(82 days)
CUSA NXT Bone Tips (K111741)
Not Found
No
The description focuses on the mechanical function of the device (ultrasonic vibration, fragmentation, aspiration) and its physical components. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
A therapeutic device is one that treats a disease or condition. This device is an accessory to a surgical aspirator system used for tissue removal during various surgical procedures, which is a surgical tool, not a treatment in itself.
No
This device is described as an accessory to a surgical aspirator system used for fragmentation, emulsification, and aspiration of tissue. Its function is to remove unwanted tissue during surgical procedures, not to diagnose medical conditions.
No
The device is described as a physical accessory (Inferior Forward Bone Tip) that attaches to a surgical handpiece and is controlled by a larger system. It is made of physical materials and undergoes electromechanical and physical performance testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical device used for fragmenting, emulsifying, and aspirating tissue during surgical procedures. 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 uses ultrasonic energy to remove tissue. It does not mention any components or functions related to analyzing samples of bodily fluids, tissues, or other substances for diagnostic purposes.
- Lack of Diagnostic Function: The device's function is to physically remove tissue, not to provide information about a patient's health status through analysis of biological samples.
IVD devices are used to perform tests on samples taken from the body (like blood, urine, tissue biopsies) to diagnose diseases, monitor health, or screen for conditions. This device operates directly on tissue within the body during surgery.
N/A
Intended Use / Indications for Use
The CUSA NXT Inferior Forward Bone Tip is an accessory 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.
Product codes (comma separated list FDA assigned to the subject device)
LFL
Device Description
The Integra CUSA NXT Inferior Forward Bone Tip (Inferior Forward Bone Tip) will attach to the Selector 24 kHz Neuro Short Handpiece (1523000M7) and will be controlled by the CUSA NXT Ultrasonic Surgical Aspirator System (CUSA NXT System). The CUSA NXT System is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, fragments, emulsifies and removes unwanted tissue. The device allows the selective dissection of target tissue while preserving vessels, ducts and other delicate structures. The system consists of a console which provides control and power functions, a surgical handpiece which provides ultrasonic mechanical energy, a single use tip, and a suction/irrigation system (manifold tubing and cooling water canister).
The Inferior Forward Bone Tip has an abrasive surface that is oriented inferiorly and distally at the distal end of the tip. This configuration facilitates the use of the system in procedures where it is necessary for practitioners to orient the surgical tip in the bottom dead center or inferior orientation.
The Inferior Forward Bone Tip consists of a titanium tip with a titanium nitride coating, silicone flue and an ultem shroud.
The Inferior Forward Bone Tip will be supplied sterile and is 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Electromechanical Test - measures frequency, stroke, lateral movement, and power
Result: Passed frequency, stroke, lateral movement, and quiescent power acceptance criteria.
Lateral Load Test - applies a lateral load on the vibrating tip to evaluate robustness
Result: 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
Result: 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
Result: No breakage of the abrasive surface occurred.
Measurement of Thermal Rise During Ultrasonic Aspiration of Representative Tissue
Result: Thermal rise in tissue field during tissue removal was found to be less than stated in the product specification.
Biocompatibility
Result: 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.
Conclusions: Testing confirmed that the performance of the Inferior Forward Bone Tip meets the product specifications. Therefore, the modification resulted in a device that performs the same as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
CUSA NXT Bone Tips (K111741)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
510(k) Summary
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 | 609-936-5583 |
| Fax number | 609-275-9447 |
| Establishment Registration | |
| Number | 1222895 |
| Name of contact person | Lindsay Mignone |
| Date prepared | November 30, 2011 |
| 807.92(a)(2) - Name of device | |
| Trade or proprietary name | Integra™ CUSA NXT™ Inferior Forward Bone Tip |
| 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 | |
| CUSA NXT Bone Tips (K111741) | |
| 807.92(a)(4) - Device description | |
| The Integra CUSA NXT Inferior Forward Bone Tip (Inferior Forward | |
| Bone Tip) will attach to the Selector 24 kHz Neuro Short Handpiece | |
| (1523000M7) and will be controlled by the CUSA NXT Ultrasonic | |
| Surgical Aspirator System (CUSA NXT System). The CUSA NXT | |
| System is an ultrasonically vibrating surgical device which, in | |
| combination with irrigation and aspiration, fragments, emulsifies and | |
| removes unwanted tissue. The device allows the selective dissection of | |
| target tissue while preserving vessels, ducts and other delicate | |
| structures. The system consists of a console which provides control | |
| and power functions, a surgical handpiece which provides ultrasonic | |
| mechanical energy, a single use tip, and a suction/irrigation system | |
| (manifold tubing and cooling water canister). | |
| The Inferior Forward Bone Tip has an abrasive surface that is oriented | |
| inferiorly and distally at the distal end of the tip. This configuration | |
| facilitates the use of the system in procedures where it is necessary for | |
| practitioners to orient the surgical tip in the bottom dead center or | |
| inferior orientation. |
.
1
| nitride coating, silicone flue and an ultem shroud. | The Inferior Forward Bone Tip consists of a titanium tip with a titanium | |||
|---|---|---|---|---|
| for single use. | The Inferior Forward Bone Tip will be supplied sterile and is intended | |||
| 807.92(a)(5) Intended use of the device | ||||
| Indications for use | The CUSA NXT Inferior Forward Bone Tip is an accessory 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 CUSA NXT system have not changed | ||||
| due to the addition of the Inferior Forward Bone Tip. | ||||
| predicate | 807.92(a)(6) Summary of the technological characteristics of the device compared to the | |||
| Characteristic | CUSA NXT Inferior Forward Tip | CUSA NXT Bone Tips (K111741) | ||
| Console used with tip | CUSA NXT Ultrasonic Surgical | CUSA NXT Ultrasonic Surgical | ||
| Aspirator System | Aspirator System | |||
| Approximate | ||||
| Frequency of | ||||
| Operation | 24 kHz | 24 kHz | ||
| Max Stroke (inches) | 0.0120 | 0.0120 | ||
| Tips Delivered As | Sterile / Single Use | Sterile / Single Use | ||
| Shroud | Uses a curved shroud, packaged | |||
| with tip | Uses a curved shroud, packaged with | |||
| tip | ||||
| Vibration of Tip | Longitudinal | Longitudinal | ||
| Design of distal end | Protrusion with 10° inverse conical | Protrusion with 10° inverse conical | ||
| (Forward) | ||||
| Protrusion with 10° conical (Reverse) | ||||
| Abrasive surface oriented inferior to | ||||
| surgical tip when bent | Abrasive surface oriented superior to | |||
| surgical tip when bent | ||||
| Pre-aspiration holes | Yes | Yes | ||
| Inner Diameter | ||||
| (inches) | 0.078 | 0.078 | ||
| Working Length | ||||
| (mm) | 88 | 88 (Forward) | ||
| 80 (Reverse) | ||||
| Bend Angle | 20° | 20° | ||
| Bend Radius (in) | 5.684 | 3.15 | ||
| Material | ||||
| Tip | Titanium 6AL4V Grade 5 | Titanium 6AL4V Grade 5 | ||
| Flue | Silicone | Silicone | ||
| Shroud | Ultem | Ultem |
CUSA NXT inferior Forward Bone Tip 510(k)
2
| 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 Inferior Forward Bone Tip meets the product |
Testing confirmed that the performance of the Interior Forward Bone Tips. Therefore, the modification resulted in a device that performs the same as the predicate device.
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3
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 heads, representing the department's commitment to health, human services, and science. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle symbol.
FEB 2 2 2012
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Integra Burlington MA, Incorporated % Ms. Lindsay Mignone 22 Terry Avenue Burlington, Massachusetts 01803
Re: K113570
Trade/Device Name: Integra CUSA NXT Inferior Forward Bone Tip Regulatory Class: Unclassified Product Code: LFL Dated: November 30, 2011 Received: December 2, 2011
Dear Ms. Mignone:
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 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.
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Page 2 - Ms. Lindsay Mignone
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please n you acontra spov.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/MedicalDevices/Safety/ReportaProblem/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,
Mark A. Mulkern
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): K113570
Device Name: Integra CUSA NXT Inferior Forward Bone Tip
Indications for Use:
The Integra CUSA NXT Inferior Forward Bone Tip is an accessory to the CUSA NXT Ultrasonic The mical 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 emulomounon and adpiractinal and affiliated organ surgery, Urological surgery, Plastic and Neconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, Thoracic surgery, Laparoscopic surgery and Thoracoscopic surgery.
X PRESCRIPTION USE _ (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)
Neil Keller for Nixon
(Division Sign-Off) Division of Surgical. Orthopedic, and Restorative Devices
510(k) Number K113570
CUSA NXT Inferior Forward Bone Tip 510(k)
04-002