(192 days)
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.
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.
The provided text describes the JAZZ Disposable Valve Kit, a medical device for use with FUJIFILM gastrointestinal endoscopes. The document is a 510(k) summary submitted to the FDA, asserting substantial equivalence to predicate devices based on performance data.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide explicit "acceptance criteria" in a quantitative format with thresholds for each test. Instead, it states that "The subject devices met performance specifications in the following additional non-clinical tests." and "Bench testing demonstrates that the subject device is as safe and effective as the predicate devices." Implied acceptance is that the device performs functionally and safely, similar to the predicate devices.
| Performance Test (Implied Acceptance Criteria: Met Specifications/Safe and Effective) | Reported Device Performance |
|---|---|
| Biocompatibility | Met consensus standards (ISO 10993-1, 10993-5, 10993-7, 10993-10) and FDA guidance. |
| Sterility | Met consensus standards (ISO 11135, ISO 11607-1). |
| JAZZ Air/Water Valve - Backflow Prevention | Validated for efficiency in preventing backflow to proximal irrigation system as defined by FDA Guidance. |
| Spring Force Testing | Performed; met performance specifications (implied by overall conclusion). |
| Suction Valve - Suction pressure | Met performance specifications. |
| Suction Valve - Tightness | Met performance specifications. |
| Suction Valve - Functional life | Met performance specifications. |
| Suction Valve - Compatibility with endoscope | Met performance specifications. |
| Air/Water Valve - Insufflation pressure | Met performance specifications. |
| Air/Water Valve - Flushing pressure | Met performance specifications. |
| Air/Water Valve - Tightness | Met performance specifications. |
| Air/Water Valve - Functional life | Met performance specifications. |
| Air/Water Valve - Compatibility with endoscope | Met performance specifications. |
| Forceps Valve - Tightness | Met performance specifications. |
| Forceps Valve - Compatibility with endoscope | Met performance specifications. |
| Forceps Valve - Compatibility with endoscopic instruments | Met performance specifications. |
| Forceps Valve - Ease of use | Met performance specifications. |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes bench testing and validation studies. It does not specify the sample sizes (e.g., number of valves tested for each parameter) used for these tests. The data provenance is not explicitly stated beyond being "bench testing" and "validation" which implies a controlled laboratory environment. There is no indication of clinical data, animal studies, or human subject data. Therefore, the data can be considered prospective in the sense that the tests were conducted specifically for this submission. The "country of origin of the data" is not stated, but the manufacturer is FUJIFILM medwork GmbH (Germany).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not describe any studies involving human experts to establish "ground truth." The performance evaluations are based on non-clinical tests (bench testing) against established standards and internal specifications to demonstrate functional performance and safety.
4. Adjudication Method for the Test Set:
Not applicable, as no studies involving human interpretation or subjective adjudication are mentioned. The testing involves objective measurements rather than expert consensus on a "ground truth" derived from images or clinical cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not conducted for this device. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or data. The JAZZ Disposable Valve Kit is an accessory for an endoscope, and its evaluation focuses on mechanical and functional performance, sterility, and biocompatibility.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
This question is not applicable to the JAZZ Disposable Valve Kit. This device is a mechanical accessory, not an algorithm or AI-driven system. Its performance is inherent in its physical and functional design, not in a standalone algorithm's output.
7. The Type of Ground Truth Used:
The "ground truth" for the performance evaluation can be considered the established consensus standards (ISO standards), FDA guidance documents, and internal performance specifications for medical devices of this type. For example, for sterility, the ground truth is that the device must meet the requirements of ISO 11135 and 11607-1. For backflow prevention, the ground truth is compliance with the FDA guidance. For functional aspects like suction pressure or tightness, the ground truth would be predetermined functional thresholds defined by the manufacturer or industry standards.
8. The Sample Size for the Training Set:
Not applicable. As a physical medical device (valve kit), there is no "training set" in the context of machine learning or AI algorithms. The design and manufacturing processes are developed based on engineering principles and regulatory requirements, not through data training.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this type of device.
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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 (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) 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: (201) 675-8947 E-Mail: jeffrey.wan@fujifilm.com
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 DisposableSuction Valve 100305 | SubstantialEquivalence | |
|---|---|---|---|
| 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 medworkGmbH | Byrne Medical | |
| Supplied Sterile | Yes | Yes | Identical |
| Sterile method | EO | EO | Identical |
| Single use | Yes | Yes | Identical |
| Compatibility | FUJIFILM G7 Series GIEndoscopes | Olympus and Pentax 90Series GI Endoscopes | Similar |
| Indications forUse | The JAZZ Suction Valve isintended to control thesuction function(aspiration of air andfluids) of a FUJIFILMgastrointestinalendoscope duringendoscopy procedures. | The DEFENDO DisposableSuction Valve is intended tobe used to control the suctionfunction of an endoscopeduring a GI endoscopicprocedure. | Identical |
| Packaging | Suction, Air/Water, andForceps Valves arehoused in a single trayand sealed with a Tyveksheet | Suction and air/water valvesare housed in a single trayand packaged in a sealedTyvek pouch. | Similar |
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| JAZZ Air/Water Valve | DEFENDO DisposableAir/Water Valve 100304 | SubstantialEquivalence | |
|---|---|---|---|
| 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 GIEndoscopes | Olympus and Pentax 90Series GI Endoscopes | Similar |
| Indications forUse | The JAZZ Air/Water Valveis intended to control air ofa FUJIFILM gastrointestinalendoscope for insufflationsand water delivery (fordistal lens cleaning) duringendoscopy procedures. | The Single Use Air/WaterValve is intended to be usedto control the air/waterfunction on an endoscopeduring a GI endoscopicprocedure. | Identical |
| Packaging | Suction, Air/Water, andForceps Valves are housedin a single tray and sealedwith a Tyvek sheet. | Suction and air/water valvesare housed in a single trayand packaged in a sealedTyvek pouch. | Similar |
| JAZZ Forceps Valve | DEFENDO DisposableBiopsy Valve Model 100301 | SubstantialEquivalence | |
|---|---|---|---|
| 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 medworkGmbH | Byrne Medical | |
| Supplied Sterile | Yes | Yes | Identical |
| Sterile method | EO | EO | Identical |
| Single use | Yes | Yes | Identical |
| Compatibility | FUJIFILM G7 Series GIEndoscopes | Olympus and Fujifilm GIEndoscopes | Similar |
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| Indications forUse | *The JAZZ ForcepsValve is intended tofacilitate passage of anendotherapy device, toprevent a leak orbackflow of air and/orfluids, and to enable thesuction function of aFUJIFILMgastrointestinalendoscope. | The Single Use Biopsy Valve isintended for covering theendoscope biopsy port duringan endoscopy procedure. TheSingle Use Biopsy Valveprovides access for endoscopicdevice passage and exchange,helps maintain sufflation, andminimizes leakage ofbiomaterial from the biopsyport throughout the endoscopicprocedure. | Identical |
|---|---|---|---|
| Packaging | Suction, Air/Water, andForceps Valves arehoused in a single trayand sealed with a Tyveksheet. | Suction and air/water valvesare housed in a single tray andpackaged in a sealed Tyvekpouch. | 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.
§ 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.