Arc EndoCuff and Arc EndoCuff Vision

K162205 · Boddingtons Plastics, Ltd. · FED · Dec 9, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K162205
• Device Name: Arc EndoCuff and Arc EndoCuff Vision
• Applicant: Boddingtons Plastics, Ltd.
• Product Code: FED · Gastroenterology, Urology
• Decision Date: Dec 9, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended 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

Device Story

Arc EndoCuff and Arc Endocuff Vision are single-use, cylindrical polymer devices attached to the distal end of an endoscope. The device features flexible 'hairs' (hinged arms) that collapse during intubation to minimize resistance and open during withdrawal to manipulate mucosal folds. This mechanism stabilizes the endoscope tip, facilitates loop reduction, and improves visualization by flattening mucosal folds and maintaining a consistent field of view. Used by physicians in clinical settings during colonoscopy; the device aids in identifying adenomas by maximizing viewable mucosa. It is manually applied and removed; it does not require electronic integration or software.

Clinical Evidence

Supported by a meta-analysis of clinical literature demonstrating a statistically significant and clinically relevant improvement in adenoma detection rates (ADR) in screening, surveillance, and diagnostic populations compared to unassisted colonoscopy.

Technological Characteristics

Cylindrical, all-polymer construction; utilizes two polymer materials for self-retention via internal ridges; features flexible hinged arms; supplied sterile via radiation; single-use; mechanical attachment to endoscope distal tip.

Indications for Use

Indicated for patients undergoing endoscopic procedures in the gastrointestinal tract, including screening, surveillance, and diagnostic colonoscopy, to assist in endoscope insertion and improve visualization of the bowel mucosa.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Arc EndoCuff (K122565)
• Arc Endocuff Vision (K151801)

Submission Summary (Full Text)

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

January 23, 2017

Boddingtons Plastics Ltd Sarah Gibson Regulatory Compliance Manager Unit 6 Pattenden Lane, Marden Tonbridge, Kent TN12 9QJ United Kingdom

Re: K162205

> Trade/Device Name: Arc EndoCuff and Arc Endocuff Vision Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FED Dated (Date on orig SE ltr): November 10, 2016 Received (Date on orig SE ltr): November 14, 2016

Dear Sarah Gibson:

This letter corrects our substantially equivalent letter of December 9, 2016

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially (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. 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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding 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 Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Benjamin R. Fisher -S

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

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### Indications for Use

510(k) Number (if known) K162205

Device Name

Arc EndoCuff and Arc Endocuff Vision

#### Indications for Use (Describe)

- 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

Type of Use (Select one or both, as applicable)

| <div> <span></span> <span></span>Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|--------------------------------------------------------------------------------------------|
| <div> <span></span> <span></span>Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# 510(k) Summary

# Summary of Safety and Effectiveness

## 510(k) number _K162205

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<br>Unit 6 Wheelbarrow Park Estate<br>Pattenden Lane<br>Tonbridge<br>Kent<br>TN12 9QJ<br>United Kingdom |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Sarah Gibson |
| Telephone: | [phone] |
| Fax: | [phone] |
| Email: | [e-mail] |
| Date of Summary: | 01st August 2016 |
| Device Name: | Arc EndoCuff and Arc Endocuff Vision |
| Proprietary Name: | Arc Endocuff Vision ARV110; ARV120; ARV130<br>and ARV140<br>Arc EndoCuff AEC110, AEC120, AEC130 and<br>AEC140 |
| 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 |
| Boddingtons Plastics Limited | Arc EndoCuff | AEC110, AEC120,<br>AEC130, AEC140 | K122565 |
| Boddingtons Plastics Limited | Arc Endocuff Vision | ARV110, ARV120,<br>ARV130, ARV140 | K151801 |

### Description

### Description of Device

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

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# Arc EndoCuff Vision

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

The Arc EndoCuff and Arc Endocuff Vision are cylindrical shaped all polymer products. They utilise the combined properties of two polymer materials to self-retain to the designated endoscope(s). The products feature a number of flexible "hairs" 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.

Both the Arc EndoCuff and Arc Endocuff Vision devices are manually pushed onto the tip of the endoscope. It is designed to grip the endoscope sufficiently so as to prevent dislodgment during the procedure but without causing damage to the endoscope. At the end of the procedure, the device is removed either manually or with a purpose designed disposable tool before the endoscope is reprocessed.

The endoscope fitted with the Arc EndoCuff or Arc Endocuff Vision is inserted into the intestine either through the anus or a stoma and is used in the standard manner. The EndoCuff stabilizes the tip of the instrument in the bowel lumen enabling the shaft of the Arc endoscope to be more easily straightened on pulling back so avoiding excessive looping. This is because the cuff maintains the position of the tip without having to angle it acutely against the bowel wall to gain purchase. The device does not hinder forward motion or cause trauma.

During extubation, the device enables tip withdrawal in a more controlled fashion and provides improved visualisation by opening up the intestinal lumen for careful examination. Mucosal folds are everted and flattened enabling a more complete view of the areas of the bowel wall that were hidden behind mucosal folds.

### 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

### Technological Characteristics

The purpose of this notification is to add additional marketing claims to the Arc EndoCuff and Arc Endocuff Vision, there are no new technological features incorporated in the devices.

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#### Conclusion

lt is concluded that the Arc EndoCuff and Arc Endocuff Vision remain safe and effective as the product design, materials and sterilisation methods remain unchanged from the original Premarket Notifications.

The expanded marketing claims are substantially equivalent and do not change fundamental scientific technology and intended use of the market cleared device. A Meta-Analysis of the Clinical literature supports the improvement of Adenoma Detection Rate claims.

### Marketing Claims

The marketing claims were supported via non-clinical performance testing, clinical data, or were based on the device design, will be included within the advertising and promotional materials for Arc EndoCuff and Arc Endocuff Vision, and are as follows;

| No. | Marketing Claims | Supporting Documentation |
|-----|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| 1 | Arc EndoCuff assisted colonoscopy results<br>in a statistically significant and clinically<br>relevant improvement in adenoma<br>detection rate in screening, surveillance,<br>and diagnostic populations, as compared<br>with unassisted colonoscopy. | Based on Clinical Data |
| 2 | Arc EndoCuff and Arc Endocuff Vision are<br>designed to increase ADR by manipulating<br>folds to maximize the viewable mucosa. | Based on Device Design<br>In addition, based on Clinical Data |
| 3 | The Arc EndoCuff and Arc Endocuff Vision<br>allows for controlled withdrawal. | Based on Device Design |
| 4 | The Arc EndoCuff and Arc Endocuff Vision<br>have been designed to minimize the<br>difficulties in loop reduction. | Based on Device Design |
| 5 | The Arc EndoCuff and Arc Endocuff Vision<br>are designed with an outer diameter to<br>provide increase wall apposition in the<br>colon. | Based on Device Design |

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#### boddingtons Arc EndoCuff Vision

| No. | Marketing Claims | Supporting Documentation |
|-----|----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| 6 | The hinged arms of the Arc EndoCuff and<br>Arc Endocuff Vision collapse into the body<br>to minimize intubation force and insertion<br>resistance. | Based on Device Design and In-vitro<br>testing. |
| 7 | The internal ridges provide a tight grip on<br>the distal end of the colonoscope and<br>minimize risk of dislodgement. | Based on Device Design and Clinical<br>Data. |
| 8 | The design is intended to minimize the risk<br>of mucosal trauma. | Based on Device Design and In-vitro<br>testing. |
| 9 | The Arc Endocuff Vision reduces the<br>likelihood of red-out. | Based on Device Design |