The CUSA® Excel+ 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. The CUSA Excel+ Ultrasonic Surgical Aspirator is indicated for use in:

Neurosurgery, Plastic and Reconstructive surgery, Orthopedic Surgery, Gynecological 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

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), 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.

AI/ML Overview

The provided text is a 510(k) summary for the CUSA® Excel+ Ultrasonic Surgical Aspirator System. It details the device, its indications for use, and how its substantial equivalence to a predicate device was established.

However, the document states that no non-clinical testing was required as the device itself was not modified. Instead, the justification for expanded indications for use for Gastrointestinal (GI) and Affiliated Organ, Urologic, General, and Laparoscopic surgeries relies entirely on peer-reviewed journal articles summarizing existing clinical evidence.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about a specific study designed to prove the device meets pre-defined acceptance criteria in the way typically expected for a new or modified device requiring such testing. The document explicitly states that the device itself was not modified, and the assessment is based on a literature review.

Here's what can be extracted and inferred based on your request categories:

1. A table of acceptance criteria and the reported device performance

This information is not available from the provided text in the traditional sense of a specific study with predefined acceptance criteria. The document relies on a review of existing literature to demonstrate that the CUSA Excel+ (and its predicate) is "safe and effective" and "successful" in various surgical procedures, which serves as the "performance" data.

However, based on the conclusions from the literature review, the implied performance characteristics that were deemed acceptable include:

Acceptance Criterion (Inferred from Literature Review)	Reported Device Performance (Summary from Literature Review)
Safety (General)	No significant issues of safety identified in specific case reports; no adverse events reported in urologic cases. The overall literature demonstrated safe use.
Effectiveness (Tissue Fragmentation/Emulsification/Aspiration)	Successfully fragments, emulsifies, and removes unwanted soft and hard tissue.
Selectivity (Preservation of surrounding structures)	Allows selective dissection of target tissue while preserving vessels, ducts, and other delicate structures. In renal cases, allows selective aspiration of parenchyma while leaving blood vessels and collecting systems intact. Able to dissect tissues while preserving main structures in laparoscopic procedures.
Morbidity Reduction (Laparoscopic procedures)	In laparoscopic liver resection, shown to decrease morbidity, shorten hospital stay, improve cosmesis, and decrease blood loss. -----------
Blood Loss Reduction	Reduced blood loss due to selectivity in renal surgery. Over 150 laparoscopic hepatectomy procedures concluded that use of CUSA led to successful surgical outcomes and reduced blood loss. Advantages in laparoscopic surgery include less blood loss.
Increased Visibility	In renal cases, found to result in increased visibility for surgeons.
Reduced Operating Time	In renal cases, found to result in reduced operating time.
Complications	A single complication observed in laparoscopic cholecystectomies: a thermal pinhole burn leading to bile leakage in one case. Otherwise, generally positive safety reporting.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: The "test set" in this case is the cumulative data reviewed across numerous peer-reviewed journal articles.
- Gastrointestinal and Affiliated Organ Surgery: Approximately 2,500 cases reported across 34 articles (focused on open hepatectomy and laparoscopic-assisted liver resection).
- Urologic Surgery: 8 urologic resection cases and 71 cases of nipple valve formation (total 79 cases) reported across 6 articles.
- General Surgery: 10 patients (carcinoma of the tongue) and 5 cases (PCSTP in children).
- Laparoscopic Surgery: 131 laparoscopic cholecystectomies, 9 laparoscopic appendectomies, 3 laparoscopic colon resections, 2 laparoscopic partial gastrectomies, 6 laparoscopic esophagectomies, and over 150 laparoscopic hepatectomy procedures.
Data Provenance: The data comes from peer-reviewed journal articles. The specific countries of origin are not mentioned in this summary, but such articles typically reflect global clinical practice. The nature of published journal articles means this is overwhelmingly retrospective observational data, summarizing past surgical outcomes.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This concept of "experts establishing ground truth for a test set" does not directly apply here. The "ground truth" is implied to be the clinical outcomes and observations reported by the surgeon-authors and clinicians in numerous peer-reviewed studies. These clinicians would be the "experts," performing the procedures and reporting on safety and effectiveness. The summary does not quantify the number of individual experts or their specific qualifications beyond being authors of peer-reviewed articles on surgical procedures.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

There was no formal adjudication method as part of a single, controlled test set. The "adjudication" is inherent in the peer-review process of the scientific articles themselves. Each article would have undergone peer review by other experts in the field, and the collective body of evidence across multiple articles provides a form of consensus.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done, and this device is not an AI-assisted diagnostic or interpretative tool. It is a surgical aspirator. The clinical evidence reviewed focuses on the device's performance in surgical procedures, not on human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This refers to an algorithm's performance without human input. Since the CUSA Excel+ is a surgical device operated by a surgeon, this question is not applicable. The device inherently requires a human-in-the-loop for its operation.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" is primarily based on clinical outcomes data (e.g., successful tissue removal, reduced blood loss, reduced operating time, decreased morbidity, absence of adverse events, preservation of structures) as reported by expert surgeons in peer-reviewed literature. This relies on the expert judgment and observations of the clinicians performing the surgeries.

8. The sample size for the training set

Not Applicable. As no new non-clinical or clinical testing was conducted for the purpose of this 510(k) (because the device was not modified), there was no "training set" in the context of developing or optimizing a new medical device or algorithm. The review simply aggregated existing clinical data.

9. How the ground truth for the training set was established

Not Applicable for the same reasons as #8.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, composed of three human profiles facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 6, 2014

Integra LifeSciences Corporation Ms. Janet C. Kay Director, Regulatory Affairs 311 Enterprise Drive Plainsboro, New Jersey 08536

Re: K141668

Trade/Device Name: CUSA® Excel+ Ultrasonic Surgical Aspirator System Regulatory Class: Unclassified Product Code: LFL Dated: October 8, 2014 Received: October 10, 2014

Dear Ms. Kay:

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

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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/Resourcesfor You/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

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices

Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

Page 1 of 2

K141668 510(k) Number (if known):

Device Name:

CUSA® Excel+ Ultrasonic Surgical Aspirator System

Indications For Use:

Neurosurgery, Plastic and Reconstructive surgery, Orthopedic Surgery, Gynecological Surgery and Thoracic Surgery and the following specific uses:

Urological surgery- including removal of renal parenchyma during nephrectomy or partial nephrectomy

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General Surgery - including removal of benign or malignant tumors or other unwanted soft or hard tissue in open or minimally invasive general surgical procedures

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The Counter Use____________

(Per 21 CFR 801 Subpart D)

(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)

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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	781-565-1347
Fax Number	781-238-0645
Establishment RegistrationNumber	3003418325
Name of Contact Person	Janet C. Kay
Date Prepared	September 22, 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
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

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Indications for Use	The CUSA® Excel+ Ultrasonic Surgical Aspirator System isindicated for use in surgical procedures where fragmentation,emulsification and aspiration of soft and hard (e.g.: bone)tissue is desirable. The CUSA Excel+ Ultrasonic SurgicalAspirator is indicated for use in:
	Neurosurgery, Plastic and Reconstructive surgery,Orthopedic Surgery, Gynecological Surgery andThoracic Surgery and the following specific uses:
	Gastrointestinal and Affiliated Organ Surgery –including removal of benign or malignant tumors orother unwanted tissue, including hepatic parenchyma,in open or laparoscopic procedures, hepatic resection,tumor resection, lobectomy or trisegmentectomy, orremoval of tissue during liver allotransplantation anddonor hepatectomy
	Urological surgery- including removal of renalparenchyma during nephrectomy or partialnephrectomy
	General Surgery – including removal of benign ormalignant tumors or other unwanted soft or hard tissuein open or minimally invasive general surgicalprocedures
	Laparoscopic Surgery - including removal of hepaticparenchyma in laparoscopic hepatic resection,lobectomy or trisegmentectomy, in laparoscopic donorhepatectomy or laparoscopic cholecystectomy orlaparoscopic pancreatic jejunostomy, orpancreatectomy, or laparoscopic appendectomy,laparoscopic colon resection or laparoscopic partial

807.92(a)(5) - Intended use of the device

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gastrectomy

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

807.92(b)(1-2) -- Nonclinical and clinical tests submitted

No nonclinical testing was required as the device itself was not modified.

The clinical evidence used to support the change to the indications for use for Gastrointestinal (GI) and Affiliated Organ, Urologic, General, and Laparoscopic surgeries are peer reviewed iournal articles:

Gastrointestinal and Affiliated Organ Surgery -

The largest body of data found was for GI and affiliated organ surgeries. Thirty-four articles reported on approximately 2,500 cases, including open hepatectomy and laparoscopic-assisted liver resection. Overall, the literature demonstrated that CUSA can be safely used in laparoscopic and open liver surgeries. The laparoscopic technique using CUSA has been shown to decrease morbidity, shorten hospital stay, improve cosmesis, and decrease blood loss. The literature showed CUSA to be safe and effective in liver surgery for pediatric, adult, and elderly patients and it has also been proven acceptable in both open and laparoscopic procedures.

Urologic Surgery -

Six articles report on the use of the CUSA system in renal surgical cases. These cases included resections performed for renal lithiasis and renal tumor removal and formation of a nipple valve during construction of a continent ileal urinary reservoir. A total of 8 urologic resection cases and 71 cases of nipple valve formation during construction of a continent ileal urinary reservoir were reported. No adverse events were reported with the use of the CUSA in these cases. The articles found that using CUSA for renal resection allows the surgeon to selectively aspirate certain tissues, including parenchyma, while leaving blood vessels and collecting systems intact. The literature reported that using CUSA resulted in increased visibility for the surgeons, reduced operating time, and a reduced volume of blood loss due to its selectivity.

General Surgery -

References are provided on the use of CUSA for the resection of carcinoma of the tongue in small numbers (10 patients) and treatment of using CUSA in papillary cystic and solid tumor of the pancreas (PCSTP) in children (5 cases). Although these case reports involve small numbers of patients no significant issues of safety or effectiveness are identified for the use of

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CUSA device in these specific indications.

Laparoscopic Surgery -

Eight articles and two abstracts reveal that CUSA has been successfully used in laparoscopic appendectomies, laparoscopic colon resections, laparoscopic cholecystectomies, laparoscopic partial gastrectomies, laparoscopic transhiatal esophagectomy, laparoscopic ablation of endometriosis, and laparoscopic hepatectomies. One hundred thirty-one laparoscopic cholecystectomies, nine laparoscopic appendectomies, three laparoscopic colon resections, and two laparoscopic partial gastrectomies were performed using CUSA. The only complication observed in these cases was a thermal pinhole burn leading to bile leakage in one case of laparoscopic cholecystectomy. The articles for these cases reported that the advantage of using CUSA for these procedures included the ability of the system to dissect tissues while preserving the main structures. Six cases of laparoscopic esophagectomy were also completed using CUSA. The authors observed that using CUSA allowed for the isolation of vessels and periesophageal lymph nodes during the procedure and that transhiatal esophagectomies were performed successfully in all patients without massive bleeding. Over 150 laparoscopic hepatectomy procedures were performed using the CUSA system. Most of the articles presented concluded that use of CUSA led to successful surgical outcomes and reduced blood loss. The laparoscopic surgery articles presented in the literature review indicate that ultrasonic aspiration is a safe technology in a number of laparoscopic procedures. It may have advantages including less blood loss and preservation of main structures, including vessels and ducts.

807.92(b)(3) – Conclusions drawn from non-clinical and clinical data

The changes from general to specific indications for use are supported by the information provided including previously cleared 510ks and peer reviewed clinical literature.

Regulation Number and Section

N/A