(64 days)
No
The summary 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 software testing described is standard verification and validation, not related to AI/ML model training or evaluation.
Yes
The device is described as a surgical aspirator system intended for the fragmentation, emulsification, and aspiration of tissue in various surgical specialties and for wound debridement, which directly addresses medical conditions and aims to restore or improve health.
No
The device is an ultrasonic surgical aspirator intended for the fragmentation, emulsification, and aspiration of tissue during surgical procedures; it is a therapeutic device, not a diagnostic one.
No
The device description clearly outlines hardware components including a console, generator, handpiece, probes, irrigation system, aspiration system, and various accessories. The intended use also describes a system for fragmentation, emulsification, and aspiration of tissue, which requires physical interaction with the body.
Based on the provided information, the Misonix Inc. neXus® Ultrasonic System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the fragmentation, emulsification, and aspiration of tissue during surgical procedures. This is a direct surgical intervention on the patient's body.
- Device Description: The device is described as a surgical aspirator system with a generator, handpiece, and probes used to remove tissue from the operative site.
- Anatomical Site: The listed anatomical sites are all locations within or on the human body where surgery is performed.
- Intended User / Care Setting: The intended user is a physician in a surgical setting.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The device's function is to physically remove tissue during surgery, not to analyze biological samples.
Therefore, the Misonix Inc. neXus® Ultrasonic System is a surgical device, not an In Vitro Diagnostic device.
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® 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.
Product codes (comma separated list FDA assigned to the subject device)
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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, Gynecology (External genitalia, Abdominal area), Thoracic Surgery, Wound Care (burn wounds, diabetic ulcers, bedsores and vaginal ulcers). Hepatic parenchyma, renal parenchyma.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician, Surgical Setting
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)
Software Verification and Validation Testing:
- 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:
- Tissue removal test using the SonaStar Elite handpiece
- DTC mode vibration test using the SonaStar Elite handpiece
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.
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
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
1
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
2
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.
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:
3
· 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.
4
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
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5
1. SUBMITTER
| Applicant: | Misonix
1938 New Highway
Farmingdale, NY 11735 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | John Salerno
Vice President of Regulatory Affairs and Quality
Assurance
Misonix
1938 New Highway
Farmingdale, NY 11735
Main: 631-694-9555
Direct: 631-927-9123
john.salerno@bioventus.com |
| Submission Correspondent: | John Salerno
Vice President of Regulatory Affairs and Quality
Assurance
Misonix
1938 New Highway
Farmingdale, NY 11735
Main: 631-694-9555
Direct: 631-927-9123
john.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.
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.
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 ●
7
. 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 segmentectomies, 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, emulsification 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, 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
8
- . 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
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 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).
10
| 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 for | |||
| Use | 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 of | |||
| Operation | Handpiece-probe assembly vibrate at resonant | ||
| frequency resulting from the conversion of the | |||
| electrical drive signal from the neXus console into | |||
| mechanical vibrations by the piezo stack. | Identical | ||
| Materials of | |||
| Construction | Front Driver: Titanium alloy | Identical | |
| Piezo ceramics: PZT (lead zirconate titanate) | Identical | ||
| Housing: PPSU | Identical | ||
| Cable: Electrical conductors, electrical shield, | |||
| silicone jacket | Identical | ||
| Reusable | |||
| Accessories | 100-60-0000 | ||
| Standard Handpiece Counter Wrench | Identical | ||
| 100-61-0000 | |||
| Standard Handpiece Torque Wrench | Identical | ||
| 100-62-0000 | |||
| SonaStar Handpiece Counter Wrench | Identical | ||
| 100-63-0000 | |||
| Handpiece Torque Wrench | Identical | ||
| Predicate Device (K221235) | Subject Device | ||
| 100-64-0000 | |||
| Access Elite Counter Wrench | Identical | ||
| 100-70-0000 | |||
| Standard Sterilization Tray | Identical | ||
| 100-71-0000 | |||
| SonaStar Sterilization Tray | Identical | ||
| 100-72-0000 | |||
| BoneScalpel Access Sterilization Tray | Identical | ||
| 100-73-0000 | |||
| SonaStar Elite Sterilization Tray | Identical | ||
| 100-21-0002 | |||
| Standard Front Housing (BoneScalpel) | Identical | ||
| 100-21-0003 | |||
| Standard Front Housing (SonicOne) | Identical | ||
| 100-24-0002 | |||
| SonaStar Long Housing (Short) | Identical | ||
| 100-24-0003 | |||
| SonaStar Short Housing (Short) | Identical | ||
| 100-24-0004 | |||
| SonaStar Lap Housing (Short) | Identical | ||
| 100-25-0002 | |||
| SonaStar Mid Housing (Long) | Identical | ||
| 100-25-0003 | |||
| SonaStar Front Housing (Long) | Identical | ||
| 100-25-0002 | |||
| SonaStar Mid Housing (Long) | Identical | ||
| 100-26-0003 | |||
| SonaStar Elite Front Housing Smooth | |||
| Predicate Device (K221235) | Subject Device | ||
| Reprocessing | |||
| (Cleaning & | |||
| Sterilization or | |||
| Reusable | |||
| Accessories) | Cleaning and Sterilize as per 100-21-1000 | ||
| Standard Handpiece IFU | Identical | ||
| Clean and Sterilize as per 100-22-1000 | |||
| BoneScalpel Access Handpiece IFU | Identical | ||
| Clean and Sterilize as per 100-24-1000 | |||
| SonaStar Handpiece IFU | Identical | ||
| Clean and Sterilize as per 100-26-1000 | |||
| SonaStar Elite Handpiece IFU | Identical | ||
| Probes & Probe Tips | |||
| Probes cleared in | |||
| K190160 | 110-31-1110 | ||
| BoneScalpel 10mm, Blunt Blade | Identical | ||
| 110-31-1120 | |||
| BoneScalpel 20mm, Blunt Blade | Identical | ||
| 110-31-1125 | |||
| BoneScalpel 25mm, Blunt Blade | Identical | ||
| 110-31-1121 | |||
| BoneScalpel 20mm, Uni-lateral Serrated Blade | Identical | ||
| 110-31-2110 | |||
| BoneScalpel 10mm MIS, Blunt Blade | Identical | ||
| 110-31-2120 | |||
| BoneScalpel 20mm MIS, Blunt Blade | Identical | ||
| 150-32-2120: | |||
| BoneScalpel Access MIS 20mm Blade & Tubeset | Identical | ||
| 110-31-1210 | |||
| BoneScalpel Micro Hook Shaver | Identical | ||
| 110-31-1220 | |||
| BoneScalpel Macro Hook Shaver | Identical | ||
| 110-31-1230 | |||
| BoneScalpel Diamond Shaver | Identical | ||
| 110-31-2210 | |||
| BoneScalpel Micro Hook MIS Shaver | Identical | ||
| 110-31-5501 | |||
| Standard Decompression Kit (20mm Blade, | |||
| microhook shaver & tubeset) | Identical | ||
| 130-35-1411 | |||
| SonaStar 1.1 mm Precision Short Tip & Tubeset | Identical | ||
| Predicate Device (K221235) | Subject Device | ||
| 130-35-1416 | |||
| SonaStar 1.6 mm Micro Short Tip & Tubeset | Identical | ||
| 130-35-1419 | |||
| SonaStar 1.9 mm Standard Short Tip and Tubeset | Identical | ||
| 130-33-2411 | |||
| SonaStar 1.1 mm Precision Long Curved Tip & Tubeset | Identical | ||
| 130-33-2416 | |||
| SonaStar 1.6 mm Micro Long Curved Tip & Tubeset | Identical | ||
| 130-33-2419 | |||
| SonaStar 1.9 mm Standard Long Curved Tip & Tubeset | Identical | ||
| 130-35-1499 | |||
| SonaStar 1.9 mm Standard Short Tip & Tubeset | Identical | ||
| 130-33-3419 | |||
| SonaStar Deep Access, 1.9 mm Standard Long Tip & Tubeset | Identical | ||
| 130-35-1220 | |||
| SonaStar Cylindrical Shaver Short Tip with | |||
| Aspiration & Tubeset | Identical | ||
| 130-33-2210 | |||
| Micro Hook Shaver Long Tip with Aspiration and | |||
| Tubeset | Identical | ||
| 120-31-10X1 | |||
| SonicOne Hatched Probe & Tubeset | Identical | ||
| 120-31-13X2 | |||
| SonicOne SonicVac & Tubeset | Identical | ||
| 12931-13C2 | |||
| SonicOne SharpVac & Tubeset | Identical | ||
| 120-31-10R1 | |||
| SonicOne Cylindrical Probe & Tubeset | Identical | ||
| Probes cleared in | |||
| K212060 | 150-32-2120: | ||
| BoneScalpel Access MIS 20mm Blade & Tubeset | Identical | ||
| 150-32-2120: | |||
| BoneScalpel Access MIS Micro Hook Shaver & | |||
| Tubeset | Identical | ||
| 130-35-5502 | |||
| SonaStar Shaver, Aspirator & Tubeset Kit | Identical | ||
| 120-31-13C3 | |||
| SonicOne Curette Tip Excel Kit | Identical | ||
| Probes cleared in | |||
| K221235 | 130-26-2416 | ||
| SonaStar Elite 1.6mm Micro Long Tip & Tubeset | Identical | ||
| Predicate Device (K221235) | Subject Device | ||
| 130-26-2498 | |||
| SonaStar Elite 1.6mm Notched Long Tip & | |||
| Tubeset | Identical | ||
| 130-26-2419 | |||
| SSE 1.9mm Standard Long Tip & Tubeset | Identical | ||
| 130-26-2499 | |||
| SonaStar Elite 1.9mm Notched Long Tip & | |||
| Tubeset | Identical | ||
| Cleaning and | |||
| Sterilization of | |||
| Sterile Single Use | |||
| Devices | EtO Sterilization | ||
| Identical Sterilization Cycles | Identical | ||
| Shelf-Life Sterile | |||
| Single Use Devices | 3 Years | ||
| Identical Sterile Barrier Packaging | Identical | ||
| Electrosurgery | |||
| Electrosurgery | |||
| Accessory | 100-29-0000 | ||
| SonaStar Monopolar Handswitch Cable | Identical | ||
| Console | |||
| P/N | 100-10-0000 | ||
| neXus Console | Identical | ||
| Classification | Class 1 | ||
| Type BF Applied Part | Identical | ||
| Power Input | |||
| Voltage | 100-240 VAC | Identical | |
| Power Input | |||
| Current | 5 A max | Identical | |
| Power Input | |||
| Frequency | 50/60Hz | Identical | |
| Ground Leakage | 500 μA (max.) | Identical | |
| Functions | Vibration | ||
| Irrigation | |||
| Aspiration | Identical | ||
| Identical | |||
| Identical | |||
| Vibration System | Continuous Wave | Identical | |
| Pulsed Wave, NEW | |||
| Frequency: | |||
| 22.0-24.5 kHz / Amplitude: up to 355 microns | |||
| 34.5-37.0 kHz / Amplitude: up to 206 microns | Frequency: | ||
| Identical | |||
| Identical | |||
| Irrigation pump | Peristaltic pump | Identical | |
| Predicate Device (K221235) | Subject Device | ||
| Irrigation Flow | |||
| Rate | Standard Handpiece | ||
| Min: 12-18 ml/min – Max: 67-85 ml/min | |||
| Flush: 67-85 ml/min | Standard Handpiece | ||
| Identical | |||
| SonaStar Long and Short Handpieces | |||
| Min: 1-3 ml/min – Max: 9-14 ml/min | |||
| Flush: 25-29ml/min | SonaStar Long and Short Handpieces | ||
| Identical | |||
| Bone Scalpel Access Handpiece | |||
| Min: 1-3 ml/min – Max: 67-85 ml/min | |||
| Flush: 67-85 ml/min | Bone Scalpel Access Handpiece | ||
| Identical | |||
| SonaStar Elite Handpiece | |||
| Min: 1-3 ml/min – Max: 17-23 ml/min | |||
| Flush: 25-29ml/min | SonaStar Elite Handpiece | ||
| Identical | |||
| Vacuum Pump | Dual Vacuum Head Pump, 24V | Identical | |
| Vacuum | |||
| Specification | Min: 2.0 inHg or lower | ||
| Max: 25 in Hg | |||
| Vacuum Sleep Mode: 0 inHg | Identical | ||
| Identical | |||
| Identical | |||
| Footswitch | 100-50-0000 | ||
| neXus Wireless Footpedal | Identical | ||
| 100-51-0000 | |||
| neXus Wired Footpedal | Identical | ||
| Console Display | neXus Console with touch screen graphical user | ||
| interface | Identical |
Table 1: Technological Comparison
11
12
13
14
15
16
| 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 Handpieces | ||
| DEFAULT 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 = 5 | ||
| Range = 20 to 100% | ||
| Aspiration: | ||
| Incremental adjustment = 5 | ||
| Range = 5 to 100% | Identical | |
| Identical | ||
| Aspiration: | ||
| Identical | ||
| Identical | ||
| SonaStar Elite Handpiece | ||
| DEFAULT SETTINGS | ||
| Vibration: 60 | ||
| Irrigation: 25 | ||
| Aspiration: 60 | ||
| Lap Endo Mode: Off | SonaStar Elite Handpiece | |
| DEFAULT SETTINGS | ||
| Identical | ||
| Identical | ||
| Identical | ||
| Lap Endo Mode: Identical | ||
| DTC (DYNAMIC TISSUE RESPONSE): Off | ||
| USER SETTINGS | ||
| Vibration: | ||
| Incremental adjustment = 5 | ||
| Range = 5 to 100% | ||
| Irrigation: | ||
| Incremental adjustment = 5 | ||
| Range = 5 to 100% | ||
| Aspiration: | ||
| Incremental adjustment = 5 | ||
| Range = 5 to 100% | USER SETTINGS | |
| Vibration: | ||
| Incremental adjustment = 5 | ||
| Range = 5 to 100% | ||
| Irrigation: | ||
| Incremental adjustment = 5 | ||
| Range = 5 to 100% | ||
| Aspiration: | ||
| Incremental adjustment = 5 | ||
| Range = 5 to 100% | ||
| DTC (DYNAMIC TISSUE RESPONSE): | ||
| Incremental adjustment = 1 | ||
| Range = 1 to 6 | ||
| Console Software | v1.9 RC2 | v1.10 RC0 |
| Dimensions | ||
| wo/Cart | 11.5" H x 16" W x 17" D | |
| 292mm H x406 mm W x 432mm D | Identical | |
| Weight wo/Cart | 45 lbs. 20.4 kg | Identical |
17
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.
18
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.