Vented Vial Access Device and the predicate devices has been performed. The results of this comparison demonstrate that the SmartSite® Vented Vial Access Device is equivalent to the marketed predicate devices in technological characteristics.
PERFORMANCE DATA
The performance data indicate that the SmartSite® Vented Vial Access Device meets specified requirements and is substantially equivalent to the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Public Health Service
DEC 2 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Stacy L. Lewis Senior Regulatory Affairs Specialist Cardinal Health, Alaris® Products 10221 Wateridge Circle San Diego, California 92121-2772
Re: K052790
K032790
Trade/Device Name: SmartSite Vented Vial Access Device, Model TBD Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: September 30, 2005 Received: October 3, 2005
Dear Ms. Lewis:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 910(4) the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in indications for use stated in the enclosers, to engage of the Medical Device interstate commerce prior to that have been reclassified in accordance with the provisions of Amendments, on to devices that have occi results to not require approval of a premarket the Federal Pood, Drug, and Oosmette , to ecefore, market the device, subject to the general approval appreation (1 Mr.). Four general controls provisions of the Act include controls provisions of the Act. "The genting of devices, good 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 If your device is classified (see above) into enontrols. Existing major regulations afflecting a (PMA), it may be subject to such additions, Title 21, Parts 800 to 898. In your device can be found in the Sous of Internants concerning your device in the Federal Register
3
Page 2 - Ms. Lewis
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that PDA s issualled of a backanting with other requirements
mean that FDA has made a determination that your device for lieferal executes mean that FDA has made a decemmanon that your ministered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by segistration of the Act or any rederal statutes and reguirements, including, but not limited to: registration
You must comply with all the Act's requirements and securing programs and You must colliply with an the Act 3 requirements (21 CFR Part 801); good manufacturing practices
and listing (21 CFR Part 807); labeling (21 CFR Part 801); CFR Part 800); and and listing (21 CFR Part 607), laceling (21 cm (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your decise to a This letter will anow you to begin mailering your device of your device to a premarket notification. The PDA miding of substants of your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), if you desire specific advice for your device on and the Also, please note the regulation please contact the Office of Comphanes at (210) - 10 - 10 - 10 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 entitled, "Misoranding by reference to premained on your responsibilities under that the may obtain other general miormation on your respectiver Assistance at its toll-free DIVIsion of Sman Manufactors (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Syrita y. Mcclain Oatts
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/1 description: The image shows the text "K052790 page 1 of". The text "ORIGINAL PREMARKET 510(K) NOTIFICATION" is below the first line of text. The text "SMARTSITE VENTED VAD" is below the second line of text.
INDICATIONS FOR USE
510(k) Number:
(To Be Assigned By FDA)
Device Trade Name:
Indications For Use:
The SmartSite® Vented Vial Access Device is intended for use by healthcarc professionals in a wide variety of healthcare environments including hospitals, healthcare facilities, and pharmacies for reconstitution or dispensing of medication. The SmartSite® Vented Vial Access Device is indicated for use with rubber-stopper medication vials for reconstitution or dispensing of medications, including chemotherapy agents.
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ OR Prescription Use X (Per 21 CFR 801.109)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sohal Ahr for ADw 12/23/05