(158 days)
ASC Maxi-Torque Plus Softip Angiographic Catheters are designed to deliver contrast medium to selected sites in the vascular system.
The ASCMPSACs are classified as Class II in 21 CFR §870.1200. The ASCMPSACs are sterile, single use, disposable devices, that are delivered non-toxic and non-pyrogenic. The ASCMPSACs consist of five components: catheter hub with luer connector, catheter shaft, catheter stem, soft distal tip, and catheter shaft braid wire. The catheter shaft has three sub-components: extrusion base coat, reinforcement braid wire, and extrusion top coat. The braiding is intended to provide torque control and strength. All versions of the catheter are designed to accommodate a maximum guidewire diameter of 0.038 inches. The strain relief is imprinted with three descriptive dimensions: the French size of the catheter, minimum inside diameter, and the catheter working length.
The document provided describes a 510(k) submission for the ASC Maxi-Torque Plus Softtip Angiographic Catheters (ASCMPSACs), asserting their substantial equivalence to a predicate device. The information focuses on safety and performance testing for a medical device rather than an AI/ML diagnostic tool. Therefore, many of the requested categories related to AI/ML study design (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, and standalone performance) are not applicable to this submission.
Here's the breakdown of the available information:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the ASCMPSACs are based on compliance with specific international standards and successful bench testing demonstrating equivalence to the predicate device. The performance is reported through a comparison of technological characteristics and successful completion of various physical and material tests.
| Feature / Test Category | Acceptance Criteria (Implied) | Reported Device Performance and Compliance |
|---|---|---|
| Technological Characteristics | Substantial equivalence to predicate device in terms of: |
- Manufacturer
- Sterile packaging
- Sterilization method
- Pyrogenicity
- Shelf Life
- Intended use
- Hub with female luer taper
- Radiopacifier materials (shaft, stem, soft tip)
- Catheter, available sizes (French)
- Catheter, available lengths (cm)
- Maximum Guide Wire O.D. (inches)
- Hub material
- Reinforcement braid material
- Shaft material
- Stem material
- Soft tip material
- Stem to soft tip attachment method
- Stem to shaft attachment method
- Specifications printed on hub/strain relief
- Maximum pressure
- Strain relief | The detailed table provided compares each technological characteristic of the ASCMPSAC to the Predicate Device (Cordis Super Torque (Infiniti™)). The ASCMPSAC is shown to be largely identical or highly similar across all these features, with minor differences only in some radiopacifier materials (stem: Bismuth Oxychloride for ASCMPSAC vs Barium Sulfate for predicate) and specifications printed on the hub/strain relief (Catheter length, outside diameter, and inside diameter for ASCMPSAC vs Catheter length, diameter, and maximum guide wire size for predicate). These differences are implicitly considered not to affect substantial equivalence. |
| Material Biocompatibility | Pass testing required by ISO-10993 for all direct and indirect blood contact materials. | All direct and indirect blood contact materials used to fabricate the ASCMPSACs pass the testing required by ISO-10993. These materials are currently used in many disposable medical devices. |
| Physical Performance (Bench Testing) | Equivalent performance to predicate device in: - Jacket tensile strength
- Stem tensile strength
- Flow rate
- Dynamic burst strength
- Static burst strength | Extensive bench testing was conducted on both the ASCMPSAC and the predicate device. Testing included jacket tensile strength, stem tensile strength, flow rate, dynamic burst strength, and static burst strength. The results demonstrated substantial equivalence, supporting the claim that the device performs as well as or better than the predicate device. |
| Compliance with Standards | Compliance with: - ISO 10555-1:1995(E) (Sterile, single-use intravascular catheters)
- 21 CFR, § 821.100 (Ethylene Oxide, Ethylene Chlorhydrin, and Ethylene Glycol residue limits)
- ANSI/AAMI/ISO 10993-7:1995 (Ethylene oxide sterilization residuals)
- ISO-10993-1 (Biological Evaluation of Medical Devices) | The ASCMPSACs comply with all listed standards, practices, and guidances. |
| Manufacturing Practices | Manufactured per specifications using good manufacturing practices to ensure safety and effectiveness. | The ASCMPSACs will be manufactured per specifications using good manufacturing practices that ensure the device is safe and effective for its intended use. |
Non-Applicable Sections for this Device Submission:
Since this document describes a traditional medical device (angiographic catheter) and its substantial equivalence claims, rather than an AI/ML-driven diagnostic or treatment device, the following categories are not relevant and thus no information is provided in the source text:
- Sample size used for the test set and the data provenance: Not an AI/ML study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not an AI/ML study.
- Adjudication method for the test set: Not an AI/ML study.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not an AI/ML study.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not an AI/ML study.
- The type of ground truth used: For mechanical device testing, the "ground truth" is typically defined by engineering specifications, material properties, and physical test results, not expert consensus or pathology in the diagnostic sense.
- The sample size for the training set: Not an AI/ML study.
- How the ground truth for the training set was established: Not an AI/ML study.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).