OpClear System

K171637 · Cipher Surgical, Ltd. · OCX · Feb 26, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K171637
• Device Name: OpClear System
• Applicant: Cipher Surgical, Ltd.
• Product Code: OCX · Gastroenterology, Urology
• Decision Date: Feb 26, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The OpClear® System consists of a reusable control unit and a range of disposable sterile single-use accessories intended to remove visual obstructions such as condensation, blood and other tissue particulates from the distal lens of a laparoscope during surgery and therefore maintaining a clear image of the surgical site.

Device Story

OpClear® System maintains laparoscopic surgical vision by cleaning distal lens of 10mm laparoscopes. System comprises reusable control unit and sterile, single-use disposable accessories. Surgeon operates pneumatic foot switch to trigger timed flows of CO2 and 0.9% saline to lens surface. CO2 delivery clears condensation; saline wash removes blood, fat, and tissue smears. Device used in hospital operating theatres by surgeons. Eliminates need to remove laparoscope from patient abdomen for manual cleaning, thereby reducing infection risk, surgical duration, and workflow interruptions. Output is maintained clear visual field on surgical monitor.

Clinical Evidence

Bench testing only. Performance validated in a simulated human abdominal cavity environment controlling pressure, atmospheric composition (CO2), temperature, humidity, and lighting. No clinical data presented.

Technological Characteristics

Control unit: painted aluminium enclosure, anodised aluminium manifold, power supply, control circuitry. Disposable: co-polyester moulding, PVC tubing, polypropylene/polyethylene wash cartridge. CO2 medical grade gas. Pneumatic footswitch. Sterilization: Ethylene Oxide (ISO 11135-2014). Electrical safety: IEC 60601-1:2005. EMC: IEC 60601-1-2:2007. Software: IEC 62304:2006.

Indications for Use

Indicated for adult patients undergoing laparoscopic surgery using 10mm laparoscopes to remove visual obstructions (condensation, blood, tissue particulates) from the distal lens to maintain surgical site visualization.

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

• Clear-Vu System (K080613)

Reference Devices

• WOM Insufflator 50L FM134 (K153513)
• 264305-20 electronic endoflator (K962863)

Submission Summary (Full Text)

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February 26, 2018

Cipher Surgical Ltd David Bentley Regulatory Consultant The Venture Centre, Sir William Lyons Road Coventry, West Midlands CV4 7EZ UK

Re: K171637

Trade/Device Name: OpClear® System Regulation Number: 21 CFR& 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCX, FEQ Dated: June 18, 2017 Received: June 23, 2017

Dear David Bentley:

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. 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.

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You must comply with all the Act's 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); 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.

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Charles Viviano -S

For 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known) K171637

Device Name

OpClear® System

Indications for Use (Describe)

The OpClear® System consists of a reusable control unit and a range of disposable sterile single-use accessories intended to remove visual obstructions such as condensation, blood and other tissue particulates from the distal lens of a laparoscope during surgery and therefore maintaining a clear image of the surgical site.

| | <span> <span style="font-family: Arial, sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</span> <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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# 510(k) SUMMARY

## Date Prepared: Feb 26, 2018

#### Submitters Information:

| Submitters Name | Cipher Surgical Limited |
|-----------------|----------------------------------------------------------------------------------------|
| Address | The Venture Centre<br>Sir William Lyons Road<br>Coventry CV4 7EZ<br>UK |
| Contact Person | Justin Buch<br>Operations Director<br>Tel: [phone]<br>[e-mail] |

#### Product Name:

| Trade or Proprietary Name OpClear® System | | |
|----------------------------------------------|----------------------------------------------|--|
| Common Name | Endoscope lens cleaning and defogging device | |
| Classification Name | Laparoscope, General and Plastic Surgery | |
| Classification | Class II | |
| Classification Regulation: | 21 CFR 876.1500 (Endoscope and accessories) | |
| Product code: | FEQ, OCX | |

## Predicate Devices:

The predicate device for the OpClear® System along with its 510(k) number is provided below:

| Device Name | Manufacturer | 510(k) Number |
|-----------------|-----------------------------------|---------------|
| Clear-Vu System | Minimally Invasive<br>Devices LLC | K080613 |

Traditional 510(k)- OpClear Cipher Surgical Ltd.

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## Device Description:

OpClear® System is a laparoscopic lens cleaning device which is intended to be used during any laparoscopic surgical procedure where there is a potential for contamination of the distal lens. Consisting of a reusable control unit and a range of sterile, invasive, single use disposables, it is intended to maintain surgical vision by removing contaminants such as condensation, blood, peritoneal fluid, smoke, fat and tissue smears that have contaminated the distal lens of the laparoscope during surgical procedures.

OpClear® System is composed of a control unit and a range of disposable accessories as shown below.

| Description | Part Number |
|----------------------|-------------|
| OpClear Control Unit | CS-CU15-03 |

#### OpClear® Control Unit

#### OpClear® Disposables

| Description | Part Number |
|----------------------------|-------------|
| OpClear 314mm x 10mm x 30° | CS-SZ10-30 |
| OpClear 314mm x 10mm x 0° | CS-SZ10-00 |
| OpClear 328mm x 10mm x 30° | CS-SR10-30 |
| OpClear 328mm x 10mm x 0° | CS-SR10-00 |
| OpClear 300mm x 10mm x 0° | CS-OS10-00 |

OpClear® System is for professional use in a theatre environment, during all Laparoscopic procedures. It is suitable for use in all adult patients who have been selected by their physician / surgeon for laparoscopic surgery using 10mm laparoscopes of a compatible length / type.

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## Indications for use:

The OpClear® System consists of a reusable control unit and a range of disposable sterile single-use accessories intended to remove visual obstructions such as condensation, blood and other tissue particulates from the distal lens of a laparoscope during surgery and therefore maintaining a clear image of the surgical site.

# Operating Principle:

During MIS, the laparoscope lens window is the surgeon's eyes and it can become covered in body fluids: peritoneal fluid, blood, and fat as well as tissue particulate or condensation impairing the surgeon's vision (via an external monitor/screen). Traditionally, cleaning the lens window of the laparoscope as a result of soiling required its removal of the laparoscope from the patient's abdomen which results in increased risk of infection, increased surgical duration, compromised surgeon workflow and compromised vision.

The OpClear® System uses carefully controlled timed flows of CO2 and saline delivered to the lens surface to maintain a clear vision and remove/reduce the need to remove the laparoscope during a surgical procedure.

## OpClear® Control Unit

The OpClear® Control Unit is a mains powered medical device which is connected to the electrical mains supply and to either a CO2 bottle or CO2 wall supply.

It supplies, on demand, CO2 to the distal lens of the laparoscope (via the OpClear® Disposable) and CO2 to operate the plunger of the sterile disposable wash cartridge.

The surgeon makes the selection of either demist function or wash function by operating a pneumatic foot switch control as and when required. Full details of the operation of the device are given in the instructions for use.

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### OpClear® Disposable

The OpClear® Disposable is a sterile, invasive, single use accessory to the OpClear® control unit, which is fitted to a compatible laparoscope immediately prior to the start of the surgical procedure. The disposable directs the CO2 and saline directly to the distal lens of the laparoscope in response to the surgeon's requirements. The CO2 supply from the control unit is used to propel the plunger of the refillable 0.9% saline cartridge (which forms part of the disposable) and deliver the saline at the desired time and position.

#### Materials:

## OpClear® Control Unit

The OpClear® control unit consists of a painted aluminium enclosure containing a power supply, control circuitry and an anodised aluminium manifold which supplies CO2.

## OpClear® Disposable

The OpClear® disposable consists of a co-polyester moulding which is bonded to the extruded PVC CO2 and saline supply tubes. The wash cartridge is formed of a polypropylene barrel with a polyethylene piston.

The co-polyester moulding is the only invasive part of the disposable.

## OpClear® Control Unit Specifications:

#### Applicable Gas: CO2 medical grade gas

- Maximum delivery pressure to OpClear® Control Unit less than 100bar ●
- Max delivery pressure from OpClear® Control Unit 1.25bar +/- 0.1bar. .

#### Weight and Dimensions OpClear® Control Unit

- Weight 4.8 kg. ●
- Height 70mm maximum, Width 330mm maximum, Depth 300mm maximum. ●

#### Footswitch

- Pneumatic switch with 3m tube
#### Alarm

- The OpClear® System alarms comply with IEC 60601-1-8. .

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Predicate Device and Reference Device Comparison Table:

| | Device | Predicate Device | Reference Devices | |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | OpClear® System | Clear-Vu System | WOM Insufflator 50L | 264305-20 electronic |
| | | | FM134 | endoflator |
| Manufacturer<br>Name | Cipher Surgical Ltd | Minimally Invasive<br>Devices LLC | World of Medicines<br>GmbH | Karl Storz |
| Device<br>Classification<br>Regulation | 21 CFR 876.1500 | 21 CFR 876.1500 | 21 CFR 884.1730 | 21 CFR 884.1730 |
| Common Name | Endoscope lens<br>cleaning and<br>defogging device | Endoscope lens<br>cleaning and defogging<br>device | Carbon Dioxide<br>Insufflator for<br>Laparoscopy and<br>Vessel Harvesting | Laparoscopic Insufflator |
| Classification<br>Name | Accessory,<br>Endoscope | Accessory, Endoscope | Insufflator Laparoscopic | Insufflator,<br>Laparoscopic |
| Product Code(s) | FEQ, OCX | GCJ, KOG | HIF, OSV | HIF |
| 510(k) | - | K080613 | K153513 | K962863 |
| | Device | Predicate Device | Reference Devices | |
| Device Name | OpClear® System | Clear-Vu System | WOM Insufflator 50L<br>FM134 | 264305-20 electronic<br>endoflator |
| Intended Use /<br>Indications for<br>Use | The OpClear® system<br>consists of a reusable<br>control unit and a<br>range of disposable<br>sterile single-use<br>accessories intended<br>to remove visual<br>obstructions such as<br>condensation, blood<br>and other tissue<br>particulates from the<br>distal lens of a<br>laparoscope during<br>surgery and therefore<br>maintaining a clear<br>image of the surgical<br>site. | The Clear-Vu System is<br>a single-use,<br>disposable<br>laparoscopic accessory<br>device that is intended<br>to facilitate intra-<br>operative defogging<br>and cleaning of the lens<br>of a laparoscope during<br>minimally-invasive<br>surgery while<br>maintaining<br>visualization of the<br>surgical site. | Intended for use during<br>diagnostic and/or<br>therapeutic endoscopic<br>procedures to distend a<br>cavity by filling it with<br>gas. The Standard,<br>Paediatric and Bariatric<br>operating modes of the<br>device are indicated to<br>fill and distend a<br>peritoneal cavity with<br>gas during a<br>laparoscopic procedure. | Designed to facilitate<br>the use of laparoscopes<br>by distending the<br>abdomen with CO2 gas<br>during laparoscopic<br>surgical and diagnostic<br>procedures. |
| Environment of<br>Use | Hospital Operating<br>Theatre | Hospital Operating<br>Theatre | Hospital Operating<br>Theatre | Hospital Operating<br>Theatre |
| Max CO2 flow<br>rate | 2.5 l/min continuous<br>6.4 l/min pulse | Dependent upon<br>concomitant insufflator | 50 l/min | 20 l/min |
| Max CO2<br>pressure | 27 mmHg | Dependent upon<br>concomitant insufflator | 30 mmHg | 30 mmHg |

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| | Device | Predicate Device | Reference Devices | |
|----------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Device Name | OpClear® System | Clear-Vu System | WOM Insufflator 50L<br>FM134 | 264305-20 electronic<br>endoflator |
| Cleaning<br>Solution | Saline 0.9% NaCl | Saline 0.9% NaCl | N/A | N/A |
| Compatible<br>Devices | Selected standard<br>rigid 10mm<br>laparoscopes with 0°<br>and 30° angle tips | Standard rigid 10mm<br>laparoscopes with 0°,<br>30° and 45° angle tips | N/A | N/A |
| Sterility | Single use<br>disposables -<br>Ethylene Oxide<br>sterilisation validated<br>in accordance with<br>ISO 11135-2014 | Radiation sterilisation -<br>ANSI / AAMI / ISO<br>11137-1:2006 | Ethylene Oxide<br>sterilisation validated in<br>accordance with ISO<br>11135-2007 | Reusable tubing<br>suitable for steam<br>sterilisation at 134°C |
| Electrical Safety | Independently tested<br>to IEC 60601-1:2005 | N/A | Independently tested to<br>IEC 60601-1:2005 | Complies with IEC<br>60601-1 |
| Electromagnetic<br>Compatibility | Independently tested<br>to<br>IEC 60601-1-2:2007 | N/A | Independently tested to<br>IEC 60601-1-2:2007 | Complies with IEC<br>60601-1 |
| Software<br>Controlled | Developed , tested<br>and verified to IEC<br>62304:2006 | N/A | Developed , tested and<br>verified to IEC<br>62304:2006 | Software controlled |

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## Summary of Non Clinical Testing:

The Device has been developed in the laboratory using a simulated human abdominal cavity environment which includes the ability to set pressure, atmospheric composition (CO2 rather than air), temperature, humidity and operational lighting environment. The suitability of this test chamber (as a simulation of the operating environment for the device) has been validated. The performance of OpClear® System has been optimised using this bench model. Performance validation has been performed following improvement in the operating parameters for the Device.

Traditional 510(k)- OpClear Cipher Surgical Ltd.

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