(186 days)
No
The summary describes a mechanical trocar system and does not mention any AI or ML components or functionalities.
No.
This device is for providing access for diagnostic and operative procedures, not for treating a disease or condition itself.
No.
The intended use states the device is for providing "dilation access with or without visualization to the abdominal and thoracic cavities for performing diagnostic and operative abdominal and thoracic procedures." While it can be used for "diagnostic" procedures, the device itself is an access tool, not a diagnostic instrument that produces a diagnosis.
No
The device description clearly details physical components (trocar, cannulas, obturators, valves, shaft) and the performance studies focus on physical characteristics and biocompatibility, indicating it is a hardware device.
Based on the provided information, the Xpan Universal Trocar System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for providing access to the abdominal and thoracic cavities for performing diagnostic and operative procedures within the body. IVD devices are used to examine specimens outside the body (in vitro) to obtain information about a patient's health.
- Device Description: The description details a physical system for creating access ports, not for analyzing biological samples.
- Lack of IVD-related information: The document does not mention any aspects related to sample collection, analysis, reagents, or diagnostic results derived from testing biological specimens.
The Xpan Universal Trocar System is a surgical access device used during minimally invasive procedures.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
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.
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdominal and Thoracic
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)
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 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
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
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
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)
| X Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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.