The Diacap LO PS (10, 12 and 15) and Diacap HI PS (10, 12, 15, 18 and 20) are, respectively, conventional permeability and high permeability hemodialyzers. The hollow, polysulfone membrane is housed within a plastic cylinder with four ports: two ports for blood compartment access and two ports for dialysate access.

AI/ML Overview

The provided text is a 510(k) summary for the B. Braun Medizintechnologie G.m.b.H. Diacap LO PS and HI PS Hemodialyzers. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include detailed acceptance criteria or a study that specifically addresses device performance against stated acceptance criteria in the way typically expected for an AI/ML device where performance metrics (e.g., sensitivity, specificity, AUC) are calculated.

This document describes a medical device (hemodialyzers), not an AI/ML system. Therefore, the questions related to AI/ML device performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment in that context are not applicable.

Instead, the performance evaluation for these hemodialyzers focused on bench and clinical testing to demonstrate performance and safety, primarily in comparison to a predicate device.

Here's how to interpret the available information:

1. Table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative table with thresholds. Instead, it states that the device's performance was evaluated against "expected values" and through "comparison with the predicate device".

Performance Aspect	Reported Device Performance	Basis for Evaluation (Implicit "Acceptance Criteria")
Ultrafiltration coefficients	"consistent with expected values"	Consistency with established physiological parameters and performance of predicate device.
Clearances (urea, creatinine, phosphate, vitamin B12)	"consistent with expected values"	Consistency with established physiological parameters and performance of predicate device.
Hemocompatibility (white cell and platelet counts)	"confirmed"	White cell and platelet counts within acceptable ranges for hemodialysis and comparable to predicate device.
Hemocompatibility (complement activation - C3a)	"evaluated" (implied as acceptable)	C3a levels within acceptable ranges for hemodialysis and comparable to predicate device.
Hemocompatibility (intrinsic and extrinsic coagulation system - TAT, thrombocyte activation)	"evaluated" (implied as acceptable)	TAT and thrombocyte activation within acceptable ranges for hemodialysis and comparable to predicate device.
Hemocompatibility (cell activation - thrombocyte and/or leukocyte adhesion and leukocyte activation)	"evaluated" (implied as acceptable)	Cell activation within acceptable ranges for hemodialysis and comparable to predicate device.

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

Sample size: Not specified. The document mentions "clinical testing" but does not detail the number of subjects or samples.
Data provenance: Not specified.

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

This information is not applicable and not provided. Performance evaluation for hemodialyzers does not typically involve "experts establishing ground truth" in the way an AI/ML diagnostic device would. Performance is assessed through direct measurement of physical and physiological parameters.

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

Not applicable and not provided.

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. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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

The "ground truth," in the context of a hemodialyzer, would be the direct measurement of its physical properties (e.g., surface area, membrane characteristics) and its performance in clearing solutes and removing fluid in bench and clinical settings, as well as the physiological response of patients (e.g., blood cell counts, inflammatory markers). It's based on direct measurement and observed physiological effects rather than expert consensus on diagnostic images or pathology.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device and thus does not have a "training set" in that sense.

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

Not applicable. This is not an AI/ML device.

Summary

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Ko71518p4 or 3

B. Braun Medizintechnologie G.m.b.H.

510(k) Notification Diacap LO PS and HI PS Hemodialyzers

510(k) SUMMARY in accordance with 21 CFR 807.92(c)

AUG 1 7 2007

1. Owner:	B. Braun MedizintechnologieSchwarzenberger Weg 73-7934212 Melsungen, Germany
Contact:	Ms. Susan OlingerCorporate Vice President, Regulatory AffairsB. Braun Medical Inc.901 Marcon BoulevardAllentown, PA 18109Telephone: (610) 596-2517Fax: (610) 266 4962Email: susan.olinger@bbraun.com

Date of Preparation: May 31, 2007

2. Device Classification:

		Conventional	High Permeability
1.	Common or Usual Name	Polysulfone Hemodialyzer	Polysulfone Hemodialyzer
2.	Trade Name	Diacap LO PS 10Diacap LO PS 12Diacap LO PS 15	Diacap HI PS 10Diacap HI PS 12Diacap HI PS 15Diacap HI PS 18Diacap HI PS 20
3.	Classification Name	Hemodialysis system andaccessories	High permeabilityhemodialysis system
4.	Regulation Number	21 CFR §876.5820	21 CFR §876.5860
5.	Class	II	II
6.	Classification ProductCode	FJI	KDI
7.	Classification Panel	Gastroenterology/Urology	Gastroenterology/Urology
8.	Prescription Status	Prescription device asdescribed in 21 CFR§801.109	Prescription device asdescribed in 21 CFR§801.109

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Diacap Models		Fresenius Models510(k) number K970700
Trade Name	Surface Area m2	Trade Name	Surface Area m2
Low Flux Models (Conventional)
LO PS 10	1.0 m2	Hemoflow F5	1.0 m2
LO PS 12	1.2 m2	Hemoflow F6	1.3 m2
LO PS 15	1.5 m2	Hemoflow F7	1.6 m2
		Hemoflow F8	1.8 m2
High Flux Models
HI PS 10	1.0 m2	Hemoflow F 50 NR	1.0 m2
HI PS 12	1.2 m2	Hemoflow F 60 A	1.3 m2
		Hemoflow F 60 B
HI PS 15	1.5 m2	Hemoflow F 70 A	1.6 m2
		Hemoflow F 70 B
		Hemoflow F 70 NR
HI PS 18	1.8 m2	Hemoflow F 80 A	1.8 m2
		Hemoflow F 80 B
HI PS 20	2.0 m2	Optiflux 200 A	2.0 m2

3. Predicate Device

4. Device Description:

5. Intended Use:

The Diacap LO PS (10, 12 and 15) and Diacap HI PS (10, 12, 15, 18 and 20) hemodialyzers are designed for single use in acute and chronic hemodialysis.

6. Substantial Equivalence Comparison:

Technical and clinical comparisons presented in the premarket notification submission are based upon the information requested in the August 7, 1998 Guidance for Industry and CDRH Reviewers, Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers, section V. The evaluation of device materials and configuration, membrane characteristics, blood volumes, sterilization methods and the results of randomized clinical studies demonstrate that the Diacap LO PS and Diacap HI PS do not raise any new issues of safety and effectiveness when compared with the predicate device.

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B. Braun Medizintechnologie G.m.b.H.

7. Performance Evaluations:

Performance and safety evaluations of Diacap LO PS (10, 12 and 15) and Diacap HI PS (10, 12, 15, 18 and 20) were based upon bench and clinical testing. Ultrafiltration coefficients and clearances of urea, creatinine, phosphate and vitamin B12 were consistent with expected values for conventional and high permeability dialyzers. Hemocompatibility was confirmed by white cell and platelet counts and the evaluation of complement activation (C3a), intrinsic and extrinsic coagulation system (TAT and thrombocyte activation) and cell activation (thrombocyte and/or leukocyte adhesion and leukocyte activation).

8. Conclusion:

The performance and safety data presented in the premarket notification support a finding of substantial equivalence between the Diacap LO PS (10, 12 and 15) and HI PS (10, 12, 15, 18 and 20) and the predicate devices already in commercial distribution in the United States.

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Image /page/3/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines extending from its head, resembling feathers or wings.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

B. Braun Medizintechnologie G.m.b.H. c/o Ms. Susan Olinger Corporate Vice President, Regulatory Affairs B. Braun Medical, Inc. (U.S.) 901 Marcon Blvd. ALLENTOWN PA 18109

K071518 Re:

Trade/Device Name: Diacap LO PS (10, 12, 15) and Diacap HI PS (10, 12, 15 18, 20) Hemodialyzers

AUG 1 7 2007

Regulation Number: 21 CFR §876.5860

Regulation Name: High permeability hemodialysis system Product Code: KDI

Regulation Number: 21 CFR §876.5820

Regulation Name: Hemodialysis system and accessories

Product Code: FJI

Regulatory Class: II

Dated: May 31, 2007 Received: June 4, 2007

Dear Ms. Olinger:

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 (Premarket Approval), 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.

Image /page/3/Picture/16 description: The image shows a circular logo for the FDA Centennial, celebrating 1906-2006. The logo features the letters "FDA" prominently in the center, with the word "Centennial" written below. Three stars are arranged beneath the word "Centennial". The entire design is encircled by text, completing the circular shape of the logo.

Protecting and Promoting Public Health

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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); 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.

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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876 xxxx 21 CFR 884.xxxx 21 CFR 892.xxxx . Other

240-276-0115 (Gastroenterology/Renal/Urology) 240-276-0115 (Obstetrics/Gynecology) 240-276-0120 (Radiology); 240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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B. Braun Medizintechnologie G.m.b.H.

510(k) Notification Diacap LO PS and HI PS Hemodialyzers

Indications for Use

510(k) Number (if known):

Device Name: Diacap LO PS (10,12,15) and Diacap HI PS (10,12,15,18,20) Hemodialyzers

Indications for Use: Diacap LO PS (10, 12, 15) and Diacap HI PS (10, 12, 15, 18, 20) Hemodialyzers are designed for single use in acute and chronic hemodialysis.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (Part 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)

Thhan

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

Page 1 of 1

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.”