The Tablo™ System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility. Treatments must be administered under physician's prescription, with a trailable as needed who is considered competent in the use of the device by the prescribing physician.

Device Description

The Tablo™ Console is a self-contained hemodialysis system (Console) intended for acute and chronic dialysis therapy with or without ultrafiltration. The Tablo Console consists of a conventional Dialysis Delivery System (DDS; Upper Module) and a compact Water Purification System (WPS; Lower Module). The Dialysis Delivery System (Upper Module) and the Water Purification System (Lower Module) are stacked and latched together to form a single integrated Console.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the Tablo Console. It outlines the device's characteristics and compares it to predicate devices to establish substantial equivalence. However, it does not contain a detailed study proving the device meets specific acceptance criteria in the manner requested (e.g., performance metrics like sensitivity, specificity, accuracy for a diagnostic device).

Instead, it describes general performance testing that was conducted to ensure the device functions as intended and complies with relevant standards and guidance documents. This type of regulatory submission often focuses on demonstrating safety and effectiveness compared to an existing device, rather than presenting a performance study with acceptance criteria in the context of, for example, a diagnostic AI model.

Therefore, many of the requested fields cannot be directly extracted from this document as the information is not present. I will fill in what can be inferred or explicitly stated based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric Category	Acceptance Criteria (Stated or Inferred)	Reported Device Performance (Stated or Inferred)	Details
General Performance	Met all performance specifications.	The Tablo Console meets all performance specifications, complies with applicable standards and FDA Guidance Documents.	General statement about overall device function.
Disinfection	Functionality of heat and chemical disinfections.	Performance testing done for heat and chemical disinfections.	Confirms the disinfection methods work as intended.
Water Quality	Production of treated water of specified quality.	Performance testing done for treated water quality.	Ensures water used for dialysis meets standards.
Dialysate Quality	Production of dialysate of specified quality.	Performance testing done for dialysate quality.	Ensures dialysate used for dialysis meets standards.
Key Functions/Features	Proper functioning of all key functions, design features, and components.	Performance testing done for all key functions/design features/components.	Verifies all parts of the device operate correctly.
Electrical Safety	Compliance with electrical safety standards.	Testing to confirm compliance with electrical safety standards.	Ensures device is electrically safe.
Electromagnetic Safety	Compliance with electromagnetic safety standards (RF emissions Class B).	Testing to confirm compliance with electromagnetic safety standards. The rating for the Subject Device is Class B.	Ensures device operates without harmful electromagnetic interference and meets specified class.
Alarms & Alerts	Proper functioning of alarms and alerts.	Performance testing done for alarms and alerts.	Verifies safety mechanisms are functional.
Software	Proper functioning of software.	Performance testing done for software.	Ensures software controls and functions correctly.
Touchscreen	Proper functioning of touchscreen.	Performance testing done for the touchscreen.	Ensures user interface works as intended.
Fluid Path Materials	Suitability/safety of fluid path materials.	Testing of the fluid path materials.	Confirms materials in contact with fluids are appropriate.

2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of a statistical study with a defined sample size (e.g., for an AI algorithm). The performance testing described refers to engineering verification and validation of the physical device and its components. Therefore, information about sample size for a test set and data provenance (country, retrospective/prospective) is not applicable or available in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to the type of device and performance testing described. Ground truth established by experts is typically relevant for diagnostic or AI-driven devices where human interpretation is being benchmarked or replicated.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable to the type of device and performance testing described. Adjudication methods are usually for expert consensus on diagnostic interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices, which is not what the Tablo Console is (it's a hemodialysis system).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this refers to an AI algorithm's performance, which is not applicable to the Tablo Console.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance would be engineering specifications, validated safety standards, and functional requirements. For example, the ground truth for "treated water quality" is defined by specific chemical and microbiological standards for water used in hemodialysis. The document indicates testing was done "in accordance with appropriate FDA guidance documents and relevant standards."

8. The sample size for the training set
This information is not applicable. The Tablo Console is a physical medical device, not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established
This information is not applicable. The device does not use a training set as it is not an AI algorithm.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 10, 2014

Home Dialysis Plus Nancy Gallo Senior Vice President, Regulatory Affairs 257 Humboldt Court Sunnyvale, CA 94089

Re: K140866 Trade/Device Name: Tablo Console Regulation Number: 21 CFR§ 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: August 1, 2014 Received: August 4, 2014

Dear Nancy Gallo,

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.

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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 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Herbert P. Lerner -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K140866

Device Name Tablo Console

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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5. 510(k) Summary

This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR Part 807.92.

5.1 Submitter's Information

Submitter's Name:	Moshe Pinto, CEO
Company:	HDPlus
Address:	257 Humboldt Ct, Sunnyvale, CA 94089
Contact Person:	Nancy Gallo, Senior Vice-President, Regulatory Affairs
Phone:	510.682.6505
Facsimile:	408.329.9091
Email:	ngallo@homedialysisplus.com
Date of SummaryPreparation:	March 31, 2014

5.2 Device Information

Trade Name:	Tablo™ Console
Common Name:	Hemodialysis Delivery System	Portable Water TreatmentSystem
Classification Name:	High Permeability HemodialysisDelivery System	Water Purification System forHemodialysis
Classification Number:	Class II per 21 CFR 876.5860	Class II per 21 CFR 876.5665
Product Code:	KDI	FIP
Classification Panel:	Gastroenterology/Urology	Gastroenterology/Urology

5.3 Predicate Device Information

Fresenius 2008T Hemodialysis Machine (K120505) Lauer Aquaboss EcoRO Dia 50 (K032004)

5.4 Device Description

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5.5 Indications for Use

The Tablo System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility. Treatments must be administered under physician's prescription, with a trained individual available as needed who is considered competent in the use of the device by the prescribing physician.

Technological Characteristics 5.6

The Tablo Console (Subject Device) utilizes two Predicate Devices; Fresenius 2008T (K120505) for the Upper Module and Lauer Aquaboss EcoRO Dia 50 (K032004) for the Lower Module.

5.6.1 Tablo Console (Upper Module) vs. Fresenius 2008T (K120505)

The Tablo Console (Upper Module) and the Predicate Device are equivalent in technological characteristics:

. Intended use - To deliver hemodialysis to patients with renal disease.
Off the shelf components - Dialyzers and non-invasive blood pressure cuffs (NIBP).
. Standards - Electrical and electromagnetic safety, and Hemodialysis System standards.
Software - Software controlled, and utilize Graphic User Interface (GUI).
. Design and Construction - Blood pump, heparin pump, alarms, alerts, air detector mechanism, and blood leak detectors.
. Disinfection - Heat and chemical disinfection.

Minor differences exist in the technological characteristics of the Subject and Predicate Devices. None of the minor differences raise any new or different questions of safety or effectiveness. The differences include:

Compatibility - The Tablo Console (Subject Device) was developed to interface with a specific Blood Tubing Set (i.e. the Tablo Cartridge), whereas the Predicate is universal in this respect.
. System level specifications - The Tablo Console and the Predicate differ in certain system level specifications like the blood and dialysate flow rates, ultrafiltration rate, dialysate temperature range, Acid and Bicarbonate concentration, ratio of mixture, and pressure ranges.
Electromagnetic Safety Rating for RF emissions - The rating for the Subject Device is Class B while the Predicate Device is Class A.

5.6.2 Tablo Console (Lower Module) vs. Aquaboss EcoRO Dia 50 (K032004)

The Tablo Console (Upper Module) and the Predicate Device are equivalent in technological characteristics:

. Intended use - To produce hemodialysis quality water.
. Water Purification Method - Reverse Osmosis.
Standards – Water for hemodialysis, and electrical and electromagnetic safety standards.

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Software - Software controlled, and utilize a user interface.
. Design and Construction – Carbon, sediment, and RO filters.

. Disinfection Method - The Tablo Console utilizes both Heat and Chemical Disinfections whereas the Predicate utilizes only Chemical Disinfection.
. Components – The Subject Device incorporates a Pre Filter and Heat Exchanger whereas the Predicate Device does not.

Performance Data 5.7

The following Performance Testing, developed in accordance with appropriate FDA guidance documents and relevant standards, has been performed on the Subject Device to support the determination of substantial equivalence:

. Performance testing for heat and chemical disinfections, treated water quality, dialysate quality, and all the key functions/design features/components.
. Testing to confirm compliance with electrical and electromagnetic safety standards and performance of alarms and alerts.
. Performance testing for software and the touchscreen.
. Testing of the fluid path materials.

Conclusion 5.8

The Performance Testing demonstrates that the Tablo Console meets all performance specifications, complies with applicable standards and FDA Guidance Documents. The Tablo Console is substantially equivalent to the Predicate Devices, and the minor differences in the technological characteristics of the Subject and the Predicate Devices do not raise any new or different questions of safety or effectiveness.

Regulation Number and Section

§ 876.5860 High permeability hemodialysis system.

(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”