The VersaCut + Tissue Morcellator is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparascopic, percutaneous and open surgical procedures whenever access to the surgical site is limited.

Device Description

The VersaCut + Tissue Morcellator system is a multiple-use electrosurgical cutting and aspiration device that provides rapid and efficient morcellation and removal of dissected tissue under direct or endoscopic visualization. The cutting action of the VersaCut + Tissue Morcellator is driven by the motor in the handpiece and the treatment site is accessed through the sheath of a nephroscope using the endoscope adapter as needed to keep the cutting blades in the field of view. The VersaCut + Tissue Morcellator is comprised of a main component as listed below:

· Control unit with aspiration pump
· Limited reuse, steam sterilizable handpieces (motor-body unit) with power cable
· Limited reuse, steam sterilizable cutting blade sets
· Reusable, steam sterilizable endoscope adapters
· Drainage tube, single use
· Reusable, multi-position, multi-staged footswitch with power cable
· Sterile, single use aspiration tubing
· Tissue collection kit components, single use
· Reusable sterilization tray, including cleaning brushes
The VersaCut + Tissue Morcellator is provided cleaned and non sterile. Before use, the handpiece, blades set and the endoscope adapters are to be cleaned and sterilized.

AI/ML Overview

Here's an analysis of the provided text regarding the VersaCut + Tissue Morcellator, focusing on the acceptance criteria and the study used to prove it:

Summary of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Standard/Requirement	Reported Device Performance / Compliance
Material/Process Standards	AAMI TIR30:2011 (Cleaning)	Device complies
	AAMI TIR12:2010 (Reprocessing)	Device complies
Risk Management	ISO 14971-1:2009	Device complies
Biocompatibility	ISO 10993-1:2009	Device complies
Quality Management System	ISO 13485:2003	Device complies
Electrical Safety	IEC 60601-1:2005	Device complies
EMC	IEC 60601-1-2:2007	Device complies
Sterilization	ANSI/AAMI/ISO 17665-1:2006	Device complies
Functional Equivalence	Safety and Efficacy	Demonstrated to be as safe and effective as the predicate device (K050639) through performance bench testing.
Intended Use	Identical to predicate device	Intended use of VersaCut + Tissue Morcellator is identical to the predicate device.
Structure, Materials, Dimensions	Identical to predicate device	Structures, materials, and dimensions are identical to the predicate device.
Differences from Predicate	Addition of Inverted Handpiece	Included
	Disposable Tissue Collector with one-way valve	Included
	Additional warning/operating step in manual	Included, to prevent reverse aspiration.

Study Details:

Sample sizes used for the test set and the data provenance:
- No specific test set sample size is mentioned for the performance bench testing.
- No information on data provenance (e.g., country of origin, retrospective/prospective) is provided, as the studies conducted were bench tests, not clinical studies involving patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for this device's performance was established by adherence to recognized technical standards and comparison to a predicate device through bench testing, not through expert review of clinical cases.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set requiring adjudication was used.
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. This device is a surgical instrument (tissue morcellator), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and AI-related effect sizes are not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a mechanical/electrical surgical tool and does not involve an algorithm or AI.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for demonstrating safety and efficacy was established by compliance with recognized industry standards (listed above) and direct comparison of performance characteristics through bench testing against a legally marketed predicate device, demonstrating functional equivalence.
The sample size for the training set:
- Not applicable. This device does not involve machine learning or AI, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable, as there is no training set.

Conclusion of the Study:

The primary study conducted was performance bench testing. This testing aimed to demonstrate that the VersaCut + Tissue Morcellator is as safe and effective as its predicate device (Lumenis VersaCut Tissue Morcellator System, K050639). The document explicitly states:

"Performance testing demonstrated that the VersaCut + Tissue Morcellator is as safe and effective as the cleared predicate device."
"Lumenis believes that clinical studies are not needed to claim safety and efficacy of the device."

The study design was a comparative bench test focusing on functional equivalence and compliance with established standards, rather than a clinical trial. The justification for substantial equivalence was based on:

Identical intended use.
Identical structures, materials, and dimensions.
Minor differences (inverted handpiece, disposable tissue collector with one-way valve, manual updates) that were addressed and shown not to negatively impact safety or effectiveness, and in some cases, improved safety (preventing reverse aspiration).

Summary

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UMENIS®

510(K) SUMMARY

MAY 1 3 2014

K133272

Page 1 of 5

VersaCut + Tissue Morcellator

510(k) Number K

Applicant's Name:	Lumenis Ltd.
	6 Hakidma Street
	P.O.Box 240
	Yokneam Industrial Park
	Yokneam, 2069204, ISRAEL
Tel:	+972-4-9599000
Fax:	+972-4-9599050
Contact Person:	Yoram Levy, Qsite
	31 Haavoda St.
	Binyamina, Israel 30500

Tel (972)4-638-8837

Fax (972)4-638-0510

Yoram@qsitemed.com

Common Name	Soft Tissue Morcellator and Accessories
Trade Name:	VersaCut + Tissue Morcellator
Device Type:	Soft Tissue Morcellator and Accessories
Preparation Date:	October 20, 2013
Classification:	Regulatory Name: Endoscope and accessoriesProduct Code: GCJRegulation No: 21 CFR 876.1500Class: IIClassification Panel: Gastroenterology Urology devices

Device Description:

2-1 VersaCut + Tissue Morcellator – Traditional 510k Notification

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MENIS®

· Control unit with aspiration pump
· Limited reuse, steam sterilizable handpieces (motor-body unit) with power cable
· Limited reuse, steam sterilizable cutting blade sets
· Reusable, steam sterilizable endoscope adapters
· Drainage tube, single use
· Reusable, multi-position, multi-staged footswitch with power cable
· Sterile, single use aspiration tubing
· Tissue collection kit components, single use
· Reusable sterilization tray, including cleaning brushes

The VersaCut + Tissue Morcellator is provided cleaned and non sterile. Before use, the handpiece, blades set and the endoscope adapters are to be cleaned and sterilized.

Intended Use Statement:

VersaCut + Tissue Morcellator - Traditional 510k Notification

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દાતારા

Substantial equivalence to the following predicate device is Predicate Devices: claimed:

Device Name	510k No	Date of Clearance
VersaCut Tissue Morcellator system	K050639	March 14, 2005

Performance Standards

VersaCut + Tissue Morcellator was tested and complies with the following standards:

AAMI TIR30:2011 A compendium. of processes, materials, . test methods, and acceptance criteria for cleaning reusable , medical devices;
AAMI TIR12:2010 Designing, testing, and labeling reusable . medical devices for reprocessing in health care facilities: A guide for medical device manufacturers;
ISO 14971-1:2009 Risk management for medical devices; ●
. ISO 10993-1:2009 Biological Evaluation of Medical devices Part1: Evaluation and testing;
ISO 13485:2003 Medical device- Quality management system-. Requirement for regulatory purpose;
IEC 60601-1:2005 Medical electrical equipment Part 1: . General requirements for basic safety and essential performance
IEC 60601-1-2:2007 Medical electrical equipment Part 1-2: . General requirements for basic safety and essential. performance Electromagnetic compatibility - Requirements and tests
ANSI/AAMI/ISO 17665-1:2006 Sterilization of health care . products - Moist Heat.

2-3 VersaCut + Tissue Morcellator - Traditional 510k Notification

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NEWILE.

Performance Bench Testing

Performance testing demonstrated that the VersaCut + Tissue Morcellator is as safe and effective as the cleared predicate device.

Summary of Pre-Clinical and clinical study

The safety and efficacy of the VersaCut + Tissue Morcellator was shown by performance bench testing.

Lumenis believes that clinical studies are not needed to claim safety and efficacy of the device

Substantial Equivalence to Predicate Devices

The VersaCut + Tissue Morcellator is a modification of the Lumenis VersaCut Tissue Morcellator System (K050639).

The intended use of the VersaCut + Tissue Morcellator is identical to the intended use of its predicate.

Both the VersaCut + Tissue Morcellator and the FDA-cleared Lumenis VersaCut Tissue Morcellator System (K050639) are multiple-use electrosurgical cutting and aspiration device that provides rapid and efficient morcellation and removal of dissected soft tissue under direct or endoscopic visualization.

The structures, the materials and the dimensions of the VersaCut + Tissue Morcellator are identical to the predicate device.

The minor differences between the VersaCut + Tissue Morcellator and its predicate device are an addition of an Inverted Handpiece, addition of a disposable tissue collector container with a one way valve to prevent reverse direction aspiration and an additional warning and operating step in the Operation Manual (OP). These additions were done in order to avoid reverse direction aspiration. See the labeling section and the device Operator Manual (Attachment No. 2). Moreover, performance testing demonstrated that the VersaCut + Tissue

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Image /page/4/Picture/1 description: The image shows the word "LUMENIS" in a bold, sans-serif font. To the left of the word is a stylized letter "L" that is also in bold. A small registration mark is located to the right of the word.

Morcellator is as safe and effective as the predicate device. Thus, the VersaCut + Tissue Morcellator is substantially equivalent to Lumenis VersaCut Tissue Morcellator System (K050639).

2-5 VersaCut + Tissue Morcellator – Traditional 510k Notification

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

May 13, 2014

Lumenis Ltd. % Mr. Yoram Levy Mr. Yoram Levy, Qsite 31 Haavoda Street Binyamina, Israel 30500

Re: K133272

Trade/Device Name: Versacut + Tissue Morcellator Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: March 19, 2014 Received: April 2, 2014

Dear Mr. Levy:

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 for associated an the 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 r ou may, merels 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 that I Dr has Intatutes and regulations administered by other Federal agencies. You must or any I carates and 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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Page 2 - Mr. Yoram Levy

forth.in 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" (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. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

K133272 510(k) Number (if known):

Device Name:

VersaCut + Tissue Morcellator

Indications for Use:

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)

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.