(133 days)
Not Found
No
The document describes irrigation tubing and does not mention any AI or ML components or functionalities.
No
The device is described as providing sterile water for irrigation and CO2 or air insufflation and lens flushing, which are procedural functions rather than direct therapeutic treatments.
No
This device is for irrigation and insufflation during endoscopic procedures, which are therapeutic and observational, not diagnostic. It provides fluids and gas, it does not analyze or detect medical conditions.
No
The device description clearly outlines physical components (tubing, bottle caps) and the performance studies focus on benchtop testing of flow and usability of physical handling, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for providing sterile water for irrigation, CO2 or air insufflation, and lens flushing during gastrointestinal/colono-endoscopy procedures. These are all procedures performed on the patient, not on a sample taken from the patient for diagnostic purposes.
- Device Description: The device description details tubing sets for delivering fluids and gases, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on in vitro testing.
- Anatomical Site: The anatomical site is the gastrointestinal tract, which is where the procedure is performed, not where a sample is collected for in vitro analysis.
In summary, the device is used during a medical procedure to facilitate visualization and manipulation within the body, not to perform diagnostic tests on samples outside the body. This aligns with the definition of a medical device used for treatment or diagnosis in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Irrigation Tubing with CO2 or Air is intended for use up to 24 hours, to provide sterile water for irrigation through the auxiliary channel (via an irrigation flushing pump when used with an Auxiliary Channel Adaptor) and CO2 or ar insufflation and lens flushing through the dual air-water channel (via a CO2 Gas Insufflator or Air pump supply) of compatible gastrointestinal/colono-endoscopes.
Product codes (comma separated list FDA assigned to the subject device)
OCX
Device Description
The proposed device consists of four separate labelled tube set devices in total, two tube sets (MAJ-2207 & MAJ-2208) designed to be used with CO2 with differing bottle cap thread variants: and two tube sets (MAJ-2209 & MAJ-2210) designed to be used with Air with differing bottle cap thread variants to fit a variety of on the market branded disposable sterile bottles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal/colono-endoscopes
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)
The following performance data were provided in support of the substantial equivalence determination. All standards applied are FDA recognised international standards.
Biocompatibility testing: The proposed Irrigation Tubing with CO2 or Air devices have an indirect contact with the patient delivering intermittent fluid or gas through the tubes into the gastrointestinal tract. Biocompatibility evaluation can be found in the following sub sections.
Electrical safety and electromagnetic compatibility (EMC): The proposed Irrigation Tubing with CO2 or Air does not contain any electronic components and is electrically inert and therefore EMC is not required.
Thermal Safety: The proposed Irrigation Tubing with CO2 or Air does not contain any electronic components and is electrically inert and therefore thermal safety is not required.
Animal and Clinical Studies: Clinical and animal studies were not necessary.
Software: The proposed Irrigation Tubing with CO2 or Air does not contain any software.
Performance Testing Bench: To demonstrate substantial equivalence KeyMed considered the following subject devices performance aspects in regards to the predicate device within the design verification and validation:
-
- Verification tests on flow performances were compared directly between the subject and predicate device through benchtop testing.
-
- Usability evaluation compared the handling, setup and operation directly between the subject and predicate device.
Basic safety and performance testing was performed in accordance with IEC standards in accordance with the design verification plan. Usability of the user interface was also assessed according to the design validation plan and IEC 62366-1:2015. In addition, verification and comparison bench studies were conducted to evaluate the functional performance.
Risk analysis was carried out in accordance with established internal acceptance criteria based on ISO 14971:2012.
Reprocessing: The proposed Irrigation Tubing with CO2 or Air are for use up to 24 hours, and are for multiple patients, with no reprocessing required between patients. This is thanks to the MAJ-1652 Auxiliary Channel Adaptor, which is intended for single-patient use and has a one way valve which acts as backflow prevention feature.
Key Results: The performance data support the safety of the devices and demonstrate that the subject devices comply with the recognised standards as specified.
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.
No reference devices were used in this submission.
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.
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April 6, 2020
KeyMed (Medical and Industrial Equipment) Ltd. % Mary Anne Patella Senior Specialist, Regulatory Affairs Olympus Surgical Tech America - Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772
K193250 Re:
Trade/Device Name: Irrigation Tubing with CO2 or Air Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCX Dated: February 26, 2020 Received: February 28, 2020
Dear Mary Patella:
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,
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) K193250
Device Name Irrigation Tubing with CO2 or Air
The Irrigation Tubing with CO2 or Air is intended for use up to 24 hours, to provide sterile water for irrigation through the auxiliary channel (via an irrigation flushing pump when used with an Auxiliary Channel Adaptor) and CO2 or ar insufflation and lens flushing through the dual air-water channel (via a CO2 Gas Insufflator or Air pump supply) of compatible gastrointestinal/colono-endoscopes.
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
2 510(k) Summary of Safety and Effectiveness
2.1 General Information
| Manufacturer: | KeyMed (Medical and Industrial Equipment) Ltd.
KeyMed House, Stock Road.
Southend-on-Sea, Essex, SS2 5QH, UK
Establishment Registration Number: 9611174 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Mary Anne Patella
Senior Specialist, Regulatory Affairs
Gyrus ACMI, Inc.
136 Turnpike Rd.
Southborough, MA 01772
Phone: (508) 804-2771
Email: MaryAnne.Patella@olympus-osta.com |
| | Establishment Registration Number: 3003790304 |
2.2 Device Identification
| Proprietary name: | Irrigation Tubing with CO2 or Air |
|---|---|
| Device Classification name: | Endoscopes and Accessories |
| Regulation Medical Specialty: | Gastroenterology/Urology |
| Regulations Number: | 21 CFR Part 876.1500 |
| Regulatory class: | Class II |
| Product code: | OCX |
2.3 Predicate Device
The proposed devices:
- MAJ-2207 Irrigation Tubing with CO2
- 트 MAJ-2208 Irrigation Tubing with CO2
- 트 MAJ-2209 Irrigation Tubing with Air
- 트 MAJ-2210 Irrigation Tubing with Air
are considered substantially equivalent to legally marketed device of K102855, 21 CFR 876.1500:
- . (100605) Universal Irrigation Solution Hybrid, Byrne Medical
No reference devices were used in this submission.
4
2.4 Product Description
The proposed device consists of four separate labelled tube set devices in total, two tube sets (MAJ-2207 & MAJ-2208) designed to be used with CO2 with differing bottle cap thread variants: and two tube sets (MAJ-2209 & MAJ-2210) designed to be used with Air with differing bottle cap thread variants to fit a variety of on the market branded disposable sterile bottles.
Indications for Use 2.5
The Irrigation Tubing with CO2/Air is intended for use for up to 24 hours, to provide sterile water for irrigation through the auxiliary channel (via an irrigation flushing pump when used with an Auxiliary Channel Adaptor) and CO2 or air insufflation and lens flushing through the dual air-water channel (via a CO2 Gas Insufflator or Air pump supply) of compatible gastrointestinal/colono-endoscopes.
Technological Characteristics 2.6
The Irrigation Tubing with CO2 or Air has the same intended use and technological characteristics as the predicate device Universal Irrigation Solution Hybrid, Byrne Medical (K102855) and any differences listed do not affect the criticality of intended use, safety or effectiveness of the device (See Table 2.1: Summary of Technological Characteristics).
| Technological
| Characteristics | Subject Device: | Predicate Device |
|---|---|---|
| Sterilisation Type | Ethylene Oxide (EO) | Ethylene Oxide (EO) |
| Length | 1550mm | 1840mm |
| Type of connection | Cap connection to sterile water | |
| bottles (1000ml). | Cap connection to sterile water bottles | |
| (1000ml). | ||
| Duration of Use | 24 hours | 24 hours |
| Number of patients | Multi Patient | Multi Patient |
Table 2.1: Summary of Technological Characteristics
2.7 Substantial Equivalence
Substantial equivalence is demonstrated by acknowledged verification/validation methodologies. The subject devices have equivalent technology, performance, dimensions and materials. The differences to the predicate device Universal Irrigation Solution Hybrid are:
- Subject devices market seperate Air and CO2 use variant. ■
- 트 Air variant does not include unneccessary (4th line) CO2 inlet line.
- 트 Optimised lengths to reduce the risk of trip hazard with excessive lengths.
- 트 Bottle cap component is two part rotatable cap.
- New PVC materials which contains less than 1% DEHP.
5
2.8 Performance Data
The following performance data were provided in support of the substantial equivalence determination. All standards applied are FDA recognised international standards.
2.8.1 Biocompatibility testing
The proposed Irrigation Tubing with CO2 or Air devices have an indirect contact with the patient delivering intermittent fluid or gas through the tubes into the gastrointestinal tract. Biocompatibility evaluation can be found in the following sub sections.
Electrical safety and electromagnetic compatibility (EMC) 2.8.2
The proposed Irrigation Tubing with CO2 or Air does not contain any electronic components and is electrically inert and therefore EMC is not required.
2.8.3 Thermal Safety
The proposed Irrigation Tubing with CO2 or Air does not contain any electronic components and is electrically inert and therefore thermal safety is not required.
2.8.4 Animal and Clinical Studies
Clinical and animal studies were not necessary.
2.8.5 Software
The proposed Irrigation Tubing with CO2 or Air does not contain any software.
Performance Testing Bench 2.8.6
To demonstrate substantial equivalence KeyMed considered the following subject devices performance aspects in regards to the predicate device within the design verification and validation:
-
- Verification tests on flow performances were compared directly between the subject and predicate device through benchtop testing.
-
- Usability evaluation compared the handling, setup and operation directly between the subject and predicate device.
Basic safety and performance testing was performed in accordance with IEC standards in accordance with the design verification plan. Usability of the user interface was also assessed according to the design validation plan and IEC 62366-1:2015. In addition, verification and comparison bench studies were conducted to evaluate the functional performance.
Risk analysis was carried out in accordance with established internal acceptance criteria based on ISO 14971:2012.
6
2.8.7 Reprocessing
The proposed Irrigation Tubing with CO2 or Air are for use up to 24 hours, and are for multiple patients, with no reprocessing required between patients. This is thanks to the MAJ-1652 Auxiliary Channel Adaptor, which is intended for single-patient use and has a one way valve which acts as backflow prevention feature.
| Standard No. | Standard Title | FDA-Recognition
no + date |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| ISO 10993-1:2018 | Biological evaluation of medical devices -- Part 1:
Evaluation and testing within a risk management process | 2-258
01/14/2019 |
| ISO 10993-5:2009 | Biological Evaluation of medical devices Part 5: Test for
in vitro cytotoxicity | 2-245
12/23/2016 |
| ISO 10993-7:2008 | Biological Evaluation of medical devices Part 7:
Ethylene oxide sterilization residuals | 14-408
01/30/2014 |
| ISO 10993-10:2010 | Biological Evaluation of medical devices Part 10: Tests
for Irritation and Skin Sensitization | 2-174
07/26/2016 |
| ISO 22442-1:2015 | Medical devices utilizing animal tissues and their
derivatives - Part 1: Application of risk management | 15-45
06/27/2016 |
| ISO 11135-1:2014 | Sterilization of health-care products. Ethylene oxide.
Requirements for the development, validation and
routine control of a sterilization process for medical
devices | 14-452
04/04/2016 |
| ISO 11607-1:2017 | Packaging for terminally sterilized medical devices --
Part 1: Requirements for materials, sterile barrier
systems and packaging systems | 14-454
01/27/2015 |
| IEC 60417:2002 DB | Graphical symbols for use on equipment - 12-month
subscription to regularly updated online database
comprising all graphical symbols published in IEC
60417 | 5-102
06/15/2016 |
| ISO 7000:2014 | Graphical symbols for use on equipment -- Registered
symbols | 5-103
06/15/2016 |
| ASTM F88 / F88M - 15 | Standard Test Method for Seal Strength of Flexible
Barrier Materials | 14-482
06/27/2016 |
| ASTM F2096 - 11 | Standard Test Method for Detecting Gross Leaks in
Packaging by Internal Pressurization (Bubble Test) | 14-359
01/15/2013 |
| ASTM F1929-15 | Standard Test Method for Detecting Seal Leaks in
Porous Medical Packaging by Dye Penetration | 14-484
06/27/2015 |
| ISO 80369-7:2016 | Small-bore connectors for liquids and gases in healthcare
applications. Connectors for intravascular or hypodermic
applications | 5-115
07/15/2019 |
2.8.8 Applied standards
Table 2.2: Applied standards
2.9 Conclusion
The performance data support the safety of the devices and demonstrate that the subject devices comply with the recognised standards as specified.
In summary, we believe the proposed Irrigation Tubing with CO2 or Air is substantially equivalent with the predicate device with respect to the general design approach, function, and the intended use. The proposed Irrigation Tubing with CO2
7
or Air raises no new concerns of safety or effectiveness when compared to the predicate device.