(23 days)
indicated for use in a variety of gynecologic, general, thoracic, and urologic endoscopic procedures to create and maintain a port of entry.
VersaOne™ Bladed Trocar is available in 11mm fixation and smooth standard. 12mm fixation and smooth standard, and 12mm fixation and smooth long. VersaOne™ Bladed Trocar consists of an obturator component with a bladed tip and a cannula assembly. VersaOne™ Bladeless Trocar is available in 5mm fixation short. standard, and long, 11mm fixation standard, 12mm fixation short, standard, and long, and 12mm smooth standard. VersaOne™ Bladeless Trocar consists of an obturator component with a bladeless tip and a cannula assembly. The devices are supplied sterile single-use.
Here's a breakdown of the acceptance criteria and study information for the VersaOne™ Bladed Trocar and VersaOne™ Bladeless Trocar, based on the provided FDA 510(k) summary:
This submission is for a medical device (surgical trocar) and the documentation primarily focuses on demonstrating substantial equivalence to predicate devices through performance testing and material compliance. As such, concepts like "acceptance criteria" for a diagnostic algorithm, "expert ground truth," "MRMC studies," or "training sets" are not applicable in this context. The "performance data" here refers to engineering and biocompatibility testing, not diagnostic accuracy.
Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria in the way one might for an AI/diagnostic device (e.g., sensitivity, specificity thresholds). Instead, the performance is evaluated against the specifications of the proposed devices and comparability to predicate devices for aspects like mechanical function and biocompatibility.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional Performance | Demonstrated to perform to specifications and comparable to predicate devices K062326, K130435 (for Bladed Trocar), and K081169, K130435 (for Bladeless Trocar). This implicitly means meeting the design requirements for creating and maintaining a port of entry, preventing pneumoperitoneum loss, accommodating instruments, and facilitating specimen retrieval. |
| Biocompatibility | Acceptable results demonstrated compliance with ISO 10993-1 standard. |
| Sterilization | Not explicitly detailed in performance data section, but implicitly part of the "substantially equivalent to predicates..." conclusion and required for pre-market notification. |
| Shelf Life | Not explicitly detailed in performance data section, but implicitly part of the "substantially equivalent to predicates..." conclusion and required for pre-market notification. |
| Technological Characteristics | Details provided in "DEVICE DESCRIPTION" and "TECHNOLOGICAL / DESIGN CHARACTERISTICS," (e.g., dolphin nose tips, bladed/bladeless designs, spring-loaded shield, seal systems, removable housing, transparent cannula sleeve, stopcock valve). Implied acceptance is that these designs enable the intended function and are comparable to predicates. |
Study Details (as inferable from the document)
Given this is a 510(k) for a physical medical device (trocar), the "study" is a series of engineering tests and biocompatibility assessments, not a clinical trial or AI performance study.
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not specify exact sample sizes for the performance tests (e.g., how many trocars were tested for insertion force, seal integrity, etc.).
- The data provenance is not mentioned, but these types of tests are typically conducted in a laboratory setting, often by the manufacturer or a contracted lab. They are prospective in the sense that the tests are designed and executed to evaluate the new device.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This concept is not applicable here. "Ground truth" in this context would be engineering specifications and standards (e.g., ISO 10993-1). The evaluation is objective, based on measurable physical properties and material responses, rather than expert interpretation.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable. Performance tests for physical devices are generally evaluated against pre-defined engineering criteria, not through expert adjudication.
-
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:
- This is not applicable. The device is a surgical instrument, not an AI or diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. The device is a surgical instrument, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For performance testing, the "ground truth" consists of engineering specifications, regulatory standards (e.g., ISO 10993-1 for biocompatibility), and established performance characteristics of the predicate devices. The device's performance is compared against these objective benchmarks rather than expert interpretation of medical images or pathology.
-
The sample size for the training set:
- This is not applicable. There is no machine learning or AI component to this device, and thus no "training set."
-
How the ground truth for the training set was established:
- This is not applicable as there is no training set.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized depiction of a human figure in profile, with three overlapping faces representing the department's focus on health and human well-being. The logo is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 2, 2015
Covidien Ms. Trang Huynh Senior Specialist, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473
Re: K151548
Trade/Device Name: VersaOne" Bladed Trocar and VersaOne™ Bladeless Trocar Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: June 2, 2015 Received: June 9, 2015
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
{1}------------------------------------------------
device-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/Resourcesfor You/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
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
VersaOne™ Bladed Trocar and VersaOne™ Bladeless 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)
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"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
PSC Publishing Services (301) 443-6740 EF
{3}------------------------------------------------
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: | June 2, 2015 |
| TRADE/PROPRIETARYNAME: | VersaOne™ Bladed TrocarVersaOne™ Bladeless 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) |
| Autosuture™ Versaport™ Plus Bladeless Trocar (K081169) | |
| Versaport™ V2 Bladeless Optical (K130435) | |
| PURPOSE OFSUBMISSION: | Obtain market clearance for VersaOne™ Bladed Trocar 11mm &12mm and VersaOne™ Bladeless Trocar 5mm, 11mm, & 12mm |
| INTENDED USE: | Use in a variety of gynecologic, general, thoracic, and urologicendoscopic procedures to create and maintain a port of entry |
{4}------------------------------------------------
DEVICE DESCRIPTION: VersaOne™ Bladed Trocar is available in 11mm fixation and smooth standard. 12mm fixation and smooth standard, and 12mm fixation and smooth long. VersaOne™ Bladed Trocar consists of an obturator component with a bladed tip and a cannula assembly. VersaOne™ Bladeless Trocar is available in 5mm fixation short. standard, and long, 11mm fixation standard, 12mm fixation short, standard, and long, and 12mm smooth standard. VersaOne™ Bladeless Trocar consists of an obturator component with a bladeless tip and a cannula assembly. The devices are supplied sterile single-use. TECHNOLOGICAL / VersaOne™ Bladed Trocar obturator has a dolphin nose (conical) DESIGN shaped tip with a sharp linear blade and a spring-loaded locking CHARACTERISTICS: 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, 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 11mm in diameter for 11mm trocars and 5mm to 12mm in diameter for 12mm trocars. The 11mm and 12mm 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. VersaOne™ Bladeless Trocar obturator has a dolphin nose (conical) shaped bladeless tip. The conical shape is for smooth insertion into the body cavity by spreading the tissue layers during insertion. 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 11mm in diameter for 11mm trocars. 5mm to 12mm in diameter for 12mm trocars, and 5mm in diameter for 5mm trocars. The 11mm and 12mm 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 biocompatibility evaluation was conducted in accordance with MATERIALS: ISO 10993-1. Acceptable results demonstrated VersaOne™ Bladed Trocar and VersaOne™ Bladeless Trocar comply with ISO 10993-1 standard.
{5}------------------------------------------------
Image /page/5/Picture/1 description: The image shows the word "COVIDIEN" in blue font. To the left of the word is a blue square with a white plus sign in the center. The plus sign is made up of smaller squares. The image is simple and clean.
| PERFORMANCE DATA: | Results from performance testing demonstrated the proposedVersaOne™ Bladed Trocar perform to specifications andcomparable to predicate devices K062326 and K130435.Results from performance testing demonstrated the proposedVersaOne™ Bladeless Trocar perform to specifications andcomparable to predicate devices K081169 and K130435. |
|---|---|
| CONCLUSION: | VersaOne™ Bladed Trocar and VersaOne™ Bladeless Trocar aresubstantially equivalent to predicates devices in terms ofindications for use, contraindications, technological characteristics,labeling, sterilization, shelf life, biocompatibility, and performance. |
§ 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.