(146 days)
No
The device description and summary of performance studies do not mention any AI or ML capabilities. The primary function is a suction pump with a timed shut-off feature for one model.
Yes.
The device description and intended use clearly state that the device is a suction pump for negative pressure wound therapy, used to promote wound healing by removing fluids and excess exudates.
No
The device is a suction pump for negative pressure wound therapy, indicated for promoting wound healing by removing fluids and debris. Its function is therapeutic, not diagnostic.
No
The device description explicitly states it is a "suction pump with collection canisters" and is a physical device that connects to a wound dressing via a tube. It also mentions operating via a mains power supply or internal battery, all indicating a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Carilex VT·One/VT·One 60days is a negative pressure wound therapy (NPWT) device. Its function is to apply suction to a wound to remove fluids and debris, which helps promote healing. It operates externally to the body and does not analyze biological samples for diagnostic purposes.
- Intended Use: The intended use clearly states it's for "removal of fluids and excess exudates, infectious material, and tissue debris, which may promote wound healing." This is a therapeutic function, not a diagnostic one.
The device description and intended use clearly indicate it's a therapeutic device used for wound management, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
Carilex VT·One/VT·One 60days is indicated for patients who benefit from removal of fluids and excess exudates, infectious material, and tissue debris, which may promote wound healing. The VT-One/VT-One 60days 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.
Product codes
OMP
Device Description
Carilex VT One and VT One 60days are suction pumps with collection canisters for negative pressure wound therapy. Carilex VT.One 60days are modified from its precursor VOLTERA Powered Suction Pump, S1001-3 Series (K112853), and they are smaller, portable and lighter in weight. The pump is connected to the wound dressing via a tube connected to a disposable canister. The device provides negative pressure wound therapy to the wound at a range of pressure settings and removes exudates from the wound site to the disposable canister. The device can operate either by a mains power supply or internal battery.
The intended use, performance, and technology for Carilex VT·One and VT·One 60days are mostly identical. However, the VT·One 60days is programmed to stop working after 60 days of use and will not re-start after this time. This feature makes VT One 60days a single patient use NPWT pump that has a lifetime of 60 days; while VT-One is a durable medical device with a minimum lifetime of 3 years.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Performance/Comparison Testing of VT.One 60days with the predicate. The pumps met all pre-determined acceptance criteria and passed the tests.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 13, 2016
Carilex Medical, Inc. % Maria Griffin Senior Consultant Mdi Consultants, Inc. 55 Northern Blvd. Great Neck, New York 11021
Re: K161410
Trade/Device Name: VT.One, VT.One 60days Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: September 8, 2016 Received: September 9, 2016
Dear Maria Griffin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K161410
Device Name Carilex VT.One/VT.One 60days
Carilex VT One/VT One 60days is indicated for patients who benefit from removal of fluids and excess exudates. infectious material, and tissue debris, which may promote wound healing. The VT One 60days 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
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
The assigned 510(k) number is: K161410
1. Submitter's Identification:
Carilex Medical, Inc. No. 77 Keji 18t Rd.,Guishan Dist. Taoyuan City Taiwan 333 Registration Number: 9710603 Contact: Henry Kao Tel: +886-3-3287882 Fax: +886-3-3288622 Email: henry.kao@carilexmedical.com
Date Summary Prepared: May 20, 2016
-
- Trade Name of the Devices: Carilex VT.One/ VT.One 60days
- Common or Usual Name: Powered Suction Pump 3.
- Classification Name: 4. Regulation Number: Product code: Panel:
Negative Pressure Wound Therapy Powered Suction Pump 878.4780 OMP General & Plastic Surgery
ട്. Predicate Device Information:
VOLTERA Powered Suction Pump, S1001-3 Series, K112853
6. Device Description:
Carilex VT One and VT One 60days are suction pumps with collection canisters for negative pressure wound therapy. Carilex VT.One 60days are modified from its precursor VOLTERA Powered Suction Pump, S1001-3 Series (K112853), and they are smaller, portable and lighter in weight. The pump is connected to the wound dressing via a tube connected to a disposable canister. The device provides negative pressure wound therapy to the wound at a range of pressure settings and removes exudates from the wound site to the disposable canister. The device can operate either by a mains power supply or internal battery.
The intended use, performance, and technology for Carilex VT·One and VT·One 60days are mostly identical. However, the VT·One 60days is programmed to stop working after 60 days of use and will not re-start after this time. This feature makes VT One 60days a single patient use NPWT pump that has a lifetime of 60 days; while VT-One is a durable medical device with a minimum lifetime of 3 years.
4
carilex®
Intended Use: 7.
Carilex VT·One/VT·One 60days is indicated for patients who benefit from removal of fluids and excess exudates, infectious material, and tissue debris, which may promote wound healing. The VT-One/VT-One 60days 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.
| Item | Proposed Devices | Predicate Device | |
|---|---|---|---|
| Device Name | VT-One | VT-One 60days | VOLTERA Powered Suction Pump, S1001-3 Series |
| Classification | Class II | Class II | |
| Code for Federal | |||
| Regulations | 878.4780 | 878.4780 | |
| Prescription | |||
| Medical Device | YES | YES | |
| Model | S1004-0012 | S1004-0022 | S1001-3 Series |
| Compatible | |||
| NPWT Dressing | DeRoyal Foam Kits (K112458) | DeRoyal Foam Kits (K112458) | |
| Intended Use | Carilex VT-One/VT-One 60days is | ||
| indicated for patients who benefit from | |||
| removal of fluids and excess exudates, | |||
| infectious material, and tissue debris, | |||
| which may promote wound healing. | The VOLTERA Powered Suction Pump, S1001- | ||
| 3 Series is indicated for patients who would | |||
| benefit from wound management via the | |||
| application of negative pressure for removal of | |||
| fluids and excess exudate, infectious material, | |||
| and tissue debris which may promote wound | |||
| healing. | |||
| Indications for | |||
| Use | The VT-One/ VT-One 60days 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 VOLTERA suction pump 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 | |||
| Contraindications | Presence of necrotic tissue Malignancy Untreated Osteomyelitis Untreated malnutrition Exposed arteries, veins, nerves, or | ||
| organs. Use over anastomotic sites | Presence of necrotic tissue Malignancy Untreated Osteomyelitis Untreated malnutrition Exposed arteries, veins, nerves, or organs. Use over anastomotic sites | ||
| Suction Capacity | 0.8 Liter / min | 0.6 Liter / min | 2.5 Liter / min |
| Max. Vacuum | - 150 mmHg | - 200 mmHg | |
| Power Input | AC 100-240V / 50-60 Hz | AC 110-240V / 47-63 Hz |
8. Technological Comparison to Predicate Devices:
5
carilex®
| Power Output | DC 12V / 1.25A | DC 9V / 3A |
|---|---|---|
| Battery Type | Lithium ion | Lithium ion |
| Operating Time | ||
| (Battery) | 16 hours, depend on use | 24~48 hours, depend on use |
| Dimensions | 150 mm x 85 mm x 50 mm | 170 mm x 160 mm x 90 mm |
| Weight | 350g | 1.35 kg |
| Operating Mode | Continuous & Intermittent | Continuous & Intermittent |
| Canister | 150 ml | 300 ml |
| Life-time | 3 years |
| 3 years |
| Software
Setting | Programmed to
be repetitively
used during
lifetime
| Programmed to be repetitively used during
lifetime |
Discussion of Non-Clinical Tests Performed for Determination of Substantial 9. Equivalence are as follows:
The following tests were performed to determine substantial equivalence:
IEC60601-1:2005+COR1(2006)+COR2(2007)+AMD1(2012) Medical Electrical Equipment – Part 1:General Requirements for basic safety and essential performance
IEC60601-1-2:2007 Medical Electrical Equipment – Part 1-2: General Requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility-Requirements and Tests
Performance/Comparison Testing of VT.One 60days with the predicate. The pumps met all pre-determined acceptance criteria and passed the tests.
Discussion of Clinical Tests Performed: 10.
Clinical tests were not performed.
11. Conclusions:
After analyzing intended use, indications for use, technology, bench test reports, shelflife reports, and EMC and electrical safety tests, it can be concluded that Carilex VT·One/ VT·One 60days is substantially equivalent to the predicate device VOLTERA Powered Suction Pump, S1001-3 Series (K112853).