(59 days)
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No
The document describes a mechanical surgical device that uses ultrasonic vibration for tissue fragmentation and aspiration. There is no mention of AI or ML in the intended use, device description, or any other section.
No
The device description indicates it is a surgical tool used for fragmentation, emulsification, and aspiration of tissue, which are surgical procedures, not therapeutic applications.
No
The device is described as an ultrasonic surgical aspirator system used for fragmentation, emulsification, and aspiration of tissue during surgical procedures. Its function is to remove unwanted tissue, not to diagnose conditions.
No
The device description clearly outlines hardware components such as a console, surgical handpiece, titanium handpiece tip, and a suction/irrigation system, indicating it is not a software-only device.
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 the living body) application, not an in vitro (outside the living body) diagnostic test.
- Device Description: The description details a surgical tool with a handpiece, tip, and console for physical tissue removal. This aligns with a surgical device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely surgical tissue removal.
N/A
Intended Use / Indications for Use
The CUSA Selector 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 Selector Integra Ultrasonic Surgical Aspirator System (Selector) is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, fragments, emulsifies and removes unwanted tissue. It allows the selective dissection of target tissue while preserving vessels, ducts and other delicate structures. The Selector consists of a console which provides control and power functions, a surgical handpiece which provides ultrasonic mechanical energy, a titanium handpiece tip and flexible irrigation flue, and a suction/irrigation system (manifold tubing and cooling water canister).
The Selector has been modified to enable it to fragment bone. This was accomplished by designing a new tip, which will be referred to as the Saber Tip, to work with existing system. Therefore no changes to the console, handpiece or suction/irrigation system were needed.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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N/A
0
5. 510(k) Summary
AUG 1 7 2007 Selector Ultrasonic Surgical Aspirator System with Bone Tip 510(k) Summary
This 510(k) Summary information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. 807.92.
1.0 The submitter of this premarket notification is:
Kevin J. O'Connell Regulatory Affairs Manager Integra Radionics, Inc. 22 Terry Avenue Burlington, MA 01803 Tel.: (781) 565-1227 Fax: (781) 238-0645
This summary was prepared on June 18, 2007.
- 2.0 The name of the device is the Integra Selector Ultrasonic Surgical Aspirator System with Bone Tip 510(k). The common name is Ultrasonic Surgical Aspirator and its classification name is instrument, ultrasonic surgical. The product code is LFL.
- 3.0 The above device is substantial equivalent to:
- Selector Integra Ultrasonic Surgical Aspirator System cleared via 510(k) . K021989 on September 13, 2002.
- Radionics CUSA Excel Ultrasonic Surgical Aspirator System with Bone Tip . cleared via 510(k) K051947 on August 22, 2005.
- Synergetics Sonotome Ultrasonic Aspirator Tips was cleared via the 510(k) . process, K020220, on August 23, 2002.
- 4.0 The Selector Integra Ultrasonic Surgical Aspirator System (Selector) is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, fragments, emulsifies and removes unwanted tissue. It allows the selective dissection of target tissue while preserving vessels, ducts and other delicate structures. The Selector consists of a console which provides control and power functions, a surgical handpiece which provides ultrasonic mechanical energy, a titanium handpiece tip and flexible irrigation flue, and a suction/irrigation system (manifold tubing and cooling water canister).
The Selector has been modified to enable it to fragment bone. This was accomplished by designing a new tip, which will be referred to as the Saber Tip, to
1
work with existing system. Therefore no changes to the console, handpiece or suction/irrigation system were needed.
- 5.0 The device like its predicates is intended for fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue. The indications for use are: 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.
- 6.0 The technological characteristics are the same or similar to those found with the predicate devices.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The text is written in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 7 2007
Integra Radionics, Inc. % Mr. Kevin J. O'Connell Regulatory Affairs Manager 22 Terry Avenue Burlington, Massachusetts 01803-2516
Re: K071669
Trade/Device Name: Selector Integra Ultrasonic Surgical Aspirator System with Bone Tip Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: LFL Dated: June 18, 2007 Received: July 24, 2007
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.
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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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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. 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
510(k) Number (if known): K071669
Device Name: Selector Integra Ultrasonic Surgical Aspirator System with Bone Tip
Indications For use: The CUSA Selector 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)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | 2071669 |
|---|---|
| --------------- | --------- |