(120 days)
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 technology described is purely mechanical/ultrasonic.
Yes
The device is intended for clinical use in various surgical specialties and wound care, directly treating medical conditions by fragmenting and aspirating tissue.
No
The device is described as an ultrasonic surgical aspirator system intended for the fragmentation, emulsification, and aspiration of tissue during surgical procedures, not for diagnosing medical conditions.
No
The device description explicitly states that the system includes a generator housed inside a console, a reusable handpiece, and various single-use disposable probes. These are physical hardware components, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device 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 description details a surgical system with a generator, handpiece, probes, irrigation, and aspiration. These are all components used for performing a physical procedure on tissue.
- 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. This device does not perform any such analysis of specimens outside the body.
The device is a surgical tool used for tissue removal and debridement in vivo (within the living body).
N/A
Intended Use / Indications for Use
The Misonix Inc. neXus® Utrasonic Surgical Aspirator System is intended for the fragmentation, emulsification and aspiration of both soft and hard (i.e.bone) tissue.
The indications for use for the Standard Handpiece in combination with BoneScalpel® and SonicOne® OR probe kit accessory configurations and the indications for the SonaStar® long and short handpiece in combination with SonaStar® probe kit accessory configurations are listed below.
Standard Handpiece with BoneScalpel Probe Kits
Indicated for use in the fragmentation of soft and hard (e.g.: bone) tissue in the following surgical specialties:
- · Neurosurgery
- · Gastrointestinal and Affiliated Organ Surgery
- · Urological Surgery
- · Plastic and Reconstructive Surgery
- · General Surgery
- · Orthopedic Surgery
- · Gynecology
External genitalia - condyloma - benign tumors (lipomas, and leiomyomas) - malignant primary and metastatic tumors of all types and the following cystic lesions: Bartholin's cysts, Vestibular adenitis, Inclusion cysts, Sebaceous cysts
Abdominal area - any abnormal growth, cystic or solid, benign or malignant, involving the ovary, fallopian tube, uterus, or the supporting structures of the uterus except as contraindicated for uterine fibroids.
· Thoracic Surgery
Limited pulmonary reception such as segmetectomies, nonanatomical subsegmentectomies and metastatectomies.
· Wound Care
Indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement.
Standard Handpiece with SonicOne Probe Kits
Indicated for use in the fragmentation of soft and hard tissue (i.e. bone) in the following surgical specialty: · Wound Care
The neXus Ultrasonic Surgical Aspirator is also indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement.
Standard Handpiece with SonicOne Probe Kits
Indicated for use in the fragmentation of soft and hard tissue (i.e. bone) in the following surgical specialty: · Wound Care
The neXus Ultrasonic Surgical Aspirator is also indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement. · Plastic and Reconstructive Surgery
Long SonaStar Handpiece & Short SonaStar Handpiece with SonaStar Probe Kits Indicated for use in the fragmentation, emulsification and aspiration of both soft and hard (i.e. bone) tissue in the following surgical specialties:
- · Neurosurgery
- · Gastrointestinal and Affiliated Organ Surgery
- · Urological Surgery
- · Plastic and Reconstructive Surgery General Surgery
- · Orthopedic Surgery
- · Gynecological Surgery except as contraindicated for uterine fibroids.
- · Thoracic Surgery
- · Laparoscopic Surgery
- · Thoracoscopic Surgery
The SonaStar Handpieces may also be combined with electrosurgery using optional RF surgery interface components.
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
Body tissues, including soft and hard (bone) tissues. Specific mentions include:
- External genitalia (condyloma, benign tumors (lipomas, fibromas, leiomyomas), malignant primary and metastatic tumors, cystic lesions like 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 for uterine fibroids)
- Lungs (limited pulmonary resection such as segmentectomies, nonanatomical subsegmentectomies, and metastatectomies)
- Wounds (burn wounds, diabetic ulcers, bedsores, vaginal ulcers)
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)
Performance studies included:
- Biocompatibility Testing: Performed on the ultrasonic tip (and sheath) and irrigation tubing in accordance with ISO 10993 standards.
- Sterilization and Shelf Life: Submission included information per FDA guidance and testing for sterile barrier and device performance on sterilized and accelerated-aged devices.
- Electrical Safety and Electromagnetic Compatibility (EMC): Testing conducted in accordance with ANSI/AAMI/ES 60601-1, IEC 60601-2-2, and IEC 60601-1-2.
- Software Verification and Validation Testing: Documentation provided as recommended by FDA guidance for software with a "major" level of concern.
- Bench Testing: Demonstrated that the device meets specifications and requirements, including Ultrasound Performance, Irrigation Performance, Aspiration Performance, OEM RF Compatibility, and Wireless Coexistence Testing.
- Animal Testing: Not applicable.
- Clinical Data: Not applicable.
Key results: The studies demonstrated that the device continues to meet all specifications and requirements, patient contacting materials are biocompatible, electrical safety and EMC requirements are met, and software is verified and validated. The performance test results demonstrated substantial equivalence to predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K070313 - AUSS-7 Ultrasonic Surgical Aspirator System, K062471 - FS 1000 RF Ultrasonic Surgical Aspirator
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 30, 2019
Misonix, Inc. John Salerno VP RA/QA & CCO 1938 New Highway Farmingdale, New York 11735
Re: K190160
Trade/Device Name: neXus Ultrasonic Surgical Aspirator System Regulatory Class: Unclassified Product Code: LFL, GEI Dated: May 7, 2019 Received: May 8, 2019
Dear John Salerno:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting
1
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for
Jennifer R. Stevenson Acting Division Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190160
Device Name
Misonix Inc. neXus® Ultrasonic Surgical Aspirator System
Indications for Use (Describe)
The Misonix Inc. neXus® Utrasonic Surgical Aspirator System is intended for the fragmentation, emulsification and aspiration of both soft and hard (i.e.bone) tissue.
The indications for use for the Standard Handpiece in combination with BoneScalpel® and SonicOne® OR probe kit accessory configurations and the indications for the SonaStar® long and short handpiece in combination with SonaStar® probe kit accessory configurations are listed below.
Standard Handpiece with BoneScalpel Probe Kits
Indicated for use in the fragmentation of soft and hard (e.g.: bone) tissue in the following surgical specialties:
- · Neurosurgery
- · Gastrointestinal and Affiliated Organ Surgery
- · Urological Surgery
- · Plastic and Reconstructive Surgery
- · General Surgery
- · Orthopedic Surgery
- · Gynecology
External genitalia - condyloma - benign tumors (lipomas, and leiomyomas) - malignant primary and metastatic tumors of all types and the following cystic lesions: Bartholin's cysts, Vestibular adenitis, Inclusion cysts, Sebaceous cysts
Abdominal area - any abnormal growth, cystic or solid, benign or malignant, involving the ovary, fallopian tube, uterus, or the supporting structures of the uterus except as contraindicated for uterine fibroids.
· Thoracic Surgery
Limited pulmonary reception such as segmetectomies, nonanatomical subsegmentectomies and metastatectomies.
· Wound Care
Indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement.
Standard Handpiece with SonicOne Probe Kits
Indicated for use in the fragmentation of soft and hard tissue (i.e. bone) in the following surgical specialty: · Wound Care
The neXus Ultrasonic Surgical Aspirator is also indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement.
Standard Handpiece with SonicOne Probe Kits
Indicated for use in the fragmentation of soft and hard tissue (i.e. bone) in the following surgical specialty: · Wound Care
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
3
Long SonaStar Handpiece & Short SonaStar Handpiece with SonaStar Probe Kits Indicated for use in the fragmentation, emulsification and aspiration of both soft and hard (i.e. bone) tissue in the following surgical specialties:
- · Neurosurgery
- · Gastrointestinal and Affiliated Organ Surgery
- · Urological Surgery
- · Plastic and Reconstructive Surgery General Surgery
- · Orthopedic Surgery
- · Gynecological Surgery except as contraindicated for uterine fibroids.
- · Thoracic Surgery
- · Laparoscopic Surgery
- · Thoracoscopic Surgery
The SonaStar Handpieces may also be combined with electrosurgery using optional RF surgery interface components.
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
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Misonix® Inc. neXus® Ultrasonic Surgical Aspirator System is provided below.
1. SUBMITTER
| Applicant: | Misonix Inc.
1938 New Highway
Farmingdale, NY |
|------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | John Salerno
VP RAQA & CCO
Misonix Inc.
1938 New Highway
Farmingdale, NY 11735
Main: 631-694-9555
Direct: 631-927-9123
jsalerno@misonix.com |
Date Prepared:
May 6, 2019
2. DEVICE
| Name of Device: | Misonix® Inc. neXus® Ultrasonic Surgical Aspirator
System |
|------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Common or Usual Name: | Ultrasonic Surgical Aspirator System |
| Classification Name: | Unclassified |
| Regulatory Class: | Pre-Amendment, 510(k) |
| Product Code:
Secondary Product Code: | LFL - instrument, ultrasonic surgical
GEI - electrosurgical, cutting & coagulation & accessories |
| FDA Panel: | General and Plastic Surgery |
PREDICATE DEVICE 3.
Predicate Device: K070313 - AUSS-7 Ultrasonic Surgical Aspirator System Secondary Predicate Device: K062471 - FS 1000 RF Ultrasonic Surgical Aspirator
DEVICE DESCRIPTION 4.
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.
5
The generator and handpiece are compatible with various single use disposable "probes" which are selected and attached to the handpiece by the end user. An irrigation unit provides sterile irrigant to the operative site. An aspiration system removes the fragmented, emulsified material and waste liquids from the operative site.
Accessories include a wireless footswitch, various probe tip combinations, sterilization trays, probe covers, assembly & disassembly wrenches, irrigation tubing sets, and waste collection canisters.
5. INDICATIONS FOR USE STATEMENT
The Misonix Inc. neXus® Ultrasonic Surgical Aspirator System is intended for the fragmentation, emulsification and aspiration of both soft and hard (i.e.bone) tissue.
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 following cystic lesions: Bartholin's cysts, Vestibular adenitis, Inclusion cysts, Sebaceous cysts
Abdominal area - any abnormal growth, cystic or solid, benign or malignant, involving the ovary, fallopian tube, uterus, or the supporting structures of the uterus except as contraindicated for uterine fibroids.
● Thoracic Surgery
Limited pulmonary reception such as segmetectomies, nonanatomical subsegmentectomies and metastatectomies.
. Wound Care
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
6
vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement.
Standard Handpiece with SonicOne Probe Kits
Indicated for use in the fragmentation and aspiration of soft and hard tissue (i.e. bone) in the following surgical specialty:
-
Wound Care
The neXus Ultrasonic Surgical Aspirator is also indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement. -
Plastic and Reconstructive Surgery .
Long SonaStar Handpiece & Short SonaStar Handpiece with SonaStar Probe Kits
Indicated for use in the fragmentation, emulsification and aspiration of both soft and hard (i.e. bone) tissue in the following surgical specialties:
- Neurosurgery ●
- Gastrointestinal and Affiliated Organ Surgery ●
- Urological Surgery
- Plastic and Reconstructive Surgery General Surgery ●
- Orthopedic Surgery ●
- Gynecological Surgery except as contraindicated for uterine fibroids. ●
- Thoracic Surgery ●
- Laparoscopic Surgery ●
- Thoracoscopic Surgery ●
The SonaStar Handpieces may also be combined with electrosurgery using optional RF surgery interface components.
SUBSTANTIAL EQUIVALENCE 6.
Comparison of Indications
The neXus system's indications for use statement is equivalent to the indications for use cleared for the of the predicate devices. Like the predicate devices, the neXus system is indicated for use in the fragmentation, emulsification and aspiration of both soft and hard (i.e. bone) tissue.
7
The surgical specialties for neXus are a combination of the surgical specialties for both predicates and are specified by handpiece.
Technological Comparisons
The table below compares the key technological feature of the subject devices to the predicate devices.
| | Subject Device | Primary Predicate
Device (K070313) | Secondary Predicate
Device (K062471) |
|--------------------------------|------------------------------------------------------------------|-------------------------------------------------------------------------|------------------------------------------------------------------|
| 510(k) Number | K190160 | K070313 | K062471 |
| Device Name | neXus Ultrasonic
Surgical Aspirator
System | AUSS-7
ULTRASONIC
SURGICAL
ASPIRATOR
SYSTEM | FS 1000 RF |
| Classification
Regulation | Unclassified | Unclassified | Unclassified |
| Classification
Product Code | LFL - Ultrasonic
Surgical Instrument | LFL - Ultrasonic
Surgical Instrument | LFL - Ultrasonic
Surgical Instrument |
| Subsequent Product
Code | GEI - Electrosurgical,
cutting & coagulation
& accessories | N/A | GEI - Electrosurgical,
cutting & coagulation &
accessories |
| Console
Classification | Class 1
Type BF Applied Part | Class 1
Type B Applied Part | Class 1
Type B Applied Part |
| Power Input Voltage | 100-240 VAC | 100-130 VAC 6.5
Amps, 50/60 Hz
200/250 VAC 2.25
Amps, 50/60 Hz | 115 VAC
230 VAC |
| Power Input Current | 5 A max | 6.5 A at 100-130
VAC,
3.25 A at 200/250
VAC | 4 A max |
| Power Input
Frequency | 50/60Hz | 50/60Hz | 50/60Hz |
| Ground Leakage | 500 µA (max.) | 300 µA (max.) | 300 µA (max.) |
Table 1: Technological Comparison | ||
---|---|---|
-- | ----------------------------------------- | -- |
8
510(k) Summary
| | Subject Device | Primary Predicate
Device (K070313) | Secondary Predicate
Device (K062471) |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Vibration System | Continuous Wave
Frequency:
22.0-24.5 kHz
Amplitude:
up to 355 microns | Continuous Wave
Frequency: 22.5Khz
Amplitude:
Up to 300 microns | Continuous Wave
Frequency: 23+/-1 kHz
or
22-24 kHz
Amplitude:
up to 355 microns |
| Irrigation pump | Peristaltic pump | Peristaltic pump | Peristaltic pump |
| Pump Flow Rate | BoneScalpel and
SonicOne related
Applications, adjustable
between:
Min: 12-18 ml/min
and
Max: 67-85 ml/min
SonaStar related
Applications, adjustable
between:
Min: 1-3 ml/min
and
Max: 9-14 ml/min | BoneScalpel and
SonicOne related
Applications:
Flow is adjustable, 0-
100ml/min | SonaStar related
Applications:
Up to 10cc/min |
| Vacuum Pump | Min: 2.0 inHg or lower
Max: 25 inHg
Vacuum Sleep Mode:
0 inHg | Max: 28" Hg Max | Min: less than 0.5" Hg
Max: 25" Hg |
| Footswitch | Wireless
- On/Off Pedal for
ultrasound, irrigation
and aspiration
-Linear amplitude
control with the degree
of pedal depression - Flush button | Wired (connected to
rear panel of console),
Single pedal
footswitch to activate
delivery of ultrasound
and irrigation | Wired - On/Off Pedal for
amplitude, irrigation and
aspiration - Flush Button - COAG with CUT
lockout feature - COAG simultaneous
with ultrasound - COAG only |
| Console | nexus Console with
touch screen graphical
user interface | Console with
membrane control
panel and graphical
user interface | Console with membrane
control panel and LED
indicators. |
| | Subject Device | Primary Predicate
Device (K070313) | Secondary Predicate
Device (K062471) |
| Dimensions wo/Cart | 11.5" H x 16" W x 17"
D 292mm H x 406 mm
W x 432mm D | 7" H x 16" W x 19" D
180mm H x 410 mm
W x 685mm D | 40" H x 25" W x 19" D
102 cm H x 63.5 cm W
x 48 cm D |
| Weight wo/Cart | 45 lbs 20.4 kg | 25.6 lbs 11.6 kg | 120 lb. 54.5 kg |
9
7. PERFORMANCE DATA
Biocompatibility Testing
The ultrasonic tip (and sheath, when applicable) are direct patient contacting devices classified as externally communicating devices, in contact with tissue, with limited contact (≤ 24h) based on their intended use. The irrigation tubing, which is in contact with the fluid path, is an indirect patient contacting device classified as externally communicating devices, in contact with tissue, with limited contact (≤ 24h).
The patient contacting components of the neXus system are the ultrasonic tip (and sheath, when applicable), which are direct patient contacting devices classified as externally communicating devices, in contact with tissue and/or bone, with limited contact duration (≤ 24h) based on their intended use. The irrigation tubing, which is in contact with the fluid path, is an indirect patient contacting device classified as externally communicating devices, in contact with tissue and/or bone, with limited contact (≤ 24h).
Biocompatibility testing (Cytotoxicity, Irritation, Sensitization, System Toxicity, and Pyrogenicity) was performed in accordance with the following standards:
- ISO 10993-1 Fourth edition 2009-10-15 ●
- ISO 10993-5 Third edition 2009-06-01 ●
- ISO 10993-7 Second edition 2008-10-15 ●
- ISO 10993-10 Third edition 2010-08-01 ●
- ISO 10993-11 Second edition 2006-08-15 ●
- ISO 10993-12:2012 Fourth edition 2012-07-01 ●
Sterilization and Shelf Life
Single Use Disposable Components - provided Sterile
The single The Probe Kits are provided sterile and are for single use. Each contains the following basic components:
- . Probe Tip assembly: titanium horn + tip, available in various sizes and types, some are provided with additional fittings, O-rings, stylets, etc.
- Probe Sheath: rigid plastic or silicone ●
- Tubing Set: irrigation only or irrigation + aspiration, and tubing "pucks"
10
These disposable components are supplied in a combined, sterile package, based on the probe tip selected by the customer.
The submission includes the required sterilization information per FDA guidance "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile" issued January 21, 2016.
The submission also includes sterile barrier testing and device performance testing on sterilized and accelerated aged devices to support a shelf life of 3 months.
Reusable Components - End user cleaned and sterilized
All reusable handpiece parts and accessories are end user cleaned and sterilized before each use as per the validated instructions contained in the Instructions for Use of each Handpiece. The instructions for use also provide the validated expected use life for the reusable components.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the subject device in accordance with the following standards:
- ANSI/AAMI/ES 60601-1:2005 + A2:2010 + A1:2012
- IEC 60601-2-2: 2017 ●
- IEC 60601-1-2: 2014 ●
Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
Bench Testing
The following performance testing demonstrated that the device continues to meet all of the specifications and requirements that were met by the predicate devices:
- Ultrasound Performance Testing ●
- Irrigation Performance Testing ●
- Aspiration Performance Testing ●
- OEM RF Compatibility
- Wireless Coexistence Testing
Animal Testing
Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device.
11
Clinical Data
Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device.
CONCLUSION 8.
The substantial equivalence information provided in this submission demonstrates that the subject device is substantially equivalent to the predicate devices in both indications for use and technological characteristics. The modifications made to the system to combine the features of the primary predicate (the AUSS-7 cleared in K070313) and the secondary predicate (the FS 1000 RF cleared in K062471) into one universal platform do not change its intended use and do not raise new questions of safety or effectiveness. The biocompatibility test results demonstrate that the patient and fluid path contacting materials are biocompatible. The EMC and Electrical Safety test results demonstrate that the neXus system meets the applicable requirements for this device type. The software documentation and test results demonstrate that the neXus system has been fully verified and validated for its intended use. And finally, the performance test results demonstrate that the specifications and requirements of the subject device are substantially equivalent to the specifications and requirements of the predicate devices. Therefore, the subject device can be found substantially equivalent to the predicate devices.