Who is the manufacturer of Xpan Universal Trocar System?

Xpan, Inc. filed the 510(k) submission for Xpan Universal Trocar System (K223562).

What is the FDA product code for Xpan Universal Trocar System?

GCJ. It is classified under 21 CFR 876.1500 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for Xpan Universal Trocar System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Xpan Universal Trocar System?

VersaStep™ Bladeless Trocar (K012539).

Who can help prepare an FDA 510(k) submission like Xpan Universal Trocar System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Xpan Universal Trocar System

K223562 · Xpan, Inc. · GCJ · Jun 2, 2023 · Gastroenterology, Urology

Device Facts

Record ID	K223562
Device Name	Xpan Universal Trocar System
Applicant	Xpan, Inc.
Product Code	GCJ · Gastroenterology, Urology
Decision Date	Jun 2, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1500
Device Class	Class 2

Intended Use

The Xpan Universal Trocar System is intended to provide dilation access with or without visualization to the abdominal and thoracic cavities for performing diagnostic and operative abdominal and thoracic procedures. - Laparoscopic access to the abdominal cavity, both primary and secondary punctures. - Thoracoscopic access to the thoracic cavity, both primary and secondary punctures.

Device Story

Xpan Universal Trocar System is a single-use, radially expandable trocar system for abdominal and thoracic access. System comprises a 3mm expandable port (expandable to 5mm or 12mm) and optical bladeless obturators. Principle of operation involves tissue dilation via rigid members surrounded by an elastomeric cover; expansion occurs upon insertion of 5mm or 12mm cannula/obturator. Device features include one-way valves, backup seals, and detachable valves for specimen removal or desufflation. Used in clinical settings (OR) by surgeons. Provides a universal port solution; allows 3mm instrument use prior to expansion. Benefits include reduced need for Veress needle, optical visualization, and versatile instrument sizing. Healthcare providers use the device to establish and maintain pneumoperitoneum for endoscopic procedures.

Clinical Evidence

Bench testing only. No clinical or animal studies were performed. Performance characteristics evaluated included insertion/retention/expansion forces, instrument compatibility, light transmission, visualization, and maintenance of pneumoperitoneum. Biocompatibility testing conducted per ISO 10993-1.

Technological Characteristics

Single-use, radially expandable trocar system. 3mm port expands to 5mm or 12mm. Features optical bladeless tips, one-way valves, and detachable valve assemblies. Materials are biocompatible per ISO 10993. Sterilization via Ethylene Oxide (ISO 11135).

Indications for Use

Indicated for patients requiring laparoscopic or thoracoscopic access to the abdominal or thoracic cavities for diagnostic or operative procedures, including both primary and secondary punctures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

VersaStep™ Bladeless Trocar (K012539)

Reference Devices

GeniCon NanoPort 3mm Trocar (K982472)
VersaOne 5mm and 12mm Optical Trocars (K112349, K130435)

Related Devices

K193272 — GTK Trocars · Guangzhou T.K Medical Instrument Co., Ltd. · Jul 9, 2020
K012539 — VERASTEP · United States Surgical, A Division of Tyco Healthc · Sep 6, 2001
K142464 — Entriport · Conmed Corporation · Mar 5, 2015
K073009 — ONEPORT SURGICAL TROCAR SYSTEM · Conmed Corporation · Dec 7, 2007
K201805 — VersaOne Reusable Positioning Trocar System · Covidien · Aug 26, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. June 2, 2023 Xpan Inc. % Michele Lucey Consultant Lakeshore Medical Device Consulting, LLC 128 Blye Hill Landing Newbury, New Hampshire 03255 Re: K223562 Trade/Device Name: Xpan Universal Trocar System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: [NOTE: Use date of most recent supplement] Received: May 4, 2023 Dear Michele Lucey: 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. 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 {1}------------------------------------------------ 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 medical devices and radiation-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, | Mark Trumbore -S | Digitally signed by Mark Trumbore -S Date: 2023.06.02 08:15:43 -04'00' | |---------------------|---------------------------------------------------------------------------------| |---------------------|---------------------------------------------------------------------------------| Mark Trumbore, 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}------------------------------------------------ #### Traditional 510(k) Premarket Notification Xoan Universal Trocal System DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) Device Name Xpan Universal Trocar System Indications for Use (Describe) The Xpan Universal Trocar System is a single use system that is intended to provide dilation access with or without visualization to the abdominal and thoracic cavities for performing diagnostic and operative abdominal and thoracic procedures. The system is indicated for the following uses: - · Laparoscopic access to the abdominal cavity, both primary and secondary punctures. - · Thoracoscopic access to the thoracic cavity, both primary and secondary punctures. Type of Use (Select one or both, as applicable) | <div> X Prescription Use (Part 21 CFR 801 Subpart D) </div> | |-----------------------------------------------------------------------------------------------------------------------------------------------------| | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for XPAN. The logo consists of a stylized letter X, with one side in black and the other in blue, followed by the letters PAN in black. The blue side of the X has an arrow pointing upwards, while the black side has an arrow pointing downwards. ## Traditional 510(k) SUMMARY Page 1 of 8 ## Submitter: | Applicant | XPAN Inc. | |---------------------------|-----------------------------------------| | Contact Person | Michele Lucey | | | Lakeshore Medical Device Consulting LLC | | | 603-748-1374 | | | Email: lucey_m@msn.com | | Date Prepared | November 17, 2022 | | Subject Device: | | | Proprietary/Trade Name | Xpan Universal Trocar System | | Common or Usual Name | Surgical Trocar | | Classification Name | Endoscope and Accessories | | Regulatory Class | Class II | | Classification Code | GCJ | | Regulation Number | 876.1500 | | Review Panel | General and Plastic Surgery | | Predicate Device: | | | Proprietary/Trade Name | VersaStep™ Bladeless Trocar | | 510(k) Number | K012539 | | Common or Usual Name | Surgical Trocar | | Classification Name | Endoscope and Accessories | | Regulatory Class | Class II | | Classification Code | GCJ | | Regulation Number | 876.1500 | | Review Panel | General and Plastic Surgery | | Reference Devices: | | | Proprietary/Trade Name | GeniCon NanoPort 3mm Trocar | | 510(k) Number | K982472 | | Common or Usual Name | Surgical Trocar | | Classification Name | Cannula, Surgical | | Regulatory Class | Class I (reclassified 2001) | | Classification Code | GEA | | Regulation Number | 876.4800 | | Review Panel | General and Plastic Surgery | | Proprietary/Trade Name | VersaOne 5mm and 12mm Optical Trocars | | 510(k) Number | K112349, K130435 | | Common or Usual Name | Surgical Trocar | | Classification Name | Endoscope and Accessories | | Regulatory Class | Class II | | Classification Code | GCJ | | Regulation Number | 876.1500 | | Review Panel | General and Plastic Surgery | {4}------------------------------------------------ #### Intended Use: The Xpan Universal Trocar System is intended to provide dilation access with or without visualization to the abdominal and thoracic cavities for performing diagnostic and operative abdominal and thoracic procedures. - Laparoscopic access to the abdominal cavity, both primary and secondary punctures. . - Thoracoscopic access to the thoracic cavity, both primary and secondary punctures. #### Device Description/Technological Characteristics: The Xpan Universal Trocar System provides a universal port solution wherein the 3mm expandable port is radially expandable from 3mm up to 12mm. Xpan is offered in three sizes and is a single use device. {5}------------------------------------------------ The 5mm and 12mm cannulas are supplied with an optical bladeless tip and include a detachable valve to allow for specimen removal or rapid desufflation. The 3mm expandable trocar can be assembled with the 5mm or 12mm Xpan obturators after tissue insertion or before tissue insertion if desired. The exterior shaft of the 3mm expandable trocar is ribbed to provide security in tissue once inserted in tissue. | Device Description | |-----------------------------------------------------------------| | Description | | 3mm expandable (up to 12mm) trocar with a 3mm obturator | | 5mm Cannula with a 5mm Obturator with an optical bladeless tip | | 12mm Cannula and a 12mm Obturator with an optical bladeless tip | #### Performance Data: Nonclinical performance data has been conducted for the Xpan Universal Trocar System was conducted to evaluate safety and performance, where appropriate device performance was compared against the predicate, reference, or legally marketed comparator devices. #### Biocompatibility Biocompatibility evaluation of the subject device was conducted in accordance with ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process and 2020 FDA Guidance, Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1''; Evaluation and testing within a risk management process. The subject device contacts tissue for less than 24 hours, so the following endpoints were considered, and all materials were found to be biocompatible: Cytotoxicity Sensitization Intracutaneous Irritation Acute Systemic Toxicity Material Mediated Pyrogenicity #### Bench Testing Design Verification testing was performed with the subject device. The following performance characteristics were evaluated: Trocar Insertion Force Trocar Retention Force Expansion Force Instrument Insertion/Removal Force Light Transmission and Tissue Visualization Insufflation and Desufflation Maintenance of Pneumoperitoneum Instrument Compatibility {6}------------------------------------------------ #### Sterilization /Shelf Life Sterilization validation was conducted in accordance with ISO11135, Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation, and routine control of a sterilization process for medical devices. Shelf life testing was performed to evaluate package integrity and device functionality following artificial aging and simulated transit conditioning. ### Animal Studies No animal studies were performed ## Clinical Studies No clinical studies were performed ## Comparison with the Predicate Device: Substantial equivalence of the Xpan Universal Trocar System is based on comparing the intended use and indications for use and technological characteristics of the predicate device. The following table compares the intended use/indications and key technological characteristics between the Xpan Universal Trocar System and the predicate device. Where technological characteristics are different, reference devices have been identified. These differences are minor and do not raise new questions of safety and effectiveness. | Feature | Subject Device | Predicate device | Reference Device #1 | Reference Devices #2 and #3 | Comparison | |----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Xpan Universal Trocar System | VersaStep (K012539) | GeniCon NanoPort 3mm Trocar (K982472) | VersaOne 5mm and 12mm Bladeless Optical Trocars (K112349 and K130435 respectively). | | | FDA Classification | Class II | Class II | Class I | Class II | Same | | Product Code(s) | GCJ | GCJ | GEA (reclassified 2001) | GCJ | Same as the predicate device | | Regulation Number | 876.1500 | 876.1500 | 878.4800 | 876.1500 | Same as the predicate device | | Anatomical Location | Abdominal and Thoracic | Abdominal and Thoracic | Abdominal and Thoracic | Abdominal and Thoracic | Same | | Feature | Subject Device | Predicate device | Reference Device #1 | Reference Devices #2 and #3 | Comparison | | | Xpan Universal Trocar System | VersaStep (K012539) | GeniCon NanoPort 3mm Trocar (K982472) | VersaOne 5mm and 12mm Bladeless Optical Trocars (K112349 and K130435 respectively). | | | Insertion | Through an incision | Through an incision | Through an incision | Through an incision | Same | | Tissue anchoring | Dilation and ridges of expandable members | The dilation of the mesh sheath | Bumps on cannula | Ridges on cannula | Differences do not raise questions of safety and effectiveness | | Initial Entry Device (Sheath) Outer Diameter | 6.6 mm | 4 mm | 8.4mm | 5mm device: 8.25 mm 12mm device: 15.4 mm | Difference does not raise questions of safety and effectiveness | | Expandable Range | 5mm and 12mm | 5mm and 12mm | N/A | N/A | Same | | Method of expansion | Three rigid members form a 3mm cannula and are surrounded by an elastomeric cover. The rigid members and elastomeric cover move radially outwards and expand upon insertion of 5mm or 12mm cannula and obturator | A collapsed mesh constrained by an outer sheath is expanded upon insertion of 5mm or 12mm cannula and blunt obturator through its lumen which disrupts the outer sheath to allow the mesh to expand. | N/A | N/A | Same, both devices accomplish expansion by increasing the radial diameter through a flexible mechanism. Structural differences do not raise new questions of safety and effectiveness | | Feature | Subject Device | Predicate device | Reference Device #1 | Reference Devices #2 and #3 | Comparison | | 3mm Trocar/Cannula capability | Xpan Universal Trocar System | VersaStep (K012539) | GeniCon NanoPort 3mm Trocar (K982472) | VersaOne 5mm and 12mm Bladeless Optical Trocars (K112349 and K130435 respectively). | | | 3mm Trocar/Cannula capability | The Xpan 3mm Expandable Trocar (equivalent of the predicate's sheath) has long, rigid members that form a rigid pathway and lumen for 3mm interventional endoscopic instruments to be used. Can be used standalone 3mm conventional trocar | The sheath is made of flexible material and has no one-way valve, it only creates an initial pathway in the tissue and cannot be used as standalone trocar/cannula for 3mm instruments. | The trocar comprises a cannula that allows entry of 3mm instruments. It also comprises a one-way valve and backup valve that provide sealing | N/A | The capability of the Xpan device as a 3mm trocar does not raise new questions of safety and effectiveness | | One Way Valve | Yes In 3mm, 5mm, and 12mm | Yes In 5mm, and 12mm only | Yes | Yes | The capability of the Xpan device at 3mm does not raise new questions of safety and effectiveness | | Backup valve for instruments seal | Yes In 3mm, 5mm, and 12mm | Yes In 5mm, and 12mm only | Yes | Yes | The capability of the Xpan device at 3mm does not raise new questions of safety and effectiveness | | Range of instrument sizes | Can be used with 3mm instruments in 3mm Expandable | No instruments before expansion of the sheath | 3mm instruments | 5mm instruments in the 5mm device | The capability of the Xpan device at 3mm does not raise new | | Feature | Subject Device | Predicate device | Reference Device #1 | Reference Devices #2 and #3 | Comparison | | | Xpan Universal Trocar System | VersaStep (K012539) | GeniCon NanoPort 3mm Trocar (K982472) | VersaOne 5mm and 12mm Bladeless Optical Trocars (K112349 and K130435 respectively). | | | | Device prior to expansion 5mm instruments in 5mm Expanded Device 5mm-12mm instruments in 12mm Expanded Device | 5mm instruments in the 5mm Expanded Device 5mm-12mm instruments in the 12mm Expanded Device | | 5mm-12mm instruments in the 12mm device | questions of safety and effectiveness | | Veress Needle Required for insertion | Not required | Required | Not required | Not required | The integrated bladeless 3mm obturator tip in the Xpan device is similar to 3mm reference device and precludes the need for a Veress needle. This difference does not raise new questions of safety and effectiveness | | Optical Insertion | Yes For 5mm and 12mm insertions only | No | No | Yes | This difference does not raise new questions of safety and effectiveness | | Detachable valve (for Specimen Retrieval) | Yes In 5mm and 12mm | Yes In 12mm only | No | No in the 5mm device Yes in the 12mm device | The additional capability of a detachable valve in both the 5mm and 12mm sizes, | | Feature | Subject Device | Predicate device | Reference Device #1 | Reference Devices #2 and #3 | Comparison | | | Xpan Universal Trocar System | VersaStep (K012539) | GeniCon NanoPort 3mm Trocar (K982472) | VersaOne 5mm and 12mm Bladeless Optical Trocars (K112349 and K130435 respectively). | | | | | | | | does not raise new questions of safety and effectiveness | | Biocompatibility | ISO 10993 | ISO 10993 | ISO 10993 | ISO 10993 | Same | | How Supplied | Sterile, single use | Sterile, single use | Sterile, single use | Sterile, single use | Same | | Sterilization Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Same | | Sterility Assurance Level | 10-6 | 10-6 | 10-6 | 10-6 | Same | {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ ## Conclusion: Substantial equivalence has been demonstrated based upon the supporting data in this submission demonstrating that the Xpan Universal Trocar System is as safe and effective as the legally marketed predicate device (K012539) and does not raise different questions of safety and effectiveness.