(29 days)
No
The device description focuses on the mechanical and physical properties of the trocar, such as its shape, materials, and sealing mechanism. There is no mention of any software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The performance studies described are also focused on physical forces and leak rates, not algorithmic performance.
No
The device is a trocar used to create and maintain a port of entry for endoscopic procedures; it is not described as directly treating a disease or condition.
No.
The device creates and maintains a port of entry for endoscopic procedures; it does not diagnose medical conditions.
No
The device description clearly details physical components like obturators, cannulas, seal systems, and stopcocks, and mentions sterilization and packaging, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for creating and maintaining a port of entry during surgical procedures. This is a surgical tool used in vivo (within the body).
- Device Description: The description details the physical components of a surgical trocar, including obturators, cannulas, seals, and stopcocks. These are all elements of a device used for accessing body cavities during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a patient's health status. There is no mention of analyzing biological samples like blood, urine, or tissue for diagnostic purposes.
IVD devices are specifically designed to perform tests on samples taken from the human body to diagnose diseases or other conditions. The VersaOne™ trocars are surgical instruments used to facilitate surgical procedures.
N/A
Intended Use / Indications for Use
The VersaOne™ optical trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry. The trocar may be used with or without visualization for primary and secondary insertions.
The VersaOne™ bladeless trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
Product codes
GCJ
Device Description
VersaOne™ Optical Trocar 15mm is available in 15mm diameter with a transparent fixation cannula and standard (100mm) length. The VersaOne™ Optical Trocar 15mm consists of an obturator component with a bladeless tip and a cannula assembly. The obturator has a dolphin nose (conical) shaped bladeless tip with transparent window at distal end. The transparent window at distal end of the obturator allows optical entry for visualization of tissue lavers during insertion. The obturator housing contains a scope retention mechanism. The cannula assembly is composed of a seal system, trocar housing, transparent cannula sleeve, and a stopcock. The seal system prevents loss of pneumoperitoneum when instruments are inserted or withdrawn. The seal system accommodates instruments ranging from 5mm to 15mm in diameter. The 15mm trocar housing is removable for specimen retrieval. The cannula sleeve has a bevel shape at the distal end to reduce penetration forces during insertion and transparent for better visualization. The stopcock valve is for insufflation and desufflation. The devices are supplied single-use. The VersaOne™ Optical Trocar 15mm is sterilized via Ethylene Oxide (EtO) sterilization method. The packaging configuration is one device packed in a sealed Nylon / Tyvek breather pouch, six pouches per display box, and both pouch and display box have appropriate labeling.
VersaOne™ Bladeless Trocar 15mm is available in two lengths (long (150mm) and standard (100mm)); both are 15mm in diameter and contain transparent fixation cannulas. VersaOne™ Bladeless Trocar consists of an obturator component with a bladeless tip and a cannula assembly. The obturator has a dolphin nose (conical) shaped bladeless tip. The cannula assembly is composed of a seal system, trocar housing, transparent cannula sleeve, and a stopcock. The seal system prevents loss of pneumoperitoneum when instruments are inserted or withdrawn. The seal system accommodates instruments ranging from 5mm to 15mm in diameter. The 15mm trocar housing is removable for specimen retrieval. The cannula sleeve has a bevel shape at the distal end to reduce penetration forces during insertion and transparent for better visualization. The stopcock valve is for insufflation and desufflation. The devices are supplied sterile single-use. The VersaOne™ Bladeless Trocar 15mm is sterilized via Ethylene Oxide (EtO) sterilization method. The packaging configuration is one device packed in a sealed Nylon / Tyvek breather pouch, six pouches per display box, and both pouch and display box have appropriate labeling.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Performance testing including ex vivo (bench) and in vivo (animal) was performed to compare the functional performance of the proposed devices and the predicate devices.
Ex vivo testing that supports the intended use of this device includes:
- Leak rate
- Insertion force
- Removal force
- Penetration force
- Fixation force
In vivo testing that supports the intended use of the device includes:
- Penetration force
- Fixation force
The results of testing demonstrate the modified VersaOne™ Optical Trocar 15mm and VersaOne™ Bladeless Trocar 15mm are substantially equivalent to the legally marketed
Key Metrics
Not Found
Predicate Device(s)
Versaport™ V2 Bladeless Optical (K130435), VersaOne™ Bladeless Trocar (K151548), Autosuture™ Versaport™ Plus Bladeless Trocar (K081169)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is placed within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.
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
March 1, 2016
Covidien Trang Huynh Senior Specialist, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473
Re: K160230
Trade/Device Name: VersaOne ™ Optical Trocar 15mm VersaOne ™ Bladeless Trocar 15mm Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: January 29, 2016 Received: February 1, 2016
Dear Trang Huynh:
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 of medical device
1
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 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.
Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160230
Device Name
VersaOne™ Optical Trocar and VersaOne™ Bladeless Trocar
Indications for Use (Describe)
The VersaOne™ optical trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry. The trocar may be used with or without visualization for primary and secondary insertions.
The VersaOne™ bladeless trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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510(k) Summary
This 510(k) summary information is submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990. The contents of the 510(k) summary have been provided in conformance with 21 CFR §807.92.
| SUBMITTER: | Medtronic Covidien
60 Middletown Avenue
North Haven, CT 06473 USA |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Ms. Trang Huynh, MS.
Senior Specialist, Regulatory Affairs
Phone: (203) 492-7473
Fax: (203) 492-5029
Email: trang.huynh27@medtronic.com |
| DATE PREPARED: | January 29, 2016 |
| PRODUCT CODE: | GCJ |
| REGULATION NUMBER: | 78 |
| CLASS CODE: | Class II, Pursuant to 21 CFR 876.1500 |
| CLASSIFICATION NAME: | Endoscope and Accessories |
| TRADE/PROPRIETARY NAME: | VersaOne™ Optical Trocar 15mm
VersaOne™ Bladeless Trocar 15mm |
| COMMON/USUAL NAME: | Surgical Trocar |
| PREDICATE DEVICES: | Versaport™ V2 Bladeless Optical (K130435)
VersaOne™ Bladeless Trocar (K151548)
Autosuture™ Versaport™ Plus Bladeless Trocar (K081169) |
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INTENDED USE: The VersaOne™ optical trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry. The trocar may be used with or without visualization for primary and secondary insertions.
The VersaOne™ bladeless trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
VersaOne™ Optical Trocar 15mm is available in 15mm diameter with DEVICE DESCRIPTION: a transparent fixation cannula and standard (100mm) length. The VersaOne™ Optical Trocar 15mm consists of an obturator component with a bladeless tip and a cannula assembly. The obturator has a dolphin nose (conical) shaped bladeless tip with transparent window at distal end. The transparent window at distal end of the obturator allows optical entry for visualization of tissue lavers during insertion. The obturator housing contains a scope retention mechanism. The cannula assembly is composed of a seal system, trocar housing, transparent cannula sleeve, and a stopcock. The seal system prevents loss of pneumoperitoneum when instruments are inserted or withdrawn. The seal system accommodates instruments ranging from 5mm to 15mm in diameter. The 15mm trocar housing is removable for specimen retrieval. The cannula sleeve has a bevel shape at the distal end to reduce penetration forces during insertion and transparent for better visualization. The stopcock valve is for insufflation and desufflation. The devices are supplied single-use. The VersaOne™ Optical Trocar 15mm is sterilized via Ethylene Oxide (EtO) sterilization method. The packaging configuration is one device packed in a sealed Nylon / Tyvek breather pouch, six pouches per display box, and both pouch and display box have appropriate labeling.
VersaOne™ Bladeless Trocar 15mm is available in two lengths (long (150mm) and standard (100mm)); both are 15mm in diameter and contain transparent fixation cannulas. VersaOne™ Bladeless Trocar consists of an obturator component with a bladeless tip and a cannula assembly. The obturator has a dolphin nose (conical) shaped bladeless tip. The cannula assembly is composed of a seal system, trocar housing, transparent cannula sleeve, and a stopcock. The seal system prevents loss of pneumoperitoneum when instruments are inserted or withdrawn. The seal system accommodates instruments ranging from 5mm to 15mm in diameter. The 15mm trocar housing is removable for specimen retrieval. The cannula sleeve has a bevel shape at the distal end to reduce penetration forces during insertion and transparent for better visualization. The stopcock valve is for insufflation and desufflation. The devices are supplied sterile single-use. The VersaOne™ Bladeless Trocar 15mm is sterilized via Ethylene Oxide (EtO) sterilization method. The packaging configuration is one device packed in a sealed Nylon / Tyvek breather pouch, six pouches per display box, and both pouch and display box have appropriate labeling.
5
SUMMARY COMPARING THE TECHNOLOGICAL CHARACTERISTICS OF THE SUBJECT AND PREDICATE DEVICES:
Modifications to the design and materials of the current Versaport™ V2 Bladeless Optical (K130435) and VersaOne™ Bladeless Trocar (K151548) have created new product codes (catalog numbers) to be launched as the VersaOne™ Optical Trocar 15mm and VersaOne™ Bladeless Trocar 15mm respectively.
The modifications include:
- Larger diameter of the cannula and obturator to accommodate a O 15mm instrument
- New seal system and material to accommodate instruments O sizes ranqing from 5mm to 15mm
Sterilization assessment/evaluation was performed to confirm EtO sterilization equivalency to the predicate devices with respect to sterilization processes per ISO 11135 requirements and EtO residuals per ISO 10993-7 requirements.
Shelf life assessment/evaluation was performed per Covidien standard operating procedures to confirm product performance overtime.
Biocompatibility testing was performed to confirm that all components are comprised of materials that are in accordance with ISO 10993-1 for their intended patient contact profile.
Performance testing including ex vivo (bench) and in vivo (animal) was performed to compare the functional performance of the proposed devices and the predicate devices.
- Ex vivo testing that supports the intended use of this device O includes:
- " Leak rate
- . Insertion force
- . Removal force
- . Penetration force
- 트 Fixation force
- In vivo testing that supports the intended use of the device O includes:
- 트 Penetration force
- Fixation force
CONCLUSION: The results of testing demonstrate the modified VersaOne™ Optical Trocar 15mm and VersaOne™ Bladeless Trocar 15mm are substantially equivalent to the legally marketed