(169 days)
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
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,
The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the format requested. The document is a 510(k) summary for the NAVIX Access Device, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against predefined acceptance criteria for a new clinical study.
However, I can extract the information that is available:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided text. The document states:
"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."
This indicates testing was performed, but specific acceptance criteria (e.g., success rates, complication rates, measurement tolerances) and corresponding performance metrics are not listed.
2. Sample size used for the test set and the data provenance
- Test set sample size: Not explicitly stated for any human or clinical testing. The document mentions "animal studies."
- Data provenance: "Animal studies" were used. No information on country of origin of data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no human clinical test set with ground truth established by experts is described. The "animal studies" would likely have their "ground truth" established by veterinary pathology or surgical observation.
4. Adjudication method for the test set
Not applicable, as no human clinical test set is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The device is a physical access device, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The NAVIX Access Device is a physical medical device, not an algorithm.
7. The type of ground truth used
For the animal studies: "performance of the system in a simulated clinical environment as well as verify the performance to design specifications." This suggests the ground truth was based on the physical observable performance of the device and whether it met its engineering specifications in a biological (animal) context.
8. The sample size for the training set
Not applicable. No "training set" in the context of an algorithm or AI is described. The mention of "design durability was tested in the laboratory" implies engineering testing, which might involve iterative design and testing, but not a "training set" in the machine learning sense.
9. How the ground truth for the training set was established
Not applicable, as no training set (for an algorithm) is mentioned. For the laboratory testing, "ground truth" would be established by engineering measurements and stress tests against predefined specifications.
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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
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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
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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
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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
§ 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.