(165 days)
Not Found
No
The document describes a surgical aspirator system that uses ultrasonic technology for tissue fragmentation and aspiration. There is no mention of AI or ML in the intended use, device description, or performance studies. The system appears to be a hardware-based device with standard software for control, not incorporating learning algorithms or data-driven decision making.
Yes
This device is intended for the fragmentation, emulsification, and aspiration of tissue in a variety of surgical specialties and for wound debridement, which are therapeutic interventions.
No
The device is an ultrasonic surgical system intended for the fragmentation, emulsification, and aspiration of tissue, primarily used in various surgical specialties for tissue removal and debridement. It does not provide diagnostic information.
No
The device description explicitly states the system includes a generator housed inside a console and a reusable handpiece, which are hardware components. The device is an ultrasonic surgical aspirator system, not a software-only application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fragmentation, emulsification, and aspiration of tissue (soft and hard) during surgical procedures and wound debridement. This is a direct surgical intervention on the patient's body.
- Device Description: The device is a surgical aspirator system with a generator, handpiece, and probes used to physically break down and remove tissue.
- Lack of Diagnostic Purpose: The device does not perform any tests on samples taken from the body to provide diagnostic information about a patient's health status. It is a therapeutic and surgical tool.
IVD devices are used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device operates in vivo (inside the body) and is used for surgical treatment.
N/A
Intended Use / Indications for Use
The Misonix Inc. neXus® Ultrasonic 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® 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 adentis, Inclusion cysts, Sebaceous cysts Abdominal area - any abnormal growth, cystic or solid, benign or maligmant, 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
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 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.
Bone Scalpel Access Handpiece with BoneScalpel Access Probe Kit
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 reception such as segmetectomies, nonanatomical subsegmentectomies and metastatectomies.
Product codes
LFL, GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Various, including external genitalia, abdominal area (ovary, fallopian tube, uterus), and thoracic (pulmonary). Wound care also indicated.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility Testing:
Cytotoxicity: ISO 10993-5
Irritation: ISO 10993-10
Sensitization: ISO 10993-10
Acute Systemic Cytotoxicity: ISO 10993-11
Pyrogenicity: USP
Sterilization and Shelf Life:
Single Use Disposable Components - provided Sterile. Sterilization method unchanged from K190160.
Reusable Components - End user cleaned and sterilized, with validated expected use life.
Shelf Life: Accelerated testing demonstrated 37-month shelf life. Real time aging studies for 13 months provided, with protocol for 37-month studies.
Electrical safety and electromagnetic compatibility (EMC):
Conducted in accordance with IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012, IEC 60601-1-2:2014, and IEC 60601-2-2:2017 (only for SonaStar handpieces with electrosurgery). No significant differences between subject and predicate device regarding compliance.
Software Verification and Validation Testing:
Documentation 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." Software considered "major" level of concern.
Bench Testing:
Ultrasound Performance Testing
Acoustic Intensity Testing
Applied Part Temperature Testing - Normal and Abnormal Operating Conditions
Hard Tissue Performance Testing
Thermal Testing of Simulated Bone Tissue on BoneScalpel Access Handpiece and Tips
Animal Testing: Not applicable.
Clinical Data: Not applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
December 13, 2021
Misonix Inc. John Salerno Vice President, Regulatory Affairs and Quality Assurance 1938 New Highway Farmingdale, New York 11735
Re: K212060
Trade/Device Name: neXus Ultrasonic Surgical Aspirator System Regulatory Class: Unclassified Product Code: LFL Dated: June 29, 2021 Received: November 9, 2021
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
1
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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 provisions (Sections (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,
Long Chen, 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
2
Indications for Use
510(k) Number (if known)
K212060
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.
The indications for use for the Standard Handpiece in combination with BoneScalpel® 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 adentis, Inclusion cysts, Sebaceous cysts Abdominal area - any abnormal growth, cystic or solid, benign or maligmant, 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
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
$\theta$
Long SonaStar Handpiece & Short SonaStar Handpiece with SonaStar Probe Kits
Indicated for use in the fragmentation, emulsification 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
3
- · 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.
Bone Scalpel Access Handpiece with BoneScalpel Access Probe Kit
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 reception such as segmetectomies, nonanatomical subsegmentectomies and metastatectomies.
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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4
510(k) Summary
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the MisonixneXus Ultrasonic Surgical Aspirator System (K212060) is provided below.
1. SUBMITTER
| Applicant: | Misonix Inc.
1938 New Highway
Farmingdale, NY 11735 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | John Salerno
Vice President of Regulatory Affairs and Quality
Assurance
Misonix Inc.
1938 New Highway
Farmingdale, NY 11735
Main: 631-694-9555
Direct: 631-927-9123
jsalerno@misonix.com |
| Submission Correspondent: | John Salerno
Vice President of Regulatory Affairs and Quality
Assurance
Main: 631-694-9555
Direct: 631-927-9123
jsalerno@misonix.com |
| Date Prepared: | November 8, 2021 |
2. DEVICE
Device Trade Name: Device Common Name: Classification Name Regulatory Class: Unclassified Product Code: LFL, GEI
neXus Ultrasonic Surgical Aspirator System Ultrasonic Surgical Aspirator System Unclassified, Pre-amendment
3. PREDICATE DEVICE
Predicate Device: K190160: Misonix neXus Ultrasonic Surgical Aspirator System
5
DEVICE DESCRIPTION 4.
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.
INTENDED USE/INDICATIONS FOR USE 5.
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 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 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 followingcystic lesions: Bartholin's cysts. Vestibular adenitis. Inclusion cvsts. 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 uterusexcept as contraindicated for uterine fibroids.
6
o Thoracic Surgery
Limited pulmonary reception such as segmetectomies, nonanatomical subsegmentectomies and metastatectomies.
o Wound Care
The neXus Ultrasonic Surgical Aspirator is also indicated for use in the debridementof 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 debridementof 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
- o 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.
Bone Scalpel Access Handpiece with BoneScalpel Access Probe Kit
7
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 o
- Plastic and Reconstructive Surgery
- General Surgery
- Orthopedic Surgery
- o Gynecology
External genitalia - condyloma - benign tumors (lipomas, fibromas, and leiomyomas)
- malignant primary and metastatic tumors of all types and the following cysticlesions: 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 uterusexcept as contraindicated for uterine fibroids.
- Thoracic Surgery ●
Limited pulmonary reception such as segmetectomies, nonanatomical subsegmentectomies and metastatectomies.
6. SUBSTANTIAL EQUIVALENCE
Comparison of Indications
| Subject Device (K212060) | Predicate Device (K190160) |
|---|---|
| BoneScalpel® Access Handpiece | Standard Handpiece |
| for use with BoneScalpel Access Probe and Tubeset Configurations | for use with BoneScalpel Probe and Tubeset Configurations |
| The Misonix Inc. neXus® Ultrasonic Surgical Aspirator System is | The Misonix Inc. neXus® Ultrasonic Surgical Aspirator System is |
| intended for the fragmentation, emulsification and aspiration of both soft | intended for the fragmentation, emulsification and aspiration of both soft |
| and hard (i.e.bone) tissue. | and hard (i.e.bone) tissue. |
| The indications for use for the Standard Handpiece in combination with | The indications for use for the Standard Handpiece in combination with |
| BoneScalpel® and SonicOne® OR probe kit accessory configurations and | BoneScalpel® and SonicOne® OR probe kit accessory configurations and |
| the indications for the SonaStar® long and short handpiece in combination | the indications for the SonaStar® long and short handpiece in combination |
| with SonaStar® probe kit accessory configurations are listed below. | with SonaStar® probe kit accessory configurations are listed below. |
| Standard Handpiece with BoneScalpel Probe Kits | Standard Handpiece with BoneScalpel Probe Kits |
| Indicated for use in the fragmentation and aspiration of soft and hard (e.g.: | Indicated for use in the fragmentation and aspiration of soft and hard (e.g.: |
| bone) tissue in the following surgical specialties: | bone) tissue in the following surgical specialties: |
| • Neurosurgery | • Neurosurgery |
| • Gastrointestinal and Affiliated Organ Surgery | • Gastrointestinal and Affiliated Organ Surgery |
| • Urological Surgery | • Urological Surgery |
| • Plastic and Reconstructive Surgery | • Plastic and Reconstructive Surgery |
| • General Surgery | • General Surgery |
| • Orthopedic Surgery | • Orthopedic Surgery |
8
Page 5 of 9
Subject Device (K212060)
BoneScalpel® Access Handpiece
for use with BoneScalpel Access Probe and Tubeset Configurations
. Gynecology
External genitalia - condyloma - benign tumors (lipomas, fibromas, and leiomyomas) - malignant primaryand metastatic tumors of all types and the following cvstic lesions: Bartholin's cvsts. 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 ascontraindicated for uterine fibroids.
. Thoracic Surgery
Limited pulmonary reception such as segmetectomies,nonanatomical subsegmentectomies and metastatectomies.
. Wound Care
The neXus Ultrasonic Surgical Aspirator is also indicatedfor 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 indicatedfor 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 withSonaStar 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
- o Gastrointestinal and Affiliated Organ Surgery
- . Urological Surgery
- . Plastic and Reconstructive Surgery General Surgery
- o Orthopedic Surgery
- . Gynecological Surgery except as contraindicated foruterine fibroids.
- o Thoracic Surgery
- . Laparoscopic Surgery
- 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 Kit
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
- o Urological Surgery
- . Plastic and Reconstructive Surgery
- . General Surgery
Predicate Device (K190160) Standard Handpiece
for use with BoneScalpel Probe and Tubeset Configurations
Gynecology
External genitalia - condyloma - benign tumors (lipomas, fibromas, and leiomyomas) - malignant primaryand metastatic tumors of all types and the following cysticlesions: Bartholin's cvsts. 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 ascontraindicated for uterine fibroids.
Thoracic Surgery
Limited pulmonary reception such as segmetectomies,nonanatomical subsegmentectomies and metastatectomies.
Wound Care
.
The neXus Ultrasonic Surgical Aspirator is also indicatedfor 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 indicatedfor 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 withSonaStar 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 foruterine fibroids.
-
. Thoracic Surgery
-
. Laparoscopic Surgery
-
Thoracoscopic Surgery
The SonaStar Handpieces may also be combined with electrosurgery using optional RF surgery interface components.
9
| Subject Device (K212060)
BoneScalpel® Access Handpiece
for use with BoneScalpel Access Probe and Tubeset Configurations | Predicate Device (K190160)
Standard Handpiece
for use with BoneScalpel Probe and Tubeset Configurations |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| • 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 ascontraindicated for
uterine fibroids. | |
| • Thoracic Surgery | |
| Limited pulmonary reception such as segmetectomies, nonanatomical
subsegmentectomies andmetastatectomies. | |
Technological Comparisons
The table below compares the key technological feature of the subject devices to the predicate device (Misonix neXus Ultrasonic Surgical Aspirator System, K190160).
| Subject Device | Predicate Device (K190160) | |
|---|---|---|
| Classification Product Code | LFL | LFL |
| Subsequent Product Code | GEI | GEI |
| Console Classification | Class 1 | |
| Type BF Applied Part | Class 1 | |
| Type BF Applied Part | ||
| Power Input Voltage | 100-240 VAC | 100-240 VAC |
| Power Input Current | 5 A max | 5 A max |
| Power Input Frequency | 50/60Hz | 50/60Hz |
| Ground Leakage | 500 μA (max.) | 500 μA (max.) |
| Vibration System | Continuous WaveFrequency: | |
| 22.0-24.5 kHz |
Amplitude:
up to 355 microns | Continuous WaveFrequency:
22.0-24.5 kHz
Amplitude:
up to 355 microns |
| | Subject Device | Predicate Device (K190160) |
| Irrigation Flow
Rate | Adjustable between:
Min: 1-3 ml/min
and
Max: 67-85 ml/min | Standard Handpiece:
BoneScalpel and SonicOne related Applications,
adjustable between:
Min: 12-18 ml/min
and
Max: 67-85 ml/min
SonaStar Short Handpiece:
SonaStar related Applications, adjustable between:
Min: 1-3 ml/min
and
Max: 9-14 ml/min |
| Vacuum Pump | Min: 2.0 inHg or lower
Max: 25 inHg
Vacuum Sleep Mode: 0 inHg | Standard Handpiece:
Not applicable
SonaStar Short Handpiece:
Min: 2.0 inHg or lower
Max: 25 inHg
Vacuum Sleep Mode: 0 inHg |
| Footswitch | Wireless
On/Off Pedal for ultrasound, irrigation, and aspiration
-Linear amplitude control with the degree of pedal
depression
Flush button
Wired
(Connected to right-hand side of the panel of console),
Single pedal footswitch to activate delivery of
ultrasoundand irrigation. | Wireless
On/Off Pedal for ultrasound, irrigation and aspiration
-Linear amplitude control with the degree of pedal
depression
Flush button
Wired
(Connected to right-hand side of the panel of console),
Single pedal footswitch to activate delivery of
ultrasoundand irrigation. |
| Console Display | neXus Console with touch screen graphical user
interface | neXus Console with touch screen graphical user
interface |
| Dimensions
wo/Cart | 11.5" H x 16" W x 17" D 292mm H x406 mm W x
432mm D | 11.5" H x 16" W x 17" D 292mm H x406 mm W x
432mm D |
| Weight wo/Cart | 45 lbs 20.4 kg | 45 lbs 20.4 kg |
Table 1: Technological Comparison
10
510(k) Summary
11
PERFORMANCE DATA 7.
Biocompatibility Testing
The ultrasonic tip (and sheath, when applicable) 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).
Thefollowing biocompatibility testing was provided for the subject device. The following testing was completed:
- Cytotoxicity: ISO 10993-5 ●
- Irritation: ISO 10993-10
- Sensitization: ISO 10993-10 ●
- Acute Systemic Cytotoxicity: ISO 10993-11
- Pyrogenicity: USP o
Sterilization and Shelf Life
Single Use Disposable Components - provided Sterile
The Probe Kits are provided sterile and are for single use. Each contains the followingbasic components:
- Probe Tip assembly: titanium horn + tip, available in various sizes and types, some areprovided with additional fittings, O-rings, stylets, etc.
- . Probe Sheath: rigid plastic or silicone
- Tubing Set: irrigation only or irrigation + aspiration, and tubing "pucks" ●
These disposable components are supplied in a combined, sterile package, based on the probe tip selected by the customer. The sterilization method is unchanged from K190160.
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.
Shelf Life
Accelerated testing performed on EtO sterilized test articles and packaging materials demonstrated that the test articles and associated sterile barrier and outer packaging are found to be acceptable for use with a 37-month shelf life. In addition, real time aging studies for 13
12
months were provided. Real time aging studies at 37-months will also be conducted and the protocol was provided.Electrical safety and electromagnetic compatibility (EMC)
Electrical safety was conducted on the subject device in accordance with the followingstandards:
- IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012
- IEC 60601-1-2:2014 ●
- o IEC 60601-2-2: 2017
There are no significant differences between the predicate device. K190160. and the subject device, as relates to compliance with IEC 60601-1:2005, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
There are no significant differences between the predicate device, K190160, and the subject device, as relates to compliance with IEC 60601-1-2:2014, Medical electrical equipment - Part1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests. Based on the analysis, emissions and immunity compliance of the neXus system are unaffected with the BoneScalpel Access handpiece, thus no further EMC testing was required.
IEC 60601-2-2:2017, Medical electrical equipment – Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories does not apply to the subject device; however, applies to the predicate neXus Ultrasonic Surgical Aspirator System with the SonaStar Long and Short Handpieces (K190160) combined with electrosurgery using optional RF surgery interface components.
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 o
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 tests were performed to support the claim of substantial equivalence:
- Ultrasound Performance Testing
- Acoustic Intensity Testing ●
- o Applied Part Temperature Testing - Normal and Abnormal Operating Conditions
- Hard Tissue Performance Testing
- Thermal Testing of Simulated Bone Tissue on BoneScalpel Access Handpiece and Tips
13
Animal Testing
Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device.
Clinical Data
Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device.
8. CONCLUSION
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. Therefore, the subject device can be found substantially equivalent to the predicate devices.