The OpClear® Platform consists of a reusable control unit and a range of disposable sterile single-use accessories intended to remove visual obstructions on the distal window of laparoscopes, such as condensation, blood and other tissue particulates, therefore maintaining a clear image of the surgical site.

The OpClear ®Platform is indicated for use in abdominal laparoscopy.

Device Description

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

Description	Part Number
OpClear Control Unit with footswitch	CS-CU33

OpClear® Disposables

OpClear Part #	Diameter	Angle	WorkingLength
CS-10-00-300	10 mm	0°	300 mm
CS-10-30-300	10 mm	30° / 45°	300 mm
CS-10-00-315	10 mm	0°	315 mm
CS-10-30-315	10 mm	30° / 45°	315 mm
CS-10-00-330	10 mm	0°	330 mm
CS-10-30-330	10 mm	30° / 45°	330 mm
CS-05-00-290	5 mm	0°	290mm
CS-05-30-290	5 mm	30° / 45°	290mm
CS-05-00-300	5 mm	0°	300mm
CS-05-30-300	5 mm	30° / 45°	300mm
CS-05-00-315	5 mm	0°	315mm
CS-05-30-315	5 mm	30° / 45°	315mm

AI/ML Overview

This document describes the OpClear® Platform, a laparoscopic lens cleaning device. The submission is a 510(k) for substantial equivalence to an existing predicate device (OpClear® System, K171637). The information provided focuses on the device's technical specifications and comparison to the predicate, rather than a clinical study evaluating its performance against specific acceptance criteria.

Therefore, I cannot fully address all aspects of your request, particularly those related to a clinical study and its acceptance criteria, as such a study is not detailed in the provided text. However, I can extract information related to non-clinical testing and the comparison between the device and its predicate.

Here's a breakdown of what can and cannot be answered based on the provided text:

What can be extracted:

Acceptance Criteria (Implied Non-Clinical): The document implies that the "suitability" and "performance" of the OpClear® Platform in a simulated abdominal cavity environment were validated by comparing them to the predicate device. However, specific numerical acceptance criteria for performance (e.g., minimum clarity achieved, cleaning time) are not explicitly stated.
Reported Device Performance (Non-Clinical): The document states that "The performance of the predicate device, OpClear® System and the subject device, OpClear® Platform, have been validated using the same bench model." It then concludes that "The proposed device has the same principles of operation and technological characteristics as the predicate device" and "does not adversely affect safety or effectiveness." This indicates that its performance in the simulated environment was considered comparable or equivalent to the predicate. Specific metrics are not provided.
Sample Size for Test Set: For non-clinical testing, it mentions "a simulated human abdominal cavity environment." The "sample size" for this bench model is not quantifiable in terms of patient numbers.
Data Provenance: The "test" (non-clinical validation) was conducted in a "laboratory." No country of origin for the "data" (results of the bench testing) is specified, nor is whether it was retrospective or prospective.
Adjudication Method: Not applicable for non-clinical bench testing.
MRMC Comparative Effectiveness Study: Not described. The document focuses on non-clinical bench testing and a comparison to a predicate device for substantial equivalence, not a clinical MRMC study.
Standalone Performance: The non-clinical testing appears to evaluate the device's functional performance in a simulated environment, which could be considered a form of standalone testing, but no specific metrics are given.
Type of Ground Truth (Non-Clinical): The ground truth for the non-clinical testing was based on the performance of the predicate device in the same simulated environment, implying that the predicate's performance was the established baseline for "clearness" or "effectiveness" in that setting.
Sample Size for Training Set: Not applicable. This device is hardware for cleaning, not an AI/ML algorithm that requires a training set in the typical sense.
How Ground Truth for Training Set was Established: Not applicable.

What cannot be extracted (due to lack of information in the document):

Explicit numerical acceptance criteria for clinical performance.
Detailed clinical performance metrics (e.g., success rates, cleaning duration in vivo).
Sample size for a clinical test set (as no clinical study is described).
Number of experts, qualifications of experts, or adjudication methods for establishing ground truth in a clinical context.
Effect size of human readers improving with AI vs. without AI assistance (as no AI component or human reader study is discussed).

Based on the provided text, here is the information that can be extracted, primarily pertaining to the non-clinical validation:

1. Table of Acceptance Criteria and Reported Device Performance

Criterion Type (Implicit Non-Clinical)	Acceptance Criteria (Implicit)	Reported Device Performance
Functional Performance	Device maintains clear vision by removing visual obstructions (condensation, blood, tissue particulates) in a simulated abdominal cavity environment, comparably to the predicate device.	"The performance of the predicate device, OpClear® System and the subject device, OpClear® Platform, have been validated using the same bench model." "The proposed device has the same principles of operation and technological characteristics as the predicate device." "OpClear® Platform does not adversely affect safety or effectiveness."
Safety & Biocompatibility	No adverse safety or effectiveness issues, with materials comparable to predicate.	"There are no significant changes to the materials, dimensions (except for the diameter) or to the assembly process of the disposables. No new biocompatibility testing is deemed to be required as compared to the predicate device."
Electrical Safety	Compliance with IEC 60601-1:2005.	"Independently tested to IEC 60601-1:2005."
Electromagnetic Compatibility	Compliance with IEC 60601-1-2-2014.	"Independently tested to IEC 60601-1-2-2014."
Software Control	Developed, tested, and verified to IEC 62304-2015.	"Developed, tested and verified to IEC 62304-2015."
Sterility	Single-use disposables sterilized with Ethylene Oxide in accordance with ISO 11135-2014.	"Single use disposables - Ethylene Oxide sterilisation validated in accordance with ISO 11135-2014."

2. Sample Size Used for the Test Set and Data Provenance

Test Set Description: Non-clinical bench testing was performed using "a simulated human abdominal cavity environment."
Sample Size: Not quantifiable in terms of patient samples; it's a simulated environment. The number of tests performed within this simulation is not specified.
Data Provenance: The testing was conducted in a "laboratory." The country of origin is not specified, nor is whether the data was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable for this non-clinical bench testing. The "ground truth" for comparison was the performance of the predicate device in the same simulated environment.

4. Adjudication Method for the Test Set

Not applicable for this non-clinical bench testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not described or presented in this document. The submission focuses on substantial equivalence based on technical characteristics and non-clinical bench testing.

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

The non-clinical "Summary of Non Clinical Testing" describes the device's functional performance in a simulated environment. This can be considered a form of standalone performance evaluation for the device's physical function (cleaning capability), but it's not "algorithm only" and doesn't involve "human-in-the-loop" as in AI-assisted diagnosis.

7. The Type of Ground Truth Used

For the non-clinical testing, the "ground truth" was established by comparing the performance of the new OpClear® Platform to the legally marketed predicate device (OpClear® System) within the simulated abdominal cavity environment. The predicate's validated performance implicitly served as the acceptable standard.

8. The Sample Size for the Training Set

Not applicable. The OpClear® Platform is a hardware device for laparoscopic lens cleaning; it does not involve AI/ML algorithms that require a "training set" in the computational sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI/ML algorithm.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 19, 2022

Cipher Surgical Limited Krupa Srivastava Regulatory Consultant The Venture Centre, Sir William Lyons Road Coventry, West Midlands CV4 7EZ UNITED KINGDOM

Re: K221824

Trade/Device Name: OpClear Platform (CU3 DI3), OpClear Control Unit with Footswitch (CS-CU33), OpClear Disposable Procedure Kits (CS-10-00-300, CS-10-30-300, CS-10-00-315, CS-10-30-315, CS-10-00-330, CS-10-30-330, CS-05-00-290, CS-05-30-290), CS-05-00-300, CS-05-30-300, CS-05-00-315, CS-05-30-315 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OCX, FEQ Dated: June 21, 2022 Received: June 23, 2022

Dear Krupa Srivastava:

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

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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 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-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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-devices/medical-device-safety/medicaldevice-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-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-devices/device-advicecomprehensive-regulatory-assistance/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. 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

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Indications for Use

510(k) Number (if known) K221824

Device Name OpClear® Platform

Indications for Use (Describe)

The OpClear ®Platform is indicated for use in abdominal laparoscopy.

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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510(k) Summary

Cipher Surgical OpClear® Platform

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510(k) SUMMARY

Date Prepared: 21 June 2022

Submitters Information:

Submitters Name	Cipher Surgical Limited
Address	The Venture CentreSir William Lyons RoadCoventry CV4 7EZUK
Contact Person	Justin BuchOperations DirectorTel: +44 2477 170700jbuch@ciphersurgical.com

Product Name:

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

Predicate Device:

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

Device Name	Manufacturer	510(k) Number
OpClear®System	Cipher Surgical Ltd.	K171637

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Device Description:

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

Description	Part Number
OpClear Control Unit with footswitch	CS-CU33

OpClear® Disposables

OpClear Part #	Diameter	Angle	WorkingLength
CS-10-00-300	10 mm	0°	300 mm
CS-10-30-300	10 mm	30° / 45°	300 mm
CS-10-00-315	10 mm	0°	315 mm
CS-10-30-315	10 mm	30° / 45°	315 mm
CS-10-00-330	10 mm	0°	330 mm
CS-10-30-330	10 mm	30° / 45°	330 mm
CS-05-00-290	5 mm	0°	290mm
CS-05-30-290	5 mm	30° / 45°	290mm
CS-05-00-300	5 mm	0°	300mm
CS-05-30-300	5 mm	30° / 45°	300mm
CS-05-00-315	5 mm	0°	315mm
CS-05-30-315	5 mm	30° / 45°	315mm

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The OpClear® Platform is for professional use in a theatre environment and is indicated for use in abdominal laparoscopy. It is suitable for use in all Patients aged 12 years old and above who have been selected by their physician / surgeon for laparoscopic surgery using 10mm and 5mm laparoscopes of a compatible length / type.

Indications for use:

The OpClear® Platform is indicated for use in abdominal laparoscopy.

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® Platform 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.

The OpClear® Disposable is available in both 10 mm and 5mm diameter variants suitable for either a 0° or angled (30° or 45°) rigid laparoscope.

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 supply pressure to OpClear® Control Unit less than 74bar ●
Max delivery pressure from OpClear® Control Unit 1.35bar.

Weight and Dimensions OpClear® Control Unit

Weight 5.8 kg. ●
Height 80mm, Width 330mm, Depth 304mm (excluding connectors). ●

Footswitch

Pneumatic switch with 3m tube

Alarm

The OpClear® System alarms comply with IEC 60601-1-8. .
Special 510(k)- OpClear® Platform Cipher Surgical Ltd.

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Comparison of the modified device to the cleared predicate device

	Device	Predicate Device	Reference Device
Device Name	OpClear® PlatformCU3 DI3	OpClear® System CU3DI2	WOM 45L core insufflator F114
ManufacturerName	Cipher Surgical Ltd	Cipher Surgical Ltd	World of Medicines GmbH
DeviceClassificationRegulation	21 CFR 876.1500	21 CFR 876.1500	21 CFR 884.1730
Common Name	Endoscope lens cleaning anddefogging device	Endoscope lens cleaningand defogging device	Carbon Dioxide Insufflator forLaparoscopy and VesselHarvesting
ClassificationName	Accessory, Endoscope	Accessory, Endoscope	Insufflator Laparoscopic
Product Code(s)	OCX, FEQ	OCX, FEQ	HIF, OSV
510(k)	-	K171637	K063367
	Device	Predicate Device	Reference Device
Device Name	OpClear® PlatformCU3 DI3	OpClear® System CU3DI2	WOM 45L core insufflator F114
DeviceDescription	The OpClear device usescarefully controlled timed flowsof CO2 and saline delivered tothe lens surface of a compatiblelaparoscope, during minimallyinvasive surgery to maintain aclear vision and remove/reducethe need to remove thelaparoscope during a surgicalprocedure.It consists of a mains powered,microprocessor controlled,reusable control unit and arange of disposable sterileaccessories.	The OpClear device usescarefully controlled timedflows of CO2 and salinedelivered to the lenssurface of a compatiblelaparoscope, duringminimally invasive surgeryto maintain a clear visionand remove/reduce theneed to remove thelaparoscope during asurgical procedure.It consists of a mainspowered, microprocessorcontrolled, reusablecontrol unit and a range ofdisposable sterileaccessories.	A microprocessor controlled CO2insufflator that consists of thefollowing major components andfeatures: a casing, a world powersupply, pressure reducers, aventing system, redundantpressure measurement, a fluidsensor, a gas heater, a softwarecontrolled graphical user interface(GUI) touch screen and varioussetting keys and displayelements. The Insufflator 50LFM134 is not intended to enterthe sterile field, and cannot besterilized. The device is to beused with specially designedsingle-use tube sets that aredelivered sterile. Specifically, theproposed device is to be usedwith a single-use tube set withheating wire and integrated filteror with a single-use tube set withintegrated filter but withoutheating wire.
	Device	Predicate Device	Reference Device
Device Name	OpClear® PlatformCU3 DI3	OpClear® System CU3DI2	WOM 45L core insufflator F114
Intended Use /Indications forUse	The OpClear® Platform consistsof a reusable control unit and arange of disposable sterilesingle-use accessories intendedto remove visual obstructionssuch as condensation, bloodand other tissue particulates,therefore maintaining a clearimage of the surgical site. TheOpClear Platform is indicated foruse in abdominal laparoscopy.	The OpClear® Systemconsists of a reusablecontrol unit and a range ofdisposable sterile single-use accessories intendedto remove visualobstructions such ascondensation, blood andother tissue particulatesfrom the distal lens of alaparoscope duringsurgery and thereforemaintaining a clear imageof the surgical site.	Intended for use duringdiagnostic and/or therapeuticendoscopic procedures to distenda cavity by filling it with gas. TheStandard, Pediatric and Bariatricoperating modes of the deviceare indicated to fill and distend aperitoneal cavity with gas duringa laparoscopic procedure.
Environment ofUse	Hospital Operating Theatre	Hospital OperatingTheatre	Hospital Operating Theatre
Patient Population	Patients over the age of 12, whohave been selected by theirphysician / surgeon forlaparoscopic surgery using 5mmand10mm laparoscopes of acompatible length / type.	Adult patients who havebeen selected by theirphysician / surgeon forlaparoscopic surgery using10mm laparoscopes of acompatible length / type.	Patients undergoing laparoscopicsurgery
	Device	Predicate Device	Reference Device
Device Name	OpClear® PlatformCU3 D13	OpClear® System CU3DI2	WOM 45L core insufflator F114
CO2 supply	High Pressure Gas Bottle orLow Pressure Central Supply	High Pressure Gas Bottleor Low Pressure CentralSupply	High Pressure Gas Bottle
Max CO2 flow rate	Adult and Pediatric mode:2.5 l/min continuous14l/min pulse	2.5 l/min continuous6.4 l/min pulse ( subsequently this has beendetermined to have beenincorrectly calculated. The maxpulse flow rate of the predicateis 14 l/min)	High Flow mode40l/minBariatric mode45 l/mLow Flow (pediatric) mode20 l/m
Max CO2 pressure	Adult mode27 mmHgPediatric mode21mmHg (Display incrementsare in 3mmHg)	27 mmHg	High flow mode (15 years andabove)30 mmHgBariatric mode70 mmHgLow flow (pediatric) mode (14years and lower)20 mmHg
Cleaning Solution	Saline 0.9% NaCl	Saline 0.9% NaCl	N/A
Power Source	Mains electricity powered controlunit	Mains electricity poweredcontrol unit	Mains electricity powered
	Device	Predicate Device	Reference Device
Device Name	OpClear® Platform CU3 DI3	OpClear® System CU3 DI2	WOM 45L core insufflator F114
Compatible Devices	Selected standard rigid 5mm and 10mm laparoscopes with 0°,30°/45° angle tips	Selected standard rigid 10mm laparoscopes with 0° and 30° angle tips	N/A
Number of uses	Control Unit - Re-usable Disposable - Single Use (3 years)	Control Unit - Re-usable Disposable - Single Use (3 years)	Re-usable Tube sets- Single Use (3 years)
Sterility	Single use disposables - Ethylene Oxide sterilisation validated in accordance with ISO 11135-2014	Single use disposables - Ethylene Oxide sterilisation validated in accordance with ISO 11135-2014	Ethylene Oxide sterilisation validated in accordance with ISO 11135-2007
Electrical Safety	Independently tested to IEC 60601-1:2005	Independently tested to IEC 60601-1-2005	Independently tested to IEC 60601-1-2005
Electromagnetic Compatibility	Independently tested to IEC 60601-1-2-2014	Independently tested to IEC 60601-1-2-2007	Independently tested to IEC 60601-1-2-2007
Software Controlled	Developed, tested and verified to IEC 62304-2015	Developed, tested and verified to IEC 62304-2006	Developed, tested and verified to IEC 62304-2006

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Special 510(k)- OpClear® Platform Cipher Surgical Ltd.

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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 the predicate device, OpClear® System and the subject device, OpClear® Platform, have been validated using the same bench model.

Conclusion:

The proposed device has the same principles of operation and technological characteristics as the predicate device.

There are no significant changes to the materials, dimensions (except for the diameter) or to the assembly process of the disposables. No new biocompatibility testing is deemed to be required as compared to the predicate device.

The OpClear Control Unit main configuration remains the same. There is no impact to the previously carried out electrical safety or the EMC testing. The sterilisation method remains the same and so does the sterile barrier.

In conclusion, OpClear® Platform does not adversely affect safety or effectiveness.

Special 510(k)- OpClear® Platform Cipher Surgical Ltd.

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.