(57 days)
No
The description focuses on mechanical cleaning of the laparoscope lens and does not mention any AI/ML components or image processing capabilities.
No
The device is described as a laparoscopic lens cleaning device intended to remove visual obstructions and maintain a clear image during surgery, which is a supportive function to a surgical procedure rather than directly treating a disease or condition.
No
The device is described as a laparoscopic lens cleaning device intended to remove visual obstructions on the distal window of laparoscopes to maintain a clear image of the surgical site. It does not perform any diagnostic function.
No
The device description explicitly states it consists of a "reusable control unit" and "disposable sterile single-use accessories," which are hardware components.
Based on the provided information, the OpClear® Platform is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to remove visual obstructions on the distal window of laparoscopes to maintain a clear image during surgery. This is a mechanical function related to the surgical procedure itself, not the analysis of biological samples.
- Device Description: The device description reinforces its function as a laparoscopic lens cleaning device used during surgery. It does not mention any interaction with biological samples for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVD devices, such as reagents, assays, sample handling, or analysis of biological markers.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The OpClear® Platform's function is purely to improve visualization during a surgical procedure, which falls outside the scope of IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
OCX, FEQ
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 | Working
Length |
|---|---|---|---|
| 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 |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal
Indicated Patient Age Range
Patients over the age of 12
Intended User / Care Setting
professional use in a theatre environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
1
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 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.
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 Centre |
| Sir William Lyons Road | |
| Coventry CV4 7EZ | |
| UK | |
| Contact Person | Justin Buch |
| Operations Director | |
| Tel: +44 2477 170700 | |
| jbuch@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 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 | Working
Length |
|----------------|----------|-----------|-------------------|
| 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 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.
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® Platform | ||
| CU3 DI3 | OpClear® System CU3 | ||
| DI2 | WOM 45L core insufflator F114 | ||
| Manufacturer | |||
| Name | Cipher Surgical Ltd | Cipher Surgical Ltd | World of Medicines GmbH |
| Device | |||
| Classification | |||
| Regulation | 21 CFR 876.1500 | 21 CFR 876.1500 | 21 CFR 884.1730 |
| Common Name | Endoscope lens cleaning and | ||
| defogging device | Endoscope lens cleaning | ||
| and defogging device | Carbon Dioxide Insufflator for | ||
| Laparoscopy and Vessel | |||
| Harvesting | |||
| Classification | |||
| Name | 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® Platform | ||
| CU3 DI3 | OpClear® System CU3 | ||
| DI2 | WOM 45L core insufflator F114 | ||
| Device | |||
| Description | The OpClear device uses | ||
| carefully controlled timed flows | |||
| of CO2 and saline delivered to | |||
| the lens surface of a compatible | |||
| laparoscope, during minimally | |||
| invasive surgery to maintain a | |||
| clear vision and remove/reduce | |||
| the need to remove the | |||
| laparoscope during a surgical | |||
| procedure. | |||
| It consists of a mains powered, | |||
| microprocessor controlled, | |||
| reusable control unit and a | |||
| range of disposable sterile | |||
| accessories. | The OpClear device uses | ||
| carefully controlled timed | |||
| flows of CO2 and saline | |||
| delivered to the lens | |||
| surface of a compatible | |||
| laparoscope, during | |||
| minimally invasive surgery | |||
| to maintain a clear vision | |||
| and remove/reduce the | |||
| need to remove the | |||
| laparoscope during a | |||
| surgical procedure. | |||
| It consists of a mains | |||
| powered, microprocessor | |||
| controlled, reusable | |||
| control unit and a range of | |||
| disposable sterile | |||
| accessories. | A microprocessor controlled CO2 | ||
| insufflator that consists of the | |||
| following major components and | |||
| features: a casing, a world power | |||
| supply, pressure reducers, a | |||
| venting system, redundant | |||
| pressure measurement, a fluid | |||
| sensor, a gas heater, a software | |||
| controlled graphical user interface | |||
| (GUI) touch screen and various | |||
| setting keys and display | |||
| elements. The Insufflator 50L | |||
| FM134 is not intended to enter | |||
| the sterile field, and cannot be | |||
| sterilized. The device is to be | |||
| used with specially designed | |||
| single-use tube sets that are | |||
| delivered sterile. Specifically, the | |||
| proposed device is to be used | |||
| with a single-use tube set with | |||
| heating wire and integrated filter | |||
| or with a single-use tube set with | |||
| integrated filter but without | |||
| heating wire. | |||
| Device | Predicate Device | Reference Device | |
| Device Name | OpClear® Platform | ||
| CU3 DI3 | OpClear® System CU3 | ||
| DI2 | WOM 45L core insufflator F114 | ||
| Intended Use / | |||
| Indications for | |||
| Use | The OpClear® Platform 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, | |||
| therefore maintaining a clear | |||
| image of the surgical site. The | |||
| OpClear Platform is indicated for | |||
| use in abdominal laparoscopy. | 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. | Intended for use during | ||
| diagnostic and/or therapeutic | |||
| endoscopic procedures to distend | |||
| a cavity by filling it with gas. The | |||
| Standard, Pediatric and Bariatric | |||
| operating modes of the device | |||
| are indicated to fill and distend a | |||
| peritoneal cavity with gas during | |||
| a laparoscopic procedure. | |||
| Environment of | |||
| Use | Hospital Operating Theatre | Hospital Operating | |
| Theatre | Hospital Operating Theatre | ||
| Patient Population | Patients over the age of 12, who | ||
| have been selected by their | |||
| physician / surgeon for | |||
| laparoscopic surgery using 5mm | |||
| and10mm laparoscopes of a | |||
| compatible length / type. | Adult patients who have | ||
| been selected by their | |||
| physician / surgeon for | |||
| laparoscopic surgery using | |||
| 10mm laparoscopes of a | |||
| compatible length / type. | Patients undergoing laparoscopic | ||
| surgery | |||
| Device | Predicate Device | Reference Device | |
| Device Name | OpClear® Platform | ||
| CU3 D13 | OpClear® System CU3 | ||
| DI2 | WOM 45L core insufflator F114 | ||
| CO2 supply | High Pressure Gas Bottle or | ||
| Low Pressure Central Supply | High Pressure Gas Bottle | ||
| or Low Pressure Central | |||
| Supply | High Pressure Gas Bottle | ||
| Max CO2 flow rate | Adult and Pediatric mode: | ||
| 2.5 l/min continuous | |||
| 14l/min pulse | 2.5 l/min continuous | ||
| 6.4 l/min pulse * | |||
| (* subsequently this has been | |||
| determined to have been | |||
| incorrectly calculated. The max | |||
| pulse flow rate of the predicate | |||
| is 14 l/min) | High Flow mode | ||
| 40l/min | |||
| Bariatric mode | |||
| 45 l/m | |||
| Low Flow (pediatric) mode | |||
| 20 l/m | |||
| Max CO2 pressure | Adult mode | ||
| 27 mmHg | |||
| Pediatric mode | |||
| 21mmHg (Display increments | |||
| are in 3mmHg) | 27 mmHg | High flow mode (15 years and | |
| above) | |||
| 30 mmHg | |||
| Bariatric mode | |||
| 70 mmHg | |||
| Low flow (pediatric) mode (14 | |||
| years and lower) | |||
| 20 mmHg | |||
| Cleaning Solution | Saline 0.9% NaCl | Saline 0.9% NaCl | N/A |
| Power Source | Mains electricity powered control | ||
| unit | Mains electricity powered | ||
| control 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.
10
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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.