BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM

K061788 · Boehringer Laboratories · OMP · Jul 11, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K061788
• Device Name: BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM
• Applicant: Boehringer Laboratories
• Product Code: OMP · General, Plastic Surgery
• Decision Date: Jul 11, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Boehringer Laboratories Suction Pump System is intended for the application of suction (negative pressure) to wounds to promote wound healing and for the removal of fluids, including wound exudate, irrigation fluids, body fluids and infectious materials.

Device Story

Powered suction pump system applies negative pressure to wounds to facilitate healing and fluid removal. System components include pump, canister, tube attachment device, wound cover, and wound contact dressing. Operated by healthcare professionals in clinical settings. Device generates suction to evacuate wound exudate, irrigation fluids, and infectious materials into a canister. Output allows clinicians to manage wound environment and monitor fluid removal. Benefits include promoted wound healing through negative pressure application.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design similarities to predicate devices.

Technological Characteristics

Powered suction pump system. Components include pump, canister, tube attachment device, wound cover, and wound contact dressing. System utilizes negative pressure for wound therapy. No specific materials or software algorithms described.

Indications for Use

Indicated for patients requiring negative pressure wound therapy to promote healing and for the removal of wound exudate, irrigation fluids, body fluids, and infectious materials.

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

• Boehringer Laboratories Suction Pump System (K060277)
• Versatile 1 Wound Vacuum System (K042134)
• Versatile 1 Wound Vacuum System (K052456)

Submission Summary (Full Text)

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# 2. 510(k) Summary

K061788

## 510(k) Summary

## Applicant Information:

- Name: Boehringer Laboratories Inc.
- 500 E. Washington St. Address: Norristown PA 19401

Phone: [phone] Fax: [phone]

- Contact: Christopher Radl, Engineering
#### Trade Name:

Boehringer Laboratories Suction Pump System

#### Common Name:

Powered Suction Pump

#### Device Classification:

Class II Product Code: JCX Regulation 878.4780 Classification Panel: General & Plastic Surgery

#### Predicate Devices:

Boehringer Laboratories Suction Pump System Versatile 1 Wound Vacuum System

K060277 K042134, K052456

#### Device Description:

The Boehringer Laboratories Suction Pump System consists of a powered suction pump for the application of suction to wounds and for fluid removal. Disposables for use with the pump include: canister, Tube Attachment Device, Cover and Wound Contact Dressing

#### Intended Use:

The Boehringer Laboratories Suction Pump System is intended for the application of suction (negative pressure) to wounds to promote wound healing and for the removal of fluids, including wound exudate, irrigation fluids, body fluids and infectious materials.

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### Technological Characteristics:

The modified Boehringer Laboratories Suction Pump System includes the same suction pump and canister as the predicate unmodified device K060277. Additional accessories have been added. These accessories are a Wound Cover, Tube Attachment Device and Wound Contact Dressing. These accessories correspond with accessories available with the predicate Versatile 1 System K042134, K052456. The labeling and indications for use statement have been revised to more specifically cover application of suction to wounds, similar to the predicate Versatile 1 System K042134, K052456,

#### Conclusion:

The Boehringer Laboratories Suction Pump System is substantially equivalent to the predicate devices.

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Public Health Service

APR - 7 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Boehringer Laboratories % Mr. John R. Boehringer 500 E. Washington Street Norristown, Pennsylvania 19401

Re: K061788

Trade/Device Name: Boehringer Laboratories Suction Pump System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: II Product Code: OMP Dated: June 22, 2006 Received: June 26, 2006

Dear Mr. Boehringer:

This letter corrects our substantially equivalent letter of July 11, 2006.

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 vour 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 R. Boehringer

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. Peterson

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): KO61789

#### Device Name: Boehringer Laboratories Suction Pump System

Indications for Use:

The Boehringer Laboratories Suction Pump System is intended for the application of suction (negative pressure) to wounds to promote wound healing and for the removal of fluids, including wound exudate, irrigation fluids, body fluids and infectious materials.

Prescription Use × (Part 21 CFR 801 Subpart D)

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Hester Lemur
(Driver Sign Off)

eral, Restorative. Division of Ger and Neurological Devices

510(k) Number K061788