(136 days)
No
The document describes a traditional ultrasonic surgical aspirator and makes no mention of AI or ML.
Yes
This device is used for surgical procedures where it fragments, emulsifies, and aspirates tissue, which directly contributes to the treatment of a condition.
No
Explanation: 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 tissue, not to diagnose conditions.
No
The device description clearly states it is an "ultrasonically vibrating surgical device" and mentions hardware-related testing like "Sterilization validations," "Electromagnetic Compatibility and Electrical Safety testing," and "Power supply re-work testing," indicating it is a physical hardware device.
Based on the provided text, 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 tissue" during surgical procedures. This describes a surgical tool used on the patient's body, not a device used to test samples outside the body (in vitro).
- Device Description: The description reinforces this by calling it an "ultrasonically vibrating surgical device" that "fragments, emulsifies and removes unwanted tissue." This is consistent with a surgical instrument.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue samples, etc.)
- Providing diagnostic information based on sample analysis
- Using reagents or assays
Therefore, the CUSA® Excel+ Ultrasonic Surgical Aspirator System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CUSA® Excel+ Ultrasonic Surgical Aspirator System is indicated for use in these surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue is desirable:
- Neurosurgery
- Gastrointestinal and Affiliated Organ Surgery .
- . Urological Surgery
- . Plastic and Reconstructive Surgery
- General Surgery
- Orthopedic Surgery .
- Gynecological Surgery
- . Thoracic Surgery
- Laparoscopic Surgery
- . Thoracoscopic Surgery
Product codes
LFL, LBK
Device Description
The CUSA Excel+ Ultrasonic Surgical Aspirator System is the current iteration of the previously cleared CUSA Excel Ultrasonic Surgical Aspirator System. Both product lines are owned by Integra LifeSciences; only the CUSA Excel+ is currently marketed in the United States. Like the CUSA Excel, the CUSA Excel+ is an ultrasonically vibrating surgical device which, in combination with irrigation, and aspiration, fragments, emulsifies and removes unwanted tissue. Minor modifications have been made to the device since the original CUSA Excel was cleared. The intended use and the fundamental scientific technology of the CUSA Excel+ are the same as the CUSA Excel.
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
Non-clinical testing was performed to support modifications, ensuring the safety and effectiveness was maintained following device modifications. Testing included:
- Sterilization validations ●
- o Electromagnetic Compatibility and Electrical Safety testing
- Noise reduction testing ●
- Non-patient contacting material change testing
- Power supply re-work testing o
All modifications have been assessed, both individually and cumulatively, and do not affect the safety and effectiveness of the device, including the intended use of the device, the fundamental scientific technology and the performance specifications of the CUSA® Excel+.
Key Metrics
Not Found
Predicate Device(s)
CUSA® Excel Ultrasonic Surgical Aspirator System K981262, CUSA® Excel Ultrasonic Surgical Aspirator System with Bone Tip K051947
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/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 three faces in profile, stacked on top of each other. The faces are oriented to the right and are connected to form a single, flowing shape. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 6, 2014
Integra LifeSciences Corporation Mr. Timothy Connors Regulatory Affairs Specialist 311 Enterprise Drive Plainsboro, New Jersey 08536
Re: K141674
Trade/Device Name: CUSA® Excel+ Ultrasonic Surgical Aspirator System Regulatory Class: Unclassified Product Code: LFL, LBK Dated: September 26, 2014 Received: September 29, 2014
Dear Mr. Connors:
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 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
1
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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/0 description: The image shows the logo for Integra. The word "INTEGRA" is written in gray, block letters. Below the word is the phrase "LIMIT UNCERTAINTY" in a smaller font. To the right of the word "INTEGRA" are four green squares of varying sizes, stacked on top of each other.
Indications for Use
Page 1
K141674 510(k) Number (if known):
Device Name:
CUSA® Excel+ Ultrasonic Surgical Aspirator System
Indications For Use:
The CUSA® Excel+ Ultrasonic Surgical Aspirator System is indicated for use in these surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue is desirable:
- Neurosurgery
- Gastrointestinal and Affiliated Organ Surgery .
- . Urological Surgery
- . Plastic and Reconstructive Surgery
- General Surgery
- Orthopedic Surgery .
- Gynecological Surgery
- . Thoracic Surgery
- Laparoscopic Surgery
- . Thoracoscopic Surgery
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801 Subpart D) | |
| AND/OR | |
| Over-The Counter Use | |
| (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92
| 807.92(a)(1) – Submitter information | |
|---|---|
| Name | Integra LifeSciences Corporation |
| Address | 311 Enterprise Drive Plainsboro, NJ 08536 USA |
| Phone Number | 609-275-0500 |
| Fax Number | 781-238-0645 |
| Establishment Registration Number | 3003418325 |
| Name of Contact Person | Timothy Connors |
| Date Prepared | June 11, 2014 |
| 807.92(a)(2) – Name of device | |
| Trade or Propriety Name | CUSA® Excel+ Ultrasonic Surgical Aspirator System |
| Common or Usual Name | Ultrasonic Surgical Aspirator |
| Classification Name | Instrument, Ultrasonic Surgical |
| Classification Panel | General and Plastic Surgery |
| Regulation | Unclassified |
| Product Code(s) | LFL, LBK |
| 807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed | |
| CUSA® Excel Ultrasonic Surgical Aspirator System K981262 |
CUSA® Excel Ultrasonic Surgical Aspirator System with Bone Tip K051947
807.92(a)(4) - Device description
The CUSA Excel+ Ultrasonic Surgical Aspirator System is the current iteration of the previously cleared CUSA Excel Ultrasonic Surgical Aspirator System. Both product lines are owned by Integra LifeSciences; only the CUSA Excel+ is currently marketed in the United States. Like the CUSA Excel, the CUSA Excel+ is an ultrasonically vibrating surgical device which, in combination with irrigation, and aspiration, fragments, emulsifies and removes unwanted tissue. Minor modifications have been made to the device since the original CUSA Excel was cleared. The intended use and the fundamental scientific technology of the CUSA Excel+ are the same as the CUSA Excel.
4
CUSA® Excel+ Ultrasonic Surgical Aspirator System
| 807.92(a)(5) – Intended use of the device | |
|---|---|
| Indications for Use | The CUSA® Excel+ Ultrasonic Surgical Aspirator System is indicated for use in these surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue is desirable: |
| • Neurosurgery • Gastrointestinal and Affiliated Organ Surgery • Urological Surgery • Plastic and Reconstructive Surgery • General Surgery • Orthopedic Surgery • Gynecological Surgery • Thoracic Surgery • Laparoscopic Surgery • Thoracoscopic Surgery |
807.92(a)(6) Summary of the technological characteristics of the device compared to the predicate
The CUSA Excel+ has the same technological characteristics compared to the predicate device, the CUSA® Excel. There were minor modifications made to the design of the console and to the sterilization method and manufacture of some accessories available for use with the CUSA Excel+. The modifications did not affect the performance specifications, mode of user operation, patient contacting materials, indications for use, or the energy source when compared to the predicate device.
807.92(b)(1-2) - Nonclinical and clinical tests submitted
Non-clinical testing was performed to support modifications, ensuring the safety and effectiveness was maintained following device modifications. Testing included:
- Sterilization validations ●
- o Electromagnetic Compatibility and Electrical Safety testing
- Noise reduction testing ●
- Non-patient contacting material change testing
- Power supply re-work testing o
5
807.92(b)(3) – Conclusions drawn from non-clinical and clinical data
All modifications have been assessed, both individually and cumulatively, and do not affect the safety and effectiveness of the device, including the intended use of the device, the fundamental scientific technology and the performance specifications of the CUSA® Excel+. The CUSA Excel+ is substantially equivalent to the predicate device.