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.

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.

AI/ML Overview

This document describes a Special 510(k) submission for the Medela® THOPAZ+ Suction Pump, which is a modified version of the legally marketed Medela® THOPAZ (K130210). The submission focuses on demonstrating substantial equivalence to the predicate device and the safety and effectiveness of the modifications.

Based on the provided information, it's important to note that this is NOT a study demonstrating the performance of an AI/ML-based medical device against specific acceptance criteria for diagnostic or prognostic tasks. Instead, it's a 510(k) summary for a hardware medical device (a suction pump) that has undergone modifications. The acceptance criteria and performance data discussed relate to the functional and safety aspects of the device, rather than diagnostic accuracy.

Here's an analysis based on the provided text, addressing your points where applicable:

Acceptance Criteria and Device Performance

The document does not present a formal table of acceptance criteria and reported device performance in the way one would for a diagnostic algorithm (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implied by the verification and validation activities conducted for the device modifications, ensuring that the device's fundamental performance characteristics (suction capacity, vacuum, and safety) remain equivalent to the predicate device and that the new features function as intended without compromising safety or effectiveness.

The core performance claims are:

Suction capacity: 5 liters per minute
Maximum vacuum: up to -10 kPa (-75 mmHg)
Classification: "low flow – low vacuum"

These are described as having the "same performance characteristics as the unmodified legally marketed device Medela® THOPAZ."

The document highlights several modifications and their justifications, which implicitly serve as "performance improvements" or "safety enhancements" that were verified.

Acceptance Criteria (Implied)	Reported Device Performance (Summary of Modifications/Verification)
Proper fixation on hospital beds (Bed Holder Fixation)	The new bed holder is optimized to allow fixation of the pump on a wider variety of hospital bed types, ensuring continuous proper fixation.
Resistance to disinfection agents/fluids (Housing Sealing)	The device is now sealed to prevent disinfection agents from entering the housing, enhancing resistance against fluids. The IP classification remains the same, indicating no degradation in ingress protection.
Reliable fluid level detection (New PCB & Fluid Level Measurement)	A new level PCB, included in the housing, is used for capacitive fluid level detection through the device wall. This provides reliable fluid measurement independent of fluid consistency (e.g., blood, water, fatty liquids). This required minor changes to the assembly (power supply, digital communication, resistors/capacitors for communication speed) and firmware adaptations to display fluid amount parameters. The normal therapy function and negative pressure generation are not impacted.
Improved seal retention and visibility (Seal/O-ring)	The color of the seal (connecting canister to device) was changed to orange and its shape slightly adapted to prevent undesired removal and improve detection of a missing seal, ensuring a better fit and better visibility that helps detecting if the seal is missing.
Compatibility with a wider range of catheter sizes (New Tubing)	New tubing sizes are introduced, extending the range available for the legally marketed device to improve connection to large catheter sizes.
Ergonomics and usability (Carrying Strap, Display, Keypad)	The carrying strap was slightly adapted in diameter and wideness to complement an optimized handle. A new, slightly bigger color display (73.4x49mm active area) was included to accommodate fluid measurement parameters. The keypad was adapted due to display size but maintains the same number of buttons for smooth transition. An environment sensor was added to the keypad to adapt display brightness to environmental conditions.
Overall Safety and Effectiveness	The modifications do not alter the Indications for Use, fundamental scientific technology, or introduce new scientific technology. All changes were evaluated as part of risk management. Subsequent verification and validation activities for the applied changes were referenced and evidence is contained within the submission, demonstrating that the product is safe for the patient, user, and bystander and raises no new safety/effectiveness questions. The device retains its core performance of 5 L/min suction capacity and -10 kPa max vacuum ("low flow – low vacuum"). The device firmware controls, checks and regulates all main device functions. The user interface (except for fluid measurement) and regulation of negative pressure functions remain unchanged from the predicate.

Here's an assessment of the other requested points, noting that many are not applicable or cannot be determined from this specific type of document (a 510(k) summary for a hardware device, not an AI study).

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable in the AI/ML context: This document is about a hardware medical device (a suction pump). There is no "test set" in the context of evaluating an algorithm's diagnostic or predictive performance.
- For the device itself: The document refers to "Subsequent verification and validation activities for the applied changes" and "risk management" with "documented evidence" in the submission. These would involve testing of the physical device and its software (firmware) functions, likely under controlled laboratory conditions, to ensure functionality, safety, and performance (e.g., flow rates, vacuum stability, alarm functions, fluid level detection accuracy, user interface operation). The specific sample sizes for these engineering tests are not detailed in this summary. Data provenance is not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable: There is no "ground truth" establishment by medical experts in the sense of labeling diagnostic images or clinical outcomes for an AI algorithm in this document. The "truth" for this device relates to its engineering specifications, safety standards, and functional performance. Experts involved would be engineers, human factors specialists, and potentially clinical users for usability studies, but their numbers and qualifications are not specified here.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable: No adjudication method for a "test set" in the AI/ML context is mentioned or relevant here.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable: This is a hardware device (a suction pump), not an AI-assisted diagnostic tool. No MRMC study was performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable: This is a hardware device. While it contains firmware (software running on the device), it's part of an electro-mechanical system. Its performance is always "human-in-the-loop" as it requires a clinician to operate it. There isn't an "algorithm only" performance in the sense of an AI model making independent decisions. The firmware controls pump functions and displays data to the user.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not Applicable in the AI/ML diagnostic sense: The "ground truth" for this device's performance relates to engineering specifications, safety standards (e.g., ISO, IEC), and functional requirements met through verification and validation testing. For example, the "ground truth" for suction capacity would be a measured flow rate, for vacuum it would be a measured pressure, and for fluid level detection it would be the actual fluid volume present vs. what the sensor reports. This is based on objective physical measurements, not medical expert consensus for a diagnostic task.
The sample size for the training set:
- Not Applicable: As this is a hardware device with firmware, there isn't a "training set" in the machine learning sense for an AI model. The firmware is developed through traditional software engineering methods, including coding, debugging, and testing, not by training on a dataset.
How the ground truth for the training set was established:
- Not Applicable: No training set in the AI/ML sense exists for this device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human figure in profile, with three overlapping faces suggesting community and connection. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the figure.

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

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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

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Indications for Use

510(k) Number K141553

Device Name Medela® THOPAZ+

Indications for Use

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)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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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 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 levelPCB 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 andshape)	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 includeinformation on allchanges	Because of all changes applied to the legally marketed device itwas 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 thenew level measurement and all other changes discussed in thisdocument.
8. Adapted device PCB	Because of the usage of a new level sensor, some minor changesof 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 capacitivethrough the device wall providing a reliable fluid measurementindependent from the fluids consistency (e.g. blood, water, fattyliquids 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 toimplement the fluid measurement the user interface had to berevised. The device firmware controls, checks and regulates allmain device functions.Generally, except for the new fluid measurement function, theuser 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 inorder to show the new fluid amount parameters. None of thesechanges impact the normal therapy function and the generationof 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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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.

Regulation Number and Section

§ 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.