KULAVAC

K122490 · CG Bio Co., Ltd. · OMP · Nov 13, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K122490
• Device Name: KULAVAC
• Applicant: CG Bio Co., Ltd.
• Product Code: OMP · General, Plastic Surgery
• Decision Date: Nov 13, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

KulaVAC Foam Dressing Kit is intended to be used in conjunction with suction devices to deliver negative pressure wound therapy to the wound. KulaVAC Foam Dressing Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing through the removal of excess exudates, infectious material, and tissue debris. It is indicated for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

Device Story

KulaVAC is a sterile, single-use wound dressing kit for Negative Pressure Wound Therapy (NPWT). The kit includes polyurethane foam, suction head, tubing, connectors, clamps, and acrylic adhesive transparent film. The device is used in conjunction with an external suction pump to deliver negative pressure to a wound site. The system promotes healing by removing excess exudates, infectious material, and tissue debris from the wound. It is intended for use in clinical settings by healthcare professionals. The dressing is applied to the wound, sealed with the adhesive film, and connected to the suction source via the provided tubing and connectors. The output is the physical removal of wound fluids, which facilitates a cleaner wound environment and supports the healing process.

Clinical Evidence

Bench testing only. Evidence includes performance testing using a mock wound model to verify equivalence to predicates, wound dressing testing per EN 13726-1, and biocompatibility testing per ISO 10993-1. Compatibility with vacuum sources was also demonstrated. All tests met acceptance criteria.

Technological Characteristics

Materials: Polyurethane foam, acrylic adhesive polyurethane film. Sensing/Actuation: Passive dressing component for NPWT; relies on external vacuum source. Form factor: Foam dressing in small, medium, and large sizes with tubing/connector accessories. Sterilization: Sterile, single-use. Connectivity: None (mechanical interface to suction pump).

Indications for Use

Indicated for patients requiring negative pressure wound therapy for chronic, acute, traumatic, subacute, and dehisced wounds, partial-thickness burns, ulcers (diabetic or pressure), flaps, and grafts.

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

• V.A.C.® GranuFoam® Dressing (K032310)
• Renasys™-F NPWT Foam Dressing (K082211)

Submission Summary (Full Text)

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K122490 page 1/3

Image /page/0/Picture/1 description: The image contains a logo with the text "CG Bio" in bold, black letters. Above the letters are three curved lines, and below the letters is the text "Cell & Gene Biotechnology" in a smaller font. The logo appears to be for a biotechnology company specializing in cell and gene therapies.

CG Bio Co., Ltd.

# 510(k) SUMMARY

## 1. Submitter Information

## Sponsor

| Name: | CG Bio Co., Ltd. |
|----------|------------------------------------------------------------------------------------------------|
| Address: | 223-23 Sangdaewon-dong, Jungwon-gu, Seongnam,<br>Gyeonggi-do, 462-120 Korea<br>www.cgbio.co.kr |
| Tel.: | [phone] |
| Fax.: | [phone] |

# US Agent

# NOV 1 3 2013

| Name: | Mr. Shawn Park |
|----------|---------------------------------------------------------------------------|
| Address: | Daewoong America Inc.<br>155 Gibbs Street, Suite #431 Rockville, MD 20850 |
| Tel.: | 301-309-1957, 301-956-0588 |
| Fax.: | 301-309-1959 |
| E-Mail: | [e-mail] |

## Official Correspondent

| Name: | Ms. Jung-Eun Im<br>Regulatory Affairs |
|----------|------------------------------------------------------|
| Address: | 163-3 Samsung-dong, Kangnam-gu, Seoul, 135-715 Korea |
| Tel.: | [phone] |
| Fax.: | [phone] |
| E-Mail: | [e-mail] |

## 2. Subject Device Information

| Type of 510(k) submission: | Traditional |
|----------------------------|-----------------------------------|
| Trade Name: | KulaVAC |
| Common/Usual Name: | Foam Dressing |
| Classification Name: | Accessory to Powered Suction Pump |
| Regulation Number: | 21 CFR 878.4780 |
| Product Code: | OMP |
| Regulation Class: | Class II |
| Panel: | General & Plastic Surgery |

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Image /page/1/Picture/1 description: The image shows a logo for CG Bio. The logo has the letters CG in large font on the left, with the word Bio in a smaller font on the right. Below the letters is the text "Cell & Gene Biotechnology" in a small font.

CG Bio Co., Ltd.

| Sponsor | K.C.I | Smith & Nephew, Inc. |
|------------------|-----------------------------|-------------------------------|
| Device Name | V.A.C.® GranuFoam® Dressing | Renasys™-F NPWT Foam Dressing |
| 510(k) Number | K032310 | K082211 |
| Product Code | OMP | OMP |
| Regulation No. | 21 CFR 878.4780 | 21 CFR 878.4780 |
| Regulation Class | II | II |

#### 3. Predicate Device Information

#### 4. Device Description

KulaVAC is wound dressing kit for Negative Pressure Wound Therapy (NPWT). The kit consists of individually reviewed medical components; polyurethane foam wound dressing, suction head, tubing, connectors, clamps and acrylic adhesive transparent film.

Foam dressing is available in three sizes; small, medium and large, and the other accessories are used to connect to a suction device.

The kit is supplied sterile and is single-use.

#### 5. Indications for Use

KulaVAC Foam Dressing Kit is intended to be used in conjunction with suction devices to deliver negative pressure wound therapy to the wound. KulaVAC Foam Dressing Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing through the removal of excess exudates, infectious material, and tissue debris. It is indicated for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

#### 6. Non-Clinical Testing

Non-clinical testing was performed to assess the safety and effectiveness of KulaVAC. The non-clinical tests included bench testing using a mock wound model to verify the substantial equivalence to the predicate device in performance, wound dressing test in accordance with EN 13726-1 and biocompatibility testing in accordance with ISO 10993-1, respectably. And the compatibility of the device with the vacuum sources was demonstrated. All tests conducted for KulaVAC had successfully met the acceptance criteria, which demonstrate the safety and effectiveness of the device.

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K122490 Page 3/3

Image /page/2/Picture/1 description: The image shows the logo for CG Bio. The logo features the letters "CG" in a large, bold font, with the word "Bio" in a smaller font to the right of the "G". Above the letters is a curved line. Below the letters is the text "Cell & Gene Technology" in a small font.

CG Bio Co., Ltd.

### 7. Comparison to Predicate Device

KulaVAC Foam Dressing Kit is substantially equivalent in design, materials, technology, function and intended use to its predicate devices. The minor technological differences between KulaVAC and its predicate devices raise no new issues of safety or effectiveness.

| Elements of<br>Comparison | Subject Device | Predicate Devices | | Verdict |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|----------------------------------|---------|
| Product Name | KulaVAC | V.A.C.®<br>GranuFoam®<br>Dressing | Renasys™-F NPWT<br>Foam Dressing | |
| 510(k) Number | Applying | K032310 | K032310 | - |
| Product Code | OMP | OMP | OMP | SE |
| Regulation No. | 21 CFR 878.4780 | 21 CFR 878.4780 | 21 CFR 878.4780 | SE |
| Materials | - Foam Dressing : Polyurethane<br>- Film Dressing : Acrylic adhesive polyurethane film | | | SE |
| Components | Composed of foam, tubing and adhesive film | | | SE |
| Intended Use | Combination with a suction device to deliver negative<br>pressure to the wound to promote wound healing by drainage<br>of fluids and infectious materials | | | SE |
| Indications | Chronic, acute, traumatic, subacute and dehisced wounds,<br>partial-thickness burns, ulcers (such as diabetic or pressure),<br>flaps and grafts. | | | SE |

#### 8. Conclusion

KulaVAC Foam Dressing Kit is substantially equivalent in design, materials, technology, function and intended use to its predicate devices. The minor technological differences between KulaVAC and its predicate devices raise no new issues of safety or effectiveness.

Performance data demonstrate that KulaVAC is as safe and effective as its predicate device, and comparable to the various controlled suction devices. Thus, KulaVAC is substantially equivalent.

#### 9. Summary Prepared Date

18 October 2013

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 13, 2013

CGBio Co., Ltd. % JungEun Im 223-23 Sangdaewon-dong, Jungwon-gu, Seongnam, Gyeonggi-do. 462-120. Korea

Re: K122490

Trade/Device Name: KulaVAC Foam Dressing Kit Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: October 18, 2013 Received: October 29, 2013

Dear JungEun Im:

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

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Page 2 -- JungEun Im

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good 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.

If you desire specific advice for vour device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Safetv/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You mav obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# David Krause -S

for Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K122490

Device Name: KulaVAC

Indications for Use:

KulaVAC Foam Dressing Kit is intended to be used in conjunction with suction devices to deliver negative pressure wound therapy to the wound. KulaVAC Foam Dressing Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing through the removal of excess exudates, infectious material, and tissue debris. It is indicated for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jiyoung Dang -S 2013.11.08 16:01:57 -05'00'

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