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510(k) Data Aggregation
(166 days)
Galvanize Therapeutics, Inc.
The INUMI™ Flex Needle is intended for use as part of the Aliya™ System for surgical ablation of soft tissue.
The INUMI™ Flex Needle (subject device) is an endoscopically compatible soft tissue ablation device that is used as part of the 510(k)-cleared Aliya™ System (K212871). The subject device has a 160 cm working length, and is compatible with endoscope working channels with a minimum of 2.0 mm diameter.
This is a 510(k) premarket notification for the INUMI™ Flex Needle, an electrosurgical cutting and coagulation device. The document focuses on demonstrating substantial equivalence to a predicate device, not on specific acceptance criteria typically associated with AI/ML device performance. Therefore, many of the requested details related to AI/ML device studies (e.g., effect size of human readers with AI, standalone algorithm performance, number of experts for ground truth, adjudication methods, training set details) are not applicable or not provided in this regulatory submission.
However, based on the provided text, I can extract information related to the performance testing conducted for this medical device to demonstrate its safety and effectiveness.
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide a direct table of specific numerical acceptance criteria. Instead, it describes various performance tests conducted and generally states that the device "demonstrated compliance," "conforms to predefined specifications," or "supports a determination of substantial equivalence."
| Category | Acceptance Criteria (Implicit/General Statement) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1 and FDA Guidance on "Biological Evaluation of Medical Devices" for patient-contacting components. | "Biocompatibility testing was performed for patient-contacting components of the INUMI™ Flex Needle in accordance with ISO 10993-1 requirements, as well as the FDA Guidance Document... September 2023." (Implies compliance was achieved). |
| Sterilization | Achieve a sterility assurance level (SAL) of 10-6 using ethylene oxide sterilization per ISO 11135:2014. | "The INUMI™ Flex Needle was validated per ISO 11135:2014 to achieve a sterility assurance level of 10-6 using ethylene oxide sterilization." |
| Shelf-Life/Package Validation | Maintain package integrity and sterility, in accordance with applicable standards (ASTM F1980-21, ISTA 3A 2018, ASTM F2096-11, ASTM F1929-15, ASTM F88/F88M-21). | "Shelf-Life and Package Validation were performed to ensure that the devices maintain package integrity and sterility. Applicable standards were used..." (Implies successful maintenance). |
| Electrical Safety and EMC | Compliance with applicable standards, including IEC 60601-1 and IEC 60601-1-2. | "Electrical safety and EMC testing was completed for the applicable components of the INUMI™ Flex Needle. The results demonstrated compliance to all applicable standards, including IEC 60601-1 and IEC 60601-1-2." |
| Capacitive Coupling | Compliance with applicable clauses of IEC 60601-2-18, per FDA Guidance on Premarket Notifications (510(k)) Submissions for Electrosurgical Devices for General Surgery. | "Capacitive coupling testing was done per FDA Guidance... according to the applicable clauses of IEC 60601-2-18." (Implies compliance was achieved). |
| Mechanical & Electrical Performance | Conformance to predefined mechanical and electrical specifications after sterilization and accelerated aging. | "Mechanical and Functional testing was completed to confirm that the performance of the INUMI™ Flex Needle conforms to the predefined mechanical and electrical specifications after sterilization and accelerated aging." |
| Ex Vivo Thermal Effects (Tissue) | Measurement of temperature-time history consistent with FDA Guidance, with comparative testing demonstrating substantial equivalence. | "The temperature-time history was measured consistent with the recommendations of the FDA Guidance... in three types of ex-vivo porcine tissue - liver, kidney, and muscle. Comparative testing was performed with the subject device and the primary predicate device." (Implies favorable comparison). |
| Comparative Ablation Performance (Animal Model) | Characterize tissue destruction with subject device and primary predicate device in accordance with FDA guidance, supporting substantial equivalence. | "Porcine model was utilized to characterize tissue destruction with subject device and the primary predicate device in the liver, kidney, and longissimus dorsi skeletal muscle in accordance with the FDA quidance..." (Implies favorable characterization and comparison). |
| Endoscopic Performance (Animal Model) | Evaluate navigation, access, and ablation of target tissues during endoscopic use. | "A chronic porcine GLP study was conducted to evaluate the performance of the endoscopic use of subject device regarding navigation, access, and ablation of target tissues." (Implies successful evaluation and performance). |
2. Sample size used for the test set and the data provenance:
- Biocompatibility: Not specified as a numerical sample size. Testing was performed on "patient-contacting components."
- Sterilization: Not specified (often involves multiple runs/batches to reach SAL 10^-6).
- Shelf-Life/Package Validation: Not specified (typically involves multiple packages/units).
- Electrical Safety, EMC, Capacitive Coupling, Mechanical/Electrical Performance: Not specified (typically involves a representative number of devices or components).
- Ex Vivo Characterization of Thermal Effects on Tissue: Tested in "three types of ex-vivo porcine tissue - liver, kidney, and muscle." The number of samples per tissue type is not specified. Data Provenance: Ex-vivo porcine tissue.
- Comparative Ablation Performance (Animal): A "Porcine model" was utilized. The number of animals or specific lesions is not stated. Data Provenance: Porcine (animal model).
- Endoscopic Performance (Animal): A "chronic porcine GLP study" was conducted. The number of animals is not stated. Data Provenance: Porcine (animal model), GLP study (implying prospective, controlled experimental design).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The studies described are primarily engineering, chemical, and animal studies, not interpretative studies requiring human expert consensus for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided. Adjudication methods are typically relevant for studies involving human interpretation or challenging diagnoses, which is not the primary focus of the performance tests outlined here for a physical medical device.
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 is not applicable. The device is an electrosurgical needle, not an AI/ML diagnostic or assistive device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical medical device, not an algorithm.
7. The type of ground truth used:
The ground truth for the various performance tests is established through:
- Compliance with validated standards: For biocompatibility (ISO 10993-1), sterilization (ISO 11135), electrical safety (IEC 60601 series), package integrity (ASTM/ISTA standards).
- Predefined mechanical and electrical specifications: For mechanical and electrical performance.
- Direct measurement and observation: For thermal effects on tissue (temperature-time history), tissue destruction, navigation, access, and ablation endpoints in animal models.
- Comparison to predicate device: For performance aspects where substantial equivalence is being demonstrated.
8. The sample size for the training set:
This is not applicable as this is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established:
This is not applicable as this is not an AI/ML device.
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(281 days)
Galvanize Therapeutics, Inc.
The Aliya System is indicated for the surgical ablation of soft tissue.
The Aliva System is designed to ablate soft tissue through the delivery of pulsed electric fields (PEF) energy to target tissue. The high frequency, short duration energy delivered to the target tissue to induce programmed cell death (apoptosis) while maintaining the cellular matrix.
The Aliya System consists of an Aliya Generator, an Aliya Ablation Device and a cardiac monitor.
Generator: The Aliya Generator is a transportable non-sterile electrical device compatible for use in the operating room environment. It consists of hardware, software, a display touch screen user interface, a power supply cord and a foot switch. It features controls to initiate and stop treatment as well as indicators to monitor the treatment and provide alerts to the user.
The Aliya Generator creates high frequency short duration energy, which is delivered to the target tissue via the Aliya Ablation Device. The Generator interfaces with the commercially available Ivy Biomedical Model 7600 cardiac monitor (Cardiac Monitor), which is provided with the Aliya System and is used in accordance with its cleared indications. The Cardiac Monitor uses a 4-lead configuration, which detects the R-wave of the electrocardiogram (ECG) signal and sends a trigger signal to the Generator for precise synchronization of energy output to the patient. This ensures reliable energy delivery synchronization with the patient's cardiac cycle thereby reducing risk of cardiac rhythm disturbances.
The Generator software includes an algorithm that interprets trigger signals from the Cardiac Monitor. The algorithm will only allow the initiation and delivery of energy output when the patient's heart rate is within acceptable limits.
Aliya Ablation Device: The Aliya Ablation Device is a monopolar electrosurgical instrument comprising the Aliya Needle and the Aliya Electrode. Both the needle and electrode are designed for sterile, single use. The Aliya Needle consists of a 19 gauge, 20cm needle with a 1 cm exposed tip and a nested stylet (which is removed once the Aliya Electrode is in position). The Aliya Electrode consists of a 21 cm probe that connects with the needle, a 3-meter cable, and a plug that connects with the Aliya Generator. When connected to the Aliya Generator, the Aliya Ablation Device delivers PEF energy to the target zone at the distal 1 cm of the needle.
The provided document does not describe the acceptance criteria or a study that proves a device meets specific performance criteria related to AI or algorithm performance (as might be expected for an AI-enabled medical device). Instead, this document is a 510(k) summary for a medical device called the "Aliya™ System," which is an electrosurgical cutting and coagulation device.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to the regulatory requirements for establishing substantial equivalence to a predicate device, primarily focusing on safety and performance through engineering and biological testing, rather than an AI model's diagnostic or predictive performance.
Therefore, the requested information about AI-related acceptance criteria, data provenance, expert-established ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set details, and ground truth establishment for an AI model cannot be extracted from this document.
The document focuses on the following types of testing and their "acceptance criteria" (implied as 'Pass' for all tests):
1. Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):
| Verification Activity | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| System Electromechanical Safety Testing | Pass | Pass |
| System Electromagnetic Compatibility Testing | Pass | Pass |
| System Ablation Tissue Effects – Ex Vivo Testing | Pass | Pass |
| Aliya Ablation Device – Electrical Test | Pass | Pass |
| Aliya Ablation Device – Mechanical Test | Pass | Pass |
| Aliya Ablation Device – Dimensional Inspection | Pass | Pass |
| Aliya Ablation Device – Packaging and Transit Test | Pass | Pass |
| Aliya Ablation Device – Shelf Life | Pass | Pass |
| Aliya Ablation Device – Biocompatibility | Pass | Pass |
| Aliya Ablation Device – Sterilization | Pass | Pass |
| Aliya Generator – System and Software Verification | Pass | Pass |
| Aliya Generator – Hardware Verification | Pass | Pass |
| Aliya Generator – Packaging and Transit Verification | Pass | Pass |
2. Sample size used for the test set and the data provenance:
- Animal Study: The document mentions "
six healthy porcine" for an in vivo animal study. This study was conducted to evaluate "safety and performance under clinically relevant operating conditions." The tissues treated were "liver, kidney, and skeletal muscle." The provenance would be experimental animal data, likely prospective as it was a study conducted specifically for this submission. The origin (country/institution) is not specified. - Ex-vivo Tissue Ablation Performance Testing: Conducted using "liver, kidney, and muscle tissue." The "sample size" in terms of number of tissue samples is not specified. Provenance is experimental, ex-vivo.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the animal study: "
three different study physicians" were involved in applying treatment. Their qualifications are not specified beyond being "study physicians." The document does not describe experts establishing ground truth in the context of diagnostic interpretation, but rather physicians performing procedures in an experimental setting. - For engineering and biological tests, "ground truth" is typically established by engineering specifications, validated test methods, and compliance with standards. No explicit "experts" (e.g., radiologists) are mentioned for establishing ground truth in a diagnostic sense.
4. Adjudication method for the test set:
- Not applicable in the context of this type of device testing. The testing described is performance, safety, and compatibility testing, not diagnostic or interpretive tasks requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. The device is not an imaging analysis or AI assistance tool for human readers. It's a surgical ablation system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable in the context of an AI algorithm. The device does have internal software (algorithm) in the Generator that "interprets trigger signals from the Cardiac Monitor" and "will only allow the initiation and delivery of energy output when the patient's heart rate is within acceptable limits." This is a functional safety algorithm, not an AI for diagnosis. The "standalone" performance for this is covered under "System and Software Verification" and "Hardware Verification" which passed.
7. The type of ground truth used:
- For the animal study: Visual inspection, "baseline and post procedure CB-CT (Cone Beam Computer Tomography) scanning procedure" to visualize treatment sites, and animal survival up to 28 days for endpoint evaluation. This is a form of in vivo outcome data and imaging-based assessment.
- For ex-vivo testing: Implied physical assessment of ablation zones in tissue.
- For other tests (electromechanical, EMC, etc.): Engineering specifications, compliance with recognized standards (listed in the document), and established test methodologies.
8. The sample size for the training set:
- Not applicable. This device is not an AI learning model that requires a "training set" in the machine learning sense. The software in the device is a rule-based algorithm, not a trainable AI model.
9. How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for an AI model. For the functional software, its "ground truth" (i.e., correct behavior) would be defined by its design specifications and validated through software verification processes.
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