Balloon BS-3 is intended to be used in combination with FUJIFILM double balloon endoscopes to assist with insertion inside the upper or lower digestive tract at medical facilities under the management of physicians.

Do not use this product for any other purpose. It is not intended for use for any neonates, infants or children.

Device Description

Balloon BS-3 is a pre-sterilized, single-use accessory used for fixing the endoscope in the body cavity. The device is fixed at the tip or bending portion of the endoscope and is inflated by filling air from the operation part of the endoscope with a special pump. The device is used for a natural opening of the human body to perform enlargement of a lumen, coelom or body cavity in order to enable and facilitate insertion of the endoscope.

AI/ML Overview

This is a 510(k) summary for a medical device called "Balloon BS-3," an endoscopic accessory. The document does not describe an AI/ML device, therefore, the requested information about acceptance criteria and studies for an AI/ML device is not applicable.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Balloon BS-2) through comparison of technological characteristics and performance data related to sterility, biocompatibility, and inflation rate.

Here's an overview of the information provided in the document:

Device Name: Balloon BS-3
Intended Use: To be used in combination with FUJIFILM double balloon endoscopes to assist with insertion inside the upper or lower digestive tract. Not for neonates, infants, or children.
Predicate Device: Balloon BS-2 (K143556)

Performance Data and Conclusions:

The document states that the following tests were conducted:

Sterility: Evaluated using ISO 11135:2014 and ASTM F1980-16.
Biocompatibility: Evaluated using ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-7:2008, ISO 10993-10:2010.
Comparative bench testing: Conducted on the subject and predicate devices to evaluate the rate of inflation.
Additional evaluation: The subject device was additionally evaluated against ISO 8600-1:2015.

The overall conclusion is that "Bench testing demonstrates that the subject device is as safe and effective as the predicate device. Thus, Balloon BS-3 is substantially equivalent to the listed predicate device."

Summary

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October 29, 2021

FUJIFILM Corporation % Jeffrey Wan Manager, Regulatory Affairs FUJIFILM Healthcare Americas Corporation 81 Hartwell Avenue, Suite 300 Lexington, MS 02421

Re: K213195 Trade/Device Name: Balloon BS-3 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FDA Dated: September 29, 2021 Received: September 29, 2021

Dear Jeffrey Wan:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213195

Device Name

Balloon BS-3

Indications for Use (Describe)

Do not use this product for any other purpose. It is not intended for use for any neonates, infants or children.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY FUJIFILM Corporation Balloon BS-3 K213195

Date: October 18, 2021

Submitter's Information:

FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-Gun, Kanagawa, 258-8538, Japan

Contact Person:

Jeffrey Wan Manager, Regulatory Affairs Telephone: (201) 675-8947 E-Mail: jeffrey.wan@fujifilm.com

Identification of the Proposed Device:

Device Name:	Balloon BS-3
Common Name:	Endoscopic Accessory
Device Class:	Class II
Classification Number:	21 C.F.R. § 876.1500
Classification Name:	Endoscope and accessories
Device Panel:	Gastroenterology/Urology
Product Code:	FDA

Predicate Devices:

Balloon BS-2 (K143556) ●

Intended Use / Indications for Use

Do not use this product for any other purpose. It is not intended for use for any neonates, infants or children.

Device Description

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human body to perform enlargement of a lumen, coelom or body cavity in order to enable and facilitate insertion of the endoscope.

Comparison of Technological Characteristics

A comparison of technological characteristics between BS-3 and the predicate BS-2 is provided below:

	Subject DeviceBS-3	Predicate DeviceBS-2
510(k) number	To be assigned	K143556
Product code	FDA	FDA
Manufacturer	FUJIFILM Corporation	FUJIFILM Corporation
Intended Use	This product is intended to be used in combinationwith FUJIFILM double balloon endoscopes toassist with insertion inside the upper or lowerdigestive tract at medical facilities under themanagement of physicians.Do not use this product for any other purpose. It isnot intended for use for any neonates, infants orchildren.	The balloon is intended to beused in combination with DoubleBalloon Endoscopes to assistwith insertion inside the upper orlower digestive tract. Thisproduct is not intended for usefor any neonates, infants orchildren.
Outer diameter	35mm	35mm
Film thickness	0.10mm	0.10mm
Working length	40mm	40mm
Total length	60mm	60mm
Compatibleendoscopes	EN-580TEl-580BT	EN-450P5/20EN-450T5EC-450BI5EN-580TEl-580BT
Sterile method	EO	Non sterile
Single use	Yes	Yes

Performance Data

Sterility of the subject devices was evaluated using the following consensus standards: ISO 11135:2014 and ASTM F1980-16.

Biocompatibility of the subject device was evaluated using the following consensus standards:

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ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-7:2008, ISO 10993-10:2010. Biocompatibility testing was performed in accordance with FDA's guidance, "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," published September 4, 2020.

Comparative bench testing was conducted on the subject and predicate devices to evaluate the rate of inflation. The subject device was additionally evaluated against ISO 8600-1:2015.

Conclusions

The subject device Balloon BS-3 shares the same intended use and similar indications as the predicate device. Bench testing demonstrates that the subject device is as safe and effective as the predicate device. Thus, Balloon BS-3 is substantially equivalent to the listed predicate device.

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.