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 Description

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.

AI/ML Overview

This document describes the Millicore AB DigiVent™ Chest Drainage System. Based on the provided text, a comprehensive study with specific acceptance criteria and detailed results proving the device meets these criteria is not detailed. The document states that "Design verification and validation testing provided in this premarket notification for the DigiVent™ Chest Drainage System demonstrates that it meets its specifications," but it does not elaborate on what those specifications or the results of the testing were.

Therefore, the following information is an interpretation based on the general context of device approval documents and the lack of specific details in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

As the specific acceptance criteria and detailed performance metrics are not explicitly stated in the provided text, this table will reflect the types of criteria generally expected for such a device and the general assertion of performance provided in the document.

Acceptance Criterion (Inferred)	Reported Device Performance
Functional Performance
Air evacuation	Met (implied by "evacuate air")
Fluid evacuation	Met (implied by "evacuate fluid")
Prevention of reaccumulation	Met (implied by "prevent air and/or fluid from reaccumulating")
Re-establishment of intrathoracic pressure	Met (implied by "re-establish and maintain normal intrathoracic pressure gradients")
Facilitation of lung re-expansion	Met (implied by "facilitate complete lung re-expansion")
Restoration of breathing dynamics	Met (implied by "restore normal breathing dynamics")
Safety and Reliability
Kink prevention	Met (explicitly mentioned: "drainage tubing (with kink prevention)")
Positive pressure relief	Met (explicitly mentioned: "positive- and negative pressure relief valves")
Negative pressure relief	Met (explicitly mentioned: "positive- and negative pressure relief valves")
Adherence to specifications	Met (explicitly stated: "demonstrates that it meets its specifications")
Substantial equivalence to predicate devices	Achieved (stated in K062302 approval letter)

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide details on the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective nature of data). It generically mentions "Design verification and validation testing."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. Ground truth establishment, if any, for performance testing is not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

The document does not mention any MRMC comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. The DigiVent™ Chest Drainage System is a medical device for drainage, not an AI-assisted diagnostic or imaging tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable as the DigiVent™ Chest Drainage System is a physical medical device, not an algorithm or AI system. Its performance would inherently be in conjunction with human use (e.g., a clinician connecting and monitoring it).

7. The Type of Ground Truth Used

The document does not specify the type of ground truth used for any testing. Given it's a physical device, ground truth would likely be based on objective physical measurements and functional performance against defined engineering and safety standards, rather than expert consensus on medical images or pathology.

8. The Sample Size for the Training Set

This information is not applicable as the DigiVent™ Chest Drainage System is a physical medical device, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as above.

Summary

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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:	+46 (0)70-687 6140
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.

INTENDED USE / INDICATION FOR USE 5.

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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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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:

Prescription Use(Part 21 CFR 801 Subpart D)	X
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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

Regulation Number and Section

§ 880.6740 Vacuum-powered body fluid suction apparatus.

(a)
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).(b)
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.