(30 days)
Not Found
No
The device description focuses on the mechanical and ultrasonic aspects of tissue fragmentation and aspiration, with no mention of AI or ML for analysis, control, or other functions. The performance studies described are bench studies related to misting and a risk-benefit analysis, not AI/ML performance metrics.
No
The device is described as a surgical aspirator system used for fragmentation, emulsification, and aspiration of tissue during various surgical procedures, which are considered interventions rather than therapeutic treatments in themselves.
No
The device is described as an "ultrasonically vibrating surgical device" used for fragmentation, emulsification, and aspiration of tissue, and its intended uses are surgical procedures to remove tissue. There is no mention of diagnostic functions.
No
The device description clearly outlines multiple hardware components including a console, hand pieces, tips, irrigation flue, suction/irrigation system, and a footswitch.
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 fragmentation, emulsification, and aspiration of tissue during surgical procedures. This is an in vivo (within a living organism) application, not an in vitro (outside of a living organism) diagnostic test performed on samples like blood, urine, or tissue biopsies.
- Device Description: The device description details a surgical aspirator system with handpieces, tips, irrigation, and aspiration components. These are tools used directly on tissue within the body during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting specific analytes, or providing diagnostic information based on laboratory testing.
Therefore, the CUSA® Excel+ Ultrasonic System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CUSA® Excel+ Ultrasonic System is indicated for fragmentation, emulsification and aspiration of soft and hard (e.g .: bone) tissue in the following surgical specialties:
Neurosurgery, Orthopedic Surgery, Plastic and Reconstructive Surgery and the following specific uses:
Gastrointestinal and Affiliated Organ Surgery - including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy
Urological Surgery - including removal of renal parenchyma during nephrectomy or partial nephrectomy
General Surgery - including removal of benign or malignant tumors or other unwanted soft or hard tissue in open or minimally invasive general surgical procedures
Laparoscopic Surgery – including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy
Gynecological Surgery - including removal of dysplastic genital or perianal epithelial tissue including vulvar and vaginal intraepithelial neoplasia, removal of condyloma, debulking of metastatic uterine, ovarian, fallopian tube or primary peritoneal carcinoma, and open or laparoscopic excision of tissue and adhesions associated with endometriosis
Product codes
LFL, LBK
Device Description
The CUSA® Excel+ Ultrasonic Surgical Aspirator System (CUSA) 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 CUSA Excel+ System consists of a console which provides control and power functions, two surgical hand pieces which provide ultrasonic mechanical energy (23kHz and 36kHz), 18 titanium hand piece tips (variety of models), a flexible irrigation flue, and a suction/irrigation system (manifold tubing and cooling water canister). The CUSA Excel+ system accommodates most commercially available suction canisters, and specimen traps (optional). A two-pedal footswitch is provided with the console. The CUSA Excel+ System may also be used with an external CUSA Electrosurgical Module (CEM), which provides optional electrosurgical capability.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hepatic parenchyma, renal parenchyma, genital, perianal, vulvar, vaginal, uterine, ovarian, fallopian tube, peritoneal, colon
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)
Integra performed a bench study to assess the impact and significance of misting, which was previously submitted as part of K150682. The results showed spray can be controlled to levels very close to zero at amplitude and aspiration settings seen during typical use. Low amplitude and high aspiration yielded reduced spray, which is addressed in the labeling.
Integra also completed a risk-benefit analysis in order to assess the potential risk associated with the dissemination of malignant cells leading to an unexpected reoccurrence or upstaging of cancer. This analysis included a risk assessment, clinical literature review, clinical perspective and post-market surveillance information relating to the use of the CUSA Excel+. The review and analysis of this information did not identify a causal relationship between CUSA use and risks associated with dissemination of malignant cells. Furthermore, it was concluded that the benefits of using CUSA for the removal of unwanted tissue in surgery outweighs the risk of disseminating malignant cells.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 28, 2017
Integra LifeSciences Corporation Alexandra Wells Regulatory and Quality Associate 311 Enterprise Drive Plainsboro, NJ 08536
Re: K172595
Trade/Device Name: CUSA® Excel+ Ultrasonic Surgical Aspirator System Regulation Number: None Regulatory Class: Unclassified Product Code: LFL, LBK Dated: August 28, 2017 Received: August 29, 2017
Dear Alexandra Wells:
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.
1
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 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 (DICE) 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" (21 CFR 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 (DICE) 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.
For
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172595
Device Name
CUSA® Excel+ Ultrasonic Surgical Aspirator System
Indications for Use (Describe)
The CUSA® Excel+ Ultrasonic System is indicated for fragmentation, emulsification and aspiration of soft and hard (e.g .: bone) tissue in the following surgical specialties:
Neurosurgery, Orthopedic Surgery, Plastic and Reconstructive Surgery and the following specific uses:
Gastrointestinal and Affiliated Organ Surgery - including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy
Urological Surgery - including removal of renal parenchyma during nephrectomy or partial nephrectomy
General Surgery - including removal of benign or malignant tumors or other unwanted soft or hard tissue in open or minimally invasive general surgical procedures
Laparoscopic Surgery – including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy
Gynecological Surgery - including removal of dysplastic genital or perianal epithelial tissue including vulvar and vaginal intraepithelial neoplasia, removal of condyloma, debulking of metastatic uterine, ovarian, fallopian tube or primary peritoneal carcinoma, and open or laparoscopic excision of tissue and adhesions associated with endometriosis
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 | 1-609-275-0500 |
| Fax Number | 1-609-275-5363 |
| Establishment Registration Number | 9004007 |
| Name of Contact Person | Alexandra Wells |
| Contact Email | alexandra.wells@integralife.com |
| Date Prepared | 08/24/2017 |
| 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 | None |
| Classification Panel | General & Plastic Surgery |
| Regulation | Unclassified |
| Product Code(s) | LFL, LBK |
| 807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed | |
| Trade or Propriety Name | CUSA® Excel+ Ultrasonic Surgical Aspirator System |
| 510(k) Number | K150682 |
| Product Code | LFL, LBK |
| Manufacturer | Integra LifeSciences Corporation |
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807.92(a)(4) - Device description
The CUSA® Excel+ Ultrasonic Surgical Aspirator System (CUSA) 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 CUSA Excel+ System consists of a console which provides control and power functions, two surgical hand pieces which provide ultrasonic mechanical energy (23kHz and 36kHz), 18 titanium hand piece tips (variety of models), a flexible irrigation flue, and a suction/irrigation system (manifold tubing and cooling water canister). The CUSA Excel+ system accommodates most commercially available suction canisters, and specimen traps (optional). A two-pedal footswitch is provided with the console. The CUSA Excel+ System may also be used with an external CUSA Electrosurgical Module (CEM), which provides optional electrosurgical capability.
| 807.92(a)(5) – Intended use of the device | |
|---|---|
| Indications for Use | The CUSA® Excel+ Ultrasonic Surgical Aspirator System is |
| indicated for fragmentation, emulsification and aspiration | |
| of soft and hard (e.g.: bone) tissue in the following | |
| specialties: | |
| Neurosurgery, Orthopedic Surgery, Plastic and | |
| Reconstructive Surgery, and Thoracic Surgery and the | |
| following specific uses: | |
| Gastrointestinal and Affiliated Organ Surgery - including | |
| removal of benign or malignant tumors or other unwanted | |
| tissue, including hepatic parenchyma, in open or laparoscopic | |
| procedures, hepatic resection, tumor resection, lobectomy or | |
| trisegmentectomy, or removal of tissue during liver | |
| allotransplantation and donor hepatectomy | |
| Urological Surgery – including removal of renal | |
| parenchyma during nephrectomy or partial nephrectomy | |
| General Surgery – including removal of benign or | |
| malignant tumors or other unwanted soft or hard tissue | |
| in open or minimally invasive general surgical | |
| procedures | |
| Laparoscopic Surgery – including removal of hepatic | |
| parenchyma in laparoscopic hepatic resection, | |
| lobectomy or trisegmentectomy, in laparoscopic donor | |
| hepatectomy or laparoscopic cholecystectomy or | |
| laparoscopic pancreatic jejunostomy, or | |
| pancreatectomy, or laparoscopic appendectomy, | |
| laparoscopic colon resection or laparoscopic partial | |
| gastrectomy | |
| Gynecological Surgery – including removal of | |
| dysplastic genital or perianal epithelial tissue including | |
| vulvar and vaginal intraepithelial neoplasia, removal of | |
| condyloma, debulking of metastatic uterine, ovarian, | |
| fallopian tube or primary peritoneal carcinoma, and | |
| open or laparoscopic excision of tissue and adhesions | |
| associated with endometriosis | |
| Comparison to Predicate | |
| Device | The change included in this submission is an update to the |
| CUSA Excel+ labeling to remove the following debulking | |
| contraindication: |
5
6
Contraindication: Use of the device for tumor debulking should be limited to patients where the benefits of debulking are believed to outweigh the risks of further dissemination of malignant cells. There is no change to the indications for use or intended use of the device when compared to the predicate. Additionally, the labeling change does not affect the materials of composition, manufacturing and sterilization process, or the fundamental scientific technology of the device. The removal of the subject contraindication does not affect the risk profile of the device as the risk of dissemination in the context of uterine fibroids is already addressed under an existing uterine fibroids contraindication. As such, the change does not affect the safety or effectiveness of the device.
807.92(a)(6) Summary of the technological characteristics of the device compared to the predicate
There are no changes to the technological characteristics of the CUSA Excel+ when compared to the predicate.
807.92(b)(1-2) - Nonclinical and clinical tests referenced
Integra performed a bench study to assess the impact and significance of misting, which was previously submitted as part of K150682. The results showed spray can be controlled to levels very close to zero at amplitude and aspiration settings seen during typical use. Low amplitude and high aspiration yielded reduced spray, which is addressed in the labeling.
Integra also completed a risk-benefit analysis in order to assess the potential risk associated
7
with the dissemination of malignant cells leading to an unexpected reoccurrence or upstaging of cancer. This analysis included a risk assessment, clinical literature review, clinical perspective and post-market surveillance information relating to the use of the CUSA Excel+. The review and analysis of this information did not identify a causal relationship between CUSA use and risks associated with dissemination of malignant cells. Furthermore, it was concluded that the benefits of using CUSA for the removal of unwanted tissue in surgery outweighs the risk of disseminating malignant cells.
807.92(b)(3) - Conclusions drawn from non-clinical and clinical data
The information from the nonclinical testing, peer reviewed clinical literature, postmarket surveillance and risk-benefit analysis concluded that the benefits of using CUSA for the removal of unwanted tissue in surgery outweighs the risks of disseminating malignant cells. It was also concluded that the debulking contraindication does not improve the risk-benefit profile of the device; therefore, the removal of the debulking contraindication would not affect the safety and effectiveness of the device nor alter its performance or function when compared to the predicate. Review and analysis of this information supports the changes in the CUSA Excel+ labeling and the substantial equivalence of the device described in this submission when compared to the predicate.