(169 days)
Not Found
No
The summary describes a mechanical device for creating and dilating access tracts, with no mention of AI, ML, image processing, or any computational analysis of data.
No.
The device's description and intended use indicate it is an accessory for creating and dilating an access tract into a pancreatic pseudocyst, which is a procedural tool rather than a device for treating a disease or condition itself.
No
The device is described as an "Access Device" intended to create and dilate an access tract for cannulation. It uses tools like a trocar, anchor balloon, and dilation balloon. Its purpose is to facilitate a procedure (cannulation for pancreatic pseudocyst) rather than to diagnose a condition.
No
The device description explicitly states it is a "multi-lumen catheter device" and includes physical components like a "trocar, an anchor balloon, and a dilation balloon." This indicates it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "cannulate the transgastric or transduodenal wall into a pancreatic pseudocyst" during endoscopic procedures. This is a surgical/interventional procedure performed directly on the patient's body.
- Device Description: The device is a catheter with tools (trocar, balloons) designed for creating and dilating an access tract within the body.
- Anatomical Site: The device is used within the transgastric or transduodenal wall and into a pancreatic pseudocyst, which are internal anatomical structures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information about a patient's health status, diagnosis, or treatment.
IVD devices are used to perform tests on samples taken from the body, not to directly interact with or modify the body itself in a surgical or interventional manner.
N/A
Intended Use / Indications for Use
The NAVIX Access Device is intended for use as an accessory to cannulate the transgastric or transduodenal wall and thus a pancreatically pseudocyst, when it is visibly bulging into the gastrointestinal tract during endoscopic procedures.
Product codes (comma separated list FDA assigned to the subject device)
KOG, GCJ
Device Description
The NAVIX Access Device is a multi-lumen catheter device that enables the physician to create and dilate an access tract through adjacent tissues. The NAVIX Access Device is exchange-free in that it delivers multiple tools without the need to exchange these tools over a guidewire. The NAVIX Access Device includes a trocar, an anchor balloon, and a dilation balloon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
transgastric or transduodenal wall, gastrointestinal tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
the trained endoscopist
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)
Xlumena performed an analysis of key characteristics of predicates in comparison to key characteristics of the NAVIX Access Device. This analysis has shown that the NAVIX Access Device is substantionally equivalent in characteristics and uses to our predicate devices in combination.
Design durability was tested in the laboratory, and animal studies were used to validate performance of the system in a simulated clinical environment as well as verify the performance to design specifications.
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.
Not Found
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
5. 510(K) SUMMARY
Proprietary Name: NAVIX Access Device
APR - 7 2010
1693279
Classification Name: KOG - endoscope and/or accessories
Common Name: Access Device
Manufacturer: Xlumena, Inc. 453 Ravendale Drive, Suite H Mountain View, California 94117
- Contact: Witney McKiernan, RN, MSN Director of Business & Clinical Affairs Xlumena, Inc. 453 Ravendale Drive, Suite H Mountain View, California 94117 (650) 961-9900 x225 Fax: (650) 961-9900 wmckiernan@xlumena.com
Preparation Date: October 16, 2009
Predicate Devices:
The NAVIX Access Device is substantially equivalent to the following currently marketed predicate devices:
- (1) Electrocautery Dilation Balloon - K082114 Approved December 19, 2008 Apollo Endosurgery, Inc. Product Code: KNS Regulation: Sec.876.4300 Endoscopic electrosurgical unit and accessories
- (2) Wilson-Cook Cystotome - K022595 Approved October 17, 2002 Wilson-Cook Medical Inc. Product Code: KNS Regulation: Sec.876.4300 Endoscopic electrosurgical unit and accessories
1
Device Description:
The NAVIX Access Device is a multi-lumen catheter device that enables the physician to create and dilate an access tract through adjacent tissues. The NAVIX Access Device is exchange-free in that it delivers multiple tools without the need to exchange these tools over a guidewire. The NAVIX Access Device includes a trocar, an anchor balloon, and a dilation balloon,
Intended Use:
The NAVIX Access Device is intended for use as an accessory to cannulate the transgastic or transcluodenal wall and this a panereally osseudowst, when it is visibly bulging into the gastrointestinalytract during endoscopto procedures
Technological Characteristics of Substantial Equivalence:
The NAVIX Access Device is substantially equivalent to the:
- (1) Electrocautery Dilation Balloon - K082114 Approved December 19, 2008 Apollo Endosurgery, Inc. Product Code: KNS Regulation: Sec.876.4300 Endoscopic electrosurgical unit and accessories
- (2) Wilson-Cook Cystotome K022595 Approved October 17, 2002 Wilson-Cook Medical Inc. Product Code: KNS Regulation: Sec.876.4300 Endoscopic electrosurgical unit and accessories
with regard to materials, safety and efficacy.
Performance Data:
Xlumena performed an analysis of key characteristics of predicates in comparison to key characteristics of the NAVIX Access Device. This analysis has shown that the NAVIX Access Device is substantionally equivalent in characteristics and uses to our predicate devices in combination.
Design durability was tested in the laboratory, and animal studies were used to validate performance of the system in a simulated clinical environment as well as verify the performance to design specifications.
Conclusion:
The NAVIX Access Device has the same intended use and utilizes the same fundamental scientific technology as that of the referenced predicate devices.
CONFIDENTIAL
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an eagle-like symbol with three talon-like shapes extending from the body.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
APR - 7 2010
Ms. Witney Mckiernan, RN, MSN Director of Business and Clinical Affairs
Xlumena ----------------------------------------------------------------------------------------------453 Ravendale Drive, Suite H MOUNTAIN VIEW CALIFORNIA 94043
Re: K093279
Trade/Device Name: NAVIX Access Device Regulation Number: 21 CFR §876.1500 · Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: March 24, 2010 Received: March 29, 2010
Dear Ms. Mckiernan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act . The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
3
Page 2 -
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): _Not known at this time ×
Device Name: NAVIX Access Device
Indications for Use:
The XIumena NAVIX Access IDevice is intended for useras an accessory to
cannulate the transgastric or transduodenal wall into a pancreativ oseudocyst. When it is visibly bulging into the gastrointestinal tractic furing endoscopic procedures
Prescription Use Over-The-Counter Use X 100 AND/OR the trained endoscopis (21 CFR 801 Subpart C) only (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Page of (POSTED NOVEMBER 13, 2003)
Signature
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.
CONFIDENTIAL