(176 days)
Not Found
No
The description focuses on mechanical and electronic components, user interface, and data display/transfer, with no mention of AI or ML capabilities.
Yes
The device is used for aspiration and removal of fluids, tissue, gases, or bodily fluids from a patient's respiratory system for therapeutic purposes, such as in cases of pneumothorax, after surgery, or pleura effusion. It is directly involved in treating medical conditions.
No
The device is described as a suction pump for aspiration and removal of surgical fluids, tissue, gases, and bodily fluids, and it has an electronic measuring and monitoring system to display therapy course information. While it monitors and displays data, its primary function is therapeutic (removal of substances), not to diagnose a condition.
No
The device description clearly states it is a physical pump with a DC-motor, membrane aggregate, and housing, indicating it is a hardware device with integrated software for control and monitoring.
Based on the provided information, the Medela THOPAZ Suction Pump is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Medela THOPAZ Function: The description clearly states the device is a suction pump used for the aspiration and removal of fluids, tissue, gases, and materials directly from a patient's respiratory support system and chest. This is a therapeutic and surgical/post-surgical procedure performed on the patient's body (in vivo).
- Intended Use: The intended use focuses on drainage and removal of substances from the body, not on analyzing specimens for diagnostic purposes.
Therefore, the Medela THOPAZ Suction Pump is a medical device used for therapeutic and procedural purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Medela® THOPAZ Suction Pump is indicated for aspiration and removal of surgical fluids, tissue, gases, bodily fluids or infectious materials from a patient's respiratory support system (after surgery).
Generally the Medela® THOPAZ is intended to be used in all situations where chest drains are applied - especially for thoracic drainage and in situations such as pneumothorax, after surgery (post operative), thorax injury, pleura effusion, pleuryempyem or other related conditions.
Product codes
BTA
Device Description
The Medela® THOPAZ pump is an innovative secretion aspirator intended to be used for thoracic drainage. Its well-proven membrane system guarantees maximum suction performance and quiet, dependable operation. Additional advantages of the Medela® THO-PAZ are: user friendliness, patient mobility, simple cleaning and integrated safety features. A comprehensive range of accessories makes the Medela® THOPAZ ideally suited for thoracic drainage while mobilizing the patient.
The Medela® THOPAZ suction pump is an AC/DC powered, maintenance-free aspirator which incorporates a DC-motor with membrane aggregate power actuation in its housing. A user friendly MMI (man machine interface) guides the user through first installation, change of settings, use, data transfer and alarm handling.
The Medela® THOPAZ suction pump has an electronic measuring and monitoring system with optical and acoustic status display. The device is a dry system, which means that no fluids are necessary for operation. Important information about the course of therapy is displayed digitally and as graphics in the display. These data can be transferred to a PC upon completion of the therapy.
The Medela® THOPAZ suction pump has a suction capacity of 5 liters per minute and a maximum vacuum up to -10 kPa (-75 mmHg). The pump is marked "low flow - low vacuum".
A variety of reusable and disposable accessories for thoracic drainage are available.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's respiratory support system, chest
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)
Not Found
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
§ 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
Section E - 510(k) Summary
This 510(k) summary for the Medela® THOPAZ Suction Pump meets the requirements of 21 CFR 807.92.
JUL 2 3 2008
Sponsor's Name, Address and Contact Person 1
Sponsor: Medela AG Medical Equipment Laettichstrasse 4b 6341 Baar Switzerland +41 41 769 5151 ext. 247 Ph: +41 41 769 5100 Fax:
Contact Person Bruno Gretler Manager Regulatory Affairs
Date Summary Prepared: January 24, 2008
2 Name of Device
| Trade Name: | Medela® THOPAZ
Secretion & Surgical Aspirator |
|----------------------|--------------------------------------------------------------------------------------------|
| Common Name: | Powered Suction Pump |
| Classification Name: | PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)
Classified Class II, per 21 CFR 878.4780 |
| Product Code: | BTA |
3 Name of the predicate Device(s)
- Medela® Vario 8/18/ci Suction Pumps, by Medela Inc. . K061205
- Medela® Dominant 35 c/i Suction Pump, by Medela AG . K043544
E_510k_Summary_THOPAZ.doc
2008-01-24
Section E - 1 of 3
1
ব Device Description
The Medela® THOPAZ pump is an innovative secretion aspirator intended to be used for thoracic drainage. Its well-proven membrane system guarantees maximum suction performance and quiet, dependable operation. Additional advantages of the Medela® THO-PAZ are: user friendliness, patient mobility, simple cleaning and integrated safety features. A comprehensive range of accessories makes the Medela® THOPAZ ideally suited for thoracic drainage while mobilizing the patient.
The Medela® THOPAZ suction pump is an AC/DC powered, maintenance-free aspirator which incorporates a DC-motor with membrane aggregate power actuation in its housing. A user friendly MMI (man machine interface) guides the user through first installation, change of settings, use, data transfer and alarm handling.
The Medela® THOPAZ suction pump has an electronic measuring and monitoring system with optical and acoustic status display. The device is a dry system, which means that no fluids are necessary for operation. Important information about the course of therapy is displayed digitally and as graphics in the display. These data can be transferred to a PC upon completion of the therapy.
The Medela® THOPAZ suction pump has a suction capacity of 5 liters per minute and a maximum vacuum up to -10 kPa (-75 mmHg). The pump is marked "low flow - low vacuum".
A variety of reusable and disposable accessories for thoracic drainage are available.
5 Indications for use
The Medela® THOPAZ Suction Pump is indicated for aspiration and removal of surgical fluids, tissue, gases, bodily fluids or infectious materials from a patient's respiratory support system (after surgery).
Generally the Medela® THOPAZ is intended to be used in all situations where chest drains are applied - especially for thoracic drainage and in situations such as pneumothorax, after surgery (post operative), thorax injury, pleura effusion, pleuryempyem or other related conditions.
Summary of Technological Characteristics 6
The Medela® THOPAZ has the same performance characteristics as the predicate devices. These differences regarding type of aggregate and display are marginal and state of the art today. Other FDA approved devices using the same technology (aggregate and display).
The Medela® THOPAZ Suction Pump is equipped with the identical technology like other marketed devices. These technological features do not affect safety and effectiveness of the device or the application (thoracic drainage).
E_510k_Summary_THOPAZ.doc
2008-01-24
2
7 Conclusion
There are no differences in performance or technology which significantly affect the safety and effectiveness of the device or the application (thoracic drainage). All conclusions are made by the decision making process according to the recommendations in the "510(k) SE Decision Making Process" document.
The Medela® THOPAZ suction pump has the identical intended uses and, where applicable, the identical technological characteristics and performance data as the predicate devices.
Based upon the information presented in this submission, it is proven that the proposed Medela® THOPAZ powered suction pump is substantially equivalent, safe and effective for the intended use.
E_510k_Summary_THOPAZ.doc
2008-01-24
Section E - 3 of 3
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged in a circular fashion around the eagle. The text is in all capital letters and is relatively small compared to the eagle symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL. 2 3 2008
Medela AG % Mr. Bruno Gretler Manager Regulatory Affairs Laettichstrasse 4b 6341 Baar Switzerland
Re: K080212
Trade/Device Name: Medela THOPAZ Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: BTA Dated: July 10, 2008 Received: July 10, 2008
Dear Mr. Gretler:
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
4
Page 2 - Mr. Bruno Gretler
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 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 yours.
Mark N. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation . Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): Kc 80212
Device Name:
Medela THOPAZ
The Medela THOPAZ Suction Pump is indicated for aspiration and removal of surgical fluids, tissue, gases, bodily fluids or infectious materials from a patient's respiratory support system (after surgery).
Generally the Medela THOPAZ is intended to be used in all situations where chest drains are applied - especially for thoracic drainage and in situations such as pneumothorax, after surgery (post operative), thorax injury, pleura effusion, pleuryempyem or other related conditions.
Prescription Use X (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
i
Page 1 of 1
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number