EXTRICARE

K132225 · Devon Medical, Inc. · OMP · May 15, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K132225
• Device Name: EXTRICARE
• Applicant: Devon Medical, Inc.
• Product Code: OMP · General, Plastic Surgery
• Decision Date: May 15, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 grafis.

Device Story

System comprises vacuum pump, canister, tubing, and NPWT bandage or foam kits; provides negative pressure to wound bed to remove exudate, infectious materials, and tissue debris. Pump features digitally programmable continuous or intermittent pressure modes. Used in clinical settings; operated by healthcare professionals. Foam kits include polyurethane foam, transparent film drape, paper ruler, and suction bell with drainage tube. Device promotes healing by maintaining negative pressure environment. Healthcare providers monitor wound status and adjust pump settings based on clinical assessment.

Clinical Evidence

Bench testing only. Performance testing included evaluation of sensors, hook, canister, clamp, air filter, and simulated wound performance. Biocompatibility testing conducted per ISO-10993, including in-vitro cytotoxicity, skin irritation, and skin sensitization, with all tests passed. Electrical safety and EMC testing performed in accordance with IEC 60601-1:2005, IEC 60601-1-2:2007, and AAMI ES 60601-1:2005.

Technological Characteristics

Powered suction pump; electrically generated vacuum source. Components: vacuum pump, canister, tubing, polyurethane foam, transparent film drape. Connectivity: standalone. Standards: IEC 60601-1:2005, IEC 60601-1-2:2007, AAMI ES 60601-1:2005, ISO-10993. Operation: digitally programmable continuous or intermittent pressure modes.

Indications for Use

Indicated for wound management in patients with chronic, acute, traumatic, subacute, or 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

• extriCARE 2400 (K110078)
• V.A.C.® Freedom™ (K032310)
• Wound Pro Apex (K100823)
• NPWT Foam Dressing Kits (K082211)

Submission Summary (Full Text)

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# 510K Summary

page 1 of 3

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# 510(K) SUMMARY

#### Submitter:

Devon Medical Inc.

# Contact Person:

Ruth Wu, COO 1100 First Avenue, Suite 202 King of Prussia, PA 19406 866.446.0092 Phone: [phone] Fax:

# Common Classification & Proprietary Names:

Negative Pressure Wound Therapy System Common Names: Proprietary Names: extriCARE 3600 extriCARE Foam Kit

#### Date Prepared:

January 16th, 2013

#### Classification

The classification name, 21 CFR Part and Paragraph number, product code and classification of the extriCARE 3600:

| FDA | Classification | Product<br>Code | Class |
|--------------------|-------------------------|-----------------|-------|
| 21 CFR<br>878.4780 | Powered Suction<br>Pump | OMP | II |

#### Predicate Devices:

The extriCARE 3600 Negative Pressure Wound Therapy System and extriCARE Foam Kit is substantially equivalent to the following:

| Predicate Device | Manufacturer | 510(k)# |
|----------------------------|--------------------------------|---------|
| extriCARE 2400 | Devon Medical | K110078 |
| V.A.C.® Freedom™ | Kinetic Concepts, Inc. | K032310 |
| Wound Pro Apex | Accuro Medical Products<br>LLC | K100823 |
| NPWT Foam<br>Dressing Kits | Smith & Nephew | K082211 |

#### Device Description

The system consists of a vacuum pump, canister, tubing, NPWT bandage or NPWT Foam Kits. In operation, the device is attached via the tubing to a

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# 510K Summary

Negative Pressure Wound bandage or foam kits. Maximum pressure and continuous mode or intermittent mode selection are digitally programmable. The extriCARE 3600 pump can be sold alone or as a part of the extriCARE 3600 system with extriCARE bandages or foam kits. The extriCARE bandages are an all-in-one wound dressing; with no wound packing required which is cleared in the predicate K110078. The foam kit consists of Polyurethane foam, transparent film drape, paper ruler, Suction Bell with connecting (drainage) tube and clamp, which is included in this submission for review.

# Intended Use:

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.

# Technological Characteristics:

The manufacturer believes that the technological characteristic of the extriCARE 3600 are substantially similar to those of the predicate devices. The extriCARE 3600 has very similar components to its predicate devices and very similar principles of operation. The device consists of an electrically generated source of vacuum and a canister. Like the predicates, vacuum, is applied for a specified period of time and intensity, according to the physician's prescription.

Both extriCARE bandages and foam dressing kits are alternatively used together with the extriCARE 3600 pumps. The extriCARE bandages are the same as stated in the previously cleared submission K110078.

The extriCARE foam kits use similar components and similar principles of operation to the predicate device. Like the predicate, the foam is placed into the wound and attached to a vacuum device, which may provide negative pressure to the wound site which may promote healing by removing wound exudates.

# Performance Testing

To ensure the performance of extriCARE® 3600 device meet the design input when conjunction with NPWT bandage and foam kits, a series of bench tests were conducted to ensure device's functions, which include the sensors, hook, canister, clamp, air filter and a simulated wound performance test.

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# 510K Summary

# EMC Testing

To verify that the device design met it's functional and performance requirements, representative samples of the device underwent function and mechanical testing, EMC testing in accordance with IEC 60601-1:2005, IEC 60601-1-2:2007 and electrical safety testing in accordance with AAMI ES 60601-1:2005 standards.

K13225 page 3 of 3

# Biocompatibility

The extriCARE 3600 system consists of the pump, bandages or alternative foam kits. While the pump has no direct body contact when used as indicated, the bandage and foam kits do have direct body contact. Per ISO-10993 requirements, the bandage samples and foam kits samples were tested for the following items and all tests were successfully passed.

- In-vitro Cytotoxicity .
- Skin irritation .
- Skin Sensitization .

# Statement of Substantial Equivalence

The extriCARE 3600 system is substantially equivalent in technology, function, operating parameters, and intended use to predicate devices that are currently commercially available and in distribution, and does not raise any new questions of safety or effectiveness.

### Conclusions

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, Devon Medical Products, believes that the extriCARE 3600 system (pump, bandage, foam, and accessories) is safe and effective and substantially equivalent to the predicate devices as described herein.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The eagle is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002

May 15, 2014

Devin Medical, Inc. Ruth Wu, Chief Operating Officer 1100 First Avenue, Suite 202 King of Prussia, Pennsylvania 19406

Re: K132225

Trade/Device Name: extriCARE® 3600 Negative Pressure Wound Therapy System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: February 11, 2014 Received: February 14, 2014

Dear Ms. Wu:

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 that I Dr has master and regulations administered by other Federal agencies. You must or any it 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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# Page 2 - Ruth Wu, Chief Operating Officer

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forth in the quality systems (QS) 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# David Krause -S

for

Binita Ashar, MD, MBA, FACS Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

cc: DMC 510(k) Staff Division D.O.

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

#### 510(k) Number (if known) K132225

#### Device Name

extriCARE 3600 Negative Pressure Wound Therapy System

#### Indications for Use (Describe)

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 grafis.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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