(217 days)
The MedicCO2LON device is intended to be used for colonic distension with CO2 gas for CT Colonography and conventional Colonoscopy procedures.
MedicCO2LON is designed to function with specific colonic insufflation administration sets that allow passage of gas from the device to the colorectal cavity. MedicCO2LON should only be used with administration sets specifically designed for this purpose.
The device should only be used by personnel trained in the practice of undertaking CT Colonography and conventional Colonoscopy examinations and the use of an automatic insufflation device.
The device should only be used for CT Colonography or conventional Colonoscopy procedures and should not be used for any other patient examination procedure.
MedicCO2LON is an automated insufflation device designed for administering and requlating colonic distension by insufflation with carbon dioxide qas, in preparation for and during CT Colonography (CTC or Virtual Colonoscopy) and conventional Colonoscopy.
Construction:
The MedicCO2LON colonic insufflator is constructed using a plastic (PC/ABS) external shell covering a metal internal frame, internal components are low voltage (3.3V, 12V and 24V DC) powered from an internal mains connected power supply.
None of the parts of the MedicCO2LON contact the patient directly and the user only has transient contact with the unit, with it being table or trolley mounted.
Use period:
The units are for short term use (normally no more than 30 min) and provides. to the patient, CO2 via an external pressure regulator to the device to insufflate the patient using a standard administration set at up to 30mmHg
The provided document is a 510(k) summary for a medical device called MedicCO2LON, a colonic insufflator. This document focuses on demonstrating substantial equivalence to a predicate device, the BRACCO PROTOCOX2L TOUCH Colon Insufflator (K132192), rather than providing detailed acceptance criteria and a comprehensive study report for a novel AI/software-based medical device.
Therefore, many of the requested details regarding acceptance criteria for AI models, sample size for test/training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone performance are not present in this type of submission. This document primarily focuses on the physical and functional comparison of a new device with an existing predicate, and engineering testing, not clinical performance studies with AI components.
However, I can extract the acceptance criteria as presented for this specific device's performance validation based on its physical/functional characteristics, and the reported performance.
Here's an attempt to answer the questions based only on the provided text, while acknowledging the limitations for an AI/software-centric request:
Acceptance Criteria and Device Performance for MedicCO2LON (Physical/Functional Device)
The provided document describes the functional performance and safety characteristics of the MedicCO2LON device, comparing it to a predicate device. The "acceptance criteria" can be inferred from the performance targets and comparisons made. The study described is primarily bench testing and engineering validation to demonstrate equivalence, not a clinical trial involving human readers or AI.
1. A table of acceptance criteria and the reported device performance
| Function/Parameter | Acceptance Criteria (Implied/Predicate Performance) | Reported MedicCO2LON Performance | Test Report Document Identification |
|---|---|---|---|
| Displayed Data (Input Pressure) | Current output pressure (Predicate) | Current Input Pressure | MCODOC121-102 Appendix Image |
| Displayed Data (Gas Flow Rate) | Not defined (Predicate) | Gas Flow Rate | MCODOC121-102 Appendix Image |
| Displayed Data (Delivered Gas Volume) | Delivered Gas Volume (Predicate) | Delivered Gas Volume | MCODOC121-102 Appendix Image |
| Displayed Data (Gas Supply Level) | Gas Supply level (Predicate) | Gas Supply level | MCODOC121-102 Appendix Image |
| Control Data (Start/Stop/Resume Flow) | Start / Stop flow (Predicate) | Start / Stop / Resume flow | MCODOC121-102 Appendix Image |
| Control Data (Reset Delivered Volume) | Reset Delivered Volume (Predicate) | Reset Delivered Volume | MCODOC121-102 Appendix Image |
| Control Data (Set Target Pressure) | Set Target Pressure (Predicate) | Set Target Pressure | MCODOC121-102 Appendix Image |
| Control Data (Set Maximum Flow) | Not defined (Predicate) | Set Maximum Flow | MCODOC121-102 Appendix Image |
| Maximum total gas volume | No maximum limit (Predicate) | 12.0 L | MCODOC166-101 Page 7 section 3.3 |
| Gas Volume Profile | Flow stops at 3L to 10L (Predicate) | Stops at 4,6,8,10,12L | MCODOC121-102 Volume Accuracy test |
| Default target flow rate | 3.0LPM (Predicate) | 3.0LPM | Power up default on screen |
| Gas Flow Start Profile | Various steps for 0-1.0L delivered volume (Predicate) | 0.5LPM per 0.5L Volume. | MCODOC121-102 Flow rate Accuracy test |
| Target Pressure | 0 to 35mmHg (Predicate) | 0 to 30mmHg | MCODOC121-102 Pressure Accuracy test |
| Volume Accuracy | Unknown (Predicate) | +/- 20% at current reading. | MCODOC121-102 Volume Accuracy test |
| Flow Adjustment | 1.0LPM (Predicate) | 0.5LPM | MCODOC121-102 Flow rate Accuracy test |
| Flow Accuracy | +20% @ 3LPM (Predicate) | +/- 10% at 3LPM | MCODOC121-102 Flow rate Accuracy test |
| Pressure Accuracy | +/- 10% (Predicate) | +/- 1mmHg of current reading | MCODOC121-102 Pressure Accuracy test |
| Safety overpressure relief | Independent Redundant Mechanical Relief (Predicate) | Independent redundant mechanical relief | MCODOC166-101 Page 6 section 3.2 |
| Safety pressure relief (mechanical) | 1.5psi (78mmHg) nominal (Predicate) | 1.5psi (78mmHg) | MCODOC166-101 Page 6 section 3.2 |
| Safety pressure relief accuracy (mechanical) | Unknown (Predicate) | +/- 20mmHg of trip pressure | MCODOC166-101 Page 6 section 3.2 |
| Safety pressure relief accuracy (electronic) | 50mmHg for 5 seconds (Predicate) | 50mmHg for 5 seconds | MCODOC166-101 Page 6 section 3.2 |
2. Sample size used for the test set and the data provenance
The document does not specify a "sample size" in terms of patient cases or imaging data. The testing described is engineering and performance testing of the device's physical functions (e.g., flow rate, pressure accuracy, volume delivery). These are physical measurements, not statistical analyses of clinical data from patients. Therefore, data provenance (country, retrospective/prospective) is not applicable in the context of this type of device submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. The "ground truth" for this device's performance is typically established by calibrated measurement equipment and engineering standards, not by human expert assessment of clinical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as the "test set" refers to engineering measurements, not clinical case reviews.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a colonic insufflator, a physical medical device for gas delivery, not an AI software supporting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance metrics (e.g., pressure, flow, volume) would be derived from:
- Calibrated measurement equipment: e.g., precise pressure gauges, flow meters, volume displacement methods.
- Engineering specifications and standards: Adherence to established safety and performance norms for medical devices.
- Comparison to predicate device's established performance.
8. The sample size for the training set
Not applicable. This is not a machine learning device.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning device.
In summary, the provided FDA 510(k) summary is for a Class II medical device (colonic insufflator) that is a physical apparatus, not an AI/software device. Consequently, the performance validation outlined focuses on engineering specifications, safety features, and functional equivalence to a predicate device, rather than the types of data-driven performance studies typically associated with AI/ML-based medical devices (e.g., diagnostic imaging aids).
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 30, 2024
Nicholas See IDE Vision, Ltd. Lodge Way Portskewett Caldicot. NP265PS United Kingdom
Re: K240847
Trade/Device Name: MedicCO2LON (MedicCO2LON) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FCX Dated: October 3, 2024 Received: October 3, 2024
Dear Nicholas See:
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 (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 available 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 Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatory
{2}------------------------------------------------
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,
Sivakami Venkatachalam -S
for
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
{3}------------------------------------------------
Indications for Use
Submission Number (if known)
Device Name
MedicCO2LON (MedicCO2LON)
Indications for Use (Describe)
The MedicCO2LON device is intended to be used for colonic distension with CO2 gas for CT Colonography and conventional Colonoscopy procedures.
MedicCO2LON is designed to function with specific colonic insufflation administration sets that allow passage of gas from the device to the colorectal cavity. MedicCO2LON should only be used with administration sets specifically designed for this purpose.
The device should only be used by personnel trained in the practice of undertaking CT Colonography and conventional Colonoscopy examinations and the use of an automatic insufflation device.
The device should only be used for CT Colonography or conventional Colonoscopy procedures and should not be used for any other patient examination procedure.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image is a logo for iDEVision. The logo is white text on a black background. The text is in a sans-serif font and is stylized.
510K Summary
Date prepared 9th May 2024, Updated 23rd October 2023
General Information:
| Contact Person: | Nicholas Adrian See |
|---|---|
| Address: | IDE Vision LtdLodge WayPortskewettCaldicotNP26 5PSMonmouthshireUnited Kingdom |
| Telephone: | +(44) 1291 425425 |
| Email: | nick@doppler.co.uk |
Device Identification:
| Trade Name: | MedicCO2LON (MedicCO2LON) |
|---|---|
| Common Name: | Insufflator, Colonic |
| Classification Name: | Endoscope and accessories |
| 21 CFR 876.1500 | |
| Product Code: | FCX |
Predicate Device Information:
| Predicate Device: | BRACCO PROTO 2 L TOUCH Colon Insufflator |
|---|---|
| 510(k) K132192 |
{5}------------------------------------------------
Image /page/5/Picture/1 description: The image shows the logo for iDEVision. The logo is white text on a black background. The text is sans-serif and the "i" in iDEVision is lowercase.
- IDE Vision Ltd Lodge Way, Portskewett, Caldicot NP26 5PS United Kingdom
Device Description:
MedicCO2LON is an automated insufflation device designed for administering and requlating colonic distension by insufflation with carbon dioxide qas, in preparation for and during CT Colonography (CTC or Virtual Colonoscopy) and conventional Colonoscopy.
Construction:
The MedicCO2LON colonic insufflator is constructed using a plastic (PC/ABS) external shell covering a metal internal frame, internal components are low voltage (3.3V, 12V and 24V DC) powered from an internal mains connected power supply.
None of the parts of the MedicCO2LON contact the patient directly and the user only has transient contact with the unit, with it being table or trolley mounted.
Use period:
The units are for short term use (normally no more than 30 min) and provides. to the patient, CO2 via an external pressure regulator to the device to insufflate the patient using a standard administration set at up to 30mmHg
Intended Use:
The MedicCO2LON device is intended to be used for colonic distension with CO.gas for CT Colonography and conventional Colonoscopy procedures.
MedicCO2LON is designed to function with specific colonic insufflation administration sets that allow passage of gas from the device to the colorectal cavity. MedicCO2LON should only be used with administration sets specifically designed for this purpose.
The device should only be used by personnel trained in the practice of undertaking CT Colonography and conventional Colonoscopy examinations and the use of an automatic insufflation device.
The device should only be used for CT Colonography or conventional Colonoscopy procedures and should not be used for any other patient examination procedure.
{6}------------------------------------------------
Image /page/6/Picture/1 description: The image shows the logo for iDEVision. The logo is white text on a black background. The text is stylized and modern.
Product Comparison:
| Parameter | MedicCO2LON | PROTOC02L TOUCH |
|---|---|---|
| 510(k) | K132192 | |
| Indication for Use | Administer and regulate CO2 as adistention media for the colonduring CT Colonography (CTC orVirtual Colonoscopy) andconventional Colonoscopy. | Administer and regulate CO2 as adistention media for the colonduring CT Colonography (CTC orVirtual Colonoscopy) andconventional Colonoscopy. |
| Applied Gas | CO2 | CO2 |
| Design | Electro-Mechanical PneumaticSystem to regulate both Flow andPressure of CO2 | Electro-Mechanical PneumaticSystem to regulate both Flow andPressure of CO2 |
| Anatomical Sites | Rectal administration of CO2 viaenema tip or catheter lumen | Rectal administration of CO2 viaenema tip or catheter lumen |
| Radiation | No ionizing radiation emitted | No ionizing radiation emitted |
| Thermal | No thermal energy introduced intopatient. | No thermal energy introduced intopatient. |
| Power supply | Switch Mode Power supply housedwithin unit | Switch Mode Power supplyhoused within unit |
| User Connections | IEC Mains inlet,Low pressure CO2 inputControlled Gas output | IEC Mains inlet,Low pressure CO2 inputControlled Gas output |
| Display type | LED Back lit colour LCD,Display Area 152 x 91mm | Back lit colour LCD, |
| Displayed data | Current output pressureGas Flow RateDelivered gas volumeGas supply level | Current output pressureGas Flow RateDelivered gas volumeGas supply level |
{7}------------------------------------------------
Image /page/7/Picture/1 description: The image shows the logo for iDEVision. The logo is white text on a black background. The text is stylized, with the "D" in "iDEVision" having a unique design.
| Controls type | Graphic touch screen controls | Graphic touch screen controls |
|---|---|---|
| Controls data | Start / Stop / Resume Flow | Start / Stop Flow |
| Reset Delivered Volume | Reset Delivered Volume | |
| Set Target pressure | Set Target Pressure | |
| Set Maximum Flow | ||
| Gas Control | ||
| Maximum total gas volume | 12.0 L | No maximum limit |
| Gas Volume Profile | Flow stops at: 4,6,8,10,12L | Flow stops at 3L to 10L |
| Default target flow rate | 3.0 LPM | 3.0LPM |
| Gas Flow Start Profile | 0.5lpm per 0.5l delivered volume totarget flow rate | 1.0lpm for 0 to 0.5l deliveredvolume2.0lpm for 0.5 to 1.0l deliveredvolume3.0lpm for greater than 1.0ldelivered volume |
| Target pressure | 0 to 30mmhgDefault 20 mmHg | 0 to 35mmHg |
| Volume Accuracy | +/-20% of current reading display | Unknown |
|---|---|---|
| Flow Adjustment | 0.5LPM | 1.0LPM |
| Flow Accuracy | +/-10% at 3LPM | +20% @ 3LPM |
| Pressure Accuracy | +/- 1mmHg of current reading | +/- 10% |
| Safely overpressure Relief | Independent RedundantMechanical Relief | Independent RedundantMechanical Relief |
| Safety Pressure Reliefpressure (mechanical) | 1.5psi (78mmHg) nominal | |
| Safety Pressure ReliefAccuracy (mechanical) | +/- 20% of trip pressure | Unknown |
{8}------------------------------------------------
Image /page/8/Picture/1 description: The image is a logo for iDEVision. The logo is white text on a black background. The text is stylized, with the "i" having a dot above it, the "D" being a blocky shape, and the "Vision" being in a more traditional font. The logo is simple and modern.
| Safety Pressure Reliefpressure (Electronic) | 50mmHg for 5 seconds | 50mmHg for 5 seconds |
|---|---|---|
| ------------------------------------------------- | ---------------------- | ---------------------- |
In all cases the insufflation gas is CO2 and this is externally connected to the units which then deliver it via an external Administration Kit. The control interfaces and displays vary slightly with 1 unit using touch screen LCD and the ProtoCO₂L using an LED display and mechanical controls.
The data displayed is the same in style but the MedicCO2Lon adds a display of the delivery gas flow rate to provide the doctor with an indication as to the rate the gas is entering the patient.
Both units deliver a volume of gas of at least 12L with the MedicCO2LON delivering 12L and the ProtoCO2L having no limit. The normal delivered volume for insufflation is between 2 – 4L, allowing for leaks 12L will be enough for all patients. Should more gas be required it implies a serious leak and this should be investigated rather than allowing limitless gas to enter the patient.
Pressure on the MedicCO2LON has a target of 30mmHg with the ProtoCO2L having a 25mmHg maximum. In all cases these values can be set to different levels by the doctor and the MedicCO2LON has pre-sets that can be set to any level the doctors require up to 30mmHg and these values are recalled for each patient.
The flow rate on both units is the same with a maximum of 3LPM, the MedicCO2LON allows an increase in 0.5LPM steps while the ProtoCO2L uses 1LPM steps. The smaller the steps the less stress applied to the patient.
Both units use mechanical safety pressure discharge valves set at 75 – 78mmHg.
Conclusion:
The MedicCO2LON device for colonic distension with CO.gas for CT Colonography and conventional Colonoscopy procedures is considered to be substantially equivalent to the predicate device. It does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device.
Clinical:
The units are used for the same clinical condition and purpose.
They are used at the same site in the body;
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image is a logo for iDEVision. The logo is white text on a black background. The text is stylized and modern.
They all use the same Administration Kit to supply the gas into the patient.
The units have similar critical performance according to expected clinical effect its intended use.
Technical:
The MedicCO2LON and the other unit are used under similar conditions of use.
The MedicCO2LON has similar specifications and properties.
The MedicCO2LON is of similar design being a standalone mains connected insufflator supplied externally with CO2.
The MedicCO2LON has similar principles of operation, Pressure, Flow, Volume and connection to the Patient.
Biological:
The MedicCO2LON uses the same materials in contact with the same human tissues in that the Administration Set (not manufactured my Ultrasound Technologies Ltd) is the same or similar to all others on the market. The Kits are ALL interchangeable and depend on the hospitals purchasing arrangements.
Tested Predicate Comparison.
All characteristics have been tested and are detailed in the documents listed:
A summery is as follows:
| Function | MedicCO2LONPerformance | Test report documentIdentification | Predicate devicePerformance |
|---|---|---|---|
| Displayed Data | Current Input Pressure | MCODOC121-102Appendix Image | Current output pressure |
| Gas Flow Rate | MCODOC121-102Appendix Image | Not defined | |
| Delivered Gas Volume | MCODOC121-102Appendix Image | Delivered Gas Volume | |
| Gas Supply level | MCODOC121-102Appendix Image | Gas Supply level | |
| Touch Screen ControlData | Start / Stop / Resume flow | MCODOC121-102Appendix Image | Start / Stop flow |
| Reset Delivered Volume | MCODOC121-102Appendix Image | Reset Delivered Volume |
{10}------------------------------------------------
Image /page/10/Picture/1 description: The image shows the logo for iDEVision. The logo is white text on a black background. The text is stylized, with the "i" having a dot above it and the "D" being a geometric shape.
| Set Target Pressure | MCODOC121-102Appendix Image | Set Target Pressure | |
|---|---|---|---|
| Set Maximum Flow | MCODOC121-102Appendix Image | Not defined | |
| Maximum total gasvolume | 12.0L | MCODOC166-101 Page 7section 3.3 | |
| Gas Volume Profile | Stops at 4,6,8,10,12L | MCODOC121-102 VolumeAccuracy test | |
| Default target flow rate | 3.0LPM | Power up default onscreen | |
| Gas Flow Start Profile | 0.5LPM per 0.5L Volume. | MCODOC121-102 Flowrate Accuracy test | |
| Target Pressure | 0 to 30mmHg | MCODOC121-102Pressure Accuracy test | |
| Volume Accuracy | +/- 20% at currentreading. | MCODOC121-102 VolumeAccuracy test | |
| Flow Adjustment | 0.5LPM | MCODOC121-102 Flowrate Accuracy test | |
| Flow Accuracy | +/- 10% at 3LPM | MCODOC121-102 Flowrate Accuracy test | |
| Pressure Accuracy | +/- 1mmHg of currentreading | MCODOC121-102Pressure Accuracy test | |
| Safety overpressure relief | Independent redundantmechanical relief | MCODOC166-101 Page 6section 3.2 | |
| Safety pressure relief(mechanical) | 1.5psi (78mmHg) | MCODOC166-101 Page 6section 3.2 | |
| Safety pressure reliefaccuracy (mechanical) | +/- 20mmHg of trippressure | MCODOC166-101 Page 6section 3.2 | |
| Safety pressure reliefaccuracy (electronic) | 50mmHg for 5 seconds | MCODOC166-101 Page 6section 3.2 |
§ 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.