(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 With the device in the open position, fluids can be injected or withdrawn.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.
§ 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.