INTEGRA(TM) CUSA NXT(TM) BONE TIPS

K111741 · Integra Burlington Ma, Inc. (Formerly Integra Radi · LFL · Aug 23, 2011 · SU

Device Facts

• Record ID: K111741
• Device Name: INTEGRA(TM) CUSA NXT(TM) BONE TIPS
• Applicant: Integra Burlington Ma, Inc. (Formerly Integra Radi
• Product Code: LFL · SU
• Decision Date: Aug 23, 2011
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended 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.

Device Story

NXT Bone Tips are sterile, single-use accessories for CUSA NXT Ultrasonic Surgical Aspirator System; attach to Selector 24 kHz Neuro Short handpiece. Device utilizes ultrasonic energy to fragment, emulsify, and aspirate hard and soft tissue; features protruded abrasive cutting surface and improved relief geometry for precise shaving/cutting. Operated by surgeons in clinical settings (OR). System provides simultaneous irrigation and aspiration. Output is physical tissue removal; healthcare provider visualizes site during procedure. Benefits include improved visualization and precise hard tissue management.

Clinical Evidence

Bench testing only. Tests included electromechanical performance (frequency, stroke, power), lateral load robustness, dry flue operation, accelerated stress bone cutting, and thermal rise measurement. Results confirmed performance within specifications and no breakage of abrasive surfaces. Biocompatibility was established via equivalence of materials and manufacturing processes to predicates.

Technological Characteristics

Materials: Titanium 6AL4V Grade 5 (tip), silicone (flue), Ultem (shroud). Energy: Ultrasonic (24 kHz). Form factor: 20° bend angle, 88mm working length. Connectivity: Attaches to CUSA NXT console/handpiece. Sterilization: Sterile, single-use. Operation: Longitudinal vibration, 0.0120 inch max stroke. Features pre-aspiration holes and specific distal protrusion geometry.

Indications for Use

Indicated for patients requiring fragmentation, emulsification, and aspiration of soft and hard tissue (including bone) during neurosurgery, GI, urological, plastic/reconstructive, general, orthopedic, gynecological, thoracic, laparoscopic, and thoracoscopic surgical procedures.

Predicate Devices

• Selector Ultrasonic Surgical Aspirator System with Bone Tip (K071669)
• CUSA Selector NXT Ultrasonic Tissue Ablation System (K081459)
• CUSA NXT Extended Length Tip (K102258)

Submission Summary (Full Text)

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# AUG 2 3 2011 - K |||74|

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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<br>Burlington, MA 01803 |
| Phone number | 781-565-1227 |
| Fax number | 781-238-0645 |
| Establishment Registration<br>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<br>CUSA Selector NXT Ultrasonic Tissue Ablation System K081459<br>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<br>Handpiece (1523000M7) and will be controlled by the CUSA NXT<br>console. Ultrasonic surgical aspirators facilitate the removal of cellular<br>and other unwanted soft and hard (e.g. bone) tissue. These systems<br>provide selective tissue disintegration with simultaneous irrigation and<br>aspiration. The modification is intended to provide improved<br>visualization due to the protruded abrasive cutting surface, concomitant<br>with improved relief geometry to enable fine and precise shaving or<br>cutting when fragmenting, emulsifying and aspirating hard tissue.<br>There are two NXT Bone Tips. The Superior Forward Bone Tip has<br>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)

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807.92(a)(6) Summary of the technological characteristics of the device compared to the predicate

| Characteristic | CUSA NXT Bone<br>Tips | Selector Ultrasonic<br>Surgical Aspirator<br>System with Bone<br>Tip K071669 | CUSA Selector<br>NXT Ultrasonic<br>Tissue Ablation<br>System K081459 | CUSA NXT<br>Extended Length<br>Tip<br>K102258 |
|---------------------------------------|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|----------------------------------------------------------------------|-------------------------------------------------|
| Console used with tip | CUSA NXT | CUSA Selector | CUSA NXT | CUSA NXT<br>CUSA Selector |
| Approximate<br>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,<br>packaged with tip | Uses Shroud with<br>handpiece | Uses Shroud with<br>handpiece | Uses a straight<br>shroud, packaged<br>with tip |
| Vibration of Tip | Longitudinal | Longitudinal | Longitudinal | Longitudinal |
| Design of distal end | Protrusion with 10°<br>inverse conical<br>(Forward)<br>Protrusion with 10°<br>conical (Reverse) | Cylindrical shape<br>with abrasive<br>surface | Cylindrical shape<br>with abrasive<br>surface | Cylindrical shape<br>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° |

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| Material | | | | |
|----------|---------------------------|---------------------------|---------------------------|---------------------------|
| Tip | Titanium 6AL4V<br>Grade 5 | Titanium 6AL4V<br>Grade 5 | Titanium 6AL4V<br>Grade 5 | Titanium 6AL4V<br>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<br>frequency, stroke, lateral movement, and<br>power | Passed frequency, stroke, lateral movement, and quiescent power<br>acceptance criteria. |
| Lateral Load Test - applies a lateral load on<br>the vibrating tip to evaluate robustness | Performance of the tips was not affected after the application of<br>the lateral load. |
| Dry Flue Test - checks the effect of<br>ultrasonically vibrating a surgical tip without<br>the presence of irrigation | Performance of the tips was not affected when operated with no<br>irrigation for the time specified. |
| Accelerated Stress Bone Cutting - tests the<br>effect of bone cutting for extended periods<br>of time | No breakage of the abrasive surface occurred. |
| Measurement of Thermal Rise During<br>Ultrasonic Aspiration of Representative<br>Tissue | Thermal rise in tissue field during tissue removal was found to be<br>less than stated in the product specification. |
| Biocompatibility | Since the modified device uses materials that have the same<br>chemical formulations, same manufacturing and same<br>sterilization processes as in the predicate device, additional<br>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)

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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 [phone] or [phone] 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)

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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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