(120 days)
The Misonix Inc. neXus® Utrasonic Surgical Aspirator System is intended for the fragmentation, emulsification and aspiration of both soft and hard (i.e.bone) tissue.
The indications for use for the Standard Handpiece in combination with BoneScalpel® and SonicOne® OR probe kit accessory configurations and the indications for the SonaStar® long and short handpiece in combination with SonaStar® probe kit accessory configurations are listed below.
Standard Handpiece with BoneScalpel Probe Kits
Indicated for use in the fragmentation of soft and hard (e.g.: bone) tissue in the following surgical specialties:
- · Neurosurgery
- · Gastrointestinal and Affiliated Organ Surgery
- · Urological Surgery
- · Plastic and Reconstructive Surgery
- · General Surgery
- · Orthopedic Surgery
- · Gynecology
External genitalia - condyloma - benign tumors (lipomas, and leiomyomas) - malignant primary and metastatic tumors of all types and the following cystic lesions: Bartholin's cysts, Vestibular adenitis, Inclusion cysts, Sebaceous cysts
Abdominal area - any abnormal growth, cystic or solid, benign or malignant, involving the ovary, fallopian tube, uterus, or the supporting structures of the uterus except as contraindicated for uterine fibroids.
· Thoracic Surgery
Limited pulmonary reception such as segmetectomies, nonanatomical subsegmentectomies and metastatectomies.
· Wound Care
Indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement.
Standard Handpiece with SonicOne Probe Kits
Indicated for use in the fragmentation of soft and hard tissue (i.e. bone) in the following surgical specialty: · Wound Care
The neXus Ultrasonic Surgical Aspirator is also indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement.
Standard Handpiece with SonicOne Probe Kits
Indicated for use in the fragmentation of soft and hard tissue (i.e. bone) in the following surgical specialty: · Wound Care
The neXus Ultrasonic Surgical Aspirator is also indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement. · Plastic and Reconstructive Surgery
Long SonaStar Handpiece & Short SonaStar Handpiece with SonaStar Probe Kits Indicated for use in the fragmentation, emulsification and aspiration of both soft and hard (i.e. bone) tissue in the following surgical specialties:
- · Neurosurgery
- · Gastrointestinal and Affiliated Organ Surgery
- · Urological Surgery
- · Plastic and Reconstructive Surgery General Surgery
- · Orthopedic Surgery
- · Gynecological Surgery except as contraindicated for uterine fibroids.
- · Thoracic Surgery
- · Laparoscopic Surgery
- · Thoracoscopic Surgery
The SonaStar Handpieces may also be combined with electrosurgery using optional RF surgery interface components.
The neXus® Ultrasonic Surgical Aspirator System is intended for fragmentation, emulsification and aspiration of both soft and hard (i.e.bone) tissue. The system includes a generator housed inside the console. A reusable handpiece is plugged directly into the front panel of the console. The generator and handpiece are compatible with various single use disposable "probes" which are selected and attached to the handpiece by the end user. An irrigation unit provides sterile irrigant to the operative site. An aspiration system removes the fragmented, emulsified material and waste liquids from the operative site. Accessories include a wireless footswitch, various probe tip combinations, sterilization trays, probe covers, assembly & disassembly wrenches, irrigation tubing sets, and waste collection canisters.
The document provided is a 510(k) Pre-Market Notification from the FDA regarding the Misonix Inc. neXus® Ultrasonic Surgical Aspirator System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy from new clinical studies. Therefore, much of the information typically found in a study proving a device meets acceptance criteria for an AI/ML product (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details) will not be present.
Instead, the acceptance criteria here relate to demonstrating that the neXus Ultrasonic Surgical Aspirator System is as safe and effective as its predicate devices. The "study" referenced in the document is a series of performance tests and compliance checks against various standards.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the 510(k) submission, "acceptance criteria" are generally compliance with recognized standards and a demonstration that the device's technological characteristics are comparable to the predicate devices and that the device performs as intended. The "reported device performance" are the results of various internal and external tests that affirm this.
| Acceptance Criteria Category | Specific Criteria (from standards or comparison) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993 series for patient and fluid path contacting components. | Biocompatibility testing (Cytotoxicity, Irritation, Sensitization, System Toxicity, Pyrogenicity) was performed in accordance with ISO 10993-1, -5, -7, -10, -11, -12, and the results "demonstrate that the patient and fluid path contacting materials are biocompatible." |
| Sterilization & Shelf Life | Compliance with FDA guidance for sterile device submissions; demonstration of sterility and performance after sterilization and aging. | Submission included required sterilization information. Sterile barrier testing and device performance testing on sterilized and accelerated aged devices supported a shelf life of 3 months for single-use disposables. Validated instructions for cleaning and sterilization, and expected use life, are provided for reusable components. |
| Electrical Safety & EMC | Compliance with ANSI/AAMI/ES 60601-1, IEC 60601-2-2, and IEC 60601-1-2 standards. | Electrical safety and EMC testing were conducted. Test results "demonstrate that the neXus system meets the applicable requirements for this device type." |
| Software V&V | Compliance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" for a "major" level of concern software. | Software verification and validation testing were conducted. Documentation was provided, and test results "demonstrate that the neXus system has been fully verified and validated for its intended use." The software was considered "major" level of concern. |
| Bench Performance | Device meets all specifications and requirements met by predicate devices for ultrasound, irrigation, aspiration, RF compatibility, and wireless coexistence. | Performance testing "demonstrated that the device continues to meet all of the specifications and requirements that were met by the predicate devices" for: Ultrasound Performance, Irrigation Performance, Aspiration Performance, OEM RF Compatibility, and Wireless Coexistence Testing. Specifications for vibration system, irrigation pump flow rate, and vacuum pump flow rate are detailed and compared to predicates. |
| Substantial Equivalence | Indications for use and technological features are equivalent to predicate devices, and do not raise new questions of safety or effectiveness. | The indications for use are equivalent, and the technological comparisons (Table 1 and following text) show similar characteristics or improvements that do not raise new safety/effectiveness concerns. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable. The document describes engineering and regulatory compliance testing rather than a clinical study with a patient test set in the context of an AI/ML algorithm. The "test set" here would refer to the specific device units and components undergoing the various bench, electrical, and biocompatibility tests.
- Data Provenance: Not applicable. The data is generated from internal testing and validation processes conducted by the manufacturer (Misonix Inc.) to demonstrate compliance with standards and equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is not a study requiring expert readers to establish ground truth for image interpretation or diagnosis. The "ground truth" for this device is its performance against engineering specifications and its compliance with regulatory standards, which is assessed through laboratory testing and comparisons to predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for diagnostic accuracy, especially when establishing ground truth from multiple expert readings. This document reports on device performance and safety testing.
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 is a traditional medical device (ultrasonic surgical aspirator) without an AI component described in the submission. Therefore, no MRMC study comparing human readers with and without AI assistance was conducted or would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. As noted, this device is an ultrasonic surgical aspirator, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this submission is based on engineering specifications, regulatory standards compliance, and direct comparisons to the established performance and characteristics of predicate devices. For biocompatibility, the ground truth is defined by the parameters and pass/fail criteria of the ISO 10993 standards. For electrical safety, it's the limits set by IEC 60601 standards. For functional performance, it is meeting the specifications equivalent to or better than the predicate devices.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As this device does not involve an AI/ML component or a training set, this question is not relevant.
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