The indications for use for the Standard Handpiece in combination with BoneScalpel® and SonicOne® OR probe kit accessory configurations, the SonaStar® Long and Short handpieces in combination with SonaStar® probe kit accessory configurations, the BoneScalpel Access® handpiece with BoneScalpel Access® probe kit accessory configurations, and the SonaStar Elite Handpiece with probe kit accessory configurations are listed below.

Standard Handpiece with BoneScalpel Probe Kit
Indicated for use in the fragmentation, emulsification 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, fibromas, 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 resection such as segmentectomical subsegmentectomies and metastatectomies. · 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 and aspiration 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

neXus SonaStar Handpieces with SonaStar Probe Kits
Indicated for use in the fragmentation and aspiration of both soft and hard (i.e., bone) tissue in the following surgical specialties:
· Gastrointestinal and Affiliated Organ Surgery - including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy
· Urological Surgery - including removal of renal parenchyma during nephrectomy or partial nephrectomy

· Plastic and Reconstructive Surgery
· General Surgery - including removal of benign or malignant tumors or other unwanted tissue in open or minimally invasive general surgical procedures
· Orthopedic Surgery
· Gynecological Surgery except as contraindicated for uterine fibroids.
· Thoracic Surgery
· Laparoscopic Surgery – including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy
· Thoracoscopic Surgery
The SonaStar Handpieces may also be combined with electrosurgery using optional RF surgery interface components.

Bone Scalpel Access Handpiece with BoneScalpel Access 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 adentis, 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 resection such as segmentectomical subsegmentectomies and metastatectomies.

SonaStar Elite Handpiece with SonaStar Elite 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 - including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy
· Urological Surgery including removal of renal parenchyma during nephrectomy or partial nephrectomy
· Plastic and Reconstructive Surgery
· General Surgery - including removal of benign or malignant tumors or other unwanted tissue in open or minimally invasive general surgical procedures
Orthopedic Surgery
· Gynecological Surgery except as contraindicated for uterine fibroids.
· Thoracic Surgery
· Laparoscopic Surgery – including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy
· Thoracoscopic Surgery
The system may also be combined with electrosurgery using optional RF surgery interface components.

Device Description

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 system 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, disposable electrocautery cable, and waste collection canisters.

AI/ML Overview

Here's an analysis of the provided text to fulfill your request regarding acceptance criteria and device performance.

Important Note: The provided document is an FDA 510(k) K231117 clearance letter for the "neXus Ultrasonic Surgical Aspirator System." This type of document is a summary of the FDA's decision and the manufacturer's provided information. It does not present a detailed study report that would typically include all the specific parameters requested (like sample size for test/training sets, experts, adjudication methods, MRMC studies, effect sizes, etc.).

Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K221235). The "performance data" section primarily refers to verification and validation activities rather than a comparative clinical trial or large-scale evaluation of a new AI algorithm.

Therefore, for many of your requested points, the answer will be "Not Applicable" or "Information Not Provided in this Document," as this submission is for a modified traditional medical device, not an AI/ML-driven diagnostic or treatment planning system that would typically undergo the stringent evaluation methods you've outlined.

Acceptance Criteria and Reported Device Performance

The core of this submission is to demonstrate that the modified neXus Ultrasonic Surgical Aspirator System is substantially equivalent to its predicate device (K221235). The "acceptance criteria" here are implicitly tied to maintaining the safety and effectiveness profile of the predicate device, particularly regarding the added "Pulsed Wave, NEW" feature for the vibration system and "DTC (DYNAMIC TISSUE RESPONSE)" capability.

1. Table of Acceptance Criteria and Reported Device Performance:

Given the nature of this 510(k) summary, the acceptance criteria are not presented in a quantitative table with specific targets as one might see for an AI/diagnostic device. Instead, they are framed as demonstrating continued functionality, safety, and equivalence to the predicate. The "reported device performance" is largely qualitative, indicating that the new features function as intended and that the overall system still meets the established performance of the predicate.

Feature/Test Category	Acceptance Criteria (Implicit from 510(k) Context)	Reported Device Performance (from K231117 text)
Indications for Use	Identical to predicate device (K221235)	"The indications for use are identical." (p. 10)
Technological Features	Identical or substantially equivalent to predicate (K221235) for most components; New features function as intended without raising new safety/effectiveness concerns.	Many components listed as "Identical" (Handpieces, Principle of Operation, Materials, Accessories, Reprocessing, Probes, Sterilization, Shelf-Life, Electrosurgery, Console dimensions/weight, Power Input, Functions, Irrigation/Vacuum flow rates/specs, Footswitch, Console Display).Key Difference/New Feature: Vibration System: "Pulsed Wave, NEW" (p. 10).New GUI Setting: "DTC (DYNAMIC TISSUE RESPONSE): Off" (default) and adjustable range 1-6 (p. 16).
Biocompatibility	No new patient-contacting materials; existing biocompatibility data remains valid.	"Not applicable. There have been no modifications related to patient contacting materials, therefore the biocompatibility testing submitted under K221235 remains valid." (p. 17)
Electrical Safety & EMC	Continued compliance with relevant safety and EMC standards; minor software update does not impact electrical safety or EMC.	"No re-testing required. The change to the neXus console is considered a minor software update only. The safety and performance of the device has been validated and verified through software testing in accordance with IEC62304. There have been no device modifications related to the construction of the console or handpiece, therefore the electrical safety and EMC testing submitted under K221235 remains valid." (p. 18)
Software V&V	Software performs as intended, new features function correctly, regression testing confirms no adverse impact elsewhere. Software classification remains "major level of concern."	"Software verification and validation testing was conducted and a summary of testing provided." Specific verification tests conducted: "DTC DSP pulse mode verification," "DTC GUI verification," "Fault detection and response test using the SonaStar Elite handpiece," "neXus test and calibration (Regression testing)," "System performance verification (Regression testing)," "SonaStar Elite GUI verification (Regression testing)." (p. 18)
Bench Testing	New features function as intended and device maintains performance characteristics (e.g., tissue removal) of the predicate.	"Tissue removal test using the SonaStar Elite handpiece," "DTC mode vibration test using the SonaStar Elite handpiece." (p. 18)

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated in terms of number of "cases" or "samples" as might be seen for a diagnostic AI. For a surgical aspirator, "test set" typically refers to the physical devices and materials (e.g., tissue phantoms, actual tissue samples for bench testing) used for verification and validation. The document does not specify the quantity of these for bench testing.
Data Provenance: Not applicable in the conventional sense of patient data. The "data" here comes from internal engineering and quality testing (software V&V, electrical safety, biological compatibility assessments, and bench performance testing). These are typically conducted in a controlled lab environment by the manufacturer. No country of origin for a patient dataset. The tests are prospective as they are conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts/Qualifications: Not applicable for this type of device submission. Ground truth for a surgical tool's performance is established through engineering specifications, physical measurements, and performance against defined test methods (e.g., how effectively it removes tissue from a phantom, its vibration amplitude). Clinical "experts" (like radiologists) are not used to establish this type of ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Adjudication Method: Not applicable. This concept applies to human consensus on complex subjective data (e.g., image interpretation). For an ultrasonic surgical aspirator, performance testing involves objective measurements (e.g., output power, vibration frequency, tissue removal efficiency, software function).

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:

MRMC Study: No. This is not an AI-driven diagnostic or image-interpretation device, so MRMC studies are not relevant. This device is a surgical tool.
Effect Size of Human Improvement with AI: Not applicable for this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Standalone Performance: Not applicable as this is not an AI algorithm but a physical medical device. The "software" component is for controlling the device's functions (e.g., vibration, irrigation, aspiration). The software's performance is verified through testing its functionalities and its impact on the device's physical outputs, but not as a "standalone" interpretation tool.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.):

Type of Ground Truth: For this device, ground truth is established through:
- Engineering specifications and design requirements: The device's components and software features are designed to meet specific physical and functional performance parameters.
- Validated test methods: Performance is measured against established procedures using instruments and materials (e.g., tissue phantoms) to quantify characteristics like vibration, flow rates, and tissue ablation effectiveness.
- Comparison to predicate device: The predicate device itself acts as a "ground truth" for acceptable performance for the intended use.
- Compliance with recognized standards: Adherence to standards like IEC62304 for software and electrical safety standards.

8. The sample size for the training set:

Sample Size: Not applicable. This is not an AI/ML device that requires a "training set" of data for model development. The software is deterministic control software, subject to traditional software development and verification processes.

9. How the ground truth for the training set was established:

Ground Truth Establishment: Not applicable, as there is no training set in the context of AI/ML.

Summary

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June 23, 2023

Misonix, LLC, a Bioventus Company John Salerno Vice President of Regulatory Affairs and Ouality Assurance 1938 New Highway Farmingdale, New York 11735

Re: K231117

Trade/Device Name: neXus Ultrasonic Surgical Aspirator System Regulatory Class: Unclassified Product Code: LFL, GEI Dated: May 26, 2023 Received: May 26, 2023

Dear John Salerno:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Mark Trumbore -S

Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K231117

Device Name

neXus Ultrasonic Surgical Aspirator System

Indications for Use (Describe)

The Misonix Inc. neXus® Ultrasonic System is intended for the fragmentation, emulsification and aspiration of both soft and hard (i.e., bone) tissue.

Standard Handpiece with BoneScalpel Probe Kit

Indicated for use in the fragmentation, emulsification 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, fibromas, 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 resection such as segmentectomical subsegmentectomies and metastatectomies. · 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 and aspiration of soft and hard tissue (i.e. bone) in the following surgical specialty:

· Wound Care

neXus SonaStar Handpieces with SonaStar Probe Kits

Indicated for use in the fragmentation and aspiration of both soft and hard (i.e., bone) tissue in the following surgical specialties:

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· Gastrointestinal and Affiliated Organ Surgery - including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy

· Urological Surgery - including removal of renal parenchyma during nephrectomy or partial nephrectomy

· Plastic and Reconstructive Surgery
· General Surgery - including removal of benign or malignant tumors or other unwanted tissue in open or minimally invasive general surgical procedures
· Orthopedic Surgery
· Gynecological Surgery except as contraindicated for uterine fibroids.
· Thoracic Surgery

· Laparoscopic Surgery – including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy

· Thoracoscopic Surgery

The SonaStar Handpieces may also be combined with electrosurgery using optional RF surgery interface components.

Bone Scalpel Access Handpiece with BoneScalpel Access 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 adentis, 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 resection such as segmentectomical subsegmentectomies and metastatectomies.

SonaStar Elite Handpiece with SonaStar Elite 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 - including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy
· Urological Surgery including removal of renal parenchyma during nephrectomy or partial nephrectomy
· Plastic and Reconstructive Surgery

· General Surgery - including removal of benign or malignant tumors or other unwanted tissue in open or minimally invasive general surgical procedures

Orthopedic Surgery
· Gynecological Surgery except as contraindicated for uterine fibroids.
· Thoracic Surgery

· Thoracoscopic Surgery

The system may also be combined with electrosurgery using optional RF surgery interface components.

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Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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1. SUBMITTER

Applicant:	Misonix1938 New HighwayFarmingdale, NY 11735
Contact:	John SalernoVice President of Regulatory Affairs and QualityAssuranceMisonix1938 New HighwayFarmingdale, NY 11735Main: 631-694-9555Direct: 631-927-9123john.salerno@bioventus.com
Submission Correspondent:	John SalernoVice President of Regulatory Affairs and QualityAssuranceMisonix1938 New HighwayFarmingdale, NY 11735Main: 631-694-9555Direct: 631-927-9123john.salerno@bioventus.com
Date Prepared:	June 22, 2023

2. DEVICE

Device Trade Name: Device Common Name: Review Panel: Classification Name Regulatory Class:

neXus Ultrasonic Surgical Aspirator System Instrument, ultrasonic surgical General and Plastic Surgery Unclassified Unclassified

{6}------------------------------------------------

Product Code: LFL, GEI

PREDICATE DEVICE 3.

Predicate Device: neXus Ultrasonic Aspirator System with SonaStar Elite Handpiece (K221235)

The predicate device has not been subject to a design-related recall.

DEVICE DESCRIPTION 4.

ર. INDICATIONS FOR USE

Indications for Use Statement:

The Misonix Inc. neXus Ultrasonic 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, the SonaStar® long and short handpieces in combination with SonaStar® probe kit accessory configurations, the BoneScalpel Access™ handpiece with BoneScalpel Access™ probe kit accessory configurations, and the SonaStar Elite Handpiece with probe kit accessory configurations are listed below.

Standard Handpiece with BoneScalpel Probe Kits

Indicated for use in the fragmentation, emulsification and aspiration 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 ●

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. Gynecology

● Thoracic Surgery

Limited pulmonary resection such as segmentectomies, nonanatomical subsegmentectomies and metastatectomies.

. Wound Care

Standard Handpiece with SonicOne Probe Kits

Indicated for use in the fragmentation, emulsification and aspiration of soft and hard tissue (i.e. bone) in the following surgical specialty:

. Wound Care

. Plastic and Reconstructive Surgery

neXus SonaStar Handpieces 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 - including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy
Urological Surgery - including removal of renal parenchyma during nephrectomy or partial nephrectomy

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. Plastic and Reconstructive Surgery
. General Surgery - including removal of benign or malignant tumors or other unwanted tissue in open or minimally invasive general surgical procedures
. Orthopedic Surgery
Gynecological Surgery except as contraindicated for uterine fibroids. .
Thoracic Surgery
Laparoscopic Surgery including removal of hepatic parenchyma in laparoscopic ● hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy
. Thoracoscopic Surgery

The SonaStar Handpieces may also be combined with electrosurgery using optional RF surgery interface components.

Bone Scalpel Access Handpiece with BoneScalpel Access Probe Kits

Indicated for use in the fragmentation and aspiration 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 Surgerv
Gynecology

. Thoracic Surgery

Limited pulmonary resection such as segmentectomies, nonanatomical subsegmentectomies and metastatectomies.

{9}------------------------------------------------

SonaStar Elite Handpiece with SonaStar Elite Probe Kits

Indicated for use in the fragmentation and aspiration of soft and hard (e.g., bone) tissue in the following surgical specialties:

. Neurosurgery
Gastrointestinal and Affiliated Organ Surgery including removal of benign or . malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy
Urological Surgery - including removal of renal parenchyma during nephrectomy or partial nephrectomy
Plastic and Reconstructive Surgery ●
General Surgery including removal of benign or malignant tumors or other ● unwanted tissue in open or minimally invasive general surgical procedures
Orthopedic Surgery
Gynecological Surgery – except as contraindicated for uterine fibroids.
Thoracic Surgery
Laparoscopic Surgery including removal of hepatic parenchyma in laparoscopic ● hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy

. Thoracoscopic Surgery

The system may also be combined with electrosurgery using optional RF surgery interface components.

SUBSTANTIAL EQUIVALENCE 6.

Comparison of Indications

The indications for use are identical.

Technological Comparisons

The table below compares the key technological features of the subject devices to the predicate device (K221235, Misonix, a Bioventus Company, neXus Ultrasonic Aspirator System with SonaStar Elite Handpiece).

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	Predicate Device (K221235)	Subject Device
510(k) Number	K221235	TBD
Company	Misonix, a Bioventus company	Misonix, a Bioventus company
Device Name	neXus Ultrasonic Surgical Aspirator System	neXus Ultrasonic Surgical Aspirator System
Product Code	LFL	LFL
	Subsequent product code: GEI	Subsequent product code: GEI
Indications forUse	See Section 5	See Section 5
Handpieces	neXus® Standard Handpiece[100-21-0001]	Identical
	neXus® SonaStar® Short Handpiece[100-24-0001]	Identical
	neXus® SonaStar® Long Handpiece[100-25-0001]	Identical
	neXus® BoneScalpel Access™ Handpiece[100-22-0001]	Identical
	SonaStar Elite (SSE) Handpiece[100-26-0001]	Identical
Principle ofOperation	Handpiece-probe assembly vibrate at resonantfrequency resulting from the conversion of theelectrical drive signal from the neXus console intomechanical vibrations by the piezo stack.	Identical
Materials ofConstruction	Front Driver: Titanium alloy	Identical
	Piezo ceramics: PZT (lead zirconate titanate)	Identical
	Housing: PPSU	Identical
	Cable: Electrical conductors, electrical shield,silicone jacket	Identical
ReusableAccessories	100-60-0000Standard Handpiece Counter Wrench	Identical
	100-61-0000Standard Handpiece Torque Wrench	Identical
	100-62-0000SonaStar Handpiece Counter Wrench	Identical
	100-63-0000Handpiece Torque Wrench	Identical
Predicate Device (K221235)	Subject Device
100-64-0000Access Elite Counter Wrench	Identical
100-70-0000Standard Sterilization Tray	Identical
100-71-0000SonaStar Sterilization Tray	Identical
100-72-0000BoneScalpel Access Sterilization Tray	Identical
100-73-0000SonaStar Elite Sterilization Tray	Identical
100-21-0002Standard Front Housing (BoneScalpel)	Identical
100-21-0003Standard Front Housing (SonicOne)	Identical
100-24-0002SonaStar Long Housing (Short)	Identical
100-24-0003SonaStar Short Housing (Short)	Identical
100-24-0004SonaStar Lap Housing (Short)	Identical
100-25-0002SonaStar Mid Housing (Long)	Identical
100-25-0003SonaStar Front Housing (Long)	Identical
100-25-0002SonaStar Mid Housing (Long)	Identical
100-26-0003SonaStar Elite Front Housing Smooth
	Predicate Device (K221235)	Subject Device
Reprocessing(Cleaning &Sterilization orReusableAccessories)	Cleaning and Sterilize as per 100-21-1000Standard Handpiece IFU	Identical
	Clean and Sterilize as per 100-22-1000BoneScalpel Access Handpiece IFU	Identical
	Clean and Sterilize as per 100-24-1000SonaStar Handpiece IFU	Identical
	Clean and Sterilize as per 100-26-1000SonaStar Elite Handpiece IFU	Identical
Probes & Probe Tips
Probes cleared inK190160	110-31-1110BoneScalpel 10mm, Blunt Blade	Identical
	110-31-1120BoneScalpel 20mm, Blunt Blade	Identical
	110-31-1125BoneScalpel 25mm, Blunt Blade	Identical
	110-31-1121BoneScalpel 20mm, Uni-lateral Serrated Blade	Identical
	110-31-2110BoneScalpel 10mm MIS, Blunt Blade	Identical
	110-31-2120BoneScalpel 20mm MIS, Blunt Blade	Identical
	150-32-2120:BoneScalpel Access MIS 20mm Blade & Tubeset	Identical
	110-31-1210BoneScalpel Micro Hook Shaver	Identical
	110-31-1220BoneScalpel Macro Hook Shaver	Identical
	110-31-1230BoneScalpel Diamond Shaver	Identical
	110-31-2210BoneScalpel Micro Hook MIS Shaver	Identical
	110-31-5501Standard Decompression Kit (20mm Blade,microhook shaver & tubeset)	Identical
	130-35-1411SonaStar 1.1 mm Precision Short Tip & Tubeset	Identical
	Predicate Device (K221235)	Subject Device
	130-35-1416SonaStar 1.6 mm Micro Short Tip & Tubeset	Identical
	130-35-1419SonaStar 1.9 mm Standard Short Tip and Tubeset	Identical
	130-33-2411SonaStar 1.1 mm Precision Long Curved Tip & Tubeset	Identical
	130-33-2416SonaStar 1.6 mm Micro Long Curved Tip & Tubeset	Identical
	130-33-2419SonaStar 1.9 mm Standard Long Curved Tip & Tubeset	Identical
	130-35-1499SonaStar 1.9 mm Standard Short Tip & Tubeset	Identical
	130-33-3419SonaStar Deep Access, 1.9 mm Standard Long Tip & Tubeset	Identical
	130-35-1220SonaStar Cylindrical Shaver Short Tip withAspiration & Tubeset	Identical
	130-33-2210Micro Hook Shaver Long Tip with Aspiration andTubeset	Identical
	120-31-10X1SonicOne Hatched Probe & Tubeset	Identical
	120-31-13X2SonicOne SonicVac & Tubeset	Identical
	12931-13C2SonicOne SharpVac & Tubeset	Identical
	120-31-10R1SonicOne Cylindrical Probe & Tubeset	Identical
Probes cleared inK212060	150-32-2120:BoneScalpel Access MIS 20mm Blade & Tubeset	Identical
	150-32-2120:BoneScalpel Access MIS Micro Hook Shaver &Tubeset	Identical
	130-35-5502SonaStar Shaver, Aspirator & Tubeset Kit	Identical
	120-31-13C3SonicOne Curette Tip Excel Kit	Identical
Probes cleared inK221235	130-26-2416SonaStar Elite 1.6mm Micro Long Tip & Tubeset	Identical
	Predicate Device (K221235)	Subject Device
	130-26-2498SonaStar Elite 1.6mm Notched Long Tip &Tubeset	Identical
	130-26-2419SSE 1.9mm Standard Long Tip & Tubeset	Identical
	130-26-2499SonaStar Elite 1.9mm Notched Long Tip &Tubeset	Identical
Cleaning andSterilization ofSterile Single UseDevices	EtO SterilizationIdentical Sterilization Cycles	Identical
Shelf-Life SterileSingle Use Devices	3 YearsIdentical Sterile Barrier Packaging	Identical
Electrosurgery
ElectrosurgeryAccessory	100-29-0000SonaStar Monopolar Handswitch Cable	Identical
Console
P/N	100-10-0000neXus Console	Identical
Classification	Class 1Type BF Applied Part	Identical
Power InputVoltage	100-240 VAC	Identical
Power InputCurrent	5 A max	Identical
Power InputFrequency	50/60Hz	Identical
Ground Leakage	500 μA (max.)	Identical
Functions	VibrationIrrigationAspiration	IdenticalIdenticalIdentical
Vibration System	Continuous Wave	IdenticalPulsed Wave, NEW
	Frequency:22.0-24.5 kHz / Amplitude: up to 355 microns34.5-37.0 kHz / Amplitude: up to 206 microns	Frequency:IdenticalIdentical
Irrigation pump	Peristaltic pump	Identical
	Predicate Device (K221235)	Subject Device
Irrigation FlowRate	Standard HandpieceMin: 12-18 ml/min – Max: 67-85 ml/minFlush: 67-85 ml/min	Standard HandpieceIdentical
	SonaStar Long and Short HandpiecesMin: 1-3 ml/min – Max: 9-14 ml/minFlush: 25-29ml/min	SonaStar Long and Short HandpiecesIdentical
	Bone Scalpel Access HandpieceMin: 1-3 ml/min – Max: 67-85 ml/minFlush: 67-85 ml/min	Bone Scalpel Access HandpieceIdentical
	SonaStar Elite HandpieceMin: 1-3 ml/min – Max: 17-23 ml/minFlush: 25-29ml/min	SonaStar Elite HandpieceIdentical
Vacuum Pump	Dual Vacuum Head Pump, 24V	Identical
VacuumSpecification	Min: 2.0 inHg or lowerMax: 25 in HgVacuum Sleep Mode: 0 inHg	IdenticalIdenticalIdentical
Footswitch	100-50-0000neXus Wireless Footpedal	Identical
	100-51-0000neXus Wired Footpedal	Identical
Console Display	neXus Console with touch screen graphical userinterface	Identical

Table 1: Technological Comparison

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Console GUI	Standard Handpiece	Standard Handpiece
	DEFAULT SETTINGS	DEFAULT SETTINGS
	Vibration: 70	Identical
	Irrigation: 70	Identical
	Aspiration: Disabled	Identical
	Lap Endo Mode: Disabled	Identical
	USER SETTINGS	USER SETTINGS
	Vibration:	Vibration:
	Incremental adjustment = 5	Identical
	Range = 5 to 100%	Identical
	Irrigation:	Irrigation:
	Incremental adjustment = 5	Identical
	Range = 5 to 100%	Identical
	Aspiration:	Aspiration:
	Incremental adjustment = 5	Identical
	Range = 5 to 100%	Identical
	SonaStar HandpiecesDEFAULT SETTINGS	SonaStar Handpieces
	Vibration: 50	DEFAULT SETTINGS
	Irrigation: 50	Identical
	Aspiration: 50	Identical
	Lap Endo Mode: Off	Lap Endo Mode: Identical
	USER SETTINGS	USER SETTINGS
	Vibration:	Vibration:
	Incremental adjustment = 5	Identical
	Range = 5 to 100%	Identical
	Irrigation:	Irrigation:
	Incremental adjustment = 5	Identical
	Range = 5 to 100%	Identical
	Aspiration:	Aspiration:
	Incremental adjustment = 5	Identical
	Range = 5 to 100%	Identical
	BoneScalpel Access Handpiece	BoneScalpel Access Handpiece
	DEFAULT SETTINGS	DEFAULT SETTINGS
	Vibration: 70	Identical
	Irrigation: 70	Identical
	Aspiration: 50	Identical
	Lap Endo Mode: On	Lap Endo Mode: Identical
	USER SETTINGS	USER SETTINGS
	Vibration:	Vibration:
	Incremental adjustment = 5	Identical
	Range = 5 to 100%	Identical
	Irrigation:	Irrigation:
	Incremental adjustment = 1	Identical
	Range = 1 to 20%	Identical
	Predicate Device (K221235)	Subject Device
	Incremental adjustment = 5Range = 20 to 100%Aspiration:Incremental adjustment = 5Range = 5 to 100%	IdenticalIdenticalAspiration:IdenticalIdentical
	SonaStar Elite HandpieceDEFAULT SETTINGSVibration: 60Irrigation: 25Aspiration: 60Lap Endo Mode: Off	SonaStar Elite HandpieceDEFAULT SETTINGSIdenticalIdenticalIdenticalLap Endo Mode: Identical
		DTC (DYNAMIC TISSUE RESPONSE): Off
	USER SETTINGSVibration:Incremental adjustment = 5Range = 5 to 100%Irrigation:Incremental adjustment = 5Range = 5 to 100%Aspiration:Incremental adjustment = 5Range = 5 to 100%	USER SETTINGSVibration:Incremental adjustment = 5Range = 5 to 100%Irrigation:Incremental adjustment = 5Range = 5 to 100%Aspiration:Incremental adjustment = 5Range = 5 to 100%DTC (DYNAMIC TISSUE RESPONSE):Incremental adjustment = 1Range = 1 to 6
Console Software	v1.9 RC2	v1.10 RC0
Dimensionswo/Cart	11.5" H x 16" W x 17" D292mm H x406 mm W x 432mm D	Identical
Weight wo/Cart	45 lbs. 20.4 kg	Identical

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7. PERFORMANCE DATA

Biocompatibility Testing

Not applicable. There have been no modifications related to patient contacting materials, therefore the biocompatibility testing submitted under K221235 remains valid.

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Electrical safety and electromagnetic compatibility (EMC)

No re-testing required. The change to the neXus console is considered a minor software update only. The safety and performance of the device has been validated and verified through software testing in accordance with IEC62304. There have been no device modifications related to the construction of the console or handpiece, therefore the electrical safety and EMC testing submitted under K221235 remains valid.

Software Verification and Validation Testing

Software verification and validation testing was conducted and a summary of testing provided. The software classification for this device is unchanged as a major level of concern. The following verification tests were conducted:

DTC DSP pulse mode verification ●
DTC GUI verification ●
Fault detection and response test using the SonaStar Elite handpiece ●
neXus test and calibration (Regression testing)
System performance verification (Regression testing) ●
SonaStar Elite GUI verification (Regression testing) ●

Bench Testing

The following tests were conducted to support the claim of substantial equivalence:

. Tissue removal test using the SonaStar Elite handpiece
DTC mode vibration test using the SonaStar Elite handpiece ●

CONCLUSION 8.

Subject device modifications do not raise new questions of safety or effectiveness. Technological comparison to the predicate and performance testing on the subject device demonstrates substantial equivalence to the predicate device for the requested intended use.

Regulation Number and Section

N/A