The Arc EndoCuff is designed to fit specific endoscopes (as designated on the packaging), and is supplied sterile following radiation sterilization and is single use only.

AI/ML Overview

The provided 510(k) summary for the Arc EndoCuff does not describe quantitative acceptance criteria or a study designed to rigorously prove that the device meets such criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices through qualitative comparisons and bench testing.

Here's an analysis of the provided information based on your requested categories:

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

No explicit quantitative acceptance criteria are provided in the document, nor are specific performance metrics reported against such criteria. The document states:

"The bench testing demonstrates that the Endocuff design combines some of the benefits of both being a slim cylindrical device (like the Olympus product) and being able to stabilise and view the mucosa effectively on a greater diameter (as does the Fujinon balloon) but within the one product."

And concludes:

"The performance data showed that the sterilisation method selected...has not introduced any additional risks and the patient contacting materials have been tested for biocompatibility with reports demonstrating no negatives in safety or effectiveness."

"The bench testing has demonstrated that the device does not introduce any additional risks when undertaking endoscopic therapy and meeting the intended use."

These statements are qualitative and comparative, focusing on the absence of additional risks and meeting intended use, rather than predefined measurable acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes "bench testing" but does not specify a "test set" in the context of clinical data, as it's not a clinical study. The testing appears to be primarily laboratory-based to assess material properties, sterilization effectiveness, and mechanical characteristics. Therefore, sample sizes for a patient test set are not applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as this was not a clinical study involving diagnosis or interpretation where expert ground truth would be established. The evaluations described ("bench testing") would likely involve engineers and materials scientists ensuring the device's physical and functional properties meet design specifications and are comparable to predicates.

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

Not applicable, as this was not a clinical study requiring adjudication of expert interpretations.

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 a mechanical accessory (EndoCuff) for an endoscope, not an AI or imaging interpretation device. Therefore, MRMC studies and "human readers improving with AI" are not relevant to this submission.

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

Not applicable. This is not an algorithm or AI-based device.

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

The concept of "ground truth" as typically used in AI or diagnostic device evaluations (e.g., pathology, clinical outcomes) is not directly applicable. For "bench testing," the "truth" would be established by validated engineering specifications, material standards (e.g., USP Class VI for biocompatibility), and direct physical measurements or observations of device function and integrity under controlled conditions.

8. The sample size for the training set

Not applicable. This is not an AI or machine learning device that requires a training set.

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

Not applicable.

Overall Conclusion on Acceptance Criteria and Study:

The Arc EndoCuff 510(k) summary primarily demonstrates substantial equivalence to existing legally marketed devices (Olympus Distal Attachment and Fujinon BS-2 balloon). The "study" referenced is bench testing, which compared the "design," "materials," and "size" of the EndoCuff to its predicates. The performance data focused on proving that:

The device combines benefits of both predicate types (slim cylindrical + ability to stabilize/view mucosa effectively).
The sterilization method does not introduce additional risks.
Biocompatibility testing showed no negatives in safety or effectiveness for patient-contacting materials.
The device does not introduce additional risks during endoscopic therapy and meets its intended use.

The acceptance criteria implicitly derive from the predicate devices' established safety and effectiveness. The "study" (bench testing) was deemed sufficient to show that the minor technological differences "do not raise different questions of safety and effectiveness" and that the device is "as safe and effective" as the predicates. No specific quantitative performance metrics or clinical study results against predefined acceptance criteria are provided because the regulatory pathway chosen emphasizes equivalence rather than novel performance claims.

Summary

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SEP 4 2012

510(k) Summary

Summary of Safety and Effectiveness

510(k) number_ كا2256) 510

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

Summary

Submitter's Identification:	Boddingtons Plastics Ltd

	Unit 6 Wheelbarrow Park Estate
	Pattenden Lane
	Tonbridge
	Kent
	TN12 9QJ
	United Kingdom
Contact:	John Bovis
Telephone:	+44 1622 833700
Fax:	+44 1622 833701
Email:	John.bovis@boddingtons.co.uk
Date of Summary:	11th May 2012
Device Name:	EndoCuff
Proprietary Name:	Arc EndoCuff AEC 110; AEC 120; AEC 140
Classification:	Endoscope and/or accessories
Product Code:	FED
Product Class:	II
Code of Federal Regulation:	21 CFR 876.1500
Panel	Gastroenterology and Urology

Substantial Equivalence:
Manufacturer	Trade Name	Model	510(k) Number
Olympus Optical Co.Ltd	Olympus DistalAttachment	MH & D-201 Series	K984358
Fujinon Corporation	Fujinon EC-450815(BS-2 Balloon only)	BS-2 Balloon	K090116

Device Cross-Reference
Arc EndoCuff	MH-Series(K984358)	D-201(K984358)	BS-2 Balloon(K090116)
Model No. AEC 110	MH-463	D-201-13404	BS-2 Balloon
Model No. AEC 120	MH-466	D-201-14304	BS-2 Balloon
Model No. AEC 140	MH-466	D-201-15004	BS-2 Balloon

lssue 2

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Description

Description of Device

The Arc EndoCuff has a short tube like shape with flexible hairs and is attached to the distal end of the endoscope to facilitate endoscopic therapy.

The Arc EndoCuff is designed to fit specific endoscopes (as designated on the packaging), and is supplied sterile following radiation sterilization and is single use only.

Indications for Use:

To be attached to the distal end of the endoscope to facilitate endoscopic therapy, to be used for the following:

Keeping the suitable depth of endoscope's view field
Helping the endoscope with being inserted into the gastrointestinal tract �

Summary of the Technological Characteristics of the Device compared to the Predicate Device

Design

The EndoCuff are a cylindrical shaped all polymer products. It utilises the combined properties of two polymer materials to self-retain to the designated endoscope(s). The product features a number of flexible "hair" features that fold within the structure of the product during intubation and forward movement when in use, and open out when drawn backward to control field of view.

Materials

EndoCuff raw materials have been purpose chosen as conforming to USP class VI and tested for biocompatibility (See Section 15).

Size:

The product is similar in bodily size and cylindrical shape to the products seen in both the Olympus Reusable (MH Series K984358) and Single-use (D-201 Series K984358) Distal Attachment model ranges.

The flexible hair features work at a similar diameter to the size of the 200 predicate Fujinon BS-2 balloon (when inflated).

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Summary of the Determination of Substantial Equivalence & Performance Data

The EndoCuff is used to maintain and maximise the endoscopes field of view during endoscopic therapy by manipulating colonic folds, maintaining a central position in the lumen and avoiding sudden slippage. The nominated predicate devices maximise the field of view in the same way, in particular:

. The Olympus Distal Attachment (MH Series and D-201 series K984358), is used to manipulate colonic folds; and
. The Fujinon BS-2 balloon (K090116) maintains central position in the lumen and avoids slippage by exerting circumferential pressure.

The bench testing demonstrates that the Endocuff design combines some of the benefits of both being a slim cylindrical device (like the Olympus product) and being able to stabilise and view the mucosa effectively on a greater diameter (as does the Fujinon balloon) but within the one product.

The design of the device is similar in length and is cylindrical in shape. Like both types of predicate devices, flexible polymers are the means for attachment/retention to the distal end of an endoscope.

The device contacts the patient in the same way and for the same period of time however they are made from different materials and are sterilised (where appropriate) using different methods.

The performance data showed that the sterilisation method selected (Arc EndoCuff is irradiated and the D-201 Series is Ethylene Oxide sterilised K984358) has not introduced any additional risks and the patient contacting materials have been tested for biocompatibility with reports demonstrating no negatives in safety or effectiveness

The bench testing has demonstrated that the device does not introduce any additional risks when undertaking endoscopic therapy and meeting the intended use.

Conclusion

After a review of the bench testing, it is concluded that the Arc EndoCuff is as safe and effective as the predicate devices for facilitating endoscopic therapy.

There are a few minor technological differences, in both materials used and the design. However the bio-compatibility testing shows that no additional risks are introduced from the materials used, and the performance testing demonstrates that there are no design weaknesses that could affect safety or effectiveness. There are no new indications for use and therefore by following the FDA 510(k) "Substantial Equivalence" decision making process,

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourD evice/PremarketSubmissions/PremarketNotification510k/ucm134783.htm

it is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

SEP 4 2012

Mr. Satish Champaneri Technical Reviewer BSI Healthcare Kitemark Court, Davy Avenue, Knowlhill MILTON KEYNES MK5 8PP UNITED KINGDOM

Re: K122565

Trade/Device Name: Arc EndoCuff AEC110; AEC120; AEC140 Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FED Dated: August 22, 2012 Received: August 22, 2012

Dear Mr. Champaneri:

We have reviewed your Section 510(k) premarket notification of intent to market the device w oneve a rowe 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 10 abs been and 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 (Act that do not require approval of a premarket approval application (PMA). Tou may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may), ate of novisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adviseration. 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 r source a view a determination that your device complies with other requirements of the Act that I Dr Hab Intacted and regulations administered by other Federal agencies. You must or ury reachard the Act's requirements, including, but not limited to: registration and listing Configry with an the Pre-Brequirence) at 801); medical device reporting (reporting of medical

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Page 2 -

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de rico-related daverse ovenas) (21 CFR Part 820); and if applicable, the electronic for in the quality by belies (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire operatio ad 110 coutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for go to mep., www.radiological Health's (CDRH's) Office of Compliance. Also, please the Conton Do 1000 and Radiovanding by reference to premarket notification" (21CFR Part note the regalation onlines and ing the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the rou may ocain outsi generers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerély yours,

Sincerely yours,

Benjamin K. Kirk

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Arc EndoCuff

510(k) number_K 122565

Indications for Use

510(k) Number (if known):

Device Name:

Arc EndoCuff AEC110; AEC120; AEC140

Indications for Use:

To be attached to the distal end of the endoscope to facilitate endoscopic therapy, to be used for the following:

Keeping the suitable depth of endoscope's view field .
Helping the endoscope with being inserted into the gastrointestinal tract .

No Over the Counter Use And/Or Prescription Use Yes

(21 CFR Part 801 Subpart D)

(21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

(Division Sign-off) currence of CDRH, Office of Device Evaluation (ODE)

Division of Reproductive, Gastro-Renal, and

Urological Devices

510(k) Number	K122565
---------------	---------

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.