(304 days)
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 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.
The provided text describes a 510(k) summary for the Integra™ CUSA NXTTM Extended Length Tip, an accessory to ultrasonic surgical aspirator systems. The summary includes non-clinical tests to demonstrate substantial equivalence to predicate devices, focusing on the device's physical and performance characteristics rather than clinical diagnostic performance. Therefore, many of the requested fields related to diagnostic studies (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance) are not applicable to this submission.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly defined by demonstrating that the new tip performs "the same" as or "less" than the predicate device in terms of potential adverse effects (like heating) while maintaining equivalent functional performance (like tissue removal rate).
| Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Electromechanical | Same frequency, stroke, lateral movement, and fragmentation power as the predicate device (35 kHz Fine Tip). Implies similar heating potential. | 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. Performance for frequency and lateral movement was also confirmed to be the same. |
| Acoustic Power Transfer | Equivalent or less acoustic power transfer in liquid compared to the predicate device (35 kHz Fine Tip, K021989). Implies reduced heating potential. | The modified tip has less acoustic power transfer in liquid as the predicate device (35 kHz Fine Tip, K021989). This indicates reduced heating potential. |
| Tissue Removal Rate & Power Usage | Equivalent tissue removal rate and power used during tissue removal as the predicate device (35 kHz Fine Tip, K021989). | The modified tip and predicate device (35 kHz Fine Tip, K021989) remove tissue at an equivalent rate, using equivalent power. |
| Thermal Rise During Aspiration | Equivalent or less thermal rise in the tissue field during tissue removal compared to the predicate device (35 kHz Fine Tip, K021989). | 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 | Materials used should have the same chemical formulations, manufacturing, and sterilization processes as the predicate device, or additional testing performed. | 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, but test results on the predicate device material were included. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not applicable. This was a non-clinical, benchtop study comparing the performance characteristics of the new tip against a predicate device, not a study involving patient data or a test set in the traditional sense of a diagnostic device.
- Data provenance: Not applicable. The tests were performed in a lab setting by the manufacturer (Integra Burlington MA, Inc.).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This was a non-clinical, benchtop study. No expert review of patient data was involved.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This was a non-clinical, benchtop study. No adjudication of patient cases was involved.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI/diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" equivalent in this context is the performance of the legally marketed predicate device (35 kHz Fine Tip, K021989). The study's goal was to demonstrate that the new device is substantially equivalent to this predicate in terms of safety and performance.
8. The sample size for the training set
- Not applicable. This is a non-clinical submission for a surgical instrument accessory, not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set or associated ground truth was established for this submission.
{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 AvenueBurlington, MA 01803 |
| Phone number | 781-565-1227 |
| Fax number | 781-238-0645 |
| EstablishmentRegistration Number | 1222895 |
| Name of contactperson | Kevin J. O'Connell |
| Date prepared | June 8, 2011 |
| 807.92(a)(2) - Name of device | |
| Trade or proprietaryname | Integra™ CUSA NXTTM Extended Length Tip |
| Common or usualname | 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 TipK071669 | |
| 807.92(a)(4) - Device description | |
| The Extended Length Tip (ELT) has been designed to be used with the35kHz Handpiece of the CUSA Selector and CUSA NXT Ultrasonic surgicalaspirators. Ultrasonic surgical aspirators facilitate the removal of cellular andother unwanted soft and hard (e.g. bone) tissue. These systems provideselective tissue disintegration with simultaneous irrigation and aspiration.The design of the 35 kHz Fine tip that is currently used with the 35kHzHandpiece has been modified to increase the working length of the deviceand reduce the bend angle. This will allow the device to be used inprocedures where the surgeon requires a longer tip. |
{1}------------------------------------------------
| distal end of the ELT will have a flat annulus and two pre-aspiration holesThe 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 theCUSA NXT and CUSA Selector Ultrasonic Surgical Aspirator Systems thatare indicated for use in surgical procedures where fragmentation,emulsification and aspiration of soft and hard (e.g. bone) tissue is desirableincluding Neurosurgery, Gastrointestinal and affiliated organ surgery,Urological surgery, Plastic and Reconstructive surgery, General surgery,Orthopedic surgery, Gynecological surgery, Thoracic surgery, Laparoscopicsurgery 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 ExtendedLength Tip | Selector IntegraUltrasonicSurgical AspiratorSystem, K021989. | CUSA SelectorNXT UltrasonicTissue AblationSystem K081459. | CUSA EXCELUltrasonicSurgical AspiratorSystem, K98126 |
| System Features | ||||
| Oscillation system | Piezoelectric | Piezoelectric | Piezoelectric | Magnetostrictive |
| Approximate Frequencyof 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 (24kHz)215 microns (35kHz) | 305 microns (24kHz)215 microns (35kHz) | 356 microns (23kHz)182 microns (36kHz) |
| 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 Specificinformation | 35 kHz ExtendedLength Tip | 35 kHz Neuro Tip | 35 kHz Neuro Tip | Curved ExtendedMicroTip |
| Approximate Frequencyof Operation | 35 kHz | 35 kHz | 35 kHz | 36 kHz |
| Shroud | Uses a straight shroud,packaged with tip | Uses Shroud withhandpiece | Uses Shroud withhandpiece | Nosecone |
| Max Stroke (inches) | 0.0069 | 0.0069 | 0.0069 | 0.0076 |
| Vibration of Tip | Longitudinal | Longitudinal | Longitudinal | Longitudinal |
| Design of distal end | Cylindrical shapewith flat annulus | Cylindrical shapewith flat annulus | Cylindrical shapewith flat annulus | Cylindrical shapewith 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 6AL4VGrade 5 | Titanium 6AL4VGrade 5 | Titanium 6AL4VGrade 5 | Titanium 6AL4VGrade 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 thatthe 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 thepredicate device (35 kHz Fine Tip). This indicates similar heating potential. |
|---|---|
| IEC 61847 Ultrasonics –Surgical Systems - acousticpower transfer | The modified tip has less acoustic power transfer in liquid as the predicate device (35kHz Fine Tip, K021989). This indicates reduced heating potential. |
| Measurement of tissueremoval rate and power usedduring tissue removal rate | The modified tip and predicate device (35 kHz Fine Tip, K021989) remove tissue at anequivalent rate, using equivalent power. |
| Measurement of ThermalRise During UltrasonicAspiration of RepresentativeTissue | Thermal rise in tissue field during tissue removal was found to be less for the new tipthan the predicate device (35 kHz Fine Tip, K021989). |
| Biocompatibility | Since the modified device uses materials that have the same chemical formulations, samemanufacturing and same sterilization processes as in the predicate device, additionaltesting was not performed. However, tests results on the predicate device material wasincluded 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.
{3}------------------------------------------------
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
{4}------------------------------------------------
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
{5}------------------------------------------------
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
1
N/A