The intended use of the device is to provide hemodialysis treatments in the acute and chronic setting, including high flux hemodialysis.
The device is intended to be used by trained operators when prescribed by a physician.
The device is intended to be use in conjunction with a hollow fiber or parallel plate dialyzer.

Indications for Use of the Hematocrit and Blood Volume Monitor Option:
The intended use of this device is to monitor Hematocrit. Percent Blood Volume Change, Oxygen Saturation value, and Access Recirculation.

The device is intended to be used as an integrated option of the System 1000 Dialysis Delivery System.
The device is intended to be used by trained operators when prescribed by a physician.
The device is intended to be used in conjunction with the Crit-Line disposable Blood Chamber. The Blood Chamber is a non reusable device.
To provide the medical professional with a means of monitoring Hematocrit. Percent Blood Volume Change, Oxygen Saturation value, and Access Recirculation during hemodialysis treatment.

Device Description

The System 1000® and AltraTouch™ 1000 devices are Single Patient Dialysis Delivery Systems for hemodialysis. The systems fulfill the following functions:

Mixes concentrate with water in the appropriate proportions to produce dialysate .
Delivers dialysate at the appropriate temperature and ionic concentration to the . dialyzer,
Removes the appropriate amount of liquid from the patient's blood .
. Along with the dialyzer and blood pump acts as a total artificial kidney.
The following option is the subject of this submission that will be implemented Note: with FDA approval.

The System 1000® and AltraTouch™ 1000 Dialysis Delivery System with HCT/BV Monitor, integrates two 510(k) approved devices into one device. [System 1000%/ AltraTouch™ 1000 Dialysis Delivery System: K910215, K954987 and K955384; andCrit-Line Instrument: K924167, K950842 and K953875] This device provides the care giver with the option to monitor hematocrit, percent blood volume change, oxygen saturation value and access recirculation. The HCT/BV Monitor uses a light emitter/light detector sensor connected to a sterile disposable Blood Chamber (Crit-Line™ Blood Chamber: K924167 and K935958) in the extracorporeal blood circuit. The sensor detects various absorption and scattering characteristics exhibited by the blood. Data from the intergraded HCT/BV Monitor are communicated to the host System 1000@/AltraTouch™ 1000 machine via the serial communication port (RS232) and displayed on CRT/LCD screen of the System 1000@/AltraTouch™ 1000 machine.

The HCT/BV Monitor option alerts the operator with audible and visual alarms if the patient's hematocrit is equal or exceeds the operator set hematocrit alarm limit or if the patient's blood volume is equal or lower than the operator set blood volume alarm limit.

AI/ML Overview

The provided text is a 510(k) summary for the Drake Willock® System 1000® AltraTouch™ 1000 Dialysis Delivery System with a Hematocrit and Blood Volume Monitor Option.

This document does not contain the acceptance criteria or a detailed study report with specific performance metrics, sample sizes, expert qualifications, or ground truth establishment methods for a device's performance. Instead, it describes a modification to an existing device, integrating a previously 510(k) cleared monitoring technology (Crit-Line™ II) into a dialysis delivery system. The primary claim for regulatory approval is substantial equivalence to the predicate devices.

Therefore, I cannot populate the requested table and answer the study-related questions directly from the provided text. The document focuses on the technological characteristics of the integrated device and its intended use in comparison to the predicate devices, rather than presenting a de novo performance study against defined acceptance criteria.

Key points from the document regarding the HCT/BV Monitor Option:

Modification: The HCT/BV Monitor feature is an integration of the stand-alone Crit-Line™ II Instrument into the System 1000®/AltraTouch™ 1000 dialysis delivery system.
Identical Circuit Design: The HCT/BV Monitor printed circuit board (PCB) has the identical circuit design as the Crit-Line II™ Instrument PCB.
Identical Blood Chamber: The Blood Chamber is the same as the Crit-Line™ Blood Chamber.
Substantial Equivalence: Althin Medical, Inc. asserts that the design and testing of this modified system demonstrate it is safe and effective, implying substantial equivalence based on the predicate devices and the identical nature of the integrated components' core technology.

Absence of requested information:

Acceptance Criteria/Reported Performance Table: No such table is present. The document focuses on the equivalence of the integrated components to previously cleared devices.
Sample Size (Test Set) & Data Provenance: Not specified for a de novo performance study. The approval is based on substantial equivalence to predicate devices, which would have had their own performance data.
Number of Experts & Qualifications: Not applicable as no new ground truth establishment study is described.
Adjudication Method: Not applicable.
MRMC Comparative Effectiveness Study: Not mentioned.
Standalone Performance Study: Covered by the predicate Crit-Line™ II Instrument's original 510(k) clearances, which are referenced. The current submission focuses on the integration not a new standalone performance of the core monitoring technology.
Type of Ground Truth: Not specified in this document for the integrated component, but would have been part of the predicate device's clearance.
Sample Size (Training Set): Not applicable for this type of 510(k) a new algorithm training is not descriebd.
Ground Truth (Training Set) Establishment: Not applicable.

In summary, the provided document is a 510(k) summary for a device modification based on the principle of substantial equivalence. It leverages the prior clearances of its components rather than presenting new, detailed performance study data against specific acceptance criteria.

Summary

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510(k) SUMMARY

Date:

January 28, 1997

Name:

Althin Medical Inc. Drake Willock® dialysis equipment

Address:

13520 S.E. Pheasant Court Portland, Oregon 97222-1298 Phone Number: 503-659-3355 Fax Number: 503-652-0225 Contact person: Thomas D. Kelly

Trade Names:

Drake Willock® System 1000® Dialysis Delivery System with Hematocrit and Blood Volume Monitor Option

AltraTouch™ 1000 Dialysis Delivery System with Hematocrit and Blood Volume Monitor Option

Common Name:

Dialysis Delivery System

Classification Name:

Hemodialysis System and accessories, Class III Device.

Product code:

78KDI

Equivalence Information:

The Hematocrit and Blood Volume (HCT/BV) Monitor feature is a modification to the predicate System 10000/AltraTouch™ 1000 dialysis delivery system [510(k) numbers K910215 System 1000® Dialysis Delivery System, K954987 AltraTouch™ 1000 machine and K955384 SND option.] that integrates the stand-alone Crit-Line™ II Instrument for measuring hematocrit (Hct), percent blood volume change (ABV), oxygen saturation (O2 Sat) and access recirculation [510(k) numbers K924167 Crit-Line I with Blood Chamber, K935958 Blood Chamber with E-Beam, K950942 Crit-Line II with Hematocrit Alarm feature and K953875 Crit-Line II with Access Recirculation feature.] into the dialysis delivery system.

The primary reason for making the modification is to provide the medical professional with a means of monitoring patient hematocrit, percent blood volume change, oxygen saturation values and access recirculation together with treatment data from the System 1000@/AltraTouch™ 1000 machine during acute and chronic hemodialysis.

The HCT/BV Monitor printed circuit board (PCB) has the identical circuit design as the Crit-Line ITM Instrument PCB. The board has been laid out to fit in the System 1000@/ AltraTouch™ 1000 mother board circuit card cage. The integrated HCT/BV Monitor PCB will utilize the user interface and display of the System 10000/AltraTouch™ 1000 Dialysis Delivery Systems. The integrated HCT/BV PCB will utilize the internal power

JUN - 2 199

970446

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K970446

supply of the System 1000®/AltraTouch™ 1000 machine instead of batteries or external power supplies as the stand-alone Crit-Line™ Instrument (predicate device) (loes.

The Blood Chamber is the same as the Crit-Line™ Blood Chamber. The label has been modified to include the Althin name for business reasons. In-Line Diagnostics will manufacture the blood chamber for Althin Medical Inc. under the name AltraCrit™ Blood Chamber.

This submission also details an external communication software package ca 1 the "FIC.T/ B V Monitor Print Utility" to transfer hematocrit (Hct), percent blood volume change (ABV), oxygen saturation (O2 Sat) and access recirculation data in an ASCII file from the host System 10000/AltraTouch™ 1000 delivery system to a standard PC cornputer disk. The Print Utility serves the identical purpose as the Procomm® software communication package currently utilized by Crit-Line II™ Instrument.

Althin Medical, Inc. believes that the design and testing of this modified System 1000(@/ AltraTouch™ 1000 Dialysis Delivery System demonstrates that it is safe and effective.

Pages of this 510(k) that refer to the new HCT/BV option are marked with star (★) in the right hand margin.

Device Description:

The System 1000® and AltraTouch™ 1000 devices are Single Patient Dialysis Delivery Systems for hemodialysis. The systems fulfill the following functions:

Mixes concentrate with water in the appropriate proportions to produce dialysate .
Delivers dialysate at the appropriate temperature and ionic concentration to the . dialyzer,
Removes the appropriate amount of liquid from the patient's blood .
. Along with the dialyzer and blood pump acts as a total artificial kidney.
The following option is the subject of this submission that will be implemented Note: with FDA approval.

Intended Use

Intended use of the System 1000®/AltraTouch™ 1000 Delivery System

The intended use of the device is to provide hemodialysis treatments in the acute and chronic setting including high flux hemodialysis.

The device is intended to be used by trained operators when prescribed by a ● physician.
The device is intended to be used in conjunction with a hollow fiber or parallel plate . dialyzer.

Intended use of the stand-alone Crit-Line™ Instrument

The intended use of the device is to determine hematocrit, percent blood volume change, oxygen saturation and access recirculation values by attaching the Crit-Line™ Sensor to a

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K970446

Crit-Line™ Blood Chamber that has been inserted into the patient's extracorporeal blood tubing.

Intended use of the System 1000®/AltraTouch™ 1000 Delivery System with the HCT/ BV Monitor option

The intended use of the device is to provide hemodialysis treatments in the acute and chronic setting including high flux hemodialysis.

The device is intended to be used by trained operators when prescribed by a . physician.
. The device is intended to be used in conjunction with a hollow fiber or parallel plate dialyzer.
. The HCT/BV Monitor option is intended to be used when hematocrit, blood volume, oxygen saturation monitoring and access recirculation determination are chosen for use in chronic or acute hemodialysis treatments.

Technological Characteristics

Althin Medical is integrating a technology invented by In-Line Diagnostics to measure hematocrit (Hct), percent blood volume change (ABV), oxygen saturation (O2 Sat) and access recirculation. Crit-Line™ is the trade name for this technology. The technology is based on the absorption characteristics of blood at three different wavelengths. Components of this technology are a sensor clip, a disposable (blood chamber), and an electronics assembly. This technology was integrated into the System 100000/ AltraTouch™ 1000 dialysis delivery system. This technology will be offered as an option to new equipment as well as a retrofit kit.

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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 features a stylized image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The logo is black and white.

家 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K970446 Mr. Thomas D. Kelly Drake Willock® System 1000® and AltraTouch™ Senior Manager of Marketing and Regulatory Affairs 1000 Dialysis Delivery Systems with Hematocrit Althin Medical, Inc. and Blood Volume Option JUN - 2 1997 13520 S.E. Pheasant Court Dated: May 14, 1997 Received: May 16, 1997 Portland, Oregon 97222-1298 Regulatory class: III and II 21 CFR §876.5860/Product code: 78 KDI 21 CFR §876.5820/Product code: 78 MQS

21 CFR §864.6400/Product code: 81 JPI

Dear Mr. Kelly:

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 devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Ameridanents, 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 Eederal 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), please contact the Office of Compliance at (301) 594-4616. 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/dsmamain.html".

Sincerely yours,

Lillian, Xia, Ph.D.

Lilian Yin, Ph.D. 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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510(k) Number (if known):

Drake Willock® System 1000® Dialysis Delivery System Device Name: AltraTouch™ 1000 Dialysis Delivery System . . . . . . . with Hematocrit and Blood Volume Option

Indications For Use:

STHE Studies I

Indications for Use of the System 1000®

The intended use of the device is to provide hemodialysis treatments . in the acute and chronic setting, including high flux hemodialysis.
The device is intended to be used by trained operators when . prescribed by a physician.
The device is intended to be use in conjunction with a hollow fiber or . parallel plate dialvzer.

Indications for Use of the Hematocrit and Blood Volume Monitor Option

The intended use of this device is to monitor Hematocrit. Percent Blood Volume Change, Oxygen Saturation value, and Access Recirculation.

The device is intended to be used as an integrated option of the . System 1000 Dialysis Delivery System.
The device is intended to be used by trained operators when . prescribed by a physician.
The device is intended to be used in conjunction with the Crit-Line . disposable Blood Chamber. The Blood Chamber is a non reusable device.
To provide the medical professional with a means of monitoring ● Hematocrit. Percent Blood Volume Change, Oxygen Saturation value, and Access Recirculation during hemodialysis treatment.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use		OR		Over-The-Counter Use
(Per 21 CFR 801.109)			(Optional Format 1-2-96)

Robert R. Rathbun/

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT,

and Radiological Devices

510(k) Number K970446

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.”