(304 days)
Not Found
No
The summary describes a physical accessory (an extended length tip) for an existing ultrasonic surgical aspirator system. There is no mention of software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies focus on physical characteristics like tissue removal rate and thermal rise.
No
The device is an accessory to a surgical aspirator system used for tissue fragmentation, emulsification, and aspiration, which are surgical procedures, not therapeutic ones in the medical sense of treating a disease or condition for healing.
No
This device is an accessory to a surgical aspirator system used for fragmentation, emulsification, and aspiration of tissue during surgical procedures, not for diagnosing conditions.
No
The device description clearly states it is a physical "Extended Length Tip" designed to be used with ultrasonic surgical aspirators, which are hardware systems. It is a physical accessory, not 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 used in surgical procedures for the fragmentation, emulsification, and aspiration of soft and hard tissue. This is a surgical tool used on the patient's body during a procedure.
- Device Description: The description details a surgical aspirator tip designed to remove tissue from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a patient's health status, diagnosis, or treatment.
IVDs are devices used to perform tests on samples taken from the human body to provide information for medical purposes. This device is a surgical instrument used directly on the patient during surgery.
N/A
Intended Use / Indications for Use
The CUSA NXT Extended Length Tip for soft tissue is an accessory to the CUSA NXT and CUSA Selector Ultrasonic Surgical Aspirator Systems that are 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 Extended Length Tip (ELT) has been designed to be used with the 35kHz Handpiece of the CUSA Selector and CUSA NXT Ultrasonic surgical aspirators. 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 design of the 35 kHz Fine tip that is currently used with the 35kHz Handpiece has been modified to increase the working length of the device and reduce the bend angle. This will allow the device to be used in procedures where the surgeon requires a longer tip. The distal end of the ELT will have a flat annulus and two pre-aspiration holes. The ELT 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)
Nonclinical tests submitted:
Electromechanical Test - measures frequency, stroke, lateral movement, and power: The test was performed using both the Selector and NXT systems which confirmed that the modified tip has the same stroke, and therefore the same fragmentation power, as the predicate device (35 kHz Fine Tip). This indicates similar heating potential.
IEC 61847 Ultrasonics – Surgical Systems - acoustic power transfer: The modified tip has less acoustic power transfer in liquid as the predicate device (35 kHz Fine Tip, K021989). This indicates reduced heating potential.
Measurement of tissue removal rate and power used during tissue removal rate: The modified tip and predicate device (35 kHz Fine Tip, K021989) remove tissue at an equivalent rate, using equivalent power.
Measurement of Thermal Rise During Ultrasonic Aspiration of Representative Tissue: Thermal rise in tissue field during tissue removal was found to be less for the new tip than the predicate device (35 kHz Fine Tip, K021989).
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. However, tests results on the predicate device material was included in the submission.
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.
K021989, K981262, K081459, K071669
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
ייִדי
۽
JUN 10 2011
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.
| 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 8, 2011 |
| 807.92(a)(2) - Name of device | |
| Trade or proprietary | |
| name | Integra™ CUSA NXTTM Extended Length 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 | |
| Selector Integra Ultrasonic Surgical Aspirator System, K021989 | |
| CUSA EXCEL Ultrasonic Surgical Aspirator System, K981262 | |
| CUSA Selector NXT Ultrasonic Tissue Ablation System K081459 | |
| Integra Selector Ultrasonic Surgical Aspirator System with Bone Tip | |
| K071669 | |
| 807.92(a)(4) - Device description | |
| The Extended Length Tip (ELT) has been designed to be used with the | |
| 35kHz Handpiece of the CUSA Selector and CUSA NXT Ultrasonic surgical | |
| aspirators. 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 design of the 35 kHz Fine tip that is currently used with the 35kHz | |
| Handpiece has been modified to increase the working length of the device | |
| and reduce the bend angle. This will allow the device to be used in | |
| procedures where the surgeon requires a longer tip. |
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| distal end of the ELT will have a flat annulus and two pre-aspiration holes
| The ELT will be supplied sterile and is intended for single use. | ||||
|---|---|---|---|---|
| 807.92(a)(5) Intended use of the device | ||||
| Indications for use | The CUSA NXT Extended Length Tip for soft tissue is an accessory to the | |||
| CUSA NXT and CUSA Selector Ultrasonic Surgical Aspirator Systems that | ||||
| are 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 systems is the same as the predicate devices, | ||||
| K071669 and K081459, listed in 807.92(a) (3) above. | ||||
| 807.92(a)(6) Summary of the technological characteristics of the device compared to the predicate | ||||
| Characteristic | CUSA NXT Extended | |||
| Length Tip | Selector Integra | |||
| Ultrasonic | ||||
| Surgical Aspirator | ||||
| System, K021989. | CUSA Selector | |||
| NXT Ultrasonic | ||||
| Tissue Ablation | ||||
| System K081459. | CUSA EXCEL | |||
| Ultrasonic | ||||
| Surgical Aspirator | ||||
| System, K98126 | ||||
| System Features | ||||
| Oscillation system | Piezoelectric | Piezoelectric | Piezoelectric | Magnetostrictive |
| Approximate Frequency | ||||
| of Operation | 24 kHz & 35 kHz | 24 kHz & 35 kHz | 24 kHz & 35 kHz | 23 kHz & 36 kHz |
| Tip Amplitude (max) | 305 microns (24 kHz) | |||
| 215 microns (35 kHz) | 305 microns (24 | |||
| kHz) | ||||
| 215 microns (35 | ||||
| kHz) | 305 microns (24 | |||
| kHz) | ||||
| 215 microns (35 | ||||
| kHz) | 356 microns (23 | |||
| kHz) | ||||
| 182 microns (36 | ||||
| kHz) | ||||
| Irrigation rate | 0-50 ml/min | 0-50 ml/min | 0-50 ml/min | 0-30 ml/min. |
| Suction (Aspiration) | ||||
| system | 0-680 mmHg | Up to 600 mmHg | 0-680 mmHg | Up to 680 mmHg |
| vibration of tip | longitudinal | longitudinal | longitudinal | longitudinal |
| Tips Delivered As | Sterile / Single Use | Sterile / Single Use | Sterile / Single Use | Non Sterile |
| Tip Specific | ||||
| information | 35 kHz Extended | |||
| Length Tip | 35 kHz Neuro Tip | 35 kHz Neuro Tip | Curved Extended | |
| Micro | ||||
| Tip | ||||
| Approximate Frequency | ||||
| of Operation | 35 kHz | 35 kHz | 35 kHz | 36 kHz |
| Shroud | Uses a straight shroud, | |||
| packaged with tip | Uses Shroud with | |||
| handpiece | Uses Shroud with | |||
| handpiece | Nosecone | |||
| Max Stroke (inches) | 0.0069 | 0.0069 | 0.0069 | 0.0076 |
| Vibration of Tip | Longitudinal | Longitudinal | Longitudinal | Longitudinal |
| Design of distal end | Cylindrical shape | |||
| with flat annulus | Cylindrical shape | |||
| with flat annulus | Cylindrical shape | |||
| with flat annulus | Cylindrical shape | |||
| with flat annulus | ||||
| Diameter (inches) | ||||
| Inner/outer | 0.063/0.077 | 0.059/0.077 | 0.059/0.077 | 0.062/0.076 |
| Length (inches) | 9.9 | 7.2 | 7.2 | 4.8 |
| Bend Angle | 12° | 20° | 20° | 12° |
| 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 | n/a |
| 807.92(b)(1-2) NONCLINICAL TESTS SUBMITTED | ||||
| Test | Result | |||
| Electromechanical Test - | ||||
| measures frequency, stroke. | The test was performed using both the Selector and NXT systems which confirmed that | |||
| the modified tin has the same stroke, and therefore the came fromomotation payar, as the |
2
ﺮ ﺍﻟﻤﺮﺍﺟﻊ (1
| measures frequency, stroke,
lateral movement, and power | the modified tip has the same stroke, and therefore the same fragmentation power, as the
predicate device (35 kHz Fine Tip). This indicates similar heating potential. |
|--------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 61847 Ultrasonics –
Surgical Systems - acoustic
power transfer | The modified tip has less acoustic power transfer in liquid as the predicate device (35
kHz Fine Tip, K021989). This indicates reduced heating potential. |
| Measurement of tissue
removal rate and power used
during tissue removal rate | The modified tip and predicate device (35 kHz Fine Tip, K021989) remove tissue at an
equivalent rate, using equivalent power. |
| Measurement of Thermal
Rise During Ultrasonic
Aspiration of Representative
Tissue | Thermal rise in tissue field during tissue removal was found to be less for the new tip
than the predicate device (35 kHz Fine Tip, K021989). |
| 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. However, tests results on the predicate device material was
included in the submission |
807.92(b)(3) CONCLUSIONS DRAWN FROM NON-CLINICAL DATA
Testing using the Selector and NXT systems confirmed that the performance of the modified tip was the same as existing tips for frequency, stroke, lateral movement and quiescent power. Based on the analysis of the design and the performance testing, the heating potential of the same or less than the predicate device.
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Integra c/o Kevin J. O'Connell Director, Regulatory Affairs 22 Terry Avenue Burlington, MA 01803
JUN 1 0 2011
Re: K102258
Trade/Device Name: CUSA NXT Extended Length Tip, an accessory of the CUSA NXT and CUSA Selector Ultrasonic Surgical Aspirator Systems Regulation Number: Unclassified Regulation Name: Ultrasonic Surgical Instrument Regulatory Class: Unclassified Product Code: LFL Dated: March 24, 2011 Received: March 25, 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
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Page 2 - Mr. 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If 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/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,
Eithermf
Malvina B. Eydelman. M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use Statement
510(k) Number (if known): _ 长1022258
Device Name: Integra CUSA NXT Extended Length Tip
Indications For Use:
The CUSA NXT Extended Length Tip for soft tissue is an accessory to the CUSA NXT and CUSA Selector Ultrasonic Surgical Aspirator Systems that are 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)
C Gr
(Division Sign-Off) Division of Ochalmic. Neurological and Ear, Nose and Throal انتخان البرج
510(k) Number K102258
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