The Diacap Pro dialyzer is a polysulfone high flux dialyzer with the surface areas 1.3 sqm, 1.6 sqm, 1.9 sqm. It is designed for single use in acute and chronic hemodialysis. The dialyzer is gamma sterilized, with a non pyrogenic fluid path, and does not contain natural rubber latex.

AI/ML Overview

This document is a 510(k) summary for the Diacap Pro Dialyzer. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a study with a defined ground truth, a common practice for AI/ML devices. Therefore, a direct response to your request, specifically sections 1-9 as they apply to AI/ML device studies, cannot be fully provided from the given text.

However, I can extract the relevant performance testing that was done and the comparison to the predicate device to illustrate how equivalence was demonstrated for this medical device, which is a key part of its acceptance for market.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a non-AI/ML device, the "acceptance criteria" are generally related to demonstrating substantial equivalence to a predicate device through functional and performance testing, rather than a specific numeric threshold for an AI model's output. The "reported device performance" is a comparison of the proposed device's characteristics and performance to the predicate device.

Performance Metric/Characteristic	Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Diacap Pro Dialyzer Performance (Proposed Device)	Predicate Diacap HI PS Dialyzer Performance (Predicate Device)
Indications for Use	Same as predicate device	Designed for single use in acute and chronic hemodialysis	Designed for single use in acute and chronic hemodialysis
Membrane Type	Same as predicate device	Asymmetric microporous hollow fiber	Asymmetric microporous hollow fiber
Chemical Composition of Membrane	Polysulfone 90-99% by weight, Polyvinylpyrrolidone 1-10% by weight (same range as predicate)	Polysulfone 90-99% by weight, Polyvinylpyrrolidone 1-10% by weight	Polysulfone 90-99% by weight, Polyvinylpyrrolidone 1-10% by weight
Effective Membrane Surface Area (m^2)	Within acceptable range/comparable to predicate models	1.3, 1.6, 1.9	1.2, 1.5, 1.8, 2.0
Number of Fibers (mean)	Within acceptable range/comparable to predicate models	8800 (13H), 10840 (16H), 12870 (19H)	8180 (12), 10150 (15), 12250 (18), 13310 (20)
Mean effective (free) length of fibers (mm)	Same as predicate device	235	235
Fiber inner diameter (nominal) in µm	Same as predicate device	200	200
Wall thickness (nominal)	Comparable to predicate, with justification for difference	37 µm (separation layer: 1 µm, support layer: 36 µm)	40 µm (separation layer: 1 µm, support layer: 39 µm) - Note: A difference acknowledged and justified.
Sterilization	Same as predicate device	Gamma	Gamma
Volume, blood compartment (mL)	Within acceptable range/comparable to predicate models	82 (13H), 100 (16H), 120 (19H)	68 (12), 90 (15), 110 (18), 121 (20)
Outer diameter cylindrical part (mm)	Within acceptable range/comparable to predicate models	39.6 (13H), 42.6 (16H), 47.6 (19H)	39.6 (12), 42.6 (15), 47.6 (18, 20)
Outer diameter (mm) blood cap	Within acceptable range/comparable to predicate models	54.0 (13H), 57.4 (16H), 62.4 (19H)	54.0 (12), 57.4 (15), 62.4 (18, 20)
Length without protection cap (mm)	Similar to predicate device	294.0 (13H), 294.6 (16H, 19H)	293 (all models) - Note: A slight difference acknowledged.
Connector blood side	Designed According to ISO 8637	Designed According to ISO 8637	Designed According to ISO 8637
Connector dialysate fluid side	Designed According to ISO 8637	Designed According to ISO 8637	Designed According to ISO 8637
Functional/Performance Testing Results	Performed similarly to predicate device; within acceptable safety and effectiveness parameters.	Testing demonstrated similar performance to the predicate device and safe/effective use (details not quantified in this summary, but studies were conducted).	Established performance in accordance with FDA guidance and ISO 8637.

2. Sample size used for the test set and the data provenance

The document mentions "functional and performance testing" and "comparative testing" on "the proposed Diacap Pro dialyzers" and "the proposed and predicate device." It also states "The following in-vitro testing was performed on the proposed device..." and "The following comparative testing was performed on the proposed and predicate device..." and "The following clinical testing was performed on the proposed device..."

However, specific sample sizes for these tests (e.g., number of dialyzers tested for each model) are not explicitly provided in this 510(k) summary. The summary refers to the methods in FDA Guidance and ISO 8637, implying that standard testing protocols were followed, which would include appropriate sample sizes.

Data provenance: Not specified, but likely laboratory testing conducted by the manufacturer or a contracted lab. This is not retrospective or prospective patient data in the context of an AI/ML study, but rather in vitro and in vivo (clinical) testing of the physical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This concept is not applicable here as this is not an AI/ML device study. Performance is assessed through physical and chemical measurements (e.g., ultrafiltration rate, clearances, pressure drops, hemolysis) and clinical testing, not human expert interpretation of an AI output.

4. Adjudication method for the test set

Not applicable as this is not an AI/ML device study requiring expert adjudication of results.

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

Not applicable. No AI component is described in this device.

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

Not applicable. No AI component is described in this device.

7. The type of ground truth used

For the functional and performance testing, the "ground truth" would be the:

Physical measurements and chemical analyses: e.g., precisely measured ultrafiltration rates, clearance values, pressure drops, and assessment of hemolysis, according to established scientific and engineering standards (e.g., ISO 8637).
Clinical data: for in-vivo ultrafiltration coefficient.

This is fundamentally different from a human-labeled ground truth for an AI/ML algorithm.

8. The sample size for the training set

Not applicable. As this is not an AI/ML device, there is no "training set." The device is physically manufactured, not trained.

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

Not applicable. No AI/ML training set.

Summary

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Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of three faces in profile, stacked on top of each other.

Re:

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

August 11, 2017

B. Braun Avitum AG % Tracv Maddock Sr. Regulatory Affairs Specialist B. Braun Medical, Inc. 901 Marcon Boulevard Allentown, PA 18109

K170574 Trade/Device Name: Diacap Pro Dialyzer Regulation Number: 21 CFR§ 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: II Product Code: KDI Dated: February 24, 2017 Received: February 27, 2017

Dear Tracy Maddock:

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.

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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 devicerelated 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Joyce M. Whang-S

Benjamin R. Fisher, Ph.D. for 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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K170574

Device Name

Diacan Pro Dialyzer

Indications for Use (Describe)

The Diacap Pro Dialyzer is designed for single use in acute and chronic hemodialysis.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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1. 510(k) SUMMARY	K170574
APPLICANT:	B. Braun Avitum AGSchwarzenberger Weg 73-7934212 Melsungen, GermanyEstablishment Registration Number: 3002879653
SUBMITTER:	B. Braun Medical Inc.901 Marcon BoulevardAllentown, PA 18109-9341610-266-0500
CONTACT:	Tracy MaddockSr. Regulatory Affairs SpecialistPhone: (610) 596-2545Fax: (610) 266-4962E-mail: tracy.maddock@bbraun.com
DATE	August 11, 2017
DEVICE NAME:	Diacap Pro DialyzerModels: Diacap Pro 13H, Diacap Pro 16H,Diacap Pro 19H
COMMON ORUSUAL NAME:	High Permeability polysulfone high flux dialyzer
DEVICECLASSIFICATION:	Class II per 21 CFR § 876.5860, Dialyzer, High PermeabilityWith or Without Sealed Dialysate SystemProduct Code: KDIClassification Panel: Gastroenterology/Urology
PREDICATE DEVICE:	Diacap HI PS (10, 12, 15, 18, 20) Hemodialyzers, (K071518)

DESCRIPTION:

INDICATIONS FOR USE:

The Diacap Pro Dialyzer is designed for single use in acute and chronic hemodialysis.

SUBSTANTIAL EQUIVALENCE:

The Diacap Pro dialyzer is substantially equivalent to the Diacap HIPS dialyzer (K071518).

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Comparison of Technological Characteristics with the Predicate Device

The proposed device has the same indications for use (for single use in acute and chronic hemodialysis) and the same principle of operation as the predicate device. The proposed device is similar in design with respect to components and materials of construction. Both devices are provided as sterile, nonpyrogenic, individually packaged devices.

A table summarizing the comparison between the Diacap Pro Dialyzer and the predicate device is provided below.

	Proposed DeviceB. Braun Avitum AGDiacap Pro Dialyzer			Predicate DeviceB. Braun Avitum AGDiacap HI PS Dialyzers(K071518)
Dialyzer model	13H	16H	19H	12	15	18	20
Indications for use	Designed for single use in acute andchronic hemodialysis			Designed for single use in acute andchronic hemodialysis
Membrane Type	Asymmetric microporous hollowfiber			Asymmetric microporous hollow fiber
Chemicalcomposition ofmembrane	Polysulfone 90-99% by weight,Polyvinylpyrrolidone 1-10% byweight			Polysulfone 90-99% by weight,Polyvinylpyrrolidone 1-10% by weight
Effectivemembrane surfacearea (m2)	1.3	1.6	1.9	1.2	1.5	1.8	2.0
Number of fibers(mean)	8800	10840	12870	8180	10150	12250	13310
Mean effective(free) length offibers (mm)	235			235
Fiber innerdiameter (nominal)in µm	200			200
Wall thickness(nominal)	37 µm with 2 layers:separation layer: 1 µm thicknesssupport layer: 36 µm thickness			40 µm with 2 layers:separation layer: 1 µm thicknesssupport layer: 39 µm thickness
Sterilization	Gamma			Gamma
Volume, bloodcompartment (mL)	82	100	120	68	90	110	121
Outer diametercylindrical part(mm)	39.6	42.6	47.6	39.6	42.6	47.6	47.6
Outer diameter(mm) blood cap	54.0	57.4	62.4	54.0	57.4	62.4	62.4
Length withoutprotection cap(mm)	294.0	294.6	294.6	293	293	293	293
Connector bloodside	Designed According to ISO 8637			Designed According to ISO 8637
Connectordialysate fluid side	Designed According to ISO 8637			Designed According to ISO 8637

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The differences between the predicate device and the proposed device include:

Alternative suppliers for PVP and PSU in addition to a new material supplier for A potting and silicone rubber
Color change of blood port caps and protective caps A
Change in design characteristics of the membrane including new packaging density ( new surface areas), change in the wall thickness and change to the fiber microondulation.

The differences, between proposed device and predicate device, do not raise any new issues of safety and effectiveness

Performance Testing

The proposed Diacap Pro dialyzers were subjected to functional and performance testing to assess the effects of the modified characteristics and to demonstrate equivalence with the predicate devices.

The following in-vitro testing was performed on the proposed device in accordance with the methods listed in the FDA Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers and in ISO 8637.

ultrafiltration rate
pressure drop blood side and dialysate side ●
clearances of urea, creatinine and vitamin B12 ●

The following comparative testing was performed on the proposed and predicate device:

. mechanical hemolysis
The following clinical testing was performed on the proposed device in accordance with the methods listed in the FDA Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers:
in-vivo ultrafiltration coefficient
Results of the testing demonstrate that the proposed device performs similarly to the predicate device and can be used safely and effectively according to its intended use.

CONCLUSION:

Results of functional and performance testing conducted on the proposed device demonstrate that the Diacap Pro dialyzers are substantially equivalent to the predicate device.

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.”