(214 days)
Not Found
No
The summary describes a device for administering CO2 during CTC and focuses on its mechanical and software validation for safety and performance, with no mention of AI or ML capabilities.
No.
The device is used to distend the colon for diagnostic imaging (Computed Tomography Colonography), not to treat a disease or condition.
No
The device administers and regulates CO2 as a distention media to the colon for Computed Tomography Colonography (CTC). It aids in diagnostic procedures by preparing the organ for imaging, but it does not perform the diagnosis itself.
No
The device description explicitly states it consists of two hardware components: the Colon Insufflator and the disposable Administration Set. The performance testing also includes electrical safety and electromagnetic compatibility testing, which are relevant to hardware components.
Based on the provided information, the PROTOCO₂L Touch Colon Insufflator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The device's intended use is to administer and regulate CO₂ as a distention media during a diagnostic procedure (Computed Tomography Colonography). It is a tool used to prepare the patient for the imaging, not a device that performs a test on a biological sample in vitro (outside the body).
- Device Description: The description confirms its function as an insufflator for colon distention during CTC.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with IVD devices. The performance testing focuses on safety, software, electrical compatibility, and mechanical performance, not on the accuracy or reliability of a diagnostic test result derived from a biological sample.
Therefore, the PROTOCO₂L Touch Colon Insufflator is a medical device used in conjunction with a diagnostic imaging procedure, but it is not an IVD itself.
N/A
Intended Use / Indications for 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).
Product codes (comma separated list FDA assigned to the subject device)
FCX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography Colonography (CTC or Virtual Colonoscopy)
Anatomical Site
colon
Rectal administration of CO₂ via enema tip or catheter lumen
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility: Patient contact materials within the PROTOCO₂L Touch tubing set were verified in accordance with ISO 10993-1: 2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. Results indicated that the materials comply with the applicable Standard.
Software Testing: The PROTOCO₂L Touch software was designed and developed according to a robust software development process, and were rigorously verified and validated. Software information is provided in accordance with internal requirements and the following guidance documents: FDA guidance: The content of premarket submissions for software contained in medical devices, 11 May 05; FDA guidance: General principles of software validation; Final guidance for industry and FDA staff, 11 Jan 02. Test results indicate that the PROTOCO₂L Touch complies with its predetermined specifications and the guidance documents.
Electrical Safety Testing: The PROTOCO₂L Touch was tested for patient safety in accordance with the following standards: IEC 60601-1: 2005, Medical electrical equipment – Part 1: General requirements 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 the applicable Standards.
Electromagnetic Compatibility Testing: The PROTOCO₂L Touch was tested for EMC in accordance with the following standard: IEC 60601-1-2: 2007, Medical Electrical Equipment, Part 1: Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility-Requirements and Tests. Test results indicated that the PROTOCO₂L Touch complies with the applicable Standard.
Performance Testing – Bench: The PROTOCO2L Touch was tested for performance in accordance with internal requirements and the following standard: IEC 62366: 2007, Medical devices - Application of usability engineering to medical devices; and ISTA Procedure 3A – 2008, Packaged-Products for Parcel Delivery System Shipments 70kg (150lb) or Less (standard, small, flat or elongated). Test results indicated that the PROTOCO₂L Touch complies with internal requirements and the applicable Standard.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 H | |||
| Monroe Township, NJ 08831 USA | |||
| Submitter and | |||
| Official Contact: | Ms. Tracey Alexander | ||
| Director 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 | ||
| Classification | |||
| Regulation: | 21 CFR §876.1500 | ||
| Product Code: | FCX | ||
| Substantially | |||
| Equivalent Devices: | New BDI Model | Predicate | |
| 510(k) Number | Predicate | ||
| Manufacturer / Model | |||
| Bracco Diagnostics Inc. | |||
| PROTOCO₂L Touch | |||
| Colon Insufflator | K030854 | E-Z-EM, Inc. (now BDI) | |
| PROTOCO₂L Colon | |||
| Insufflator with | |||
| Performance | |||
| Improvements | |||
| K013219 | E-Z-EM, Inc. (now BDI) | ||
| PROTOCO₂L Colon |
Insufflator.
1
510(k) Premarket Notification Bracco Diagnostics Inc. PROTOCO2L Touch Colon Insufflator 510(k) Summary
| Device Description: | 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. |
| 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). |
The PROTOCO2L Touch employs the same technological Technology characteristics as the predicate devices. Compurison:
| Characteristic
Comparisons: | E-Z-EM, Inc.
PROTOCO₂L Colon
Insufflator Model 6400 | E-Z-EM, Inc.
PROTOCO₂L Colon
Insufflator with
Performance Improvements | Bracco Diagnostics Inc.
PROTOCO₂L Touch Colon
Insufflator |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The E-Z-EM PROTOCO₂L
COLON Insufflator
administers and regulates
carbon dioxide (CO₂) as a
distention media to the colon
during CT Colonography
(CTC or Virtual
Colonoscopy) and
conventional Colonoscopy. | The E-Z-EM PROTOCO₂L
COLON Insufflator
administers and regulates
carbon dioxide (CO₂) as a
distention media to the colon
during CT Colonography
(CTC or Virtual
Colonoscopy) and
conventional Colonoscopy. | The PROTOCO₂L Touch
Colon Insufflator is designed
to administer and regulate
CO₂ as a distention media to
the colon during Computed
Tomography Colonography
(CTC or Virtual
Colonoscopy). |
| Design Approach | Electro-mechanical
pneumatic system to regulate
CO₂ flow and pressure. | Electro-mechanical
pneumatic system to regulate
CO₂ flow and pressure. | Same as predicates |
| Anatomical Sites | Rectal administration of CO₂
via enema tip or catheter
lumen | Rectal administration of CO₂
via enema tip or catheter
lumen | Same as predicates. |
| Location of Unit | Located next to CT gantry. | Located next to CT gantry. | Same as predicates. |
2
510(k) Premarket Notification Bracco Diagnostics Inc. PROTOCO2L Touch Colon Insufflator 510(k) Summary
Summary of Performance Testing:
| Sterilization and
Shelf-Life | The PROTOCO₂L Touch is not shipped sterile, and is not intended to
be sterilized by the user. Additionally, the PROTOCO₂L Touch does
not have a shelf life. Therefore, this section is not applicable. |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | Patient contact materials within the PROTOCO₂L Touch tubing set
were verified in accordance with:
• ISO 10993-1: 2009, Biological evaluation of medical devices - Part
1: Evaluation and testing within a risk management process.
Results indicated that the materials comply with the applicable
Standard. |
| Software Testing | The PROTOCO₂L Touch software was designed and developed
according to a robust software development process, and were
rigorously verified and validated.
Software information is provided in accordance with internal
requirements and the following guidance documents:
• FDA guidance: The content of premarket submissions for software
contained in medical devices, 11 May 05;
• FDA guidance: General principles of software validation; Final
guidance for industry and FDA staff, 11 Jan 02.
Test results indicate that the PROTOCO₂L Touch complies with its
predetermined specifications and the guidance documents. |
| Electrical Safety
Testing | The PROTOCO₂L Touch was tested for patient safety in accordance
with the following standards:
• IEC 60601-1: 2005, Medical electrical equipment – Part 1: General
requirements 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 the
applicable Standards. |
3
510(k) Premarket Notification . Bracco Diagnostics Inc. PROTOCO2L Touch Colon Insufflator 510(k) Summary
| Electromagnetic
Compatibility
Testing | The PROTOCO₂L Touch was tested for EMC in accordance with the
following standard:
IEC 60601-1-2: 2007, Medical Electrical Equipment, Part 1: Part
1-2: General Requirements for Safety - Collateral Standard:
Electromagnetic Compatibility-Requirements and Tests | |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | Test results indicated that the PROTOCO₂L Touch complies with the
applicable Standard. | |
| Performance Testing
– Bench | The PROTOCO2L Touch was tested for performance in accordance
with internal requirements and the following standard:
IEC 62366: 2007, Medical devices - Application of usability
engineering to medical devices; and ISTA Procedure 3A – 2008, Packaged-Products for Parcel Delivery
System Shipments 70kg (150lb) or Less (standard, small, flat or
elongated) | |
| | Test results indicated that the PROTOCO₂L Touch complies with
internal requirements and the applicable Standard. | |
| Conclusion | Verification and validation activities were conducted to establish the
performance and safety characteristics of the device modifications
made to the PROTOCO2L Touch. The results of these activities
demonstrate that the PROTOCO₂L Touch is safe and effective when
used in accordance with its intended use and labeling. | |
| | Therefore, the PROTOCO₂L Touch is considered substantially
equivalent to the predicate device. | |
.
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4
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.
5
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
6
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 |
| regulates CO2 as a distention media to the colon during | |
| Computed Tomography Colonography (CTC or Virtual | |
| 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)