(63 days)
Not Found
No
The device description details a purely mechanical valve system with no mention of software, algorithms, or data processing.
No
The device is described as an accessory to an intravascular administration set, providing access for fluid administration. It does not actively treat a condition or provide therapy itself.
No
The device is described as an accessory for intravascular administration sets, designed to provide access for fluid administration, not for diagnosis. It facilitates the flow of fluids to and from a patient's vascular system, which is a therapeutic or administrative function.
No
The device description clearly details a physical, mechanical valve with a housing, poppet, spring, and O-rings, indicating it is a hardware 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 an accessory to an intravascular administration set for administering fluids to a patient's vascular system. This is a therapeutic or delivery function, not a diagnostic one.
- Device Description: The description details a mechanical valve for controlling fluid flow. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Elements: The description does not mention any components or processes related to testing or analyzing samples (like blood, urine, etc.) to diagnose a condition or provide information about a patient's health status.
- Anatomical Site: The device interacts with the patient's vascular system for fluid delivery, not for obtaining or analyzing samples for diagnostic purposes.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely related to the delivery of fluids into the body.
N/A
Intended Use / Indications for Use
The CML is a single use, sterile, non-pyrogenic, swab-able, bi-directional valve device intended for use as an accessory to Intravascular Administration Set. The CML provides access for the administration of fluids from a container to a patient's vascular system through the administration needle or catheter (which is inserted into the vein or artery).
Product codes
FPA
Device Description
The Closed Male Luer is a normally closed two-way luer activated valve. Within the housing of the Closed Male Luer is a spring-loaded poppet whose head is flush with the male luer of the device. The poppet has an outer diameter that is smaller than the inner diameter of the housing. O-rings are positioned between the housing and poppet that form a physical seal between the poppet and the inner wall of the housing. The fluid pathway is opened when a female luer engages the male luer of the device. The female luer will push the poppet from its normally closed position, allowing fluid to flow freely to the female luer. The device at this stage is considered in the "open position". With the device in the open position, fluids can be injected or withdrawn. The O-rings maintain contact with the inner wall of the housing and the poppet at all times preventing fluid from flowing past the O-rings. Once the female luer connector is removed from the device, the spring-loaded poppet is allowed to return to the "closed position".
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)
Clave Connector K970855
Reference Device(s)
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
ר 143143 ! £22
AUG 3 - 2005
510(k) SUMMARY
| §807.92(a)(1) | |
|---|---|
| Submitted By | Jim Coombes |
| ICU Medical, Inc. | |
| 951 Calle Amanecer | |
| San Clemente, CA 92673 | |
| 949-366-3571 | |
| Contact Person | Jim Coombes |
| Quality Engineer | |
| Date of Summary Preparation: | May 23, 2005 |
| §807.92(a)(2) | |
| Trade Name: | CML TM |
| Common Name: | Closed Male Luer |
| Classification Name: | Intravascular administration set (21 CFR 880.5440) |
| §807.92(a)(3) | |
| Legally Marketed Substantially Equivalent Device: | Clave Connector K970855 |
| §807.92(a)(4) | |
| Description of Device: | The Closed Male Luer is a normally closed two-way luer activated valve. Within the housing of the Closed Male Luer is a spring-loaded poppet whose head is flush with the male luer of the device. The poppet has an outer diameter that is smaller than the inner diameter of the housing. O-rings are positioned between the housing and poppet that form a physical seal between the poppet and the inner wall of the housing. The fluid pathway is opened when a female luer engages the male luer of the |
1
device. The female luer will push the poppet from its normally closed position, allowing fluid to flow freely to the female luer. The device at this stage is considered in the "open position". With the device in the open position, fluids can be injected or withdrawn. The O-rings maintain contact with the inner wall of the housing and the poppet at all times preventing fluid from flowing past the O-rings. Once the female luer connector is removed from the device, the spring-loaded poppet is allowed to return to the "closed position".
8807.92(a)(5)
Intended Use:
The CML is a single use, sterile, non-pyrogenic, swab-able, bi-directional valve device intended for use as an accessory to Intravascular Administration Set. The CML provides access for the administration of fluids from a container to a patient's vascular system through the administration needle or catheter (which is inserted into the vein or artery).
$807.92(a)(6)
Summary of Technological Characteristics
| Characteristic Compared | CML | Clave Connector |
|---|---|---|
| Product Labeling | See Directions for Use, | |
| Sterile, Do Not Reuse, No | ||
| Latex | See Directions for Use, Sterile, | |
| Do Not Reuse, No Latex | ||
| Intended Use | Intended for use as an | |
| accessory to intravascular | ||
| administration set | Intended for use as an | |
| accessory to intravascular | ||
| administration set | ||
| Design | One piece design activated | |
| by luer connection to allow | ||
| fluid flow | One piece design activated by | |
| luer connection to allow fluid | ||
| flow | ||
| Materials | Hard plastic housing, fluid | |
| path. Silicone seal, silicone | ||
| spring retention, liquid | ||
| silicone lubricant | Hard plastic housing, fluid | |
| path. Silicone seal, silicone | ||
| spring compression, liquid | ||
| silicone lubricant |
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 lines representing its wings, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged in a circle around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 - 2005
Mr. Jim Coombes Quality Engineer ICU Medical, Incorporated 951 Calle Amanecer San Clemente, California 92673
Re: K051437
Trade/Device Name: CML 1000 Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: II Product Code: FPA Dated: May 24, 2005 Received: June 1, 2005
Dear Mr. Coombes:
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. Coombes
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 (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,
Chris Liu, 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
4
Indications for Use
510(k) Number (if known): K051437
Device Name: CML TM
Indications For Use: The CML™ is a single use, sterile, non-pyrogenic, swab-able, bi-directional valve device intended for use as an accessory to intravascular administration set. The CML provides access for the administration of fluids from a container to a patient's vascular system through the administration needle or catheter (which is inserted into the vein or artery).
Prescription Use V (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)
Draon
5/3/2008
Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K051437
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