(75 days)
Not Found
No
The document describes a standard suction pump with electronic monitoring and data display, but there is no mention of AI or ML capabilities for analysis, prediction, or decision support.
Yes
The device is used for aspiration and removal of bodily fluids to treat existing medical conditions such as pneumothorax, pleural effusion, and empyema, which are therapeutic actions.
No
The description explicitly states "Thopaz+ is intended to be used for aspiration and removal of surgical fluids, tissue, gases, bodily fluids or infectious materials," indicating its function as a therapeutic/removal device, not a diagnostic one. While it monitors drainage, this monitoring is for therapy management, not for diagnosing a condition.
No
The device description explicitly details hardware components such as a suction pump, membrane system, DC-motor, and a physical user interface (MMI) with optical and acoustic displays. It is clearly a physical medical device with integrated software for control and monitoring.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "aspiration and removal of surgical fluids, tissue, gases, bodily fluids or infectious materials" and is indicated for "thoracic drainage in the pleural and mediastinal cavity". This describes a device used for collecting and removing substances from the body, not for performing diagnostic tests on those substances in vitro (outside the body).
- Device Description: The description details a "suction pump" and its mechanism for aspiration and monitoring of drained air and fluid. This aligns with a device for physical removal of substances, not for analyzing them for diagnostic purposes.
- Lack of Diagnostic Elements: There is no mention of the device performing any tests, analyses, or measurements on the collected fluids or materials to diagnose a condition. The monitoring is related to the volume and flow of the drained substances, which is relevant to the drainage process itself, not to a diagnostic evaluation of the substances.
- No Mention of IVD-Specific Components or Processes: The description does not mention reagents, assays, or other components typically associated with in vitro diagnostic devices.
In summary, the Thopaz+ is a medical device used for therapeutic purposes (drainage) and monitoring the drainage process, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
Thopaz+ is intended to be used for aspiration and removal of surgical fluids, tissue, gases, bodily fluids or infectious materials. Thopaz+ is indicated for all situations where chest drains are applied – especially for thoracic drainage in the pleural and mediastinal cavity in situations such as pneumothorax, after cardiac or thoracic surgery (post-operative), thorax injury, pleural effusion, pleural empyema or other related conditions. Thopaz+ is intended for use on patients in appropriate care settings.
Product codes
BTA
Device Description
The Medela® THOPAZ* suction 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® THOPAZ* are: User friendliness, patient mobility, simple cleaning and integrated safety features. A comprehensive range of accessories makes the Medela® THOPAZ* suction pump 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 for air and fluid being drained 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 pleural and mediastinal drainage are available.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pleural and mediastinal cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
appropriate care settings
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)
Medela® THOPAZ, K130210
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 25, 2014
Medela AG Mr. Orlando Antunes VP Regulatory Affairs Laettichstrasse 4b CH-6341 Baar, Switzerland
Re: K141553
Trade/Device Name: Medala ® THOPAZ+ Regulation Number: 21 CFR 878.4780 Regulation Name: Pump, Portable, Aspiration (manual or powered) Regulatory Class: II Product Code: BTA Dated: July 28, 2014 Received: July 31, 2014
Dear Mr. Antunes:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical
1
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number K141553
Device Name Medela® THOPAZ+
Indications for Use
Thopaz+ is intended to be used for aspiration and removal of surgical fluids, tissue, gases, bodily fluids or infectious materials. Thopaz+ is indicated for all situations where chest drains are applied - especially for thoracic drainage in the pleural and mediastinal cavity in situations such as pneumothorax, after cardiac or thoracic surgery (post-operative), thorax injury, pleural effusion, pleural empyema or other related conditions. Thopaz+ is intended for use on patients in appropriate care settings.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
- Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Image /page/3/Picture/0 description: The image shows the word "medela" in black font, followed by a logo of three orange teardrop shapes arranged in a triangular pattern. The word "medela" is written in a simple, sans-serif font. The logo is positioned to the right of the word.
Medela AG, Laettichstrasse 4b, CH-6341 Baar, Switzerland t Person: Orlando Antunes +41 (41) 561 66 71 / +41 (41) 769 51 00 orlando.antunes@medela.ch cial 510(k) Submission for Medela® THOPAZ* Suction Pump
K141553
Section 7 - 510(k) Summary
This 510(k) summary for the Medela * THOPAZ* Suction Pump meets the requirements of 21 CFR 807.92.
Sponsor's Name, Address and Contact Person 1
- Sponsor: Contact Person Medela AG Orlando Antunes Medical Equipment VP Regulatory Affairs Laettichstrasse 4b 6341 Baar Switzerland Phone: +41 41 5626671 Fax: +41 41 769 5100
Summary prepared 02 June 2014
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 unmodified legally marketed device
- Medela® THOPAZ, K130210
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Image /page/4/Picture/0 description: The image shows the word "medela" in black, bold font. To the right of the word is an orange graphic of three teardrop shapes clustered together. The teardrop shapes are arranged in a triangular pattern, with one at the top and two at the bottom.
Medela AG, Laettichstrasse 4b, CH-6341 Baar, Switzerland son: Orlando Antunes +41 (41) 561 66 71 / +41 (41) 769 51 00 orlando.antunes@medela.ch cial 510(k) Submission for Medela® THOPAZ+ Suction Pump
4 Device Description
The Medela® THOPAZ* suction 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® THOPAZ* are: User friendliness, patient mobility, simple cleaning and integrated safety features. A comprehensive range of accessories makes the Medela® THOPAZ* suction pump 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 for air and fluid being drained 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 pleural and mediastinal drainage are available.
5 Indications for use
Thopaz* is intended to be used for aspiration and removal of surgical fluids, tissue, gases, bodily fluids or infectious materials. Thopaz* is indicated for all situations where chest drains are applied – especially for thoracic drainage in the pleural and mediastinal cavity in situations such as pneumothorax, after cardiac or thoracic surgery (post-operative), thorax injury, pleural effusion, pleural empyema or other related conditions. Thopaz* is intended for use on patients in appropriate care settings.
6 Summary of Technological Characteristics
The Medela THOPAZ* has the same performance characteristics as the unmodified legally marketed device Medela® THOPAZ. Modifications to the unmodified legally marketed device are outlined in section 12 – Outline of modifications – Justification for Special 510k. There are no differences in performance or technology which significantly affect the safety and effectiveness of the device or the application (pleural and mediastinal drainage). The outline of changes in-
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Image /page/5/Picture/0 description: The image shows the Medela logo. The word "medela" is written in black, lowercase letters. To the right of the word is a symbol of three orange teardrop shapes arranged in a triangular pattern.
Medela AG, Laettichstrasse 4b, CH-6341 Baar, Switzerland : Person: Orlando Antunes +41 (41) 561 66 71 / +41 (41) 769 51 00 orlando.antunes@medela.ch ecial 510(k) Submission for Medela® THOPAZ* Suction Pump
cludes the identification of the changes that indicate submission of a Special 510(k) as required per FDA memorandum #K97-1 "Deciding When to Submit a 510(k) for a Change to an Existing Device". Subsequent verification and validation activities for the applied changes are referenced and evidence is contained within this submission. All modifications to the unmodified legally marketed device are evaluated as part of the risk management as outlined in attachment 16 Risk Management. Documented evidence is contained in this submission.
7 Conclusion
With regards to the legally marketed device Medela® THOPAZ, K130210 several minor changes have been implemented and are documented in this Special 510(k) device modification as shortly summarized below.
| 1. | Fixation of bed holder | The new bed holder is optimized to allow fixation of the pump on the hospital bed. To reflect the increasing variety of bed types, the new optimized version of the bed holder is implemented to allow continuous proper fixation of the THOPAZ+ to hospital beds. |
|---|---|---|
| 2. | Sealing of housing | The device is now sealed to prevent from any disinfection agents going into the housing. The additional sealing is only an improve- ment and the IP classification remains the same as before. Never- theless it was introduced to enhance resistance against fluids, e.g. disinfectant fluids used. |
| 3. | Inclusion of new level | |
| PCB in housing | The new sensor is included in the housing which is used for fluid level detection that is now introduced (refer also to change 09). | |
| 4. | Seal / O-ring (color and | |
| shape) | The color of the seal which seals the connection of the canister to the device has been changed to orange and has been slightly adapted in order to prevent undesired removal of the seal. | |
| In order to improve the detection of a missing seal the color of the seal was changed to orange and the new seal is sticking better to the housing with a slightly adapted geometry. | ||
| 5. | New tubing accesso- | |
| ries | New tubing sizes are introduced to the subject device. These sizes extend the range of sizes that has existed for the legally marketed device in order to improve connection to large catheter sizes. | |
| 6. | Optimization of carry- | As a result of the optimized handle the carrying strap was slightly |
| ing strap | adapted in diameter and wideness. | |
| 7. IFU revised to include | ||
| information on all | ||
| changes | Because of all changes applied to the legally marketed device it | |
| was necessary to adapt the instructions for use. The new instruc- | ||
| tions for use generally compromises the same information. | ||
| Though, it has been complemented with the information for the | ||
| new level measurement and all other changes discussed in this | ||
| document. | ||
| 8. Adapted device PCB | Because of the usage of a new level sensor, some minor changes | |
| of the assembly were implemented: |
- New level sensor power supply
- Digital communication interface
- Optimization of resistors and capacitors to enhance com-
munication speed | |
| 9. Fluid level measure-
ment | In order to measure also the fluid levels resulting from the drain-
age a new PCB was added. The PCB can measure fluids capacitive
through the device wall providing a reliable fluid measurement
independent from the fluids consistency (e.g. blood, water, fatty
liquids etc.). | |
| 10. Device Firmware | The device FW from Thopaz+ is based on the firmware of the le-
gally marketed device THOPAZ, K130210. However in order to
implement the fluid measurement the user interface had to be
revised. The device firmware controls, checks and regulates all
main device functions.
Generally, except for the new fluid measurement function, the
user interface remains unchanged. All functions regarding regula-
tion of the negative pressure work for both devices.
For the new Thopaz+ the firmware had to be adapted mainly in
order to show the new fluid amount parameters. None of these
changes impact the normal therapy function and the generation
of the negative pressure. | |
| 11. Color display and key- | In order to include the fluid measurement the device was | |
| | | |
| pad | equipped with a new slightly bigger color display. The active area | |
| | is now 73.4X49mm. | |
| | Because of the bigger size of the display the keypad needed to be | |
| | adapted. However, the keypad still provides the same amount of | |
| | buttons to approve a good transition from the legally marketed | |
| | device to Thopaz+. Because of the higher brightness of the new | |
| | color display an environment sensor was included to the new | |
| | keypad, which allows to adapt the display brightness according to | |
| | the environmental brightness. | |
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Image /page/6/Picture/0 description: The image shows the word "medela" in black font. To the right of the word is a logo consisting of three orange teardrop shapes arranged in a triangular pattern. The logo is slightly smaller than the word "medela".
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Image /page/7/Picture/0 description: The image contains the word "medela" in bold, black font. To the right of the word is an orange graphic of three teardrop shapes. The teardrop shapes are arranged in a triangular pattern.
Medela AG, Laettichstrasse 4b, CH-6341 Baar, Switzerland t Person: Orlando Antunes +41 (41) 561 66 71 / +41 (41) 769 51 00 orlando.antunes@medela.ch Special 510(k) Submission for Medela® THOPAZ* Suction Pump
None of the modifications alters the Indications for Use in a significant way, nor the fundamental scientific technology, and do not introduce a fundamentally new scientific technology.
We therefore believe that the information presented in this Special 510(k) demonstrates that the product is safe for the patient, user, and bystander and does not raise any new questions regarding safety and effectiveness.