(320 days)
Not Found
No
The device description and performance studies focus on the physical components and their functionality in delivering fluids/gases, with no mention of AI/ML or data processing.
No.
The devices provide sterile water, CO2, and/or air to an endoscope, which are supportive functions for a diagnostic or interventional procedure, rather than directly treating a condition or disease.
No
The device is intended to provide sterile water, CO2, and/or air to an endoscope during gastrointestinal endoscopic procedures, which indicates an assistive or procedural function rather than a diagnostic one.
No
The device description explicitly states it is a "combination of tubes, fittings and valves," which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide sterile water, CO2, and/or air to an endoscope during a gastrointestinal endoscopic procedure. This is a procedural support device, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description confirms it's a system of tubes, fittings, and valves for delivering fluids and gases to an endoscope.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, the ENDOtube devices fall under the category of medical devices used to facilitate a medical procedure, not IVD devices.
N/A
Intended Use / Indications for Use
The ENDOtube devices are a combination of tubes, fittings and valves intended to provide sterile water and/or CO2 and/ or air to an endoscope during gastrointestinal endoscopic procedure. These devices are intended to be used by healtheare professional only. In procedure room, all ENDOtube devices are 24 hours use disposable products except the one-way valves which are single use products and the insufflation connectors which are multiple patient use.
Product codes
OCX
Device Description
The ENDOtube kits are a combination of tubes, fittings and valves intended to provide sterile water and/or CO2 and/or air to an endoscope during a GI endoscopic procedure.
The ENDOtube products are compatible with various endoscopes (FujiFilm® 500/600 series and 700 series, OLYMPUS® 140, 160, 180 and 190 and PENTAX®), and irrigation pumps (OLYMPUS®, Erbe® and EMED®).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intestinal mucosa
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professional, procedure room
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)
Non-clinical testing was performed. Testing included: connection and usability testing for endoscope column compatibility (with Olympus, Pentax, Fujifilm endoscopes), irrigation peristaltic pump compatibility (with Olympus, Erbe, Emed), insufflator compatibility (with Olympus UCR, Fujifilm GW-1 and GW-100), and universal water bottle cap presence and effectiveness. Leak test and usability testing for fluid supply (sterile water, air, CO2) was performed and passed. Cross-contamination test for one-way valve presence and effectiveness passed. Durability test for tube use period (multi-patient use, up to 24 hours) passed. Operational test for one-way valve use period (single use, up to 2 hours) passed. Performance test for device shelf-life (2 years) passed. Operational test for insufflation connector use period (multi-patient use) passed. Performance test for insufflation connector processing (reprocessable) passed. Sterilization validation for tube and valve sterilization (EO sterilization) passed. Biocompatibility testing (AAMI/ISO 10993) for main materials (biocompatible, inert metallic materials, elastomers and thermoplastic polymer) passed. Chemical characterization for no DEHP pass.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
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September 29, 2021
Nissha Medical Technologies SAS Roch Mignot Ouality & Regulatory Affairs Manager ZA Des Boutries 12 Rue Des Cayennes Conflans STE Honorine, Yvelines 78700 FRANCE
Re: K203350
Trade/Device Name: ENDOtube Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: OCX Dated: August 12, 2021 Received: August 19, 2021
Dear Roch Mignot:
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
1
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 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,
for
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) K203350
Device Name ENDOtube
Indications for Use (Describe)
The ENDOtube devices are a combination of tubes, fittings and valves intended to provide sterile water and/or CO2 and/ or air to an endoscope during gastrointestinal endoscopic procedure. These devices are intended to be used by healtheare professional only. In procedure room, all ENDOtube devices are 24 hours use disposable products except the one-way valves which are single use products and the insufflation connectors which are multiple patient use.
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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Image /page/3/Picture/0 description: The image contains the logo for "NISSHA MEDICAL TECHNOLOGIES". The word "NISSHA" is written in large, bold, blue letters. Below the word "NISSHA" is the phrase "MEDICAL TECHNOLOGIES" written in smaller, light gray letters. The logo is simple and modern.
SUBMITTER l.
NISSHA MEDICAL TECHNOLOGIES SAS
Z.A. DES BOUTRIES 12, RUE DES CAYENNES B.P. 310 78703 CONFLANS SAINTE HONORINE CEDEX France
Phone: +33 1 39 72 66 66 Fax: +33 1 39 72 61 61
Under registration number: 3004762958
A division of NISSHA MEDICAL TECHNOLOGIES
400 EXCHANGE STREET BUFFALO, NY 14204 United States of America Tel: 716.853.7500
Contact Person:
Roch MIGNOT, Quality and Requlatory Affairs Manager - France Tel: +33 1 39 72 77 - Cellphone: +33 7 85 19 39 07 Email: rmignot@nisshamedical.com
Date Prepared: October 30, 2020 Date Revised: December 30, 2020 Date Latest Reviewed: August 03, 2021
II. DEVICE
| Device / Property Name | ENDOtube |
|---|---|
| Common / Usual Name | Endoscopic tubing kit |
| Classification / Regulation Number 21CFR | 876.1500 |
| Classification Name | Endoscope and accessories |
| Product Code | OCX |
| Product Code Name | Endoscopic Irrigation/Suction System |
| Regulatory Class | II |
| Device Panel | Gastroenterology/Urology |
The ENDOtube products include several families as detailed bellow in VOL_002_Submission Context in the file 005_Product List and bellow.
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Image /page/4/Picture/0 description: The image shows the logo for Nissha Medical Technologies. The word "NISSHA" is written in large, bold, blue letters. Below the word "NISSHA" is the phrase "MEDICAL TECHNOLOGIES" in smaller, gray letters. The logo is simple and modern, and the colors are clean and professional.
| Family | Reference | Description |
|---|---|---|
| ENDOtube for Wash Bottle | S-FLO000001 | Sterile disposable tubing - Olympus Gl endoscopes |
| S-FLP000002 | Sterile disposable tubing - Pentax Gl endoscopes | |
| S-FLF000003 | Sterile disposable tubing - Fujifilm Gl endoscopes 5-600 series | |
| S-FLF000004 | Sterile disposable tubing - Fujifilm Gl endoscopes 700 series | |
| ENDOtube for Wash Bottle | S-FLO001CO2 | Sterile disposable tubing + CO2 option - Olympus Gl endoscopes |
| ENDOtube for Wash Bottle | S-FLP002CO2 | Sterile disposable tubing + CO2 option - Pentax Gl endoscopes |
| ENDOtube for Wash Bottle | S-FLF003CO2 | Sterile disposable tubing + CO2 option - Fujifilm Gl endoscopes 5-600 series |
| ENDOtube for Wash Bottle | S-FLF004CO2 | Sterile disposable tubing + CO2 option - Fujifilm Gl endoscopes 700 series |
| ENDOtube for Insufflation | S-TUBCO2LUER | CO2 insufflation sterile tubing with hydrophobic filter - Luer connection |
| S-TUBCO2FUJI | CO2 insufflation sterile tubing with hydrophobic filter - Adapter connection | |
| 04628 | Connection adapter for insufflator FUJIFILM GW-1 | |
| ENDOtube for Insufflation | 04700 | Connection adapter for insufflator OLYMPUS UCR |
| ENDOtube for Insufflation | 04712 | Connection adapter for insufflator FUJIFILM GW-100 |
| ENDOtube for Wash Pump | S-PLO000100 | Sterile disposable irrigation tubing - Emed pump/Olympus Gl endoscopes |
| S-PLO000300 | Sterile disposable irrigation tubing - Olympus pump/Olympus Gl endoscopes | |
| S-PLO000400 | Sterile disposable irrigation tubing - Endogator pump/Olympus Gl endoscopes | |
| S-PLO000600 | Sterile disposable irrigation tubing - Erbe pump/Olympus Gl endoscopes | |
| S-PLPPLF200 | Sterile disposable irrigation tubing - Emed pump/Pentax-Fujifilm Gl endoscopes | |
| S-PLPPLF500 | Sterile disposable irrigation tubing - Endogator pump/Pentax-Fujifilm Gl | |
| endoscopes | ||
| S-PLPPLF700 | Sterile disposable irrigation tubing - Erbe pump/Pentax-Fujifilm Gl endoscopes | |
| ENDOtube for Wash Pump | S-100100 | Sterile single use one-way water jet connector for Olympus |
| ENDOtube for Wash Pump | S-100300 | Sterile single use one-way water jet connector for Fujifilm |
| ENDOtube for Wash Bottle | ||
| CO2 Insufflation | S-FLOCO2LUER | Sterile ENDOtube for Wash Bottle with CO2 tubing - for Olympus/Luer Insufflator |
| Connection | ||
| S-FLOCO2FUJI | Sterile ENDOtube for Wash Bottle with CO2 tubing - for Olympus/Adapter | |
| Insufflator Connection | ||
| S-FLPCO2LUER | Sterile ENDOtube for Wash Bottle with CO2 tubing - for Pentax/Luer Insufflator | |
| Connection | ||
| S-FLPCO2FUJI | Sterile ENDOtube for Wash Bottle with CO2 tubing - for Pentax/Adapter | |
| Insufflator Connection | ||
| S-FLFCO2LUER | Sterile ENDOtube for Wash Bottle with CO2 tubing - for Fujifilm 5-600/Luer | |
| Insufflator Connection | ||
| S-FLFCO2FUJI | Sterile ENDOtube for Wash Bottle with CO2 tubing - for Fujifilm 5-600/Adapter | |
| Insufflator Connection | ||
| S-FLF7CO2LUER | Sterile ENDOtube for Wash Bottle with CO2 tubing - for Fujifilm 700/Luer | |
| Insufflator Connection | ||
| S-FLF7CO2FUJI | Sterile ENDOtube for Wash Bottle with CO2 tubing - for Fujifilm 700/Adapter | |
| Insufflator Connection |
PREDICATE DEVICE lll.
In order to properly cover the entire product range of the application, two predicates have been selected. The primary predicate is ENDOGATOR™ (K092429).
| Device Name | ENDOGATOR™ | ENDO SMART CAP™ |
|---|---|---|
| 510(k) Number | K092429 | K093665 |
| Class | II | II |
| Indications For Use | The ENDOGATOR™ system (tubing | |
| and accessories to accommodate | ||
| various endoscopes and irrigation | ||
| pumps) is intended to provide | ||
| irrigation via sterile water supply | ||
| during GI endoscopic procedures | ||
| when used in conjunction with an | ||
| irrigation pump (or cautery unit). | The ENDO SMARTCAP™ is | |
| intended to be used with an | ||
| air or CO2 source and/or a | ||
| pump along with a sterile | ||
| water source to supply air or | ||
| CO2 and sterile water to an | ||
| endoscope during endoscopic | ||
| procedures. |
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Image /page/5/Picture/0 description: The image shows the logo for Nissha Medical Technologies. The word "NISSHA" is written in large, bold, blue letters. Below the word "NISSHA", the words "MEDICAL TECHNOLOGIES" are written in smaller, gray letters. The logo is simple and modern.
IV. Device Description
IV.1. General
The ENDOtube kits are a combination of tubes, fittings and valves intended to provide sterile water and/or CO2 and/or air to an endoscope during a GI endoscopic procedure.
Visual description of ENDOtube products in the endoscopic column can be found in the Figure 1.
Image /page/5/Figure/7 description: The image shows a medical device with different tubes and components. There are three tubes labeled "Endo tube for insufflation", "Endo tube for wash bottle", and "Endo tube for wash pump". The tubes are connected to the medical device, which includes a monitor, a control panel, and a pump.
Figure 1: Visual description of the ENDOtube
The ENDOtube products are compatible with various endoscopes (FujiFilm® 500/600 series and 700 series, OLYMPUS® 140, 160, 180 and 190 and PENTAX®), and irrigation pumps (OLYMPUS®, Erbe® and EMED®).
IV.2. ENDOtube for Wash Bottle
The ENDOtube for Wash Bottle kits are a combination of tubes, fittings and valves intended to provide sterile water, air or CO2 to an endoscope during a GI endoscopic procedure.
The product is composed of at least two tubes bounded to a hermetic universal cap. The cap is screwed on a sterile water bottle. One tube is connected to the air output of the endoscopic column, and drive air into the bottle to put the sterile water bottle under is therefore forced into a second tube that is connected to the air/water channel of the endoscope. The device can also provide directly air or CO2 to the endoscope through another channel.
IV.3. ENDOtube for Wash Pump
The ENDOtube for Wash Pump kits are a combination of tubes, fittings and valves intended to provide sterile water to an endoscope through a peristaltic pump during a GI endoscopic procedure.
The product is composed of one or more tubes bounded one after another. On one extremity, the tube is inserted into sterile water bottle. On the other extremity the tube is connected to the water-jet channel of the endoscope. The central part is inserted into the pumping part of a peristaltic pump.
6
The ENDOtube for Wash Pump family contains also two independent single use one-way valves, used as an interface to connect the ENDOtube for Wash Pump tube to the endoscope waterjet channel.
ENDOtube for Insufflation IV.4.
The ENDOtube for Insufflation kits are a combination of tubes, fittings and filters intended to provide CO2 or air to an endoscope during a GI endoscopic procedure.
Form on side, the tube is connected to an independent CO2 or air supply. On the other side, it's connected to an ENDOtube for Wash Bottle. The product drive air or CO2 to put the sterile water bottle under pressure, to power it through the ENDOtube for Wash Bottle to the endoscope.
The ENDOtube for Insufflation family contains also three independent insufflation connectors used to adapt the ENDOtube for Insufflation tube to common independent CO2 or air supply devices.
IV.5. ENDOtube for Wash Bottle CO2 Insufflation
The ENDOtube for Wash Bottle CO2 Insufflation kits are a combination of tubes, fittings, valves and filters intended to provide sterile water and/or CO2 and/or air to an endoscope during a GI endoscopic procedure.
It's the combination of an ENDOtube for Wash Pump and an ENDOtube for Insufflation, bounded through a valve.
Indications for Use V.
The ENDOtube devices are a combination of tubes, fittings and valves intended to provide sterile water and/or CO2 and/or air to an endoscope during gastrointestinal endoscopic procedure. These devices are intended to be used by healthcare professional only. In procedure room, all ENDOtube devices are 24 hours use disposable products except the one-way valves which are single use products and the insufflation connectors which are multiple patient use.
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Image /page/7/Picture/0 description: The image shows the logo for Nissha Medical Technologies. The word "NISSHA" is in large, blue, sans-serif font. Below that, in a smaller, gray, sans-serif font, are the words "MEDICAL TECHNOLOGIES."
VI. Technological characteristics comparison
| Trade Name | ENDOtube (subject
device) | ENDOGATOR™
(primary predicate) | ENDO SMARTCAP™ |
|-------------------------------------------------------------|--------------------------------------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------|
| 510(k) number | K203350 | K092429 | K093665 |
| Intended Use | Endoscopic Accessories | Endoscopic Accessories | Endoscopic Accessories |
| Endoscope column
compatibility | OLYMPUS® GI
endoscopes 140, 160,
180 and 190 | OLYMPUS® GI
endoscopes 140, 160,
180 and 190 | OLYMPUS® GI
endoscopes 140, 160
and 180 |
| | PENTAX® GI endoscopes | PENTAX® GI endoscopes | PENTAX® GI endoscopes |
| | FUJIFILM® GI 500/600
series and 700 series
endoscopes | N/A | FUJIFILM® GI 500/600
series and 700 series
endoscopes |
| | OLYMPUS®, Erbe®,
EMED® | OLYMPUS®, Erbe®,
EMED® | OLYMPUS®, Erbe®,
EMED® |
| Irrigation peristatic
pump compatibility | OLYMPUS®, Erbe®,
EMED® | OLYMPUS®, Erbe®,
EMED® | OLYMPUS®, Erbe®,
EMED® |
| Insufflator compatibility | OLYMPUS® UCR,
FUJIFILM® GW-1 and
GW-100 | Not compatible with
OLYMPUS® or FUJIFILM®
GW-1 and GW-100 | N/A |
| Universal water bottle
cap | Common sterile water
bottle brands | Common sterile water
bottle brands | Common sterile water
bottle brands |
| Fluid supply | Sterile water; Air; CO2 | Sterile water | Sterile water; Air; CO2 |
| One-way valve (for
irrigation pump
compatible device) | Present | Present | Present |
| Tube use period | Multi-patient use,
without reprocessing
Up to 24 hours | Multi-patient use,
without reprocessing
Up to 24 hours | Multi-patient use,
without reprocessing
Up to 24 hours |
| One-way valve use
period | Single use
Up to 2 hours | Single use
Not communicated but
expected to be up to 2
hours | Single use
Not communicated but
expected to be up to 2
hours |
| Insufflation connector
use period | Multi-patient use | N/A | N/A |
| Insufflation connector
process | Reprocessable | N/A | N/A |
| Device shelf-life | 2 years | 2 years | 2 years |
| Tube and valve
sterilization | EO sterilization | EO sterilization | EO sterilization |
| Insufflation connector
sterilization | Non-sterile | N/A | N/A |
| Main materials | Biocompatible | Biocompatible | Biocompatible |
| | Inert metallic
materials, | Inert metallic
materials, | Inert metallic materials, |
| | elastomers and | elastomers and | elastomers and |
| | thermoplastic | thermoplastic | thermoplastic polymer |
| | polymer | polymer | |
| | Not made with DEHP | Contain DEHP | Contain DEHP |
| Device tissue contact | Intestinal mucosa
indirect contact for the
patient | Intestinal mucosa
indirect contact for the
patient | Intestinal mucosa
indirect contact for the
patient |
| | Skin direct contact for
the end-user | Skin direct contact for
the end-user | Skin direct contact for
the end-user |
| | PVC/Silicone | PVC/Silicone | PVC/Silicone |
| Tube materials | PVC/Silicone | PVC/Silicone | PVC/Silicone |
| Connector and valve
materials | SAN/ABS | SAN/ABS | SAN/ABS |
| Trade Name | ENDOtube (subject
device) | ENDOGATOR™
(primary predicate) | ENDO SMARTCAP™ |
| 510(k) number | K203350 | K092429 | K093665 |
| Bottle cap material | PC | PE/SAN | PE/SAN |
| Bottle cap seal material | TPU | Silicone | Silicone |
| Testing | Fluid and Pressure
Testing, flow rated data | Not provided in 510(k)
summary | Not provided in 510(k)
summary |
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Image /page/8/Picture/2 description: The image shows the logo for Nissha Medical Technologies. The word "NISSHA" is written in large, bold, blue letters. Below the word "NISSHA" is the phrase "MEDICAL TECHNOLOGIES" written in smaller, gray letters. The logo is simple and modern.
Substantial Equivalence Discussion VII.
Based on the above comparison of intended use, endoscope compatibilities, testing methods and construction materials employed, the subject device ENDOtube (multiple models) are substantially equivalent to the two named predicates. The main asset of a device that is intended to provide sterile water, air or CO2 to an endoscope are the safety of use and the compatibility of the product with the environment of a medical theater.
The comparison between ENDOtube devices and the predicates are mainly based on these attributes.
- Compatibility with the main endoscope, pump and sterile water bottle available on the market
- Ability to provide sterile water, air or CO2
- Sterilized, cross-contamination proof devices
- Main materials used
VIII. Non-clinical Testing Summary
| Description | Parameter | Test description | Conclusion |
|---|---|---|---|
| Endoscope | |||
| column | |||
| compatibility | OLYMPUS® GI endoscopes | ||
| 140, 160, 180 and 190 | Connection and usability testing | Pass | |
| PENTAX® GI endoscopes | Connection and usability testing | Pass | |
| FUJIFILM® GI 500/600 | |||
| series and 700 series | |||
| endoscopes | Connection and usability testing | Pass | |
| Irrigation peristaltic | |||
| pump compatibility | Olympus®, Erbe®, EMED® | Connection and usability testing | Pass |
| Insufflator | |||
| compatibility | OLYMPUS® UCR, | ||
| FUJIFILM® GW-1 and GW- | |||
| 100 | Connection and usability testing | Pass | |
| Universal water | |||
| bottle cap | Presence and effectiveness | Connection and usability testing | Pass |
| Fluid supply | Sterile water; Air; CO2 | Leak test and usability testing | Pass |
| One-way valve (for | |||
| irrigation pump | |||
| compatible device) | Presence and effectiveness | Cross-contamination test | Pass |
| Tube use period | Multi-patient use, without | ||
| reprocessing | |||
| Up to 24 hours | Durability test | Pass | |
| One-way valve use | Single use | Operational test | Pass |
- CONFIDENTIAL AND PROPRIETARY -ENDOtube 510(k) Traditional Submission
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| Description | Parameter | Test description | Conclusion |
|---|---|---|---|
| period | Up to 2 hours | ||
| Device shelf-life | 2 years | Performance test | Pass |
| Insufflation connector | |||
| use period | Multi-patient use | Operational test | Pass |
| Insufflation connector | |||
| processing | Reprocessable | Performance test | Pass |
| Tube and valve | |||
| sterilization | EO sterilization | Sterilization validation | Pass |
| Main materials | Biocompatible | Biocompatibility testing (AAMI/ISO 10993) | Pass |
| Inert metallic materials, | |||
| elastomers and | |||
| thermoplastic polymer | Biocompatibility testing (AAMI/ISO 10993) | Pass | |
| No DEHP | Chemical characterization | Pass |
Clinical Testing IX.
Not required for a finding of substantial equivalence.
X. Conclusion
Based on the above comparisons of intended use, endoscope, testing methods and construction materials employed, the subject device ENDOtube (multiple models) are substantially equivalent to the two named predicates. The main asset of a device that is intended to provide sterile water, air or CO2 to an endoscope are the safety of use and the compatibility of the product with the environment of a medical theater. The comparison between ENDOtube devices and the predicates are mainly based on these following attributes:
- Compatibility with the main endoscope, pump and sterile water bottle available on the market;
- Ability to provide sterile water, air or CO2;
- Sterilized, cross-contamination proof devices;
- Main materials used.
Therefore, the ENDOtube is substantially equivalent to the named predicate devices.