(56 days)
No
The device description and intended use focus on mechanical components and optical visualization for surgical access, with no mention of AI or ML capabilities.
No
The device is described as a "reusable positioning trocar system" intended to "create and maintain a port of entry" for endoscopic procedures, which is a surgical access tool, not a device for treating a disease or condition itself.
No
The device description indicates it is a reusable positioning trocar system used to create and maintain a port of entry for endoscopic procedures, not to diagnose a medical condition. While it allows for optical entry and visualization, this is for guiding insertion, not for diagnostic interpretation of tissue or conditions.
No
The device description clearly outlines physical components (cannula, cap, seal, obturator) and their materials and functions, indicating it is a hardware medical device. There is no mention of software as a component or function.
Based on the provided information, the VersaOne™ reusable positioning trocar system is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "create and maintain a port of entry" during surgical procedures. This is a surgical instrument used on the patient, not a device used to test samples from the patient (like blood, urine, or tissue) in a laboratory setting.
- Device Description: The description details the physical components of a surgical trocar (cannula, obturator, seal, etc.) and how it functions to create an opening for instruments. It does not describe any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in samples.
- Providing diagnostic information about a patient's health status.
- Reagents, calibrators, or controls.
The device is clearly a surgical instrument used for accessing the body during minimally invasive procedures.
N/A
Intended Use / Indications for Use
The VersaOne™ reusable positioning trocar system is intended for use in a variety of gynecologic, general, thoracic and urological endoscopic procedures to create and maintain a port of entry. The 11mm and 12 mm trocar may be used with or without visualization for primary and secondary insertions.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The VersaOne™ Reusable Positioning Trocar System is available in 8mm bladeless and 11mm and 12mm optical configuration is available in standard (100mm) and long (150mm) trocar lengths. The VersaOne™ Reusable Positioning Trocar System is a four-component trocar, consisting of a reusable positioning cannula – which includes the cannula and cap, a single patient use seal, and a single patient use obturator. Each trocar size is suitable for use with instruments ranging from 5 mm up to the diameter of the cannula and cap. The 8mm bladeless obturator has a dolphin nose (conical) shaped bladeless tip and rounded doorknob obturator cap. The 11mm and 12mm optical obturator have a dolphin nose (conical) shaped bladeless tip with a transparent window at the distal end. The transparent window at the distal end of the obturator allows for optical entry for visualization of tissue layers during insertion. The optical obturator housing contains a scope retention mechanism. The cannula seal is a stand-alone component, self-adjusting for 5mm-12mm instruments. The seal assembly prevents a loss of pneumoperitoneum and includes a 3-way stopcock for insufflation. The smooth titanium cannula sleeve has a bevel shape at the distal end to reduce penetration forces during insertion and laser marked graphics intended for future compatibility with Covidien/ Medtronic products. The seal and obturators are supplied sterilized via Ethylene Oxide (EtO) sterilization method) single use, whereas the cannula (cannula and cap) is supplied non-sterile and require sterilization by the user. All components are packaged individually.
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)
Performance studies were conducted to demonstrate the proposed VersaOne™ Reusable Positioning Trocar System is substantially equivalent to the predicate devices.
Bench (in-vitro) Performance Testing:
- Visual Inspection
- Instrument Insertion and Removal Force
- Insertion and Removal Force using VersaOne™ Obturator
- Leak Rate
- Insufflation Rate
- Desufflation Rate
- In Vitro Penetration Force
Acute Animal (in-vivo) Performance Testing:
- In-Vivo Penetration Force Standard Incision
- Snap Feature Engagement Strength
- Seal System Lock Torque Strength
- Obturator Snap Button Force
- Cannula Strength Test
- Cannula Cap Attachment Torque
- Cannula Cap Removal Torque
- Seal Assembly Insertion / Removal Force
Human Factors/Usability evaluations were completed per applicable standard and guidance. A summative usability report is included as part of the objective evidence demonstrating safety and effectiveness.
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.
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
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August 26, 2020
Covidien Stephanie Wilde Specialist, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473
Re: K201805
Trade/Device Name: VersaOne™ Reusable Positioning Trocar System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: June 30, 2020 Received: July 1, 2020
Dear Stephanie Wilde:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201805
Device Name
VersaOne™ Reusable Positioning Trocar System
Indications for Use (Describe)
The VersaOne™ reusable positioning trocar system is intended for use in a variety of gynecologic, general, thoracic and urological endoscopic procedures to create and maintain a port of entry. The 11mm and 12 mm trocar may be used with or without visualization for primary and secondary insertions.
| 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) |
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3
Traditional 510(k) Summary
| Submitter | |
|---|---|
| Company | Covidien |
| 60 Middletown Avenue | |
| North Haven, CT 06473 | |
| Contact Person | Stephanie Wilde |
| Regulatory Affairs Specialist | |
| Tel: (203) 492-5590 | |
| Cell: (475) 331-0244 | |
| Email: Stephanie.wilde@medtronic.com | |
| Date Prepared | 24 August 2020 |
| Device | |
| Trade/Proprietary Name | VersaOne™ Reusable Positioning Trocar System |
| Common Name | Surgical Trocar |
| Classification Name | Endoscope and Accessories |
| Regulatory Class | II |
| Product Code | GCJ |
| Predicate Devices | |
| Primary | K130435 - Versaport™ V2 Bladeless Optical Trocar |
| Secondary | K162584 – VersaOne™ Bladeless Trocar |
| Reference Device | K963115 – Versaport™ RT Trocar System |
Device Description
The VersaOne™ Reusable Positioning Trocar System is available in 8mm bladeless and 11mm and 12mm optical configuration is available in standard (100mm) and long (150mm) trocar lengths. The VersaOne™ Reusable Positioning Trocar System is a four-component trocar, consisting of a reusable positioning cannula – which includes the cannula and cap, a single patient use seal, and a single patient use obturator. Each trocar size is suitable for use with instruments ranging from 5 mm up to the diameter of the cannula and cap. The 8mm bladeless obturator has a dolphin nose (conical) shaped bladeless tip and rounded doorknob obturator cap. The 11mm and 12mm optical obturator have a dolphin nose (conical) shaped bladeless tip with a transparent window at the distal end. The transparent window at the distal end of the obturator allows for optical entry for visualization of tissue layers during insertion. The optical obturator housing contains a scope retention mechanism. The cannula seal is a stand-alone component, self-adjusting for 5mm-12mm instruments. The seal assembly prevents a loss of pneumoperitoneum and includes a 3-way stopcock for insufflation. The smooth titanium cannula sleeve has a bevel shape at the distal end to reduce penetration forces during insertion and laser marked graphics intended for future compatibility with Covidien/ Medtronic products. The seal and obturators are supplied sterilized via Ethylene Oxide (EtO) sterilization method) single use, whereas the cannula (cannula and cap) is supplied non-sterile and require sterilization by the user. All components are packaged individually.
Indications for Use
The VersaOne™ reusable positioning trocar system is intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry. The 11mm and 12mm trocar may be used with or without visualization for primary and secondary insertions.
4
Comparison of Technological Characteristics with The Predicate Device
Creating and maintaining a port of entry during endoscopic procedures is the technological principle for both the proposed and predicate devices. The following table provides a summary comparison of the technological characteristics between the proposed device and predicate devices. The differences in technological characteristics do not raise new questions of safety and effectiveness.
| Feature | Proposed Device | Primary Predicate | Secondary Predicate |
|---|---|---|---|
| VersaOne™ Reusable | |||
| Positioning Trocar System | K130435 – Versaport™ V2 | ||
| Bladeless Optical Trocar | K162584 - VersaOne™ | ||
| Bladeless Trocar | |||
| Indications for | |||
| Use | The VersaOne™ reusable | ||
| positioning trocar system is | |||
| intended for use in a variety of | |||
| gynecologic, general, thoracic | |||
| and urologic endoscopic | |||
| procedures to create and | |||
| maintain a port of entry. The | |||
| 11 mm and 12 mm trocar may | |||
| be used with or without | |||
| visualization for primary and | |||
| secondary insertions. | The Versaport™ Bladeless | ||
| 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. | |||
| Positioning Cannula Assembly | |||
| (Reusable) | Cannula with seal system | ||
| (Single-Use) | Cannula with seal system | ||
| (Single-Use) | |||
| Trocar | |||
| Configuration | Seal (Single-Use) | ||
| Bladeless Obturator | |||
| (Single-Use) | |||
| Optical Obturator (Single-Use) | Optical Obturator (Single-Use) | Bladeless Obturator | |
| (Single-Use) | |||
| Trocar Sizes | 8mm, 11mm, 12mm | 11mm and 12mm | 8mm |
| Trocar Lengths | Standard, Long | Short, Standard, Long | Standard, Long |
| Seal cover | |||
| Seal assembly | |||
| Seal snap | |||
| Envelope seal | |||
| 3-way stopcock | |||
| Seal body | Seal cover | ||
| Seal assembly | |||
| Seal housing | Seal cover | ||
| Seal assembly | |||
| Seal housing | |||
| Seal System | |||
| Configuration | |||
| Instrument | |||
| Compatibility | Accommodates instrument | ||
| diameter sizes | |||
| 5mm to 8mm, | |||
| 5mm to 11mm, | |||
| and 5mm to 12mm | Accommodates instruments | ||
| diameter sizes | |||
| 5mm to 11mm, | |||
| and 5mm to 12mm | Accommodates instrument | ||
| diameter sizes | |||
| 5mm to 8mm | |||
| Cap | |||
| Cannula Body | |||
| Cannula Sleeve | Seal system | ||
| Specimen removal button | |||
| Cannula housing | |||
| 3-way stopcock | |||
| Cannula sleeve | Seal system | ||
| Specimen removal button | |||
| Cannula housing | |||
| 3-way stopcock | |||
| Cannula sleeve | |||
| Cannula | |||
| Assembly | |||
| Configuration | |||
| Cannula Sleeve | Titanium Smooth with laser | ||
| marked graphics at the distal | |||
| end | Transparent Fixation (Ribbed) | ||
| Transparent Smooth | Transparent Fixation (Ribbed) | ||
| 8mm Bladeless | |||
| 11mm Bladeless Optical | |||
| 12mm Bladeless Optical | 11mm Bladeless Optical | ||
| 12mm Bladeless Optical | 8mm Bladeless | ||
| Obturator | |||
| Use Conditions | Single use, supplied sterile | ||
| Reusable, supplied non-sterile | Single use, supplied sterile | Single use, supplied sterile | |
| Sterilization | |||
| (single use) | Ethylene oxide (EtO) cycle to | ||
| a SAL of 10-6 | Ethylene oxide (EtO) cycle to | ||
| a SAL of 10-6 | Ethylene oxide (EtO) cycle to | ||
| a SAL of 10-6 | |||
| Reprocessing | |||
| (reusable) | Manual or automated cleaning | ||
| and autoclave | Predicate does not have | ||
| reusable components | Predicate does not have | ||
| reusable components | |||
| Shelf Life | 5 years | 5 years | 5 years |
| (single use) | |||
| Feature | Proposed Device | Primary Predicate | Secondary Predicate |
| Reuse Life | |||
| (reusable) | VersaOne™ Reusable | ||
| Positioning Trocar System | K130435 – Versaport™ V2 | ||
| Bladeless Optical Trocar | K162584 – VersaOne™ | ||
| Bladeless Trocar | |||
| IFU provides the user with a | |||
| method to ascertain whether | |||
| the device has exceeded its | |||
| use life | Predicate does not have | ||
| reusable components | Predicate does not have | ||
| reusable components | |||
| Biocompatibility | Materials used have been | ||
| evaluated and tested per ISO | |||
| 10993-1. | Materials used have been | ||
| evaluated and tested per ISO | |||
| 10993-1. |
5
Performance Data
The following performance data were provided in support of the substantial equivalence determination
Cleaning and Sterilization
Sterilization studies were completed for the single use components (seal, bladeless obturator, and bladeless optical obturator) sterilized by ethylene oxide, ensuring sterilization of 10 ° and demonstrating compliance with applicable FDA quidance and international standards. Cleaning and sterilization studies completed for the reusable component (cannula and cap) of the system, also demonstrated compliance with applicable FDA guidance and standards.
Shelf Life/ Reliability
All components of the proposed device were assessed to confirm compliance with the design inputs throughout its intended life.
Biocompatibility
Biocompatibility testing was completed in accordance with applicable FDA guidance and international standards related to ISO 10993-1. The following tests were conducted, which are appropriate to the patient contact profile of the proposed devices:
- Cytotoxicity .
- Sensitization .
- Intracutaneous Irritation .
- Pyrogenicity
- Acute Systemic Toxicity .
- Chemical Characterization .
Performance Testing
Performance studies were conducted to demonstrate the proposed VersaOne™ Reusable Positioning Trocar System is substantially equivalent to the predicate devices.
Bench (in-vitro) Performance Testing:
- Visual Inspection .
- Instrument Insertion and Removal ● Force
- . Insertion and Removal Force using VersaOne™ Obturator
- Leak Rate ●
- Insufflation Rate ●
- Desufflation Rate ●
- In Vitro Penetration Force ●
Acute Animal (in-vivo) Performance Testing:
- In-Vivo Penetration Force Standard Incision .
- Snap Feature Engagement Strength ●
- Seal System Lock Torque Strength ●
- Obturator Snap Button Force ●
- Cannula Strength Test ●
- Cannula Cap Attachment Torque ●
- Cannula Cap Removal Torque ●
- Seal Assembly Insertion / Removal ● Force
6
Human Factors/Usability
Human factors and usability evaluations were completed per applicable standard and guidance. A summative usability report is included as part of the objective evidence demonstrating safety and effectiveness.
Conclusion
The supporting data enclosed in this submission demonstrates that the proposed VersaOne™ Reusable Positioning Trocar System is substantially equivalent to the predicate devices and does not present any new issues of safety or effectiveness.