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510(k) Data Aggregation
(233 days)
PHASE ONE MEDICAL
The Symetrex Long Term Hemodialysis Catheter is a symmetric tip dual lumen catheter designed for chronic hemodialysis and apheresis. It may be inserted percutaneously or by cut down. Catheters with greater than 37cm implant length are indicated for femoral placement.
The Symetrex Long Term Hemodialysis Catheter is a chronic. 15.5 French, dual lumen, radiopaque catheter made of polyurethane. It has a polyester retention cuff and two female luer adapters. The retention cuff promotes tissue ingrowth to anchor the catheter in the subcutaneous tunnel. The luer adapters are identical in color to indicate the reversibility of this catheter. This catheter features symmetrical side channels with a distal tip configuration designed to separate the intake flow from the output flow in both directions.
This document is a 510(k) Summary for the Symetrex Long Term Hemodialysis Catheter. It focuses on demonstrating substantial equivalence to predicate devices, rather than providing a detailed study proving the device meets specific acceptance criteria in the manner typically associated with clinical trial outcomes or AI/algorithm performance.
Therefore, many of the requested sections (2-6, 8-9) are not applicable or cannot be extracted from this document as it does not describe a study involving an algorithm or human readers.
Here's the information that can be extracted or deduced from the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative, measurable way for the device's functional performance. Instead, it relies on demonstrating substantial equivalence to predicate devices through comparative functional testing and material testing. The performance is reported as meeting these equivalence standards.
| Acceptance Criteria Category (Implied by equivalence) | Reported Device Performance |
|---|---|
| Intended Use Equivalence | The Symetrex Long Term Hemodialysis Catheter has the same intended use (chronic hemodialysis and apheresis) as the predicate devices. |
| Technological Characteristics Equivalence | Catheter Type: Implanted Vascular Access (Same as predicates) |
| Intended Use: Hemodialysis and Apheresis (Same as predicates) | |
| Lumen Configuration: 2 Kidney Shaped Lumens (Different from one predicate with 2 Kidney Shaped Arterial and 1 Round Venous, but deemed equivalent) | |
| Catheter O.D.: 15.5 Fr. (Same as one predicate, different from another) | |
| Arterial/Venous Access Lumens: Yes (Same as predicates) | |
| Color Coded Female Luers: No (Different from predicates, but indicates interchangeability, implying equivalent safety/functionality) | |
| Color Coded Clamp on Extensions: Yes (Different from predicates) | |
| Suture Wing on Cath. Hub: Yes (Same as predicates) | |
| Catheter Cuff for Tissue In-Growth: Yes (Same as predicates) | |
| Radiopaque Catheter Lumen: 20% Barium Sulfate (Same as predicates) | |
| Offset Tip for Arterial / Venous Separation: Symmetrical Tip (Same as one predicate, different from another with Stepped Tip, but deemed equivalent) | |
| Hub junction for catheter lumen / extension tubing: Injection Molded, One Piece Hub (Same as predicates) | |
| Dilator Provided for Catheter Insertion: 10-12 Fr. Dilator, 12-14 Fr. Dilator (Different sizes from predicates, but dilators are provided) | |
| Tunneling Tool provided for Catheter Insertion: Yes (Same as predicates) | |
| Injection Sites supplied with Catheter: Yes : Qty 2 Latex Free Injection Sites (Same as predicates) | |
| Priming Volume Printed on Female Luers: Yes: Priming Volume Printed on I.D. Tag (Different location/method than one predicate, but still provided) | |
| Catheter Identification and Reference size printed on Catheter Hub: Yes: Name of Catheter Printed on Hub (Different location than one predicate, but still provided) | |
| Safety and Effectiveness Equivalence (Non-Clinical) | Comparative functional testing to predicate devices performed based on ISO 10555-1 and FDA's Draft Guidance. Material testing included ISO 10993 Biocompatibility Testing. The device conforms to special controls mandated by 21 CFR 876.5540. Testing results revealed the subject device to be substantially equivalent to the predicate device, raising no new questions of safety and effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "comparative functional testing" and "material testing" but does not specify sample sizes or data provenance.
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)
This information is not applicable as this document does not describe a study involving expert-established ground truth for a diagnostic or AI device. The ground truth for device performance is established through engineering and material testing standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as this document does not describe a study involving human readers or adjudication.
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
This information is not applicable. This document describes a medical device (hemodialysis catheter), not an AI system or diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This document describes a medical device (hemodialysis catheter), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical testing, the "ground truth" is established by:
- ISO 10555-1 standards: These international standards define requirements for sterile, single-use intravascular catheters. Meeting these standards serves as the "ground truth" for functional performance.
- FDA's Implanted Blood Access Devices for Hemodialysis - Draft Guidance for Industry and Food and Drug Administration Staff: This guidance provides the "ground truth" for regulatory expectations and acceptable performance characteristics for such devices.
- ISO 10993 Biocompatibility Testing: These standards establish the "ground truth" for material safety and biological compatibility.
- 21 CFR 876.5540 (Special Controls): This regulation specifies the "ground truth" for mandatory controls for blood access devices.
8. The sample size for the training set
This information is not applicable as this document describes a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable as this document describes a physical medical device, not an AI model.
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