BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR

K132192 · Bracco Diagnostic, Inc. · FCX · Feb 14, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K132192
• Device Name: BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR
• Applicant: Bracco Diagnostic, Inc.
• Product Code: FCX · Gastroenterology, Urology
• Decision Date: Feb 14, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The PROTOCO2L Touch Colon Insufflator administers and regulates CO2 as a distention media to the colon during Computed Tomography Colonography (CTC or Virtual Colonoscopy).

Device Story

The PROTOCO2L Touch is an electro-mechanical pneumatic system used in clinical settings (near CT gantry) to administer and regulate CO2 gas for colonic distention during Computed Tomography Colonography (CTC). The device consists of the main insufflator unit and a disposable, non-sterile administration set. It functions by delivering CO2 at controlled pressures and flow rates to the colon via a rectal enema tip or catheter. The system is operated by healthcare professionals to ensure uniform colonic distention, which improves the diagnostic quality of the CTC procedure. By providing consistent, regulated insufflation, the device facilitates clearer imaging of the colon, aiding clinicians in the detection of abnormalities during virtual colonoscopy.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including electrical safety, electromagnetic compatibility, biocompatibility of patient-contact materials, and software verification and validation.

Technological Characteristics

Electro-mechanical pneumatic system for CO2 regulation. Components include the insufflator unit and disposable administration set. Patient-contact materials verified per ISO 10993-1. Electrical safety per IEC 60601-1 and UL 60601-1. EMC per IEC 60601-1-2. Usability engineering per IEC 62366. Packaged for transport per ISTA Procedure 3A.

Indications for Use

Indicated for patients undergoing Computed Tomography Colonography (CTC or Virtual Colonoscopy) requiring colonic distention via CO2 insufflation.

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.

Predicate Devices

• PROTOCO2L Colon Insufflator with Performance Improvements (K030854)
• PROTOCO2L Colon Insufflator (K013219)

Submission Summary (Full Text)

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# 510(k) Premarket Notification Bracco Diagnostics Inc. PROTOCO2L Touch Colon Insufflator 510(k) Summary

FEB 1 4 2014

| Submission Date: | 12 July 2013 | | |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------|----------------------------------------------------------------------------------------------|
| Submitter: | Bracco Diagnostics Inc.<br>259 Prospect Plains Road, Building H<br>Monroe Township, NJ 08831 USA | | |
| Submitter and<br>Official Contact: | Ms. Tracey Alexander<br>Director Regulatory Affairs<br>[phone]<br>[phone] (fax)<br>[e-mail] | | |
| Trade Name: | Bracco Diagnostics Inc. PROTOCO₂L Touch Colon Insufflator | | |
| Common Name: | CO₂ Colon Insufflator | | |
| Classification Name: | Endoscope and accessories | | |
| Classification<br>Regulation: | 21 CFR §876.1500 | | |
| Product Code: | FCX | | |
| Substantially<br>Equivalent Devices: | New BDI Model | Predicate<br>510(k) Number | Predicate<br>Manufacturer / Model |
| | Bracco Diagnostics Inc.<br>PROTOCO₂L Touch<br>Colon Insufflator | K030854 | E-Z-EM, Inc. (now BDI)<br>PROTOCO₂L Colon<br>Insufflator with<br>Performance<br>Improvements |
| | | K013219 | E-Z-EM, Inc. (now BDI)<br>PROTOCO₂L Colon |

Insufflator.

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## 510(k) Premarket Notification Bracco Diagnostics Inc. PROTOCO2L Touch Colon Insufflator 510(k) Summary

| Device Description: | The Bracco Diagnostics Inc. (BDI) PROTOCO₂L Touch Colon<br>Insufflator (PROTOCO₂L Touch) administers and regulates CO₂ as a<br>distention media to the colon during Computed Tomography<br>Colonography (CTC or Virtual Colonoscopy). Insufflation during CTC<br>is used to distend the colon with uniform pressure in order to properly<br>present the colon during the given diagnostic procedure. |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The PROTOCO2L Touch consists of two (2) components: |
| | (1) the Colon Insufflator, and |
| | (2) the disposable, non-sterile Administration Set. |
| Intended Use: | The PROTOCO₂L Touch Colon Insufflator administers and regulates<br>CO₂ as a distention media to the colon during Computed Tomography<br>Colonography (CTC or Virtual Colonoscopy). |

The PROTOCO2L Touch employs the same technological Technology characteristics as the predicate devices. Compurison:

| Characteristic<br>Comparisons: | E-Z-EM, Inc.<br>PROTOCO₂L Colon<br>Insufflator Model 6400 | E-Z-EM, Inc.<br>PROTOCO₂L Colon<br>Insufflator with<br>Performance Improvements | Bracco Diagnostics Inc.<br>PROTOCO₂L Touch Colon<br>Insufflator |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The E-Z-EM PROTOCO₂L<br>COLON Insufflator<br>administers and regulates<br>carbon dioxide (CO₂) as a<br>distention media to the colon<br>during CT Colonography<br>(CTC or Virtual<br>Colonoscopy) and<br>conventional Colonoscopy. | The E-Z-EM PROTOCO₂L<br>COLON Insufflator<br>administers and regulates<br>carbon dioxide (CO₂) as a<br>distention media to the colon<br>during CT Colonography<br>(CTC or Virtual<br>Colonoscopy) and<br>conventional Colonoscopy. | The PROTOCO₂L Touch<br>Colon Insufflator is designed<br>to administer and regulate<br>CO₂ as a distention media to<br>the colon during Computed<br>Tomography Colonography<br>(CTC or Virtual<br>Colonoscopy). |
| Design Approach | Electro-mechanical<br>pneumatic system to regulate<br>CO₂ flow and pressure. | Electro-mechanical<br>pneumatic system to regulate<br>CO₂ flow and pressure. | Same as predicates |
| Anatomical Sites | Rectal administration of CO₂<br>via enema tip or catheter<br>lumen | Rectal administration of CO₂<br>via enema tip or catheter<br>lumen | Same as predicates. |
| Location of Unit | Located next to CT gantry. | Located next to CT gantry. | Same as predicates. |

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### 510(k) Premarket Notification Bracco Diagnostics Inc. PROTOCO2L Touch Colon Insufflator 510(k) Summary

### Summary of Performance Testing:

| Sterilization and<br>Shelf-Life | The PROTOCO₂L Touch is not shipped sterile, and is not intended to<br>be sterilized by the user. Additionally, the PROTOCO₂L Touch does<br>not have a shelf life. Therefore, this section is not applicable. |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | Patient contact materials within the PROTOCO₂L Touch tubing set<br>were verified in accordance with:<br>• ISO 10993-1: 2009, Biological evaluation of medical devices - Part<br>1: Evaluation and testing within a risk management process.<br>Results indicated that the materials comply with the applicable<br>Standard. |
| Software Testing | The PROTOCO₂L Touch software was designed and developed<br>according to a robust software development process, and were<br>rigorously verified and validated.<br>Software information is provided in accordance with internal<br>requirements and the following guidance documents:<br>• FDA guidance: The content of premarket submissions for software<br>contained in medical devices, 11 May 05;<br>• FDA guidance: General principles of software validation; Final<br>guidance for industry and FDA staff, 11 Jan 02.<br>Test results indicate that the PROTOCO₂L Touch complies with its<br>predetermined specifications and the guidance documents. |
| Electrical Safety<br>Testing | The PROTOCO₂L Touch was tested for patient safety in accordance<br>with the following standards:<br>• IEC 60601-1: 2005, Medical electrical equipment – Part 1: General<br>requirements for basic safety and essential performance; and<br>• UL 60601-1: 2006, Medical Electrical Equipment, Part 1:<br>Particular Requirements for Safety.<br>Test results indicated that the PROTOCO₂L Touch complies with the<br>applicable Standards. |

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#### 510(k) Premarket Notification . Bracco Diagnostics Inc. PROTOCO2L Touch Colon Insufflator 510(k) Summary

| Electromagnetic<br>Compatibility<br>Testing | The PROTOCO₂L Touch was tested for EMC in accordance with the<br>following standard:<br>IEC 60601-1-2: 2007, Medical Electrical Equipment, Part 1: Part<br>1-2: General Requirements for Safety - Collateral Standard:<br>Electromagnetic Compatibility-Requirements and Tests | |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | Test results indicated that the PROTOCO₂L Touch complies with the<br>applicable Standard. | |
| Performance Testing<br>– Bench | The PROTOCO2L Touch was tested for performance in accordance<br>with internal requirements and the following standard:<br>IEC 62366: 2007, Medical devices - Application of usability<br>engineering to medical devices; and ISTA Procedure 3A – 2008, Packaged-Products for Parcel Delivery<br>System Shipments 70kg (150lb) or Less (standard, small, flat or<br>elongated) | |
| | Test results indicated that the PROTOCO₂L Touch complies with<br>internal requirements and the applicable Standard. | |
| Conclusion | Verification and validation activities were conducted to establish the<br>performance and safety characteristics of the device modifications<br>made to the PROTOCO2L Touch. The results of these activities<br>demonstrate that the PROTOCO₂L Touch is safe and effective when<br>used in accordance with its intended use and labeling. | |
| | Therefore, the PROTOCO₂L Touch is considered substantially<br>equivalent to the predicate device. | |

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an abstract caduceus, which is a symbol often associated with healthcare and medicine.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 14, 2014

Bracco Diagnostics, Inc. Tracey Alexander Director Regulatory Affairs 259 Prospect Plains Road, Building H Monroe Township, NJ 08831

Re: K132192

> Trade/Device Name: PROTOCO₂L Touch Colon Insufflator Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FCX Dated: January 16, 2014 Received: January 22, 2014

Dear Tracey Alexander,

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. 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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Page 2 - Tracey Alexander

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Herbert P. Lerner -S

for

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

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### Indications for Use

| 510(k) Number (if known): | K 132192 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | PROTOCO2L Touch Colon Insufflator |
| Indications for Use: | The PROTOCO2L Touch Colon Insufflator administers and<br>regulates CO2 as a distention media to the colon during<br>Computed Tomography Colonography (CTC or Virtual<br>Colonoscopy). |

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

#### Herbert Baller 2014.02.174114:06: 17 -05'00'