(25 days)
Accessory to a piston syringe for needleless access to sterile drug vials without the use of needles.
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.
This document (K080989) is a 510(k) premarket notification for the ICU Medical Universal Vial Access Device. It is a submission to demonstrate substantial equivalence to legally marketed predicate devices, not a study presenting specific performance data or a statistical analysis with detailed acceptance criteria.
Therefore, the requested information regarding acceptance criteria, reported performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details cannot be fully extracted from the provided text. The document focuses on regulatory compliance and substantial equivalence, not a detailed technical performance study report.
Here's a breakdown of what can be inferred from the provided text, and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as quantifiable metrics with pass/fail thresholds in the provided text. The document refers to conforming to "requirements of published international standards as well as those FDA recognized standards and/or published guidelines." This is a general statement of compliance, not a specific set of acceptance criteria with numerical targets.
- Reported Device Performance: While the document states the device "conform[s] to the requirements" and has an "established and validated history of meeting the 10⁻⁶ level" for Sterility Assurance Level (SAL), it does not provide specific test results comparing the new device's performance against numerical acceptance criteria.
| Acceptance Criteria (Implied) | Reported Device Performance (Inferred) |
|---|---|
| Conformance to international and FDA-recognized standards/guidelines | Conforms to requirements of published international standards and FDA recognized standards/guidelines. |
| Sterility Assurance Level (SAL) | Established and validated history of meeting the 10⁻⁶ level (for ICU Medical's products, implying the new device meets this established standard). |
| Hydrophobic filter efficacy | Ensures airborne contaminates larger than 0.2µm are excluded. (No specific test data or efficacy percentage reported, only a functional statement). |
| Functionality (vial access, needleless access) | "No functional differences between any of the predicate devices or the proposed devices in terms of use." (Implies meeting the functional performance of predicates, but no specific metrics are given). The device enables "needleless port for withdrawal of medications or other IV fluids." |
| Adaptability to vial sizes | "Improved clip that can adapt to all sizes of drug vials." (A qualitative statement of improvement, without specific range or fit criteria.) |
| Manufacturing Quality | "Manufactured in a quality environment that is certified independently and complies with cGMPs." |
| Safety and Effectiveness for Intended Use | "Materials, performance, and operational features... are substantially equivalent and safe and effective for their intended use." (This is a conclusion of the 510(k) submission, not a detailed performance report). Note: This section indicates that "Safety and Performance" will conform to requirements, but doesn't report the tested performance. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not mentioned. No information is provided about specific test sets, their size, or the number of units tested.
- Data Provenance: Not mentioned. There is no information about country of origin, or whether any data used for internal verification was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. The document does not describe a study involving expert-established ground truth for a test set. This is a regulatory submission for substantial equivalence based on engineering and design considerations, not an AI/diagnostic device performance study.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set:
- Not applicable. There is no mention of a test set requiring adjudication in the context of this 510(k) submission.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No. This is not an AI-assisted diagnostic device, but a medical accessory (vial access device). Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.
- Effect Size: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This is a physical medical device, not an algorithm, so "standalone (algorithm only)" performance is not a relevant concept for this submission.
7. The type of ground truth used:
- Not applicable in the context of a diagnostic performance study. The 510(k) submission relies on demonstrating substantial equivalence to predicate devices, compliance with established standards, and internal verification processes to ensure the device's functional and safety characteristics. The "ground truth" here would be established engineering and biological safety standards, along with the proven performance of the predicate devices.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set.
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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.
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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.
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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
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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
§ 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).