(109 days)
Not Found
No
The device description and performance studies focus solely on the physical components and their functional performance (flow rates, leak tests, integrity, etc.). There is no mention of any software, algorithms, image processing, or data analysis that would indicate the presence of AI/ML.
No.
The device is described as tubing to connect sources of air/CO2 and water to an endoscope for irrigation during procedures, rather than directly treating a condition.
No
Explanation: The device description states its purpose is to supply air/CO2 and water during gastrointestinal endoscopic procedures, not to diagnose medical conditions. It serves as an accessory for an endoscope.
No
The device description and performance studies clearly indicate that this is a physical medical device (tubing) with associated hardware testing (assembling integrity, flow tests, leak tests, sterilization, shelf life, biocompatibility). There is no mention of software components.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is used to supply air/CO2 and water during gastrointestinal endoscopic procedures. This is a direct interaction with the patient's body during a medical procedure, not for examining specimens in vitro (outside the body).
- Device Description: The description details tubing for connecting sources to an endoscope for irrigation and insufflation, which are actions performed on the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
The device is a medical device used in vivo (within the body) during a procedure, not an IVD.
N/A
Intended Use / Indications for Use
The Air/Water Bottle Tubing is to connect an air/CO2 source, a sterile water source (water bottle), and an endoscope to supply air/CO2 and water during gastrointestinal endoscopic procedures. This device is intended to be used for not more than 24 hours. It is a 24-hour multi-patient use device.
The CO2 Source Tubing is intended to be used with a carbon dioxide (CO2) source with the purpose of supplying CO2 to the endoscope during endoscopic procedures. This device is intended to be used for not more than 24 hours. It is a 24-hour multi-patient use device.
Product codes (comma separated list FDA assigned to the subject device)
OCX, FCX
Device Description
The proposed device includes two (2) categories:\
- Air/Water Bottle Tubing\
- CO2 Source Tubing
The Air/Water Bottle Tubing and CO2 Source Tubing are intended for 24-hour multi-patient use. Air/water bottle tubing is supplied in sterile and CO₂ Source Tubing is supplied in non-sterile.
6.1 The Air/Water Bottle Tubing
The Air/Water Bottle Tubing is manufactured for use in conjunction with a sterile water bottle, and together with OLYMPUS®140/240, 160/260, 180/280, 190/290 series endoscopes. The Air/Water Bottle Tubing is individually packed in sealed package, sold as a sterile device. The Air/Water Bottle Tubing is designed to be attached to the air/water port of the endoscopes to provide irrigation through the air/water channel to the distal end of endoscope.
There are two types of the device Air/Water Bottle Tubing provided by the manufacturer, such as type A and type B. Type B has an additional air extended tubing but type A does not. The clinician selects the appropriate model according to the actual clinical needs.
6.2 The CO2 Source Tubing
The CO2 Source Tubing is manufactured for use in conjunction with air/water bottle tubing and CO2 insufflator. The CO2 Source tubing is individually packed in a sealed package, and sold as a non-sterile device. The CO2 Source Tubing is designed to be attached to the air/water bottle tubing and the outlet of the CO2 insufflator to provide irrigation and CO2 insufflation through the air/water channel to the distal end of endoscope.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital and or 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The bench testing was performed to support substantial equivalence. The following testing were performed on samples from initial lots, including sterilization.
9.1 Performance Test
9.1.1 Air/Water Bottle Tubing\
- 9.1.1.1 Assembling Integrity\
- 9.1.1.2 Two-Way Valve Integrity\
- 9.1.1.3 Air Flow Test\
- Water Flow Test 9.1.1.4\
- 9.1.1.5 Air Leak Test\
- 9.1.1.6 Flow Clamp Test\
- 9.1.1.7 Water Backflow Test\
- 9.1.1.8 24-Hour Use Test\
- 9.1.1.9 Endoscope Compatibility\
- 9.1.1.10 Compatibility With Bottle
9.1.2 CO2 Source Tubing\ - 9.1.2.1 Assembling Integrity\
- 9.1.2.2 Co2 Delivery Test\
- 9.1.2.3 Water Delivery Test\
- 9.1.2.4 Air Leak Test\
- 9.1.2.5 Compatibility With Air/Water Bottle Tubing
9.2 Sterilization
The Air/Water Bottle Tubing is sold in a sterile package, like the predicate devices. The proposed devices have been sterilized in a validated EO sterilization cycle. The EO sterilization cycle has a Sterility Assurance Level (SAL) of 10 °. EO residuals on the components are below the maximum levels defined in ISO 10993-7:2008 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide sterilization residuals. The Air/Water Bottle Tubing, and the predicate devices, are not labeled as pyrogen-free because they do not have any blood or cerebrospinal fluid contact. The CO2 Source Tubing is supplied in non-sterile.
9.3. Shelf Life
The Air/Water Bottle Tubing and the CO2 Source Tubing both have three (3) years shelf life, which have been validated in an accelerated testing according to ASTM F1980-21 and the requirements on packaging for terminally sterilized medical device per ISO 11607-1 Second Edition 2019-02 and ISO 11607-2 Second Edition 2019-02 have also met. The testing successfully demonstrated essential performance was achieved before and after the shelf life testing.
9.4. Biocompatibility
Biocompatibility testing has been performed to show that all patient contacting materials meet applicable biocompatibility standards per ISO 10993-1:2009 and 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". it included the following tests:
Acute Systemic Toxicity Test,
In Vitro Cytotoxicity Test,
Skin Sensitization Test
and Intracutraneous Reactivity
The Air/Water Bottle Tubing and the CO2 Source Tubing are classified as surface device with mucosal membrane contact for a limited duration (not more than 24 hours), the test result show that the proposed devices are biocompatible.
Clinical Testing: Similar devices have been on the market for many years with proven safety and effectiveness for the use of the device. These devices have no direct patient contact. Based on this history and the use of the device, clinical testing was not necessary to support substantial equivalence data. The non-clinical testing performed supports the safety and effectiveness of the devices and provides data to show substantial equivalence to the predicate device.
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.
September 8, 2023
Zhejiang Chuangxiang Medical Technology Co., LTD. Lucius Long RA Manager Room 101,201,301,401,501, Building 50, No.650 Hongfeng Road Donghu Street, Yuhang District Hangzhou, Zhejiang Province 311100 China
Re: K231471
Trade/Device Name: Air/Water Bottle Tubing, CO2 Source Tubing Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OCX, FCX Dated: August 10, 2023 Received: August 10, 2023
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 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.
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 (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 mediation-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)
K231471
Device Name Air/Water Bottle Tubing, CO2 Source Tubing
Indications for Use (Describe)
The Air/Water Bottle Tubing is to connect an air/CO2 source, a sterile water source (water bottle), and an endoscope to supply air/CO2 and water during gastrointestinal endoscopic procedures. This device is intended to be used for not more than 24 hours. It is a 24-hour multi-patient use device.
The CO2 Source Tubing is intended to be used with a carbon dioxide (CO2) source with the purpose of supplying CO2 to the endoscope during endoscopic procedures. This device is intended to be used for not more than 24 hours. It is a 24-hour multi-patient use device.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/1 description: The image shows the logo for MEDNOVA. The logo consists of a hexagon shape on the left side, with the left side being blue and the right side being green. To the right of the hexagon shape is the text "MEDNOVA", with the "MED" being blue and the "NOVA" being green. Above the text "MEDNOVA" is Chinese characters in blue.
Medical Technology Co.,LTD.
Page: 1 / 8
510(k) Summary( 21CFR 807.92) Section 5
1. Submitter's information
Name: Zhejiang Chuangxiang Medical Technology Co., LTD. Address: Room 101, 201, 301, 401, 501, Building 50, No.650 Hongfeng Road Donghu Street, Yuhang District, Hangzhou City, Zhejiang Province,311100,P.R. China
2. Sponsor contact
Contact person: Lucius.Long Email: lucius.long@med-nova.com Telephone: 86-571-89167088 Fax: 86-571-89167086
3. Date of Submission
09-Aug- 2023
4. Device Identification
Trade/Device Name:Air/Water Bottle Tubing Regulation name: Endoscope and accessories Regulation class: II Regulation number: 876.1500 Panel: Gastroenterology/Urology Product code: OCX Product Code Name: Endoscopic Irrigation/Suction System
Trade/Device Name: CO2 Source Tubing Regulation name: Endoscope and accessories Regulation class: II Regulation number: 876.1500 Panel: Gastroenterology/Urology Product code: FCX Product Code Name: Insufflator, Automatic Carbon-Dioxide For Endoscope
5. Predicative device identification
510(k) Number: K093665 Device 1 Name: Endo SmartCap™ Tubing
4
K231471 Page 2 of 8
Image /page/4/Picture/1 description: The image contains a logo with text. On the left side of the logo, there is a hexagon shape with a smaller hexagon inside. The color of the hexagon changes from green to blue. To the right of the hexagon, there is Chinese text that translates to "Creative Medicine". Below the Chinese text is the word "MEDNOVA" in English. The first half of the word is in blue, and the second half is in green.
Medical Technology Co.,LTD.
Page: 2 / 8
Product Code: FAJ 510(k) Number: K093665 Device 2 Name: Endo SmartCap™ CO2 Source Tubing Product Code: FAJ
6. Device description
The proposed device includes two (2) categories:
- Air/Water Bottle Tubing
- CO2 Source Tubing
The Air/Water Bottle Tubing and CO2 Source Tubing are intended for 24-hour multi-patient use. Air/water bottle tubing is supplied in sterile and CO₂ Source Tubing is supplied in non-sterile.
6.1 The Air/Water Bottle Tubing
The Air/Water Bottle Tubing is manufactured for use in conjunction with a sterile water bottle, and together with OLYMPUS®140/240, 160/260, 180/280, 190/290 series endoscopes. The Air/Water Bottle Tubing is individually packed in sealed package, sold as a sterile device. The Air/Water Bottle Tubing is designed to be attached to the air/water port of the endoscopes to provide irrigation through the air/water channel to the distal end of endoscope.
There are two types of the device Air/Water Bottle Tubing provided by the manufacturer, such as type A and type B. Type B has an additional air extended tubing but type A does not. The clinician selects the appropriate model according to the actual clinical needs.
6.2 The CO2 Source Tubing
The CO2 Source Tubing is manufactured for use in conjunction with air/water bottle tubing and CO2 insufflator. The CO2 Source tubing is individually packed in a sealed package, and sold as a non-sterile device. The CO2 Source Tubing is designed to be attached to the air/water bottle tubing and the outlet of the CO2 insufflator to provide irrigation and CO2 insufflation through the air/water channel to the distal end of endoscope.
7. Indications for Use
The Air/Water Bottle Tubing is to connect an air/CO₂ source, a sterile water source (water bottle), and an endoscope to supply air/CO2 and water during gastrointestinal
5
Image /page/5/Picture/1 description: The image shows the logo for MEDNOVA, a medical technology company. The logo consists of a stylized hexagon shape in blue and green, with the company name "MEDNOVA" written in blue and green letters below it. To the right of the hexagon is Chinese text in blue. The logo is clean and modern, and the colors are bright and eye-catching.
Medical Technology Co.,LTD.
Page: 3 / 8
endoscopic procedures. This device is intended to be used for not more than 24 hours. It is a 24-hour multi-patient use device.
The CO2 Source Tubing is intended to be used with a carbon dioxide (CO2) source with the purpose of supplying CO2 to the endoscope during endoscopic procedures. This device is intended to be used for not more than 24 hours. It is a 24-hour multi-patient use device.
8. Technological Characteristics:
Table 1 and 2 summarize the technological characteristics of the Air/Water Bottle Tubing and CO2 Source Tubing compared to the predicate device.
Table 1 Summary of design, features and principles of operation between the technological characteristics of the Air/Water Bottle Tubing compared to the predicate devices.
| Item | Proposed device | Predicate device | Comparison to
Predicate Devices |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Device name | Air/Water Bottle Tubing | Endo SmartCap™ Tubing | N/A |
| K number | / | K093665 | N/A |
| Manufacturer | Zhejiang Chuangxiang Medical
Technology Co., LTD. | Medivators, Inc | N/A |
| Product code | OCX | FAJ | N/A |
| Regulation
No. | 876.1500 | 876.1500 | Same |
| Regulatory
Classification | II | II | Same |
| Regulation
Description | Endoscope and accessories | Endoscope and accessories | Same |
| Page: 4 / 8 | | | |
| Indications for
Use | The Air/Water Bottle Tubing is to
connect an air/CO2 source, a
sterile water source (water
bottle), and an endoscope to
supply air/CO2 and water during
gastrointestinal endoscopic
procedures. This device is
intended to be used for not
more than 24 hours. It is a
24-hour multi-patient use device. | Endo SmartCap™ Tubing is
intended to be used with an air or
CO2 source and / or pump along
with a sterile water source to
supply air or CO2 and sterile water
to an gastrointestinal endoscope
during endoscopic procedures. | Substantial
Equivalent |
| Compatibility | OLYMPUS®140/240, 160/260,
180/280, 190/290 series Gl
endoscopes | OLYMPUS®140/240, 160/260,
180/280, 190/290 series Gl
endoscopes | Same |
| Materials | Polyvinyl Chloride,
Silicone,Polycarbonate, Nickel
plated brass, Polyoxymethylene,
MABS, Polyformaldehyde Resin,
Styrene Acrylonitrile, Styrene
Acrylonitrile | Methyl
methacrylate-acrylonitrile-butadi
ene-styrene copolymer,
Polycarbonate, Polyethylene,
Polyvinyl Chloride, Thermoplastic
Elastomer, Nitrile Butadiene
Rubber | Substantial
Equivalent |
| Environment
of Use | Hospital and or clinics | Hospital and or clinics | Same |
| Sterilization | EO gas | EO gas | Same |
| Packaging | Each model packed separately in
a seal pouched | Each model packed separately in
a seal pouched | Same |
| Manufacturin
g method | Injection molding | Injection molding | Same |
| Shelf Life | Three years (36months) | Three years (36months) | Same |
6
Image /page/6/Picture/1 description: The image shows the logo for MEDNOVA. The logo consists of a green and blue hexagon shape on the left, with the text "MEDNOVA" in green below it. To the right of the hexagon shape, there are three blue Chinese characters.
g Medical Technology Co.,LTD. Z
Table 2 Summary of design, features and principles of operation between the technological characteristics of the CO₂ Source Tubing compared to the predicate devices.
| Item | Proposed device | Predicate device | Comparison to
Predicate Devices |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| | | | Page: 5 / 8 |
| Device name | CO₂ Source Tubing | Endo SmartCap™ CO₂Source Tubing | N/A |
| K number | / | K093665 | N/A |
| Manufacturer | Zhejiang Chuangxiang Medical Technology Co., LTD. | Medivators, Inc | N/A |
| Product code | FCX | FAJ | N/A |
| Classification | II | II | Same |
| Regulation No. | 876.1500 | 876.1500 | Same |
| Regulation Description | Endoscope and accessories | Endoscope and accessories | Same |
| Supplied Sterile | No | No | Same |
| Supplied Sterile | No | No | Same |
| Indications for Use | The CO₂ Source Tubing is intended to be used with a carbon dioxide (CO₂) source with the purpose of supplying CO₂ to the endoscope during endoscopic procedures. This device is intended to be used for not more than 24 hours. It is a 24-hour multi-patient use device. | Endo SmartCap™ CO₂ Source Tubing with Luer Input is intended to be used with a CO₂ insufflator along with Endo SmartCap™ Irrigation Tubing or ENDOGATOR™ Hybrid Irrigation Tubing to supply CO₂ to a GI endoscope during GI endoscopic procedures | Substantial Equivalent |
| Environment of Use | Hospital and or clinics | Hospital and or clinics | Same |
| Materials | Polyvinyl Chloride, Polycarbonate, Polypropylene, Polytetrafluorethylene | Polycarbonate, Polyvinyl Chloride, high impact polystyrene, Polyethylene terephthalate, polytetrafluoroethylene | Substantial Equivalent |
| Packaging | Each model packed separately in a seal pouched | Each model packed separately in a seal pouched | Same |
| Manufacturin
g method | | | |
| Shelf Life | Three years (36months) | Three years (36months) | Same |
7
Image /page/7/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 gradient fill, transitioning from green at the bottom to blue at the top. Inside the hexagon, there is a stylized white shape. To the right of the geometric shape, there is text in blue that appears to be Chinese characters. Below the Chinese characters, there is the word "MEDNOVA" in a combination of blue and green.
Zhejiang Chuangxiang Medical Technology Co.,LTD.
8
Image /page/8/Picture/1 description: The image shows the logo for MEDNOVA. The logo consists of a green and blue hexagon shape on the left, with the text "MEDNOVA" in blue and green on the right. Above the text "MEDNOVA" are three blue Chinese characters.
Medical Technology Co.,LTD.
9. Non-clinical Performance Data
The bench testing was performed to support substantial equivalence. The following testing were performed on samples from initial lots, including sterilization.
9.1 Performance Test
9.1.1 Air/Water Bottle Tubing
- 9.1.1.1 Assembling Integrity
- 9.1.1.2 Two-Way Valve Integrity
- 9.1.1.3 Air Flow Test
- Water Flow Test 9.1.1.4
- 9.1.1.5 Air Leak Test
- 9.1.1.6 Flow Clamp Test
- 9.1.1.7 Water Backflow Test
- 9.1.1.8 24-Hour Use Test
- 9.1.1.9 Endoscope Compatibility
- 9.1.1.10 Compatibility With Bottle
9.1.2 CO2 Source Tubing
- 9.1.2.1 Assembling Integrity
- 9.1.2.2 Co2 Delivery Test
- 9.1.2.3 Water Delivery Test
- 9.1.2.4 Air Leak Test
- 9.1.2.5 Compatibility With Air/Water Bottle Tubing
9.2 Sterilization
The Air/Water Bottle Tubing is sold in a sterile package, like the predicate devices. The proposed devices have been sterilized in a validated EO sterilization cycle. The EO sterilization cycle has a Sterility Assurance Level (SAL) of 10 °. EO residuals on the components are below the maximum levels defined in ISO 10993-7:2008 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide sterilization residuals. The Air/Water Bottle Tubing, and the predicate devices, are not labeled as pyrogen-free because they do not have any blood or cerebrospinal fluid contact.
9
Image /page/9/Picture/1 description: The image contains a logo with a geometric shape in green and blue, followed by the text "创想医学" in blue. Below the Chinese characters, the word "MEDNOVA" is written in green. The text "Zhejiang Chuangxiang Medical Technology Co.,LTD." is written in a smaller font below the logo.
Page: 7 / 8
The CO2 Source Tubing is supplied in non-sterile.
9.3. Shelf Life
The Air/Water Bottle Tubing and the CO2 Source Tubing both have three (3) years shelf life, which have been validated in an accelerated testing according to ASTM F1980-21 and the requirements on packaging for terminally sterilized medical device per ISO 11607-1 Second Edition 2019-02 and ISO 11607-2 Second Edition 2019-02 have also met. The testing successfully demonstrated essential performance was achieved before and after the shelf life testing.
9.4. Biocompatibility
Biocompatibility testing has been performed to show that all patient contacting materials meet applicable biocompatibility standards per ISO 10993-1:2009 and 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". it included the following tests:
Acute Systemic Toxicity Test,
In Vitro Cytotoxicity Test,
Skin Sensitization Test
and Intracutraneous Reactivity
The Air/Water Bottle Tubing and the CO2 Source Tubing are classified as surface device with mucosal membrane contact for a limited duration (not more than 24 hours), the test result show that the proposed devices are biocompatible.
10. Clinical Testing
Similar devices have been on the market for many years with proven safety and effectiveness for the use of the device. These devices have no direct patient contact. Based on this history and the use of the device, clinical testing was not necessary to support substantial equivalence data. The non-clinical testing performed supports the safety and effectiveness of the devices and provides data to show substantial equivalence to the predicate device.
11. Conclusions
The Air/Water Bottle Tubing and CO2 Source Tubing have the same intended use as the predicate devices.
10
Image /page/10/Picture/1 description: The image shows a logo for a company called MEDNOVA. The logo consists of a geometric shape in shades of green on the left, followed by the company name in blue. The word "MEDNOVA" is written in a smaller font size below the Chinese characters.
ng Medical Technology Co.,LTD. Zhejiang Chua
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Based on the technological characteristics and overall performance of the devices in bench testing, Chuangxiang believes that no significant differences exist between the proposed devices and the predicate devices.
The proposed devices don't raise any new issues of safety and effectiveness.
From a clinical perspective and comparing design specifications, the proposed device Air/Water Bottle Tubing and CO2 Source Tubing, and the predicate device are substantially equivalent.