(276 days)
No
The summary describes a traditional ultrasonic surgical aspirator system with no mention of AI or ML capabilities in its function, description, or performance studies.
Yes.
The device is used for fragmentation, emulsification, and aspiration of soft and hard tissue, including the removal of tumors and other unwanted tissue, which are therapeutic interventions.
No
This device is described as an "ultrasonically vibrating surgical device" used for fragmentation, emulsification, and aspiration of tissue, and its indications for use are therapeutic surgical procedures, not the diagnosis of medical conditions.
No
The device description clearly outlines hardware components such as a console, hand pieces, tips, tubing, canister, and footswitch, 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:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The CUSA® Excel+ Ultrasonic Surgical Aspirator System is a surgical device that physically fragments, emulsifies, and aspirates tissue during a surgical procedure. It is used to remove unwanted tissue from the body.
- Intended Use: The intended use clearly describes surgical procedures and the removal of tissue in vivo (within the living body).
- Device Description: The description details a surgical system with handpieces, tips, irrigation, and suction, all designed for use during surgery.
There is no indication that this device is used to examine specimens outside of the body for diagnostic purposes. Its function is entirely within the surgical setting for tissue removal.
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 turnors 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 turnors 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 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, 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), titanium hand piece tips (variety of models), flexible irrigation flue, and a suction/irrigation system (manifold tubing and cooling water canister). The CUSA Excel+ system accommodates most commercially available suction canisters. A two-pedal footswitch is provided with the console.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hepatic parenchyma, renal parenchyma, genital epithelial tissue (vulvar, vaginal, perianal), uterine, ovarian, fallopian tube, peritoneal, endometrial.
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
Integra performed a bench study to assess the impact and significance of spray patterns. A series of randomized experiments covering different settings were performed. Irrigation spray was imaged and plotted for different operating settings of the CUSA system. 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.
The clinical evidence used to support the revision to the indications for use is provided from peer-reviewed clinical literature. An analysis of peer-reviewed articles on the use of CUSA presents clinical evidence to support the indications of CUSA in Gynecological Surgery The clinical literature describes the use of CUSA for these indications in over 500 patients in 34 articles published between 1988 and 2014. Specifically, in the literature, CUSA was used to treat 230 patients with dysplasia, 101 patients with condyloma, 164 patients requiring debulking procedures, and 15 patients with endometriosis. In dysplasia cases, CUSA produced excellent cosmetic results with limited scarring and, compared to topical treatments, CUSA effectively reduced recurrence rates. Specifically, VAIN (Vaginal Intraepithelial Neoplasia) is inherently a problematic disease to treat due to its anatomical location. Use of CUSA successfully overcame this difficulty with VAIN while resulting in minimal bleeding. Likewise, in condyloma cases, CUSA was successful in achieving desired treatment outcomes. As in the case of VAIN and VIN (Vulvar Intraepithelial Neoplasia), CUSA allowed for removal of epithelial lesions with fast healing, minimal patient discomfort, and improved cosmetic results in condyloma-related procedures. In the clinical literature, use of CUSA also did not result in any postoperative complications or scarring. In debulking cases, CUSA allowed for dissection of tumor masses that could not be resected safely by standard techniques or were located in areas that were considered unresectable. Many articles demonstrated the safe and effective use of CUSA in debulking ovarian cancer, as well as metastases from endometrial cancer, tubal adenocarcinoma, and peritoneal tumors. In these cases, CUSA significantly reduced or eliminated residual disease with minimal complications while not requiring the resection of normal structures. One article noted risk of DIC (Disseminated Intravascular Coagulation), however, no other studies found such a risk of DIC in a CUSA population of over 500 patients. In cases where endometrial tissue was removed, CUSA effectively removed the endometrial tissue while preserving vessels and nerves.
Key Metrics
Not Found
Predicate Device(s)
CUSA® Excel Plus Ultrasonic Surgical Aspirator; K141668
Reference Device(s)
CUSA® 200C, 200T, 200M, 200H Ultrasonic Aspirator; K894600, CUSA® 200C, 200T Ultrasonic Aspirator; K931902
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The caduceus is rendered in a simple, black line drawing, and the text is also in black. The overall design is clean and professional, reflecting the department's role in public health and welfare.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18, 2015
Integra Lifesciences Corp. Jennifer Siegel Regulatory, Quality and Clinical Associate 311 Enterprise Drive Plainsboro, NJ 08536
K150682 Trade/Device Name: CUSA® Excel+ Ultrasonic Surgical Aspirator System Regulation Number: N/A Regulation Name: Instrument, Ultrasonic Surgical Regulatory Class: Unclassified Product Code: LFL, LBK Dated: October 20, 2015 Received: October 21, 2015
Dear Jennifer Siegel,
Re:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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" (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 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,
Herbert P. Lerner -S
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
2
Indications for Use
510(k) Number (if known) K150682
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 turnors 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 turnors 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 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 | 609-936-5459 |
| Establishment Registration Number | 3003418325 |
| Name of Contact Person | Jennifer Siegel |
| Date Prepared | 02/18/2014 |
| 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 | Class II unclassified |
| Product Code(s) | LFL, LBK |
| 807.92(a)(3) – Legally marketed device(s) to which equivalence is claimed | |
| CUSA® Excel Plus Ultrasonic Surgical Aspirator; K141668 | |
| Reference Devices: CUSA® 200C, 200T, 200M, 200H Ultrasonic Aspirator; K894600 |
CUSA® 200C, 200T Ultrasonic Aspirator; K931902
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, 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), titanium hand piece tips (variety of models), flexible irrigation flue, and a suction/irrigation system (manifold tubing and cooling water canister). The CUSA Excel+ system accommodates most commercially available suction canisters. A two-pedal footswitch is provided with the console.
4
| 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 surgical | |
| 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 parenchym | |
| 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 |
5
| This 510(k) adds specific indications to the already cleared
general indications for the CUSA Excel+. The addition of these
new indications does not change the intended use of the CUSA
Excel+ as these indications do not alter the principles of
| operations (ultrasonic ablation) for this device. |
|---|
807.92(a)(6) Summary of the technological characteristics of the device compared to the predicate
The technological characteristic of the device are the same compared to the predicate device.
6
807.92(b)(1-2) – Nonclinical and clinical tests submitted
Integra performed a bench study to assess the impact and significance of spray patterns. A series of randomized experiments covering different settings were performed. Irrigation spray was imaged and plotted for different operating settings of the CUSA system. 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.
The clinical evidence used to support the revision to the indications for use is provided from peer-reviewed clinical literature. An analysis of peer-reviewed articles on the use of CUSA presents clinical evidence to support the indications of CUSA in Gynecological Surgery The clinical literature describes the use of CUSA for these indications in over 500 patients in 34 articles published between 1988 and 2014. Specifically, in the literature, CUSA was used to treat 230 patients with dysplasia, 101 patients with condyloma, 164 patients requiring debulking procedures, and 15 patients with endometriosis. In dysplasia cases, CUSA produced excellent cosmetic results with limited scarring and, compared to topical treatments, CUSA effectively reduced recurrence rates. Specifically, VAIN (Vaginal Intraepithelial Neoplasia) is inherently a problematic disease to treat due to its anatomical location. Use of CUSA successfully overcame this difficulty with VAIN while resulting in minimal bleeding.
Likewise, in condyloma cases, CUSA was successful in achieving desired treatment outcomes. As in the case of VAIN and VIN (Vulvar Intraepithelial Neoplasia), CUSA allowed for removal of epithelial lesions with fast healing, minimal patient discomfort, and improved cosmetic results in condyloma-related procedures. In the clinical literature, use of CUSA also did not result in any postoperative complications or scarring.
In debulking cases, CUSA allowed for dissection of tumor masses that could not be resected safely by standard techniques or were located in areas that were considered unresectable. Many articles demonstrated the safe and effective use of CUSA in debulking ovarian cancer, as well as metastases from endometrial cancer, tubal adenocarcinoma, and peritoneal tumors. In these cases, CUSA significantly reduced or eliminated residual disease with minimal complications while not requiring the resection of normal structures. One article noted risk of DIC (Disseminated Intravascular Coagulation), however, no other studies found such a risk of DIC in a CUSA population of over 500 patients.
7
In cases where endometrial tissue was removed, CUSA effectively removed the endometrial tissue while preserving vessels and nerves.
It should be noted that one case study for the treatment of vulvar carcinoma, which is outside the scope of these expanded indications, suggests a risk of dissemination by CUSA. However, the author states in the conclusion of the study that "it is impossible to assess whether the early locoregional tumor recurrence in this patient was related to the use of CUSA or was due to embolization of the micrometastases before surgery." CUSA offers significant benefits in Gynecological Surgery, such as decreased complications, improved cosmetic effect, and the ability to reach difficult locations that impact patient survival. CUSA is able to remove lesions while not damaging surrounding tissue. Therefore, patients are able to have a same day discharge for many of these critical procedures.
807.92(b)(3) - Conclusions drawn from non-clinical and clinical data
The information from the nonclinical testing and the peer reviewed clinical literature supports the proposed changes from general to specific indications in gynecologic surgery.