(63 days)
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).
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 With the device in the open position, fluids can be injected or withdrawn.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".
The provided text is a 510(k) summary for a medical device called "CML™" (Closed Male Luer). It establishes substantial equivalence to a legally marketed predicate device, the "Clave Connector K970855." This document does not describe an acceptance criteria table or a study proving that the device meets specific performance criteria. Instead, it focuses on demonstrating that the new device has similar technological characteristics and intended use as an existing cleared device.
Therefore, I cannot extract the requested information as it is not present in the provided text. The questions regarding acceptance criteria, reported device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not addressed in this type of regulatory submission summary.
The document is a 510(k) summary, which is a regulatory submission for medical devices to demonstrate substantial equivalence to a predicate device, not a performance study report.
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ר 143143 ! £22
AUG 3 - 2005
510(k) SUMMARY
| §807.92(a)(1) | |
|---|---|
| Submitted By | Jim CoombesICU Medical, Inc.951 Calle AmanecerSan Clemente, CA 92673949-366-3571 |
| Contact Person | Jim CoombesQuality 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 |
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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, NoLatex | See Directions for Use, Sterile,Do Not Reuse, No Latex |
| Intended Use | Intended for use as anaccessory to intravascularadministration set | Intended for use as anaccessory to intravascularadministration set |
| Design | One piece design activatedby luer connection to allowfluid flow | One piece design activated byluer connection to allow fluidflow |
| Materials | Hard plastic housing, fluidpath. Silicone seal, siliconespring retention, liquidsilicone lubricant | Hard plastic housing, fluidpath. Silicone seal, siliconespring compression, liquidsilicone lubricant |
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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.
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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
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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
Page 1 of
§ 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.