(106 days)
Not Found
Not Found
No
The summary describes a simple mechanical connector for fluid administration and contains no mention of AI or ML.
No
This device is an accessory for fluid administration and does not directly provide therapeutic treatment itself.
No
The device is described as an accessory for administering fluids, not for diagnosing conditions or diseases.
No
The device description clearly states it is a physical, single-use, sterile, non-pyrogenic device intended for use as an accessory to an intravascular administration set. This indicates a hardware component, 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 it's for the administration of fluids to a patient through a cannula placed in a vein or artery. This is a direct interaction with the patient's circulatory system for therapeutic or supportive purposes.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such testing.
- Device Description: The description reinforces its use as an accessory to an intravascular administration set, which is consistent with delivering substances into the body, not analyzing samples from the body.
Therefore, the ICU Needleless Connector is a medical device used for patient care, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
As an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
Product codes
FPA
Device Description
The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to Intravascular administration set.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
Reference Device(s)
IVAC SmartSite™
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
ICU Medical Inc. CLAVE CONNECTOR
JUN 24 1997
510(k) Notification Page 21 of 24
Appendix H. 510(k) Summary of Safety and Effectiveness 17.
The following section is included as required by the Safe Medical Device Act (SMDA) of 1990.
| Name: | ICU Medical, Inc. |
|---|---|
| Address: | 951 Calle Amanecer |
| San Clemente, CA 92673 |
Contact Person: Arlene Dutchik Phone Number: (714)366-2183 Fax Number: (714)366-8368
510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K970855
Applicant Information:
Date Prepared: May 14, 199 Name: ICU Medical Inc. Address: 951 Calle Amanecer San Clemente, CA 92673
Contact Person: Arlene Dutchik Phone Number: (714)366-2183 (714)366-8368 Fax Number:
Device Information:
Trade Name: Clave Connector Common Name: Intravascular Administration Set Classification Name: Intravascular Administration Set
Equivalent Device:
IVAC SmartSite™
Device Description:
The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to Intravascular administration set.
Intended Use:
As an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
1
ICU Medical Inc. CLAVE CONNECTOR
i.
510(k) Notification Page 22 of 24
Comparison To Predicate Device:
| Characteristic Compared | CLAVE® NEEDLELESS CONNECTOR | IVAC NEEDLE FREE VALVE ADMINISTRATION SETS (SMARTSITE™) |
|---|---|---|
| Product Labeling | Sterile Use, Non-Pyrogenic, Sterile fluid pathway in unopened, undamaged package. Directions for use on labeling. | Sterile Use, Directions for use on labeling |
| Intended Use | Needleless injection port to access any vein, or artery. | Needleless valve (luer lock) |
| Design | One piece design activated by luer connection to allow fluid flow. | One piece design activated by luer connection to allow fluid flow. |
| Materials | Internal Conduit-Polycarbonate | |
| Housing-Polyester | ||
| Silicone Seal-Silicone Rubber | ||
| Ring-Polypropylene | ||
| Lubricant-Flurosilicone | ||
| Breather Cap-Polypropylene | ||
| Packaging-Medical packaging grade fiber-free peelable paper lidding and pouching material. | Unknown |
.. ...
:
Aline Antchik
Arlene Dutchik Regulatory Affairs Specialist ICU Medical, Inc.
نر
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The seal is black and white and appears to be a scanned image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Arlene Dutchik Requlatory Affairs Specialist ICU Medical, Incorporated 951 Calle Amanecer San Clemente, California 92673
JUN 24 1997
Re : K970855 Trade Name: Clave Connector Regulatory Class: II Product Code: FPA Dated: May 14, 1997 Received: May 19, 1997
Dear Ms. Dutchik:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਬੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Paqe 2 - Ms. Dutchik
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597.
Sincerely yours,
Patricia Cicerite for
Timothy A. Ulatowski Director
Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
ICU Medical Inc. CLAVE CONNECTOR 510(k) Notification Page 16 of 24
12. Appendix C. Indications for Use
The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
(Division Sign-Off) Patricia Crucenta
Division of Dental, Infection Control,
and General Hospital Devices
10 General Hospital Devices
510(k) Number K970855
Prescription Use
(Per 21 CFR 801.109)
05/14/97510KCLAVE-1.doc