BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR by BRACCO DIAGNOSTIC, INC.

The Bracco Diagnostics, Inc. (BDI) CO2MPACT ENDOSCOPIC INSUFFLATOR™ is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.

The BDI CO2MPACT ENDOSCOPIC INSUFFLATOR™ allows the physician to modulate and control the CO2 to the patient in an identical manner to that being done currently with room air which is supplied by an air pump in the light source of the endoscopic equipment.

Device Description

The Bracco Diagnostics, Inc. (BDI), CO2MPACT ENDOSCOPIC INSUFFLATOR™ (CO2MPACT) is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope. The BDI CO2MPACT regulates CO2 flow rate and pressure during the insufflation process.

The BDI CO2MPACT allows the physician to modulate and control the CO2 to the patient in an identical manner to that being done currently with room air which is supplied by an air pump in the light source of the endoscopic equipment.

Consistent with the predicate devices, the BDI CO2MPACT is used to administer CO2 to the patient for distention purposes. For this application, the actual displacement of CO2 to the patient through the endoscope is controlled by the clinician modulating an "air-water" valve on the endoscope. The BDI CO2MPACT only provides source pressure and flow to the endoscope in a similar manner to the predicates BDI CO2Efficient Endoscopic Insufflator (K053008) and Olympus UCR Endoscopic CO2 Regulation Unit (K081173), or the internal air pump included within the endoscope light source.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Bracco Diagnostics, Inc. CO2MPACT ENDOSCOPIC INSUFFLATOR™:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicitly based on stated tests and standards)	Reported Device Performance
Performance Testing	Compliance with internal requirements and applicable standards for controlling CO2 flow rate and pressure for gastrointestinal distention.	The BDI CO2MPACT complies with its predetermined specification and with the applicable Standards.
Biocompatibility	Patient contact materials (within device and tubing set) perform according to ISO 10993-1: 2009.	Verification results indicated that the materials comply with predetermined specifications.
Software Testing	Software modifications designed/developed according to robust software development process, verified, and validated (following FDA guidance: "Content of premarket submissions for software contained in medical devices," "Off-the-shelf software use in medical devices," "General principles of software validation;" and IEC 60601-1-4: 2000).	Test results indicate that the BDI CO2MPACT complies with its predetermined specification.
Electrical Safety	Patient safety complies with IEC 60601-1: 1988 (Am1: 1991, Am2: 1995) and UL 60601-1: 2006.	Test results indicated that the BDI CO2MPACT complies with applicable Standards.
Electromagnetic Compatibility (EMC)	EMC complies with IEC 60601-1-2: 2007.	Test results indicated that the BDI CO2MPACT complies with applicable Standards.
Conclusion of Equivalence	Device demonstrated to be safe and effective for its intended use and substantially equivalent to predicate device.	Verification and validation activities... demonstrate that the BDI CO2MPACT is safe and effective when used in accordance with its intended use and labeling. Therefore, the BDI CO2MPACT is considered substantially equivalent to the predicate device.

2. Sample Size Used for the Test Set and the Data Provenance

The provided text does not specify a sample size for a test set in the context of clinical data or patient studies. The testing described is primarily bench testing, software verification/validation, and compliance with recognized standards (electrical safety, EMC, biocompatibility).

The data provenance is internal testing by Bracco Diagnostics, Inc. on the device itself and its components. There is no mention of external data or patient data, nor is there any indication of retrospective or prospective data collection from human subjects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable or not provided in the submission. The "ground truth" for the tests described relates to compliance with engineering standards and internal specifications, which would be established by the engineering and quality control teams at Bracco Diagnostics, Inc., rather than clinical experts establishing ground truth for diagnostic accuracy.

4. Adjudication Method for the Test Set

This information is not applicable or not provided. Since the testing is primarily objective measurements against specifications and standards, a clinical adjudication method (like 2+1, 3+1 concensus) is not relevant to the studies described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This device is a CO2 insufflator, a physical medical device, not an AI or imaging diagnostic tool. Therefore, questions regarding human reader improvement with or without AI assistance are not relevant to this submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm study was not done. As mentioned, this is a physical medical device, not a software algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" used for evaluating the device's performance was predetermined specifications and applicable engineering/medical device standards (e.g., ISO, IEC, UL, FDA guidances for software). This is not a clinical ground truth like pathology, expert consensus on images, or patient outcomes data.

8. The Sample Size for the Training Set

This information is not applicable or not provided. There is no mention of a "training set" as this device does not involve machine learning or AI that would require such a set. Any "development" or "design" process for the device refers to engineering and software development, not model training.

9. How the Ground Truth for the Training Set was Established

This information is not applicable or not provided for the reasons stated in point 8.

Summary

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K111648

Page 1 of 4

NOV - 3 2011

. . . . .

Submission Date:	06 June 2011
Submitter:	Bracco Diagnostics, Inc.532 Broadhollow Road, Suite 126Melville, NY 11747 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. CO2MPACT ENDOSCOPICINSUFFLATOR™
Common Name:	CO2 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.CO2MPACT ENDOSCOPICINSUFFLATOR™	K053008	E-Z-EM, Inc. (now BDI)/ CO2EfficientEndoscopic Insufflator
		K081173	Olympus MedicalSystems, Corp. / UCREndoscopic CO2Regulation Unit

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K 111648
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The Bracco Diagnostics, Inc. (BDI), CO2MPACT ENDOSCOPIC Device Description: INSUFFLATOR™ (CO2MPACT) is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope. The BDI CO2MPACT regulates CO2 flow rate and pressure during the insufflation process.

The BDI CO2MPACT allows the physician to modulate and control the CO2 to the patient in an identical manner to that being done currently with room air which is supplied by an air pump in the light source of the endoscopic equipment.

Consistent with the predicate devices, the BDI CO2MPACT is used to administer CO2 to the patient for distention purposes. For this application, the actual displacement of CO2 to the patient through the endoscope is controlled by the clinician modulating an "air-water" valve on the endoscope. The BDI CO2MPACT only provides source pressure and flow to the endoscope in a similar manner to the predicates BDI CO2Efficient Endoscopic Insufflator (K053008) and Olympus UCR Endoscopic CO2 Regulation Unit (K081173), or the internal air pump included within the endoscope light source.

Intended Use:

Technology Comparison: The BDI CO2MPACT employs the same technological characteristics as the predicate devices.

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K/// 648
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Summary of Performance Testing:

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Performance Testing	The BDI CO2MPACT was tested for performance in accordance withinternal requirements.
	Test results indicated that the BDI CO2MPACT complies with itspredetermined specification and with the applicable Standards.
BiocompatibilityVerification	Patient contact materials within the BDI CO2MPACT and the tubingset was verified for performance in accordance with:
	• ISO 10993-1: 2009, Biological evaluation of medical devices – Part1: Evaluation and testing within a risk management process.
	Verification results indicated that the materials comply withpredetermined specifications.
Software Testing	Software device modifications made to the BDI CO2MPACT weredesigned and developed according to a robust software developmentprocess, and were rigorously verified and validated.
	Software information is provided in accordance with:
	• FDA guidance: The content of premarket submissions for softwarecontained in medical devices, 11 May 05;
	• FDA guidance: Off-the-shelf software use in medical devices, 09Sep 99;
	• FDA guidance: General principles of software validation; Finalguidance for industry and FDA staff, 11 Jan 02; and
	• IEC 60601-1-4: 2000, Medical electrical equipment – Part 1-4:General requirements for safety - Collateral standard:Programmable electrical medical systems.
	Test results indicate that the BDI CO2MPACT complies with itspredetermined specification.

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K 111648

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Special 510(k) Premarket Notification Bracco Diagnostics, Inc. CO2MPACT ENDOSCOPIC INSUFFLATOR™ 510(k) Summarv

Electrical Safety The BDI CO2MPACT was tested for patient safety in accordance with: Testing . IEC 60601-1: 1988, Am1: 1991, Am2: 1995, Medical Electrical Equipment, Part 1: General Requirements for Safety; and . UL 60601-1: 2006, Medical Electrical Equipment, Part 1: Particular Requirements for Safety. Test results indicated that the BDI CO2MPACT complies with applicable Standards. Electromagnetic The BDI CO2MPACT was tested for EMC in accordance with: Compatibility IEC 60601-1-2: 2007, Medical Electrical Equipment, Part 1: Part . Testing 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility-Requirements and Tests Test results indicated that the BDI CO2MPACT complies with applicable Standards. Performance Testing The BDI CO2MPACT was tested for performance in accordance with - Bench internal requirements. Test results indicated that the BDI CO2MPACT complies with applicable Standards. Conclusion Verification and validation activities were conducted to establish the performance and safety characteristics of the device modifications made to the BDI CO2MPACT. The results of these activities demonstrate that the BDI CO2MPACT is safe and effective when used in accordance with its intended use and labeling. Therefore, the BDI CO2MPACT is considered substantially equivalent to the predicate device.

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

Ms. Tracev Alexander Director Regulatory Affairs Bracco Diagnostics, Inc. 532 Broadhollow Road, Suite 126 MELVILLE NY 11747

NOV - 3 2011

Re: K111648

Trade/Device Name: Bracco Diagnostics, Inc. CO2MPACT ENDOSCOPIC INSUFFLATOR™ Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FCX Dated: October 14, 2011 Received: October 20, 2011

Dear Ms. 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. 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

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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.

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,

Hubert Lenoir MD

Herbert P. Lerner, M.D., Director (Acting) 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

K/11448

510(k) Number (if known):

Device Name:

Indications for Use:

Bracco Diagnostics, Inc. CO2MPACT ENDOSCOPIC INSUFFLATOR™

Over-The-Counter Use

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

(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 Lehman

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K111648

Page 1 of 1

Regulation Number and Section

§ 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.