(172 days)
Not Found
No
The device description and performance studies focus on the mechanical function and comparison to predicate devices, with no mention of AI/ML or related concepts.
No.
A therapeutic device is one that treats a disease or condition. This device is used to create and maintain a port of entry for endoscopic procedures, which is an enabling or accessory function, not a direct therapeutic one.
No
Explanation: The device is described as a surgical instrument used to create and maintain a port of entry during endoscopic procedures, not to diagnose medical conditions.
No
The device description clearly states it is a "Bladed Trocar" consisting of physical components (obturator and cannula assembly) and is supplied sterile for single-use, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for creating and maintaining a port of entry in endoscopic procedures. This is a surgical tool used directly on the patient's body.
- Device Description: The description details a physical device (trocar) with a bladed tip and cannula assembly, designed for surgical access.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide information about a patient's health status.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is a surgical instrument used for access during procedures.
N/A
Intended Use / Indications for Use
indicated for use in a variety of gynecologic, general, thoracic, and urologic endoscopic procedures to create and maintain a port of entry.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
VersaOne™ Bladed Trocar is available in diameter 5mm, cannula fixation and smooth, and length standard and short. VersaOne™ Bladed Trocar consists of an obturator component with a bladed tip and a cannula assembly. The devices are supplied sterile single-use.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Results from performance testing demonstrated the proposed VersaOne™ Bladed Trocar perform to specifications and comparable to predicate devices K062326 and K112349.
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 22, 2016
Covidien Trang Huynh Senior Specialist, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473
Re: K152149
Trade/Device Name: VersaOne™ V2 Bladed Trocar Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: January 15, 2016 Received: January 20, 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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" (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.
Jennifer R. Stevenson -S
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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017 |
|-------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Indications for Use | See PRA Statement below. |
| 510(k) Number ( if known ) | K152149 |
|---|---|
| Device Name | VersaOne™ Bladed Trocar |
| Indications for Use ( Describe ) | indicated 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)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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and review the collection of information. Send comments regarding this burden estimate or any other aspect
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
| FORM FDA 3881 (1/14)
| Page 1 of 1 | |
|---|---|
| ------------------------------------- | -- |
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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: | Covidien
60 Middletown Avenue
North Haven, CT 06473 USA |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Trang Huynh
Senior Specialist, Regulatory Affairs |
| | Phone: (203) 492-7473 |
| | Fax: (203) 492-5029 |
| | Email: trang.huynh27@medtronic.com |
| DATE PREPARED: | July 30, 2015 |
| TRADE/PROPRIETARY NAME: | VersaOne™ Bladed Trocar |
| COMMON/USUAL NAME: | Surgical Trocar |
| CLASSIFICATION NAME: | Endoscope and Accessories |
| PRODUCT CODE: | GCJ |
| FDA PANEL NUMBER: | 78 |
| CLASS CODE: | Pursuant to 21 CFR 876.1500, Class II device |
| PREDICATE DEVICES: | Autosuture™ Modified Versaport™ Trocar with Fixation Sleeve
(K062326) |
| | Versaport™ V2 Bladeless Optical (K112349) |
| PURPOSE OF SUBMISSION: | Obtain market clearance for VersaOne™ Bladed Trocar 5mm |
| INTENDED USE: | Indicated for use in a variety of gynecologic, general, thoracic, and urologic endoscopic procedures to create and maintain a port of entry |
| DEVICE DESCRIPTION: | VersaOne™ Bladed Trocar is available in diameter 5mm, cannula fixation and smooth, and length standard and short. VersaOne™ Bladed Trocar consists of an obturator component with a bladed tip and a cannula assembly. The devices are supplied sterile single-use. |
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| TECHNOLOGICAL /
DESIGN
CHARACTERISTICS: | VersaOne™ Bladed Trocar obturator has a dolphin nose (conical)
shaped tip with a sharp linear blade and a spring-loaded locking
shield. The blade is used to cut the tissues as the trocar is
inserted into the body cavity. The shield advances to cover the
blade upon entry into a free space. The cannula assembly is
composed of a seal system, transparent cannula sleeve, and a
stopcock. The seal system prevents loss of Pneumoperitoneum
when instruments are inserted or withdrawn. The cannula sleeve
has a bevel shaped at the distal end to reduce penetration forces
during insertion and transparent for better visualization. The
stopcock valve is for insufflation and desufflation. |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MATERIALS: | The biocompatibility evaluation was conducted in accordance with
ISO 10993-1. Acceptable results demonstrated VersaOne™
Bladed Trocar complies with ISO 10993-1 standard. |
| PERFORMANCE DATA: | Results from performance testing demonstrated the proposed
VersaOne™ Bladed Trocar perform to specifications and
comparable to predicate devices K062326 and K112349. |
| CONCLUSION: | VersaOne™ Bladed Trocar is substantially equivalent to
predicates devices in terms of indications for use,
contraindications, technological characteristics, labeling,
sterilization, shelf life, biocompatibility, and performance. |