(59 days)
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.
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.
This 510(k) summary describes a device modification, specifically a new bone tip for an existing ultrasonic surgical aspirator system. The submission focuses on demonstrating substantial equivalence to predicate devices for the expanded use case of fragmenting bone and does not include a study or acceptance criteria in the typical sense of evaluating a diagnostic or AI-driven device.
Therefore, many of the requested categories in your prompt are not applicable to this type of regulatory submission. The document explicitly states that "no changes to the console, handpiece or suction/irrigation system were needed," only the tip was modified. This implies that the core performance of the aspirator system for soft tissue fragmentation remains established by the previous 510(k) clearances.
Here's an analysis based on the provided document, addressing the applicable points and explaining why others are not relevant:
1. Table of Acceptance Criteria and Reported Device Performance:
There is no explicit table of acceptance criteria or reported device performance metrics in this 510(k) summary for the new bone tip. The submission relies on demonstrating substantial equivalence to predicate devices that are already cleared for fragmenting both soft and hard (bone) tissue. The acceptance is implied by the FDA's decision letter of "substantial equivalence" as detailed in the document.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. This submission is for a device modification (new tip) and relies on demonstrating substantial equivalence to already-cleared predicate devices. There is no new "test set" of data or patient samples presented in this summary to evaluate the performance of this specific bone tip. The evaluation would have been based on engineering design, material compatibility, and potentially bench testing to confirm the tip's ability to fragment bone, as opposed to a clinical study with human data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. As noted above, there is no new "test set" for performance evaluation in the context of a diagnostic or AI study. The core claim is substantial equivalence to predicate devices already cleared for the indications of use.
4. Adjudication Method for the Test Set:
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
Not applicable. This is not a diagnostic or AI device that would typically involve a MRMC study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:
Not applicable. This is a surgical instrument, not an algorithm or AI.
7. The Type of Ground Truth Used:
The "ground truth" in this context is the established safety and efficacy of the predicate devices for fragmenting both soft and hard tissue. The new bone tip is designed to achieve the same functional outcome as the bone tips of the predicate devices. The assessment relies on a comparison of technological characteristics and intended use.
8. The Sample Size for the Training Set:
Not applicable. This is 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.
Summary of what the document does provide regarding acceptance:
- Acceptance Criteria (Implicit): The primary acceptance criterion for this 510(k) submission is to demonstrate substantial equivalence to legally marketed predicate devices. This means proving that the modified device is as safe and effective as the predicate device(s) for its intended use, which now includes bone fragmentation.
- Study Proving Acceptance: The "study" is a comparison and justification presented in the 510(k) submission itself, stating:
- The device (Selector Ultrasonic Surgical Aspirator System with Bone Tip) is substantially equivalent to:
- Selector Integra Ultrasonic Surgical Aspirator System (K021989) - cleared for general ultrasonic aspiration.
- Radionics CUSA Excel Ultrasonic Surgical Aspirator System with Bone Tip (K051947) - a predicate device that already includes a bone tip, directly supporting the expanded indication.
- Synergetics Sonotome Ultrasonic Aspirator Tips (K020220) - another predicate for aspirator tips.
- The modification involves designing a new bone tip (Saber Tip) to work with the existing system.
- No changes were needed for the console, handpiece, or suction/irrigation system.
- The technological characteristics are the same or similar to those found with the predicate devices.
- The indications for use are aligned with the predicate devices, specifically mentioning fragmentation, emulsification, and aspiration of "soft and hard (e.g., bone) tissue."
- The device (Selector Ultrasonic Surgical Aspirator System with Bone Tip) is substantially equivalent to:
The FDA's decision letter (starting on page 2 of the input) confirms that the FDA reviewed the submission and determined that the device is "substantially equivalent" to the legally marketed predicate devices, thereby allowing it to proceed to market. This determination is the documented acceptance.
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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
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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.
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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 |
|---|---|
| --------------- | --------- |
N/A