(160 days)
No
The document describes a conventional hemodialysis system and does not mention any AI or ML components or capabilities.
Yes.
The device is used to treat patients with renal failure, performing functions such as hemodialysis and ultrafiltration, which are therapeutic interventions.
No
Explanation: The device is described as a hemodialysis system used for treating patients with renal failure. Its function is therapy (hemodialysis), not diagnosis.
No
The device description explicitly states that the Tablo™ Console is a "self-contained hemodialysis system" consisting of a "conventional Dialysis Delivery System (DDS; Upper Module)" and a "compact Water Purification System (WPS; Lower Module)". These are clearly hardware components. The performance studies also mention testing of hardware aspects like electrical and electromagnetic safety, fluid path materials, and heat/chemical disinfections.
Based on the provided text, the Tablo™ System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use describes the device as being used for hemodialysis in patients with renal failure. This is a therapeutic treatment performed directly on the patient, not a test performed on a sample taken from the patient.
- Device Description: The description details a hemodialysis system with a Dialysis Delivery System and a Water Purification System. These components are involved in the process of filtering the patient's blood, which is a therapeutic function.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on the analysis of samples
- Using reagents or assays to detect specific substances in samples
The Tablo™ System is a therapeutic medical device used for hemodialysis.
N/A
Intended Use / 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 trailable as needed who is considered competent in the use of the device by the prescribing physician.
Product codes
KDI, FIP
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.
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
Not Found
Intended User / Care Setting
acute or chronic care facility
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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.
Key results: 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are black against a white background.
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)
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.
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 Summary | |
| Preparation: | March 31, 2014 |
5.2 Device Information
| Trade Name: | Tablo™ Console | |
|---|---|---|
| Common Name: | Hemodialysis Delivery System | Portable Water Treatment |
| System | ||
| Classification Name: | High Permeability Hemodialysis | |
| Delivery System | Water Purification System for | |
| Hemodialysis | ||
| 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
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.
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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.
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:
- . 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.