(25 days)
No
The summary describes a mechanical device for accessing drug vials and makes no mention of AI or ML.
No
The device is described as an accessory for needleless access to drug vials, facilitating medication withdrawal, but it does not directly treat or diagnose a medical condition.
No
The device description states its purpose is for "needleless access to sterile drug vials" and "withdrawal of medications or other IV fluids." This describes a tool for administering or retrieving substances, not for diagnosing conditions or diseases.
No
The device description clearly states it is a "single use - universally adaptable and needleless drug container access disposable," indicating a physical, disposable hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Accessory to a piston syringe for needleless access to sterile drug vials without the use of needles." This describes a device used for accessing and transferring medications, which is a clinical procedure performed on a patient or for preparing medications for a patient.
- Device Description: The description reinforces this by stating it's for "withdrawal of medications or other IV fluids."
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition
- Being used in a laboratory setting for diagnostic purposes
The device is clearly intended for use in the preparation and administration of medications, which falls under the category of medical devices used in patient care, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Accessory to a piston syringe for needleless access to sterile drug vials without the use of needles.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The ICU Medical Universal Vial Access Device is a single use - universally adaptable and needleless drug container access disposable. The proprietary technology of the Clave enables the device to have a needleless port for withdrawal of medications or other IV fluids as directed by the physician.
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
Not Found
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)
ICU Medical Universal Vial Access Device conform to the requirements of published international standards as well as those FDA recognized standards and/or published guidelines prior to marketing the device. Additionally, ICU Medical's Sterility Assurance Level, (SAL) has an established and validated history of meeting the 10% level. These devices are be packaged in a way as to ensure conformity with that SAL level. The manufacturing of these devices will be assembled in a quality environment that is certified independently and complies with cGMPs.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
0
ICU MEDICAL INC. 4455 Atherton Drive Salt Lake City, Utah (801) 264 - 1332, Phone (801) 264 - 1755, Fax Tracy S. Best, Sr. Regulatory Affairs Specialist Preparation Date: April 04, 2008
ICU Medical, Inc.
MAY - 2 2008
SPECIAL 510(K) Summary of Safety and Effectiveness for the:
| Trade Name: | Universal Vial Access Device |
|---|---|
| Common Name: | Accessory to Piston Syringe, Needleless |
| Classification Name: | Piston Syringe, Accessory 21 CFR 880.5860, Class II Device |
| Product Code: | FMF |
Legally Marketed Predicate Devices for Substantial Equivalence:
*K934561 - One Time Vial Access - ICU Medical, Inc. *K934591 - Clave Vial Access Spike -- ICU Medical, Inc.
Rationale for SE:
These combo device is the vial access spike and the proprietary Clave® needleless access device. This device integrates the spike portion and the Clave with an improved clip that can adapt to all sizes of drug vials. A hydrophobic filter ensures airborne contaminates larger than 0.2um. There are no functional differences between any of the predicate devices or the proposed devices in terms of use.
Description of Submitted Device:
The ICU Medical Universal Vial Access Device is a single use - universally adaptable and needleless drug container access disposable. The proprietary technology of the Clave enables the device to have a needleless port for withdrawal of medications or other IV fluids as directed by the physician.
Intended Use:
Accessory to a piston syringe for needleless access to sterile drug vials without the use of needles.
Safety and Performance:
ICU Medical Universal Vial Access Device conform to the requirements of published international standards as well as those FDA recognized standards and/or published guidelines prior to marketing the device. Additionally, ICU Medical's Sterility Assurance Level, (SAL) has an established and validated history of meeting the 10% level. These devices are be packaged in a way as to ensure conformity with that SAL level. The manufacturing of these devices will be assembled in a quality environment that is certified independently and complies with cGMPs.
Conclusion:
The matcrials, performance, and operational features of both the submitted device and the predicate devices are substantially equivalent and safe and effective for their intended use.
1
Image /page/1/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally aligned. The text appears to be part of a document or sign.
Image /page/1/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Tracy Best Senior Regulatory Affairs Specialist ICU Medical, Incorporated 4455 Atherton Drive Salt Lake City, Utah 84123
Re: K080989
Trade/Device Name: ICU Medical Universal Vial Access Device Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: April 4, 2008 Received: April 7, 2008
Dear Ms. Best:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
MAY - 2 2008
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 - Ms. Best
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clus
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
3
Indications for Use
510(k) Number (if known):
Device Name:
ICU Medical Universal Vial Access Device
Indications for Use:
Accessory to a piston syringe for needleless access to sterile drug vials without the use of needles.
Prescription Use _ XX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jas all fin AD
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital Division Control, Dental Devices
510(k) Number: K080989