(214 days)
The PROTOCO₂L Touch Colon Insufflator administers and regulates CO₂ as a distention media to the colon during Computed Tomography Colonography (CTC or Virtual Colonoscopy).
The Bracco Diagnostics Inc. (BDI) PROTOCO₂L Touch Colon Insufflator (PROTOCO₂L Touch) administers and regulates CO₂ as a distention media to the colon during Computed Tomography Colonography (CTC or Virtual Colonoscopy). Insufflation during CTC is used to distend the colon with uniform pressure in order to properly 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.
The provided text describes a 510(k) Premarket Notification for the Bracco Diagnostics Inc. PROTOCO₂L Touch Colon Insufflator. This is a submission for a medical device that administers and regulates CO₂ for colon distention during CT Colonography, aiming to demonstrate substantial equivalence to existing predicate devices.
The document does not contain information about:
- Acceptance criteria and device performance in the context of diagnostic accuracy (e.g., sensitivity, specificity, AUC).
- Any details of a study involving a test set, data provenance, number or qualifications of experts, or adjudication methods for establishing ground truth for a test set.
- A multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
- A standalone performance study of an algorithm.
- The type of ground truth used (pathology, outcomes data, etc.) for any clinical performance evaluation.
- The sample size for a training set or how ground truth for a training set was established.
Instead, the performance testing described focuses on:
- Sterilization and Shelf-Life: Not applicable as the device is not shipped sterile and has no shelf life.
- Biocompatibility: Verification of patient contact materials within the tubing set against ISO 10993-1: 2009.
- Software Testing: Design and development based on a robust software development process, with verification and validation against internal requirements and FDA guidance documents ("The content of premarket submissions for software contained in medical devices," "General principles of software validation").
- Electrical Safety Testing: Compliance with IEC 60601-1: 2005 and UL 60601-1: 2006.
- Electromagnetic Compatibility (EMC) Testing: Compliance with IEC 60601-1-2: 2007.
- Performance Testing – Bench: Compliance with internal requirements, IEC 62366: 2007 (usability engineering), and ISTA Procedure 3A – 2008 (packaged-products for parcel delivery).
The conclusion states that these verification and validation activities demonstrate that the device is safe and effective and substantially equivalent to the predicate device.
Therefore, I cannot provide a table of acceptance criteria for diagnostic performance or details about a study evaluating such performance, as the provided text does not contain that information. The "acceptance criteria" and "device performance" in this context refer to engineering, safety, and software validation rather than diagnostic accuracy.
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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.259 Prospect Plains Road, Building HMonroe Township, NJ 08831 USA | ||
| Submitter andOfficial Contact: | Ms. Tracey AlexanderDirector Regulatory Affairs+1 (609) 524-2865+1 (631)-847-3904 (fax)tracey.alexander@diag.bracco.com | ||
| Trade Name: | Bracco Diagnostics Inc. PROTOCO₂L Touch Colon Insufflator | ||
| Common Name: | CO₂ Colon Insufflator | ||
| Classification Name: | Endoscope and accessories | ||
| ClassificationRegulation: | 21 CFR §876.1500 | ||
| Product Code: | FCX | ||
| SubstantiallyEquivalent Devices: | New BDI Model | Predicate510(k) Number | PredicateManufacturer / Model |
| Bracco Diagnostics Inc.PROTOCO₂L TouchColon Insufflator | K030854 | E-Z-EM, Inc. (now BDI)PROTOCO₂L ColonInsufflator withPerformanceImprovements | |
| K013219 | E-Z-EM, Inc. (now BDI)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 ColonInsufflator (PROTOCO₂L Touch) administers and regulates CO₂ as adistention media to the colon during Computed TomographyColonography (CTC or Virtual Colonoscopy). Insufflation during CTCis used to distend the colon with uniform pressure in order to properlypresent 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 regulatesCO₂ as a distention media to the colon during Computed TomographyColonography (CTC or Virtual Colonoscopy). |
The PROTOCO2L Touch employs the same technological Technology characteristics as the predicate devices. Compurison:
| CharacteristicComparisons: | E-Z-EM, Inc.PROTOCO₂L ColonInsufflator Model 6400 | E-Z-EM, Inc.PROTOCO₂L ColonInsufflator withPerformance Improvements | Bracco Diagnostics Inc.PROTOCO₂L Touch ColonInsufflator |
|---|---|---|---|
| Indications for Use | The E-Z-EM PROTOCO₂LCOLON Insufflatoradministers and regulatescarbon dioxide (CO₂) as adistention media to the colonduring CT Colonography(CTC or VirtualColonoscopy) andconventional Colonoscopy. | The E-Z-EM PROTOCO₂LCOLON Insufflatoradministers and regulatescarbon dioxide (CO₂) as adistention media to the colonduring CT Colonography(CTC or VirtualColonoscopy) andconventional Colonoscopy. | The PROTOCO₂L TouchColon Insufflator is designedto administer and regulateCO₂ as a distention media tothe colon during ComputedTomography Colonography(CTC or VirtualColonoscopy). |
| Design Approach | Electro-mechanicalpneumatic system to regulateCO₂ flow and pressure. | Electro-mechanicalpneumatic system to regulateCO₂ flow and pressure. | Same as predicates |
| Anatomical Sites | Rectal administration of CO₂via enema tip or catheterlumen | Rectal administration of CO₂via enema tip or catheterlumen | 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 andShelf-Life | The PROTOCO₂L Touch is not shipped sterile, and is not intended tobe sterilized by the user. Additionally, the PROTOCO₂L Touch doesnot have a shelf life. Therefore, this section is not applicable. |
|---|---|
| Biocompatibility | Patient contact materials within the PROTOCO₂L Touch tubing setwere verified in accordance with:• ISO 10993-1: 2009, Biological evaluation of medical devices - Part1: Evaluation and testing within a risk management process.Results indicated that the materials comply with the applicableStandard. |
| Software Testing | The PROTOCO₂L Touch software was designed and developedaccording to a robust software development process, and wererigorously verified and validated.Software information is provided in accordance with internalrequirements and the following guidance documents:• FDA guidance: The content of premarket submissions for softwarecontained in medical devices, 11 May 05;• FDA guidance: General principles of software validation; Finalguidance for industry and FDA staff, 11 Jan 02.Test results indicate that the PROTOCO₂L Touch complies with itspredetermined specifications and the guidance documents. |
| Electrical SafetyTesting | The PROTOCO₂L Touch was tested for patient safety in accordancewith the following standards:• IEC 60601-1: 2005, Medical electrical equipment – Part 1: Generalrequirements for basic safety and essential performance; and• UL 60601-1: 2006, Medical Electrical Equipment, Part 1:Particular Requirements for Safety.Test results indicated that the PROTOCO₂L Touch complies with theapplicable Standards. |
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510(k) Premarket Notification . Bracco Diagnostics Inc. PROTOCO2L Touch Colon Insufflator 510(k) Summary
| ElectromagneticCompatibilityTesting | The PROTOCO₂L Touch was tested for EMC in accordance with thefollowing standard:IEC 60601-1-2: 2007, Medical Electrical Equipment, Part 1: Part1-2: General Requirements for Safety - Collateral Standard:Electromagnetic Compatibility-Requirements and Tests | |
|---|---|---|
| Test results indicated that the PROTOCO₂L Touch complies with theapplicable Standard. | ||
| Performance Testing– Bench | The PROTOCO2L Touch was tested for performance in accordancewith internal requirements and the following standard:IEC 62366: 2007, Medical devices - Application of usabilityengineering to medical devices; and ISTA Procedure 3A – 2008, Packaged-Products for Parcel DeliverySystem Shipments 70kg (150lb) or Less (standard, small, flat orelongated) | |
| Test results indicated that the PROTOCO₂L Touch complies withinternal requirements and the applicable Standard. | ||
| Conclusion | Verification and validation activities were conducted to establish theperformance and safety characteristics of the device modificationsmade to the PROTOCO2L Touch. The results of these activitiesdemonstrate that the PROTOCO₂L Touch is safe and effective whenused in accordance with its intended use and labeling. | |
| Therefore, the PROTOCO₂L Touch is considered substantiallyequivalent 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 (800) 638-2041 or (301) 796-7100 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 andregulates CO2 as a distention media to the colon duringComputed Tomography Colonography (CTC or VirtualColonoscopy). |
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'
§ 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.