(166 days)
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.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.