(54 days)
Not Found
No
The device description and intended use clearly define the device as a set of mechanical valves for controlling fluid and gas flow in endoscopes. There is no mention of any software, algorithms, or data processing that would indicate the presence of AI or ML. The performance studies focus on biological evaluation, sterilization, and physical properties, not algorithmic performance.
No
The device primarily controls the flow of fluids and gases within an endoscope, facilitating diagnostic or procedural access rather than directly treating a disease or condition.
No
This device is a collection of sterile units intended to be fitted to endoscopes to control the flow of fluids, gases, and other materials. Its function is operational and supportive during an endoscopic procedure, not to diagnose a condition.
No
The device description clearly states it is a collection of sterile units intended to be fitted to endoscopes, describing physical components like valves and adapters. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being fitted to endoscopes to control the flow of fluids, gases, and materials during endoscopic procedures. This is a functional role within a medical procedure, not a diagnostic one.
- Device Description: The description reinforces the function of controlling flow within endoscope channels.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or to provide information for the diagnosis of a disease or condition.
- Performance Studies: The performance studies focus on biological evaluation, sterilization, and physical properties, which are relevant to a device used in a medical procedure, not a diagnostic test.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely procedural and supportive of the endoscopic examination itself.
N/A
Intended Use / Indications for Use
The Pentax Medical Valve Set is a collection of several sterile units. It is intended to be fitted to Pentax endoscopes' working channels/ports to control the flow of fluids, gases and other materials.
-
Disposable Air/Water Valve: This unit is intended to be fitted to an endoscope air/water channel to control the inflow of medical gases and water, whilst preventing back-flow.
-
Disposable Suction Valve: This unit is intended to be fitted to an endoscope suction channel to control the operations of suction, whilst preventing inflow of air.
-
Disposable Biopsy Valve: This unit is intended to be fitted to an endoscope biopsy port to prevent leakage of gases and body fluids during an endoscopic procedure.
-
Disposable Water Jet Adapter: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.
Product codes
ODC
Device Description
The Pentax Medical Valve Set is a collection of several sterile units. It is intended to be fitted to Pentax endoscopes' working channels/ports to control the flow of fluids, gases and other materials. The sterile units may consist of Disposable Air/Water Valve, Disposable Suction Valve, Disposable Biopsy Valve and Disposable Water Jet Adapter. Disposable Endoscopy Adapter Set may be configured as single valve or multiple valves in any combination up to a maximum of 4 valves.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital/clinics
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Bench tests were performed on Pentax Medical Valve Set for Appearance and Physical properties, and the results were passing. No clinical study was included in the submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol on the left is a stylized representation of a human figure. The text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The words "U.S. FOOD & DRUG" are on the top line, and the word "ADMINISTRATION" is on the bottom line.
November 21, 2022
Yangzhou Fartley Medical Instrument Technology Co., Ltd. Tina Han, RA Specialist Beizhou Road, Lidian Town, Guangling District Yangzhou, Jiangsu 225106 CHINA
Re: K222980 Trade/Device Name: Pentax Medical Valve Set Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: ODC Dated: September 16, 2022 Received: September 28, 2022
Dear Tina Han:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 -S
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
2
Indications for Use
510(k) Number (if known) K222980
Device Name Pentax Medical Valve Set
Indications for Use (Describe)
The Pentax Medical Valve Set is a collection of several sterile units. It is intended to be fitted to Pentax endoscopes' working channels/ports to control the flow of fluids, gases and other materials.
-
Disposable Air/Water Valve: This unit is intended to be fitted to an endoscope air/water channel to control the inflow of medical gases and water, whilst preventing back-flow.
-
Disposable Suction Valve: This unit is intended to be fitted to an endoscope suction channel to control the operations of suction, whilst preventing inflow of air.
-
Disposable Biopsy Valve: This unit is intended to be fitted to an endoscope biopsy port to prevent leakage of gases and body fluids during an endoscopic procedure.
-
Disposable Water Jet Adapter: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.
| 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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3
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
5.1 Submitter
| Submitted by: | Yangzhou Fartley Medical Instrument Technology Co., Ltd.
Address:Beizhou Road, Lidian Town, Guangling District, Yangzhou
225106 Jiangsu, China |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Han Xi
RA Specialist
Phone: 0086-15051101225
Email: th@fartley.com |
| Date Prepared: | September 20, 2022 |
5.2 Device
| Device Name: | Pentax Medical Valve Set |
|---|---|
| Classification Name: | Endoscope Channel Accessory |
| Regulatory Class: | II |
| Regulation Number: | 21 CFR 876.1500 |
| Regulation Name: | Endoscope and Accessories |
| Product Code: | ODC |
5.3 Predicate Device
| Device Name: | Disposable Endoscopy Adapter Set, K220210 |
|---|---|
| Manufacturer: | Yangzhou Fartley Medical Instrument Technology Co., Ltd. |
| Classification Name: | Endoscope Channel Accessory |
| Regulatory Class: | II |
| Regulation Number: | 21 CFR 876.1500 |
| Regulation Name: | Endoscope and Accessories |
| Product Code: | ODC |
5.4 Device Description
The Pentax Medical Valve Set is a collection of several sterile units. It is intended to be fitted to Pentax endoscopes' working channels/ports to control the flow of fluids, gases and other materials. The sterile units may consist of Disposable Air/Water Valve, Disposable Suction Valve, Disposable Biopsy Valve and Disposable Water Jet Adapter. Disposable Endoscopy Adapter Set may be configured as single valve or multiple valves in any combination up to a maximum of 4 valves.
5.5 Indication for Use:
The Pentax Medical Valve Set is a collection of several sterile units. It is intended to be fitted to
4
Pentax endoscopes' working channels/ports to control the flow of fluids, gases and other materials.
-
Disposable Air/Water Valve: This unit is intended to be fitted to an endoscope air/water channel to control the inflow of medical gases and water, whilst preventing back-flow.
-
Disposable Suction Valve: This unit is intended to be fitted to an endoscope suction channel to control the operations of suction, whilst preventing inflow of air.
-
Disposable Biopsy Valve: This unit is intended to be fitted to an endoscope biopsy port to prevent leakage of gases and body fluids during an endoscopic procedure.
-
Disposable Water Jet Adapter: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.
5.6 Comparison of Technological Characteristics
The Pentax Medical Valve Set consist of Disposable Air/Water Valve, Disposable Suction Valve, Disposable Biopsy Valve and Disposable Water Jet Adapter which are compatible with Pentax endoscopes,our existing predicated device of Disposable Endoscopy Adapter Set,K220210 also consist of Pentax series of Disposable Air/Water Valve, Disposable Suction Valve, Disposable Biopsy Valve and Disposable Water Jet Adapter.
The Disposable Air/Water Valve, Disposable Suction Valve and Disposable Water Jet Adapter among them are completely same,the only difference is the valve cap of Disposable Biopsy Valve.
Thus,the Pentax Medical Valve Set has substantially equivalent device design, configuration, packaging fundamental technology, sterilization process and intended use as those featured in our existing predicated device of Disposable Endoscopy Adapter Set,K220210. The differences between the proposed device and the predicate devices do not raise any questions regarding its safety and effectiveness. The differences are listed in the table below.
| Item | Pentax Medical
Valve Set(Proposed
Device) | Disposable Endoscopy
Adapter Set, K220210 | Discussion |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Indication
for Use | The Pentax Medical
Valve Set is a
collection of several
sterile units. It is
intended to be fitted
to Pentax
endoscopes'
working
channels/ports to
control the flow of
fluids, gases and
other materials.
- Disposable
Air/Water Valve:
This unit is | The Disposable Endoscopy
Adapter Set is a collection of
several sterile units. It is
intended to be fitted to
multiple endoscope working
channels/ports to control the
flow of fluids, gases and
other materials. - Disposable Air/Water
Valve: This unit is intended
to be fitted to an endoscope
air/water channel to control
the inflow of medical gases
and water, whilst preventing
back-flow. | Substantially equivalent |
| Item | Pentax Medical
Valve Set(Proposed
Device) | Disposable Endoscopy
Adapter Set, K220210 | Discussion |
| | intended to be fitted
to an endoscope
air/water channel to
control the inflow
of medical gases
and water, whilst
preventing
back-flow. - Disposable | - Disposable Suction Valve:
This unit is intended to be
fitted to an endoscope
suction channel to control the
operations of suction, whilst
preventing inflow of air. - Disposable Biopsy Valve:
This unit is intended to be
fitted to an endoscope biopsy
port to prevent leakage of
gases and body fluids during
an endoscopic procedure. - Disposable Water Jet
Adapter: This unit is
intended to provide irrigation
via sterile water supply
during GI endoscopic
procedures when used in
conjunction with an
irrigation pump. | |
| | Suction Valve: This
unit is intended to
be fitted to an
endoscope suction
channel to control
the operations of
suction, whilst
preventing inflow
of air. - Disposable Biopsy
Valve: This unit is
intended to be fitted
to an endoscope
biopsy port to
prevent leakage of
gases and body
fluids during an
endoscopic
procedure. - Disposable Water
Jet Adapter: This
unit is intended to
provide irrigation
via sterile water
supply during GI
endoscopic
procedures when
used in conjunction
with an irrigation
pump. | | |
| Product | ODC | ODC | Same |
| Item | Pentax Medical
Valve Set(Proposed
Device) | Disposable Endoscopy
Adapter Set,K220210 | Discussion |
| Code | | | |
| Regulation
Number | 21 CFR 876.1500 | 21 CFR 876.1500 | Same |
| Classification | II | II | Same |
| Air/Water Valve | | | |
| Compatible
Endoscopes | PENTAX GI Video
Endoscope 90K/90i
Series; K10/i10
Series | Olympus
140/160/180/190/240/260/2
90 series endoscopes;
PENTAX GI Video
Endoscope 90K/90i Series,
K10/i10 Series;
Fujifilm® 500/600/
700 series endoscopes | Substantially equivalent
supported by bench
testing. |
| Sterile | EO Sterilization | EO Sterilization | Same |
| Material | Silicone Rubber,
ABS, SUS304 | Silicone Rubber, ABS,
SUS304 | Substantially equivalent
supported by
biocompatibility testing. |
| Environment
Use | Hospital/clinics | Hospital/clinics | Same |
| Suction Valve | | | |
| Compatible
Endoscopes | PENTAX GI Video
Endoscope 90K/90i
Series; K10/i10
Series | Olympus
140/160/180/190/240/260/2
90 series endoscopes;
PENTAX GI Video
Endoscope 90K/90i Series;
K10/i10 Series;
Fujifilm® 500/600/
700 series endoscopes | Substantially equivalent
supported by bench
testing. |
| Sterile | EO Sterilization | EO Sterilization | Same |
| Material | ABS, Silicone
Rubber, SUS304 | ABS, Silicone Rubber,
SUS304 | Substantially equivalent
supported by
biocompatibility testing. |
| Environment
Use | Hospital/clinics | Hospital/clinics | Same |
| Biopsy Valve | | | |
| Compatible
Endoscopes | PENTAX GI
Video Endoscope
90K/90i Series;
K10/i10 Series. | Olympus
140/160/180/190/240/260/2
90 series endoscopes;
PENTAX GI
Video | Substantially equivalent
supported by bench
testing. |
| Item | Pentax Medical
Valve Set(Proposed
Device) | Disposable Endoscopy
Adapter Set, K220210 | Discussion |
| | | Endoscope 90K/90i Series;
K10/i10 Series;
Fujifilm® 500/600/
700 series endoscopes | |
| Sterile | EO Sterilization | EO Sterilization | Same |
| Material | Silicone Rubber | Silicone Rubber | Same |
| Environment
Use | Hospital/clinics | Hospital/clinics | Same |
| Water Jet Adapter | | | |
| Compatible
Endoscopes | PENTAX GI Video
Endoscope 90K/90i
Series; K10/i10
Series; | Olympus
140/160/180/190/240/260/2
90 series endoscopes;
PENTAX GI Video
Endoscope 90K/90i Series;
K10/i10 Series;
Fujifilm® 500/600/
700 series endoscopes | Substantially equivalent
supported by bench
testing. |
| Sterile | EO Sterilization | EO Sterilization | Same |
| Material | Metal Type:PC,
SUS303,Silicone
Rubber
Plastic Type: PC,
Silicone Rubber | Metal Type:PC,
SUS303,Silicone Rubber
Plastic Type: PC, Silicone
Rubber | Substantially equivalent
supported by
biocompatibility testing. |
| Environment
Use | Hospitals/clinics | Hospitals/clinics | Same |
5
6
7
5.7 Non-clinical Performance Data
The proposed device meets the requirements of ISO 10993 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing", ISO 11135-1 "Sterilization of Health Care products Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices", and ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals" .
The following bench tests were performed on Pentax Medical Valve Set: Appearance, Physical properties. The results of all testing were passing.
5.8 Clinical Test Data
No Clinical Study is included in this submission.
5.9 Conclusion
8
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, Based on the information provided in this premarket notification, Yangzhou Fartley Medical Instrument Technology Co., Ltd. has demonstrated that proposed device Pentax Medical Valve Set is substantially equivalent to our existing predicated device of Disposable Endoscopy Adapter Set,K220210.