JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve

K210625 · Fujifilm Medwork GmbH · ODC · Sep 10, 2021 · Gastroenterology, Urology

Device Facts

• Record ID: K210625
• Device Name: JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve
• Applicant: Fujifilm Medwork GmbH
• Product Code: ODC · Gastroenterology, Urology
• Decision Date: Sep 10, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The JAZZ Disposable Valve Kit is comprised of the JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve. The JAZZ Suction Valve is intended to control the suction (aspiration of air and fluids) of a FUIFILM gastrointestinal endoscope during endoscopy procedures. The JAZZ Air/Water Valve is intended to control air of a FUJIFILM gastrointestinal endoscope for insufflations and water delivery (for distal lens cleaning) during endoscopy procedures. The JAZZ Forceps Valve is intended to facilitate passage of an endotherapy device, to prevent a leak or backflow of air and/or fluids, and to enable the suction function of a FUJIFILM gastrointestinal endoscope.

Device Story

JAZZ Disposable Valve Kit consists of three single-use, sterile valves (Suction, Air/Water, Forceps) designed for FUJIFILM G7 gastrointestinal endoscopes. Valves replace reusable components, eliminating manual cleaning/reprocessing. Suction valve controls aspiration of air/fluids; Air/Water valve manages insufflation and lens cleaning; Forceps valve seals biopsy port to prevent leakage while allowing instrument passage. Used in clinical endoscopy settings by physicians/endoscopy staff. Output is mechanical control of endoscope functions; benefits include reduced cross-contamination risk and simplified workflow via single-use design.

Clinical Evidence

No clinical data. Bench testing only. Evaluated per ISO 10993 (biocompatibility) and ISO 11135/11607 (sterility). Functional testing included suction pressure, insufflation/flushing pressure, tightness, functional life, and endoscope compatibility. Validated for backflow prevention per FDA guidance on cross-contamination.

Technological Characteristics

Single-use, sterile (EO) valves. Materials evaluated per ISO 10993. Mechanical operation via spring-loaded mechanisms. Designed for specific compatibility with FUJIFILM G7 series GI endoscopes. No software or electronic components.

Indications for Use

Indicated for use during gastrointestinal endoscopy procedures with FUJIFILM G7 series endoscopes to control suction, air/water insufflation, and facilitate endotherapy device passage.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• DEFENDO Disposable Suction Valve Model 100305 (K102581)
• DEFENDO Disposable Air/Water Valve Model 100304 (K102409)
• DEFENDO Disposable Biopsy Valve Model 100301 (K090851)

Submission Summary (Full Text)

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September 10, 2021

FUJIFILM medwork GmbH % Jeffrey Wan Manager, Regulatory Affairs FUJIFILM Medical Systems U.S.A., Inc. 81 Hartwell Avenue, Suite 300 Lexington, MA 02421

K210625 Re:

> Trade/Device Name: JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: ODC, FDF Dated: August 6, 2021 Received: August 9, 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

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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 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 ([e-mail]) or phone [phone] 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) K210625

Device Name

JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve

Indications for Use (Describe)

The JAZZ Disposable Valve Kit is comprised of the JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve.

The JAZZ Suction Valve is intended to control the suction (aspiration of air and fluids) of a FUIFILM gastrointestinal endoscope during endoscopy procedures.

The JAZZ Air/Water Valve is intended to control air of a FUJIFILM gastrointestinal endoscope for insufflations and water delivery (for distal lens cleaning) during endoscopy procedures.

The JAZZ Forceps Valve is intended to facilitate passage of an endotherapy device, to prevent a leak or backflow of air and/or fluids, and to enable the suction function of a FUJIFILM gastrointestinal endoscope.

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

X 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 medwork GmbH JAZZ Disposable Valve Kit

Date: Auqust 6, 2021

## Submitter's Information:

FUJIFILM medwork GmbH Medworkring 1 91315 Höchstadt, Germany

### Contact Person:

Jeffrey Wan Manager, Regulatory Affairs Telephone: [phone] E-Mail: [e-mail]

### ldentification of the Proposed Device:

Device Name: JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve Common Name: Endoscope Channel Accessory Device Class: Class II Classification Number: 21 C.F.R. § 876.1500 Classification Name: Endoscope and accessories Device Panel: Gastroentereology/Urology Product Codes: ODC, FDF

### Predicate Devices:

- DEFENDO Disposable Suction Valve Model 100305 (K102581) ●
- DEFENDO Disposable Air/Water Valve Model 100304 (K102409)
- DEFENDO Disposable Biopsy Valve Model 100301 (K090851) .

#### Intended Use / Indications for Use

The JAZZ Disposable Valve Kit is comprised of the JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve.

The JAZZ Suction Valve is intended to control the suction function of air and fluids) of a FUJIFILM gastrointestinal endoscope during endoscopy procedures.

The JAZZ Air/Water Valve is intended to control air of a FUJIFILM gastrointestinal endoscope for insufflations and water delivery (for distal lens cleaning) during endoscopy procedures.

The JAZZ Forceps Valve is intended to facilitate passage of an endotherapy device, to prevent a leak or backflow of air and/or fluids, and to enable the suction function of a FUJIFILM gastrointestinal endoscope.

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#### Device Description

The JAZZ Disposable Valve Kit is comprised of the JAZZ Suction Valve, Air/Water Valve, and Forceps Valve. These devices are intended for single-use and are supplied sterile, eliminating the need for manual cleaning and reprocessing. These valves are designed to the corresponding port of a FUJIFILM G7 gastrointestinal endoscope. The air/water valve can be activated to control air and water flow, while the suction valve can be activated to aspirate excess fluids or other debris. The forceps valve forms a tight seal with the biopsy port to prevent leakage of biomaterial, provide easy passage of endotherapy devices, and support thesuction function.

### Comparison of Technological Characteristics

A comparison of technological characteristics between the JAZZ Disposable Valve Kit and the DEFENDO disposable valves is provided below:

| | JAZZ Suction Valve | DEFENDO Disposable<br>Suction Valve 100305 | Substantial<br>Equivalence |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| 510(k) number | To be assigned | K102581 | |
| Product Code | ODC | ODC, FDF | Similar |
| Regulation No. | 21CFR § 876.1500 | 21CFR § 876.1500 | Identical |
| Classification | 2 | 2 | Identical |
| Manufacturer | FUJIFILM medwork<br>GmbH | Byrne Medical | |
| Supplied Sterile | Yes | Yes | Identical |
| Sterile method | EO | EO | Identical |
| Single use | Yes | Yes | Identical |
| Compatibility | FUJIFILM G7 Series GI<br>Endoscopes | Olympus and Pentax 90<br>Series GI Endoscopes | Similar |
| Indications for<br>Use | The JAZZ Suction Valve is<br>intended to control the<br>suction function<br>(aspiration of air and<br>fluids) of a FUJIFILM<br>gastrointestinal<br>endoscope during<br>endoscopy procedures. | The DEFENDO Disposable<br>Suction Valve is intended to<br>be used to control the suction<br>function of an endoscope<br>during a GI endoscopic<br>procedure. | Identical |
| Packaging | Suction, Air/Water, and<br>Forceps Valves are<br>housed in a single tray<br>and sealed with a Tyvek<br>sheet | Suction and air/water valves<br>are housed in a single tray<br>and packaged in a sealed<br>Tyvek pouch. | Similar |

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| | JAZZ Air/Water Valve | DEFENDO Disposable<br>Air/Water Valve 100304 | Substantial<br>Equivalence |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| 510(k) number | To be assigned | K102409 | |
| Product Code | ODC | ODC, FDF | Similar |
| Regulation No. | 21CFR § 876.1500 | 21CFR § 876.1500 | Identical |
| Classification | 2 | 2 | Identical |
| Manufacturer | FUJIFILM medwork GmbH | Byrne Medical | |
| Supplied Sterile | Yes | Yes | Identical |
| Sterile method | EO | EO | Identical |
| Single use | Yes | Yes | Identical |
| Compatibility | FUJIFILM G7 Series GI<br>Endoscopes | Olympus and Pentax 90<br>Series GI Endoscopes | Similar |
| Indications for<br>Use | The JAZZ Air/Water Valve<br>is intended to control air of<br>a FUJIFILM gastrointestinal<br>endoscope for insufflations<br>and water delivery (for<br>distal lens cleaning) during<br>endoscopy procedures. | The Single Use Air/Water<br>Valve is intended to be used<br>to control the air/water<br>function on an endoscope<br>during a GI endoscopic<br>procedure. | Identical |
| Packaging | Suction, Air/Water, and<br>Forceps Valves are housed<br>in a single tray and sealed<br>with a Tyvek sheet. | Suction and air/water valves<br>are housed in a single tray<br>and packaged in a sealed<br>Tyvek pouch. | Similar |

| | JAZZ Forceps Valve | DEFENDO Disposable<br>Biopsy Valve Model 100301 | Substantial<br>Equivalence |
|------------------|-------------------------------------|-------------------------------------------------|----------------------------|
| 510(k) number | To be assigned | K090851 | |
| Product Code | ODC | ODC | Identical |
| Regulation No. | 21CFR § 876.1500 | 21CFR § 876.1500 | Identical |
| Classification | 2 | 2 | Identical |
| Manufacturer | FUJIFILM medwork<br>GmbH | Byrne Medical | |
| Supplied Sterile | Yes | Yes | Identical |
| Sterile method | EO | EO | Identical |
| Single use | Yes | Yes | Identical |
| Compatibility | FUJIFILM G7 Series GI<br>Endoscopes | Olympus and Fujifilm GI<br>Endoscopes | Similar |

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| Indications for<br>Use | *The JAZZ Forceps<br>Valve is intended to<br>facilitate passage of an<br>endotherapy device, to<br>prevent a leak or<br>backflow of air and/or<br>fluids, and to enable the<br>suction function of a<br>FUJIFILM<br>gastrointestinal<br>endoscope. | The Single Use Biopsy Valve is<br>intended for covering the<br>endoscope biopsy port during<br>an endoscopy procedure. The<br>Single Use Biopsy Valve<br>provides access for endoscopic<br>device passage and exchange,<br>helps maintain sufflation, and<br>minimizes leakage of<br>biomaterial from the biopsy<br>port throughout the endoscopic<br>procedure. | Identical |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Packaging | Suction, Air/Water, and<br>Forceps Valves are<br>housed in a single tray<br>and sealed with a Tyvek<br>sheet. | Suction and air/water valves<br>are housed in a single tray and<br>packaged in a sealed Tyvek<br>pouch. | Similar |

# Performance Data

Biocompatibility of the subject device was evaluated using the following consensus standards: 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 StandardISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," published June 16, 2016.

Sterility of the subject devices was evaluated using the following consensus standards: ISO 11135:2014 and ISO 11607-1:2019.

The JAZZ Air/Water Valve was validated for its efficiency in preventing backflow to the proximal irrigation system as defined by the FDA Guidance, "Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes" published November 29, 2016.

Spring force testing was performed to evaluate the springs used in the subject devices.

The subject devices met performance specifications in the following additional non-clinical tests:

### Suction Valve

- Suction pressure
- -Tightness
- Functional life -
- Compatibility with endoscope -

### Air/Water Valve

- Insufflation pressure ।

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- Flushing pressure -
- Tightness -
- Functional life -
- -Compatibility with endoscope

### Forceps Valve

- Tightness -
- -Compatibility with endoscope
- Compatibility with endoscopic instruments -
- -Ease of use

### Conclusions

The subject device JAZZ Disposable Valve Kit shares the same intended use and substantially similar indications to the predicate devices. Bench testing demonstrates that the subject device is as safe and effective as the predicate devices. Thus, JAZZ Disposable Valve Kit is substantially equivalent to the listed predicate devices.