(7 days)
Not Found
No
The device description focuses on mechanical components and vacuum regulation, with no mention of AI/ML terms or functionalities.
No
The device is a suction pump designed for aspiration and collection of secretions and fluids, which is a supportive function during medical procedures rather than directly treating a disease or condition.
No.
The device description and intended use clearly state that the device is for aspiration and collection of secretions, body fluids, and tissue, which is a therapeutic rather than diagnostic function.
No
The device description clearly outlines a physical suction pump with hardware components like a diaphragm-type pump, vacuum regulator, vacuum-gauge, and collection jar. It is not solely software.
Based on the provided information, the ATMOS C361/C451 Suction Pump™ device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the aspiration and collection of secretions, body fluids, and tissue from wounds during surgery or at the patient's bedside. This is a direct interaction with the patient's body for therapeutic or procedural purposes.
- Device Description: The description details a surgical suction unit that generates a vacuum to withdraw and collect fluids. This is a mechanical process for removing substances from the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The ATMOS C361/C451 does not perform any analysis or testing of the collected fluids. It simply collects them.
Therefore, the ATMOS C361/C451 Suction Pump™ is a medical device used for surgical and bedside suction, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ATMOS C361/C451 Suction Pump™ device is intended for aspiration and collection of secretions, body fluids and tissue from wounds during surgery or at the patient's bedside.
Product codes
BTA
Device Description
The ATMOS C361/C451 device is an AC/DC-powered surgical suction unit. With a direct docking and direct docking disposable system, hose connection errors are not possible. There is only one connection for the hose to the patient. The connection from the jar to the pump is integrated in the container lid.
The ATMOS C361/C451 is centered on a silent diaphragm-type pump which generates a vacuum inside the collection jar, allowing secretions to be withdrawn and collected. Using a vacuum regulator and the vacuum-gauge, the target vacuum and airflow rate can be adjusted.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
during surgery or at the patient's bedside.
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
The ATMOS C361/C451 Suction Pump™ device have been designed and tested to applicable safety standards. The C361/C451 Suction Pump does not raise any new issues of safety, efficacy, or performance of the product.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
FEB 2 2009
|Coq443
This 510(k) summary of safety and effectiveness information is being submitted in accordanc with the requirements of SMDA 1990.
Date Prepared:
July 7, 2008
Submitter's Information: 21 CFR 807,92(a)(1)
Mr. Marco Schlegel, President ATMOS Inc. 3717 Huckleberry Road Allentown, PA 18104 Tel: 610.351.7221 610.351.6527 Fax: Email: MSchlegel@atmosmed.de
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)
| Product Name: | ATMOS C361/C451 Suction PumpTM |
|---|---|
| Common Name: | Powered suction pump |
| Classification Name: | Pump, Portable, Aspiration (Manual or Powered) 878.4780, |
| Class II | |
| Product Code: | BTA |
Predicate Device: 21 CFR 807. 92(a)(3)
| 510(k) Number | K042943 |
|---|---|
| Device Name | NOUVAG AG - VACUSON 40 AND VACUSON 60 |
| Applicant | NOUVAG AG |
| Reusswehrstrasse 1 | |
| Gebenstorf, SZ 5412 | |
| Regulation Number | 878.4780 |
| Classification Product Code | BTA |
| Decision Date | 12/17/2004 |
| Decision | substantially equivalent (SE) |
| Classification Advisory Committee | General & Plastic Surgery |
Device Description: 21 CFR 807 92(a)(4)
The ATMOS C361/C451 device is an AC/DC-powered surgical suction unit. With a direct docking and direct docking disposable system, hose connection errors are not possible. There is only one connection for the hose to the patient. The connection from the jar to the pump is integrated in the container lid.
The ATMOS C361/C451 is centered on a silent diaphragm-type pump which generates a vacuum inside the collection jar, allowing secretions to be withdrawn and collected. Using a vacuum regulator and the vacuum-gauge, the target vacuum and airflow rate can be adjusted.
Indications for Use: 21 CFR 807 92(a)(5)
1
1
510(k) Summary of Safety and Effectiveness
The ATMOS C361/C451 Suction Pump™ device is intended for aspiration and collection of secretions, body fluids and tissue from wounds during surgery or at the patient's bedside.
Technological Characteristics: 21 CFR 807 92(a)(6)
ATMOS C361/C451 Suction Pump™ device are substantially equivalent to other legally marketed devices in the United States. The C361/C451 functions in a manner similar and are intended for the same use as the predicate.
Brief summary of Non-clinical Tests and Results
The ATMOS C361/C451 Suction Pump™ device have been designed and tested to applicable safety standards. The C361/C451 Suction Pump does not raise any new issues of safety, efficacy, or performance of the product.
Conclusion: 21 CFR 807 92(b)(1)
The 510(k) for the ATMOS C361/C451 Suction Pump™ device contains adequate information and data to enable FDA to determine substantial equivalence to the predicate device. The device will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ATMOS, Inc. % TUV Rheinland of North America, Inc. Tamas Borsai 12 Commerce Road Newton, Connecticut 06470
FEB 2 7 2009
Re: K090445
Trade/Device Name: ATMOS C361/C451 Suction Pump™ Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: BTA Dated: February 20, 2009 Received: February 20, 2009
Dear Tamas Borsai:
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.
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Tamas Borsai
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 vours.
Daniel Keane
CMark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K090445
Device Name: ATMOS C361/C451 Suction Pump™ .
Indications for Use:
The ATMOS C361/C451 Suction Pump™ device is intended for aspiration and collection of secretions, body fluids and tissue from wounds during surgery or at the patient's bedside.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division, Sign-Off Office of in With Olaghastle Device Evaluation and Safety
510(() Number Shholo >
New Neurological Devices Division of General, Restorative, (IIQ-ugis noisivid)
Page 1 of 1 Updated June 4, 2007
510(k)