Who is the manufacturer of PhySoftAMS®?

Physician Software Systems, LLC filed the 510(k) submission for PhySoftAMS® (K232283).

What is the FDA product code for PhySoftAMS®?

MQS. It is classified under 21 CFR 876.5820 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for PhySoftAMS®?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like PhySoftAMS®?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PhySoftAMS®

K232283 · Physician Software Systems, LLC · MQS · Dec 14, 2023 · Gastroenterology, Urology

Device Facts

Record ID	K232283
Device Name	PhySoftAMS®
Applicant	Physician Software Systems, LLC
Product Code	MQS · Gastroenterology, Urology
Decision Date	Dec 14, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.5820
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

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.

Device Story

PhySoftAMS® is a software application for anemia management in dialysis clinics. It ingests patient hemoglobin (Hgb) and ESA dosage data from electronic health records (EHR). The device uses PK/PD modeling to project patient response to ESA therapy and generate dosing schedule recommendations. It is operated by physicians, nurses, and clinicians via a web-based GUI or integrated EHR API. The system evaluates data sufficiency for modeling; if adequate, it provides dosing options for clinical review. The device assists, but does not replace, clinical judgment; providers must integrate recommendations with patient history and symptoms. Benefits include standardized tracking and data-driven support for maintaining target Hgb levels.

Clinical Evidence

Bench testing only. Software verification and validation demonstrated that modifications perform as intended and do not impact the modeling process or device functions compared to the predicate.

Technological Characteristics

Software application; PK/PD modeling engine for ESA dose-Hgb response; web-based GUI or API-based EHR integration; data storage and reporting; automated flagging of patients exceeding limits.

Indications for Use

Indicated for adult stage 5 chronic kidney disease (CKD) patients undergoing dialysis to assist clinicians in managing anemia and optimizing erythropoiesis-stimulating agent (ESA) dosage.

Regulatory Classification

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.

Predicate Devices

PhySoft AMS™ (K130579)

Reference Devices

Dosis Smart Anemia Manager (K180410)

Related Devices

K130579 — PHYSOFT AMS · Physicians Software Systems, LLC · Dec 19, 2013
K180410 — Dosis SAM · Dosis, Inc. · Jan 16, 2019
K093834 — CRIT-LINE ANEMIA MANAGEMENT SOFTWARE · Hema Metrics, LLC · Sep 29, 2010
K130460 — NXSTAGE DOSING CALCULATOR · Nxstage Medical, Inc. · Jul 11, 2013
K101344 — G+ SYSTEM · Glytec, LLC (Formally Known AS Glucotec, Inc.) · Jun 28, 2010

Submission Summary (Full Text)

{0}------------------------------------------------ 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) K232283 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ ## 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 | {5}------------------------------------------------ | 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. {7}------------------------------------------------ | 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 | {8}------------------------------------------------ {9}------------------------------------------------ ### 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.