(126 days)
The Negative Pressure Wound Therapy Device is indicated for wound management via the application of negative pressure to the wound by the removal of wound exudate, infectious materials, and tissue debris from the wound bed.
The Negative Pressure Wound Therapy Device is indicated for the following wound types: chronic, acute, traumatic, subacute, and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps, and grafts.
The Negative Pressure Wound Therapy Device is a portable, rechargeable, battery powered pump capable of delivering bespoke continuous and/or intermittent negative pressure intended to allow wound management by draining and removing wound exudates, infectious material, and tissue debris from the wound bed. The Negative Pressure Wound Device is packaged and provided with the following components: Negative Pressure Wound Therapy Pump and Collection Canister.
Patients with chronic, acute, traumatic, subacute, and dehisced wounds, partial-thickness burns, diabetic ulcers, neuropathic ulcers, pressure ulcers, flaps, and grafts may benefit from this system.
The Negative Pressure Wound Therapy Device used with wound dressings can produce a negative pressure environment in either intermittent or continuous mode. This allows the user to program the specific pressure ranging from 50mmHg to 200mmHg (V-Move) and 0 to 200 mmHg (V-Grand).
In intermittent mode, the pump will alternate between applying pressure for 5 continuous minutes and reducing pressure to 0 for 2 minutes for V-Move. In intermittent mode, therapy pressure, operating time, and interval time can be adjusted for V-Grand.
The Negative Pressure Wound Therapy Device is compatible with the Longterm NPWT Foam Dressing Kit (K211571).
The device is used in professional medical facilities.
The Negative Pressure Wound Therapy pump accessories that are included in this 510(k) submission and will be commercialized separately are the following: 300cc Collection Canister 500cc Collection Canister 1000cc Collection Canister
The provided document is an FDA 510(k) clearance letter for a Negative Pressure Wound Therapy Device (V-Move, V-Grand). It does not contain any information about acceptance criteria or a study proving the device meets those criteria (e.g., accuracy, sensitivity, specificity, or human improvement with AI assistance).
The document primarily focuses on:
- Substantial Equivalence: Comparing the new device to existing predicate devices (K132225 and K162159) based on indications for use, contraindications, principle of operation, vacuum modes, negative pressure ranges, canister sizes, prescription use, sterility, weight, user life, energy source, tubing material, and battery type.
- Non-Clinical Testing: Mentioning that non-clinical tests were conducted for safety (ANSI AAMI ES60601-1, IEC60601-1-2), biocompatibility (not required as components are not tissue contacting), performance (bench tests including safety, environmental, device performance, and function tests), and software validation.
- Absence of Clinical Study: Explicitly stating that "No clinical testing was required to support substantial equivalence."
Therefore, based solely on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets them because such information is not present. The device is cleared based on substantial equivalence to predicate devices rather than direct performance metrics derived from clinical or AI-driven studies.
To address your request, if this were a device involving AI or complex performance metrics, the missing information would typically include:
-
Table of Acceptance Criteria and Reported Device Performance: This would specify quantitative metrics (e.g., accuracy, sensitivity, specificity, precision, F1-score) and the threshold they needed to meet for acceptance, along with the actual performance achieved in a test set.
-
Sample Size and Data Provenance: Details on the number of cases/patients in the test set, their country of origin, and whether the data was collected retrospectively or prospectively.
-
Number and Qualifications of Experts for Ground Truth: The number of human experts (e.g., radiologists, pathologists) who reviewed the test data to establish the correct diagnoses or labels, along with their professional qualifications and experience.
-
Adjudication Method: How disagreements among experts were resolved to arrive at a definitive ground truth (e.g., majority vote, senior expert arbitration).
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: If human readers were involved, whether a study was conducted to assess the improvement in human performance (e.g., diagnostic accuracy) when assisted by the AI device compared to unassisted human performance, and the calculated effect size.
-
Standalone Performance: Data on the device's performance (e.g., diagnostic accuracy) when operating without human intervention.
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Type of Ground Truth: Whether the ground truth was established by expert consensus, surgical pathology, long-term patient outcomes, or other definitive methods.
-
Training Set Sample Size: The number of cases/patients used to train the device's algorithm.
-
Training Set Ground Truth Establishment: How the ground truth for the training data was determined.
In summary, the provided document does not contain the specific information requested about acceptance criteria and performance study results because it details a 510(k) clearance based on substantial equivalence, not a performance study with detailed AI or clinical metrics.
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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.
August 19, 2024
Med Way Inc. % Charles Mack Principal Engineer Irc 2950 E Lindrick Drive Chandler, Arizona 85249
Re: K241023
Trade/Device Name: Negative Pressure Wound Therapy Device (V-Move, V-Grand) Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: March 23, 2024 Received: April 15, 2024
Dear Charles Mack:
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.
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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.
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 mediation-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 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) K241023
Device Name
Negative Pressure Wound Therapy Device (V-Move, V-Grand)
Indications for Use (Describe)
The Negative Pressure Wound Therapy Device is indicated for wound management via the application of negative pressure to the wound by the removal of wound exudate, infectious materials, and tissue debris from the wound bed.
The Negative Pressure Wound Therapy Device is indicated for the following wound types: chronic, acute, traumatic, subacute, and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps, and grafts.
| 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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | ||
| Prescription Use (Part 21 CFR 801 Subpart D) | ||||
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY AS RÉQUIRED BY 21CFR807.92(c)
| Preparation Date: | August 19, 2024 |
|---|---|
| Manufacturer's Name and Address: | Med Way Inc.1650 Horizon Pkwy NE, Suite 450,Buford, GA, USA 30518Tel: (888) 563-3929 |
| Corresponding Official: | Charles Mack |
| Telephone Number: | 931-625-4938 |
| Email Address: | charliemack@irc-us.com |
| Trade Name: | Negative Pressure Wound TherapyDeviceModel: V-Move, V-Grand |
| Common Name(s): | negative pressure wound therapypowered suction pump |
| Regulation Name(s): | Powered suction pump |
| Regulation Number(s): | 21CFR878.4780 |
| Primary Product Code: | OMP |
| Device Class: | Class II |
| Predicate Device: | K132225 |
| Trade Name: | EXTRICARE |
| Common Name: | negative pressure wound therapypowered suction pump |
| Regulation Number(s): | 21CFR878.4780 |
| Product Code: | OMP |
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Device Description:
The Negative Pressure Wound Therapy Device is a portable, rechargeable, battery powered pump capable of delivering bespoke continuous and/or intermittent negative pressure intended to allow wound management by draining and removing wound exudates, infectious material, and tissue debris from the wound bed. The Negative Pressure Wound Device is packaged and provided with the following components: Negative Pressure Wound Therapy Pump and Collection Canister.
Patients with chronic, acute, traumatic, subacute, and dehisced wounds, partial-thickness burns, diabetic ulcers, neuropathic ulcers, pressure ulcers, flaps, and grafts may benefit from this system.
The Negative Pressure Wound Therapy Device used with wound dressings can produce a negative pressure environment in either intermittent or continuous mode. This allows the user to program the specific pressure ranging from 50mmHg to 200mmHg (V-Move) and 0 to 200 mmHg (V-Grand).
In intermittent mode, the pump will alternate between applying pressure for 5 continuous minutes and reducing pressure to 0 for 2 minutes for V-Move. In intermittent mode, therapy pressure, operating time, and interval time can be adjusted for V-Grand.
The Negative Pressure Wound Therapy Device is compatible with the Longterm NPWT Foam Dressing Kit (K211571).
The device is used in professional medical facilities.
The Negative Pressure Wound Therapy pump accessories that are included in this 510(k) submission and will be commercialized separately are the following: 300cc Collection Canister 500cc Collection Canister 1000cc Collection Canister
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Indications for Use
The Negative Pressure Wound Therapy Device is indicated for wound management via the application of negative pressure to the wound by the removal of wound exudate, infectious materials, and tissue debris from the wound bed.
The Negative Pressure Wound Therapy Device is indicated for the following wound types: chronic, acute, traumatic, subacute, and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps, and grafts.
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K241023
Page 4 of 6
| Item | Subject Device | Predicate Device | Reference Device | Comment |
|---|---|---|---|---|
| 510(k) | K241023 | K132225 | K162159 | - |
| Device | Negative Pressure WoundTherapy Device | Negative Pressure WoundTherapy System | VCare 1000-300S System | - |
| Model | V-Move, V-Grand | extriCARE 3600 | VCare 1000-300S Pump | - |
| Applicant | MED WAY INC. | Devin Medical, Inc. | VR Medical TechnologyCompany, Ltd. | - |
| Product code | OMP | OMP | OMP | - |
| RegulationNumber | 878.4780 | 878.4780 | 878.4780 | - |
| Indication for Use | The Negative PressureWound Therapy Device isindicated for woundmanagement via theapplication of negativepressure to the wound by theremoval of wound exudate,infectious materials, andtissue debris from the woundbed.The Negative PressureWound Therapy Device isindicated for the followingwound types: chronic, acute,traumatic, subacute anddehisced wounds, partial-thickness burns, ulcers (suchas diabetic or pressure), flapsand grafts. | The extriCARE 3600Negative Pressure WoundTherapy System is indicatedfor wound management viathe application of negativepressure to the wound by theremoval of wound exudate,infectious materials, andtissue debris from the woundbed.The extriCARE 3600Negative Pressure WoundTherapy System is indicatedfor the following wound types:chronic, acute, traumatic,subacute and dehiscedwounds,partial-thickness burns, ulcers(such as diabetic orpressure), flaps and grafts. | The VR Medical VCare 1000-300S Negative PressureWound Therapy System is anintegrated woundmanagement system,indicated for woundmanagement via theapplication of negativepressure to the wound, inorder for the removal of fluids,including wound exudates,irrigation fluids, body fluidsand infectious materials.The system is intended forpatients with chronic, acute,traumatic, subacute anddehisced wounds, partial-thickness burns, ulcers (suchas diabetic or pressure), flapsand grafts. | IdenticalNote 1 |
| Contraindications | - Exposed vessels, organs,or nerves.- Anastomotic sites.- Exposed arteries or veinsin a wound.- Fistulas, unexplored ornon-enteric.- Untreated osteomyelitis.- Malignancy in the wound.- Excess amount ofnecrotic tissue witheschar.- Wounds which are toolarge or too deep to beaccommodated by thedressing.- Inability to be followedby a medicalprofessional or to keepscheduled appointments.- Allergy to urethanedressings andadhesives.- Use of topical productswhich must be appliedmore frequently thanthedressing change scheduleallows | Exposed vessels, organs,or nerves.Anastomotic sites.Exposed arteries or veinsin a wound.Fistulas, unexplored ornon-enteric.Untreated osteomyelitis.Malignancy in the wound.Excess amount ofnecrotic tissue witheschar.Wounds which are toolarge or too deep to beaccommodated by thedressing.Inability to be followedby a medicalprofessional or to keepscheduled appointments.Allergy to urethanedressings andadhesives.Use of topical productswhich must be appliedmore frequently thanthedressing change scheduleallows | Exposed vessels, organs,or nerves.Anastomotic sites.Exposed arteries or veinsin a wound.Fistulas, unexplored ornon-enteric.Untreated osteomyelitis.Malignancy in the wound.Excess amount ofnecrotic tissue witheschar.Wounds which are toolarge or too deep to beaccommodated by thedressing.Inability to be followedby a medicalprofessional or to keepscheduled appointments.Allergy to urethanedressings andadhesives.Use of topical productswhich must be appliedmore frequently thanthedressing change scheduleallows | Identical |
| Item | Subject Device | Predicate Device | ReferenceDevice | Comment |
| Principle ofOperation | A vacuum pump generates vacuum. Acollection canister is connected to thevacuum pump, and a tubingconnecting the wound dressing andthe canister bringswound exudate | A vacuum pump generates vacuum. Acollection canister is connected to thevacuum pump, and atubingconnecting the wound dressing andthe canister bringswound exudate | A vacuum pumpgenerates vacuum. Acollection canister isconnected to the vacuumpump, and a tubingconnecting the wounddressing and thecanister bringswound exudate | Identical |
| Vacuum mode | Continuous and Intermittent | Continuous and Intermittent | Continuous and Intermittent | Identical |
| NegativePressure | 50 | 40~200 mmHg | 20~200 mmHg | Note 2 |
| Canister | 300cc, 500cc(V-Move)500cc, 1000cc(V-Grand) | 400cc, 1000cc | 140, 400, 600cc | Note 2 |
| Prescription Use | Yes | Yes | Yes | Identical |
| Sterility | Non-sterile (exclude dressing) | Non-sterile (exclude dressing) | Non-sterile (excludedressing) | Identical |
| Weight | 1.5 lbs (0.7kg) for V-Move;8.1 lbs (3.7kg) for V-Grand | 2.87 lbs (1.3kg) | 0.51 lbs (0.23kg) | Note 3 |
| User Life | Indefinite, with routine servicing andrepair | Indefinite, with routine servicing andrepair | Indefinite, with routineservicing and repair | Identical |
| Energy source | AC and Battery | AC and Battery | AC and Battery | Identical |
| NegativePressureTubing | PVC | PVC | PVC | Identical |
| Battery | Lithium battery | Lithium battery | Lithium battery | Identical |
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K241023
Page 5 of 6
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Testing
Non-clinical tests were conducted to verify that the proposed devices met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed devices comply with the following standards:
Safety and EMC
- ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]
- IEC60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical . equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Biocompatibility
The Pump and the Cannister are not tissue contacting. No biocompatibility test submitted.
Performance
To ensure the performance of subject device meet the design input, a series of bench tests were conducted which including safety test, environmental test, device performance test, function test etc.
Software
The software validation was conducted according to the FDA guidance "Content of Premarket Submissions for Device Software Functions". Testing concluded that the subject device met the requirement.
Clinical Study:
No clinical testing was required to support substantial equivalence
Conclusion:
In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Part 807, and based on the information provided in this pre-market notification, the subject device is as safe and as effective as and substantially equivalent to the predicate devices as described herein.
§ 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.