(75 days)
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Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of braided tubes and connectors, with no mention of AI or ML.
No
This device is described as an "accessory device" that provides an extended connection for delivering contrast medium. It does not directly treat a medical condition or disease, which is the primary function of a therapeutic device.
No
Explanation: The device is described as an accessory for delivering radiopaque contrast medium, which is a therapeutic or interventional function, not a diagnostic one. It facilitates the delivery of a contrast agent that enables a diagnostic procedure (angiography), but the device itself does not perform diagnosis.
No
The device description clearly states it is a physical device consisting of braided polymeric tubing and luer connectors, intended for delivering contrast medium. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to deliver radiopaque contrast medium to selected sites in the vascular system. This is a procedure performed in vivo (within the living body) for imaging purposes.
- Device Description: The description details a physical tube with connectors for connecting to an injector and a catheter, designed for fluid delivery. This is consistent with a medical device used for a procedure, not for testing samples in vitro (outside the living body).
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with such specimens in this manner.
The device described is a medical device used in a clinical procedure, specifically angiography.
N/A
Intended Use / Indications for Use
ASC High Pressure Braided Tubes are accessory devices to angiographic catheters intended to provide an extended luminal connection between an angiographic injector and an angiographic catheter for the purpose of delivering radiopaque contrast medium to selected sites in the vascular system.
Product codes
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Device Description
The HPBT are sterile, single use, disposable devices, that are delivered non-toxic and non-pyrogenic. The HPBT consists of braided polymeric tubing terminated at both ends with luer connectors. The luer connector may be one of three types: male rotating, or female. A typical HPBT is shown below. Cross-sectional views of the three luer connectors are shown on the next page. The tubing has three sub-components: extrusion base coat, reinforcement nylon braid, and extrusion top coat.
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
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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 HPBT complies with the following standards, practices, and guidances:
- Medical Devices-Validation and Routine Control of Ethylene Oxide . Sterilization, ANSI/AAMI/ISO 11135-1994, Approved March 24, 1994 by the American National Standards Institute, Inc.
- 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
- . Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - General Requirements: International Standards Organization Reference Number 594-1:1986 (E)
- . Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - lock fittings: International Standards Organization Reference Number 594-2:1991 (E)
- Biological Evaluation of Medical Devices, ISO-10993-1
This has been demonstrated by extensive bench testing of both devices. Testing includes component tensile strength, static burst strength, and luer compatibility. Furthermore, the device has similar technological characteristics to High Pressure Catheter Connector which is legally manufactured by the USCI® Bard Corporation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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).
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ા રે વિવ 11 11
| Summary of Safety and Effectiveness
| for |
|---|
| ASC High Pressure Braided Tubing |
| submitted by |
| Adam Spence Corporation |
| 1746 Route 34 |
| Wall, NJ 07719 |
| Phone: (908) 681-7070 |
| Facsimile: (908) 222-5928 |
Identification of a Legally Marketed Predicate Device
The Adam Spence Corporation High Pressure Braided Tubing (HPBT) is substantially equivalent to the High Pressure Catheter Connector that is manufactured and marketed by the USCI® Bard Corporation.
Device Description
The HPBT are sterile, single use, disposable devices, that are delivered non-toxic and non-pyrogenic. The HPBT consists of braided polymeric tubing terminated at both ends with luer connectors. The luer connector may be one of three types: male rotating, or female. A typical HPBT is shown below. Cross-sectional views of the three luer connectors are shown on the next page. The tubing has three sub-components: extrusion base coat, reinforcement nylon braid, and extrusion top coat.
Image /page/0/Figure/9 description: The image shows a technical drawing of a tubing system. The system consists of a "Rotating Male Luer" on the left, connected to a "Fixed Female Luer" on the right, with "Polyurethane Braided Tubing" in between. The drawing provides a detailed view of the connection and the tubing material.
Typical HPBT
1
Image /page/1/Figure/2 description: The image shows three sets of technical drawings of mechanical parts. Each set includes a cross-sectional view from the side and a top-down view. The drawings appear to be detailed schematics, possibly for manufacturing or engineering purposes, with precise lines and concentric circles indicating cylindrical shapes and internal structures.
Cross-sectional Views
Intended Use
ASC High Pressure Braided Tubes are accessory devices to angiographic catheters intended to provide an extended luminal connection between an angiographic injector and an angiographic catheter for the purpose of delivering radiopaque contrast medium to selected sites in the vascular system.
Summary of Technological Characteristics
The table below compares the technological characteristics of the HPBT to the predicate device.
| Feature | HPBT | Predicate Device |
|---|---|---|
| Manufacturer | Adam Spence Corporation | USCI® Bard Corporation |
| Sterile packaging | Mylar® and Tyvek® heat seal pouch | Mylar® and Tyvek® heat seal pouch |
| Sterilization method | Ethylene Oxide Gas | Ethylene Oxide Gas |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic |
| Shelf life | 3 years | Not shown in labeling |
| Available with rotat- | ||
| ing or non-rotating | ||
| male luer lock con- | ||
| nectors | Yes | Non-Rotating Only |
| Available working | ||
| lengths (inches) | 10, 16, 20, 30, and 48 | 10 and 20 |
"T
2
| Feature | HPBT | Predicate Device |
|---|---|---|
| Intended use | ASC High Pressure Braided Tubes are | |
| accessory devices to angiographic | ||
| catheters intended to provide an extended luminal connection between an | ||
| angiographic injector and an angiographic catheter for the purpose of delivering radiopaque contrast medium to | ||
| selected sites in the vascular system. | USCI® Catheter Connectors are designed to provide an extension from an | |
| angiographic catheter to a standard automatic contrast media (dye) injector. | ||
| Nominal Inside Diameter (Inches) | 0.071 | 0.105 |
| Nominal Outside | ||
| Diameter | 0.142 | 0.208 |
| Luer material | Polycarbonate | Polycarbonate |
| Reinforcement braid | ||
| material | Nylon | Non-braided |
| Tubing material | Polyurethane | Vinyl |
| Rated pressure (PSI) | 1200 | 1100 |
Summary of Performance Data
The HPBT complies with the following standards, practices, and guidances:
- Medical Devices-Validation and Routine Control of Ethylene Oxide . Sterilization, ANSI/AAMI/ISO 11135-1994, Approved March 24, 1994 by the American National Standards Institute, Inc.
- 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
- . Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - General Requirements: International Standards Organization Reference Number 594-1:1986 (E)
- . Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - lock fittings: International Standards Organization Reference Number 594-2:1991 (E)
- Biological Evaluation of Medical Devices, ISO-10993-1 ●
3
The HPBT is substantially equivalent to High Pressure Catheter Connector which is legally marketed by the USCI® Bard Corporation. This has been demonstrated by extensive bench testing of both devices. Testing includes component tensile strength, static burst strength, and luer compatibility. Furthermore, the device has similar technological characteristics to High Pressure Catheter Connector which is legally manufactured by the USCI® Bard Corporation.
All direct and indirect blood contact materials used to fabricate the HPBT pass the testing required by ISO-10993-1. These materials are currently used in many disposable medical devices.
Since the HPBT mects the requirements of the stated standards and embodies 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 HPBT will be manufactured per specifications and good manufacturing practices that ensure the device is safe and effective for its intended use.