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 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.

AI/ML Overview

The provided text states that a clinical evaluation was conducted for PhySoft AMS™ to demonstrate its safety and effectiveness. However, it does not provide specific details about the acceptance criteria or the results of the study in a format that allows for the extraction of a table of acceptance criteria and reported device performance, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC study details, standalone performance, type of ground truth, training set sample size, or how ground truth for the training set was established.

The document only generally concludes that "The Performance data demonstrated the safety and effectiveness of PhySoft AMS™ in anemia management for hemodialysis patients." and that it is "substantially equivalent" to its predicate device. This implies that testing was done, but the detailed methodology and results are not included in this summary.

Therefore, I cannot provide the requested information from the given input.

Summary

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DEC 1 9 2013

510(k) Summary

510(k) Number: K130579

1. Submitter Information

Submitter Name:	Physician Software Systems, LLC3333 Warrenville Road, Suite 200Lisle, Illinois 60532Phone: 331-213-9000Fax: 331-213-9009
Contact Person:	Lewis A. MitchellChief 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

5. Device Description

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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™	PredicateDevice(CLAM)
Indications for Use	Management of anemia in dialysis patientsunder ESA treatment	Same
Principle of Operation	Track and trend Hgb and ESA dosages whichcan be used to determine future ESA dosages	Same
Technology	Application used to trend patient datacollected 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 anemiamanagement	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-response model to computepatient dose-response.Accounts for the effect ofmultiple prior ESA dosagesEstimates ongoing dosingschedules to achieve target Hgblevels	Uses a fixedphenomenological dose-response model for allpatients.Accounts for the effect ofthe last ESA dosageProvides a single ESA dosingrecommendation to achievea change in Hgb trend
Data Entry	Patient data is transferredelectronically from existinghealthcare provider informationsystems.	Patient data is obtainedfrom a combination ofhealthcare provider manualdata entry and directly froma Hgb measurement device.
Data Storage	Data is stored electronically onlocal or remote database server	Data is stored electronicallyon computer media ornetworked server
Data Network Access	Data is accessed over secureInternet connections	Data is accessed on localcomputer or network
Safeguards/Alerts	System flags patients who do notrespond as predicted and mayhave undetected health issuesthat do not fit the most probablemodel.Evaluates patient readiness forapplication of algorithm tomodel ESA dose-Hgb response(sufficient history of Hgb andESA dosing).	System flags patientsexceeding target limits butdoes not flag patients whodo not respond as predictedover time.Does not evaluate patientreadiness.

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

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Indications for Use Statement

510(k) Number: K130579

Device Name: PhySoft AMS™

Indications for Use:

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)

Image /page/6/Picture/11 description: The image shows the text "Glenn B. Bell -S". The text is in a bold, sans-serif font. The letters "D A" are in a stylized font, with the letters overlapping each other. The letters "D A" are also surrounded by a geometric design. The text is black against a white background.

Regulation Number and Section

§ 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.