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.

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.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the "Irrigation Tubing with CO2 or Air" device, demonstrating its substantial equivalence to a predicate device. However, it does not contain detailed information about acceptance criteria or a study proving the device meets those criteria, as typically found in an AI/ML medical device submission.

The document pertains to an irrigation tubing device, which is a simple medical device, and not an AI/ML-driven device. Therefore, many of the requested categories (like number of experts for ground truth, MRMC study, training set sample size, etc.) are not applicable to this type of submission.

Based on the provided text, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

The document mentions "established internal acceptance criteria based on ISO 14971:2012" for risk analysis, and "design verification and validation" for performance. It also lists specific tests conducted. However, it does not provide a table detailing quantitative acceptance criteria (e.g., specific flow rates, leak tolerances) and the corresponding measured performance values.

Partial Information Available:

Acceptance Criteria Category	Reported Device Performance (Summary)
Flow Performance	Compared directly between subject and predicate device through benchtop testing. (No specific thresholds or measured values provided.)
Usability	Evaluation compared handling, setup, and operation directly between subject and predicate device. (No specific metrics or scores provided.)
Basic Safety & Performance	Performed in accordance with IEC standards and design verification plan. (No specific pass/fail criteria or results provided.)
Risk Analysis	Carried out in accordance with established internal acceptance criteria based on ISO 14971:2012. (No specific risk levels or mitigations detailed here.)
Biocompatibility	Evaluation conducted for indirect patient contact. (No specific criteria or pass/fail reported, just that testing was done.)
Sterilization	EO sterilization. (Compliance with ISO 11135-1:2014 implied by standard application.)
Packaging integrity	Testing performed (ASTM F88, F2096, F1929). (Compliance implied by standard application.)
Small-bore connectors	Compliance with ISO 80369-7:2016 implied by standard application.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not specified. The document mentions "benchtop testing" and "usability evaluation" but does not quantify the number of units or test iterations.
Data Provenance: Not applicable in the context of clinical data for an AI/ML device. For the performance testing bench, it refers to internal testing by KeyMed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable. This device is not an AI/ML device that requires expert-established ground truth for performance evaluation in the typical sense. Performance is assessed through engineering and physical tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable, as this is not an AI/ML device requiring human adjudication of performance.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is not an AI/ML product.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable in the context of clinical ground truth for an AI/ML device. For this physical device, "ground truth" would be established through engineering specifications, material properties, and physical measurements against defined standards.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML device and does not have a training set.

9. How the ground truth for the training set was established:

Not applicable. This device is not an AI/ML device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a symbol of the agency's mission to protect and promote public health through the regulation and supervision of food safety, tobacco, pharmaceuticals, medical devices, and other related products.

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

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

{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, UKEstablishment Registration Number: 9611174
Official Correspondent:	Mary Anne PatellaSenior Specialist, Regulatory AffairsGyrus ACMI, Inc.136 Turnpike Rd.Southborough, MA 01772Phone: (508) 804-2771Email: 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

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).

TechnologicalCharacteristics	Subject Device:	Predicate Device
Sterilisation Type	Ethylene Oxide (EO)	Ethylene Oxide (EO)
Length	1550mm	1840mm
Type of connection	Cap connection to sterile waterbottles (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:

1. Verification tests on flow performances were compared directly between the subject and predicate device through benchtop testing.
1. 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-Recognitionno + date
ISO 10993-1:2018	Biological evaluation of medical devices -- Part 1:Evaluation and testing within a risk management process	2-25801/14/2019
ISO 10993-5:2009	Biological Evaluation of medical devices Part 5: Test forin vitro cytotoxicity	2-24512/23/2016
ISO 10993-7:2008	Biological Evaluation of medical devices Part 7:Ethylene oxide sterilization residuals	14-40801/30/2014
ISO 10993-10:2010	Biological Evaluation of medical devices Part 10: Testsfor Irritation and Skin Sensitization	2-17407/26/2016
ISO 22442-1:2015	Medical devices utilizing animal tissues and theirderivatives - Part 1: Application of risk management	15-4506/27/2016
ISO 11135-1:2014	Sterilization of health-care products. Ethylene oxide.Requirements for the development, validation androutine control of a sterilization process for medicaldevices	14-45204/04/2016
ISO 11607-1:2017	Packaging for terminally sterilized medical devices --Part 1: Requirements for materials, sterile barriersystems and packaging systems	14-45401/27/2015
IEC 60417:2002 DB	Graphical symbols for use on equipment - 12-monthsubscription to regularly updated online databasecomprising all graphical symbols published in IEC60417	5-10206/15/2016
ISO 7000:2014	Graphical symbols for use on equipment -- Registeredsymbols	5-10306/15/2016
ASTM F88 / F88M - 15	Standard Test Method for Seal Strength of FlexibleBarrier Materials	14-48206/27/2016
ASTM F2096 - 11	Standard Test Method for Detecting Gross Leaks inPackaging by Internal Pressurization (Bubble Test)	14-35901/15/2013
ASTM F1929-15	Standard Test Method for Detecting Seal Leaks inPorous Medical Packaging by Dye Penetration	14-48406/27/2015
ISO 80369-7:2016	Small-bore connectors for liquids and gases in healthcareapplications. Connectors for intravascular or hypodermicapplications	5-11507/15/2019

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.

Regulation Number and Section

§ 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.