(132 days)
Not Found
No
The document describes simple mechanical valves for controlling flow during endoscopy and explicitly states "Mentions AI, DNN, or ML: Not Found".
No.
The device facilitates a GI Endoscopic procedure by controlling the flow of medical gases, water, and suction, and providing access for endoscopic devices, but it does not directly treat a disease or condition.
No
Explanation: This device is a set of disposable valves for an endoscope. Its stated intended use is to control the inflow of medical gases and water, control suction, and allow access for/exchange of endoscopic devices, all while preventing backflow or leakage. These functions are operational in nature, facilitating the endoscopic procedure, rather than providing diagnostic information.
No
The device description and performance studies clearly indicate that this is a physical medical device (valves) and not software. The testing performed relates to physical properties and performance of the valves.
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's function as controlling the flow of gases, water, and providing access for endoscopic devices during a GI Endoscopic procedure. This is a direct interaction with the patient's body for procedural purposes, not for examining specimens in vitro (outside the body) to obtain diagnostic information.
- Device Description: The description focuses on the mechanical function and compatibility with endoscopes, not on analyzing biological samples.
- Performance Studies: The performance studies described are related to the mechanical and functional aspects of the valves (leak tests, flow tests, compatibility, etc.) and biocompatibility, not on the accuracy or reliability of diagnostic measurements from biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, tissue, etc.), generating diagnostic results, or providing information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnostic purposes. This device's function is purely procedural and supportive during an endoscopic examination.
N/A
Intended Use / Indications for Use
Disposable Valve Sets includes either one air/water and suction valve or one air/water, suction and biopsy valve.
Disposable Air/Water Valve
This device intended to be fitted to an edoscope air/water channel to enable the operator to control inflow of medical gases and water, whilst preventing backflow during a GI Endoscopic procedure.
Disposable Suction Valve
The device intended to be fitted to an endoscope suction channel to enable the operator to control suction whilst preventing inflow of air during a GI Endoscopic procedure.
Disposable Biopsy Valve
This device is intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of bio material during an endoscopic procedure.
Product codes (comma separated list FDA assigned to the subject device)
ODC, OCX
Device Description
Disposable Valve Sets includes either one air/water and suction valve or one air/water, suction and biopsy valve, So we divided into two models for these devices. One suction valve, air/water valve and biopsy valve means model B, one suction valve and air/water valve means model A. These devices are supplied sterile. These valves easily incorporate into infection prevention policies as a single use item, and these valves are suitable for Olympus 140/160/190/240/260 series endoscopes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
GI Endoscopic procedure.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
In-vitro Testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests. A summary of the test results has been provided for:
Disposable Suction Valve
-
- Endoscope Compatibility
-
- Vacuum Leak Test
-
- Suction Flow Test
-
- Depression Force Test
Disposable Air/Water Valve
-
- Endoscope Compatibility
-
- Water Flow Test
-
- Air Flow Test
-
- Leak Test
-
- Depression Force Test
Disposable Biopsy Valve
- Depression Force Test
-
- Endoscope Compatibility
-
- Leak Test
-
- Squeegee Leak Test
The EO residual was measured after sterilization of the device to meet the criteria defined in ISO 10993-7 Second Edition 2008-10-15.
The EO sterilization cycle has a Sterility Assurance Level (SAL) of 10 °.
The shelf-life for three years had been validated in accelerated testing according to ASTM F1980-16 (2016) and the requirements on packaging for terminally sterilized medical device per ISO 11607-1 First Edition 2006-04-15 and ISO 11607-2 First Edition 2006-04-15 are also met. The testing successfully demonstrated essential performance is achieved before and after the shelf life test.
Biocompatibility testing was performed in accordance with the FDA Guidance," Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued on June 16, 2016. The cytotoxicity, sensitization and intracutaneous irritation test were performed to demonstrate the biocompatibility of the device.
The device has undergone both bench testing of performance and laboratory biocompatibility testing for cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity and pyrogen test in accordance with 21 CFR, Part 58. The Disposable Valve Sets results in no safety or efficacy concerns regarding biocompatibility or performance. Likewise, in conformance with 21 CFR 807.92(b)(3), the device performs as well as the predicate in all testing performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
December 30, 2019
Zhejiang Chuangxiang Medical Technology Co., LTD. Lucius Long RA Manager 301B, No.22, XinYan Road Hanzhou, Zhejiang 311100 CHINA
Re: K192258
Trade/Device Name: Disposable Valve Sets Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODC, OCX Dated: August 21, 2019 Received: November 26, 2019
Dear Lucius Long:
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 control's 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.
1
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 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 (OS) 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. Acting 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) K192258
Device Name Disposable Valve Sets
Indications for Use (Describe)
Disposable Valve Sets includes either one air/water and suction valve or one air/water, suction and biopsy valve.
Disposable Air/Water Valve
This device intended to be fitted to an endoscope air/water channel to enable the operator to control inflow of medical gases and water, whilst preventing backflow during a GI Endoscopic procedure.
Disposable Suction Valve
The device intended to be fitted to an endoscope suction channel to enable the operator to control suction whilst preventing inflow of air during a GI Endoscopic procedure.
Disposable Biopsy Valve
This device is intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of bio material during an endoscopic procedure.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
Image /page/3/Picture/1 description: The image shows a logo for a company called MEDNOVA. The logo consists of a geometric shape in shades of green and blue, along with the company name in blue and green text. The text "MEDNOVA" is in a sans-serif font, with "MED" in blue and "NOVA" in green. Below the logo is the text "Zhejiang Chuangxiang Medical Technolo", which is likely the full name of the company.
ng Medical Technology Co.,Ltd
Page:
Section 8 510(k) Summary( 21CFR 807.92)
1. Submitter's information
Name: Zhejiang Chuangxiang Medical Technology Co., LTD.
Address: 301B, No.22, XinYan Road Yuhang Economic And Technological Development Zone Hangzhou Zhejiang China
Contact person: Lucius.Long Telephone: 86-571-89167088 Fax: 86-571-89167086
- Date of Submission Dec. 24, 2019
3. Device
Trade/Device Name: Disposable Valve Sets Regulation name: Endoscope and accessories Regulation class: II Regulation number:876.1500 Panel: Gastroenterology/Urology Product code: ODC, OCX
4. Predicative device
4.1) 510(k) Number: K181509, Device Name: Endorate™ Valve Sets
5. Device description
Disposable Valve Sets includes either one air/water and suction valve or one air/water, suction and biopsy valve, So we divided into two models for these devices. One suction valve, air/water valve and biopsy valve means model B, one suction valve and air/water valve means model A. These devices are supplied sterile. These valves easily incorporate into infection prevention policies as a single use item, and these valves are suitable for Olympus 140/160/190/240/260 series endoscopes. The following table shows the details information on the model.
4
Image /page/4/Picture/0 description: The image contains a logo with a geometric shape on the left and text on the right. The geometric shape is a hexagon with a smaller hexagon inside, and it is filled with a gradient of blue and green. To the right of the shape, there is the text "MEDNOVA" in blue and green, with the word "MED" in blue and the word "NOVA" in green. Above the text "MEDNOVA", there are three Chinese characters in blue.
g Medical Technology Co.,Ltd
2 / 7 Page:
| Model | Specification | ENDOSCOPIC COMPATIBILITY | Sterilization
(Y/N) |
|-------|---------------|--------------------------|------------------------|
| A | MD-A-AW01 | Olympus | Y |
| B | MD-B-AW02 | 140/160/180/190/240/260 | Y |
6. Indications for use
Disposable Valve Sets includes either one air/water and suction valve or one air/water, suction and biopsy valve.
Disposable Air/Water Valve
This device intended to be fitted to an edoscope air/water channel to enable the operator to control inflow of medical gases and water, whilst preventing backflow during a GI Endoscopic procedure.
Disposable Suction Valve
The device intended to be fitted to an endoscope suction channel to enable the operator to control suction whilst preventing inflow of air during a GI Endoscopic procedure.
Disposable Biopsy Valve
This device is intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of bio material during an endoscopic procedure.
5
Image /page/5/Picture/1 description: The image contains a logo for a company called MEDNOVA. The logo consists of a hexagon shape with a white outline and a gradient fill of green and blue. To the right of the hexagon is the company name, with "MED" in blue and "NOVA" in green. Above the company name are three blue Chinese characters.
Zhejiang Chuangxiang Medical Technology Co.,Ltd
Page:
7. Technological Characteristics
The following tables are summaries of the proposed device's technological characteristics as compared to the predicate devices.
Table 7.1 comparison of Disposable Air/Water Valve
| Item | Proposed device | Predicate device | Comparison to
Predicate Devices |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Device name | Disposable Air/Water Valve | Andorate Disposable Air/Water valve | / |
| 510(k) number | / | K181509 | / |
| Manufacturer | Zhejiang Chuangxiang
Medical Technology Co., LTD. | Smardata Suzhou Co., Ltd | / |
| Product Code | ODC | ODC | Same |
| Regulation No. | 876.1500 | 876.1500 | Same |
| Class | II | II | Same |
| Indications for Use | This device intended to be
fitted to an edoscope
air/water channel to enable
the operator to control inflow
of medical gases and water,
whilst preventing backflow
during a GI Endoscopic
procedure. | The ENDORATE™ Disposable
Air/Water valve is intended to be
used control the air/water
function of an endoscope during a
GI Endoscopic procedure. | Substantial
Equivalence |
| Supplied Sterile | Sterile | Sterile | Same |
| Sterilization method | EO | EO | Same |
| Compatibility | Olympus®
140/160/180/190/240/260
series endoscopes | Olympus®
140/160/180/190/240/260 series
Endoscope | Same |
| Single Use | Yes | Yes | Same |
| Packaging | Suction, air/water and/or
biopsy valves are housed in a
single tray and packaged in a
sealed pouched | Suction, air/water, biopsy valves are
housed in a single tray and
packaged in a sealed pouched | Substantial
Equivalence |
| Shelf Life | Three years | Three years | Substantial
Equivalence |
6
Image /page/6/Picture/1 description: The image contains a logo for Zhejiang Chuangxiang Medical Technology Co., Ltd. The logo features a stylized hexagon shape in green and blue, with the text "MEDNOVA" underneath. The company name is written in a larger font below the logo.
Page:
| Item | Proposed device | Predicate device | Comparison to
Predicate Devices |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Device name | Disposable Suction Valve | Endorate™
Disposable
Suction Valve | / |
| 510(k) number | / | K181509 | / |
| Manufacturer | Zhejiang Chuangxiang
Medical Technology Co.,
LTD. | Smardata Suzhou Co., Ltd | / |
| Product Code | ODC | ODC | Same |
| Regulation No. | 876.1500 | 876.1500 | Same |
| Class | II | II | Same |
| Indications for
Use | The device intended to be
fitted to an endoscope
suction channel to enable
the operator to control
suction whilst preventing
inflow of air during a GI
Endoscopic procedure. | The ENDORATE™ Disposable
Suction valve is intended to
be used control the suction
function of an endoscope
during a GI Endoscopic
procedure. | Substantial
Equivalence |
| Supplied Sterile | Sterile | Sterile | Same |
| Sterilization
method | EO | EO | Same |
| Compatibility | Olympus®
140/160/180/190/240/260
series Endoscope | Olympus®
140/160/180/190/240/260
series Endoscope | Same |
| Single Use | Yes | Yes | Same |
| Packaging | Suction, air/water and/or
biopsy valves are housed in a
single tray and packaged in a
sealed pouched | Suction, air/water, biopsy
valves are housed in a single
tray and packaged in a sealed
pouched | Substantial
Equivalence |
| Shelf Life | Three years | Three years | Substantial
Equivalence |
Table 7.2 comparison of Disposable Suction Valve
7
Image /page/7/Picture/1 description: The image contains the logo for Zhejiang Chuangxiang Medical Technology Co., Ltd. The logo features a stylized hexagon shape in green and blue gradient, along with the company name in both Chinese and English. The Chinese characters are larger and in blue, while the English name "MEDNOVA" is in green. Below the logo, the full company name "Zhejiang Chuangxiang Medical Technology Co.,Ltd" is written in black text.
Page:
| Item | Proposed device | Predicate device | Comparison
to Predicate
Devices | |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|----------------------------|
| Device name | Disposable Biopsy Valve | Endorate™ Disposable
biopsy Valve | / | |
| 510(k) number | / | K181509 | / | |
| Manufacturer | Zhejiang Chuangxiang
Medical Technology Co., LTD. | Smardata Suzhou Co.,
Ltd | / | |
| Product Code | OCX | OCX | Same | |
| Regulation No. | 876.1500 | 876.1500 | Same | |
| Class | II | II | Same | |
| Indications for
Use | This device is intended to be
fitted to an endoscope biopsy
port to enable access
for/exchange of endoscopic
devices while maintaining
insufflation and minimizing
leakage of bio material during
an endoscopic procedure. | The Endorate™
Disposable biopsy valve is
intended to cover the
endoscope biopsy port
during an endoscopy
procedure. In addition, the
valve provides access for
endoscopic device passage
and exchange, helps
maintain insufflation and
minimizes leakage of
biomaterial from the biopsy
port throughout the
endoscopic procedure. | Substantial
Equivalence | |
| Supplied Sterile | Sterile | Sterile | Same | |
| Sterilization
method | EO | EO | Same | |
| Compatibility | Olympus
140/160/180/190/240/260
series endoscopes | Olympus® / Fujinon®
and Pentax ® Endoscopes | Substantial
Equivalence | |
| Single Use | Yes | Yes | Same | |
| Packaging | Suction, air/water and/or biopsy
valves are housed in a single
tray and packaged in a sealed
pouched | Suction, Air/Water, biopsy
valves are housed in a single
tray and packaged in a
sealed pouch.
Non Sterile Biopsy valve is | Substantial
Equivalence | |
| | | | Page: 6 / 7 | |
| | | also sold individually
packaged in a sealed pouch.
Biopsy valve is either in blue
or black depending on the
availability. | | |
| Shelf Life | Three years | Three years | | Substantial
Equivalence |
Table 7.3 comparison of Disposable Biopsy Valve
8
Image /page/8/Picture/1 description: The image shows the logo for MEDNOVA. The logo consists of a hexagon shape on the left, with the text "MEDNOVA" written in blue and green on the bottom. To the right of the hexagon and text is Chinese characters in blue.
iang Medical Technology Co.,Ltd
8. Performance data
In-vitro Testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests. A summary of the test results has been provided for:
Disposable Suction Valve
-
- Endoscope Compatibility
-
- Vacuum Leak Test
-
- Suction Flow Test
-
- Depression Force Test
Disposable Air/Water Valve
-
- Endoscope Compatibility
-
- Water Flow Test
-
- Air Flow Test
-
- Leak Test
-
- Depression Force Test
- Disposable Biopsy Valve
-
- Endoscope Compatibility
-
- Leak Test
-
- Squeegee Leak Test
The EO residual was measured after sterilization of the device to meet the criteria defined in ISO 10993-7 Second Edition 2008-10-15.
The EO sterilization cycle has a Sterility Assurance Level (SAL) of 10 °.
The shelf-life for three years had been validated in accelerated testing according to ASTM F1980-16 (2016) and the requirements on packaging for terminally sterilized medical device per ISO 11607-1 First Edition 2006-04-15 and ISO 11607-2 First Edition 2006-04-15 are also met. The testing successfully demonstrated essential performance is achieved before and after the shelf life test.
Biocompatibility testing was performed in accordance with the FDA Guidance," Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued on June 16, 2016. The cytotoxicity, sensitization and intracutaneous irritation test were performed to demonstrate the biocompatibility of the device.
9
K192258 page 7 of 7
Image /page/9/Picture/1 description: The image contains the logo for Zhejiang Chuangxiang Medical Technology Co., Ltd. The logo features a stylized hexagon shape in green and blue, with the text "MEDNOVA" underneath. To the right of the logo are Chinese characters, and below the logo is the company name in English. The text is clear and legible.
Page:
9. Non-Clinical Testing:
The device has undergone both bench testing of performance and laboratory biocompatibility testing for cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity and pyrogen test in accordance with 21 CFR, Part 58. The Disposable Valve Sets results in no safety or efficacy concerns regarding biocompatibility or performance. Likewise, in conformance with 21 CFR 807.92(b)(3), the device performs as well as the predicate in all testing performed.
10. Conclusions
Chuangxiang medical has demonstrated that the proposed device Disposable Valve Sets is substantially equivalent to Smardata Suzhou Co., Ltd. currently marketed Endorate™ Valve Sets (K181509).