NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM

K080275 · Iasis Medical, Inc. · OMP · Oct 9, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K080275
• Device Name: NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM
• Applicant: Iasis Medical, Inc.
• Product Code: OMP · General, Plastic Surgery
• Decision Date: Oct 9, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NPD 1000 Negative Pressure Wound Therapy System is a portable, low-powered, battery-operated suction pump intended for the application of suction to remove a small amount of fluid from the wound bed including wound exudate and infectious material which may promote wound healing.

Device Story

NPD 1000 Negative Pressure Wound Therapy System; portable, battery-operated electromechanical suction pump. Used with accessory wound dressing to apply controlled negative pressure (vacuum) to wound bed. Removes small amounts of fluid, wound exudate, and infectious material; intended to promote wound healing. Operated by healthcare providers or patients in clinical or home settings. Output is negative pressure; clinical decision-making guided by wound status and exudate removal requirements.

Clinical Evidence

Bench testing only. Device underwent functional and mechanical testing, EMC testing per IEC 60601-1-2:2001, and electrical safety testing per UL 60601-1:2006 to verify design requirements.

Technological Characteristics

Portable, battery-operated electromechanical suction pump. System includes pump and accessory wound dressing. Electrical safety: UL 60601-1:2006. EMC: IEC 60601-1-2:2001. Operates via controlled negative pressure (vacuum).

Indications for Use

Indicated for patients requiring suction to remove small amounts of wound exudate and infectious material from the wound bed to promote healing. Device is a portable, battery-operated suction pump.

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. Therapy Systems-ActiV.A.C. Therapy Unit M (K063692)
• Boehringer Laboratories Suction Pump System (K060277)

Submission Summary (Full Text)

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KOSCQ75

OCT 0 9 2008

## 510(k) Summary

| Submitter: | Kalypto Medical<br>6393 Oakgreen Avenue<br>Hastings, MN 55033 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | John Buan, Vice President of Product Development<br>Phone [phone], Fax [phone] |
| Date Prepared: | August 14, 2008 |
| Trade Name: | NPD 1000 Negative Pressure Wound Therapy System |
| Classification: | Powered Suction Pump<br>Class II<br>21 CFR 878.4780 |
| Product Code: | BTA JCX |
| Predicate Device(s): | The subject device is equivalent to the following device:<br>• V.A.C. Therapy Systems-ActiV.A.C. Therapy Unit M: K063692<br>• Boehringer Laboratories Suction Pump System: K060277 |
| Device Description: | The NPD 1000 Negative Pressure Wound Therapy System includes a<br>small, portable, low powered, battery operated electromechanical<br>pump used with an accessory wound dressing. The system uses<br>controlled negative pressure (vacuum) to remove exudates, which<br>may promote wound healing. |
| Intended Use: | The NPD 1000 Negative Pressure Wound Therapy System is a<br>portable, low-powered, battery-operated suction pump intended for the<br>application of suction to remove a small amount of fluid from the<br>wound bed including wound exudate and infectious material which<br>may promote wound healing. |
| Functional and Safety<br>Testing: | To verify that the device design met its functional and performance<br>requirements, representative samples of the device underwent<br>functional and mechanical testing, EMC testing in accordance with<br>IEC 60601-1-2:2001 and electrical safety testing in accordance with<br>UL 60601-1:2006. |
| Conclusion: | Kalypto Medical considers the NPD 1000 Negative Pressure Wound<br>Therapy System to be equivalent to the predicate devices listed<br>above. This conclusion is based upon the devices' similarities in<br>principles of operation, technology, and indications for use. |

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Public Health Service

APR - 7 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kalypto Medical % Mr. John Baun 6393 Oakgreen Avenue Hastings, Minnesota 55033

Re: K080275

Trade/Device Name: NPD 1000 Negative Pressure Wound Therapy System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: II Product Code: OMP Dated: August 14, 2008 Received: August 15, 2008

Dear Mr. Baun:

This letter corrects our substantially equivalent letter of October 9, 2008.

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 (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.

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

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Page 2 - Mr. John Baun

limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): 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.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

For Nathan

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K080275

Device Name: NPD 1000 Negative Pressure Wound Therapy System

Indications for Use:

The NPD 1000 Negative Pressure Wound Therapy System is a portable, low-powered, battery-operated suction pump intended for the application of suction to remove a small amount of fluid from the wound bed including wound exudate and infectious material which may promote wound healing.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Nad AP Syden for man

Division of General, Restorative, and Neurological Devic

510(k) Number