Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a mechanical accessory (bone tips) for an existing ultrasonic surgical aspirator system. There is no mention of AI or ML in the intended use, device description, or performance studies.

Therapeutic

Yes
The device is used in surgical procedures for fragmentation, emulsification, and aspiration of tissue, which are direct interventions aimed at treating a medical condition.

Diagnostic

No

This device is described as an accessory to an ultrasonic surgical aspirator system, and its intended use is for fragmentation, emulsification, and aspiration of tissue during surgical procedures, not for diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components (titanium tip, silicone flue, ultem shroud) and describes a hardware modification (new bone tips) for an existing ultrasonic surgical aspirator system. There is no mention of software being the primary or sole component.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for use in surgical procedures for fragmentation, emulsification, and aspiration of soft and hard tissue. This is an in vivo (within a living organism) application, not an in vitro (outside of a living organism) diagnostic test.
Device Description: The description details a surgical tool that physically interacts with tissue for removal, not a device that analyzes biological samples to diagnose a condition.
Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue samples outside the body).
- Providing diagnostic information about a patient's health status.
- Using reagents or assays.

The device is a surgical instrument used during a procedure, not a diagnostic test performed on a sample.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

LFL

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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

Nonclinical Tests:

Electromechanical Test: Measured frequency, stroke, lateral movement, and power. Passed frequency, stroke, lateral movement, and quiescent power acceptance criteria.
Lateral Load Test: Applied a lateral load on the vibrating tip to evaluate robustness. Performance of the tips was not affected after the application of the lateral load.
Dry Flue Test: Checked the effect of ultrasonically vibrating a surgical tip without the presence of irrigation. Performance of the tips was not affected when operated with no irrigation for the time specified.
Accelerated Stress Bone Cutting: Tested the effect of bone cutting for extended periods of time. No breakage of the abrasive surface occurred.
Measurement of Thermal Rise During Ultrasonic Aspiration of Representative Tissue: Found thermal rise in tissue field during tissue removal to be less than stated in the product specification.
Biocompatibility: No additional testing was performed since the modified device uses materials with the same chemical formulations, manufacturing, and sterilization processes as the predicate device.

Conclusion: 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.

Key Metrics

Not Found

Predicate Device(s)

K071669, K081459, K102258

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

N/A

Summary

0

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 Avenue
Burlington, MA 01803
Phone number	781-565-1227
Fax number	781-238-0645
Establishment Registration
Number	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 K071669
CUSA Selector NXT Ultrasonic Tissue Ablation System K081459
CUSA NXT Extended Length Tip K102258
807.92(a)(4) - Device description
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.
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 Bone
Tips | Selector Ultrasonic
Surgical Aspirator
System with Bone
Tip K071669 | CUSA Selector
NXT Ultrasonic
Tissue Ablation
System K081459 | CUSA NXT
Extended Length
Tip
K102258 |
|---------------------------------------|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|----------------------------------------------------------------------|-------------------------------------------------|
| Console used with tip | CUSA NXT | CUSA Selector | CUSA NXT | CUSA NXT
CUSA Selector |
| Approximate
Frequency 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 with
handpiece | Uses Shroud with
handpiece | Uses a straight
shroud, packaged
with tip |
| Vibration of Tip | Longitudinal | Longitudinal | Longitudinal | Longitudinal |
| Design of distal end | Protrusion with 10°
inverse conical
(Forward)
Protrusion with 10°
conical (Reverse) | Cylindrical shape
with abrasive
surface | Cylindrical shape
with abrasive
surface | Cylindrical shape
with 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° |

2

Material
Tip	Titanium 6AL4V
Grade 5	Titanium 6AL4V
Grade 5	Titanium 6AL4V
Grade 5	Titanium 6AL4V
Grade 5
Flue	Silicone	TPX	TPX	Silicone
Shroud	Ultem	Ultem	Ultem	Ultem

807.92(b)(1-2) NONCLINICAL TESTS SUBMITTED

Test	Result
Electromechanical Test - measures
frequency, stroke, lateral movement, and
power	Passed frequency, stroke, lateral movement, and quiescent power
acceptance criteria.
Lateral Load Test - applies a lateral load on
the vibrating tip to evaluate robustness	Performance of the tips was not affected after the application of
the lateral load.
Dry Flue Test - checks the effect of
ultrasonically vibrating a surgical tip without
the presence of irrigation	Performance of the tips was not affected when operated with no
irrigation for the time specified.
Accelerated Stress Bone Cutting - tests the
effect of bone cutting for extended periods
of time	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 was found to be
less than stated in the product specification.
Biocompatibility	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.

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)

.

..

3

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

4

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

5

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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