(126 days)
No
The 510(k) summary describes a standard negative pressure wound therapy device with programmable pressure and modes. There is no mention of AI or ML in the intended use, device description, or performance studies. The software validation is described as following standard FDA guidance, not specific to AI/ML.
Yes
The device is indicated for wound management, including various types of wounds, burns, ulcers, flaps, and grafts, using negative pressure to remove exudate and infectious materials, which are therapeutic actions.
No
The device is a Negative Pressure Wound Therapy Device, which is used for wound management by applying negative pressure to remove exudate and debris from the wound bed. It does not perform any diagnostic functions.
No
The device description explicitly states it is a "portable, rechargeable, battery powered pump" and includes physical components like a "Negative Pressure Wound Therapy Pump and Collection Canister." This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Negative Pressure Wound Therapy Device works directly on the wound to remove exudate, infectious materials, and tissue debris. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states "wound management via the application of negative pressure to the wound". This is a treatment, not a diagnostic test.
- Device Description: The description focuses on the mechanical function of the pump and collection canister for removing materials from the wound.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, providing diagnostic information, or using reagents or assays typically associated with IVDs.
Therefore, the Negative Pressure Wound Therapy Device is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
OMP
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wound bed
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional medical facilities.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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.
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.
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.
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.
2
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
3
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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4
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 30518 | |
| Tel: (888) 563-3929 | |
| Corresponding Official: | Charles Mack |
| Telephone Number: | 931-625-4938 |
| Email Address: | charliemack@irc-us.com |
| Trade Name: | Negative Pressure Wound Therapy |
| Device | |
| Model: V-Move, V-Grand | |
| Common Name(s): | negative pressure wound therapy |
| powered 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 therapy |
| powered suction pump | |
| Regulation Number(s): | 21CFR878.4780 |
| Product Code: | OMP |
5
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
6
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.
7
K241023
Page 4 of 6
| Item | Subject Device | Predicate Device | Reference Device | Comment |
|---|---|---|---|---|
| 510(k) | K241023 | K132225 | K162159 | - |
| Device | Negative Pressure Wound | |||
| Therapy Device | Negative Pressure Wound | |||
| Therapy 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 Technology | |
| Company, Ltd. | - | |||
| Product code | OMP | OMP | OMP | - |
| Regulation | ||||
| Number | 878.4780 | 878.4780 | 878.4780 | - |
| Indication 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. | The extriCARE 3600 | |||
| Negative Pressure Wound | ||||
| Therapy System 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 extriCARE 3600 | ||||
| Negative Pressure Wound | ||||
| Therapy System 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 VR Medical VCare 1000- | |||
| 300S Negative Pressure | ||||
| Wound Therapy System is an | ||||
| integrated wound | ||||
| management system, | ||||
| indicated for wound | ||||
| management via the | ||||
| application of negative | ||||
| pressure to the wound, in | ||||
| order for the removal of fluids, | ||||
| including wound exudates, | ||||
| irrigation fluids, body fluids | ||||
| and infectious materials. | ||||
| The system is intended for | ||||
| patients with chronic, acute, | ||||
| traumatic, subacute and | ||||
| dehisced wounds, partial- | ||||
| thickness burns, ulcers (such | ||||
| as diabetic or pressure), flaps | ||||
| and grafts. | Identical | |||
| Note 1 | ||||
| Contraindications | - Exposed vessels, organs, | |||
| or nerves. |
- Anastomotic sites.
- Exposed arteries or veins
in a wound. - Fistulas, unexplored or
non-enteric. - Untreated osteomyelitis.
- Malignancy in the wound.
- Excess amount of
necrotic tissue with
eschar. - Wounds which are too
large or too deep to be
accommodated by the
dressing. - Inability to be followed
by a medical
professional or to keep
scheduled appointments. - Allergy to urethane
dressings and
adhesives. - Use of topical products
which must be applied
more frequently than
the
dressing change schedule
allows | Exposed vessels, organs,
or nerves.
Anastomotic sites.
Exposed arteries or veins
in a wound.
Fistulas, unexplored or
non-enteric.
Untreated osteomyelitis.
Malignancy in the wound.
Excess amount of
necrotic tissue with
eschar.
Wounds which are too
large or too deep to be
accommodated by the
dressing.
Inability to be followed
by a medical
professional or to keep
scheduled appointments.
Allergy to urethane
dressings and
adhesives.
Use of topical products
which must be applied
more frequently than
the
dressing change schedule
allows | Exposed vessels, organs,
or nerves.
Anastomotic sites.
Exposed arteries or veins
in a wound.
Fistulas, unexplored or
non-enteric.
Untreated osteomyelitis.
Malignancy in the wound.
Excess amount of
necrotic tissue with
eschar.
Wounds which are too
large or too deep to be
accommodated by the
dressing.
Inability to be followed
by a medical
professional or to keep
scheduled appointments.
Allergy to urethane
dressings and
adhesives.
Use of topical products
which must be applied
more frequently than
the
dressing change schedule
allows | Identical |
| Item | Subject Device | Predicate Device | Reference
Device | Comment |
| Principle of
Operation | A vacuum pump generates vacuum. A
collection canister is connected to the
vacuum pump, and a tubing
connecting the wound dressing and
the canister brings
wound exudate | A vacuum pump generates vacuum. A
collection canister is connected to the
vacuum pump, and a
tubing
connecting the wound dressing and
the canister brings
wound exudate | A vacuum pump
generates vacuum. A
collection canister is
connected to the vacuum
pump, and a tubing
connecting the wound
dressing and the
canister brings
wound exudate | Identical |
| Vacuum mode | Continuous and Intermittent | Continuous and Intermittent | Continuous and Intermittent | Identical |
| Negative
Pressure | 50200 mmHg200 mmHg
(V-Move)
0
(V-Grand) | 40200 mmHg | 20200 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 (exclude
dressing) | 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 and
repair | Indefinite, with routine servicing and
repair | Indefinite, with routine
servicing and repair | Identical |
| Energy source | AC and Battery | AC and Battery | AC and Battery | Identical |
| Negative
Pressure
Tubing | PVC | PVC | PVC | Identical |
| Battery | Lithium battery | Lithium battery | Lithium battery | Identical |
8
K241023
Page 5 of 6
9
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.