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The SABER™ .014 and SABERX™ .014 PTA Dilatation Catheters are intended to dilate stenoses in the peripheral vasculature, including femoral, popliteal and infra popliteal arteries. The device is also indicated for post-dilation of balloon-expandable and self-expanding stents in the peripheral vasculature.

The SABER™ .014 and SABERX™ .014 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter are single-use sterile devices, sterilized by ethylene oxide.

The SABER™ .014 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is an over-the-wire (OTW) coaxial lumen catheter with a semi-compliant balloon mounted on its distal end. It is compatible with 0.014" (0.3556 mm) guidewire. The catheter is available in working lengths of 90 cm and 150 cm with balloon diameters ranging from 1.25 mm to 5.0 mm, and balloon lengths ranging from 15 mm to 300 mm.

Radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. For balloon lengths greater than or equal to 100 mm, the distal section will have two (2) adjacent marker bands and the proximal section will have one (1) marker band. For balloon lengths less than 100 mm, the distal and proximal section will each have one (1) marker band. The catheter tip is tapered to ease entry into peripheral arteries and to facilitate the crossing of tight stenoses. SABER™ .014 balloons are coated with a dual-layer hydrophilic material designed to increase lubricity throughout the lifetime of the device.

The working pressure range for the balloon is between the nominal pressure and the rated burst pressure. All balloons distend to sizes above the nominal size at pressures greater than the nominal pressure. Consult the compliance chart on the tray label for typical diameters of the balloons at given pressures.

The balloon lumen is used to inflate and deflate the balloon. The nominal balloon size in printed on the hub. The guidewire lumen is used to track the catheter over a prepositioned guidewire.

The radiopaque marker bands (the length between the outer edge of most proximal to the outer edge of most distal marker band) indicate the stated nominal length of the balloon.

The SABERX™ .014 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is a catheter with a distal inflatable balloon. The catheter is available in working lengths of 90 cm, 150 cm and 200 cm with balloon diameters ranging from 1.25 mm to 6.0 mm, and balloon lengths ranging from 15 mm to 300 mm. The catheter utilizes a Rapid Exchange design, consisting of a single inflation lumen and a distal guidewire lumen. The guidewire lumen begins at the distal tip and terminates at the guidewire exit port. The proximal hub is used as a balloon inflation port.

Radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. For balloon lengths greater than or equal to 100 mm, the distal section will have two (2) adjacent marker bands and the proximal section will have one (1) marker band. For balloon lengths less than 100 mm, the distal and proximal section will each have one (1) marker band. The catheter tip is tapered to ease entry into peripheral arteries and to facilitate the crossing of tight stenoses. SABERX™ .014 balloons are coated with a dual-layer hydrophilic material designed to increase lubricity throughout the lifetime of the device.

The working pressure range for the balloon is between the nominal pressure and the rated burst pressure. All balloons distend to sizes above the nominal size at pressures greater than the nominal pressure. Consult the compliance chart on the tray label for typical diameters of the balloons at given pressures.

The radiopaque marker bands (the length between the outer edge of most proximal to the outer edge of most distal marker band) indicate the stated nominal length of the balloon.

The associated accessories for SABERX™ .014 PTA Dilatation Catheter include:

• Flushing Needle

The SABER™ .014 and SABERX™ .014 PTA Dilatation Catheter are for use in a catherization lab, hospital or other suitable healthcare facility by appropriately trained medical professionals only.

The Cordis US Corp's SABER™ .014 and SABERX™ .014 PTA Dilatation Catheters, intended to dilate stenoses in peripheral vasculature and for post-dilation of stents, demonstrated substantial equivalence to predicate devices through various performance tests.

Here's an overview of the acceptance criteria and the studies that prove the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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The Jade PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilation of balloon expandable and self-expanding stents in the peripheral vasculature.

The JADE Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter is a rapid exchange balloon catheter for peripheral indications with a working length of 150cm. The minimally compliant balloons, available in diameters from 1.5-6.0mm and lengths from 15-120mm, can be inflated by injecting dilute contrast media solution through the trailing hub of the catheter. The balloon material is made of a minimally compliant material with a rated burst pressure of 20 atm (Ø1.5-4.0mm) or 18atm (Ø4.5-6.0mm). Hydrophilic lubricious coatings are applied to the distal section of the catheter. The proximal shaft of the catheter is composed of a female luer connector bonded to a nylon tube which is internally supported by a stainless steel hypotube. Two radiopaque platinum/iridium marker bands are located within the balloon shoulders. The internal lumen of the catheter accepts a maximum 0.014 inch (0.36mm) guidewire. The guidewire enters the catheter tip and advances coaxially out the RX port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard length guidewire. Two marked sections, 3mm in length located on the proximal shaft specifically designed to be highly visible, indicate catheter position relative to the guiding catheter or guiding sheath. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

The provided text is a 510(k) Summary for the Jade PTA Balloon Dilatation Catheter. It describes the device, its intended use, and the performance data submitted to support its substantial equivalence to predicate devices. However, it does not contain information about a study proving the device meets acceptance criteria related to an AI/ML algorithm or its performance with human readers. The information provided is for a physical medical device (a balloon catheter), not an AI/ML diagnostic or assistive tool.

Therefore, I cannot fulfill your request as the necessary information regarding AI/ML acceptance criteria, human reader studies, ground truth establishment for AI/ML, sample sizes for training/test sets for AI/ML, or expert qualifications for AI/ML ground truth is not present in the provided document.

The "Performance Data" section in the document refers to in vitro performance tests and biocompatibility tests for the physical catheter, not an AI/ML system.

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The balloon dilatation catheter is intended to dilate stenoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.

The non-compliant PTA (Over-the-Wire, OTW) balloon dilatation catheter family consists of Castor NC (0.014"), Achilles NC (0.018") and Hermes NC (0.035") PTA balloon catheter. The PTA (OTW type) device is an over the wire (OTW) peripheral balloon catheter, specially designed for Percutaneous Transluminal Angioplasty (PTA). The catheter working length is 70, 90 and 150cm. Balloon diameters range from Ø2.0mm to Ø10.0mm, balloon work length range from 10mm to 150mm. The three PTA balloon dilatation catheters are filed in one 510(k) submission due to the similar/equivalent construction and identical material of the products. The comparison of them was summarized in Table 1. The differences only exist in the guide wire compatibility and the balloon configuration which have been controlled by the Design Verification. The balloon material is made of a non-compliant Nylon material for diameter 2.0mm to 10.0mm with a rated burst pressure of 18-22 atmospheres. It is a coaxial double lumen catheter with a balloon located near the distal tip. One lumen is used for inflation of the balloon and accessed via the side leg port. The second lumen, starting at the straight entry port, allows access to the distal tip of the catheter for guide wire insertion. The three products of the non-compliant PTA (OTW type) balloon catheter family have different diameter of the guide wire port from max.0.014" to 0.035". The guide wire compatibility was shown in table 1. The balloon has radiopaque markers for positioning the balloon relative to the stenosis. The radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. The balloon is dilated using the side leg port, at which the balloon material expands to a known diameter at specific pressure. The working pressure range for the balloon is between the nominal size pressure and the rated burst pressure. All balloons distend to sizes above the nominal size at pressures greater than the nominal pressure. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

The provided text is a 510(k) summary for the BrosMed Medical Co., Ltd.'s Castor, Achilles, and Hermes NC PTA Balloon Dilatation Catheters. This document details the regulatory approval process for a medical device by demonstrating its substantial equivalence to previously cleared predicate devices.

It is crucial to understand that this document describes the acceptance criteria and study results for a medical device (balloon dilatation catheters), NOT for an Artificial Intelligence (AI) device. The questions posed in your prompt (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone algorithm performance) are highly specific to AI/Machine Learning model evaluations, which are not applicable to the traditional medical device approval process described here.

Therefore, I cannot directly answer your questions as they relate to AI. However, I can extract the information relevant to the device's performance and acceptance criteria as presented in a traditional medical device context:

Here's a breakdown of the acceptance criteria and performance as described for these PTA Balloon Dilatation Catheters, framed as closely as possible to your request, while acknowledging the inherent differences:

The study conducted was a series of in-vitro performance tests and biocompatibility tests to demonstrate that the device meets predetermined acceptance criteria and is substantially equivalent to predicate devices. There is no mention of an "AI" component, data sets for training/testing AI models, or human expert consensus for "ground truth" derived from imaging.

Acceptance Criteria and Reported Device Performance (Table)

For a medical device like a balloon dilatation catheter, acceptance criteria are typically engineering specifications, material properties, and functional performance benchmarks. The document states that "The test results met all acceptance criteria, were similar to predicate devices, and ensure that the PTA balloon catheter design and construction are suitable for its intended use." Specific numerical acceptance criteria are not detailed in this public summary, but the types of tests conducted demonstrate the areas where performance was evaluated.

Specific parameters evaluated include: |
| Dimensional Verification | Met acceptance criteria. |
| Balloon Preparation | Met acceptance criteria. |
| Deployment & Retraction | Met acceptance criteria. |
| Balloon Rated Burst Pressure | Met acceptance criteria. (Rated Burst Pressure (RBP) stated as 18, 20, 22 atm for all models). The actual test result met or exceeded this. |
| Balloon Fatigue | Met acceptance criteria. |
| Balloon Compliance | Met acceptance criteria. |
| Balloon Inflation/Deflation | Met acceptance criteria. |
| Catheter Bond Strength | Met acceptance criteria. |
| Tip Pull Strength | Met acceptance criteria. |
| Flexibility & Kinking | Met acceptance criteria. |
| Torque Strength | Met acceptance criteria. |
| Radiopacity | Met acceptance criteria. |
| Coating Integrity | Met acceptance criteria. |
| Particulate Evaluation | Met acceptance criteria. |
| Balloon Burst (in stents) | Met acceptance criteria. |
| Balloon Fatigue (in stents) | Met acceptance criteria. |
| Biocompatibility | "The test results met all acceptance criteria..." Again, specific quantitative details are not provided, but the umbrella statement indicates successful performance.

Specific tests include: |
| Cytotoxicity | Met acceptance criteria. |
| Sensitization | Met acceptance criteria. |
| Hemocompatibility | Met acceptance criteria. |
| Pyrogenicity | Met acceptance criteria. |
| Acute Systemic Toxicity | Met acceptance criteria. |
| Intracutaneous Reactivity | Met acceptance criteria. |
| Genotoxicity | Met acceptance criteria (bacterial mutagenicity and in vitro mouse lymphoma). |

Since the device is a physical medical instrument and not an AI algorithm, most of your specific AI-related questions (2-9) are not directly applicable. However, I can provide the closest equivalent information from the document:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: The document does not specify exact sample sizes for each in-vitro or biocompatibility test. It generally states that "tests were conducted on the PTA balloon catheter." For physical device testing, sample sizes are typically determined by engineering and statistical principles to ensure sufficient data for reliability and statistical significance, but these are not disclosed in this summary.
• Data Provenance: The tests are performed by the manufacturer, BrosMed Medical Co., Ltd., based in Dongguan, China. The data originates from these internal, pre-market validation studies. All tests are inherently "prospective" in the sense that they are designed and executed to specifically test the device's performance against predefined criteria.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• This question is not applicable. "Ground truth" in the context of this device refers to objective measurements and adherence to engineering specifications and biological safety standards (e.g., a balloon bursting at or above its rated pressure, or a material not causing a cytotoxic reaction). There is no "expert consensus" in the sense of human interpretation of complex medical data for performance claims, as would be the case for an AI diagnostic tool.

4. Adjudication Method for the Test Set:

• This question is not applicable. Performance is based on objective measurements against engineering specifications and validated test methods, not on human interpretation or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC study was NOT done. This type of study is specific to evaluating diagnostic tools (often imaging-based AI) where human readers (e.g., radiologists) interpret cases with and without AI assistance to measure improvement in diagnostic accuracy. This is not relevant for a balloon dilatation catheter.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• This question is not applicable as there is no algorithm or AI component to this device. Its performance is inherent to its physical design, materials, and manufacturing.

7. The Type of Ground Truth Used:

• The "ground truth" for this device's performance validation is established through:
  • Engineering Specifications: Predefined performance metrics (e.g., burst pressure, dimensions, flexibility) that the device must meet.
  • Validated Test Methods: Adherence to recognized national and international standards for medical device testing.
  • Biocompatibility Standards: Compliance with established biological safety requirements for materials in contact with the human body.
  • Comparison to Predicate Devices: Demonstrating "substantial equivalence" means showing that the device performs similarly to or better than existing, legally marketed devices.

8. The Sample Size for the Training Set:

• This question is not applicable. There is no "training set" in the context of a physical medical device. The device is designed, manufactured, and then validated through testing.

9. How the Ground Truth for the Training Set Was Established:

• This question is not applicable for the reasons stated above.

In summary, the provided document is a regulatory submission for a conventional medical device, not an AI/ML algorithm. The acceptance criteria revolve around the physical and biological performance of the catheter, and the "study" consists of a battery of engineering and biocompatibility tests designed to prove its safety and effectiveness relative to existing predicate devices.

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