(64 days)
The CT Midlines are indicated for Short-Term peripheral access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter.
The CT Midlines are designed for peripheral vein catheterization and power injection of contrast media, available in 4Fx20cm single-lumen or 5Fx20cm double-lumen configurations. Fundamentally, the proposed device is physically identical to the predicate K 121094 aside from the clamp, which is now colored purple to indicate power injection.
The provided document is a 510(k) summary for the Medcomp CT Midline device, indicating that it is being submitted for substantial equivalence to existing predicate devices, K121094 (Midline) and K091953 (Pro-PICC CT). The primary focus of the submission is to demonstrate that the CT Midline, while otherwise identical to predicate K121094, is also safe and effective for power injection, an indication shared with predicate K091953.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly labeled as such but are derived from the performance data presented for the proposed CT Midline and compared against the predicate devices, particularly the Pro-PICC CT (K091953) for power injection capabilities. The document asserts that the proposed device is "substantially equivalent" to predicate devices. For mechanical performance, specifically power injection, the CT Midline is compared to the Pro-PICC CT.
| Attribute | Acceptance Criteria (Predicate K091953) | Reported Device Performance (CT Midline - Proposed) |
|---|---|---|
| Power Injection Flow Rate | 4F: Flow Rate (cc/sec)- 3.9; Machine Pressure (psi)- 183 | |
| 5F: Flow Rate (cc/sec)- 4.9; Machine Pressure (psi)- 212 | 4F (V-9131): Flow Rate (cc/sec)- 4.9; Machine Pressure (psi)- 213; HYDAC Pressure (psi)- 168 | |
| 5F (V-9077): Flow Rate (cc/sec)- 6.9; Catheter Pressure (psi)- 244; HYDAC Pressure (psi)- 181 | ||
| Max Static Burst | 4F: Average max burst pressure 288±4 psi; Range 279-293 psi | |
| 5F: Average max burst pressure 269±4 psi; Range 262-278 psi | 4F (V-9043): Average max burst pressure 302±5 psi; Range 292-312 psi | |
| 5F (V-9073): Average max burst pressure 249±8 psi; Range 241-262 psi | ||
| Air Leakage | Passed in accordance with ISO 10555-1, Annex D (Predicate K121094) | All versions passed in accordance with ISO 10555-1, Annex D. |
| Liquid Leakage | Passed in accordance with ISO 10555-1, Annex C (Predicate K121094) | All versions passed in accordance with ISO 10555-1, Annex C. |
| Biocompatibility | Materials are identical to legally marketed K121094 with the exception of the Acetal clamp which was cleared in legally marketed K091953. Biocompatibility summaries located in Section 15 page 1. (This implies predicate devices met ISO 10993 requirements.) | Results for all biocompatibility testing demonstrate the materials used meet the requirements of ISO 10993. |
| Sterility | 100% Ethylene Oxide (Predicate K121094 and K091953) | 100% Ethylene Oxide |
| Intended Use | Short-Term peripheral access for IV therapies, blood sampling, and power injection of contrast media (Predicate K091953 for power injection) | Short-Term peripheral access for IV therapies, blood sampling, and power injection of contrast media. |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a nonclinical performance test study. It specifically focused on the power injection capabilities, as this was the key performance difference between the proposed CT Midline and the primary predicate (K121094).
The document states: "The following tests were performed to establish the device's equivalence to the relevant predicate device: o Power Injection Flow Rate o Max Static Burst. These tests highlight the relevant difference between the proposed device and predicate K121094 by testing for the safety and effectiveness of the proposed device with regard to the expanded indication for use of power injection."
The reported performance data for the CT Midline in the table above demonstrates that for both 4F and 5F configurations, the proposed device achieved equal or higher flow rates and burst pressures compared to the predicate Pro-PICC CT (K091953) for power injection. This indicates that the CT Midline meets or exceeds the power injection performance of the predicate device with that indication.
For air leakage, liquid leakage, biocompatibility, and sterility, the claims of substantial equivalence are based on either being identical in materials to a cleared predicate or passing relevant ISO standards, which implies meeting the acceptance criteria set by those standards.
The remaining information requested is largely not applicable (NA) or not explicitly provided in the given excerpts, as this is a 510(k) summary for a medical device (catheter), not an AI/software device or a clinical study in the typical sense that would involve human readers, ground truth consensus, or training data for an algorithm.
2. Sample size used for the test set and the data provenance:
- Sample Size: The exact sample sizes for the power injection and static burst tests are not explicitly stated as "n=X". However, for the Max Static Burst, the standard deviation and range are provided (e.g., "302±5psi," "range of burst pressures was 292-312 psi"), which implies multiple tests were performed on multiple units to generate an average and range. Without the full Section 18 (reference testing summaries and protocols), the specific number of units tested is unknown.
- Data Provenance: This is an in-vitro nonclinical performance test, conducted by the manufacturer (Medcomp). Therefore, it is a prospective test conducted on manufactured devices, likely in a laboratory setting. Country of origin of the data is the US, where Medcomp is located.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- NA. This is a hardware device performance test. There are no human experts establishing ground truth for image interpretation or diagnosis. The "ground truth" is defined by the physical properties of the device and its performance under specified testing conditions as measured by instruments.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- NA. There is no adjudication method as this is a physical performance test, not a subjective judgment task.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- NA. This is not an AI or imaging device subject to MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- NA. This is not an algorithm. Standalone performance refers to the device's functional attributes (e.g., flow rate, burst pressure) under test conditions as measured by equipment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the nonclinical performance tests (power injection, static burst, leakage, biocompatibility), the "ground truth" is defined by the measured physical properties and performance characteristics of the device under controlled laboratory conditions, verified against established ISO standards and the performance of legally marketed predicate devices.
8. The sample size for the training set:
- NA. This is a physical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established:
- NA. This is a physical device, not an algorithm that requires a training set and its associated ground truth establishment.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”