(84 days)
Not Found
No
The summary describes a mechanical valve for fluid administration and withdrawal, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as an accessory to an intravascular administration set, providing access for fluid administration or withdrawal, rather than directly treating a disease or condition.
No
The device is described as an accessory to an intravascular administration set for fluid administration and withdrawal, not for diagnosis.
No
The device description clearly states it is a "bi-directional valve" and an "accessory to Intravascular administration set," indicating a physical hardware component.
Based on the provided information, the CLC 2000 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the CLC 2000 is an accessory to an intravascular administration set for administering and withdrawing fluids from a patient's vascular system. This involves direct interaction with the patient's body and fluids within the body.
- IVD Definition: In vitro diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes. They perform tests outside of the living body.
- Device Description: The description reinforces its use as a valve for accessing the vascular system, not for analyzing specimens.
The CLC 2000 is a medical device used for accessing the patient's circulatory system, which is a different category than IVD devices.
N/A
Intended Use / Indications for Use
The CLC 2000 is a single use, sterile, non-pyrogenic, swab-able, bi-directional valve intended for use as an accessory to Intravascular administration set. The CLC 2000 provides access for the administration of fluids from a container to a patient's vascular system through the administration sot's needle or catherer (which is inserted into a vein or artery). The CLC 2000 also provides access for the withdrawal of fluids from a patient's vascular system.
Product codes
FPA
Device Description
The CLC 2000 is a single use, sterile, non-pyrogenic, swab-able, bi-directional valve 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
NOV 17 1997
K473/47
510(k) Summary of Safety and Effectiveness
The following section is included as required by the Safe Medical Device Act (SMDA) of 1990.
ICU Medical, Inc. Name: Address: 951 Calle Amanecer San Clemente, CA 92673
Contact Person: Salvadore F. Palomares Phone Number: (714)366-2183 (714)366-8368 Fax Number:
510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is belng submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K973167
Applicant Information:
| Date Prepared: | November 14, 1997 |
|---|---|
| Name: | ICU Medical Inc. |
| Address: | 951 Calle Amanecer |
| San Clemente, CA 92673 |
Contact Person: Salvadore F. Palomares Phone Number: (714)366-2183 Fax Number: (714)366-8368
Device Information:
Trade Name: CLC 2000 Common Name: Intravascular Administration Set Classification Name: Intravascular Administration Set
Equivalent Device:
B. Braun V2 Ultrasite Injection Site (K955585) ICU Medical CLAVE Connector (K970855)
Device Description:
The CLC 2000 is a single use, sterile, non-pyrogenic, swab-able, bi-directional valve intended for use as an accessory to Intravascular administration set.
Intended Use:
The CLC 2000 provides access for the administration of fluids from a container to a patient's vascular system through the administration sot's needle or catherer (which is inserted into a vein or artery). The CLC 2000 also provides access for the withdrawal of fluids from a patient's vascular system.
1
Comparison To Predicate Device:
| Product Labeling | Sterile, Non-Pyrogenic, Single
Use, Swab-able, IV Connector.
Directions for Use included | Sterile, Non-Pyrogenic, Single
Use, Directions for Use
included |
|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The CLC 2000 is a swab-able,
bi-directional valve used to
access any vein or artery or
aspiration of fluids from a
patient's vascular system. | The Ultrasite Injection Site Is
used for the injection
gravity/pump flow or aspiration
of fluids. |
| Design | Swab-able bl-directional luer
activated valve. Closed system
activated by a luer taper. The
luer taper physically moves the
poppet and O-rings, opening
the valve. With the valve in the
open position, fluids can be
injected or withdrawn. The
poppet and O-rings move to the
sealed position automatically
when the luer taper is removed.
As the poppet and O-rings
move to the seal position, fluid
is displaced through the male
luer preventing blood from
entering the lumen of the
catheter. | Swab-able cap-less two-way
valve. Closed system activated
by a luer taper. The luer taper
puts pressure on the plunger,
opening the valve. With the
valve in the open position,
fluids can be injected or
withdrawn. The valve closes
automatically when the luer
taper is removed. |
| Materials | Body - 30% glass filled
polyester
Poppet - Polycarbonate
O-rings - Silicone Rubber
Spring - Stainless Steel 302
Packaging-Medical packaging
grade fiber-free peelable paper
lidding and pouching material. | Body - Polyurethane
Plunger - latex free non-
compromised elastomeric
material
Spring - metal
Packaging-Medical packaging
grade fiber-free peelable paper
lidding and pouching material. |
Sffalman
Salvadore F. Palomares Manager of Regulatory Affairs iCU Medical, Inc.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES ---
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. The bottom half of the circle contains a stylized image of three human profiles facing right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 7 1997
Mr. Salvadore F. Palomares Manager of Regulatory Affairs ICU Medical, Incorporated 951 Calle Amenecer San Clemente, California 92673
K973167 Re : CLC 2000 Swabbable IV Connector Trade Name: Requlatory Class: II Product Code: FPA Dated: Auqust 21, 1997 Received: August 25, 1997
Dear Mr. Palomares:
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 The general controls provisions of the Act 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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531
3
Page 2 - Mr. Palomares
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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 requlation (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 general 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timo A Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
. Enclosure
4
510(k) Number (if known): K973167
Device Name: CLC 2000 SWahle V Connector
Indications For Use:
The CLC 2000 is a single use, sterile, non-pyrogenic, swab-able, bi-directional valve intended for use as an accessory to Intravascular administration set. The CLC 2000 provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein or artery). The CLC 2000 also provides access for the withdrawal of fluids from a patient's vascular system.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NBBDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Paulocesar Cavalcante
(Division Sign-Off) (1) wision of Dental, Infection Com a d General Hospital D E, Nik) Number .
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________