(63 days)
The CUSA NXT Bone Tips are accessories to the CUSA NXT Ultrasonic Surgical Aspirator System that is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable, including Neurosurgery, Gastrointestinal and affiliated organ surgery, Urological surgery, Plastic and Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, Thoracic surgery, Laparoscopic surgery and Thoracoscopic surgery.
The indications for use for the NXT system have not changed due to the addition of the NXT Bone Tips.
The NXT Bone tips will attach to the Selector 24 kHz Neuro Short Handpiece (1523000M7) and will be controlled by the CUSA NXT console. Ultrasonic surgical aspirators facilitate the removal of cellular and other unwanted soft and hard (e.g. bone) tissue. These systems provide selective tissue disintegration with simultaneous irrigation and aspiration. The modification is intended to provide improved visualization due to the protruded abrasive cutting surface, concomitant with improved relief geometry to enable fine and precise shaving or cutting when fragmenting, emulsifying and aspirating hard tissue. There are two NXT Bone Tips. The Superior Forward Bone Tip has an abrasive surface that is oriented superiorly and distally at the distal end of the tip. The Superior Reverse Bone Tip has an abrasive surface that is oriented superiorly and proximally at the distal end of the tip.
The NXT Bone Tips consist of a titanium tip with a titanium nitride coating, silicone flue and an ultem shroud.
The NXT Bone Tips will be supplied sterile and are intended for single use.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Electromechanical Test (frequency, stroke, lateral movement, quiescent power) | Device meets specified frequency, stroke, lateral movement, and quiescent power limits. | Passed frequency, stroke, lateral movement, and quiescent power acceptance criteria. |
| Lateral Load Test (robustness under lateral load) | Performance of tips is not affected after application of lateral load. | Performance of the tips was not affected after the application of the lateral load. |
| Dry Flue Test (operation without irrigation for specified time) | Performance of tips is not affected when operated with no irrigation for specified time. | Performance of the tips was not affected when operated with no irrigation for the time specified. |
| Accelerated Stress Bone Cutting (effect of extended bone cutting) | No breakage of the abrasive surface occurs. | No breakage of the abrasive surface occurred. |
| Measurement of Thermal Rise During Ultrasonic Aspiration of Representative Tissue | Thermal rise in tissue field during tissue removal is less than stated product specification. | Thermal rise in tissue field during tissue removal was found to be less than stated in the product specification. |
| Biocompatibility | Materials have the same chemical formulations, manufacturing processes, and sterilization as predicate device. | Since the modified device uses materials that have the same chemical formulations, same manufacturing and same sterilization processes as in the predicate device, additional testing was not performed. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state sample sizes for each test in the non-clinical study. It describes the individual tests performed. The data provenance is internal to Integra Burlington MA, Inc., as these are non-clinical studies conducted to support a 510(k) submission. Therefore, it is retrospective as it was conducted prior to submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable. The study involves non-clinical performance and safety testing of a medical device, not evaluation of medical images or diagnoses requiring expert ground truth establishment. The "ground truth" here is objective physical and mechanical performance measurements against established engineering specifications.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving expert consensus on subjective evaluations. The non-clinical tests described involve objective measurements against predefined acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The document describes non-clinical testing of a device's physical and mechanical performance, not its comparative effectiveness with human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This question is not applicable. The device described is a surgical instrument (ultrasonic surgical aspirator tips), not an algorithm or AI system. The tests evaluate the device's standalone physical and mechanical performance.
7. The Type of Ground Truth Used:
The "ground truth" in this context refers to the defined engineering specifications and performance limits for the Integra™ CUSA NXT™ Bone Tips. These are established based on the safety and effectiveness requirements for similar devices and the intended function of the device (fragmentation, emulsification, and aspiration of tissue). For biocompatibility, the ground truth is established by the equivalence of materials, manufacturing, and sterilization processes to a predicate device.
8. The Sample Size for the Training Set:
This information is not applicable. The document describes the testing of a medical device, not the training of an AI algorithm.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable, as there is no training set for an AI algorithm. The tests conducted are to verify the device's performance against predefined engineering and safety specifications.
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AUG 2 3 2011 - K |||74|
ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮ
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92. "
| 807.92(a)(1) - Submitter Information | |
|---|---|
| Name | Integra Burlington MA, Inc. |
| Address | 22 Terry AvenueBurlington, MA 01803 |
| Phone number | 781-565-1227 |
| Fax number | 781-238-0645 |
| Establishment RegistrationNumber | 1222895 |
| Name of contact person | Kevin J. O'Connell |
| Date prepared | June 10, 2011 |
| 807.92(a)(2) - Name of device | |
| Trade or proprietary name | Integra™ CUSA NXT™ Bone Tips |
| Common or usual name | Ultrasonic Surgical Aspirator |
| Classification name | Instrument, Ultrasonic Surgical |
| Classification panel | General and Plastic Surgery |
| Regulation | Unclassified |
| Product Code(s) | LFL |
| 807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed | |
| Selector Ultrasonic Surgical Aspirator System with Bone Tip K071669CUSA Selector NXT Ultrasonic Tissue Ablation System K081459CUSA NXT Extended Length Tip K102258 | |
| 807.92(a)(4) - Device description | |
| The NXT Bone tips will attach to the Selector 24 kHz Neuro ShortHandpiece (1523000M7) and will be controlled by the CUSA NXTconsole. Ultrasonic surgical aspirators facilitate the removal of cellularand other unwanted soft and hard (e.g. bone) tissue. These systemsprovide selective tissue disintegration with simultaneous irrigation andaspiration. The modification is intended to provide improvedvisualization due to the protruded abrasive cutting surface, concomitantwith improved relief geometry to enable fine and precise shaving orcutting when fragmenting, emulsifying and aspirating hard tissue.There are two NXT Bone Tips. The Superior Forward Bone Tip hasan abrasive surface that is oriented superiorly and distally at the distal end of the tip. The Superior Reverse Bone Tip has an abrasive surface | |
| that is oriented superiorly and proximally at the distal end of the tip. | |
| The NXT Bone Tips consist of a titanium tip with a titanium nitride coating, silicone flue and an ultem shroud. | |
| The NXT Bone Tips will be supplied sterile and are intended for single use. | |
| 807.92(a)(5) Intended use of the device | |
| Indications for use | The CUSA NXT Bone Tips are accessories to the CUSA NXT Ultrasonic Surgical Aspirator Systems that is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable, including Neurosurgery, Gastrointestinal and affiliated organ surgery, Urological surgery, Plastic and Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, Thoracic surgery, Laparoscopic surgery and Thoracoscopic surgery. |
| The indications for use for the NXT system have not changed due to the addition of the NXT Bone Tips. |
CUSA NXT Bone Tips 510(k)
Page 4 of 40
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807.92(a)(6) Summary of the technological characteristics of the device compared to the predicate
| Characteristic | CUSA NXT BoneTips | Selector UltrasonicSurgical AspiratorSystem with BoneTip K071669 | CUSA SelectorNXT UltrasonicTissue AblationSystem K081459 | CUSA NXTExtended LengthTipK102258 |
|---|---|---|---|---|
| Console used with tip | CUSA NXT | CUSA Selector | CUSA NXT | CUSA NXTCUSA Selector |
| ApproximateFrequency of Operation | 24 kHz | 24 kHz | 24 kHz | 35 kHz |
| Max Stroke (inches) | 0.0120 | 0.0120 | 0.0120 | 0.0069 |
| Tips Delivered As | Sterile / Single Use | Sterile / Single Use | Sterile / Single Use | Non Sterile |
| Shroud | Uses a curved shroud,packaged with tip | Uses Shroud withhandpiece | Uses Shroud withhandpiece | Uses a straightshroud, packagedwith tip |
| Vibration of Tip | Longitudinal | Longitudinal | Longitudinal | Longitudinal |
| Design of distal end | Protrusion with 10°inverse conical(Forward)Protrusion with 10°conical (Reverse) | Cylindrical shapewith abrasivesurface | Cylindrical shapewith abrasivesurface | Cylindrical shapewith flat annulus |
| Pre-aspiration holes | Yes | No | No | Yes |
| Inner Diameter (inches) | 0.078 | 0.078 | 0.078 | 0.062 |
| Working Length (mm) | 88 | 96 | 96 | 178 |
| Bend Angle | 20° | 20° | 20° | 12° |
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| Material | ||||
|---|---|---|---|---|
| Tip | Titanium 6AL4VGrade 5 | Titanium 6AL4VGrade 5 | Titanium 6AL4VGrade 5 | Titanium 6AL4VGrade 5 |
| Flue | Silicone | TPX | TPX | Silicone |
| Shroud | Ultem | Ultem | Ultem | Ultem |
807.92(b)(1-2) NONCLINICAL TESTS SUBMITTED
| Test | Result |
|---|---|
| Electromechanical Test - measuresfrequency, stroke, lateral movement, andpower | Passed frequency, stroke, lateral movement, and quiescent poweracceptance criteria. |
| Lateral Load Test - applies a lateral load onthe vibrating tip to evaluate robustness | Performance of the tips was not affected after the application ofthe lateral load. |
| Dry Flue Test - checks the effect ofultrasonically vibrating a surgical tip withoutthe presence of irrigation | Performance of the tips was not affected when operated with noirrigation for the time specified. |
| Accelerated Stress Bone Cutting - tests theeffect of bone cutting for extended periodsof time | No breakage of the abrasive surface occurred. |
| Measurement of Thermal Rise DuringUltrasonic Aspiration of RepresentativeTissue | Thermal rise in tissue field during tissue removal was found to beless than stated in the product specification. |
| Biocompatibility | Since the modified device uses materials that have the samechemical formulations, same manufacturing and samesterilization processes as in the predicate device, additionaltesting was not performed. |
807.92(b)(3) CONCLUSIONS DRAWN FROM NON-CLINICAL DATA
Testing confirmed that the performance of the NXT Bone Tips meets the product specification of the modified tips, which are based on the predicate device. Therefore the modification resulted in a device that performs the same as the predicate device.
CUSA NXT Bone Tips 510(k)
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Integra Burlington MA, Inc. % Mr. Kevin J. O'Connell 22 Terry Avenue Burlington, Massachusetts 01803
AUG 2 3 2011
Re: K111741
Trade/Device Name: Integra™ CUSA NXT™ Bone Tips Regulatory Class: Unclassified Product Code: LFL Dated: June 20, 2011 Received: June 21, 2011
Dear Mr. O'Connell:
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. 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 (reporting of medical
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Page 2 - Mr. Kevin J. O'Connell
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 (reporting of medical device-related adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also. please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/Mecica!Devices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Euinl Keith
Mark N. Melkerson Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Integra CUSA NXT Bone Tips
Indications for Use:
The CUSA NXT Bone Tips are accessories to the CUSA NXT Ultrasonic Surgical Aspirator System that is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable, including Neurosurgery, Gastrointestinal and affiliated organ surgery, Urological surgery, Plastic and Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, Thoracic surgery, Laparoscopic surgery and Thoracoscopic surgery.
PRESCRIPTION USE X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nail R. Qgle faraxm
Division Sign Off
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111741
CUSA NXT Bone Tips 510(k)
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