(37 days)
Not Found
Not Found
No
The summary describes a mechanical chest drain and does not mention any AI or ML components or functionalities.
Yes
The device is intended to treat medical conditions by evacuating air/fluid from the chest cavity, re-establishing lung expansion, and facilitating blood reinfusion, all of which are direct therapeutic actions.
No
The device, a chest drain, is used to evacuate air and/or fluid from the chest cavity and re-establish lung expansion, which are therapeutic functions, not diagnostic.
No
The device description explicitly names a physical product, "Atrium Medical Corporation Express™ Chest Drain," which is a hardware device used for draining the chest cavity. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used to evacuate air and fluid from the chest cavity and facilitate blood collection and reinfusion. These are procedures performed directly on the patient's body, not on samples taken from the body for diagnostic purposes.
- Device Description: The device is described as a "Chest Drain," which is consistent with a device used for drainage procedures within the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are typically used to test samples to diagnose diseases or conditions.
Therefore, the Atrium Medical Corporation Express™ Chest Drain is a medical device used for therapeutic and procedural purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
To evacuate air and/or fluid from the chest cavity or mediastinum.
To help re-establish lung expansion and restore breathing dynamics.
To facilitate postoperative collection and reinfusion of autologous blood from the patient's pleural cavity or mediastinal area.
Product codes
KDQ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chest cavity or mediastinum, pleural cavity or mediastinal area
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the Department of Health & Human Services (USA). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with stylized wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 5 2008
Atrium Medical Corporation c/o Ms. Karen Hall Director of Regulatory and Quality Affairs 5 Wentworth Drive Hudson, New Hampshire 03051
Re: K081718
Atrium Express Chest Drain Regulation Number: 21 CFR 880.6740 Regulation Name: bottle, collection, vacuum Regulatory Class: Class II (two) Product Code: KDQ Dated: June 13, 2008 Received: June 24, 2008
Dear Ms. Hall:
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. Iisting 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.
1
Page 2 - Ms. Preeti Jain
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 clectronic 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) 276-0120. 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,
Dina R. Wiener
Image /page/1/Picture/5 description: The image shows a signature. The signature is illegible, but it appears to be written in cursive. There is a horizontal line underneath the signature. The signature is black and the background is white.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications For Use
510(k) Number (if known):_ 长ひ8|718
Device Name: __ Atrium Medical Corporation Express™ Chest Drain
Indications For Use:
To evacuate air and/or fluid from the chest cavity or mediastinum.
To help re-establish lung expansion and restore breathing dynamics.
To facilitate postoperative collection and reinfusion of autologous blood from the patient's pleural cavity or mediastinal area.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) | |
| 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)
Dune R. Vc. Ames
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number_ko81718
Page 1 of _ 1
Atrium Medical Corporation
.
CONFIDENTIAL
Page B-1