(33 days)
Not Found
No
The summary describes a mechanical fluid control device with a needleless port. There is no mention of any computational or data-driven features that would indicate the presence of AI or ML.
No
The device is a stopcock used for fluid administration or withdrawal, which is an accessory to a therapeutic process but not directly therapeutic itself.
No
Explanation: The device is described as administering or withdrawing fluids and providing needleless access for medication administration, which are therapeutic and fluid management functions, not diagnostic.
No
The device description clearly describes a physical medical device (stopcock) with a fluid path and physical components, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used to "administer or withdraw fluids that flow from a container to a patient's vascular system". This describes a device used in vivo (within the body) for direct patient care, not for testing samples in vitro (outside the body).
- Device Description: The description focuses on the mechanical function of a stopcock and needleless connector for fluid administration and withdrawal. It does not mention any components or processes related to analyzing biological samples.
- 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.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
The device is a medical device used for fluid management in a clinical setting, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The ICU Medical Clave Stopcock is a device used to administer or withdraw fluids that flow from a container to a patient's vascular system through a needle or catheter inserted into a vein or artery. This device is a four-way stopcock with an integral CLAVE side-port for closed, needleless access to the patient tubing or other fluid container.
Product codes
FMG, LHI
Device Description
The Clave® Stopcock is a device that incorporates the functionality of needleless connectivity with the 4-way flow valve of a stopcock. The fluid path has three positions: Flush Position; Flow Position; and Port Access Position. The proprietary technology of the Clave enables the device to have a needleless port for administration 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
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)
Not Found
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
§ 880.5440 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
FEB 1 3 2008
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: January 09, 2008
SPECIAL 510(K) Summary of Safety and Effectiveness for the:
| Trade Name: | Clave® Stopcock |
|---|---|
| Common Name: | Accessory, Set, Administration, I.V. |
| Classification Name: | Set, Administration, Intravascular, 21 CFR 880.5440, Class II Device |
| Product Code: | Primary Code: FMG, Secondary Code: LHI |
Legally Marketed Predicate Devices for Substantial Equivalence:
- K 941190 - Clave Connector - ICU Medical, Inc. * K970855 - Clave Connector - ICU Medical, Inc. *K953573 - ICU Stopcock with Extension Tubing -- ICU Medical, Inc.
Rationale for SE:
This submission is a combination of two devices that have been in the field for more than 15 years. These two devices are regarded highly within the industry and valued by our customers. This device will integrate the spike portion of the Clave into the molded portion of the Stopcock or the spike portion will function separately as it does now and be used as the base plug for the Stopcock portion. Then the other portions of the device remain the same as does the indications for use. There are no functional differences between any of the predicate devices or the proposed devices in terms of use.
Description of Submitted Device:
The Clave® Stopcock is a device that incorporates the functionality of needleless connectivity with the 4-way flow valve of a stopcock. The fluid path has three positions: Flush Position; Flow Position; and Port Access Position. The proprietary technology of the Clave enables the device to have a needleless port for administration of medications or other IV fluids as directed by the physician.
Intended Use:
The ICU Medical Clave Stopcock is a device used to administer or withdraw fluids that flow from a container to a patient's vascular system through a needle or catheter inserted into a vein or artery. This device is a four-way stopcock with an integral CLAVE side-port for closed, needleless access to the patient tubing or other fluid container.
1
| Component: | ICU Medical, Inc.
Clave Stopcock | ICU Medical, Inc.
Clave | ICU Medical, Inc.
Stopcock with ext. Tubing |
|-----------------------|-------------------------------------|----------------------------|------------------------------------------------|
| Stopcock Housing: | Polycarbonate | | Polycarbonate |
| Stopcock Plug: | Polycarbonate | | Polycarbonate |
| Stopcock Handle: | HD Polyethylene | | Polyethylene & HDPE |
| Clave Body: | Valox | Valox | N/A |
| Clave Plug: | Silicone | Silicone | N/A |
| Clave Spike | Polycarbonate | Polycarbonate | N/A |
| Package: | Peel Blister pak | Peel Blister Pak | Peel Blister Pak |
| Sterilization method: | EtO or E-Beam | E-Beam | EtO or E-Beam |
| 510(k) Approval | This submission | K941190 or K970855 | K953573 |
Technological Characteristics and Substantial Equivalence Table:
The operational characteristics are identical as they have only changed to morph two devices together. Operation is the same for all Clave or Stopcocks, including the predicate devices .
Safety and Performance:
ICU Medical Clave Stopcock 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 will be packaged in a way as to ensure conformity with that SAL level. The manufacturing of these devices will be assembled in a quality environmy that is certified independently and complies with cGMPs.
Conclusion:
The materials, performance, and operational features of both the submitted device and the predicate devices are substantially equivalent and safe and effective for their intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three curved lines representing its wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 3 2008
Mr. Tracy S. Best Senior Regulatory Affairs Specialist ICU Medical, Incorporated 4455 Atherton Drive Salt Lake City, Utah 84123
Re: K080077
Trade/Device Name: ICU Medical Clave® Stopcock Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FMG, LHI Dated: January 9, 2008 Received: January 15, 2008
Dear Mr. 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.
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 - Mr. 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 I ederal 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 (QS) 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clu S
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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ררמנגסט X 1 of )
Indications for Use
510(k) Number (if known):
Device Name:
ICU Medical Clave® Stopcock
Indications for Use:
The ICU Medical Clave Stopcock is a device used to administer or withdraw fluids that flow from a container to a patient's vascular system through a needle or catheter inserted into a vein or artery. This device is a four-way stopcock with an integral CLAVE side-port for closed, needleless access to the patient tubing or other fluid container.
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)
China man
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: ____ ├ ψ ふゆゅ2つ