(152 days)
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.
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.
The provided text is a 510(k) summary for the ICU Medical Universal Single-Use Spikes. It states that the device is substantially equivalent to a predicate device (K964435 - IV Sets- ICU Medical, Inc.) based on having the same intended use and materials.
However, the document does not contain any information regarding specific acceptance criteria, performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone).
The document focuses on establishing substantial equivalence for regulatory purposes rather than describing a detailed performance study with acceptance criteria. It mentions "Safety and Performance" and states that "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." This implies adherence to general standards relevant to such medical devices, but it does not specify quantitative acceptance criteria or the studies used to demonstrate compliance to them in this document.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- MRMC comparative effectiveness study results
- Standalone performance study results
- Type of ground truth used
- Sample size for the training set
- How the ground truth for the training set was established
This information is typically found in detailed testing reports, design validation documentation, or other sections of a 510(k) submission, but it is not present in the provided "Summary of Safety and Effectiveness."
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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
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: 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.
.
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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.
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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
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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
§ 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.