(90 days)
No
The summary describes a traditional ultrasonic surgical aspirator system and does not mention any AI or ML components or capabilities.
Yes
The device is intended for the fragmentation, emulsification, and aspiration of tissue in various surgical specialties and for wound debridement, which are therapeutic interventions.
No
This device is intended for the fragmentation, emulsification, and aspiration of tissue in surgical procedures and wound care, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states the system includes a generator housed inside a console and a reusable handpiece, which are hardware components.
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 clearly states the device is for the "fragmentation, emulsification and aspiration of both soft and hard (i.e., bone) tissue" in various surgical specialties and wound care. This describes a surgical tool used directly on the patient's body during a procedure.
- Device Description: The description details a system with a generator, handpiece, probes, irrigation, and aspiration system. These are components of a surgical device used for tissue manipulation and removal.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The neXus system does not perform any such analysis on specimens. It is used in vivo (within the body) during surgery.
The device is a surgical aspirator system, which is a type of medical device used in surgical procedures.
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 AccessTM handpiece with BoneScalpel AccessTM 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 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.
· 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, emulsification 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
· 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 maligmant, 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
· Thoracoscopic Surgery
The system may also be combined with electrosurgery using optional RF surgery interface components.
Product codes
LFL, GEI, LBK
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
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 - 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 (burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site), Laparoscopic Surgery (hepatic parenchyma, donor hepatectomy, cholecystectomy, pancreatic jejunostomy, pancreatectomy, appendectomy, colon resection, partial gastrectomy), Thoracoscopic Surgery.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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: The ultrasonic tip and sheaths are direct patient contacting devices. The irrigation tubing is an indirect patient contacting device. The devices were compared to master products for original premarket clearances (K190160 for neXus Ultrasonic Surgical Aspirator System and K212060 for Misonix BoneScalpel Access Handpiece and Tubeset Kits). The endpoints tested were Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Irritation or Intracutaneous Reactivity (ISO 10993-10), Acute Systemic Toxicity (ISO 10993-11), and Pyrogenicity (USP ). New materials were assembled in a master product configuration and tested, results meet ISO 10993-1 requirements.
Sterilization and Shelf Life: Single Use Disposable Components are provided sterile with a 37-month shelf life based on accelerated aged testing and a 13-month ambient conditions real time shelf life. Reusable Components are cleaned and sterilized by the end user per validated instructions in the Instructions for Use.
Electrical Safety and Electromagnetic Compatibility (EMC): Tested in accordance with IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012, IEC 60601-2-2: 2017, and IEC 60601-1-2:2015. Wireless coexistence testing from K190160 remains valid.
Software Verification and Validation Testing: Conducted and documented as per FDA guidance for "major" level of concern software.
Bench Testing:
- Acoustic Intensity Testing
- Applied Part Temperature Testing - Normal and Abnormal Operating Conditions
- Probe Vibration Testing
- Soft Tissue Performance Testing
- Probe Life Testing
Animal Testing: Not applicable.
Clinical Data: Not applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K200774, CUSA Clarity Ultrasonic Aspirator System, Integra LifeSciences
Reference Device(s)
K212960, neXus Ultrasonic Surgical Aspirator System, Misonix Inc., K190160, neXus Ultrasonic Surgical Aspirator System, Misonix Inc.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/2 description: The image shows 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, and then the word "ADMINISTRATION" in a smaller font size below that.
July 28, 2022
Misonix Inc. % John Salerno Vice President of Regulatory Affairs and Quality Assurance Misonix 1938 New Highway Farmingdale, New York 11735
Re: K221235
Trade/Device Name: neXus Ultrasonic Surgical Aspirator System Regulatory Class: Unclassified Product Code: LFL, GEI, LBK Dated: April 27, 2022 Received: April 29, 2022
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.
For: 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221235
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 AccessTM handpiece with BoneScalpel AccessTM 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 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 metastatectornes.
· 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, emulsification of both soft and hard (i.e. bone) tissue in the following surgical specialties:
3
· 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 appendectorny, 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 maligmant, 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 appendectorny, laparoscopic colon resection or laparoscopic partial
4
· Thoracoscopic Surgery
The system 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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5
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the neXus Ultrasonic Aspirator System is provided below.
1. SUBMITTER
| Applicant: | Misonix, a Bioventus Company
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: | Sharon Klugewicz
Senior Vice President, Quality and Regulatory Affairs
Bioventus
4721 Emperor Blvd.
STE 100
Durham, NC 27703
Main: 919-474-6700
Mobile: 516-425-4446
sharon.klugewicz@bioventus.com |
| Date Prepared: | April 26, 2022 |
DEVICE
| Device Trade Name: | neXus Ultrasonic Aspirator System |
|---|---|
| Device Common Name: | Instrument, Ultrasonic Surgical |
| Classification Name: | Unclassified |
| Regulatory Class: | Unclassified |
| Product Code: | LFL, GEI, LBK |
PREDICATE DEVICE 2.
| Predicate Device: | K200774, CUSA Clarity Ultrasonic Aspirator System, Integra
LifeSciences |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Reference Devices: | K212960, neXus Ultrasonic Surgical Aspirator System,
Misonix Inc.
K190160, neXus Ultrasonic Surgical Aspirator System,
Misonix Inc. |
6
DEVICE DESCRIPTION 3.
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 4.
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
- 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.
7
● 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. -
o 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
- o 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 o unwanted tissue in open or minimally invasive general surgical procedures
- Orthopedic Surgery ●
8
- Gynecological Surgery - except as contraindicated for uterine fibroids.
- Thoracic Surgery o
- 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 Surgerv
- Urological Surgery ●
- Plastic and Reconstructive Surgery
- General Surgery ●
- o Orthopedic Surgery
- o Gynecology
External genitalia - condyloma - benign tumors (lipomas, fibromas, and leiomyomas) - malignant primary and metastatic turnors of all tvpes 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.
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:
- o Neurosurgerv
9
- o 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
- o 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 o 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 5.
Technological Comparisons
The table below compares the key technological feature of the subject devices to the predicate device (K200774, CUSA Clarity).
Device Comparison Table
| Subject Device | Predicate Device (K200774) | |
|---|---|---|
| 510(k) Number | TBD | K200774 |
| Company | Misonix, a Bioventus company | Integra LifeSciences |
| Device Name | neXus Ultrasonic Surgical Aspirator | |
| System | CUSA Clarity Ultrasonic Surgical | |
| Aspirator System | ||
| Product Code | LFL | LFL |
| Subsequent product code: GEI | Subsequent product code: LBK | |
| Subject Device | Predicate Device (K200774) | |
| Compatible Handpieces | SonaStar Elite (SSE) Handpiece (36 kHz) | |
| [Part number 100-26-0001] | CUSA Clarity 36 kHz Handpiece | |
| [Part number C7036] | ||
| neXus® Standard Handpiece (23 kHz) | ||
| [Part number: 100-21-0001] | CUSA Clarity 23kHz Handpiece | |
| [Part number C7023] | ||
| neXus® SonaStar® Short Handpiece (23 kHz) | ||
| [Part number 100-24-0001] | ||
| neXus® SonaStar® Long Handpiece (23 kHz) | ||
| [Part number 100-25-0001] | ||
| neXus® BoneScalpel Access™ Handpiece (23 kHz) | ||
| [Part number 100-22-0001] | ||
| 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. | Handpiece-probe assembly vibrate at resonant frequency resulting from the conversion of the electrical drive signal from the CUSA Clarity console into mechanical vibrations by the piezo stack. |
| Reusable Accessories | neXus Console | CUSA Clarity Console |
| neXus Cart | CUSA Clarity Cart | |
| neXus Aspiration Filter | CUSA Clarity Contamination Guard | |
| neXus Footswitch | CUSA Clarity Footswitch | |
| neXus Power Cords | CUSA Clarity Power Cords | |
| neXus SonaStar Elite 36 kHz Handpiece | ||
| neXus Handpiece Front Housing | CUSA Clarity 36 kHz Handpiece | |
| neXus SonaStar Elite 36 kHz Handpiece Torque Wrench. | CUSA Clarity 36 kHz Handpiece Torque Wrenches | |
| neXus SonaStar Elite 36 kHz Handpiece Counter Wrenches | CUSA Clarity 36 kHz Handpiece Torque Base | |
| neXus Handpiece Cleaning Brush Kits | CUSA Clarity 36 kHz Cleaning Brushes | |
| neXus SonaStar Sterilization Trays | CUSA Clarity 36 kHz Sterilization Trays | |
| Disposable Accessories | neXus Hard Plastic Sheaths | CUSA Clarity Nosecone |
| neXus Soft Rubber Sheaths | CUSA Clarity Flue | |
| Tip Stylets | Tip Stylets | |
| Aspiration Canister | Aspiration Canister | |
| Specimen Canister | ||
| Single Use Probe and Tubeset Kits | Single Use Probe Tips | |
| Single Use Aspiration Tubing | ||
| Single Use Irrigation Tubing | ||
| Subject Device | Predicate Device (K200774) | |
| Cleaning & Sterilization | Reusable accessories are to be cleaned | |
| and sterilized by moist heat (steam) by | ||
| the user prior to use using cleaning and | ||
| sterilization protocols published in the | ||
| IFU. | ||
| Single use items are provided sterile and | ||
| are to be disposed of after use. | Reusable accessories are to be cleaned and | |
| sterilized by moist heat (steam) by the user | ||
| prior to use using cleaning and sterilization | ||
| protocols published in the IFU. | ||
| Single use items are provided sterile and | ||
| are to be disposed of after use. | ||
| Probe and Tubeset Kits | Probe and Tubeset Kits are provided. | |
| Tubesets are bi-lumen designs with an | ||
| irrigation and aspiration tube leg. | Separate probe, irrigation tubeset, and | |
| aspiration tubeset packages are provided. | ||
| Electrosurgery | The subject SonaStar Elite 36 kHz | |
| handpiece system can interface with | ||
| electrosurgery generators for monopolar | ||
| electro cautery using an optional RF | ||
| surgery interface component. | The CUSA Clarity 36 kHz handpiece | |
| system does not interface with | ||
| electrosurgery generators and does not | ||
| offer an optional RF surgery interface | ||
| component. | ||
| Console | ||
| Generator Classification | Class 1 | Class 1 |
| Applied Part Classification | Type BF Applied Part | Type CF Applied Part |
| Power Input Voltage | 100-240 VAC | 100-240V VAC |
| Power Input Current | 5A max | 5A max |
| Power Input Frequency | 50/60Hz | 50/60Hz |
| Functions | Vibration | |
| Irrigation | ||
| Aspiration | Vibration | |
| Irrigation | ||
| Aspiration | ||
| Vibration System | Frequency: 34.5-37.0 kHz | |
| Amplitude: Up to 206 microns | Frequency: 35.55 - 36.25 kHz | |
| Amplitude: Up to 210 microns | ||
| Irrigation pump | Peristaltic pump | Peristaltic pump |
| Irrigation Flow Rate | Normal: 2-20ml/min | |
| Flush: 25ml/min | Normal: 2-20ml/min | |
| Flush: 25ml/min | ||
| Aspiration Vacuum Pump | Built-in vacuum pump | Built-in vacuum pump |
| Aspiration Vacuum | ||
| Specification | Max: 635 mm (25.0 in) mercury | Max: 640 mm (25.2 in) mercury |
| Subject Device | Predicate Device (K200774) | |
| Footswitch | Wireless | |
| Optional Wired | ||
| Pedal and Push button | Wired | |
| Dual Pedal | ||
| PRESET: Operation at set Ultrasound, | ||
| Irrigation and Aspiration regardless of | ||
| Pedal position during actuation | STANDARD: Operation at set Ultrasound, | |
| Irrigation and Aspiration regardless of | ||
| Pedal position during actuation | ||
| LINEAR: Amplitude control with the | ||
| degree of pedal depression | PROPORTIONAL: Amplitude control | |
| with the degree of pedal depression | ||
| FLUSH: Actuated via Push Button | ||
| switch | FLUSH: Actuated via Pedal | |
| Console Display | Touch screen graphical user interface | Touch screen graphical user interface |
| Console GUI | Default Settings: | Default Settings: |
| Vibration: 60% | ||
| Irrigation: 25% | ||
| Aspiration: 60% | Vibration: 60% | |
| Irrigation: 3 ml/min | ||
| Aspiration: 60% | ||
| Footswitch mode: Preset | Footswitch mode: Standard | |
| Aspiration mode: Lap Endo Mode Off | Aspiration mode: Constant | |
| Tissue Select: Off | ||
| User Settings: | User Settings: | |
| Vibration: | ||
| Incremental adjustment = 5 | ||
| Range = 5 to 100% | Vibration: | |
| Incremental adjustment = 5 | ||
| Range = 10 to 100% | ||
| Irrigation: | ||
| Incremental adjustment = 5 | ||
| Range = 5 to 100% | Irrigation: | |
| Incremental adjustment = 1 | ||
| Range = 2 to 20ml/min | ||
| Aspiration: | ||
| Incremental adjustment = 5 | ||
| Range = 5 to 100% | Aspiration: | |
| Incremental adjustment = 5 | ||
| Range = 10 to 100% | ||
| Console dimensions | 11.5" H x 16" W x 17" D (*) | |
| 292mm H x406 mm W x 432mmD | ||
| (*) Dimensions, without cart | 19.5" H x 13.75" W x 18" D (*) | |
| 493mm H x349 mm W x 457mm D | ||
| (*) Dimensions, without cart | ||
| Console weight without | ||
| cart | 45 lbs. 20.4 kg | 65 lbs. 29.5 kg |
| Cart | Cart provides a secure platform for the | |
| console. It has a handle and locking | ||
| casters and provides storage for the | ||
| footswitch and power cord. | Cart provides a secure platform for the | |
| console. It has a handle and locking casters | ||
| and provides storage for the footswitch and | ||
| power cord. |
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PERFORAMNCE DATA 6.
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 ( ●
The change in the indications for use for the subject device comparted to the master products do not raise new questions of safety related to biocompatibility. There is no change in target populations, target anatomical sites, use environment, user population, category of body contact, body tissue contact, duration of contact, biocompatibility endpoints, type of contact (direct, indirect, or transient).
There is no change in principle of operation, geometry, sterilization process, or manufacturing process between the subject product and the master products that would raise new questions about biocompatibility. There is one new material, two minor changes in material formulation. and changes in manufacturers. Biocompatibility testing was required based on the material changes for the subject product.
The new materials were assembled in a master product configuration and submitted for biocompatibility testing to the endpoints listed above. The results meet the requirements of ISO 10993-1.
Sterilization and Shelf Life
Sterility
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:
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- o 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"
These disposable components are supplied in a combined, sterile package, based on the probe tip selected by the customer.
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
The single use disposable kits have now been tested to support a 37-month shelf life. The results of the accelerated aged 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.
The single use disposable kits have also been tested to support a 13-month ambient conditions real time shelf life.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety was conducted on the subject device in accordance with the following standards:
- IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 ●
- IEC 60601-2-2: 2017
- o IEC 60601-1-2:2015
There have been no device modifications related to the wireless communications between the footswitch and the console, therefore the wireless coexistence testing submitted under K190160 remains valid.
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 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:
- Acoustic Intensity Testing .
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- Applied Part Temperature Testing - Normal and Abnormal Operating Conditions
- o Probe Vibration Testing
- Soft Tissue Performance Testing ●
- Probe Life Testing ●
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.
7. CONCLUSION
The substantial equivalence information provided in this submission demonstrates that the subject device is substantially equivalent to the predicate device in both indications for use and technological characteristics. Therefore, the subject device can be found substantially equivalent to the predicate device.