VT Dressing Kits

K172725 · Carilex Medical, Inc. · OMP · Jun 8, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K172725
• Device Name: VT Dressing Kits
• Applicant: Carilex Medical, Inc.
• Product Code: OMP · General, Plastic Surgery
• Decision Date: Jun 8, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Carilex VT Dressing Kits is intended to be used with the Carilex VT device (S1 series) to manage wounds through removal of fluids, and the NPWT system is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of fluids, excess exudates, infectious material, and tissue debris.

Device Story

Carilex VT Dressing Kits are single-use wound dressings designed for use with Carilex VT (S1 series) negative pressure wound therapy (NPWT) suction pumps. The kit consists of reticulated flexible polyether-based polyurethane foam, a film drape, and a port set (connector, tube, clip). The dressing is applied to the wound site and connected to the suction pump, which applies negative pressure to remove wound exudate, infectious material, and tissue debris. This process promotes wound healing. The device is intended for clinical or home use by patients or healthcare providers. The healthcare provider monitors the wound and the dressing's performance. The kit is sterilized via ethylene oxide and packaged in a Tyvek pouch.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including biocompatibility testing (ISO 10993), extractable/leachable studies, and performance comparison testing against the predicate device. All tests met pre-determined acceptance criteria.

Technological Characteristics

Materials: Reticulated flexible polyether-based polyurethane foam, polyurethane film with acrylic adhesive. Components: Foam, film drape, port set. Sterilization: Ethylene Oxide. Shelf-life: 2 years. Biocompatibility: Complies with ISO 10993. Connectivity: Passive component for use with Carilex VT suction pump.

Indications for Use

Indicated for patients with traumatic wounds, dehisced wounds, partial-thickness burns, chronic wounds (pressure ulcers, diabetic foot ulcers, venous leg ulcers), acute wounds, and flaps and grafts. Contraindicated for necrotic tissue, malignancy, untreated osteomyelitis, untreated malnutrition, exposed arteries/veins/nerves/organs, use over anastomotic sites, and non-enteric/unexplored fistulas.

Regulatory Classification

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.

Predicate Devices

• DeRoyal Foam Kits w/DOME/TR of Prospera PRO-I, PRO-II and PRO-III Negative Pressure Wound Therapy System (K112458)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" being the largest and most prominent.

June 8, 2018

Carilex Medical, Inc. % Maria Griffin Senior Consultant mdi Consultants. Inc. 55 Northern Blvd. Great Neck, New York 11021

Re: K172725

Trade/Device Name: VT Dressing Kits Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: May 7, 2018 Received: May 7, 2018

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, 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); good

{1}------------------------------------------------

manufacturing practice requirements as set forth in 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.

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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Jennifer R. Stevenson -S3

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}------------------------------------------------

# Indications for Use

510(k) Number (if known) K172725

Device Name Carilex VT Dressing Kits

## Indications for Use (Describe)

Carilex VT Dressing Kits is intended to be used with the Carilex VT device (S1 series) to manage wounds through removal of fluids, and the NPWT system is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of fluids, excess exudates, infectious material, and tissue debris.

The Carilex VT Dressing Kits is indicated for use for 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)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(k) SUMMARY

The assigned 510(k) number is: K172725

#### Submitter's Information 1.

Carilex Medical, Inc. No. 77, Keji 18t Rd., Guishan Dist., Taoyuan City, Taiwan 333 Registration Number: 9710603 Contact: Henry Kao Tel: [phone] Fax: [phone]

Date Summary Prepared: June 6, 2018

#### Trade Name of the Device: Carilex VT Dressing Kits 2.

- 3. Common or Usual Name: Wound Dressing for Negative Pressure Wound Therapy
- 4. Classification Name: Negative Pressure Wound Therapy Powered Suction Pump Regulation Number: 878.4780 Product Code: OMP Panel: General & Plastic Surgery

#### 5. Predicate Device Information:

DeRoyal Foam Kits w/DOME/TR of Prospera PRO-I, PRO-II and PRO-III Negative Pressure Wound Therapy System, K112458

#### Device Description 6.

Carilex VT Dressing Kits is the wound dressing to be used with the Carilex VT suction pumps for negative pressure wound therapy. This single-use dressing is manufactured using a reticulated flexible polyether and polyurethane hydrophobic material, housed in a medical grade peel pouch, and sterilized by Ethylene Oxide. The Carilex VT Dressing Kits is available in three sizes; 1) small 2) medium and 3) large

#### 7. Intended Use

Carilex VT Dressing Kits is intended to be used with the Carilex VT device (S1 series) to manage wounds through removal of fluids, and the NPWT system is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of fluids, excess exudates, infectious material, and tissue debris.

{4}------------------------------------------------

# ca

#### Technological Comparison to Predicate Devices: 8.

| δ. Item | Proposed Device | Predicate Device |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Carilex VT Dressing Kits | DeRoyal Foam Kits |
| Classification | Class II | Class II |
| Code for Federal<br>Regulations | 878.4780 | 878.4780 |
| Prescription Medical<br>Device | YES | YES |
| Product Code | OMP | OMP |
| Compatible NPWT<br>pump | Carilex VT Device<br>(S1 series K112853, K161410) | Prospera PRO-I, PRO- II and PRO-III |
| Indications for Use | Carilex VT Dressing Kits is intended to<br>be used with the Carilex VT device (S1<br>series) to manage wounds through<br>removal of fluids, and the NPWT system<br>is indicated for patients who would<br>benefit from a suction device,<br>particularly as the device may promote<br>wound healing by removal of fluids,<br>excess exudates, infectious material, and<br>tissue debris. The Carilex VT Dressing<br>Kits is indicated for use for patients with<br>the following wounds:<br>Traumatic Dehisced wounds Partial-thickness burns Chronic wounds including pressure<br>ulcers, diabetic foot ulcers and<br>venous leg ulcers Acute wounds Flaps and grafts | The Prospera Negative Pressure Wound<br>Therapy System is indicated for patients<br>that would benefit from a suction device<br>particularly as the device may promote<br>wound healing by removal of wound<br>exudate, debris, and infectious material<br>or for the aspiration and removal of<br>surgical fluids, tissue (including bone),<br>gases, bodily fluids or infectious material<br>from the patient's airway or respiratory<br>support system. The Prospera Negative<br>Pressure Wound Therapy may be used<br>during surgery or at the patient's bedside<br>and is indicated for home use. |
| Contraindications | Presence of Necrotic Tissue Malignancy Untreated Osteomyelitis Untreated Malnutrition Exposed Arteries, Veins, Nerves,<br>or Organs Use Over Anastomotic Sites Use in Non-enteric and<br>Unexplored Fistulas, as well for<br>Use Over Exposed Bone or Tendon | Necrotic Tissue Unexplored or Non-enteric Fistulas Untreated Osteomyelitis Wound Containing Malignant<br>Tissue Exposed Arteries, Veins, or Internal<br>Organs Exposed Anastomotic Site |
| Single Use or Reusable | Single Use | Single Use |
| Method of Sterilization | Ethylene Oxide | Ethylene Oxide |
| Biocompatibility | All components comply with ISO 10993 | All components comply with ISO 10993 |
| Packaging | Individually packaged and sterilized<br>components are kitted into Tyvek pouch. | Individually packaged and sterilized<br>components are kitted into Tyvek pouch. |
| Shelf-life | 2 years | 3 years |
| Dressing Kits<br>Components | Black Foam, Film Drape, Port Set<br>(composed of Circle Drape, Connecting<br>Tube, Port, Clip, Lockable Connector) | Black Foam, Transeal, Dome Connector<br>(composed of Circle Drape, Connecting<br>Tube, Port, Clip, Connector) |

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the word "carilex" in a light blue color. The font is sans-serif and appears to be a custom design. A small registered trademark symbol is located to the right of the word.

| Black<br>Foam | Dimension | Small: 80x100x30 mm | Small: 80x100x30 mm | | | | |
|----------------------------|-----------|-----------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|-----------|----------|-------------------------------------------------------------|
| | | Medium: 125x200x30 mm | Medium: 125x200x30 mm | | | | |
| | | Large: 150x250x30 mm | Large: 150x250x30 mm | | | | |
| | Material | Reticulated Flexible Polyether Based<br>Polyurethane Foam | Reticulated Flexible Polyether Based<br>Polyurethane Foam | | | | |
| | | Film<br>Drape/<br>Transeal | Dimension | 250x216mm | 203x305mm | Quantity | Large Kits: 3 pcs<br>Medium Kits: 2 pcs<br>Small Kits: 1 pc |
| Film<br>Drape/<br>Transeal | Dimension | | 250x216mm | 203x305mm | | | |
| | Quantity | | Large Kits: 3 pcs<br>Medium Kits: 2 pcs<br>Small Kits: 1 pc | Large Kits: 3 pcs<br>Medium Kits: 2 pcs<br>Small Kits: 1 pc | | | |
| | Material | | Polyurethane Film Coated with Acrylic<br>Adhesive | Polyurethane Film Coated with Acrylic<br>Adhesive | | | |

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

The following tests were performed to determine substantial equivalence:

The biocompatibility tests were performed with the final finished form of VT Dressing Kits in accordance with ISO 10993. In addition, an extractable/leachable study and associated risk assessment were carried out to evaluate the biocompatibility of the device. The dressing kits have been shown to be biocompatible for the intended use.

Performance/Comparison Testing of VT Dressing Kits with the predicate. The dressing kits met all pre-determined acceptance criteria and passed the tests.

# 10. Clinical Test

Clinical tests were not performed.

# 11. Conclusion

After analyzing intended use, indications for use, technology, bench test reports, shelf-life reports, sterilization reports, and biocompatibility reports, it can be concluded that Carilex VT Dressing Kits is substantially equivalent to the predicate device DeRoyal Foam Kits (K112458).