BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap
K172575 · Baronova, Inc. · FED · Jan 18, 2018 · Gastroenterology, Urology
Device Facts
Record ID
K172575
Device Name
BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap
Applicant
Baronova, Inc.
Product Code
FED · Gastroenterology, Urology
Decision Date
Jan 18, 2018
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Indications for Use
The disposable Overtube is a device used in conjunction with an endoscope for foreign body removal or endoscopic procedures requiring multiple insertions of the endoscope into the upper gastrointestinal tract. The Endoscope Caps are intended to keep suitable endoscopic view field during endoscopic procedures.
Device Story
BAROnova Retrieval Kit comprises endoscopic accessories including an overtube set, endoscope caps, and a push tube. Overtube consists of polymer extrusion with metallic coil reinforcement, atraumatic tip, handle, flexible PVC obturator, and polymer seal cap. Endoscope caps are plastic, provided in two sizes for standard endoscopes. Push tube is a plastic probe used to facilitate foreign object removal. Device used in clinical settings by gastroenterologists/urologists during endoscopic procedures. Overtube facilitates multiple endoscope insertions into the upper GI tract; endoscope caps maintain clear visualization. Kit includes sizing guide to assist in cap selection. Benefits include improved procedural efficiency and visualization during foreign body retrieval or complex endoscopic interventions.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing including dimensional, mechanical strength, simulated use, and biocompatibility testing.
Technological Characteristics
Overtube: polymer extrusion, metallic coil reinforcement, PTFE tip, flexible PVC obturator, polymer seal cap. Endoscope Caps: polycarbonate. Non-sterile. Manual operation. No energy source. Dimensions vary to accommodate standard endoscopes.
Indications for Use
Indicated for patients undergoing endoscopic procedures in the upper gastrointestinal tract requiring foreign body removal or multiple endoscope insertions, and for maintaining a suitable endoscopic field of view.
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.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
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# SECTION 5: 510(k) SUMMARY STATEMENT
This 510(k) summary is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990, 21 CFR 807.92.
# 1. General Information
Date of Submission: August 25, 2017
| Submitted By: | BAROnova, Inc. |
|---------------|----------------------|
| | 1509 Industrial Road |
| | San Carlos, CA 94070 |
| Contact Person: | Lian Cunningham, MD, PhD |
|-----------------|-------------------------------------|
| | VP, Regulatory and Clinical Affairs |
| | Phone 650-638-9796 ext. 22 |
| | Fax: 650-638-9049 |
| | lcunningham@baronova.com |
# 2. Trade/Proprietary Name of Device:
| Common/Usual Name: | Endoscopic Accessories, Endoscopic Overtube<br>Endoscope Cap |
|-------------------------|----------------------------------------------------------------------------------|
| Trade Name: | BAROnova Retrieval Kit<br>BAROnova Endoscopic Overtube<br>BAROnova Endoscope Cap |
| Regulation Number | 876.1500 |
| Regulation Description: | Endoscope and accessories |
| Product Codes: | FED, OCX |
| Device Panel: | Gastroenterology/Urology |
| Device Classification: | Class II |
# 3. Legally Marketed Predicate Devices for Claimed Equivalence:
| Name: | US Endoscopy Guardus® Overtube |
|-----------|--------------------------------|
| 510(k) #: | K040836 |
| Name: | US Endoscopy Distal Attachment Cap |
|-----------|------------------------------------|
| 510(k) #: | K140315 |
## 4. Device Description
The BAROnova Retrieval Kit includes the following products:
- BAROnova Overtube Set (Overtube with a mated Obturator and • Seal Cap)
- Endoscope Cap Set (Endoscope Caps, Small and Large) ●
- Push Tube ●
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#### . Endoscope Cap Sizing Guide
The BAROnova Overtube Set (BAROnova Overtube) consists of a non-sterile, polymer extrusion with a metallic coil reinforcement, atraumatic tip and handle, in addition to a mated Obturator made of flexible PVC with a tapered tip, and a flexible polymer seal cap. The BAROnova Endoscope Cap Set (BAROnova Endoscope Caps) consists of two non-sterile, plastic caps for use with standard endoscopes. The Endoscope Caps are provided in two sizes to accommodate a range of standard endoscope sizes. The Push Tube (Class I, regulated under 876.4730 - Manual Gastroenterology-Urology-Urology Surgical Instrument and Accessories) and the Endoscope Cap Sizing Guide (Class I, regulated under 876.1500 - Endoscope and Accessories), are optional accessories included in the Retrieval Kit for use with the BAROnova Overtube and BAROnova Endoscope Caps respectively. The Push Tube is a non-sterile, plastic probe with a handle, which may be used to facilitate removal of foreign objects through the BAROnova Overtube. The Endoscope Sizing Cap Guide is an optional accessory for the BAROnova Endoscope Caps to assist the user in selecting the correct size Cap.
### 5. Indications for Use Statement
The Indications for Use for the products included within the Retrieval Kit are as below:
The disposable Overtube is a device used in conjunction with an endoscope for foreign body removal or endoscopic procedures requiring multiple insertions of the endoscope into the upper gastrointestinal tract.
The Endoscope Caps are intended to keep suitable endoscopic view field during endoscopic procedures.
### 6. Substantial Equivalence Comparison
### Indications for Use
The BAROnova Overtube has the same indications for use as the predicate Guardus Overtube therefore the BAROnova device meets the standard of substantial equivalence.
Substantial equivalence for the BAROnova Endoscope Caps is supported by the predicate US Endoscopy Distal Attachment Cap, which includes the same Indication for Use statement. The BAROnova device is indicated to keep a suitable endoscopic view field during endoscopic procedures, whereas the predicate device is indicated both to keep a suitable endoscopic view field and for mucosal resection during endoscopic procedures. The indication for use for the BAROnova Endoscope Caps is within the indication for use for the predicate device and therefore the BAROnova device meets the standard of substantial equivalence.
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Technological Characteristics
Aside from minor differences in dimensions and the inclusion of an integrated PTFE tip, the BAROnova Overtube has the same material and technological characteristics as the predicate Guardus Overtube. Dimensional, mechanical, biocompatibility, and preclinical simulated use data confirmed that the BAROnova Overtube performs as intended and that no new issues of safety and effectiveness are introduced.
Key technological characteristics of the BAROnova Endoscope Caps are similar to the predicate device. The BAROnova Endoscope Caps are dimensionally similar to the predicate US Endoscopy Distal Attachment Cap. The predicate device is made entirely of silicone whereas the distal portion (tissue contacting portion) of the BAROnova device is made of a polycarbonate. This difference is not significant as these two materials are performing the same intended function. The predicate device is provided sterile, due to its indication for mucosal resection. The BAROnova device is intended for keeping a suitable endoscopic field of view, which does not require a sterile device. Dimensional, mechanical, biocompatibility, and preclinical simulated use data confirmed that the BAROnova Endoscope Caps perform as intended and that no new issues of safety and effectiveness are introduced.
# 7. Summary of Performance Data (Non-clinical testing)
Non-clinical testing of the subject devices for structural and functional use has been performed, including dimensional, mechanical strength, simulated use, and biocompatibility. The subject devices were found to meet all requirements.
# 8. Conclusion
Substantial equivalence of the BAROnova Retrieval Kit is supported by a comparison of the intended use, indications for use, design and materials with the Guardus Overtube (K040836) and by a comparison of the intended use, indications for use, design and materials to the US Endoscopy Distal Attachment Cap (K140315), as well as acceptable results from preclinical, mechanical and biocompatibility tests.
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Image /page/4/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. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 18, 2018
BAROnova, Inc. Lian Cunningham, MD, Ph.D. Vice President, Clinical Affairs 1509 Industrial Road San Carlos, CA 94070
Re: K172575
> Trade/Device Name: BAROnova Retrieval Kit, BAROnova Endoscopic Overtube, BAROnova Endoscope Cap Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FED. OCX Dated: December 13, 2017 Received: December 14, 2017
Dear Lian Cunningham:
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. Iisting 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 statutes and regulations administered by other Federal agencies.
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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); 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.
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 http://www.fda.gov/MedicalDevices/SafetyReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
