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510(k) Data Aggregation
(30 days)
Pressure Products Medical Device Manufacturing LLC.
The Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access. The Transseptal Needle is intended for single use only.
The Transseptal Sharp Needle consists of a stainless-steel needle and nitinol stylet. The needle comes in two lengths equivalent to the lengths of the TSN Transseptal Needle (predicate) - 71cm and 98cm, and two curves, Curve0 (59°) and Curve1 (72°). The size is 18 gauge with an inner diameter of .0325" at the proximal body and necks down to 21 gauge with an inner diameter of 0.0230" at the distal end with a sharp a-bevel offset tip. The transseptal sharp needle includes a 0.018" diameter nitinol stylet wire with an intermediate 0.013" section, a bulbous distal tip, and a proximal clear plastic handle with an internal mechanism configured to both provide feedback on the position of the stylet tip and as well as to maintain the stylet tip in the extended position to reduce the possibility for further penetration of the needle after the initial crossing of the septum. The components of the Transseptal Sharp Needle include the transseptal sharp needle, stylet. sterile packaqing, and labeling.
There are four model numbers for the transseptal sharp needle: CLICK071, CLICK098, CLICK171, and CLICK198. The Transseptal Sharp Needle is sterilized by 100% ethylene oxide cycle and is for single use-only. The Transseptal Sharp Needle is used in a healthcare facility/hospital.
The transseptal sharp needle is used in transseptal procedures to puncture the fossa ovalis and gain access to the left atrium through the right side of the heart. The device is used by inserting the device through a transseptal dilator assembly. The devices are inserted in the femoral vein. The transeptal sharp needle is then advanced to the fossa ovalis. This mimics the procedure with the predicate device, TSN Transseptal Needle. Both the proposed device and the predicate device (K17950) have a needle point, made of stainless steel, have similar hub and handle, and have similar dimensions, design, and functionality. The needle's duration in the body is less than 24 hours.
The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "SafeSharp Transseptal Needle." It details the device's indications for use, its comparison to a predicate device, and the performance testing conducted to demonstrate substantial equivalence.
However, the request asks for specific information related to acceptance criteria and a study that proves the device meets acceptance criteria, particularly in the context of an AI/Software as a Medical Device (SaMD).
Reading through the entire document, there is no mention of an AI or software component for the "SafeSharp Transseptal Needle." The device is a physical medical instrument (a needle and stylet) used for puncturing the interatrial septum. The performance testing outlined (visual/dimensional inspection, particulate testing, pull tests, leak testing, simulated use) are all standard engineering and material tests for a physical device, not for evaluating an AI algorithm's performance.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/SaMD.
The document does not describe:
- A table of acceptance criteria and reported device performance for an AI/SaMD.
- Sample size, data provenance, number of experts, or adjudication methods for an AI/SaMD test set.
- MRMC comparative effectiveness study or standalone AI performance.
- Type of ground truth, training set size, or how ground truth was established for an AI/SaMD.
It seems there might be a misunderstanding or a misapplication of the prompt to this specific document, which describes a conventional hardware medical device.
Ask a specific question about this device
(93 days)
Pressure Products Medical Device Manufacturing LLC.
SafeSept® is indicated for use in procedures where access to the left atrium via the transseptal technique is desired. The SafeSept® Transseptal Guidewire is intended for single use only.
The SafeSept® .018" Transseptal Guidewire is made of nitinol, a flexible memory wire material, device that is 140cm in length. The proximal end of the wire has 4 sets of laser-etched markings, which increase in quantity toward the proximal end of the wire. An echogenic marker was added along the shaft proximal to the radiopaque coil. A radiopaque coil located along the shaft, made of a platinum/tungsten alloy, aids in visual quidance during transseptal procedures. The sharp distal tip is able to perforate through the fossa ovalis, a thin wall separating the right and left interatrial septum, when it is supported by a transseptal needle and dilator. When the wire is no longer supported, it is atraumatic and operates as typical quidewire.
The components of the SafeSept® include the .018" transseptal guidewire, dispenser and straightener, and sterile packaging and labeling. The model number of the subject device is SS-140. The SafeSept® .018" Transseptal Guidewire is sterilized by 100% ethylene oxide cycle and is for single use-only.
The subject device is used in transseptal procedures to gain access to the left atrium through the right side of the heart. The device is used by a surgeon by inserting the device through the femoral vein. The subject device is then advanced to the fossa ovalis with the support of the transseptal needle and dilator. The guidewire is used in conjunction with a transseptal needle and dilator. Its duration in the body is less than 24 hours. The SafeSept® .018" Transseptal Guidewire is used in a healthcare facility/hospital.
This document is a 510(k) premarket notification for a medical device called the SafeSept® Transseptal Guidewire (SS-140). It focuses on establishing substantial equivalence to a legally marketed predicate device, rather than providing a study proving performance against acceptance criteria in the context of an AI/ML device.
Therefore, the specific information requested in the prompt related to acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, and MRMC studies, which are typically associated with AI/ML device evaluations, cannot be found in this document.
The document describes the device, its intended use, and compares its technological characteristics to a predicate device. It also mentions performance testing conducted to support substantial equivalence.
Here's an analysis of what is available in the document, framed as closely as possible to your request, but with the understanding that it's for a traditional medical device, not an AI/ML system:
1. Table of Acceptance Criteria and Reported Device Performance & 6. Standalone Performance:
The document doesn't present a formal table of "acceptance criteria" with quantitative targets and reported performance outcomes in the way an AI/ML device would. Instead, it states that various performance tests were conducted to demonstrate comparability to the predicate device. The implied acceptance criterion for these tests is that the subject device's performance should be "comparable" or "similar" to the predicate.
| Test Category | Implied Acceptance Criteria (Comparable to Predicate) | Reported Device Performance |
|---|---|---|
| Bench Testing | - 'J' curve dimensions |
- Tip thickness
- Outer diameter
- Overall length
- Proximal marking locations
- Tensile and compressive forces during insertion and withdrawal
- Peak tensile forces
- Torsion withstand
- Puncture force | "These results were comparable to the predicate device."
"The subject device data was comparable to the predicate device."
"subject device was able to withstand torsional forces expected during a transseptal procedure."
"the subject device puncture force... was similar to the predicate device." |
| Integrity/Coating | - Proximal Marking Integrity - Lubrication Coating
- 2x Sterile | "Proximal marking integrity was tested according to ISO 11070 and comparable to the predicate device."
(Details on lubrication and sterile testing comparability are not explicitly stated, but implied by the overall conclusion of substantial equivalence based on performance data.) |
| Simulated Use | In Vitro Simulated Use Testing | (Details on specific outcomes not provided, but implies satisfactory performance for substantial equivalence.) |
| Packaging/Transit | - Package integrity (ASTM F88, ASTM 2096, ASTM F1929) - Transit robustness (ASTM D4169) | "packaging testing per ASTM F88, ASTM 2096, and ASTM F1929."
"Transit testing was performed per ASTM D4169... and transit testing was similar to the predicate device." |
| Biocompatibility | Same material and coating as predicate, allowing adoption of predicate's biocompatibility data. | "Biocompatibility testing was performed on the predicate device... the biocompatibility testing was adopted for the SafeSept® .018" transseptal guidewire." |
This device is not an AI/ML device, so the concept of "standalone performance" in the context of an algorithm's output (without human intervention) is not applicable here. The performance described is the standalone performance of the physical guidewire itself.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify exact sample sizes for bench testing (e.g., number of guidewires tested for dimensions, tensile strength, etc.). It refers to "the subject device data" and "the predicate device."
- Data Provenance: The tests are described as "Bench Testing" and "In Vitro Simulated Use Testing," suggesting they were conducted in a lab environment. There is no mention of country of origin for the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. This is a physical medical device, not an AI/ML system that requires expert-established ground truth for image interpretation or diagnosis. The "ground truth" for its performance is determined by physical and material testing against established standards and comparison to a predicate device.
4. Adjudication Method for the Test Set:
Not applicable. There is no expert adjudication process described, as it's not relevant for the type of testing performed on this physical device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. The device is a guidewire, not an AI system. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or mentioned.
7. Type of Ground Truth Used:
For the performance testing, the "ground truth" is based on:
- Physical and Dimensional Measurements: Conformance to specified engineering dimensions and properties.
- Mechanical Test Standards: Performance against established ISO and ASTM standards for medical devices (e.g., ISO 11070, ASTM D4169, ASTM F88, ASTM 2096, ASTM F1929).
- Comparison to Predicate Device: The primary "ground truth" for substantial equivalence is that the new device's performance is comparable to that of the legally marketed predicate device.
8. Sample Size for the Training Set:
Not applicable. This is a physical medical device, not an AI/ML system, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there's no training set for an AI/ML algorithm, this question is not relevant.
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(29 days)
Pressure Products Medical Device Manufacturing LLC
The SafeSept Blunt Needle is used in conjunction with a transseptal guidewire to puncture the interatinal septum during a transseptal catheterization procedure to gain left heart access. The SafeSept Blunt Needle is intended for single use only.
The Transseptal Extended Cannula is a stainless-steel device that comes in three lengths, 71cm, 89cm and 98cm. The body of the Transseptal Extended Cannula is equivalent to the transseptal cannula length, 69.7cm for the 71cm extended cannula, 87.7cm for the 89cm extended cannula, and 96.7cm for the 98cm extended cannula, and two distal curves, Curve0 and Curve1. The size is 18 gauge with an inner diameter of .0325" at the proximal body and necks down to 21 gauge with an inner diameter of 0.0195" at the distal end, terminating with a radiused tip. The components of the Transseptal Extended Cannula include the transseptal extended cannula, sterile packaging and labeling. There are six model numbers for the cannula: SBN071, SBN089, SBN098, SBN171, SBN189, and SBN198. The Transseptal Extended Cannula is sterilized by 100% ethylene oxide cycle and is for single use-only. The Transseptal Extended Cannula is used in a healthcare facility/hospital.
The provided text does not describe an AI/ML medical device and therefore does not contain information about acceptance criteria or studies that involved AI/ML performance.
The document is a 510(k) premarket notification for a medical device called the "SafeSept Blunt Needle" (also referred to as "Transseptal Extended Cannula"). It outlines the device's indications for use, technological characteristics, comparison to a predicate device, and performance testing data.
The performance testing listed includes:
- Visual and dimensional inspection
- Particulate testing (USP, Light Obscuration Method)
- Mating Joint Pull test (Handle to Hub)
- Mating Joint Pull test (Cannula to Extension)
- Strength of Union Cannula Hub and Cannula
- Guidewire Restriction Inspection
- Radius Tip Inspection
- Hub Female Luer Taper
- Water Leak Testing
- Air Leak Testing
- Packaging Testing
- Biocompatibility testing (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogenicity, Genotoxicity, Hemocompatibility including Hemolysis and Complement Activation)
These tests are standard for physical medical devices to ensure their safety and effectiveness in their intended use, but they do not relate to the performance of an AI/ML algorithm.
Ask a specific question about this device
(191 days)
Pressure Products Medical Device Manufacturing LLC
The Transseptal Introducer is used for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum. The Transseptal Introducer is intended for single use only.
The Transseptal Introducer consists of a high-density polvethylene (HDPE) sheath, a dilator with a lubricious hydrophobic coating, and an uncoated introducer quidewire in a dispenser. The transseptal introducer comes in two French sizes, 8F and 8.5F, two lengths, 63cm and 81cm, and two curves, LO (50°) and L1 (40°, 51°). The components of the Transseptal Introducer include the transseptal sheath, transseptal dilator, introducer guidewire with dispenser, sterile packaging and labeling. There are eight model numbers: TSIL0863, TSIL1863, TSIL0881, TSIL1881, TSIL08563, TSIL18563, TSIL08581, and TSIL18581. The Transseptal Introducer is sterilized by 100% ethylene oxide cycle and is for single-use only. The Transseptal Introducer is used in a healthcare facility/hospital.
The Transseptal Introducer is used in transseptal procedures to introduce cardiovascular catheters into the left side of the heart after transseptal access was achieved with a transseptal needle and dilator. The device is used by inserting the device through the femoral vein in conjunction with a transseptal needle. The introducer quidewire is inserted through the femoral vein and guides the needle up to the fossa ovalis in the right atrium. The needle punctures the fossa ovalis and the dilator is used to insert and dilate the fossa further where the needle has punctured. This allows the sheath to cross and creates access to the left side of the heart. The introducer's duration in the body is less than 24 hours.
Based on the provided text, the document describes a 510(k) premarket notification for a medical device (TSI Transseptal Introducer), which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving de novo clinical effectiveness. Therefore, the information typically associated with acceptance criteria and a study proving a novel device's performance (such as an AI algorithm's performance) is not present in this document.
For a 510(k) submission like this, "acceptance criteria" are generally related to engineering and performance verification tests to show the device functions as intended and is equivalent to the predicate, not clinical accuracy or diagnostic performance in the way an AI often requires. The "study" here is primarily a series of bench and biocompatibility tests, not a clinical study involving human patients or ground truth established by experts for diagnostic purposes.
Here's a breakdown of why many of your requested points cannot be answered from this document, and what is provided instead:
Information NOT Applicable/Present for this Type of Device Submission:
- Acceptance Criteria Table (Diagnostic Performance): This device is a catheter introducer, not a diagnostic tool or AI. Its "performance" is demonstrated through engineering and biocompatibility tests, not diagnostic metrics like sensitivity/specificity.
- Sample size for the test set (Diagnostic): No diagnostic test set is mentioned. The sample sizes would apply to the quantities of devices tested in bench studies.
- Data provenance (Diagnostic): Not applicable for bench tests.
- Number of experts and qualifications (Diagnostic Ground Truth): Not applicable as there's no diagnostic ground truth to establish.
- Adjudication method (Diagnostic): Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: This is typically for evaluating diagnostic tools where human readers interpret data, often with AI assistance. It's not relevant for a transseptal introducer.
- Effect size of human reader improvement with AI assistance: Not applicable as there is no AI component.
- Standalone (algorithm only) performance: Not applicable as there is no algorithm.
- Type of ground truth (expert consensus, pathology, outcomes data): Not applicable, as the "ground truth" for a device like this is its physical properties meeting specifications and biocompatibility.
- Sample size for the training set: There is no AI model or training set.
- How the ground truth for the training set was established: Not applicable.
What the Document Does Provide (Related to "Acceptance Criteria" for a Device Submission of this Type):
The "acceptance criteria" for a 510(k) of a traditional medical device are met by demonstrating substantial equivalence to a predicate device through:
- Direct Comparison of Characteristics: Showing the subject device has similar design, materials, and intended use as the predicate.
- Performance Testing: Bench tests to confirm the device functions as expected and safely.
- Biocompatibility Testing: Demonstrating the materials are safe for human contact.
1. A table of acceptance criteria and the reported device performance
As mentioned, a formal table of diagnostic acceptance criteria with specific performance metrics (like sensitivity, specificity, AUC) is not provided because this is a physical medical device, not a diagnostic algorithm.
Instead, the document lists "Performance Testing" and "Biocompatibility Data" as the studies performed to support substantial equivalence. The acceptance criterion for these tests is implicitly that the device performs equivalently or within acceptable limits to ensure safety and effectiveness, similar to the predicate.
Reported Device Performance (as stated in the document):
"The results of the testing demonstrated the subject device performed equivalently to the predicate device."
"The Transseptal Introducer met the requirements set forth in ISO-10993."
Summary of "Performance Tests" (acting as the "study" for this type of device):
| Acceptance Criteria Category / Test Type | Specific Tests Conducted | Reported Device Performance (General Statement) |
|---|---|---|
| Physical/Mechanical Performance | - Visual and dimensional inspection |
- Particulate testing (USP , Light Obscuration Method)
- Liquid leakage from sheath introducers under pressure
- Air pressure leak test
- Sideport-stopcock-hub tug test
- Sheath joint pull tests
- Guidewire restriction
- Curve template inspection
- Dilator flexibility testing
- Corrosion resistance
- Guidewire tensile strength
- Fracture and flex testing
- Curve integrity testing
- Packaging testing
- In vitro simulated use
- Surface morphology assessment | The results of the testing demonstrated the subject device performed equivalently to the predicate device. |
| Sterilization Validation | - Validated in accordance with ANSI/AAMI/ISO 11135-1 (Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of sterilization process for medical devices). | Sterilized to a SAL of 10^-6^. |
| Biocompatibility | - ISO 10993-5 Cytotoxicity - ISO 10993-10 Sensitization
- ISO 10993-10 Irritation/Intracutaneous Reactivity
- ISO 10993-11 Acute Systemic Toxicity
- ISO 10993-11 Pyrogenicity
- ISO 10993-3 Genotoxicity
- ISO 10993-4 Hemocompatibility ASTM Hemolysis Complete
- ISO 10993-4 Hemocompatibility - Complement Activation Complete with C3a & SC5b-9
- ASTM F2382-17 Partial Thromboplastin Time (PTT) testing
- Platelet/Leukocyte Count (Guideline: ASTM F2888-13) | The Transseptal Introducer met the requirements set forth in ISO-10993. (Considered an external communicating device with circulating blood contact and limited exposure (less than 24 hours)). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for each specific bench test, but implied to be sufficient for engineering validation. (e.g., "The results of the testing demonstrated...") This is typical for bench testing where the focus is on meeting specifications rather than generalizability to a patient population.
- Data Provenance: Not applicable. These are laboratory-based engineering and biological tests, not patient data from specific countries.
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)
- Not applicable. There is no ground truth established by medical experts in the context of diagnostic accuracy for this device. The "ground truth" is that the device physically meets its engineering specifications and is biocompatible.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are relevant for subjective interpretations, typically in diagnostic studies. Bench tests follow objective pass/fail criteria.
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
- No, this type of study was not done. It is not relevant for a catheter introducer.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is adherence to established engineering specifications, safety standards, and biocompatibility requirements (e.g., ISO 10993 standards) which are objectively measured.
8. The sample size for the training set
- Not applicable, as this is a physical medical device, not an AI model.
9. How the ground truth for the training set was established
- Not applicable.
Ask a specific question about this device
(148 days)
Pressure Products Medical Device Manufacturing LLC
The Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access. The Transseptal Needle is intended for single use only.
The Transseptal Needle consists of a stainless-steel needle and stylet. The needle comes in three lengths equivalent to the lengths of a conventional Brockenbrough (BRK) needle (predicate) - 71cm, 89cm, and 98cm, and two curves, Curve0 and Curve1. The needle size is 18 gauge with an inner diameter of .033" at the proximal body and necks down to 21 gauge with an inner diameter of .018" at the distal end, terminating with an angled tip. The components of the Transseptal Needle include the Transseptal Needle and Stylet, and sterile packaging and labeling. There are six model numbers for the Transseptal Needle, TSN071, TSN089, TSN098, TSN171, TSN189, and TSN198. The Transseptal Needle is sterilized by 100% ethylene oxide cycle and is for single-use only. The Transseptal Needle is used in a healthcare facility/hospital.
The Transseptal needle is used in transseptal procedures to puncture the fossa ovalis and gain access to the left atrium through the right side of the heart. The device is used by inserting the device through a transseptal dilator and sheath assembly. The devices are inserted in the femoral vein. The Transseptal needle tip is able to perforate through the fossa ovalis, a thin wall between the right and left atrium. The needle's duration in the body is less than 24 hours.
This document is a 510(k) Pre-Market Notification from the FDA for a medical device called the "TSN Transseptal Needle". The information provided pertains to the device itself and its equivalence to a predicate device, not to an AI/ML-based diagnostic or prognostic tool. Therefore, the questions regarding acceptance criteria, study details, expert involvement, MRMC studies, standalone performance, and ground truth establishment, which are typical for AI/ML device evaluations, are not applicable to this document.
The document discusses the substantial equivalence of the TSN Transseptal Needle to a legally marketed predicate device (St. Jude Medical, BRK Transseptal Needle, K122587). The focus is on the needle's design, materials, indications for use, and performance testing related to its physical and functional characteristics.
Here’s a breakdown of what is available and why the requested information is not applicable:
- Device: TSN Transseptal Needle
- Purpose: To puncture the interatrial septum during transseptal catheterization.
- Regulatory Classification: Class II, Product Code DRC (Trocar, 21 CFR 870.1390).
Why the Requested Information is Not Applicable:
The provided text describes a mechanical medical device, not an AI/ML system. The concept of "acceptance criteria" in this context refers to engineering specifications and performance tests ensuring the device's physical integrity, functionality (e.g., puncture force, guidewire passage), and biocompatibility, rather than diagnostic accuracy or algorithmic performance.
Therefore, the following specific points from your request cannot be answered from the provided text:
- A table of acceptance criteria and the reported device performance (in the context of AI/ML): The document lists performance tests (e.g., visual/dimensional inspection, particulate testing, mating joint pull test, water/air leak testing, biocompatibility tests). These are mechanical and material performance criteria, not AI/ML model performance metrics like sensitivity, specificity, or AUC.
- Sample sizes used for the test set and the data provenance: Not applicable to a mechanical device. The "tests" here are physical experiments on samples of the device, not a test set of patient data for an algorithm.
- Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for a physical device is established through engineering specifications and industry standards.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable, as this is for evaluating human interpretation with and without AI assistance.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as there is no algorithm.
- The type of ground truth used: For a mechanical device, ground truth relates to meeting design specifications and safety standards, established through physical testing and material science, not clinical outcomes for diagnostic accuracy.
- The sample size for the training set: Not applicable, as there is no AI/ML model to train.
- How the ground truth for the training set was established: Not applicable.
Information that is available regarding "performance testing" for this mechanical device:
- Performance Testing Categories: Visual and dimensional inspection, Particulate testing (USP), Mating Joint Pull test, Guidewire Restriction Inspection, Strength of Union Cannula Hub and Cannula, Needle Point Inspection, Hub Female Luer Taper, Water Leak Testing, Air Leak Testing, Packaging Testing.
- Biocompatibility Testing: Conducted per ISO 10993 (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogenicity, Genotoxicity, Hemocompatibility). The device met the requirements.
- Comparison to Predicate: The device was found substantially equivalent to the St. Jude Medical, BRK Transseptal Needle (K122587) in design, technological characteristics, materials, and performance testing. Key differences (reverse bevel, clear hub, stylet handle/diameter, non-skiving) are noted and presumably were addressed in the performance testing to demonstrate equivalence.
Ask a specific question about this device
(144 days)
Pressure Products Medical Device Manufacturing LLC
The Transseptal Cannula is used in conjunction with a transseptal guidewire to puncture the interatival septum during a transseptal catheterization procedure to gain left heart access. The Transseptal Cannula is intended for single use only.
The Transseptal Cannula is a stainless steel device that comes in three lengths equivalent to the body of a transseptal needle, 69.7cm for the 71cm cannula, 87.7cm for the 89cm cannula, and 96.7cm for the 98cm cannula, and two distal curves, Curve0 and Curve1. The size is 18 gauge with an inner diameter of .033" at the tip. The components of the Transseptal Cannula include the transseptal cannula, sterile packaging and labeling. There are six model numbers for the cannula: TSC071, TSC089, TSC171, TSC189, and TSC198. The Transseptal Cannula is sterilized by 100% ethylene oxide cycle and is for single use-only. The Transseptal Cannula is used in a healthcare facility/hospital.
The Transseptal Cannula is used in transseptal procedures to provide structural support to a transseptal guidewire to gain access to the left atrium through the right side of the heart. The device is used by a physician by inserting the device through a transseptal dilator and sheath assembly. The devices are inserted in the femoral vein. The transseptal quidewire is then advanced to the fossa ovalis with the support of the Transseptal Cannula and dilator. This allows physicians to use a transseptal guidewire in difficult cases where there is a particularly tough septum as the Transseptal Cannula provides the extra support needed. The cannula's duration in the body is less than 24 hours.
This FDA 510(k) summary is for a medical device called the "Needle Free Transseptal Cannula." It details the device's characteristics and compares it to a legally marketed predicate device to establish substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative manner for specific performance metrics like a cut-off value for a pull test. Instead, it lists the types of performance tests conducted, implying that the device was deemed acceptable if it passed these tests, meaning it met internal specifications or comparative standards.
Since quantitative acceptance criteria and specific reported numerical performance values are not given, the table below will list the tests performed and indicate that the device "met requirements" or "passed" as implied by the "Conclusion" section stating the device is substantially equivalent based on performance testing.
| Acceptance Criteria Category | Reported Device Performance (as implied) |
|---|---|
| Visual and dimensional inspection | Met requirements (Passed) |
| Particulate testing (USP, Light Obscuration Method) | Met requirements (Passed) |
| Mating Joint Pull test (Handle to Hub) | Met requirements (Passed) |
| Guidewire Restriction Inspection | Met requirements (Passed) |
| Strength of Union Cannula Hub and Cannula | Met requirements (Passed) |
| Needle Point Inspection | Met requirements (Passed) |
| Hub Female Luer Taper | Met requirements (Passed) |
| Water Leak Testing | Met requirements (Passed) |
| Air Leak Testing | Met requirements (Passed) |
| Packaging Testing | Met requirements (Passed) |
| Biocompatibility (ISO 10993-5 Cytotoxicity) | Met requirements (Passed) |
| Biocompatibility (ISO 10993-10 Sensitization) | Met requirements (Passed) |
| Biocompatibility (ISO 10993-10 Irritation/Intracutaneous Reactivity) | Met requirements (Passed) |
| Biocompatibility (ISO 10993-11 Acute Systemic Toxicity) | Met requirements (Passed) |
| Biocompatibility (ISO 10993-11 Pyrogenicity) | Met requirements (Passed) |
| Biocompatibility (ISO 10993-3 Genotoxicity) | Met requirements (Passed) |
| Biocompatibility (ISO 10993-4 Hemocompatibility – ASTM Hemolysis) | Met requirements (Passed) |
| Biocompatibility (ISO 10993-4 Hemocompatibility Complement Activation) | Met requirements (Passed) |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not provide details on the sample size used for specific performance tests (e.g., number of units tested for pull strength, a specific number of animals or human subjects for biocompatibility). The provenance of the data is not explicitly stated in terms of country of origin, but all tests were conducted according to recognized international standards (e.g., USP , ISO 10993 series). The nature of the tests indicates that these are laboratory/bench tests rather than clinical studies with human patient data; therefore, the terms "retrospective or prospective" do not directly apply in the usual sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This section is not applicable (N/A) as the device is a mechanical instrument and the tests described are primarily material, mechanical, and biocompatibility evaluations, not diagnostic image or data interpretation that typically requires expert "ground truth" establishment.
4. Adjudication Method for the Test Set
This section is not applicable (N/A) for the same reasons as point 3. Adjudication methods (like 2+1 or 3+1) are typically used for disagreements in human expert assessments of data, which is not relevant here.
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 section is not applicable (N/A). The device is a physical medical instrument (a cannula), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or AI-related effectiveness is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable (N/A) as the device is a physical medical instrument, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests would be defined by the specifications and standards that the device had to meet (e.g., a certain pull strength, absence of particulates beyond a threshold, non-toxicity). For biocompatibility, the ground truth is established by the normative criteria outlined in the ISO 10993 standards. It is based on objective measurements and established scientific/engineering criteria rather than expert consensus on complex data or patient outcomes.
8. The Sample Size for the Training Set
This section is not applicable (N/A). As a physical medical device, there is no "training set" in the context of machine learning. The device design and manufacturing processes are validated through design verification and validation testing, not through data training.
9. How the Ground Truth for the Training Set was Established
This section is not applicable (N/A) for the same reasons as point 8.
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(90 days)
Pressure Products Medical Device Manufacturing LLC
The SafeSept® is indicated for use in procedures where access to the left atrium via the transseptal technique is desired. The SafeSept® Transseptal Guidewire is intended for single use only.
The SafeSept® Needle Free Transseptal Guidewire (SafeSept NF) is 0.031" in diameter and 180cm long and consists of a flexible memory wire material called nitinol. The components of the SafeSept NF include the 0.031" transseptal guidewire, dispenser and straightener, and sterile packaging and labeling. There is one model number for the SafeSept NF, SSNF. The SafeSept NF is sterilized by 100% ethylene oxide cvcle and is for single-use only. The SafeSept is used in a healthcare facility/hospital.
The SafeSept NF is used in transseptal procedures to gain access to the left atrium through the right side of the heart. The device is used by inserting the device through a transseptal dilator and sheath located in the femoral vein. The SafeSept NF is then advanced to the fossa ovalis with the support of the dilator and sheath. The SafeSept NF's sharp distal tip is able to perforate through the fossa ovalis, a thin wall between the right and left atrium, when it is supported by a transseptal dilator and sheath. When the wire is no longer supported, it is atraumatic and operates as a typical 0.031" diameter guidewire. A radiopaque coil located along the shaft allows for fluoroscopic visualization of the wire within the left atrium and proximal marker bands help determine the location of the quidewire tip in relation to the needle. The guidewire duration in the body is less than 24 hours.
This document is an FDA 510(k) clearance letter and summary for a medical device, the SafeSept Needle Free Transseptal Guidewire. It does not describe a study involving an algorithm or AI, nor does it present acceptance criteria and performance data for such a device. Instead, it focuses on demonstrating substantial equivalence to a legally marketed predicate device through physical and biological performance testing.
Therefore, many of the requested categories are not applicable to the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document lists performance tests but does not explicitly state quantitative acceptance criteria or raw performance data (e.g., specific tensile strength values, fracture thresholds, etc.). It only states that the device "performed equivalently to the predicate device" and "met the requirements set forth in ISO-10993."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance Testing: | |
| Visual and dimensional inspection | Performed equivalently to the predicate device |
| Particulate testing (USP , Light Obscuration Method) | Performed equivalently to the predicate device |
| Surface finish assessment | Performed equivalently to the predicate device |
| Corrosion resistance | Performed equivalently to the predicate device |
| Guidewire tensile strength | Performed equivalently to the predicate device |
| Fracture and Flex testing | Performed equivalently to the predicate device |
| Curve Integrity testing | Performed equivalently to the predicate device |
| Torque Testing | Performed equivalently to the predicate device |
| Packaging testing | Performed equivalently to the predicate device |
| Radiopacity assessment | Performed equivalently to the predicate device |
| Sterilization (ANSI/AAMI/ISO 11135-1 to SAL of 10-6) | Validated to SAL of 10-6 |
| Biocompatibility Data (ISO 10993 standards): | |
| ISO 10993-5 Cytotoxicity | Met the requirements set forth in ISO-10993 |
| ISO 10993-10 Sensitization | Met the requirements set forth in ISO-10993 |
| ISO 10993-10 Irritation/Intracutaneous Reactivity | Met the requirements set forth in ISO-10993 |
| ISO 10993-11 Acute Systemic Toxicity | Met the requirements set forth in ISO-10993 |
| ISO 10993-11 Pyrogenicity | Met the requirements set forth in ISO-10993 |
| ISO 10993-3 Genotoxicity | Met the requirements set forth in ISO-10993 |
| ISO 10993-4 Hemocompatibility ASTM Hemolysis Complete | Met the requirements set forth in ISO-10993 |
| ISO 10993-4 Hemocompatibility In-vivo Dog Thromboresistance | Met the requirements set forth in ISO-10993 |
| ISO 10993-4 Hemocompatibility Complement Activation Complete with C3a & SC5b-9 | Met the requirements set forth in ISO-10993 |
2. Sample sized 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 testing described is primarily laboratory/bench testing and animal testing for biocompatibility, not clinical data sets.
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)
Not applicable. This is not an AI/algorithm study involving expert review for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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
Not applicable. This document does not describe an AI device or an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/algorithm device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the performance testing, the "ground truth" would be the established engineering and ISO standards/requirements for the mechanical and biological properties of the device, and the performance of the predicate device.
8. The sample size for the training set
Not applicable. This is not an AI/algorithm device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
Ask a specific question about this device
(228 days)
Pressure Products Medical Device Manufacturing LLC
The SafeSept is indicated for use in procedures where access to the transseptal technique is desired. The SafeSept Transseptal Guidewire is intended for single use only.
The SafeSept® Transseptal Guidewire is 0.014″ in diameter and 135cm long and consists of a flexible memory wire material called nitinol. The components of the SafeSept include the 0.014″ transseptal guidewire, dispenser and straightener, and sterile packaging and labeling. There is one model number for the SafeSept, SS-135. The SafeSept is sterilized by 100% ethylene oxide cycle and is for single-use only. The SafeSept is used in a healthcare facility/hospital.
The SafeSept is used in transseptal procedures to gain access to the left atrium through the right side of the heart. The device is used by inserting the device through the femoral vein. The SafeSept is then advanced to the fossa ovalis with the support of the needle and dilator. The SafeSept's sharp distal tip is able to perforate through the fossa ovalis, a thin wall between the right and left atrium, when it is supported by a transseptal needle and dilator. When the wire is no longer supported, it is atraumatic and operates as a typical 0.014″ diameter guidewire. A radiopaque coil located along the shaft allows for fluoroscopic visualization of the wire within the left atrium and proximal marker bands help determine the location of the guidewire tip in relation to the tip of the needle. The guidewire's duration in the body is less than 24 hours.
This document is a 510(k) Pre-market Notification for a medical device called the SafeSept Transseptal Guidewire. It does not describe an AI/ML powered device, therefore, the requested information about acceptance criteria and studies does not apply in the context of an algorithmic device.
The document discusses the substantial equivalence of the SafeSept Transseptal Guidewire to a legally marketed predicate device (Oscor, SafeSept® Transseptal Trocar Guidewire, K081986). The primary difference noted is the length of the guidewire.
Here's an overview of the performance and biocompatibility testing conducted to support substantial equivalence:
Performance Testing:
- Visual and dimensional inspection
- Particulate testing (USP , Light Obscuration Method)
- Surface finish assessment
- Corrosion resistance
- Guidewire tensile strength
- Fracture and Flex testing
- Curve Integrity testing
- Torque Testing
- Packaging testing
- Radiopacity assessment
- Sterilization validation (in accordance with ANSI/AAMI/ISO 11135-1)
These tests demonstrated that the subject device performed equivalently to the predicate device.
Biocompatibility Testing (in accordance with FDA 510(k) Memorandum #G95-1 and ISO 10993):
- ISO 10993-5 Cytotoxicity
- ISO 10993-10 Sensitization
- ISO 10993-10 Irritation/Intracutaneous Reactivity
- ISO 10993-11 Acute Systemic Toxicity
- ISO 10993-11 Pyrogenicity
- ISO 10993-3 Genotoxicity
- ISO 10993-4 Hemocompatibility - ASTM Hemolysis Complete
- ISO 10993-4 Hemocompatibility - In-vivo Dog Thromboresistance
- ISO 10993-4 Hemocompatibility Complement Activation Complete with C3a & SC5b-9
The SafeSept transseptal guidewire is categorized as an external communicating device with circulating blood contact and limited exposure (less than 24 hours), and it met the requirements of ISO-10993.
Regarding your specific questions related to AI/ML powered devices:
- Acceptance Criteria & Device Performance Table: Not applicable as this is not an AI/ML device. The document primarily focuses on demonstrating substantial equivalence to a predicate device through physical and biological performance testing, rather than an algorithmic performance.
- Sample size for test set and data provenance: No "test set" in the context of an algorithm. Performance tests were conducted on the device itself.
- Number of experts for ground truth: Not applicable. Ground truth for an AI/ML algorithm is not relevant here.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for training set: Not applicable.
- How ground truth for training set was established: Not applicable.
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