K Number
K173407
Device Name
VT - 100, VT - 200
Date Cleared
2018-08-09

(281 days)

Product Code
Regulation Number
878.4780
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Carilex VT • 100/VT • 200 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. The VT · 100/VT · 200 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.
Device Description
Carilex VT • 100 and VT • 200 are suction pumps with collection canisters for negative pressure wound therapy. The VT · 100 and VT · 200 are modified from their precursor VOLTERA Powered Suction Pump, S1001-3 Series (K112853). The pump is connected to the wound dressing via a tube connected to a disposable canister. The devices provide 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 devices can operate either by a mains power supply or internal battery. The VT • 200 is developed with technology and components that are almost identical to VT • 100, but for marketing differentiation it is designed with a new outer case which contains extra room to allow incorporation with different types of air compressors in the future.
More Information

No
The description focuses on the mechanical function of a suction pump for negative pressure wound therapy and explicitly states "Mentions AI, DNN, or ML: Not Found".

Yes
The device is indicated for wound management via negative pressure application to promote wound healing, which is a therapeutic purpose.

No.
The device is a suction pump designed for negative pressure wound therapy to remove fluids and debris, not to provide diagnostic information about a patient's condition.

No

The device description explicitly states that the devices are "suction pumps with collection canisters" and are connected to the wound dressing via a tube, indicating a hardware-based system for negative pressure wound therapy.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for wound management via the application of negative pressure to remove fluids and debris directly from the wound. This is a therapeutic intervention applied to the body, not a diagnostic test performed on a sample taken from the body.
  • Device Description: The device is a suction pump with collection canisters. It physically removes exudate from the wound.
  • No mention of in vitro testing: There is no indication that this device is used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or treatment.

IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This device is a therapeutic device used to treat a wound directly.

N/A

Intended Use / Indications for Use

Carilex VT • 100/VT • 200 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. The VT · 100/VT · 200 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 (comma separated list FDA assigned to the subject device)

OMP

Device Description

Carilex VT • 100 and VT • 200 are suction pumps with collection canisters for negative pressure wound therapy. The VT · 100 and VT · 200 are modified from their precursor VOLTERA Powered Suction Pump, S1001-3 Series (K112853). The pump is connected to the wound dressing via a tube connected to a disposable canister. The devices provide 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 devices can operate either by a mains power supply or internal battery. The VT • 200 is developed with technology and components that are almost identical to VT • 100, but for marketing differentiation it is designed with a new outer case which contains extra room to allow incorporation with different types of air compressors in the future.

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance/Comparison Testing of VT · 100/VT · 200 with the predicate. The pumps met all pre-determined acceptance criteria and passed the tests (suction pressure, fluid removal rate, alarm functionality).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K112853

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K112458

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.

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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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 9, 2018

Carilex Medical, Inc. Henry Kao RA Specialist No. 77 Keji 1st Rd., Guishan Dist. Taoyuan City, Taiwan 333

Re: K173407

Trade/Device Name: VT - 100, VT - 200 Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: July 6, 2018 Received: July 9, 2018

Dear Henry Kao:

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. 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 located at https://www.accessdata.fda.gov/scripts/cdrl/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.

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 803) for

1

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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

2

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
10(k) Number (if known)K172407
----------------------------------

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51

Carilex VT · 100/VT · 200 Device Name

Indications for Use (Describe)

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  • · Traumatic
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  • Dehisced wounds

  • Partial-thickness burns

  • Chronic wounds including pressure ulcers, disbetic foot ulcers and venous leg ulcers

  • Acute wounds

  • Flaps and grafts

Type of Use (Select one or both, as applicable)

A Presscription Use (Part 21 CFR 801 Suppart DJ

_ Over-The-Counter Use (2) CFR 801 Support C

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Department of Health and Human Services

Office of Chief Information Officer Food and Drug Administration

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Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

Department of Health and Human Service
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

Department of Health and Human Servic
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

Department of Health and Human Servic
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

Department of Health and Human Servi
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

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Food and Drug Administration
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Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

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K173407 Carilex VT.100/VT.200 Page 1/4

510(k) SUMMARY

The assigned 510(k) number is: K173407

Submitter's Information 1.

Carilex Medical, Inc. No. 77, Keji 186 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: October 27, 2017

  • Trade Name of the Device: Carilex VT · 100 & VT · 200 2.
    1. Common or Usual Name: Powered Suction Pump
    1. Classification Name: Negative Pressure Wound Therapy Powered Suction Pump Regulation Number: 878.4780 Product Code: ОМР Panel: General & Plastic Surgery

5. Predicate Device Information:

VOLTERA Powered Suction Pump, S1001-3 Series, K112853

6. Device Description

Carilex VT • 100 and VT • 200 are suction pumps with collection canisters for negative pressure wound therapy. The VT · 100 and VT · 200 are modified from their precursor VOLTERA Powered Suction Pump, S1001-3 Series (K112853). The pump is connected to the wound dressing via a tube connected to a disposable canister. The devices provide 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 devices can operate either by a mains power supply or internal battery. The VT • 200 is developed with technology and components that are almost identical to VT • 100, but for marketing differentiation it is designed with a new outer case which contains extra room to allow incorporation with different types of air compressors in the future.

4

7. Intended Use

Carilex VT • 100/VT • 200 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. The VT · 100/VT · 200 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.

ItemProposed DevicesPredicate Device
Device NameVT · 200VT · 100VOLTERA Powered Suction
Pump
ModelS1002-0012S1001-0032S1001-3 Series
ClassificationClass IIClass IIClass II
Code for Federal
Regulations878.4780878.4780878.4780
Product CodeOMPOMPOMP
Prescription Medical
DeviceYESYESYES
Compatible NPWT
DressingDeRoyal Foam Kits
(K112458)DeRoyal Foam Kits
(K112458)DeRoyal Foam Kits
(K112458)
Intended UseCarilex VT · 200 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.Carilex VT · 100 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.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.
The VT • 200 suction therapyThe VT • 100 suction therapyThe VOLTERA suction pump
unit is indicated on use withunit is indicated on use withis indicated on use with
patients with the followingpatients with the followingpatients with the following
wounds:wounds:wounds:
> Traumatic> Traumatic> Traumatic
> Dehisced wounds> Dehisced wounds> Dehisced wounds
> Partial thickness burns> Partial thickness burns> Partial thickness burns
Indications for Use> Chronic wounds
including pressure
ulcers, diabetic foot
ulcers, and venous leg
ulcers> Chronic wounds
including pressure
ulcers, diabetic foot
ulcers, and venous leg
ulcers> Chronic wounds
including pressure
ulcers, diabetic foot
ulcers, and venous leg
ulcers
> Acute wounds> Acute wounds> Acute wounds
> Flaps and grafts> Flaps and grafts> Flaps and grafts
> Presence of necrotic
tissue> Presence of necrotic
tissue> Presence of necrotic
tissue
> Malignancy> Malignancy> Malignancy
> Untreated Osteomyelitis> Untreated Osteomyelitis> Untreated Osteomyelitis
> Untreated malnutrition> Untreated malnutrition> Untreated malnutrition
Contraindications> Exposed arteries, veins,
nerves, or organs.> Exposed arteries, veins,
nerves, or organs.> Exposed arteries, veins,
nerves, or organs.
> Use over anastomotic
sites> Use over anastomotic
sites> Use over anastomotic
sites
> Unexplored or
non-enteric fistulas> Unexplored or
non-enteric fistulas
> Exposed bone or tendons> Exposed bone or tendons
Suction Capacity9.5 Liter / min2.5 Liter / min2.5 Liter / min
Max. Vacuum-200 mmHg-200 mmHg-200 mmHg
Power InputAC 100-240V / 50-60 HzAC 100-240V / 50-60 HzAC 100-240V / 47-63 Hz
Power OutputDC 9.1V / 3.3ADC 9.1V / 3.3ADC 9V / 3A
Battery TypeLithium-ionLithium-ionLithium-ion
Operating Time
(Battery)At least 24 hours,
depend on useAt least 24 hours,
depend on useAt least 24 hours,
depend on use
Dimensions18 x 17.5 x 9 cm18 x 17 x 9 cm17 x 16 x 9 cm
Weight1.35 kg1.35 kg1.35 kg
Operating ModeContinuous & IntermittentContinuous & IntermittentContinuous & Intermittent
Canister300/500 ml300/500 ml300/800 ml
Life-time3 years3 years3 years

Technological Comparison to Predicate Devices: 8.

5

carilex*

6

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9. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

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 60601-1-2:2007

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 · 100/VT · 200 with the predicate. The pumps met all pre-determined acceptance criteria and passed the tests (suction pressure, fluid removal rate, alarm functionality).

10. Discussion of Clinical Tests Performed

Clinical tests were not performed.

11. 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 • 100 and VT • 200 are substantially equivalent to the predicate device (K112853).