(201 days)
Not Found
No
The description focuses on the mechanical and electrosurgical aspects of tissue morcellation and removal, with no mention of AI or ML capabilities.
No
The device description indicates it is an electrosurgical cutting and aspiration device used for morcellation and removal of dissected tissue during surgical procedures. It does not describe any therapeutic function that treats or cures a disease or condition. Its purpose is to remove tissue, which is a surgical tool function.
No
The device is described as an electrosurgical cutting and aspiration device for morcellation and removal of dissected tissue during surgical procedures. Its intended use and description do not mention any diagnostic capabilities or functions.
No
The device description explicitly lists multiple hardware components including a control unit, handpieces, cutting blade sets, endoscope adapters, footswitch, and other physical accessories.
Based on the provided information, the VersaCut + Tissue Morcellator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the "morcellation and removal of dissected tissue during pelviscopic, laparascopic, percutaneous and open surgical procedures." This describes a surgical tool used on the patient's body to remove tissue, not a device used to examine or analyze samples outside the body.
- Device Description: The description details a system with a handpiece, cutting blades, aspiration, and a control unit. These are components of a surgical instrument, not an IVD device which would typically involve reagents, analyzers, or test kits for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory tests.
Therefore, the VersaCut + Tissue Morcellator is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelviscopic, laparascopic, percutaneous and open surgical procedures
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)
Performance testing demonstrated that the VersaCut + Tissue Morcellator is as safe and effective as the cleared predicate device.
The safety and efficacy of the VersaCut + Tissue Morcellator was shown by performance bench testing.
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
§ 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.
0
UMENIS®
510(K) SUMMARY
MAY 1 3 2014
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
| 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 accessories | |
| Product Code: GCJ | ||
| Regulation No: 21 CFR 876.1500 | ||
| Class: II | ||
| Classification Panel: Gastroenterology Urology devices |
Device Description:
2-1 VersaCut + Tissue Morcellator – Traditional 510k Notification
1
MENIS®
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.
Intended Use Statement:
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.
VersaCut + Tissue Morcellator - Traditional 510k Notification
2
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
3
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
4
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
5
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
6
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
7
INDICATIONS FOR USE STATEMENT
K133272 510(k) Number (if known):
Device Name:
VersaCut + Tissue Morcellator
Indications for Use:
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.
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)