MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM

K062302 · Millicore AB · KDQ · Oct 6, 2006 · General Hospital

Device Facts

• Record ID: K062302
• Device Name: MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM
• Applicant: Millicore AB
• Product Code: KDQ · General Hospital
• Decision Date: Oct 6, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6740
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DigiVent™ Chest Drainage System is indicated to evacuate air and/or fluid from the chest cavity or mediastinum, to help prevent air and/or fluid from reaccumulating in the chest cavity or mediastinum, to help re-establish and maintain normal intrathoracic pressure gradients, and to facilitate complete lung re-expansion and restore normal breathing dynamics.

Device Story

DigiVent Chest Drainage System consists of collection chamber, controller unit, pressure regulator, drainage tubing, and relief valves. Device manages thoracic drainage by evacuating air/fluid from chest cavity or mediastinum; maintains intrathoracic pressure gradients; facilitates lung re-expansion. Used in clinical settings to restore normal breathing dynamics. System operates by regulating pressure to prevent reaccumulation of air/fluid. Healthcare providers monitor system to ensure effective drainage and lung recovery.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

System includes collection chamber, controller unit, pressure regulator, drainage tubing with kink prevention, and positive/negative pressure relief valves. Standalone device.

Indications for Use

Indicated for patients requiring evacuation of air or fluid from the chest cavity or mediastinum to restore normal intrathoracic pressure and lung expansion.

Regulatory Classification

Identification

A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.

Predicate Devices

• Express™ Chest Drainage System (K984496)
• Pleur-evac®, SAHARA (K962856)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: This image shows a table with information about the DigiVent Chest Drainage System. The table includes the name of the system, the type of 510(k) application (Traditional), and the date of approval (August 2, 2006). The table also includes the section number of the 510(k) summary, which is Section 5. The logo of Millicore is on the left side of the table.

#### 1. SUBMITTER/510(K) Holder

OCT - 6 2006

Millicore AB Bredgränd 4 111 30 Stockholm Sweden

| Contact Person: | Mr. Ola Cornelius |
|-----------------|--------------------|
| Telephone: | [phone] |
| Date Prepared: | August 2, 2006 |

#### 2. DEVICE NAME

| Proprietary Name: | DigiVent™ Chest Drainage System |
|----------------------|---------------------------------|
| Common/Usual Name: | Chest drainage system |
| Classification Name: | Bottle, Collection, Vacuum |

#### PREDICATE DEVICES 3.

- Express™ Chest Drainage System, Atrium Medical Corp., K984496 .
- Pleur-evac®, SAHARA, Deknatel DSP Worldwide Inc. (K962856) .

#### DEVICE DESCRIPTION 4.

The DigiVent™ Chest Drainage System consists primarily of a collection chamber and a Controller Unit. Pressure regulator, drainage tubing (with kink prevention), positive- and negative pressure relief valves, and hangers complete the system. Thoracic catheters (chest tubes) are not included.

#### INTENDED USE / INDICATION FOR USE 5.

The DigiVent™ Chest Drainage System is indicated to evacuate air and/or fluid from the chest cavity or mediastinum, to help prevent air and/or fluid from reaccumulating in the chest cavity or mediastinum, to help re-establish and maintain normal intrathoracic pressure gradients, and to facilitate complete lung re-expansion and restore normal breathing dynamics.

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| DigiVent™ Chest Drainage System | Traditional 510(k) | August 2, 2006 |
|---------------------------------|--------------------|----------------|
| Image: Millicore logo | 510(k) Summary | Section 5 |

### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The DigiVent™ Chest Drainage System is substantially equivalent to cited predicate devices based on intended use and operational characteristics. Design verification and validation testing provided in this premarket notification for the DigiVent™ Chest Drainage System demonstrates that it meets its specifications.

.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 6 2006

Millicore AB C/O Ms. Rosina Robinson Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

Re: K062302

Trade/Device Name: Millicore AB DigiVent™ Chest Drainage System Regulation Number: 21 CFR 880.6740 Regulation Name: Vacuum-Powered Body Fluid Suction Apparatus Regulatory Class: II Product Code: KDO Dated: August 2, 2006 Received: August 8, 2006

Dear Ms. Robinson:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Ms. Robinson

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); good manufacturing practice requirements as set 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.

This letter will allow you to begin 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). 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/industry/support/index.html.

Sincerely yours,

Clas

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known): __

Device Name: Millicore AB DigiVent™ Chest Drainage System

## Indications for Use:

The DigiVent™ Chest Drainage System is indicated to evacuate air and/or fluid from the chest cavity or mediastinum, to help prevent air and/or fluid from reaccumulating in the chest cavity or mediastinum, to help re-establish and maintain normal intrathoracic pressure gradients, and to facilitate complete lung re-expansion and restore normal breathing dynamics.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X |
|-------------------------------------------------|---|
|-------------------------------------------------|---|

AND/OR

Over-The-Counter Use_ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anthony V. nut

11 : Sun-( 1) n of Anesthesiology, General Hospital, on Control, Dental Devices

. K 4623402