(183 days)
Not Found
No
The summary describes a standard medical device for thoracic drainage with an electronic monitoring system, but there is no mention of AI or ML capabilities.
No
The device is used for aspiration and removal of fluids and gases from a patient's respiratory support system after surgery (thoracic drainage), which is a supportive rather than a therapeutic function. Therapeutic devices are typically those that treat or cure a disease or condition.
No
The device is described as a "drainage suction unit" intended for "aspiration and removal of surgical fluids, tissue, gases, bodily fluids or infectious material." This is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "drainage suction unit" and describes physical components like a "hose set" and "collection container," indicating it is a hardware device with an electronic monitoring system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the aspiration and removal of fluids, tissue, gases, and infectious material from a patient's respiratory support system. This is a direct interaction with the patient's body for therapeutic or procedural purposes.
- Device Description: The device is described as a "drainage suction unit" for "mobile thoracic drainage." This further reinforces its function as a medical device used to manage bodily fluids and gases within the patient.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis on specimens.
The device is clearly a medical device used for a therapeutic or procedural purpose related to patient care, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The ATMOS E 201 Thorax and the ATMOS S 201 Thorax are indicated for aspiration and removal of surgical fluids, tissue, gases, bodily fluids or infectious material from a patient's respiratory support system after surgery. The general indication of the ATMOS S 201 Thorax and the ATMOS E 201 Thorax is thoracic drainage.
Product codes (comma separated list FDA assigned to the subject device)
BTA
Device Description
The ATMOS S 201 Thorax and ATMOS E 201 Thorax drainage suction units are devices for mobile thoracic drainage. The devices are intended for short-time (
§ 878.4780 Powered suction pump.
(a)
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.(b)
Classification. Class II.
0
510(k) Summary of Safety and Effectiveness
103042
Page 1 of ②
APR 1 5 2011
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared:
"
ﺤ
August 09, 2010
Submitter's Information: 21 CFR 807.92(a)(1)
ATMOS Inc. 3717 Huckleberry Road Allentown, PA 18104 Phone: 610.351.7221
Contact Person: Katrin Georges Manager Regulatory Affairs
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)
| Product Name: | ATMOS S 201 Thorax and ATMOS E 201 Thorax |
|---|---|
| Common Name: | Powered suction pump |
| Classification Name: | PUMP, PORTABLE, SUCTION UNIT (AC-POWERED OR BATTERY) 878.4780, Class II |
| Product Code: | BTA |
Predicate Devices: 21 CFR 807. 92(a)(3)
| 510(k) Number | K080212 |
|---|---|
| Device Name | Medela THOPAZ |
| Applicant | Medela AG |
| Medical Equipment | |
| Laettichstrasse 4b | |
| 6341 Baar | |
| Switzerland | |
| Regulation Number | 878.4780 |
| Classification Product Code | BTA |
| Decision Date | 07/23/2008 |
| Decision | Substantially equivalent (SE) |
| Classification Advisory Committee | General & Plastic Surgery |
| 510(k) Number | K043582 |
|---|---|
| Device Name | Ocean Chest Drain |
| Applicant | Atrium Medical Corporation |
| 5 Wentworth Dr. | |
| Hudson; NH 03051 | |
| Regulation Number | 880.6740 |
| Classification Product Code | KDQ |
| Decision Date | 01/21/2005 |
| Decision | Substantially Equivalent (SE) |
| Classification Advisory Committee | General Hospital |
1
Page (2) of
510(k) Summary of Safety and Effectiveness
KID 3049
Device Description: 21 CFR 807 92(a)(4)
The ATMOS S 201 Thorax and ATMOS E 201 Thorax drainage suction units are devices for mobile thoracic drainage. The devices are intended for short-time (