(152 days)
No
The device description and intended use are for a simple mechanical component (universal spikes) used in IV administration sets. There is no mention of any computational or analytical capabilities, let alone AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No
The device, Universal Spikes, are used to build Intravascular Administration Sets. These sets provide access for administering fluids to a patient's vascular system. While they are part of a medical procedure, their primary function is to facilitate fluid delivery, not to directly treat a disease or condition therapeutically. Their purpose is supportive (administration of fluids), not curative or diagnostic.
No
The device, Universal Spikes, is used to build Intravascular Administration Sets for administering fluids to a patient's vascular system. Its function is drug/fluid delivery, not diagnosis.
No
The device description clearly states it is a physical device ("Universal Spikes are used to build Intravascular Administration Sets") and mentions components and assembly, indicating hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Universal Spikes are used to build Intravascular Administration Sets for the administration of fluids to a patient's vascular system. This is a direct interaction with the patient's body for therapeutic or supportive purposes.
- Device Description: The description reinforces this by explaining how the sets provide access to the patient's vascular system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is used inside the body for fluid delivery.
N/A
Intended Use / Indications for Use
Universal Spikes are used to build Intravascular Administration Sets which are Single Use, sterile, non- pyrogenic device and provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter inserted into a vein.
Product codes
FMG
Device Description
Universal Spikes are used to build Intravascular Administration Sets which are Single Use, sterile, non- pyrogenic device and provides access for the administration of fluids from a controliner to a patient's vascular system through the administration set's needle or catheter inserted into a ven. Each set will be manufactured to unique specifications using dimensions, components, and configurations specified by the customer. Standard sets will also be offered. Components used in the IV sets may be either manufactured by ICU medical or purchased from other manufacturers. Components will be assembled into configurations specified by the customer and packaged.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's vascular system
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 Single-Use Spikes 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 history
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
Image /page/0/Picture/0 description: The image shows a handwritten text that reads "K08 283.6 1 of 2". The text appears to be a label or identifier, possibly for a document or item. The handwriting is clear and legible, with distinct characters and spacing. The phrase "1 of 2" suggests that this is part of a series or set of two items.
ICU MEDICAL INC.
4455 Atherton Drive Salt Lake City, Utah (801) 264 - 1410, Phone (801) 264 - 1755, Fax Niloufar Samimi, Regulatory Affairs Specialist Preparation Date: February 23, 2009
FEB 2 5 2009
Special 510(K) Summary of Safety and Effectiveness for the:
Trade Name: Universal Single-Use Spikes
Common Name: Set IV, Fluid transfer
Classification Name: Set IV, Fluid transfer, 21 CFR 880.5440, Class II Device
Legally Marketed Predicate Devices for Substantial Equivalence:
K964435- IV Sets- ICU Medical, Inc.
Rationale for SE:
Spikes in this submission have a same intended use and materials as predicate device. Therefore, ICU Medical believes they are substantially equivalent to the predicate device.
Description of Submitted Device:
Universal Spikes are used to build Intravascular Administration Sets which are Single Use, sterile, non- pyrogenic device and provides access for the administration of fluids from a controliner to a patient's vascular system through the administration set's needle or catheter inserted into a ven. Each set will be manufactured to unique specifications using dimensions, components, and configurations specified by the customer. Standard sets will also be offered. Components used in the IV sets may be either manufactured by ICU medical or purchased from other manufacturers. Components will be assembled into configurations specified by the customer and packaged.
Intended Uses of the ICU Medical Universal Single-Use Spikes:
Universal Spikes are used to build Intravascular Administration Sets which are Single Use, sterile, non- pyrogenic device and provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter inserted inato er vein.
Safety and Performance:
ICU Medical Universal Single-Use Spikes 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 history
1
: Conclusion:
The materials, performance, and operational features of both the submitted device and the predicate device are substantially equivalent and are safe and effective for their intended use.
.
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 features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The text is in uppercase letters and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Niloufar Samimi Regulatory Affairs Specialist ICU Medical, Incorporated 4455 Atherton Drive Salt Lake City, Utah 84123
FEB 2 2009
Re: K082836
Trade/Device Name: Universal Single-Use Spikes Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FMG Dated: January 29, 2009 Received: February 2, 2009
Dear Ms. Samimi:
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.
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.
3
Page 2 -- Ms. Samimi
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (QSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.
Anthony J. Martin for
City of Valdosta, GA M.D.
Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name:
ICU Medical Universal Single -Use Spikes
Indications for Use:
Universal Spikes are used to build Intravascular Administration Sets which are Single Use, sterile, non- pyrogenic device and provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter inserted into a vein.
Prescription Use XX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(DIVISION SE
Division of Anasthesiology, General Ho Infection Control, Dental Device
510(k) Number: K082854