The MAQUET Hemoconcentrators are used to remove excess fluid from the blood or to concentrate highly diluted blood solutions. They are only intended for use for blood concentration during and/or following cardiopulmonary bypass procedures. The maximum duration of use is 6 hours. The physician in charge of treatment has sole responsibility for decisions concerning use of the hemoconcentrator.

Device Description

BC 60 plus, BC 140 plus Hemoconcentrators are used to remove excess fluid from the blood during and/or following cardiopulmonary bypass procedures. Hemoconcentrators are ready for use after they have been filled and vented as the membrane contains no stabilizers. The type of Hemoconcentrator used is determined by the protocol used.

AI/ML Overview

This document describes a 510(k) premarket notification for the MAQUET BC 60 plus and BC 140 plus Hemoconcentrators. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with detailed performance metrics.

Therefore, many of the requested items (e.g., acceptance criteria table with reported performance, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, specific training set details, and type of ground truth used) are not applicable or not provided in this type of regulatory submission.

Here's a breakdown of what can be extracted based on the provided text:

1. A table of acceptance criteria and the reported device performance

This information is not explicitly provided in the format of acceptance criteria and reported performance values. The submission states that the devices met the requirements of ISO standards and that evaluation and testing demonstrated substantial equivalence. However, the specific quantitative acceptance criteria or the reported performance data against those criteria are not detailed in this public FDA summary. The assessment revolves around equivalence to predicate devices, not the new establishment of performance criteria for this specific device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The submission states that "evaluation and testing on safety and effectiveness was executed" and lists general areas (Integrity, Performance, Biocompatibility, Sterility) that were tested/evaluated. However, details about sample sizes, study design (retrospective/prospective), or data provenance are absent.

3. 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)

This is not applicable/not provided. This type of information is typically relevant for studies evaluating diagnostic or AI-driven devices where human expert consensus forms a "ground truth" for comparison. Hemoconcentrators are physical medical devices, and their performance is assessed through engineering and biological testing, not through expert interpretation of data points that require "ground truth" establishment in the way an image analysis algorithm might.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable/not provided for the same reasons as item 3. Adjudication methods are used in studies involving human interpretation or subjective assessments to resolve discrepancies, which is not the primary method for evaluating the performance of a physical device like a hemoconcentrator.

5. 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

This is not applicable/not provided. MRMC studies are specific to diagnostic devices where human readers (e.g., radiologists) interpret images or data, and their performance is compared with and without AI assistance. This device is a hemoconcentrator, not a diagnostic imaging or AI system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable/not provided. This question pertains to AI algorithms. The MAQUET Hemoconcentrators are physical devices that perform a function and are not AI algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

As noted previously, the concept of "ground truth" in the context of expert consensus or pathology is not directly applicable to the evaluation of a hemoconcentrator. The "truth" in this context would be the objective measurements of the device's technical performance and biological safety as defined by the relevant ISO standards and predicate device performance. For biocompatibility, established biological endpoints and validated testing methods would constitute the "ground truth."

8. The sample size for the training set

This is not applicable/not provided. This question applies to machine learning models. The MAQUET Hemoconcentrators are physical medical devices, not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

This is not applicable/not provided for the same reason as item 8.

Summary of the Study and Device Evaluation:

The study proving the device meets criteria for substantial equivalence (which is the regulatory standard for this 510(k) submission) is based on non-clinical testing.

Acceptance Criteria/Performance Standards: The devices were tested to and met the requirements of:
- ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing. (This implies meeting established biocompatibility endpoints).
- ISO 8637: Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators. (This implies meeting established performance and safety requirements for these types of devices).
- The overall "acceptance criteria" were demonstrating substantial equivalence in safety and effectiveness to the predicate devices: Hemocor HPH® 700 (K983085) and Hemocor HPH® 1400 (K923139). This equivalence was assessed across the "principals of operation, performance and indications for use."
Areas Tested/Evaluated:
- Integrity
- Performance
- Biocompatibility
- Sterility

Limitations of the provided text: This 510(k) summary is a high-level overview. It confirms that testing was done and standards were met, but it does not provide the detailed results, specific test protocols, or quantitative data that would fulfill many of the requested items (e.g., exact performance numbers, sample sizes, or specific ground truth methodologies for each test). The purpose of this summary is to demonstrate regulatory compliance through substantial equivalence, not to provide a detailed scientific publication of a study's methodology and results.

Summary

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K123288

JUN 2 6 2013

MAQUET GETINGE GROUP

510(k) Summary

[as required by 21 CFR 807.92(c)]

Submitter	MAQUET Cardiopulmonary AGKehler Strasse 3176437 RastattGermany
Contact Person	Dr. Ingrid RichterPhone: 011 49 7478 921 337Fax: 011 49 7478 921 8667e-mail: ingrid.richter@maquet.com
Date Prepared	October 19, 2012
Device Trade Name	Hemoconcentrators : BC 60 plus, BC 140 plus
Common/Usual Name	Hemoconcentrator
Classification Names	High Permeability Hemodialysis SystemHemoconcentrator(21 CFR 876.5860 - Product Code: KDI)
Predicate Devices	Hemocor HPH® 700, Minntech Corp. USA,K983085Hemocor HPH® 1400, Minntech Corp. USA,

Device Description

Page 1 of 2

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MAQUET GETINGE GROUP

Indications for Use

The maximum duration of use is 6 hours.

The physician in charge of treatment has sole responsibility for decisions concerning use of the hemoconcentrator.

Statement of Technical Comparison

The Hemoconcentrators, BC 60 plus, BC 140 plus are comparable to the Hemocor HPH® 700 K983085, Hemocor HPH® 1400 K923139 from Minntech Corp. USA, reqarding the principals of operation, performance and indications for use.

Non-clinical Testing

The Hemoconcentrators BC 60 plus and BC 140 plus have been tested to and met the requirements of ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing as well as the requirements of ISO 8637 Cardiovascular implants and extracomoreal systems - Haemodialysers. haemodiafilters, haemofilters and haemoconcentrators.

Determination of Substantial Equivalence

Evaluation and testing on safety and effectiveness was executed to demonstrate that the Hemoconcentrators BC 60 plus, BC 140 plus described in this submission are substantially equivalent to the Hemocor HPH® 700 (K983085), Hemocor HPH® 1400 (K923139) from Minntech Corp., USA.

The following areas have been tested and / or evaluated:

Integrity .
Performance -
Biocompatibility -
Sterility .

Conclusion

The data given demonstrate that the Hemoconcentrator BC 60 plus and BC 140 plus are substantially equivalent to the named predicate devices which have FDA market clearance.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized waves or lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002

June 26, 2013

MAQUET Cardiopulmonary AG % Ms. Ingrid Richter Regulatory Affairs Manager Kehler Strasse 31 RASTATT 76437 GERMANY

Re: K123288

Trade/Device Name: BC 60 plus, BC 140 plus Hemoconcentrator Regulation Number: 21 CFR§ 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: May 17, 2013 Received: May 20, 2013

Dear Ms. Richter:

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.

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Page 2 - Ms. Ingrid Richter

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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 vours.

Herbert P. Lerner -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): __K123288

Device Name:

BC 60 plus, BC 140 plus Hemoconcentrator

Indications for Use:

The physician in charge of treatment has sole responsibility for decisions concerning use of the hemoconcentrator.

Prescription Use × (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Herbert P. Lerner -S

K123288

Regulation Number and Section

§ 876.5860 High permeability hemodialysis system.

(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”