Intended to relieve or mitigate overhydration in patients undergoing cardiopulmonary procedures and to increase the concentration of cells and proteins in the blood.

Device Description

The Low Volume Hemoconcentrator is similar to the F Series F400 Hemoconcentrator. Both hemoconcentrators are hollow fiber-type filters and will be provided with and without a tubing set. The Low Volume Hemoconcentrator has an active membrane surface area of 0.35M2 and a priming volume of 27 ml.

AI/ML Overview

The provided text describes a 510(k) submission for a device modification, specifically the Fresenius F Series Low Volume Hemoconcentrator. This document is a regulatory submission for a medical device whose performance is characterized by physical specifications and in-vitro performance rather than clinical outcomes or diagnostic accuracy. Therefore, many standard AI/ML evaluation metrics like sensitivity, specificity, or AUC, and ground truth establishment methods typically associated with clinical studies, are not applicable here.

The "acceptance criteria" and "device performance" are presented as a comparison table between the modified device and its predicate device, demonstrating that the new device meets the necessary physical and performance characteristics to be considered substantially equivalent.

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

The acceptance criteria for this device are implicitly defined by its substantial equivalence to the predicate device (F400 Hemoconcentrator, K974584), meaning its specifications and performance characteristics must be comparable or within acceptable ranges relative to the predicate. The reported device performance for the new "Low Volume Hemoconcentrator" is shown in the table below, alongside the predicate device's data for comparison.

Product Specifications	Acceptance Criteria (Predicate F400 Hemoconcentrator)	Reported Device Performance (Low Volume Hemoconcentrator)	Met?
Indication for Use	Intended to relieve or mitigate overhydration in patients undergoing cardiopulmonary procedures and to increase the concentration of cells and proteins in the blood.	Intended to relieve or mitigate overhydration in patients undergoing cardiopulmonary procedures and to increase the concentration of cells and proteins in the blood.	Yes
Active Membrane Surface (M²)	0.7	0.35	N/A
Priming Volume (ml)	42	27	N/A
Unit Length (with endcaps) (cm)	33	33	Yes
Unit Inner Diameter (cm)	2.8	2.8	Yes
Number of Fibers	4,600	2530	N/A
Fiber Lumen Diameter (µm)	200	200	Yes
Fiber Wall Diameter (µm)	40	40	Yes
Fiber Length (cm)	22.5	22.5	Yes
Fiber Membrane Material	Fresenius Polysulfone	Fresenius Polysulfone	Yes
Housing Material	Polycarbonate	Polycarbonate	Yes
Potting (resin) Material	Polyurethane	Polyurethane	Yes
End Cap	Screw-type, silicone O-ring	Screw-type, silicone O-ring	Yes
Blood Connector	Luer connector	Luer connector	Yes
Ultrafiltrate Connector (cm, inch)	6.35, ¼	6.35, ¼	Yes
Sterilization	EtO	EtO	Yes
Pyrogenicity	Non-pyrogenic (LAL assay)	Non-pyrogenic (LAL assay)	Yes
Glycerol rinse required	No	No	Yes
Molecular Weight Cutoff (daltons)	Approx. 65,000	Approx. 65,000	Yes
Max. Transmembrane Pressure (mmHg)	600	600	Yes
Max. Blood Flow (ml/min)	500	300	N/A
Pressure Drop (mmHg) at QB = 100 ml/min	32.50	80.00	N/A
Pressure Drop (mmHg) at QB = 200 ml/min	85.00	172.50	N/A
Pressure Drop (mmHg) at QB = 300 ml/min	116.25	270.00	N/A
Ultrafiltration Rate (ml/min) at TMP=525, QB = 100 ml/min	54.0	46.0	N/A
Ultrafiltration Rate (ml/min) at TMP=525, QB = 200 ml/min	84.0	68.0	N/A
Ultrafiltration Rate (ml/min) at TMP=525, QB = 300 ml/min	106.5	84.7	N/A

Note: For parameters like Active Membrane Surface, Priming Volume, Number of Fibers, Max. Blood Flow, Pressure Drop, and Ultrafiltration Rate, changes are expected due to the "Low Volume" nature of the device modification. The "Met?" column indicates whether the new device's characteristic is identical to the predicate (Yes) or if it's a designed difference due to the modification (N/A – meaning it's not expected to be identical but aligns with the intended modification and is presumed acceptable by the FDA for substantial equivalence).

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

The document does not detail specific "test set" sample sizes in the context of clinical or performance data collection on multiple units. The data presented is for the design specifications and nominal performance characteristics of the device itself.

Sample Size: Not explicitly stated as this is a device modification submission based on technical specifications and in-vitro performance, not a clinical trial. The performance characteristics (e.g., pressure drop, ultrafiltration rate) are likely derived from bench testing or engineering calculations based on the design, rather than a "test set" of many devices.
Data Provenance: Not specified, but generally, such technical specifications and in-vitro test data would be generated within the manufacturing and R&D facilities of Fresenius Hemotechnology Inc. (location: Concord, CA). The data is not derived from human subjects, thus "retrospective or prospective" is not applicable in the typical clinical sense.

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 to this type of device submission. There is no "ground truth" established by experts in the sense of clinical diagnoses or interpretations for this mechanical device. The "truth" lies in the engineering specifications and in-vitro performance data, which are verified through standard engineering and laboratory testing protocols.

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

Not applicable. This is not a study involving human interpretation or clinical adjudication.

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 device is a hemoconcentrator, not an AI/ML-enabled diagnostic or therapeutic device that would involve human readers or AI assistance.

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

Not applicable. This device is a physical medical device, not an algorithm or software.

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

The "ground truth" for this device modification is the verified engineering specifications, material properties, and in-vitro performance measurements (e.g., pressure drop, ultrafiltration rates) obtained through standardized laboratory testing and quality control processes. This is analogous to "bench testing" or "design verification" rather than clinical "ground truth."

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."

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

Not applicable, as there is no training set for this device.

Summary

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K99 2275 p.1/2

SPECIAL 510(k): DEVICE MODIFICATION FRESENIUS F SERIES HEMOCONCENTRATOR

510(k) Summary for the Fresenius Modified F400 and F400TS (Low Volume) Hemoconcentrators

Submitter's Name and Address:	Fresenius Hemotechnology Inc.110 Mason Circle Suite AConcord, CA 94520
Phone Number:	(800) 909-3872
Telefax Number:	(925) 688-0990
Contact Person:	Virginia Singer, Manager Regulatory Affairs andQuality Assurance
Date Summary Prepared:	June 21, 1999
Device Trade Name:	Fresenius F Series Low Volume Hemoconcentrator
Common name:	Hemoconcentrator
Classification Name:	High Permeability Hemodialysis System (21 CFR876.5860)
Substantial Equivalence:	The proposed device is substantially equivalent tothe Fresenius F Series F400 Hemoconcentrator
Device Description:	The Low Volume Hemoconcentrator is similar to theF Series F400 Hemoconcentrator. Bothhemoconcentrators are hollow fiber-type filters andwill be provided with and without a tubing set. TheLow Volume Hemoconcentrator has an activemembrane surface area of 0.35M2 and a primingvolume of 27 ml.
Intended Use:	Intended to relieve or mitigate overhydration inpatients undergoing cardiopulmonary proceduresand to increase the concentration of cells andproteins in the blood.
Technological Characteristics:	The proposed device has the same technologicalcharacteristics and is similar in design andconfigurations compared with the predicate device(See table on next page).

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K992275 p 2/2

Product Specifications	Low VolumeHemoconcentrator(This submission)	F400 Hemoconcentrator(K974584)
Indication for Use	Intended to relieve or mitigateoverhydration in patientsundergoing cardiopulmonaryprocedures and to increasethe concentration of cells andproteins in the blood.	Intended to relieve ormitigate overhydration inpatients undergoingcardiopulmonary proceduresand to increase theconcentration of cells andproteins in the blood.
Active Membrane Surface (M²)	0.35	0.7
Priming Volume (ml)	27	42
Unit Length (with endcaps) (cm)	33	33
Unit Inner Diameter (cm)	2.8	2.8
Number of Fibers	2530	4,600
Fiber Lumen Diameter (µm)	200	200
Fiber Wall Diameter (µm)	40	40
Fiber Length (cm)	22.5	22.5
Fiber Membrane Material	Fresenius Polysulfone	Fresenius Polysulfone
Housing Material	Polycarbonate	Polycarbonate
Potting (resin) Material	Polyurethane	Polyurethane
End Cap	Screw-type, silicone O-ring	Screw-type, silicone O-ring
Blood Connector	Luer connector	Luer connector
Ultrafiltrate Connector (cm, inch)	6.35, ¼	6.35, ¼
Sterilization	EtO	EtO
Pyrogenicity	Non-pyrogenic (LAL assay)	Non-pyrogenic (LAL assay)
Glycerol rinse required	No	No
Molecular Weight Cutoff (daltons)	Approx. 65,000	Approx. 65,000
Max. Transmembrane Pressure (mmHg)	600	600
Max. Blood Flow (ml/min)	300	500
Pressure Drop (mmHg)*
Nominal, QB = 100 ml/min	80.00	32.50
Nominal, QB = 200 ml/min	172.50	85.00
Nominal, QB = 300 ml/min	270.00	116.25
Ultrafiltration Rate (ml/min)
Nominal, TMP=525, QB = 100 ml/min	46.0	54.0
Nominal, TMP=525, QB = 200 ml/min	68.0	84.0
Nominal, TMP=525, QB = 300 ml/min	84.7	106.5**

Substantial Equivalence Comparison Chart Low Volume Hemoconcentrator vs. Predicate F400 Hemoconcentrator

*Pressure Drop and Ultrafiltration Rate will vary according to blood flow rate, transmembrane pressure, temperature, hematocrit and protein concentration.

** Data not previously reported in K974584

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 4 1999

Ms. Virginia Singer Manager, Regulatory Affairs and Quality Assurance Fresenius Hemotechnology Inc. 110 Mason Circle, Suite A Concord, CA 94520-1238

Re: K992275 Fresenius F Series Low Volume Hemoconcentrator Dated: June 30, 1999 Received: July 7, 1999 Regulatory Class: III 21 CFR §876.5860/Procode: 78 KDI

Dear Ms. Singer:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), piease contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

Page 1 of 1

510(k) Number ( if known):

Fresenius F Series Modified F400 and F400TS (Low Volume) Hemoconcentrators Device Name:

The Fresenius F Series Hemoconcentrators are indicated to relieve or mitigate Indications for Use: overhydration in patients undergoing cardiopulmonary procedures and to increase the concentration of cells and proteins in the blood.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Ewind le. Segman
OR

Over-The-Counter Use_

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number .

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.”