(561 days)
The CLC2000 is intended for use as an accessory to a vascular access device. The CLC2000 has been shown to reduce thrombotic occlusion within the internal catheter lumen and fibrin formation in an animal study. The CLC2000 is designed to assist in maintaining catheter patency. The CLC2000 does not require the use of needles and therefore will passively aid in the reduction of needlestick injuries.
The CLC2000 is a swab-able normally closed two-way luer activated valve. Within the housing of CLC2000, is a spring-loaded poppet whose head protrudes out of the female luer of the device. The poppet has an outer diameter that is smaller than the inner diameter of the housing. O-rings are positioned at the head and base of the poppet and form a physical seal between the poppet and the inner wall of the housing. A male luer with a rotating collar protrudes from the housing. The fluid pathway is opened when a male luer taper engages the female luer on the device. The male luer will push the poppet and the O-rings from their normally closed positions. The inner wall of the housing opens up at a point below the rest position of the top O-ring. When the top O-ring passes this point, it looses contact with the inner wall of the housing allowing fluid to flow freely to the male 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 With the device in the open position, fluids can be injected or withdrawn.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 bottom O-ring maintains contact with the inner wall of the housing at all times preventing fluid from flowing past the bottom O-ring. Once the luer taper is removed from the device, the spring-loaded poppet and O-rings are allowed to return to the "closed position". As the O-rings slide back up, the fluid trapped between the O-rings is forced out through the male luer, creating a positive displacement of fluid. This displacement of fluid prevents blood from being drawn into the lumen of the catheter when the male luer is removed from the device.
The provided text does not contain detailed information about a study that establishes acceptance criteria and proves the device meets them. Instead, it is a 510(k) summary and an FDA clearance letter for a medical device called the CLC2000® Catheter Patency Device.
This type of submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results with acceptance criteria and performance metrics in the format requested. The document does mention an "animal study" but provides very limited information about its methodology, sample size, or specific findings.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can be extracted or inferred, and what is missing based on the prompt's requirements:
1. Table of Acceptance Criteria and Reported Device Performance:
No such table or specific acceptance criteria are provided in the document. The clearance is based on substantial equivalence, not on meeting predefined performance targets from a specific study.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not specified. The document mentions an "animal study" but provides no details on the number of animals or data points.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): "Animal study" is mentioned, implying prospective data. No country of origin is specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable/Not mentioned. For an animal study focused on physical outcomes like thrombotic occlusion, "expert ground truth" in the clinical imaging sense is not typically used. The assessment would likely involve pathology or direct observation/measurement.
4. Adjudication Method:
Not applicable/Not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done or reported in this document. The device is a physical accessory, not an AI or imaging diagnostic tool that would typically involve human readers.
6. Standalone (Algorithm Only) Performance:
Not applicable. The CLC2000 is a physical medical device, not an algorithm.
7. Type of Ground Truth Used:
The document briefly states: "The CLC2000 has been shown to reduce thrombotic occlusion within the internal catheter lumen and fibrin formation in an animal study." This suggests that pathology or direct observation/measurement of biological outcomes (thrombotic occlusion, fibrin formation) in the animal models would serve as the ground truth.
8. Sample Size for the Training Set:
Not applicable. The CLC2000 is a physical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
Summary of what is available from the text:
- Device Name: CLC2000® Catheter Patency Device
- Intended Use: As an accessory to a vascular access device to reduce thrombotic occlusion and fibrin formation, assisting in maintaining catheter patency, and passively aiding in reduction of needlestick injuries.
- Study Mentioned: An "animal study" which "has been shown to reduce thrombotic occlusion within the internal catheter lumen and fibrin formation."
- Ground Truth (Likely): Biological outcomes like thrombotic occlusion and fibrin formation, probably confirmed via pathology or direct measurement in the animal study.
The document primarily serves as evidence of FDA clearance based on substantial equivalence to a predicate device (ICU Medical CLC2000 K973167 and B.Braun Safsite®), rather than a detailed performance study report.
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KO21692
DEC = 4.2003
-
- A revision of the Summary of S&E with the correct name and indication/intended use,
| 510(K) Summary | |
|---|---|
| Name: | ICU Medical, Inc. |
| Address: | 951 Calle AmanecerSan Clemente, CA 92673 |
| Contact Person: | Dale Fairchild |
| Phone Number: | 949-366-2183 ext. 4319 |
| FAX: | 949-366-8368 |
| 510(K) Summary of Safety and Effectiveness | |
| The 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: | K021692 |
| Trade Name: | CLC2000® Catheter Patency Device |
| Common Name: | Accessory, Intravenous Administration Device |
| Classification Name: | Same |
| Equivalent Device: | ICU Medical CLC2000 (K973167)B.Braun Safsite® (510(K) number unknown) |
| Device Description: | |
| The CLC2000 is a swab-able normally closed two-way luer activated valve. Within the housing ofCLC2000, is a spring-loaded poppet whose head protrudes out of the female luer of the device. Thepoppet has an outer diameter that is smaller than the inner diameter of the housing. O-rings arepositioned at the head and base of the poppet and form a physical seal between the poppet and theinner wall of the housing. A male luer with a rotating collar protrudes from the housing. | |
| The fluid pathway is opened when a male luer taper engages the female luer on the device. Themale luer will push the poppet and the O-rings from their normally closed positions. The inner wall ofthe housing opens up at a point below the rest position of the top O-ring. When the top O-ring passesthis point, it looses contact with the inner wall of the housing allowing fluid to flow freely to the maleluer. The device at this stage is considered in the "open position". With the device in the openposition, fluids can be injected or withdrawn. The bottom O-ring maintains contact with the inner wallof the housing at all times preventing fluid from flowing past the bottom O-ring. Once the luer taper isremoved from the device, the spring-loaded poppet and O-rings are allowed to return to the "closedposition". As the O-rings slide back up, the fluid trapped between the O-rings is forced out throughthe male luer, creating a positive displacement of fluid. This displacement of fluid prevents blood frombeing drawn into the lumen of the catheter when the male luer is removed from the device. | |
| Intended Use: | |
| The CLC2000 is intended for use as an accessory to a vascular access device. The CLC2000 willreduce thrombotic occlusion within the internal catheter lumen and fibrin formation. The CLC2000 isdesigned to assist in maintaining catheter patency. The CLC2000 does not require the use of needlesand therefore will passively aid in the reduction of needlestick injuries. | |
| Biocompatibility: | |
| The patient contacting materials used to manufacture the CLC2000 meet ISO 10993 for ExternalCommunicating Devices, Blood Path Indirect, Prolonged Contact Duration. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The symbol is positioned in the center of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 4.2003
Ms. Alison Burcar Regulatory Affairs IUC Medical, Incorporated 951Calle Amanecer San Clemente, California 92673
Re: K021692
Trade/Device Name: CLC2000 Catheter Patency Device Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: September 5, 2003 Received: September 8, 2003
Dear Mr. Burcar
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 - Ms. Burcar
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 (301) 594-4618. 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/dsma/dsmamain.html
Sincerely yours,
Susan Runn
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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$\langle021692$
Indications for Use
510(k) Number (if known): K021692
Device Name: CLC2000®
Indications For Use:
The CLC2000 is intended for use as an accessory to a vascular access device. The CLC2000 has been shown to reduce thrombotic occlusion within the internal catheter lumen and fibrin formation in an animal study. The CLC2000 is designed to assist in maintaining catheter patency. The CLC2000 does not require the use of needles and therefore will passively aid in the reduction of needlestick injuries.
Susan Russoe
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
1421692 510(k) Number: __
Prescription Use (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)
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.