(158 days)
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Not Found
No
The device description and performance studies focus on the mechanical properties and material compatibility of a physical catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
This device is designed to deliver contrast medium for diagnostic imaging, not to treat a condition. While it is used in a medical procedure, its function is for diagnostic purposes, not therapeutic intervention.
Yes
The "Intended Use / Indications for Use" states that the device is "designed to deliver contrast medium to selected sites in the vascular system." Delivering contrast medium is a common step in diagnostic imaging procedures to visualize anatomical structures.
No
The device description clearly outlines physical components such as a catheter hub, shaft, stem, tip, and braid wire, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "deliver contrast medium to selected sites in the vascular system." This is a therapeutic or interventional use, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a catheter designed for physical insertion into the vascular system. This aligns with a medical device used for procedures, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to deliver a substance within the body, which is a different category of medical device.
N/A
Intended Use / Indications for Use
ASC Maxi-Torque Plus Softip Angiographic Catheters are designed to deliver contrast medium to selected sites in the vascular system.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
vascular system
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The ASCMPSACs comply with the following standards, practices, and guidances:
- Sterile, single-use intravascular catheters: International Standards Organization Reference Number 10555-1:1995(E) (1995)
- Ethylene Oxide, Ethylene Chlorhydrin, and Ethylene Glycol, Proposed . Maximum Residue Limits and Maximum Levels of Exposure, 21 CFR, § 821.100, Proposed Rule, June 23, 1978
- Biological Evaluation of Medical Devices-Part 7: Ethylene oxide sterili-. zation residuals, American National Standard, ANSI/AAMI/ISO 10993-7:1995
- Biological Evaluation of Medical Devices, ISO-10993-1
The ASCMPSACs are substantially equivalent to catheters which are legally marketed by the Cordis Corporation under the Infiniti™ and TorquePlus™ trademarks. This has been demonstrated by extensive bench testing of both devices. Testing includes jacket tensile strength, stem tensile strength, flow rate, dynamic burst strength and static burst strength. Furthermore, the devices have the same technological characteristics as the Cordis Infiniti™ and TorquePlus™ Angiographic Catheters. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
11 N 13 1997
510(k), ASC Maxi-Torque Plus Softip Angiographic Catheters (ASCMPSACs)
Page 39 of 42
Image /page/0/Figure/3 description: The image shows a document titled "Summary of Safety and Effectiveness for ASC Maxi-Torque Plus Softtip Angiographic Catheters." It indicates that the document was submitted by Adam Spence Corporation, located at 1746 Route 34, Wall, NJ 07719. The phone number is (908) 681-7070, and the facsimile number is (908) 222-5928.
Identification of a Legally Marketed Predicate Device
The ASC French Maxi-Torque Plus Softip Angiographic Catheters (ASCMPSACs) are substantially equivalent to catheters that are manufactured and marketed by the Cordis Corporation under the Infiniti™ and TorquePlus™ trademarks.
Device Description
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 is shown below.
Image /page/0/Figure/8 description: The image shows a diagram of a medical instrument. The instrument has several parts, including a hub, strain relief, shaft, stem, and soft tip. The shaft is long and thin, and the stem is curved. The soft tip is located at the end of the stem.
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.
1
Intended for Use
ASC Maxi-Torque Plus Softip Angiographic Catheters are designed to deliver contrast medium to selected sites in the vascular system.
Summary of Technological Characteristics
The table below compares the technological characteristics of the catheter to the predicate device.
| Feature | ASCMPSAC | Predicate Device |
|---|---|---|
| Manufacturer | Adam Spence Corporation | Cordis Super Torque (Infiniti™) |
| Sterile packaging | On a card, inserted into a pouch made | |
| of Mylar® and Tyvek® | On a card, inserted into a pouch made | |
| of Mylar® and Tyvek® | ||
| Sterilization method | Ethylene Oxide Gas | Ethylene Oxide Gas |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic |
| Shelf Life | 3 years | 3 years |
| Intended use | ASCMPSACs are designed to deliver | |
| contrast medium to selected sites in the | ||
| vascular system. | Cordis catheters are designed to deliver | |
| radiopaque contrast media to selected | ||
| sites in the vascular system. | ||
| Hub with female luer | ||
| taper | Yes | Yes |
| Radiopacifier, shaft | Barium Sulfate | Barium Sulfate |
| Radiopacifier, stem | Bismuth Oxychloride | Barium Sulfate |
| Radiopacifier, soft tip | Bismuth Subcarbonate | Bismuth Subcarbonate |
| Catheter, available | ||
| sizes (French) | 5, 6, and 7 | 5, 6, and 7 |
| Catheter, available | ||
| lengths (cm) | 65, 80, 100, 110, and 125 | 65, 80, 100, 110, and 125 |
| Maximum Guide | ||
| Wire O.D. (inches) | 0.038 | 0.038 |
| Hub material | Nylon | Nylon |
| Reinforcement braid | ||
| material | 300 Series Stainless Steel | 300 Series Stainless Steel |
| Shaft material | 2 layer coaxial nylon extrusion | 2 layer coaxial nylon extrusion |
| Stem material | Nylon | Nylon |
| Soft tip material | Nylon | Nylon |
Table Continued on Next Page
2
| Feature | ASCMPSAC | Predicate Device |
|---|---|---|
| Stem to soft tip at- | ||
| tachment method | Heat fuse | Heat fuse |
| Stem to shaft attach- | ||
| ment method | Heat fuse | Heat fuse |
| Specifications printed | ||
| on hub or strain relief | Catheter length, outside diameter, and | |
| inside diameter | Catheter length, diameter, and maxi- | |
| mum guide wire size | ||
| Maximum pressure | 1200 PSI | 1200 PSI |
| Strain relief | Yes | Yes |
Table Continued
Summary of Performance Data
The ASCMPSACs comply with the following standards, practices, and guidances:
- Sterile, single-use intravascular catheters: International Standards Organi-● zation Reference Number 10555-1:1995(E) (1995)
- Ethylene Oxide, Ethylene Chlorhydrin, and Ethylene Glycol, Proposed . Maximum Residue Limits and Maximum Levels of Exposure, 21 CFR, § 821.100, Proposed Rule, June 23, 1978
- Biological Evaluation of Medical Devices-Part 7: Ethylene oxide sterili-. zation residuals, American National Standard, ANSI/AAMI/ISO 10993-7:1995
- Biological Evaluation of Medical Devices, ISO-10993-1 ●
The ASCMPSACs are substantially equivalent to catheters which are legally marketed by the Cordis Corporation under the Infiniti™ and TorquePlus™ trademarks. This has been demonstrated by extensive bench testing of both devices. Testing includes jacket tensile strength, stem tensile strength, flow rate, dynamic burst strength and static burst strength. Furthermore, the devices have the same technological characteristics as the Cordis Infiniti™ and TorquePlus™ Angiographic Catheters.
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.
The ASCMPSACs will be manufactured per specifications using good manufacturing practices that ensure the device is safe and effective for its intended use.
3
Since the ASCMPSAC meets the requirements of the stated standards and embody technological characteristics essentially identical to the predicate device, we believe the device is safe and effective and performs as well as or better than the predicate device. The ASCMPSACs will be manufactured per specifications and good manufacturing practices that ensure the device is safe and effective for its intended use.