(289 days)
Not Found
Yes
The device description explicitly mentions "modeling an individual patient's Hgb response to ESAs" and "ESA dose-Hgb response modeling capability," which strongly suggests the use of algorithms that learn from patient data to predict responses, a core characteristic of machine learning. While the terms "AI" or "ML" are not explicitly used, the described functionality aligns with ML principles for personalized modeling and prediction.
No
The device provides dosage recommendations for erythropoiesis-stimulating agents (ESAs) but does not directly administer therapy or provide a therapeutic effect. It is a decision support tool for managing anemia.
No
The device provides ESA dosage recommendations and helps manage anemia based on patient data, but it explicitly states it is "not a substitute for, but rather intended to assist, clinical judgment" and that "No medical decision should be based solely on the patient Hgb response to dosing regimen options calculated by this device." It does not directly diagnose a condition; rather, it provides information to aid in the management of an already diagnosed condition (anemia in CKD patients).
Yes
The device description explicitly states that PhySoft AMS™ is a "software application" and that "No components of PhySoft AMS™ are required to be installed at end user or healthcare provider locations," indicating it is accessed via a web browser and server, which is characteristic of a software-only device.
Based on the provided information, PhySoft AMS™ is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description of PhySoft AMS™ clearly state that it obtains, tracks, and trends patient data and provides ESA dosage recommendations. It does not involve the analysis of biological samples like blood, urine, or tissue.
- The device description focuses on software functionality and data processing. It describes a web application that interacts with healthcare provider information systems to access patient data and perform modeling. There is no mention of any components that would be used to analyze biological specimens.
- The intended use is to assist in the management of anemia based on existing patient data and clinical judgment. While it uses patient data, it doesn't perform a diagnostic test on a specimen to determine a patient's condition. It provides recommendations based on existing information.
Therefore, PhySoft AMS™ falls under the category of a clinical decision support software or a medical device software, but not an In Vitro Diagnostic.
No
The provided input states "Control Plan Authorized (PCCP) and relevant text: Not Found", which does not indicate that the FDA explicitly reviewed and approved or cleared a PCCP for this device.
Intended Use / Indications for Use
PhySoft AMS™ is a web application used to obtain, track and trend patient data pertaining to the management of anemia, and to provide a schedule of erythropoiesis-stimulating agent (ESA) dosage recommendations to help achieve and maintain target hemoglobin levels in dialysis patients. PhySoft AMS™ is intended to help physicians, nurses, clinicians and anemia managers manage anemia in adult stage 5 chronic kidney disease (CKD) patients.
The PhySoft AMS™ is not a substitute for, but rather intended to assist, clinical judgment. The ESA dosing regimen options calculated by this device are intended to be used by qualified and trained medical personnel to inform the optimization of the dosage of ESAs in accordance with their approved labeling in conjunction with clinical history, symptoms, and other diagnostic measurements, as well as the medical professional's clinical judgment. No medical decision should be based solely on the patient Hgb response to dosing regimen options calculated by this device.
Product codes
MQS, JQP
Device Description
PhySoft AMS™ is a software application used to obtain, track and trend patient data pertaining to the management of anemia, and to provide a schedule of ESA dosage recommendations to help achieve and maintain target Hgb levels in dialysis patients. PhySoft AMS™ is intended to help physicians, nurses, clinicians and anemia managers manage anemia in adult stage 5 CKD patients.
PhySoft AMS™ is intended for use by medical personnel such as clinicians, nurses, and physicians in dialysis clinics or other settings where anemia management for hemodialysis patients is conducted.
Healthcare professionals access PhySoft AMS™ using a web browser communicating with the PhySoft AMS™ web application server. Patient information is obtained by PhySoft AMS™ from healthcare provider information systems. No components of PhySoft AMS™ are required to be installed at end user or healthcare provider locations.
PhySoft AMS™ assesses if there is adequate data to model an individual patient's Hgb response to ESAs. The results of this assessment are reviewed by the physician who, after considering any additional relevant information about the patient's condition, decides if they want to apply the PhySoft AMS™ ESA dose-Hgb response modeling capability to the particular patient's data. If adequate data are available, PhySoft AMS™ enables a physician to model a patient and select from dosing schedule options to achieve target Hgb levels or, at the physician's discretion, override the presented dosing schedule options.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult
Intended User / Care Setting
Physicians, nurses, clinicians and anemia managers; dialysis clinics or other settings where anemia management for hemodialysis patients is conducted.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The software validation, bench testing, and a clinical evaluation were conducted for PhySoft AMS™. The Performance data demonstrated the safety and effectiveness of PhySoft AMS™ in anemia management for hemodialysis patients.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
DEC 1 9 2013
510(k) Summary
510(k) Number: K130579
1. Submitter Information
| Submitter Name: | Physician Software Systems, LLC
3333 Warrenville Road, Suite 200
Lisle, Illinois 60532
Phone: 331-213-9000
Fax: 331-213-9009 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lewis A. Mitchell
Chief Executive Officer |
| Date Prepared: | December 18, 2013 |
2. Name of Device
| Trade Name | PhySoft AMS™ |
|---|---|
| Classification Name | Hemodialysis System and Accessories |
| Classification Panel | 76 Gastroenterology/Urology |
| Classification Regulations | 876.5820 |
| Product Code | MQS |
| Device Classification | Class II |
3. Predicate Device Information
| Trade Name | Crit Line Anemia Management (CLAM) |
|---|---|
| 510(k) | K093834 |
| Classification Name | Hemodialysis System and Accessories |
| Classification Regulations | 876.5820, 862.2100 |
1
| Product Code | MQS, JQP |
|---|---|
| Device Classification | Class II |
4. Intended Use
PhySoft AMS™ is a web application used to obtain, track and trend patient data pertaining to the management of anemia, and to provide a schedule of erythropoiesis-stimulating agent (ESA) dosage recommendations to help achieve and maintain target hemoglobin levels in dialysis patients. PhySoft AMS™ is intended to help physicians, nurses, clinicians and anemia managers manage anemia in adult stage 5 chronic kidney disease (CKD) patients.
The PhySoft AMS™ is not a substitute for, but rather intended to assist, clinical judgment. The ESA dosing regimen options calculated by this device are intended to be used by qualified and trained medical personnel to inform the optimization of the dosage of ESAs in accordance with their approved labeling in conjunction with clinical history, symptoms, and other diagnostic measurements, as well as the medical professional's clinical judgment. No medical decision should be based solely on the patient Hgb response to dosing regimen options calculated by this device.
5. Device Description
PhySoft AMS™ is a software application used to obtain, track and trend patient data pertaining to the management of anemia, and to provide a schedule of ESA dosage recommendations to help achieve and maintain target Hgb levels in dialysis patients. PhySoft AMS™ is intended to help physicians, nurses, clinicians and anemia managers manage anemia in adult stage 5 CKD patients.
PhySoft AMS™ is intended for use by medical personnel such as clinicians, nurses, and physicians in dialysis clinics or other settings where anemia management for hemodialysis patients is conducted.
Healthcare professionals access PhySoft AMS™ using a web browser communicating with the PhySoft AMS™ web application server. Patient information is obtained by PhySoft AMS™ from healthcare provider information systems. No components of PhySoft AMS™ are required to be installed at end user or healthcare provider locations.
PhySoft AMS™ assesses if there is adequate data to model an individual patient's Hgb response to ESAs. The results of this assessment are reviewed by the physician who, after considering any additional relevant information about the patient's condition,
2
decides if they want to apply the PhySoft AMS™ ESA dose-Hgb response modeling capability to the particular patient's data. If adequate data are available, PhySoft AMS™ enables a physician to model a patient and select from dosing schedule options to achieve target Hgb levels or, at the physician's discretion, override the presented dosing schedule options.
6. Technological Characteristics
Both PhySoft AMS™ and CLAM are software application to record, track, and trend patient data, and provide ESA dosage recommendations in accordance with the ESA approved labeling. The table below compares the similarities of PhySoft AMS™ to the predicate device (CLAM) with respect to technological characteristics.
| Similarities to CLAM (Predicate Device) | ||
|---|---|---|
| Item | PhySoft AMS™ | Predicate |
| Device | ||
| (CLAM) | ||
| Indications for Use | Management of anemia in dialysis patients | |
| under ESA treatment | Same | |
| Principle of Operation | Track and trend Hgb and ESA dosages which | |
| can be used to determine future ESA dosages | Same | |
| Technology | Application used to trend patient data | |
| collected during each dialysis treatment | Same | |
| Patient Demographics | Adult stage 5 chronic kidney disease patients | Same |
| Intended User | Physician/Clinicians/Nurses | Same |
| Data Storage | Data is stored electronically | Same |
| Data Management | Generates reports and graphs to assist anemia | |
| management | Same | |
| Safeguards/Alerts | System flags patients who exceed limits | Same |
3
Differences between PhySoft AMS™ and the predicate device (CLAM) are summarized in the table below.
| Differences with CLAM (Predicate Device) | ||
|---|---|---|
| Item | PhySoft AMS™ | Predicate Device (CLAM) |
| Technology/Algorithm | Uses individualized dose- | |
| response model to compute | ||
| patient dose-response. |
Accounts for the effect of
multiple prior ESA dosages
Estimates ongoing dosing
schedules to achieve target Hgb
levels | Uses a fixed
phenomenological dose-
response model for all
patients.
Accounts for the effect of
the last ESA dosage
Provides a single ESA dosing
recommendation to achieve
a change in Hgb trend |
| Data Entry | Patient data is transferred
electronically from existing
healthcare provider information
systems. | Patient data is obtained
from a combination of
healthcare provider manual
data entry and directly from
a Hgb measurement device. |
| Data Storage | Data is stored electronically on
local or remote database server | Data is stored electronically
on computer media or
networked server |
| Data Network Access | Data is accessed over secure
Internet connections | Data is accessed on local
computer or network |
| Safeguards/Alerts | System flags patients who do not
respond as predicted and may
have undetected health issues
that do not fit the most probable
model.
Evaluates patient readiness for
application of algorithm to
model ESA dose-Hgb response
(sufficient history of Hgb and
ESA dosing). | System flags patients
exceeding target limits but
does not flag patients who
do not respond as predicted
over time.
Does not evaluate patient
readiness. |
7. Performance Data
The software validation, bench testing, and a clinical evaluation were conducted for PhySoft AMS™. The Performance data demonstrated the safety and effectiveness of PhySoft AMS™ in anemia management for hemodialysis patients.
8. Conclusion
PhySoft AMS™ and CLAM are substantially equivalent with respect to intended use, technological characteristics, and performance.
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Food and Drug Administration 1 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 19, 2013
Physician Software System, LLC Lewis A. Mitchell Chief Executive Officer 3333 Warrenville Road, Suite 200 Lisle, IL 60532
Re: K130579
Trade/Device Name: PhySoft AMS™ Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: Class II Product Code: MQS Dated: November 8, 2013 Received: November 12, 2013
Dear Lewis A. Mitchell,
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.
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
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Page 2 - Lewis A. Mitchell
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Glena Bell -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal. and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use Statement
510(k) Number: K130579
Device Name: PhySoft AMS™
Indications for Use:
PhySoft AMS™ is a web application used to obtain, track and trend patient data pertaining to the management of anemia, and to provide a schedule of erythropoiesis-stimulating agent (ESA) dosage recommendations to help achieve and maintain target hemoglobin levels in dialysis patients. PhySoft AMS™ is intended to help physicians, nurses, clinicians and anemia managers manage anemia in adult stage 5 chronic kidney disease (CKD) patients.
The PhySoft AMS™ is not a substitute for, but rather intended to assist, clinical judgment. The ESA dosing regimen options calculated by this device are intended to be used by qualified and trained medical personnel to inform the optimization of the dosage of ESAs in accordance with their approved labeling in conjunction with clinical history, symptoms, and other diagnostic measurements, as well as the medical professional's clinical judgment. No medical decision should be based solely on the patient Hgb response to dosing regimen options calculated by this device.
Prescription Use _ YES (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
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