(317 days)
The "Carilex" VT · 200-i NX suction therapy unit is indicated on use with patients with the following wounds:
- · Traumatic
- Dehisced wounds
- Partial thickness burns
- · Chronic wounds including pressure ulcers, diabetic foot ulcers and venous leg ulcers
- Acute wounds
- · Flaps and grafts
The device is not intended for home use. Wound irrigation/Instillation function is not intended for use in a homecare setting.
Carilex VT 200-i NX is a powered, portable suction device with battery backup that provides localized negative pressure wound therapy when used with the VT Dressing kits to remove body fluids, irrigation fluids, infectious material and tissue debris from the wound.
Carilex VT 200-i NX have shown that they may help promote the healing of several different kind of wounds via fluid removal. When in use, the vacuum air suction pump in the control unit suck the air from the wound through the connecting hose and dressing to create a negative pressure environment of the wound. The suction of the pump will help remove excess fluids from the wound. VT Dressing kits will be placed onto the wound by healthcare professional and a tube will be connected from the wound to the canister on the pump. After the dressing and tube are correctly applied and connected, turn on the VT · 200 i NX device and set to the pressure setting that is prescribed by healthcare provider. The canister will then collect the excess fluid. This device is not intended for home use.
Carilex VT-200-i NX is an updated version of Carilex VT-100/VT-200 (K173407) via engineering change, and its software and hardware modifications are made to add instill function. The instillation mode is a modified continuous mode, where wound irrigation solution is simultaneously infused during negative pressure suction to assist in wound cleaning and removal of infectious substances. There has been no change to the operating principle, mechanism of action or fundamental scientific technology of the predicate device. The Carilex VT-200-i NX is developed with technology and components that are almost identical to Carilex VT·100/ VT·200.
Carilex VT-200-i NX use the same collection canisters as predicate, VT-100, and VT-200 that are supplied non-sterile, single-use with a volume capacity of 300 ml or 1000ml. The canister is permanently sealed to minimize the potential of users coming into contact with exudates. Two tubes with two connector attached to its distal end is attached to the canister, and this connector which can be provided with or without lock feature attaches to the corresponding tubing included in the Carilex VT Dressing Kits.
The Carilex VT-200-i NX is a powered, portable suction device used for negative pressure wound therapy. The device has an instillation mode for wound irrigation.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria were demonstrated through a series of bench tests comparing the Carilex VT-200-i NX to its predicate device, Carilex VT-100/VT-200 (K173407). The aim was to show the overall system performance, including suction pressure, fluid removal rate, and alarm functions.
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance (Carilex VT-200-i NX) |
|---|---|---|
| Suction Pressure | Compare suction pressure with no fluid (air) under continuous and intermittent mode. | Demonstrated to be within specification, comparable to predicate. (Details not explicitly quantified, but overall conclusion states "within specification") |
| Fluid Removal Rate | Compare suction pressure and fluid removal rate with plasma under continuous and intermittent mode. | Demonstrated to be within specification, comparable to predicate. (Details not explicitly quantified, but overall conclusion states "within specification") |
| Compare suction pressure and fluid removal rate with Simulated Body Fluid (SBF) under continuous and intermittent mode. | Demonstrated to be within specification, comparable to predicate. (Details not explicitly quantified, but overall conclusion states "within specification") | |
| Test suction pressure and fluid removal rate with Normal saline introduced under instill mode. | Demonstrated to be within specification, comparable to predicate. (Details not explicitly quantified, but overall conclusion states "within specification") | |
| Alarm Functions | Compare leakage alarm function under continuous and intermittent mode. | Functionality demonstrated, comparable to predicate. (Details not explicitly quantified, but overall conclusion states "within specification" and results "can be concluded that Carilex VT 200-i NX are substantially equivalent") |
| Compare canister-full alarm function under continuous and intermittent mode. | Functionality demonstrated, comparable to predicate. (Details not explicitly quantified, but overall conclusion states "within specification" and results "can be concluded that Carilex VT 200-i NX are substantially equivalent") | |
| Compare blockage alarm function with default time delay (1 min) under continuous and intermittent mode. | Functionality demonstrated, comparable to predicate. (Details not explicitly quantified, but overall conclusion states "within specification" and results "can be concluded that Carilex VT 200-i NX are substantially equivalent") | |
| Instillation Specific | Test the possibility of pooling occurring at the simulated wound site under instill mode. | Functionality demonstrated (implying no pooling or controlled pooling as intended by the instillation function), comparable to predicate's similar function. (Details not explicitly quantified, but overall conclusion states "within specification" and results "can be concluded that Carilex VT 200-i NX are substantially equivalent") |
| Test leakage indicator function under instill mode. | Functionality demonstrated, comparable to predicate. (Details not explicitly quantified, but overall conclusion states "within specification" and results "can be concluded that Carilex VT 200-i NX are substantially equivalent") | |
| Test canister-full indicator function under instill mode. | Functionality demonstrated, comparable to predicate. (Details not explicitly quantified, but overall conclusion states "within specification" and results "can be concluded that Carilex VT 200-i NX are substantially equivalent") | |
| Test blockage indicator function under instill mode. | Functionality demonstrated, comparable to predicate. (Details not explicitly quantified, but overall conclusion states "within specification" and results "can be concluded that Carilex VT 200-i NX are substantially equivalent") | |
| Electrical/Safety | AAMI/ANSI ES60601-1:2005/(R) 2012+A1:2012, C1:2009/(R) 2012+A2:2010/(R)2012 Medical Electrical Equipment – Part 1 : General Requirements for basic safety and essential performance | The device complies with the standard. |
| IEC 60601-1-2:2014 Medical Electrical Equipment – Part 1-2: General Requirements for basic safety and essential performance – Collateral Standard: Electromagnetic Compatibility- Requirements and Tests | The device complies with the standard. | |
| Usability | IEC 62366:2015 and FDA guidance for usability study to evaluate safety and effectiveness under intended user and conditions of use. | A usability study was conducted and evaluated the safety and effectiveness. (Details not provided within the document, but implies satisfactory results for substantial equivalence conclusion) |
2. Sample Size Used for the Test Set and Data Provenance
The document describes "head to head simulated use testing" and "the above tests" (referring to the listed methods 1-11 and the electrical/EMC tests) as being performed to demonstrate substantial equivalence. However, it does not explicitly state the specific sample sizes used for each of these performance tests (e.g., number of runs, devices tested, or duration). The data provenance is also not specified; it is implied to be internal bench testing performed by the manufacturer/sponsor for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since the tests described are bench tests involving simulated use, and not clinical studies with patient data requiring expert adjudication of ground truth, there is no mention of experts being used to establish ground truth for the test set. The "ground truth" for these tests would be the established performance specifications and expected outcomes under controlled testing conditions, as measured by standard laboratory equipment and procedures.
4. Adjudication Method for the Test Set
Not applicable, as the tests were bench tests comparing device performance to specifications and a predicate, rather than human-interpreted data requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case comparative effectiveness study was mentioned. The submission focuses on the stand-alone performance and technical equivalence to predicate devices, not on human reader improvement with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
The studies described are for the "algorithm only" in the sense that they evaluate the performance of the device itself (Carilex VT-200-i NX) without human intervention in operating the core functions during the specified tests. The tests directly assess the device's technical capabilities (suction pressure, fluid removal, alarm functions, instillation mode) against predetermined benchmarks and its predicate device.
7. Type of Ground Truth Used
The ground truth for the performance tests was based on established engineering specifications, physical measurements (e.g., pressure, fluid volume, time delays for alarms), and direct comparison to the performance of a legally marketed predicate device (Carilex VT-100/VT-200). For the electrical and EMC tests, the ground truth was compliance with recognized international standards (AAMI/ANSI ES60601-1 and IEC 60601-1-2).
8. Sample Size for the Training Set
This information is not applicable. The Carilex VT-200-i NX is a medical device for negative pressure wound therapy, not an AI/machine learning device that requires a "training set" in the context of data-driven model development. The modifications were engineering changes to hardware and software to add an instill function to an existing device.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no mention of a training set for an AI/machine learning model. The device's functionality is based on electromechanical principles and control software for specific therapy modes.
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April 17, 2024
Carilex Medical, Inc. % Aristotle Nafpliotis Official Correspondent mdi Consultants. Inc. 55 Northern Blvd., Suite 200 Great Neck. New York 11021
Re: K231646
Trade/Device Name: Carilex VT • 200-i NX Regulatory Class: Class II Product Code: OMP Dated: March 13, 2024 Received: March 13, 2024
Dear Aristotle Nafpliotis:
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 (the 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.
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"
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2
(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 OS 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.
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.
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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-regulatoryassistance/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,
Yu-chieh Chiu -S
Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control 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) K231646
Device Name Carilex VT · 200-i NX
Indications for Use (Describe)
The "Carilex" VT · 200-i NX suction therapy unit is indicated on use with patients with the following wounds:
- · Traumatic
- Dehisced wounds
- Partial thickness burns
- · Chronic wounds including pressure ulcers, diabetic foot ulcers and venous leg ulcers
- Acute wounds
- · Flaps and grafts
The device is not intended for home use. Wound irrigation/Instillation function is not intended for use in a homecare setting.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
Submitter's Information 1.
Carilex Medical, Inc. No. 77, Keji 1st Rd., Guishan Dist., Taoyuan City, 333, Taiwan Registration Number: 9710603 Contact: Pauline Su Tel: +886-3-3287882 Fax: +886-3-3288622 Email: Pauline.su(@carilexmedical.com Date Summary Prepared: Feb 15, 2023
2. Trade Name of the Device: Carilex VT-200-i NX
Regulation Name: Powered Suction Pump 3.
| 4. | Classification Name: | Negative Pressure Wound Therapy Powered Suction Pump |
|---|---|---|
| Regulation Number: | 21 CFR 878.4780 | |
| Product Code: | OMP | |
| Panel: | General & Plastic Surgery |
Predicate Device Information: 5.
Carilex VT·100 and VT·200, S1001-3 Series, K173407 Cardinal Health, Sved®, K142916
Device Description 6.
Carilex VT 200-i NX is a powered, portable suction device with battery backup that provides localized negative pressure wound therapy when used with the VT Dressing kits to remove body fluids, irrigation fluids, infectious material and tissue debris from the wound.
Carilex VT 200-i NX have shown that they may help promote the healing of several different kind of wounds via fluid removal. When in use, the vacuum air suction pump in the control unit suck the air from the wound through the connecting hose and dressing to create a negative pressure environment of the wound. The suction of the pump will help remove excess fluids from the wound. VT Dressing kits will be placed onto the wound by healthcare professional and a tube will be connected from the wound to the canister on the pump. After the dressing and tube are correctly applied and connected, turn on the VT · 200 i NX device and set to the pressure setting that is prescribed by healthcare provider. The canister will then collect the excess fluid. This device is not intended for home use.
Carilex VT-200-i NX is an updated version of Carilex VT-100/VT-200 (K173407) via engineering change, and its software and hardware modifications are made to add instill function. The instillation mode is a
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modified continuous mode, where wound irrigation solution is simultaneously infused during negative pressure suction to assist in wound cleaning and removal of infectious substances. There has been no change to the operating principle, mechanism of action or fundamental scientific technology of the predicate device. The Carilex VT-200-i NX is developed with technology and components that are almost identical to Carilex VT·100/ VT·200.
Carilex VT-200-i NX use the same collection canisters as predicate, VT-100, and VT-200 that are supplied non-sterile, single-use with a volume capacity of 300 ml or 1000ml. The canister is permanently sealed to minimize the potential of users coming into contact with exudates. Two tubes with two connector attached to its distal end is attached to the canister, and this connector which can be provided with or without lock feature attaches to the corresponding tubing included in the Carilex VT Dressing Kits.
7. Intended Use(s)
Carilex VT . 200-i NX is an integrated wound management system, indicated for patients who would benefit from wound management via the application of negative pressure for removal of fluids, including wound exudate, irrigation fluids, body fluids, infectious material and tissue debris which may promote wound healing. The device is not intended for home use. Wound irrigation/Instillation function is not intended for use in a homecare setting.
8. Indication for use
The "Carilex" VT · 200-i NX suction therapy unit is indicated on use with patients with the following wounds:
- A Traumatic
- Dehisced wounds A
- A Partial-thickness burns
-
Chronic wounds including pressure ulcers, diabetic foot ulcers and venous leg ulcers
- A Acute wounds
- A Flaps and grafts
The device is not intended for home use. Wound irrigation function is not intended for use in a homecare setting.
Technological Comparison to Predicate Devices: 9.
According to the comparison table below, there were no clinicant differences identified and some similar technical characteristics identified between proposed device (VT200-i NX) and predicate device (VT·200 and Sved®). Therefore, it can be concluded that Carilex VT·200-i NX are substantially equivalent to the predicate device (K173407 and K142916).
| Item | Proposed Devices | Predicate Device 1 | Predicate Device 2 |
|---|---|---|---|
| Company | Carilex Medical Inc. | Carilex Medical Inc. | Cardinal Health |
| Device Name | VT-200-i NX | VT·200 | Sved® |
| Model | S1002-0062 | S1002-0012 | - |
| Item | Proposed Devices | Predicate Device 1 | Predicate Device 2 |
| FDAClearance | N/A | K173407 | K142916 |
| Classification | Class II | Class II | Class II |
| Code forFederalRegulations | 878.4780 | 878.4780 | 878.4780 |
| Product Code | OMP | OMP | OMP |
| PrescriptionMedicalDevice | YES | YES | YES |
| CompatibleDressing | Carilex VT Dressing Kits(K172725) | DeRoyal Foam Kits(K112458) | Cardinal Health™ NPWTDressing (K161418) |
| Intended Use | .Carilex VT-200-i NX is anintegrated wound managementsystem, indicated for patientswho would benefit from woundmanagement via the applicationof negative pressure for removalof fluids, including woundexudate, irrigation fluids, bodyfluids, infectious material andtissue debris which maypromote wound healing. Thedevice is not intended for homeuse. Woundirrigation/Instillation function isnot intended for use in ahomecare setting. | Carilex VT-200 is indicated forpatients who would benefit fromwound management via theapplication of negative pressurefor removal of fluids and excessexudate, infectious material, andtissue debris which maypromote wound healing. | The Cardinal Health NPWTSVED system is an integratedwound management system,indicated for the application ofcontinual or intermittentnegative pressure wound therapyto the wound as the device maypromote wound healing by theremoval of fluids, includingwound exudates, irrigationfluids, body fluids andinfectious materials. |
| Indicationsfor Use | The Carilex VT-200-i NXsuction therapy unit is indicatedon use with patients with thefollowing wounds:> Traumatic> Dehisced wounds> Partial thickness burns> Chronic wounds includingpressure ulcers, diabeticfoot ulcers, and venous legulcers | The VT-200 suction therapy unitis indicated on use with patientswith the following wounds:> Traumatic> Dehisced wounds> Partial thickness burns> Chronic wounds includingpressure ulcers, diabeticfoot ulcers, and venous legulcers> Acute wounds | The SVED® NPWT System isintended for patients withchronic, acute, traumatic,subacute and dehisced wounds,surgical incisions followingsutured or stapled closure,partial-thickness burns, ulcers(such as diabetic or pressure),flaps and grafts. |
| Item | Proposed Devices | Predicate Device 1 | Predicate Device 2 |
| Flaps and graftsThe device is not intended forhome use. Woundirrigation/Instillation function isnot intended for use in ahomecare setting. | |||
| Contraindications | Presence of necrotic tissue | Presence of necrotic tissue | The SVED® is contraindicatedfor patients with malignancy inthe wound, untreatedosteomyelitis, non-enteric andunexplored fistulas, or necrotictissue with eschar present. |
| Malignancy | Malignancy | ||
| Untreated Osteomyelitis | Untreated Osteomyelitis | ||
| Untreated malnutrition | Untreated malnutrition | ||
| Exposed arteries, veins,nerves, or organs. | Exposed arteries, veins,nerves, or organs. | ||
| Use over anastomotic sites | Use over anastomotic sites | ||
| Unexplored or non-entericfistulas | Unexplored or non-entericfistulas | ||
| Exposed bone or tendons | Exposed bone or tendons | ||
| SuctionCapacity | 9.5 Liter / min | 9.5 Liter / min | NA |
| Max. Vacuum | -200 mmHg | -200 mmHg | -150mmHg |
| Power Input | AC 100-240V / 50-60 Hz | AC 100-240V / 50-60 Hz | 100-240VAC, 50-60Hz |
| Power Output | DC 9.1V / 3.3A | DC 9.1V / 3.3A | 15VDC, 2Amp |
| Battery Type | Lithium-ion | Lithium-ion | NA |
| OperatingTime(Battery) | At least 24 hours, depend on use | At least 24 hours, depend on use | up to 10.5 hours |
| Dimensions | 18 x 17.5 x 9 cm | 18 x 17.5 x 9 cm | 7.6 x 2.8 x 7.1 in. |
| Weight | 1.35 kg | 1.35 kg | 0.9kg (2.0 lb.) |
| OperatingMode | Continuous &Intermittent & Instill | Continuous &Intermittent | Continuous &Intermittent &Simultaneous irrigationtechnology |
| Pressureduringinstillation | higher pressure: -80 to -200mmHglower pressure: -20 to -80mmHg | - | higher pressure: -50 or -120 or -150 mmHglower pressure: -25 mmHg |
| Rate of fluidinstillation | Max 200ml/hr | - | Set the drip rate per physicianorder. |
| Canister | 300/500/1000 mlWith double lumens | 300/500/1000 mlWith single lumen | 300/500 ml |
| Sterile | Non-Sterile | Non-Sterile | Non-Sterile |
| Item | Proposed Devices | Predicate Device 1 | Predicate Device 2 |
| Life-time | 3 years | 3 years | 3 years |
| ElectricalSafety | ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012,C1:2009/(R)2012 andA2:2010(R)2012. | AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012,C1:2009/(R)2012 andA2:2010/(R)2012 | IEC 60601-1 |
| EMC | IEC 60601-1-2:2014,EN 60601-1-2:2015 | IEC 60601-1-2:2007 | IEC 60601-1-2 |
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Operating Mode & Pressure setting
The general therapy modes, continuous and intermittent, of the all devices are the same, but proposed devices (VT 200-i NX) is with additional mode for instill. The instillation mode is a modified continuous mode, where wound irrigation solution is simultaneously infused during negative pressure suction to assist in wound cleaning and removal of infectious substances. This principle is similar to the predicate device 2 (Sved®) Simultaneous irrigation technology. The predicate device (SVED®) allows for the optional use of wound irrigation to the wound bed. During irrigation, the predicate device (SVED®) will provide higher pressure (-50 or -120 or -150 mmHg) and approximately -25 mmHg lower pressure.
Canister
The canister compatible with the proposed device (VT . 200-i NX) has undergone a mechanical design revision, incorporating additional tubing to accurately detect the pressure at the wound site.
EMC
The electric design of both device is the same, in addition, proposed devices (VT200-i NX) is compliance with the most updated standards.
10. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
This submission is to provide an update to the existing cleared Carilex VT · 100/ VT · 200. The subject and predicate devices are based on the following same technical elements:
- Continuous and Intermittent treatment modes with the addition of instillation mode in the subject device ●
- Pressure sensing technology within the pump ●
- Available for use with 300cc and 500cc, 1000cc canisters
- Use AC and Rechargeable battery
The following technological differences exist between the subject and predicate devices:
- The updated Carilex VT·200-i NX has an updated indications for use to include the removal of irrigation ● fluids via the application of negative pressure. This better aligns the indications for use with the "OMP" regulation definition.
- The updated Carilex VT 200-i NX has had other enhancements including:
- Canister with additional tubing to detect the pressure of wound site accuracy O
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- . The Electronic Magnetic Compatibility testing has been performed to comply with IEC 60601-1-2:2014 standard. It does not raise any issue in safety and effectiveness.
11. Summary for Performance Testing
- To demonstrate that the Carilex VT-200-i NX are substantially equivalent to the predicate. Carilex I. VT-100 and VT-200 Powered Suction Pump, S1001-3 Series (K173407), head to head simulated use testing has been conducted which demonstrate the overall system performance of Carilex VT·200-i NX.
- Method 1 Compare suction pressure with no fluid introduced (air) under continuous and intermittent mode.
- Compare suction pressure and fluid removal rate with plasma introduced under Method 2 continuous and intermittent mode.
- Compare suction pressure and fluid removal rate with Simulated Body Fluid (SBF) Method 3 introduced under continuous and intermittent mode.
- Method 4 Compare leakage alarm function under continuous and intermittent mode.
- Method 5 Compare canister-full alarm function under continuous and intermittent mode.
- Compare blockage alarm function with default time delay (1 min) under continuous and Method 6 intermittent mode.
- Method 7 Test suction pressure and fluid removal rate with Normal saline introduced under instill mode.
- Method 8 Test the possibility of pooling occurring at the simulates wound site under instill mode
- Method 9 Test leakage indicator function under instill mode
- Method 10 Test canister-full indicator function under instill mode
- Test blockage indicator function under instill mode Method 11
- II. The following tests were performed to determine substantial equivalence: AAMI/ANSI ES60601-1:2005/(R) 2012+A1:2012, C1:2009/(R) 2012+A2:2010/(R)2012 Medical Electrical Equipment – Part 1 : General Requirements for basic safety and essential performance
IEC 60601-1-2:2014
Medical Electrical Equipment – Part 1-2: General Requirements for basic safety and essential performance – Collateral Standard: Electromagnetic Compatibility- Requirements and Tests
According to the results derived from the above tests, it can be concluded that Carilex VT 200-i NX are substantially equivalent to the predicate device Carilex VT·100 (K173407) in terms of generating suction pressure and removing fluids from wound model within specification.
- III. Usability Testing
A usability study was conducted in accordance with IEC 62366:2015 and FDA guidance to evaluate the safety and effectiveness of the VT · 200-i NX under the intended user and conditions of use.
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12. Conclusion
After analyzing intended use, indications for use, technology, bench test report, shelf-life test reports, software documents, and EMC and electrical safety test reports, it can be concluded that Carilex VT-200i NX are substantially equivalent to the predicate device Carilex VT-100 and VT-200 (K173407) and Cardinal Sved® (K142916).
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.