(32 days)
No
The summary describes a mechanical device (trocar) with modifications to its physical dimensions. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on mechanical properties like force and leak rate.
No
The device is a surgical instrument (trocar) used to create and maintain a port of entry during endoscopic procedures, which is a tool for a procedure, not a device that provides therapy.
No
The device is described as a trocar intended to create and maintain a port of entry for endoscopic procedures, which is an instrument for surgical access, not for diagnosis.
No
The device description and performance studies clearly indicate this is a physical medical device (trocar) with hardware components (cannula, obturator) and involves bench top and animal testing related to physical properties like force and leak rate. There is no mention of software as the primary component or function.
Based on the provided information, 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 in endoscopic procedures. This is a surgical tool used in vivo (within the body) for accessing anatomical sites.
- Device Description: The description focuses on the physical components (cannula and obturator) and their function in accommodating instruments during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body, not to directly interact with the body during a procedure like a trocar does.
N/A
Intended Use / Indications for Use
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
Modifications to the design of the current VersaOne™ Bladeless Trocar (K151548) include diameter change to the cannula and obturator components to accommodate an 8mm instrument.
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
Sterilization assessment was performed to confirm EO sterilization equivalency to the predicate device with respect to sterilization processes per ISO 11135 requirements and EO residuals per ISO 10993-7 requirements.
Shelf life assessment was performed per Covidien standard operating procedures to confirm product performance over time.
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 bench top and animal was performed to compare the functional performance of the subject device and the predicate device.
Bench top testing that supports the intended use of this device includes:
. Leak rate
. Insertion force & Removal force
. Penetration force & Fixation force
- Animal testing that supports the intended use of the device o includes:
- Penetration force & Fixation force
Key Metrics
Not Found
Predicate Device(s)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 18, 2016
Covidien LLC Ms. Trang Huynh Principal Regulatory Affairs Specialist 60 Middletown Avenue North Haven, Connecticut 06473
Re: K162584
Trade/Device Name: VersaOne™ Bladeless Trocar Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: October 11, 2016 Received: October 12, 2016
Dear Ms. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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,
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
2
Indications for Use
510(k) Number (if known) K162584
Device Name VersaOne™ Bladeless Trocar
Indications for Use (Describe)
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)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/0 description: The image shows the logos of Medtronic and Covidien. The Medtronic logo is on the left, and the Covidien logo is on the right. The Medtronic logo includes a circular design to the left of the company name, which is written in blue. The Covidien logo includes a blue square with a white cross in the center, and the company name is written in blue to the right of the square.
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 llc
60 Middletown Avenue
North Haven, CT 06473 USA |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Trang Huynh
Principal Regulatory Affairs Specialist
Phone: (203) 492-7473
Fax: (203) 492-5029
Email: trang.huynh27@medtronic.com |
| DATE PREPARED: | September 16, 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™ Bladeless Trocar |
| COMMON/USUAL NAME: | Surgical Trocar |
| PREDICATE DEVICES: | VersaOne™ Bladeless Trocar (K151548)
Autosuture™ Versaport™ Plus Bladeless Trocar (K081169) |
| INTENDED USE: | 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. |
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Image /page/4/Picture/0 description: The image shows the logos of Medtronic and Covidien. The Medtronic logo is on the left, and the Covidien logo is on the right. The Medtronic logo is a blue wordmark with a stylized atom symbol to the left. The Covidien logo is a blue square with a white cross in the center, followed by the company name in black text.
Modifications to the design of the current VersaOne™ Bladeless Trocar (K151548) include diameter change to the cannula and obturator components to accommodate an 8mm instrument.
Sterilization assessment was performed to confirm EO sterilization equivalency to the predicate device with respect to sterilization processes per ISO 11135 requirements and EO residuals per ISO 10993-7 requirements.
Shelf life assessment was performed per Covidien standard operating procedures to confirm product performance over time.
SUMMARY COMPARING THE TECHNOLOGICAL CHARACTERISTIC S OF THE SUBJECT AND PREDICATE DEVICES:
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 bench top and animal was performed to compare the functional performance of the subject device and the predicate device.
- o Bench top testing that supports the intended use of this device includes:
- . Leak rate
- . Insertion force & Removal force
- Penetration force & Fixation force
- Animal testing that supports the intended use of the device o includes:
- Penetration force & Fixation force
The results of testing demonstrated the modified VersaOne™ Bladeless CONCLUSION: Trocar 8mm is substantially equivalent to the legally marketed device.