(59 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on mechanical components and basic pressure regulation.
Yes
The device is indicated to evacuate air and/or fluid, prevent reaccumulation, re-establish pressure gradients, and facilitate lung re-expansion, all of which are therapeutic actions.
No
The device is described as evacuating air/fluid and re-establishing normal intrathoracic pressure, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states that the system consists of hardware components such as a collection chamber, Controller Unit, pressure regulator, drainage tubing, valves, and hangers.
Based on the provided information, the DigiVent™ Chest Drainage System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used to evacuate air and fluid from the chest cavity or mediastinum to aid in lung re-expansion and restore breathing. This is a direct intervention on the patient's body.
- Device Description: The description details components like a collection chamber, controller unit, tubing, and valves, all consistent with a device used for drainage and pressure management within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or treatment. IVDs typically involve analyzing blood, urine, tissue, or other bodily fluids.
Therefore, the DigiVent™ Chest Drainage System is a medical device used for therapeutic and management purposes within the patient's body, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
KDO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Chest cavity or mediastinum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Design verification and validation testing provided in this premarket notification for the DigiVent™ Chest Drainage System demonstrates that it meets its specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
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.
1
| 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.
.
2
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.
3
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
4
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
| (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