(136 days)
Unknown
The description mentions "model patient ESA dose-Hgb response dynamics" and "project future ESA dose-Hgb response," which could potentially involve AI/ML, but the summary does not explicitly state the use of these technologies. The lack of information on training/test sets further supports the "Unknown" classification.
No
The device is a software application that provides dosage recommendations and tracks patient data for anemia management, which assists medical professionals in making judgments but does not directly treat or diagnose.
No
Explanation: The PhySoft Anemia Management System® provides "ESA dosage recommendations" and helps "manage anemia" by tracking and trending patient data. It explicitly states it is "not a substitute for" but "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 or disease; rather, it aids in the management of an already diagnosed condition (anemia) and provides dosing guidance based on existing data. While it uses data to help manage, it does not confirm the presence or absence of a disease.
Yes
The device description explicitly states it is a "software application" and describes its functionality solely in terms of data processing, recommendations, and user interfaces (web application, API). There is no mention of any associated hardware components that are part of the medical device itself.
Based on the provided information, the PhySoft Anemia Management System® (PhySoftAMS®) is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- PhySoftAMS® Function: PhySoftAMS® is a software application that uses patient data (likely including results from IVD tests like hemoglobin levels, but the software itself doesn't perform the test) to track trends and provide dosage recommendations for a medication (ESA). It assists in managing a condition (anemia) based on existing data and clinical judgment.
- No Sample Analysis: The description clearly states that PhySoftAMS® "obtains, tracks and trends patient data" and provides "dosage recommendations." There is no mention of the software analyzing biological samples or performing any diagnostic tests on those samples.
Therefore, while PhySoftAMS® utilizes data that may be generated by IVD tests (like hemoglobin levels), the software itself does not perform the in vitro diagnostic function. It is a clinical decision support tool based on existing patient data.
N/A
Intended Use / Indications for Use
The PhySoft Anemia Management System® (PhySoftAMS®) is a software 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. PhySoftAMS® is intended to help physicians. nurses, clinicians, and anemia managers manage anemia in adult stage 5 chronic kidney disease (CKD) patients.
PhySoftAMS® is not a substitute for, but is rather intended to assist, clinical judgment. The erythropoiesis-stimulating agent (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
Device Description
PhySoftAMS® is a software 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. PhySoftAMS® is intended to help physicians, nurses, clinicians and anemia managers manage anemia in adult stage 5 chronic kidney disease (CKD) patients.
PhySoftAMS® 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 PhySoftAMS® directly using a web application graphical user interface (GUI) or indirectly using the drug dosing-related screens of a third party's electronic health record (EHR) system via an application programming interface (API) provided by the PhySoftAMS® application server.
PhySoftAMS® evaluates whether adequate historical data is available to model patient ESA dose-Hgb response dynamics and project future ESA dose-Hgb response. If adequate data is available, PhySoftAMS® enables a physician to model a patient and select from one or more dosing schedule options most likely to result in achieving 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
PhySoftAMS® is intended to help physicians, nurses, clinicians, and anemia managers manage anemia in adult stage 5 chronic kidney disease (CKD) patients.
PhySoftAMS® 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.
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
Bench testing results demonstrate the modified device performance is computationally equivalent to the performance of the predicate device.
Software verification and validation of the device modifications that are the subject of this submission demonstrated that the enhancements for the subject (modified) device perform as intended and have no effect on the modeling process or other device functions of PhySoftAMS®.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 14, 2023
Physician Software Systems, LLC Lewis Mitchell CEO 3333 Warrenville Road, Suite 200 Lisle, Illinois 60532
Re: K232283
Trade/Device Name: PhySoftAMS® Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis System and Accessories Regulatory Class: II Product Code: MQS Dated: November 23, 2023 Received: November 24, 2023
Dear Lewis 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
2
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Maura Rooney Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
PhySoftAMS®
Indications for Use (Describe)
The PhySoft Anemia Management System® (PhySoftAMS®) is a software 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. PhySoftAMS® is intended to help physicians. nurses, clinicians, and anemia managers manage anemia in adult stage 5 chronic kidney disease (CKD) patients.
PhySoftAMS® is not a substitute for, but is rather intended to assist, clinical judgment. The erythropoiesis-stimulating agent (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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
510(k) Number: K232283
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: | November 16, 2023 | |
| Type of Submission: | Traditional 510(k) Submission | |
2. Name of Device
| Common Name: | Anemia Management System |
|---|---|
| Trade Name: | PhySoftAMS® |
| Classification Name: | Hemodialysis System and Accessories |
| Classification Panel: | 76 Gastroenterology/Urology |
| Classification Regulations: | 21 CFR 876.5820 |
| Product Code: | MQS |
| Device Classification | Class II |
3. Predicate Device Information
| Common Name: | Anemia Management System |
|---|---|
| Trade Name: | PhySoft AMS™ |
| 510(k): | K130579 |
| Classification Name: | Hemodialysis System and Accessories |
| Classification Panel: | 76 Gastroenterology/Urology |
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| Classification Regulations: | 21 CFR 876.5820 |
|---|---|
| Product Code: | MQS |
| Device Classification | Class II |
4. Reference Device Information
| Common Name: | Anemia Management System |
|---|---|
| Trade Name: | Dosis Smart Anemia Manager |
| 510(k): | K180410 |
| Classification Name: | Hemodialysis System and Accessories |
| Classification Panel: | 76 Gastroenterology/Urology |
| Classification Regulations: | 21 CFR 876.5820 |
| Product Code: | MQS |
| Device Classification | Class II |
The Dosis Smart Anemia Manager cleared under K180410 is included as a reference device in support of the subject device's capability to use the client EHR as a user-interaction alternative to the predicate device's GUI. Both the subject device and the reference device can be accessed via a web browser or web-enabled electronic health record [EHR] system. The reference device was found substantially equivalent to the PhySoftAMS® predicate device under K180410.
5. Device Description
PhySoftAMS® is a software 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. PhySoftAMS® is intended to help physicians, nurses, clinicians and anemia managers manage anemia in adult stage 5 chronic kidney disease (CKD) patients.
PhySoftAMS® 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 PhySoftAMS® directly using a web application graphical user interface (GUI) or indirectly using the drug dosing-related screens of a third party's electronic health record (EHR) system via an application programming interface (API) provided by the PhySoftAMS® application server.
PhySoftAMS® evaluates whether adequate historical data is available to model patient ESA dose-Hgb response dynamics and project future ESA dose-Hgb response. If adequate data is
6
available, PhySoftAMS® enables a physician to model a patient and select from one or more dosing schedule options most likely to result in achieving target Hgb levels or, at the physician's discretion. override the presented dosing schedule options.
6. Intended Use
Indications for use of the subject device
PhySoftAMS® is a software 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. PhySoftAMS® is intended to help physicians, nurses, clinicians and anemia managers manage anemia in adult stage 5 chronic kidney disease (CKD) patients.
PhySoftAMS® is not a substitute for, but is rather intended to assist, clinical judgment. The erythropoiesis-stimulating agent (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.
Comparison of indications for use statements
PhySoftAMS® has the same intended use and indications for use as the predicate device, cleared under K130579.
The indications for use statement for both the predicate device and the subject (modified) device are identical, except that "web application" in the first sentence of the first paragraph has been changed to "software application." The subject device includes an option to integrate the software directly into the user's internal EHR systems using an API, whereas the predicate device is accessible only as a web application through a secure virtual private network (VPN).
Like the subject device, the reference device cleared under K180410 is also accessible via a web browser or web-enabled EHR system.
7. Technological Characteristics
PhySoftAMS® is a modified version of the predicate device. The software codebase remains unchanged with the exception of updates and maintenance performed since its initial release in 2013 to improve the overall user experience and the modifications that are the subject of this 510(k) submission. The table below contains the key technological characteristics that remain identical between the predicate and the modified device.
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| Characteristic | PhySoftAMS® | Predicate
(PhySoft AMSTM) |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Indications for Use | Management of anemia in dialysis patients under ESA
treatment (full indications for use statement provided
above) | Identical |
| Principle of
Operation | Track and trend past Hgb and ESA dosages to determine
future ESA dosages based on PK/PD modeling of
patient response to ESAs | Identical |
| Technology | Application used to trend patient data collected during
each dialysis treatment | Identical |
| Patient
Demographics | Adult stage 5 chronic kidney disease patients | Identical |
| Intended Users | Physicians, clinicians, nurses, anemia managers | Identical |
| Data Storage | Data is stored electronically | Identical |
| Data Management | Generates reports and graphs to assist with anemia
management | Identical |
| Safeguards/Alerts | System flags patients who exceed limits | Identical |
Differences between the modified version of PhySoftAMS® and the predicate are summarized in the table below. The modifications allow integration of PhySoftAMS® with users' EHR systems.
| Characteristic | Modified PhySoftAMS®
(Subject Device) | Predicate (PhySoft AMSTM)
(K130579) |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| User Interface | The web-based version offers the
same GUI accessed online via
VPN-secured HTTPS connection. | GUI accessed online via VPN-
secured HTTPS connection. |
| | Integration with users' EHR
systems via API is also available
as an option. | While the predicate device was
not accessible through users'
EHR systems, the Dosis Smart
Anemia Manager cleared under
K180410 is included as a
reference device in support of the
subject device's capability to use
the client EHR as a user-
interaction alternative to the
predicate device's GUI. Both the
subject device and the reference
device can be accessed via a web
browser or web-enabled EHR
system. FDA determined the
reference device was substantially
equivalent to the predicate device. |
| | Modified PhySoftAMS®
(Subject Device) | Predicate (PhySoft AMSTM)
(K130579) |
| Characteristic | | |
| Data Entry | The web-based version
electronically obtains patient data
required for anemia management
from the healthcare provider's
EHR at regular intervals.
For those using the API, the
application directly interacts with
the user's EHR for access to
patient data. | Electronically obtains patient data
required for anemia management
from the healthcare provider's
EHR at regular intervals |
| Recommendation Delivery | The web-based version delivers
recommendations via web-based
GUI.
For those using the API, a Dosing
Recommendation Manager
(DRM) routes recommendations
from the recommendation
database to external systems. | Delivers recommendations via
web-based GUI. |
| Patient Modeling Trigger | Users of the web-based version
manually trigger the modeling
function with a GUI button when
informed that the data
requirements for patient modeling
have been satisfied.
For those using the API, where
the GUI button is not available, a
Modeled Patient Dosing
Recommendation Engine
(MPDRE) automatically activates
the modeling process when the
data requirements for patient
modeling have been satisfied.
Healthcare professionals are still
required to review the results of
the model in conjunction with
clinical history, symptoms, and
other diagnostic measurements, as
well as the medical professional's
clinical judgment, and no medical
decision related to the model's
recommendations should be
based solely on the patient Hgb
response to dosing regimen | User manually triggers the
modeling function with a GUI
button when informed that the
data requirements for patient
modeling have been satisfied |
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8. Performance
Bench testing results demonstrate the modified device performance is computationally equivalent to the performance of the predicate device.
Software verification and validation of the device modifications that are the subject of this submission demonstrated that the enhancements for the subject (modified) device perform as intended and have no effect on the modeling process or other device functions of PhySoftAMS®.
9. Conclusion
The modified PhySoftAMS® that is the subject of this submission and PhySoft AMS™ as cleared under K130579 are substantially equivalent with respect to intended use, technological characteristics, and performance. The bench testing and software verification and validation results demonstrate that the modified device is as safe, as effective, and performs as well as the legally marketed predicate device.