(82 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on hardware and control technology updates for usability, not AI/ML capabilities.
Yes.
The device's intended use clearly states it is used in surgical procedures where fragmentation, emulsification, and aspiration of tissue are desirable, which are therapeutic actions performed on patients.
No
The device is an aspirator system used for fragmentation, emulsification, and aspiration of tissue during surgical procedures, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it consists of a System Console and a Service Module, which are hardware components.
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 for "fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue" during surgical procedures. This describes a surgical tool used on the patient's body, not a device used to test samples from the body (like blood, urine, or tissue samples) in a laboratory setting.
- Device Description: The description details a surgical aspirator system with a console and service module, designed for physical manipulation of tissue during surgery. This aligns with a surgical device, not an IVD.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The CUSA Selector™ NXT is a surgical instrument used for tissue removal during surgery.
N/A
Intended Use / Indications for Use
The CUSA Selector NXT Ultrasonic Surgical Aspirator is intended for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue and hard (e.g. bone) is desirable. Such functions are within the indications of use for the predicate devices.
The CUSA Selector™ NXT Ultrasonic Surgical Aspirator System 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 CUSA Selector NXT Ultrasonic Surgical Aspirator consists of two components: System Console and Service Module. The System Console operates the full functions of the aspirator, but does not have an on-board aspiration source. The Service Module is an add-on that provides an integrated system look with a fully independent aspiration source. The product is being updated to improve usability and control technology within the system. It will utilize the existing set of Selector handpieces.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
AUG 1 3 2008
CUSA Selector NXT Ultrasonic Surgical Aspirator Module 510(k) Summary
Submitter's Name and Address:
Integra Radionics 22 Terry Avenue Burlington, MA 01803 781-565-1227 (Telephone) 781-238-0645 (Fax)
Contact Person and Telephone Number:
Kevin J. O'Connell Director Regulatory Affairs and Quality Assurance Integra Radionics, Inc. Tel.: (781) 565-1227
Date Summary was Prepared: May 12, 2008.
Name of the Device:
| Trade Name: | CUSA Selector NXT Ultrasonic Surgical Aspirator |
|---|---|
| Common Name: | Ultrasonic Surgical Aspirator |
| Classification Name: | Instrument, Ultrasonic Surgical |
| Product Code: LFL | |
| Classification Panel: | General and Plastic Surgery |
Substantial Equivalence:
The CUSA Selector NXT Ultrasonic Surgical Aspirator is intended for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue and hard (e.g. bone) is desirable. Such functions are within the indications of use for the predicate devices. The technological characteristics are similar to those found in the following predicate devices: Selector Ultrasonic Surgical Aspirator with Bone Tip cleared via 510(k) K071669 on August 17, 2007, Selector Quantum Ultrasonic Surgical Aspirator cleared via 510(k) K042277 on September 29, 2004, and Selector Integra Ultrasonic Surgical Aspirator System cleared via 510(k) K021989 on September 13, 2002.
The CUSA Selector NXT Ultrasonic Surgical Aspirator consists of two components: System Console and Service Module. The System Console operates the full functions of the aspirator, but does not have an on-board aspiration source. The Service Module is an
CUSA Selector NXT Ultrasonic Tissue Ablation System 510(k)
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add-on that provides an integrated system look with a fully independent aspiration source. The product is being updated to improve usability and control technology within the system. It will utilize the existing set of Selector handpieces.
CUSA Selector NXT Ultrasonic Tissue Ablation System 510(k)
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:
:
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all caps and is evenly spaced around the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 3 2008
Integra Radionics, Inc. % Mr. Kevin J. O'Connell Director, RA/QA 22 Terry Avenue Burlington, Massachusetts 01803-2516
Re: K081459
Trade/Device Name: CUSA Selector™ NXT Ultrasonic Surgical Aspirator System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regula.ory Class: II Product Code: LFL Dated: May 21, 2008 Received: May 27, 2008
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
3
Page 2 - Mr. Kevin J. O'Connell
This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276 3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Millman
- Mark N. Melkerson Director Division of General, Restorative and Neurological 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): 1 081459
Device Name: CUSA Selector™ NXT Ultrasonic Surgical Aspirator System
Indications For Use:
The CUSA Selector™ NXT Ultrasonic Surgical Aspirator System 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)
ision Sign-Off) Division of General, Restorative, and Neurological Devices
CUSA Selector NXT Ultrasonic Tissue Ablation System Page 2