(207 days)
The SmartSite® Stopcock is indicated for fluid flow, directional control and for providing access port(s) for administration of solutions and blood products. Typical uses include pressure monitoring, intravenous fluid administration and transfusion. The SmartSite® valve port allows the user to access the primary line without the use of a needle.
The SmartSite® Stopcock is a single use 4-way stopcock with an integrated SmartSite® needle free valve on the side port. Arrows on the handle point to the direction of flow. The side port consists of a SmartSite® needle free valve that provides closed, needle-free access that seals upon removal and does not require re-capping between uses. The SmartSite® Stopcock share similar characteristics and will operate the same as currently marketed stopcocks, as an accessory to an IV administration set that regulates the directional flow to a patient's vascular system and provides an access port(s) for the administration of solutions.
This document is a 510(k) summary for the Cardinal Health, Alaris® Products® SMARTSITE® STOPCOCK. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain the detailed performance data or study results typically found in an academic paper or a more comprehensive technical report that would directly answer your questions about acceptance criteria and how a study proves those criteria are met for an AI/ML device.
This submission is for a medical device (a stopcock) used in intravenous administration, not for an AI/ML powered medical device. Therefore, the questions related to AI/ML device performance, such as sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and effect sizes of AI assistance, are not applicable to this document. The "performance data" section in {3} merely states that the device "meets specified requirements" and is "substantially equivalent to the predicate devices" without detailing the specific criteria or the studies conducted.
To directly answer your request based on the provided text, the following information is available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list acceptance criteria in a quantitative table format or detailed performance results. Instead, it makes a general statement:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specified requirements (implied by substantial equivalence) | Meets specified requirements and is substantially equivalent to the predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable or not provided. This is a traditional medical device submission, not an AI/ML device, and no specific test set sample size or data provenance details are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable or not provided. This is a traditional medical device submission, not an AI/ML device, and no expert ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable or not provided.
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
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable or not provided. The substantial equivalence is based on technological characteristics and functional performance compared to predicate devices, rather than a "ground truth" in the AI/ML sense.
8. The sample size for the training set
Not applicable or not provided. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable or not provided. This is not an AI/ML device.
{0}------------------------------------------------
ORIGINAL PR
SUMMARY OF SAFETY AND EFFECTIVENESS Cardinal Health, Alaris® Products® SMARTSITE® STOPCOCK
DEC 1 4 2007
SUBMITTER INFORMATION
| A. | Company Name: | Cardinal Health, Alaris® Products |
|---|---|---|
| B. | Company Address: | 10221 Wateridge CircleSan Diego, CA 92121-2733 |
| C. | Company Phone:Company Fax: | (858) 617-5889(858) 617-5960 |
| D. | Contact Person: | Stacy L. LewisPrincipal Regulatory Affairs SpecialistCardinal Health, Alaris® Products |
| E. | Date Summary Prepared: | December 12, 2007 |
DEVICE IDENTIFICATION
| A. | Generic Device Name: | Stopcock |
|---|---|---|
| B. | Trade/Proprietary Name: | SmartSite® Stopcock |
| C. | Classification: | Class II |
| D. | Product Code: | FMG, Stopcock, IV Administration Se |
DEVICE DESCRIPTION
The SmartSite® Stopcock is a single use 4-way stopcock with an integrated SmartSite® needle free valve on the side port. Arrows on the handle point to the direction of flow. The side port consists of a SmartSite® needle free valve that provides closed, needle-free access that seals upon removal and does not require re-capping between uses.
{1}------------------------------------------------
SUMMARY OF SAFETY AND EFFECTIVENESS Cardinal Health, Alaris® Products SMARTSITE® STOPCOCK Page 2 of 3
DEVICE DESCRIPTION (Continued)
The SmartSite® Stopcock share similar characteristics and will operate the same as currently marketed stopcocks, as an accessory to an IV administration set that regulates the directional flow to a patient's vascular system and provides an access port(s) for the administration of solutions.
SUBSTANTIAL EQUIVALENCE
The Cardinal Health, Alaris® Products SmartSite® Stopcock is of comparable type and is substantially equivalent to the following predicate devices:
| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|---|---|---|---|
| Elcam Closed SwabbableStopcock | Elcam Medical | K060231 | 04/13/06 |
| SmartSite® Needle Free Valve | Cardinal Health, AlarisProducts | K960280 | 04/04/96 |
INTENDED USE
The SmartSite® Stopcock is indicated for fluid flow, directional control and for providing access port(s) for administration of solutions and blood products. Typical uses include pressure monitoring, intravenous fluid administration and transfusion. The SmartSite® valve port allows the user to access the primary line without the use of a needle.
TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the SmartSite® Stopcock and the predicate devices has been performed. The results of this comparison demonstrate that the SmartSite® Stopcock is equivalent to the marketed predicate devices in technological characteristics.
{2}------------------------------------------------
SUMMARY OF SAFETY AND EFFECTIVENESS Cardinal Health, Alaris® Products SMARTSITE® STOPCOCK Page 3 of 3
PERFORMANCE DATA
The performance data indicate that the SmartSite® Stopcock meets specified requirements and is substantially equivalent to the predicate devices.
{3}------------------------------------------------
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DEC 1 4 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Stacy L. Lewis Principal Regulatory Affairs Specialist Cardinal Health, Alaris Products 10020 Pacific Mesa Boulevard San Diego, California 92121-2772
Re: K071400
Trade/Device Name: SmartSite® StopCock Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FMG Dated: November 27, 2007 Received: November 28, 2007
Dear Ms. Lewis:
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.
{4}------------------------------------------------
Page 2 - Ms. Lewis
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) 276-00115. 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 tollfree number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Anthon D.mister for
Shirin, Ph.D.
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
{5}------------------------------------------------
ATTACHMENT A
INDICATIONS FOR USE
510(k) Number: K071400
SmartSite® Stopcock Device Trade Name:
Indications For Use:
The SmartSite® Stopcock is indicated for fluid flow, directional control and for providing access port(s) for administration of solutions and blood products. Typical uses include pressure monitoring, intravenous fluid administration and transfusion. The SmartSite® valve port allows the user to access the primary line without the use of a needle.
Prescription Use X (Per 21 CFR 801.109)
Over-The-Counter Use
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cenir Homan
To
1471444
§ 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.