(434 days)
- Indicated for treatment of the chronic or acute uremic patient where hemodialysis, including high flux dialysis, is prescribed by the physician.
- Indicated for hemodialysis in a variety of environments, to include acute care facility, chronic dialysis facility, self care facility, or home setting, where the patient has been trained and certified to be competent in the use of this device by the attending physician.
The PHD Personal Hemodialysis System is an automated high flux hemodialysis system using a double needle configuration. It is designed to perform safe and effective personal hemodialysis as prescribed by the patient's physician, while minimizing the time and effort to perform each treatment. A computer-like touch screen prompts the operator through each step of the procedure. The PHD System consists of several components that combine to deliver hemodialysis and perform ultrafiltration. These include the PHD Instrument (PHDi), the PHD Water Pre-Treatment System (WPS), the PHD Blood Tubing Set (BTS), the PHD Chemical Concentrate Bottles (CCBs), and the PHD Transducer Protector (TP). The PHD Instrument orchestrates and performs the entire pre-treatment, treatment, and post treatment cycle. It accomplishes this by working in conjunction with the WPS (or equivalent), BTS, CCBs, TP, and a commercially available hollow fiber membrane dialyzer. Between treatments, the system automatically cleans and disinfects the blood tubing set, dialyzer, and all other components in the fluid pathway. Also, the machine checks the efficiency and integrity of the dialyzer. The PHD Instrument electronically stores information about the patient, prescription, treatment schedule, and machine set-up while allowing for updates according to individual needs.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Aksys PHD® Personal Hemodialysis System:
The document is a 510(k) summary for the Aksys PHD Personal Hemodialysis System. It focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness through extensive clinical trials with predefined, quantitative acceptance criteria for device performance.
Therefore, many of the specific details requested in your prompt (like MRMC studies, sample sizes for training/test sets, expert qualifications for ground truth) are not present in this type of regulatory submission. This document highlights a predicate pathway, where the new device is compared to existing, legally marketed devices.
Let's break down what information is available:
1. Table of Acceptance Criteria and Reported Device Performance
Instead of clearly defined acceptance criteria with specific thresholds, the document states general equivalency.
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Efficacy | Substantially equivalent to conventional hemodialysis equipment | "Clinical data has shown the PHD System is substantially equivalent to conventional equipment in terms of efficacy." |
| Accuracy (Kt/V) | Substantially equivalent to conventional hemodialysis equipment | "Parameters used to establish the substantial equivalence of the PHD clinical study were accuracy of delivered Kt/V..." |
| Accuracy (Ultrafiltration) | Substantially equivalent to conventional hemodialysis equipment | "...accuracy of ultrafiltration..." |
| Safety / Adverse Events | Comparable incidence of adverse events to conventional hemodialysis equipment | "...and incidence of adverse events." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Twenty-three (23) patients
- Data Provenance: The document does not specify the country of origin. It indicates data was collected from "3 sites." It is a prospective study as it's described as a "clinical study" designed to "establish the substantial equivalence."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the 510(k) summary. Given the nature of hemodialysis output (Kt/V, ultrafiltration measurements), the "truth" is likely derived from the machine's own measurements or standard clinical assessments rather than expert consensus on images.
4. Adjudication Method for the Test Set
This information is not provided. For parameters like Kt/V and ultrafiltration, it's unlikely that a traditional expert adjudication method (e.g., 2+1) would be used. The "truth" would be objective measurements. Adverse events would be recorded and reviewed by the clinical study team and potentially a data safety monitoring board, but not "adjudication" in the sense of resolving conflicting interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC study was not done. MRMC studies are typically for diagnostic imaging devices where human readers interpret images. This device is a treatment system, and the study focused on clinical outcomes and machine performance. Therefore, there's no "effect size of how much human readers improve with AI vs without AI assistance" to report. The PHD System is a standalone treatment device, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself operates in an "algorithm only" mode for delivering treatment parameters once programmed by a clinician and operated by a trained user. The clinical study assessed the performance of the entire system (device + intended use) against conventional methods. It's not a diagnostic algorithm that would typically have a "standalone" performance evaluation separated from human interpretation. The system performs its functions autonomously once set up.
7. The Type of Ground Truth Used
The ground truth implicitly used for the clinical study's parameters (Kt/V accuracy, ultrafiltration accuracy, adverse events) would be:
- Kt/V and Ultrafiltration: Clinical measurements and calculations performed by the device and/or standard clinical protocols, compared against expected or benchmark values from conventional systems.
- Adverse Events: Documented clinical observations and patient outcomes.
8. The Sample Size for the Training Set
This information is not provided. The PHD System is a medical device, not a machine learning algorithm in the modern sense that requires a "training set" of data to learn from. Its operational parameters are based on engineering design, physics, and medical principles, not on iterative learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" in the context of a machine learning algorithm, this question is not applicable. The device's functionality is designed and validated through engineering principles and testing, not by training on patient data.
In summary: The provided 510(k) summary describes a traditional medical device submission for a hemodialysis system, demonstrating substantial equivalence to existing predicate devices. It does not contain information about AI/ML algorithm development, reader studies, or detailed performance metrics and ground truth establishment typically found in submissions for AI-powered diagnostic tools. The clinical study was primarily designed to show that the new device performs comparably to established hemodialysis equipment in terms of safety and efficacy parameters relevant to hemodialysis treatment.
{0}------------------------------------------------
MAR 2 6 2002
510(k) SUMMARY
DATE:
January 11, 2001
APPLICANT INFORMATION:
Submitter's Name: Address:
Aksys, Ltd 2 Marriott Drive Lincolnshire, IL 60069
Contact Person: Phone Number: Fax Number:
Jan L. Zorn (847) 229-2109
(847) 229-2300
DEVICE INFORMATION:
Trade Name:
PHD® Personal Hemodialysis System
Common Name:
Hemodialysis equipment
Classification Name:
High permeability hemodialysis system (per 21 CFR 876,5860) Water purification system for hemodialysis (per 21 CRF 876.5665)
SUBSTANTIALLY EQUIVALENT DEVICES:
Hemodialysis Delivery Systems
-
- Gambro Multipurpose System MPS-10 Gambro, Inc. (K881270)
-
- Fresenius 2008 Touch Panel Control Dialysis System Fresenius USA, Inc. (K890824)
-
- RSP® Hemodialysis Machine Travenol Laboratories, Inc. (Pre-Amendment)
Reuse Equipment for Hemodialysis
-
- HR 3000 Home Patient Reprocessing Device Colorado Medical, Inc. (K841153)
-
- Renatron II Dialyzer Reprocessing System Minntech Corp. (K904210)
510(K) SUMMARY: PHDTM PERSONAL HEMODIALYSIS SYSTEM
PAGE 1
{1}------------------------------------------------
Water Purification Systems for Hemodialysis
- Gambro WRO 10-01 Water Purification Monitor 6. Gambro, Inc. (K811678)
-
- ZyzaTech Series Reverse Osmosis Systems ZyzaTech Water Systems, Inc. (K964539)
Arterial-Venous Blood Tubing Sets for Hemodialysis
-
- Gambro Venous Blood Line Gambro, Inc. (K770691)
-
- Erika Model 9608 Arterial Blood Line National Medical Care, Inc. (K870722)
Dialysate Chemical Concentrates
-
- Hemodialysis Bath Concentrate Solutions for Hemodialysis. Dial Medical of Florida, Inc. (K864265)
-
- Liquiflo™ and BiocarbTM Dry Bicarbonate Concentrates Fresenius USA, Inc. (K896111)
Transducer Protectors
-
- Dualex® Transducer Protector Millipore Corporation (K934069)
DEVICE DESCRIPTION:
The PHD Personal Hemodialysis System is an automated high flux hemodialysis system using a double needle configuration. It is designed to perform safe and effective personal hemodialysis as prescribed by the patient's physician, while minimizing the time and effort to perform each treatment. A computer-like touch screen prompts the operator through each step of the procedure.
The PHD System consists of several components that combine to deliver hemodialysis and perform ultrafiltration. These include the PHD Instrument (PHDi), the PHD Water Pre-Treatment System (WPS), the PHD Blood Tubing Set (BTS), the PHD Chemical Concentrate Bottles (CCBs), and the PHD Transducer Protector (TP).
The PHD Instrument orchestrates and performs the entire pre-treatment, treatment, and post treatment cycle. It accomplishes this by working in conjunction with the WPS (or equivalent), BTS, CCBs, TP, and a commercially
S10(K) Summary: PHD™ Personal Hemodialysis System
Page 2
{2}------------------------------------------------
available hollow fiber membrane dialyzer. Between treatments, the system automatically cleans and disinfects the blood tubing set, dialyzer, and all other components in the fluid pathway. Also, the machine checks the efficiency and integrity of the dialyzer. The PHD Instrument electronically stores information about the patient, prescription, treatment schedule, and machine set-up while allowing for updates according to individual needs.
INTENDED USE:
- Indicated for treatment of the chronic or acute uremic patient where . hemodialysis, including high flux dialysis, is prescribed by the physician.
- Indicated for hemodialysis in a variety of environments, to include acute care . facility, chronic dialysis facility, self care facility, or home setting, where the . patient has been trained and certified to be competent in the use of this device by the attending physician.
COMPARISON TO PREDICATE DEVICES:
The Premarket Notification demonstrates substantial equivalence to the identified predicate devices by comparison of design, components, technology, functionality, and intended use.
Hemodialysis Delivery Systems - Common Technological Characteristics
- Utilizes single-pass and recirculation of the hemodialysis solution from a . reservoir.
- 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 an artificial kidney. .
- Warms incoming water and dialysate with a heater. .
- Monitors the temperature and conductivity of the dialysate before it enters the � dialyzer.
- Controls the flow of dialysate to and from the dialyzer. ●
- Regulates the pressure in the ultrafiltration circuit so that a precise amount of ◆ dialysate is removed from the post dialyzer circuit which causes a like amount of liquid to be removed from the dialyzed blood compartment.
- Controls the blood flow through the extracorporeal circuit by use of a blood t pump.
- Automatically cleans, disinfects, and rinses fluid pathways.
- Monitors system functions and alerts (alams) operator when abnormal functions or conditions are detected.
510(K) SUMMARY: PHD™ PERSONAL HEMODIALYSIS SYSTEM
{3}------------------------------------------------
- Incorporates an integrated reverse osmosis based water purification system. 4
- Produces an on-line sterile electrolyte-containing solution which can be � infused into the extracorporeal circuit for priming, rinse-back, and infusion of replacement solution during patient treatment.
Reuse Equipment for Hemodialysis - Common Technological Characteristics
- Provides in situ cleaning and disinfection of a previously used hemodialyzer . and blood tubing set (arterial and venous lines) for single patient reuse
- Measures the performance of the dialyzer during the reprocessing / reuse of ● the hemodialyzer by means of a sodium clearance
- Measures dialyzer integrity by means of a pressure decay test. .
Water Purification Systems for Hemodialysis - Common Technological Characteristics
- Provides water purification for a single patient hemodialysis machine utilizing ♥ reverse osmosis of pre-treated water through a spiral wound polyamide thin film reverse osmosis membrane
- Utilizes particle filters, and carbon filters for the pre-treatment of water ●
- . Integrates alarm systems for monitoring poor water quality
- Provides water temperature and pressure regulation for incoming water .
- Utilizes conductivity to monitor water quality .
Arterial-Venous Blood Tubing Sets for Hemodialysis - Common Technological Characteristics
- Incorporates standard diameter and wall thickness tubing for the . extracorporeal circuit
- Incorporates conventional connectors and component parts .
- ♥ Incorporates a blood pump tubing segment, which can be used with a peristaltic blood pump.
- Designed for reprocessing and reuse in the same patient �
- Incorporates arterial pressure monitoring capability in the extracorporeal . circuit
- . Incorporates a venous drip chamber without a filter.
- Incorporates venous pressure monitoring capability in the extracorporeal . circuit
Dialysate Chemical Concentrates -Common Technological Characteristics
- Contains the essential electrolytes and dextrose in the appropriate ● concentrations that when proportioned with the appropriate volume of pretreated water, will provide safe and effective hemodialysis solutions according to the physician's prescription.
- Concentrate solutions and powders are packaged and stored in containers . made of high density polyethylene
- Requires both bicarbonate concentrate and acidified concentrate that when t combined with pre-treated water, produce the hemodialysis solution.
510(K) SUMMARY: PHDIM PERSONAL HEMODIALYSIS SYSTEM
{4}------------------------------------------------
Transducer Protectors - Common Technological Characteristics
- Provides a sterile hydrophobic barrier between the extracorporeal circuit and . the venous pressure monitoring device contained/integrated into the hemodialysis machine.
- Utilizes a membrane barrier made of PTFE. .
- Freely transmits gas, but does not allow the passage of fluids. .
- Removes, by filtration, particles and microorganisms larger the 0.2 um. .
CLINICAL TESTING:
Twenty three patients from 3 sites contributed substantial equivalence data to the PHD clinical study. Parameters used to establish the substantial equivalence of the PHD System were accuracy of delivered Kt/V, accuracy of ultrafiltration, and incidence of adverse events.
Clinical data has shown the PHD System is substantially equivalent to conventional equipment in terms of efficacy, accuracy, and safety.
510(K) SUMMARY: PHDTM PERSONAL HEMODIALYSIS SYSTEM
{5}------------------------------------------------
Image /page/5/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest. The profiles are all connected by a single line that runs through the middle of them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the profiles.
MAR 2 6 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jan L. Zorn Director of Regulatory Affairs Aksys, Ltd. Two Marriott Drive LINCOLNSHIRE IL 60069
Re: K010131
Trade/Device Name: Aksys PHD® Personal Hemodialysis System Regulation Number: 21 CFR 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: 78 KDI Dated: December 21, 2001 Received: December 26, 2001
Dear Ms. Zorn:
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. Drue, 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. Ilisting 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 (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. 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.
{6}------------------------------------------------
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.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
{7}------------------------------------------------
Statement of Indications for Use
510(k) Number (if known): K010131
Device Name: PHD® Personal Hemodialysis System
Indications for Use:
- . Indicated for the treatment of the chronic or acute uremic patient where hemodialysis, including high flux dialysis, is prescribed by the physician.
- Indicated for hemodialysis in a variety of environments, to include acute care . facility, chronic dialysis facility, self care facility, or home setting, where the operator has been trained and certified to be competent in the use of this device by the attending physician.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
(Division Sign-Off) 0 Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K010131
Prescription Use (Per 21 CFR 801.109)
Over-the Counter Use (Optional Format 1-2-96)
§ 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.”