← Product Code [FCX](/productcode/FCX) · K190985

# BAROnova Insufflation System, BAROnova Accessory Kit (K190985)

_Baronova, Inc. · FCX · May 14, 2019 · Gastroenterology, Urology · SESK_

**Canonical URL:** https://fda.innolitics.com/device/K190985

## Device Facts

- **Applicant:** Baronova, Inc.
- **Product Code:** [FCX](/productcode/FCX.md)
- **Decision Date:** May 14, 2019
- **Decision:** SESK
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.1500
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology

## Indications for Use

The BAROnova Insufflation System is designed to use air as a distention media in the gastrointestinal tract when used in conjunction with the BAROnova TPS Delivery Device. The BAROnova Accessory Kit, consisting of the BAROnova Insufflation System, TPS Stand, and Hook Tool is designed to facilitate use of the BAROnova TPS Delivery Device.

## Device Story

BAROnova Insufflation System provides pressure-controlled air to the stomach during endoscopic placement of the BAROnova Transpyloric Shuttle (TPS). System components include a portable air compressor, power adapter, pressure regulator box, and disposable tubing. The compressor and power adapter are identical to those in the PARI Trek S nebulizer. The regulator box features a precision low-pressure regulator, redundant pressure relief valves, and a calibrated pressure gauge to monitor output. The system is used by physicians during endoscopic procedures to facilitate TPS skin expansion. The Accessory Kit also includes a weighted aluminum/plastic TPS stand for supporting the delivery device handle and a stainless steel hook tool for cutting tension lines during troubleshooting. The device functions similarly to standard endoscopic air pumps but operates in a lower pressure range to enhance safety.

## Clinical Evidence

Bench testing only. Non-clinical functional and simulated use testing was performed to verify performance against requirements and applicable standards.

## Technological Characteristics

System includes portable air compressor, power adapter, pressure regulator box, and disposable tubing. Features precision low-pressure regulator, redundant pressure relief valves, and calibrated pressure gauge. Materials include aluminum (stand base) and plastic. Operates on air as distension media. Designed for lower pressure range than predicate. Non-sterile accessories (stand, hook tool).

## Regulatory 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.

## Predicate Devices

- Bracco Diagnostics, Inc. CO2mpact Endoscopic Insufflator ([K111648](/device/K111648.md))

## Reference Devices

- PARI Trek S nebulizer compressor ([K060357](/device/K060357.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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May 14, 2019

BAROnova, Inc. Lian Cunningham Senior Vice President, Clinical Affairs & Regulatory Affairs 1551 Industrial Road San Carlos, California 94070

# Re: K190985

Trade/Device Name: BAROnova Insufflation System, BAROnova Accessory Kit Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: FCX, FEQ Dated: April 12, 2019 Received: April 15, 2019

# 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. 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. However, you are responsible to determine that the medical devices you use as components in the BAROnova Accessory Kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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 

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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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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,

Daniel G. Walter, Jr. Assistant Division Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known)

Device Name BAROnova Insufflation System

Indications for Use (Describe)

The BAROnova Insufflation System is designed to use air as a distention media in the gastrointestinal tract when used in conjunction with the BAROnova TPS Delivery Device.

Type of Use (Select one or both, as applicable)

> 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 Druq 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."

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#### Indications for Use

510(k) Number (if known)

Device Name BAROnova Accessory Kit

Indications for Use (Describe)

The BAROnova Accessory Kit, consisting of the BAROnova Insufflation System, TPS Stand, and Hook Tool is designed to facilitate use of the BAROnova TPS Delivery Device.

Type of Use (Select one or both, as applicable)

> 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."

EF

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#### 510(k) SUMMARY STATEMENT SECTION 5.1: "

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: April 12, 2019

| Submitted By:   | BAROnova, Inc.<br>1551 Industrial Road<br>San Carlos, CA 94070                                 |
|-----------------|------------------------------------------------------------------------------------------------|
| Contact Person: | Lian Cunningham, MD, PhD<br>SVP, Regulatory and Clinical Affairs<br>Phone 650-638-9796 ext. 22 |

Fax: 650-638-9094

## 2. Device Information:

| Common/Usual Name:      | Endoscopic Insufflation System, Accessories |
|-------------------------|---------------------------------------------|
| Trade Name:             | BAROnova Accessory Kit                      |
|                         | BAROnova Insufflation System                |
| Regulation Number       | 876.1500                                    |
| Regulation Description: | Endoscope and accessories                   |
| Product Code:           | FCX, FEQ                                    |
| Device Panel:           | Gastroenterology/Urology                    |
| Device Classification:  | Class II                                    |

lcunningham@baronova.com

## 3. Legally Marketed Predicate Device for Claimed Equivalence:

Predicate Device: Bracco Diagnostics, Inc. CO2mpact Endoscopic Insufflator™ Name: 510(k) #: K111648

Reference Predicate Device: PARI Trek™ S nebulizer compressor Name: 510(k) #: K060357

## 4. Device Description

The BAROnova Accessory Kit includes the following products:

- . BAROnova Insufflation System
- . BAROnova Transpyloric Shuttle (TPS) Stand
- . Hook Tool

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The BAROnova Insufflation System is designed to provide pressure-controlled air to the stomach for insufflation within the gastric space during endoscopic procedures for placement of the BAROnova Transpyloric Shuttle (TPS) device. The Insufflation System is used in conjunction with the BAROnova TPS Delivery Device to facilitate TPS skin expansion during deployment once the Delivery Device is inserted. Prior to initiating TPS coil advancement with the handle controls, the TPS Delivery Device is connected to the reusable Insufflation System using the disposable tubing set provided within the TPS Delivery Device Kit. The reusable components of the Insufflation System are composed of a portable air Compressor, a Power Adapter, and Pressure Regulator Box. The air Compressor and Power Adapter are the identical components as utilized in the PARI Trek S nebulizer (K060357). The Pressure Regulator Box includes a precision low-pressure regulator and redundant pressure relief valves to limit system output pressure. The Box also includes a calibrated pressure gauge for testing and monitoring the performance of the system. The BAROnova Insufflation System allows the physician to deliver pressure-controlled air to the patient in a manner consistent with that being done currently in a routine endoscopic procedure with room air which is supplied by an air pump in the console of the endoscopic equipment.

The TPS Stand (Class I, regulated under 878.4800 – Manual surgical instrument for general use) and Hook Tool (Class I, regulated under 876.4730 - Manual Gastroenterology-Urology Surgical Instrument and Accessories), are optional accessories included in the Accessory Kit for use with the BAROnova TPS Delivery Device. The TPS Stand is a non-sterile, reusable plastic stand with a weighted aluminum base provided for the convenience of the operator, and can be used to support the TPS Delivery Device handle during TPS deployment. The Hook Tool is a stainless steel reusable tool which may be used to facilitate cutting of tension lines for deployment troubleshooting.

### 5. Indications for Use Statement

Indications for Use for the Accessory Kit:

The BAROnova Accessory Kit, consisting of the BAROnova Insufflation System, TPS Stand, and Hook Tool, is designed to facilitate use of the BAROnova TPS Delivery Device.

Indications for Use for the Insufflation System included within the Accessory Kit: The BAROnova Insufflation System is designed to use air as a distention media in the gastrointestinal tract when used in conjunction with the BAROnova TPS Delivery Device.

#### Substantial Equivalence Comparison 6.

Indications for Use:

The BAROnova Insufflation System has an almost identical Indication for Use statement as the predicate device listed in this submission. Both the subject device and the predicate device utilize a gas as a distention media in the

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gastrointestinal tract. The BAROnova Insufflation System has a narrower indication in that it is designed to be used only with the BAROnova TPS Delivery Device. The Indication for Use statement for the BAROnova Insufflation System meets the standard of substantial equivalence.

### Technological Characteristics:

The BAROnova Insufflation System is similar in size and construction to the predicate device, with minor technological differences. The BAROnova Insufflation System operates in a lower overall pressure range than the predicate device providing additional safety against over pressurization within the gastrointestinal system. The BAROnova Insufflation System utilizes air as distension media, while the predicate device uses CO2; however, both air and CO2 are commonly used for GI insufflation so this difference does not affect the substantial equivalence of the devices.

The BAROnova Insufflation System has a similar (narrower) intended use and similar technological characteristics as the listed predicate device and therefore meets the standard of substantial equivalence.

## 7. Summary of Performance Data (Non-clinical testing)

Non-clinical testing of the subject device for functional and simulated use has been performed, as well as testing to applicable standards. The subject device was found to meet all requirements. The results of the testing performed demonstrate that the BAROnova Insufflation System is safe and effective when used in accordance with its intended use and labeling.

#### 8. Conclusion

Substantial equivalence of the BAROnova Insufflation System (and BAROnova Accessory Kit which contains the Insufflation System, TPS Stand and Hook Tool) is supported by a comparison of the intended use, indications for use, design and materials with the Bracco Diagnostics, Inc. CO2mpact Endoscopic Insufflator (K111648) as well as acceptable results from verification and validation tests.

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**Source:** [https://fda.innolitics.com/device/K190985](https://fda.innolitics.com/device/K190985)

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