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

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.

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 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.

AI/ML Overview

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.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

May 30, 2019

Misonix, Inc. John Salerno VP RA/QA & CCO 1938 New Highway Farmingdale, New York 11735

Re: K190160

Trade/Device Name: neXus Ultrasonic Surgical Aspirator System Regulatory Class: Unclassified Product Code: LFL, GEI Dated: May 7, 2019 Received: May 8, 2019

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 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-reporting

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combination-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.

for

Jennifer R. Stevenson Acting Division 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) K190160

Device Name

Misonix Inc. neXus® Ultrasonic Surgical Aspirator System

Indications for Use (Describe)

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.

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

· Thoracic Surgery

Limited pulmonary reception such as segmetectomies, nonanatomical subsegmentectomies and metastatectomies.

· Wound Care

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

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

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· 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.

Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C)

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In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Misonix® Inc. neXus® Ultrasonic Surgical Aspirator System is provided below.

1. SUBMITTER

Applicant:	Misonix Inc.1938 New HighwayFarmingdale, NY
Contact:	John SalernoVP RAQA & CCOMisonix Inc.1938 New HighwayFarmingdale, NY 11735Main: 631-694-9555Direct: 631-927-9123jsalerno@misonix.com

Date Prepared:

May 6, 2019

2. DEVICE

Name of Device:	Misonix® Inc. neXus® Ultrasonic Surgical AspiratorSystem
Common or Usual Name:	Ultrasonic Surgical Aspirator System
Classification Name:	Unclassified
Regulatory Class:	Pre-Amendment, 510(k)
Product Code:Secondary Product Code:	LFL - instrument, ultrasonic surgicalGEI - electrosurgical, cutting & coagulation & accessories
FDA Panel:	General and Plastic Surgery

PREDICATE DEVICE 3.

Predicate Device: K070313 - AUSS-7 Ultrasonic Surgical Aspirator System Secondary Predicate Device: K062471 - FS 1000 RF Ultrasonic Surgical Aspirator

DEVICE DESCRIPTION 4.

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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.

5. 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.

Standard Handpiece with BoneScalpel 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 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

● Thoracic Surgery

Limited pulmonary reception such as segmetectomies, nonanatomical 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

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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 .

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.

SUBSTANTIAL EQUIVALENCE 6.

Comparison of Indications

The neXus system's indications for use statement is equivalent to the indications for use cleared for the of the predicate devices. Like the predicate devices, the neXus system is indicated for use in the fragmentation, emulsification and aspiration of both soft and hard (i.e. bone) tissue.

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The surgical specialties for neXus are a combination of the surgical specialties for both predicates and are specified by handpiece.

Technological Comparisons

The table below compares the key technological feature of the subject devices to the predicate devices.

	Subject Device	Primary PredicateDevice (K070313)	Secondary PredicateDevice (K062471)
510(k) Number	K190160	K070313	K062471
Device Name	neXus UltrasonicSurgical AspiratorSystem	AUSS-7ULTRASONICSURGICALASPIRATORSYSTEM	FS 1000 RF
ClassificationRegulation	Unclassified	Unclassified	Unclassified
ClassificationProduct Code	LFL - UltrasonicSurgical Instrument	LFL - UltrasonicSurgical Instrument	LFL - UltrasonicSurgical Instrument
Subsequent ProductCode	GEI - Electrosurgical,cutting & coagulation& accessories	N/A	GEI - Electrosurgical,cutting & coagulation &accessories
ConsoleClassification	Class 1Type BF Applied Part	Class 1Type B Applied Part	Class 1Type B Applied Part
Power Input Voltage	100-240 VAC	100-130 VAC 6.5Amps, 50/60 Hz200/250 VAC 2.25Amps, 50/60 Hz	115 VAC230 VAC
Power Input Current	5 A max	6.5 A at 100-130VAC,3.25 A at 200/250VAC	4 A max
Power InputFrequency	50/60Hz	50/60Hz	50/60Hz
Ground Leakage	500 µA (max.)	300 µA (max.)	300 µA (max.)

	Table 1: Technological Comparison
--	-----------------------------------------	--

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510(k) Summary

	Subject Device	Primary PredicateDevice (K070313)	Secondary PredicateDevice (K062471)
Vibration System	Continuous WaveFrequency:22.0-24.5 kHzAmplitude:up to 355 microns	Continuous WaveFrequency: 22.5KhzAmplitude:Up to 300 microns	Continuous WaveFrequency: 23+/-1 kHzor22-24 kHzAmplitude:up to 355 microns
Irrigation pump	Peristaltic pump	Peristaltic pump	Peristaltic pump
Pump Flow Rate	BoneScalpel andSonicOne relatedApplications, adjustablebetween:Min: 12-18 ml/minandMax: 67-85 ml/minSonaStar relatedApplications, adjustablebetween:Min: 1-3 ml/minandMax: 9-14 ml/min	BoneScalpel andSonicOne relatedApplications:Flow is adjustable, 0-100ml/min	SonaStar relatedApplications:Up to 10cc/min
Vacuum Pump	Min: 2.0 inHg or lowerMax: 25 inHgVacuum Sleep Mode:0 inHg	Max: 28" Hg Max	Min: less than 0.5" HgMax: 25" Hg
Footswitch	Wireless- On/Off Pedal forultrasound, irrigationand aspiration-Linear amplitudecontrol with the degreeof pedal depression- Flush button	Wired (connected torear panel of console),Single pedalfootswitch to activatedelivery of ultrasoundand irrigation	Wired- On/Off Pedal foramplitude, irrigation andaspiration - Flush Button- COAG with CUTlockout feature- COAG simultaneouswith ultrasound- COAG only
Console	nexus Console withtouch screen graphicaluser interface	Console withmembrane controlpanel and graphicaluser interface	Console with membranecontrol panel and LEDindicators.
	Subject Device	Primary PredicateDevice (K070313)	Secondary PredicateDevice (K062471)
Dimensions wo/Cart	11.5" H x 16" W x 17"D 292mm H x 406 mmW x 432mm D	7" H x 16" W x 19" D 180mm H x 410 mmW x 685mm D	40" H x 25" W x 19" D 102 cm H x 63.5 cm Wx 48 cm D
Weight wo/Cart	45 lbs 20.4 kg	25.6 lbs 11.6 kg	120 lb. 54.5 kg

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7. PERFORMANCE DATA

Biocompatibility Testing

The ultrasonic tip (and sheath, when applicable) are direct patient contacting devices classified as externally communicating devices, in contact with tissue, with limited contact (≤ 24h) based on their intended use. The irrigation tubing, which is in contact with the fluid path, is an indirect patient contacting device classified as externally communicating devices, in contact with tissue, with limited contact (≤ 24h).

The patient contacting components of the neXus system are the ultrasonic tip (and sheath, when applicable), which are direct patient contacting devices classified as externally communicating devices, in contact with tissue and/or bone, with limited contact duration (≤ 24h) based on their intended use. The irrigation tubing, which is in contact with the fluid path, is an indirect patient contacting device classified as externally communicating devices, in contact with tissue and/or bone, with limited contact (≤ 24h).

Biocompatibility testing (Cytotoxicity, Irritation, Sensitization, System Toxicity, and Pyrogenicity) was performed in accordance with the following standards:

ISO 10993-1 Fourth edition 2009-10-15 ●
ISO 10993-5 Third edition 2009-06-01 ●
ISO 10993-7 Second edition 2008-10-15 ●
ISO 10993-10 Third edition 2010-08-01 ●
ISO 10993-11 Second edition 2006-08-15 ●
ISO 10993-12:2012 Fourth edition 2012-07-01 ●

Sterilization and Shelf Life

Single Use Disposable Components - provided Sterile

The single The Probe Kits are provided sterile and are for single use. Each contains the following basic components:

. Probe Tip assembly: titanium horn + tip, available in various sizes and types, some are provided with additional fittings, O-rings, stylets, etc.
Probe Sheath: rigid plastic or silicone ●
Tubing Set: irrigation only or irrigation + aspiration, and tubing "pucks"

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These disposable components are supplied in a combined, sterile package, based on the probe tip selected by the customer.

The submission includes the required sterilization information per FDA guidance "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile" issued January 21, 2016.

The submission also includes sterile barrier testing and device performance testing on sterilized and accelerated aged devices to support a shelf life of 3 months.

Reusable Components - End user cleaned and sterilized

All reusable handpiece parts and accessories are end user cleaned and sterilized before each use as per the validated instructions contained in the Instructions for Use of each Handpiece. The instructions for use also provide the validated expected use life for the reusable components.

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the subject device in accordance with the following standards:

ANSI/AAMI/ES 60601-1:2005 + A2:2010 + A1:2012
IEC 60601-2-2: 2017 ●
IEC 60601-1-2: 2014 ●

Software Verification and Validation Testing

Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.

Bench Testing

The following performance testing demonstrated that the device continues to meet all of the specifications and requirements that were met by the predicate devices:

Ultrasound Performance Testing ●
Irrigation Performance Testing ●
Aspiration Performance Testing ●
OEM RF Compatibility
Wireless Coexistence Testing

Animal Testing

Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device.

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Clinical Data

Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device.

CONCLUSION 8.

The substantial equivalence information provided in this submission demonstrates that the subject device is substantially equivalent to the predicate devices in both indications for use and technological characteristics. The modifications made to the system to combine the features of the primary predicate (the AUSS-7 cleared in K070313) and the secondary predicate (the FS 1000 RF cleared in K062471) into one universal platform do not change its intended use and do not raise new questions of safety or effectiveness. The biocompatibility test results demonstrate that the patient and fluid path contacting materials are biocompatible. The EMC and Electrical Safety test results demonstrate that the neXus system meets the applicable requirements for this device type. The software documentation and test results demonstrate that the neXus system has been fully verified and validated for its intended use. And finally, the performance test results demonstrate that the specifications and requirements of the subject device are substantially equivalent to the specifications and requirements of the predicate devices. Therefore, the subject device can be found substantially equivalent to the predicate devices.

Regulation Number and Section

N/A