(186 days)
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.
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. 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.
The provided text is a 510(k) Premarket Notification for the "Xpan Universal Trocar System." This document is primarily concerned with demonstrating "substantial equivalence" of a new medical device to existing legally marketed devices, rather than establishing acceptance criteria or performing a study to prove a device meets specific performance metrics in the way one might for an AI/ML-based diagnostic device.
The document focuses on:
- Device Description: What the Xpan Universal Trocar System is and its components.
- Intended Use: The medical procedures it's designed for (laparoscopic and thoracoscopic access).
- Performance Data (Nonclinical): Bench testing (e.g., Insertion Force, Retention Force, Insufflation) and biocompatibility, as well as sterilization and shelf life.
- Comparison with Predicate Device: A detailed table comparing the new device's features to those of a predicate device (VersaStep Bladeless Trocar, K012539) and reference devices.
Crucially, the document explicitly states: "No animal studies were performed" and "No clinical studies were performed." This means there is no data presented in this document about:
- Acceptance criteria related to AI/ML performance (e.g., sensitivity, specificity, AUC).
- Sample sizes for test sets or training sets in the context of AI/ML.
- Expert involvement for ground truth establishment.
- Adjudication methods.
- MRMC studies or standalone algorithm performance.
- Ground truth types (pathology, outcomes data, expert consensus).
The "performance data" mentioned refers to engineering and material safety tests, not performance in a diagnostic or AI/ML context that would involve metrics like accuracy, sensitivity, or human reader improvement.
Therefore, based on the provided document, it is not possible to answer your questions regarding acceptance criteria and performance study details that relate to AI/ML or diagnostic accuracy, as this submission is for a physical medical device (a surgical trocar) and explicitly states no clinical or animal studies were performed.
The document's purpose is to show that the new trocar is substantially equivalent to existing trocars based on intended use, technological characteristics, and non-clinical bench testing, and that any differences do not raise new questions of safety and effectiveness. It does not involve any AI/ML components or comparative effectiveness studies with human readers.
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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
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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,
| MarkTrumbore -S | Digitally signed byMark Trumbore -SDate: 2023.06.0208:15:43 -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
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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)
| X Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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/TradeName | 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 |
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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.
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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
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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 | Predicatedevice | ReferenceDevice #1 | Reference Devices#2 and #3 | Comparison |
|---|---|---|---|---|---|
| Xpan UniversalTrocar System | VersaStep(K012539) | GeniConNanoPort 3mmTrocar(K982472) | VersaOne 5mm and12mm BladelessOptical Trocars(K112349 andK130435respectively). | ||
| FDAClassification | Class II | Class II | Class I | Class II | Same |
| Product Code(s) | GCJ | GCJ | GEA(reclassified 2001) | GCJ | Same as thepredicate device |
| RegulationNumber | 876.1500 | 876.1500 | 878.4800 | 876.1500 | Same as thepredicate device |
| AnatomicalLocation | Abdominal andThoracic | Abdominal andThoracic | Abdominal andThoracic | Abdominal andThoracic | Same |
| Feature | Subject Device | Predicatedevice | ReferenceDevice #1 | Reference Devices#2 and #3 | Comparison |
| Xpan UniversalTrocar System | VersaStep(K012539) | GeniConNanoPort 3mmTrocar(K982472) | VersaOne 5mm and12mm BladelessOptical Trocars(K112349 andK130435respectively). | ||
| Insertion | Through anincision | Through anincision | Through anincision | Through an incision | Same |
| Tissueanchoring | Dilation andridges ofexpandablemembers | The dilation ofthe mesh sheath | Bumps oncannula | Ridges on cannula | Differences donot raisequestions ofsafety andeffectiveness |
| Initial EntryDevice (Sheath)Outer Diameter | 6.6 mm | 4 mm | 8.4mm | 5mm device: 8.25 mm12mm device: 15.4mm | Difference doesnot raisequestions ofsafety andeffectiveness |
| ExpandableRange | 5mm and 12mm | 5mm and 12mm | N/A | N/A | Same |
| Method ofexpansion | Three rigidmembers form a3mm cannula andare surrounded byan elastomericcover. The rigidmembers andelastomeric covermove radiallyoutwards andexpand uponinsertion of 5mmor 12mm cannulaand obturator | A collapsedmeshconstrained byan outer sheathis expandedupon insertionof 5mm or12mm cannulaand bluntobturatorthrough itslumen whichdisrupts theouter sheath toallow the meshto expand. | N/A | N/A | Same, bothdevicesaccomplishexpansion byincreasing theradial diameterthrough a flexiblemechanism.Structuraldifferences donot raise newquestions ofsafety andeffectiveness |
| Feature | Subject Device | Predicate device | Reference Device #1 | Reference Devices #2 and #3 | Comparison |
| 3mmTrocar/Cannulacapability | Xpan UniversalTrocar System | VersaStep(K012539) | GeniConNanoPort 3mmTrocar(K982472) | VersaOne 5mm and12mm BladelessOptical Trocars(K112349 andK130435respectively). | |
| 3mmTrocar/Cannulacapability | The Xpan 3mmExpandableTrocar (equivalentof the predicate'ssheath) has long,rigid membersthat form a rigidpathway andlumen for 3mminterventionalendoscopicinstruments to beused. Can be usedstandalone 3mmconventionaltrocar | The sheath ismade of flexiblematerial and hasno one-wayvalve, it onlycreates an initialpathway in thetissue andcannot be usedas standalonetrocar/cannulafor 3mminstruments. | The trocarcomprises acannula thatallows entry of3mminstruments. Italso comprises aone-way valveand backup valvethat providesealing | N/A | The capability ofthe Xpan deviceas a 3mm trocardoes not raisenew questions ofsafety andeffectiveness |
| One Way Valve | YesIn 3mm, 5mm,and 12mm | YesIn 5mm, and12mm only | Yes | Yes | The capability ofthe Xpan deviceat 3mm does notraise newquestions ofsafety andeffectiveness |
| Backup valvefor instrumentsseal | YesIn 3mm, 5mm,and 12mm | YesIn 5mm, and12mm only | Yes | Yes | The capability ofthe Xpan deviceat 3mm does notraise newquestions ofsafety andeffectiveness |
| Range ofinstrument sizes | Can be used with3mm instrumentsin 3mmExpandable | No instrumentsbeforeexpansion ofthe sheath | 3mm instruments | 5mm instruments inthe 5mm device | The capability ofthe Xpan deviceat 3mm does notraise 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 expansion5mm instruments in 5mm Expanded Device5mm-12mm instruments in 12mm Expanded Device | 5mm instruments in the 5mm Expanded Device5mm-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 | YesFor 5mm and 12mm insertions only | No | No | Yes | This difference does not raise new questions of safety and effectiveness |
| Detachable valve (for Specimen Retrieval) | YesIn 5mm and 12mm | YesIn 12mm only | No | No in the 5mm deviceYes in the 12mm device | The additional capability of a detachable valve in both the 5mm and 12mm sizes, |
| Feature | Subject Device | Predicatedevice | ReferenceDevice #1 | Reference Devices#2 and #3 | Comparison |
| Xpan UniversalTrocar System | VersaStep(K012539) | GeniConNanoPort 3mmTrocar(K982472) | VersaOne 5mm and12mm BladelessOptical Trocars(K112349 andK130435respectively). | ||
| does not raisenew questions ofsafety andeffectiveness | |||||
| Biocompatibility | ISO 10993 | ISO 10993 | ISO 10993 | ISO 10993 | Same |
| How Supplied | Sterile, single use | Sterile, singleuse | Sterile, single use | Sterile, single use | Same |
| SterilizationMethod | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Same |
| SterilityAssurance Level | 10-6 | 10-6 | 10-6 | 10-6 | Same |
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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.
§ 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.