The CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET is intended to connect a CO2 source (insufflator), and a sterile water source (water bottle), to an endoscope to supply CO2 during gastrointestinal endoscopic procedures.

Device Description

The Bracco Diagnostics Inc. (BDI) CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET (ILTS) is intended for use with BDI CO2 Endoscopic Insufflators and OEM endoscope systems, in this specific case the Olympus® 140, 160, 180, and 190 series endoscopes. The ILTS is supplied sterilized using Gamma radiation to a Sterility Assurance Level (SAL) of 10-6. The ILTS is individually packaged At the time of this submission, accelerated aging tests confirmed a one (1) year shelf life.

AI/ML Overview

The provided text describes the acceptance criteria and the studies conducted for the "Bracco Diagnostics, Inc. CO2 Endoscopic Insufflator In Line Tubing Set (ILTS)."

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Sterilization	Sterility Assurance Level (SAL) of 10^-6 in accordance with ISO 11137-1:2006 and ISO 11137-2:2006.	Verified to a sterility assurance level of 10^-6. Complies with ISO 11137-1:2006 and ISO 11137-2:2006.
Packaging	Packaging validated in accordance with ISO 11607-1:2006 (requirements for materials, sterile barrier systems, and packaging systems) and ISO 11607-2:2006 (validation requirements for forming, sealing, and assembly processes).	Verification results indicate that the ILTS packaging complies with the standards.
Shelf-Life	Initially, a shelf life of at least one (1) year. (Based on accelerated aging tests).	Accelerated aging tests confirmed a one (1) year shelf life.
Biocompatibility	Patient contact materials verified in accordance with ISO 10993-1:2009 (Biological evaluation of medical devices - Part I: Evaluation and testing within a risk management process).	Verification results indicated that the ILTS patient contact materials comply with the standard.
Performance Testing	Predetermined specifications for: - Device compatibility - Usability - Environmental - Delivery flow rate - Delivery pressure - Leakage - Mechanical integrity - Shipping and transportation - Labeling	Test results indicate that the ILTS complies with its predetermined specification for all listed performance parameters (device compatibility, usability, environmental, delivery flow rate, delivery pressure, leakage, mechanical integrity, shipping and transportation, and labeling).

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

The document does not explicitly state the sample sizes used for each specific test (e.g., sterilization validation, biocompatibility, performance testing). Instead, it refers to "verification results" and "test results" indicating compliance with standards.

The data provenance is not specified regarding country of origin or whether studies were retrospective or prospective. Given the nature of a 510(k) submission for a medical device accessory, these would typically be internal laboratory tests and validations rather than clinical studies with patient data.

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

This information is not applicable to this type of device and study. The "ground truth" for a medical tubing set's performance is established by objective engineering and scientific standards (e.g., sterility, biocompatibility, flow rates) rather than expert clinical consensus or interpretation of subjective data.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in studies involving expert interpretation, such as image reading or clinical assessments, to resolve discrepancies. This is not relevant for the objective performance testing described for this device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret output (e.g., medical images) with and without AI assistance. The "LINE TUBING SET" is a hardware accessory, not a diagnostic AI tool.

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

This question is not applicable. The device is a physical tubing set, not an algorithm. The performance testing described (sterilization, shelf-life, biocompatibility, device compatibility, flow rate, etc.) constitutes its standalone performance assessment.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

International Standards: e.g., ISO 11137 for sterilization, ISO 11607 for packaging, ISO 10993-1 for biocompatibility.
Predetermined Specifications: Internal engineering specifications for performance parameters like delivery flow rate, delivery pressure, leakage, and mechanical integrity.

8. The Sample Size for the Training Set

This is not applicable. The ILTS is a passive medical device accessory, not an AI/ML algorithm that requires a training set.

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

This is not applicable as there is no training set for this device.

Summary

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K123047 pg 1 of 4

510(k) Summary

Submission Date:
------------------	--

26 September 2012

Submitter:

Bracco Diagnostics, Inc. 107 College Road Princeton, NJ 08540 USA

Submitter and Official Contact:

Bracco Diagnostics Inc. 532 Broadhollow Road, Suite 126 Melville, NY 11747

Ms. Tracey Alexander Director Regulatory Affairs Phone: +1 (609) 524-2865 Fax: +1 (631) 847-3904 Email: tracey.alexander@diag.bracco.com

Trade Name:

LINE TUBING SET

Common Name: Tubing Set

Classification Name: Endoscope and accessories

Classification 21 CFR §876.1500 Regulation:

Product Code: FCX, FDS

Substantially Equivalent Devices: BDI Model

Predicate 510(k) Number

K954451

Bracco Diagnostics, Inc. CO2 ENDOSCOPIC INSUFFLATOR IN

. K053008 Bracco Diagnostics, Inc. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET

Predicate Manufacturer and Model

AUG 0 6 2013

E-Z-EM, Inc. (now BDI) CO2 Efficient Endoscopic Insufflator

Olympus America, Inc. EVIS 140 System (MH-970 Water Container Accessory)

Page I of 4

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K123047

pg 2 of 4

Device Description:	The Bracco Diagnostics Inc. (BDI) CO2 ENDOSCOPICINSUFFLATOR IN LINE TUBING SET (ILTS) is intended for usewith BDI CO2 Endoscopic Insufflators and OEM endoscope systems, inthis specific case the Olympus® 140, 160, 180, and 190 seriesendoscopes.
	The ILTS is supplied sterilized using Gamma radiation to a SterilityAssurance Level (SAL) of 10-6.
	The ILTS is individually packaged At the time of this submission,accelerated aging tests confirmed a one (1) year shelf life.
Intended Use:	The CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET isintended to connect a CO2 source (insufflator), and a sterile watersource (water bottle), to an endoscope to supply CO2 duringgastrointestinal endoscopic procedures.
TechnologyComparison:	The ILTS employs the same technological characteristics as thepredicate devices.
CharacteristicComparisons:	E-Z-EM, Inc.(Bracco Diagnostics, Inc.)CO2 ENDOSCOPICINSUFFLATOR Tubing Set(K053008)	Olympus MH-970Water Container(Accessory within theOlympus EVIS 140 VideoEndoscopy System)(K954451)	Bracco Diagnostics, Inc.CO2 ENDOSCOPICINSUFFLATORIN LINE TUBING SET
Intended Use	The CO2 ENDOSCOPICINSUFFLATOR IN LINETUBING SET is intendedto be used with a CO2source and insufflator,along with a sterile watersource, to supply CO2 andsterile water to anendoscope duringgastrointestinalendoscopic procedures.	The Olympus MH-970Water Container isintended to be used with aCO2 source andinsufflator, along with asterile water source, tosupply CO2 and sterilewater to an endoscopeduring endoscopicprocedures.	The CO2ENDOSCOPICINSUFFLATOR INLINE TUBING SETis intended to connecta CO2 source(insufflator), and asterile water source(water bottle), to anendoscope to supplyCO2 duringgastrointestinalendoscopicprocedures.
Compatibility	Connects to OEMendoscope systems thatare equipped with anexternal CO2 luerconnector.	Connects to Olympus®140, series endoscopes.	Same for both predicates
Sterility Method	Non-sterile.	Glutaraldehyde;Autoclavable(Provided non-sterile)	Radiation(Provided sterile)
Sterility Assurance Level	Not applicable	Unknown	10-6
Disposable or Reusable	Disposable	Reusable	Disposable
Packaging	Poly bag	Unknown	10" x 14" Tyvek ®,peelable pouch or similar
Shelf-Life	Six (6) years	Unknown	One (1) year initially

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Performance Testing:

Sterilization

Shelf-Life

The ILTS is gamma radiation sterilized and was validated to a sterility assurance level of 106 in accordance with the following standards:

· ISO 11137-1: 2006, Sterilization of health care products -Requirements for validation and routine control – Radiation sterilization; and
ISO 11137-2:2006 (currently under revision), Sterilization of health . care products -- Radiation -- Part 2: Establishing the sterilization dose.

Verification results indicate that the ILTS complies with the standards.

The ILTS is sterilized and its packaging was validated in accordance with the following standards:

ISO 11607-1: 2006 Packaging for terminally sterilized medical . devices - Part 1 : requirements for materials, sterile barrier systems and packaging systems; and
. ISO 11607-2: 2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes.

Verification results indicate that the ILTS complies with the standards.

Biocompatibility

ILTS patient contact materials were verified in accordance with the following standard:

. ISO 10993-1: 2009, Biological evaluation of medical devices - Part I : Evaluation and testing within a risk management process.
Verification results indicated that the ILTS patient contact materials comply with the standard.

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K123047 pg 4 of 4

The ILTS was tested for performance in accordance with its Performance Testing predetermined specifications. Testing included: – Bench

. Device compatibility;
Usability; .
Environmental; .
Delivery flow rate; .
. Delivery pressure;
. Leakage;
. Mechanical integrity;
Shipping and transportation; and .
. Labeling.

Test results indicate that the ILTS complies with its predetermined specification.

Verification and validation activities were conducted to establish the Conclusion performance and safety characteristics of the ILTS. The results of these activities demonstrate that the ILTS is safe and effective when used in accordance with its intended use and labeling.

Therefore, the ILTS is considered substantially equivalent to the predicate devices.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

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

August 6, 2013

Bracco Diagnostics, Inc. % Tracey Alexander Director Regulatory Affairs 532 Broadhollow Road, Suite 126 Melville, NY 11747

Re: K123047

Trade/Device Name: Bracco Diagnostics, Inc. CO2ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FCX, FDS Dated: July 12, 2013 Received: July 26, 2013

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 10 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warrantics. 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.

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Page 2 - Tracey Alexander

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 (reporting of medical device-related 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 contact 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/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/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 123047 Device Name: Bracco Diagnostics, Inc. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET Indications for Use: The CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET is intended to connect a CO2 source (insufflator), and a sterile water source (water bottle), to an endoscope to supply CO2 during gastrointestinal endoscopic procedures.

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 P. Lerner -S

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K123047 510(k) Number _

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.