PHYSOFT AMS

K130579 · Physicians Software Systems, LLC · MQS · Dec 19, 2013 · Gastroenterology, Urology

Device Facts

• Record ID: K130579
• Device Name: PHYSOFT AMS
• Applicant: Physicians Software Systems, LLC
• Product Code: MQS · Gastroenterology, Urology
• Decision Date: Dec 19, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

PhySoft AMS™ is a web-based software application for anemia management in hemodialysis clinics. It ingests patient Hgb and ESA dosage data from existing healthcare information systems. The device uses an individualized dose-response model to analyze historical patient data, accounting for multiple prior ESA dosages to estimate ongoing dosing schedules aimed at achieving target Hgb levels. It is operated by physicians, nurses, and clinicians via web browser. The system provides dosing schedule recommendations and flags patients who do not respond as predicted or who deviate from the model. Physicians review these outputs alongside clinical history and symptoms to inform ESA dosage optimization. The device assists clinical decision-making but does not replace professional judgment; it aims to improve anemia management efficiency and patient outcomes by providing data-driven dosing guidance.

Clinical Evidence

Software validation, bench testing, and a clinical evaluation were conducted. The performance data demonstrated safety and effectiveness for anemia management in hemodialysis patients.

Technological Characteristics

Web-based software application; operates via secure internet connection; integrates with existing healthcare provider information systems for data acquisition; utilizes an individualized dose-response modeling algorithm; provides electronic reporting and trending; includes automated safety alerts for patient non-response and data sufficiency checks.

Indications for Use

Indicated for adult stage 5 chronic kidney disease (CKD) patients undergoing hemodialysis requiring anemia management via erythropoiesis-stimulating agent (ESA) therapy.

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

• Crit Line Anemia Management (CLAM) (K093834)

Submission Summary (Full Text)

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# DEC 1 9 2013

# 510(k) Summary

#### 510(k) Number: K130579

## 1. Submitter Information

| Submitter Name: | Physician Software Systems, LLC<br>3333 Warrenville Road, Suite 200<br>Lisle, Illinois 60532<br>Phone: [phone]<br>Fax: [phone] |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lewis A. Mitchell<br>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 |

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| 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,

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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<br>Device<br>(CLAM) |
| Indications for Use | Management of anemia in dialysis patients<br>under ESA treatment | Same |
| Principle of Operation | Track and trend Hgb and ESA dosages which<br>can be used to determine future ESA dosages | Same |
| Technology | Application used to trend patient data<br>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<br>management | Same |
| Safeguards/Alerts | System flags patients who exceed limits | Same |

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K130579

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-<br>response model to compute<br>patient dose-response.<br><br>Accounts for the effect of<br>multiple prior ESA dosages<br><br>Estimates ongoing dosing<br>schedules to achieve target Hgb<br>levels | Uses a fixed<br>phenomenological dose-<br>response model for all<br>patients.<br><br>Accounts for the effect of<br>the last ESA dosage<br><br>Provides a single ESA dosing<br>recommendation to achieve<br>a change in Hgb trend |
| Data Entry | Patient data is transferred<br>electronically from existing<br>healthcare provider information<br>systems. | Patient data is obtained<br>from a combination of<br>healthcare provider manual<br>data entry and directly from<br>a Hgb measurement device. |
| Data Storage | Data is stored electronically on<br>local or remote database server | Data is stored electronically<br>on computer media or<br>networked server |
| Data Network Access | Data is accessed over secure<br>Internet connections | Data is accessed on local<br>computer or network |
| Safeguards/Alerts | System flags patients who do not<br>respond as predicted and may<br>have undetected health issues<br>that do not fit the most probable<br>model.<br><br>Evaluates patient readiness for<br>application of algorithm to<br>model ESA dose-Hgb response<br>(sufficient history of Hgb and<br>ESA dosing). | System flags patients<br>exceeding target limits but<br>does not flag patients who<br>do not respond as predicted<br>over time.<br><br>Does not evaluate patient<br>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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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of a stylized human figure with outstretched arms, representing care and protection. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

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 [phone] or [phone] 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 [phone] or [phone] 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

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## 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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