(235 days)
The Tablo® Hemodialysis System and TabloCart™ is indicated for use in patients with acute and/or chronic renal failure, with or without ultration, in an acute or chronic care facility. Treatments must be administered under physician's prescription and observed by a trained individual who is considered competent in the use of the Tablo Hemodialysis System is also indicated for use in the home. Treatment types available include Intermittent Hemodialysis (IHD), Sustained Low Efficiency Dialysis (SLED/ SLEDD), Prolonged Intermittent Renal Replacement Therapy (PIRRT), and Isolated Ultrafiltration.
The Tablo® Hemodialysis System is a self-contained hemodialysis system intended for acute and chronic dialysis therapy, with or without ultrafiltration, in an acute, chronic care facility or in the home. The Tablo Hemodialysis System consists of: Tablo Console and Software, Tablo Cartridge. The TabloCart™ is an optional accessory to the Tablo Hemodialysis System that raises the height of the Tablo console and includes larger wheels that rotate and lock in more functional directions than the Tablo console without a cart, aiding in overall system mobility. When configured with a Prefiltration Drawer, the cart has replaceable, large-capacity cartridge filters (sediment and/or carbon) that serve as "prefilters" to help remove major sediment and chlorine/chloramines from supply water before it enters the Tablo console's water purification system. The cart with prefiltration also includes backflow prevention and a booster pump to transport water from the incoming water supply to the Tablo console. The TabloCart with Prefiltration Drawer consists of: Tablo Cart Wheeled Platform, Fluidics Drawer and Software.
The provided document is an FDA 510(k) Premarket Notification review letter for the Tablo® Hemodialysis System; TabloCart™ with Prefiltration Drawer (K232776). This document primarily focuses on demonstrating substantial equivalence to a predicate device (Tablo Hemodialysis System, K223248) rather than detailing specific acceptance criteria and a study proving the device meets those criteria in the context of device performance metrics (e.g., accuracy, sensitivity, specificity for an AI/algorithm-based device).
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" as requested in the prompt typically refer to a device's performance against predefined metrics (e.g., clinical accuracy, diagnostic performance, or a specific functional output) which are common for AI/algorithm-based devices. However, the Tablo Hemodialysis System and its accessory cart are not an AI/algorithm-based device in the common sense (e.g., for image analysis or disease diagnosis). Instead, it's a medical device for renal replacement therapy, and the 510(k) submission focuses on demonstrating that the new accessory (the cart with prefiltration) does not alter the fundamental safety and effectiveness of the existing, cleared hemodialysis system.
Therefore, many of the specific questions in the prompt (e.g., sample size for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to this type of device and submission. The "study" proving acceptance criteria here is primarily a series of bench performance tests, biocompatibility testing, electromagnetic compatibility (EMC) and electrical safety testing, and software verification and validation testing to confirm that the addition of the cart does not negatively impact the established safety and performance of the base hemodialysis system.
Here's an attempt to address the prompt based on the available information, highlighting what is applicable and what is not:
Acceptance Criteria and Study Proving Device Meets Acceptance Criteria for the Tablo® Hemodialysis System with TabloCart™ with Prefiltration Drawer (K232776)
Given that this 510(k) submission is for an accessory cart to an already cleared hemodialysis system, the "acceptance criteria" revolve around demonstrating that the modified device (system with cart) maintains the same safety and effectiveness as the predicate device (system without cart). The "study" is a compilation of various engineering and performance tests rather than a single clinical trial or AI validation study.
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device and submission, the acceptance criteria are largely implied by demonstrating substantial equivalence to the predicate device. They are not typically laid out as quantitative performance metrics (like accuracy or sensitivity) as would be for an AI diagnostic device. Instead, they relate to maintaining fundamental safety, performance, and functionality.
| Acceptance Criteria (Implied) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Maintenance of Predicate Indications for Use | The Tablo® Hemodialysis System and TabloCart retains the same Indications for Use as the predicate Tablo Hemodialysis System (K223248), with the addition of "and TabloCart" to the statement. This indicates that the addition of the cart does not change the medical conditions for which the device is intended. |
| Maintenance of Predicate Intended Use | The primary intended use of the Tablo Hemodialysis System (treatment of ESRD patients needing hemodialysis) remains unchanged. The TabloCart has its own specific intended use as an accessory (increased height, improved mobility, additional prefiltration), which complements, rather than alters, the console's existing intended use. |
| Biocompatibility | Materials used for the Tablo Hemodialysis System and the TabloCart with Prefiltration Drawer are considered equivalent to the predicate. Biocompatibility evidence was provided in the submission. |
| Electromagnetic Compatibility (EMC) and Electrical Safety | No difference in EMC and electrical safety from the predicate device was found. Existing evidence from K223248, which included the Tablo Hemodialysis System and TabloCart with Prefiltration (implying this configuration was already considered in the predicate's testing), was deemed sufficient. No additional testing was needed. |
| Software Functionality and Safety | The cart's software functions independently of the console's software. If the cart's software fails, it enters bypass mode without interrupting the console's operation. Software verification and validation (V&V) testing was conducted and passed at the system level (console with cart). The cart's software was assessed as a Minor Level of Concern according to FDA guidance. Cybersecurity risks were evaluated. This demonstrates that the addition of the cart does not introduce new software-related safety- or effectiveness issues. |
| Sterilization & Shelf Life (Cleaning, Disinfection) | The TabloCart is a reusable, non-sterile accessory. Cleaning and disinfection methods for the cart are the same as for the predicate Tablo Hemodialysis System and are described in the device labeling. The addition of the cart does not modify the console's existing cleaning/disinfection protocols. |
| Bench Performance (Physical/Mechanical Functionality, Water Filtration) | Additional bench testing was conducted to support the accessory TabloCart with Prefiltration, focused on its new functionalities (e.g., mobility, physical dimensions, prefiltration capabilities). While specific metrics are not detailed in the summary, the "performance characterization of the subject device is the predicate Tablo Hemodialysis System" indicating that the core hemodialysis function is maintained, and the cart's new features perform as intended without compromising the primary device. This includes the cart's ability to "help remove major sediment and chlorine/chloramines from supply water" before it enters the console's purification system, implying successful filtration performance. Specific configurations of filters (2S, 2C, SC) are noted, suggesting testing for these variants. |
| No New Human Factors Issues | No new Human Factors validation study was deemed necessary. This implies that the usability and user interaction with the system, even with the added cart, are not negatively impacted or present new risks, maintaining consistency with the predicate device's established usability. |
2. Sample size used for the test set and the data provenance:
- Not applicable in the context of typical AI/algorithm test sets. The "test set" here refers to the physical device and its components undergoing engineering and functional verification.
- Data Provenance: The testing was conducted by the manufacturer, Outset Medical, Inc., presumably in their facilities (San Jose, CA, USA). The studies are prospective in the sense that they were designed and executed specifically to support this 510(k) submission for the modified device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not an AI/diagnostic device where expert consensus defines a "ground truth" for disease states in a dataset. "Ground truth" for this device is based on engineering specifications, physical measurements, chemical analysis (for water purity), and functional performance verification against design requirements. The "experts" involved would be engineers, quality control personnel, and regulatory specialists within Outset Medical, Inc.
4. Adjudication method for the test set:
- Not applicable. Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in expert interpretations of data (e.g., medical images). For engineering tests, results are typically objective measurements or pass/fail criteria based on predefined specifications.
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:
- Not applicable. This is not an AI-assisted diagnostic device, so MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical hemodialysis system with an accessory, not a standalone algorithm.
7. The type of ground truth used:
- Engineering Specifications and Physical/Chemical Standards: For example, the ground truth for water quality would be established by relevant water quality standards for hemodialysis (e.g., AAMI standards). For mechanical aspects, it would be the design specifications (dimensions, mobility, filter capacity). For software, it would be the functional requirements and safety standards.
8. The sample size for the training set:
- Not applicable. This refers to machine learning models, which is not what this device is.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym with the full name of the agency on the right. The FDA part is in blue, with the acronym in a solid blue square and the full name written in a smaller font next to it.
May 3, 2024
Outset Medical, Inc. Joshua J. Mink Senior Manager, Regulatory Affairs 3052 Orchard Drive San Jose, CA 95134
Re: K232776
Trade/Device Name: Tablo® Hemodialysis System; TabloCart™ with Prefiltration Drawer Regulation Number: 21 CFR§ 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI, FIP Dated: April 29, 2024 Received: April 30, 2024
Dear Joshua J. Mink:
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.
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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" (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 QS 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.
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3
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 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 -S
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
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Indications for Use
510(k) Number (if known) K232776
Device Name Tablo® Hemodialysis System; TabloCart™ with Prefiltration Drawer
Indications for Use (Describe)
The Tablo® Hemodialysis System and TabloCart™ is indicated for use in patients with acute and/or chronic renal failure, with or without ultration, in an acute or chronic care facility. Treatments must be administered under physician's prescription and observed by a trained individual who is considered competent in the use of the Tablo Hemodialysis System is also indicated for use in the home. Treatment types available include Intermittent Hemodialysis (IHD), Sustained Low Efficiency Dialysis (SLED/ SLEDD), Prolonged Intermittent Renal Replacement Therapy (PIRRT), and Isolated Ultrafiltration.
| 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) |
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510(k) Summary
(21 CFR § 807.92)
I. SUBMITTER
| Name: | Outset Medical, Inc.3052 Orchard DriveSan Jose, CA 95134 |
|---|---|
| Contact Details: | Joshua MinkSenior Manager, Regulatory AffairsOutset Medical, Inc.+1 (979) 229-6998jmink@outsetmedical.com |
Date Prepared:
September 8, 2023
II. DEVICE
| Trade/Proprietary Name: | Tablo® Hemodialysis SystemTabloCart™ with Prefiltration Drawer |
|---|---|
| Common /Generic Name: | High Permeability Hemodialysis System |
| Classification Regulations: | 21 CFR § 876.5860 – High permeability hemodialysis system21 CFR § 876.5665 – Water purification system for hemodialysis |
| Product Codes: | KDI; FIP |
| Regulatory Class: | Class II |
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III. PREDICATE DEVICE
The legally marketed predicate device to which substantial equivalence is claimed: Tablo Hemodialysis System, K223248
IV. MODIFICATION TO THE EXISTING DEVICE
Modifications described in this Traditional 510(k) do not add, delete, or modify the description of the currently marketed Tablo® Hemodialysis System², cleared under K223248. The system has been modified to include addition of an optional prefiltration cart without altering the system's intended use, indications for use, incoming water specifications or the fundamental scientific technology or principle of operation for the system.
The TabloCart™ with Prefiltration Drawer² is an optional accessory to the Tablo Hemodialysis System that raises the height of the system and includes larger wheels that rotate and lock in more functional directions than the system without cart, aiding in system mobility. When configured with a prefiltration drawer, the cart has replaceable, large-capacity cartridge filters (sediment and/or carbon) that serve as "prefilters" to help remove major sediment and chlorine/chloramines from supply water before it enters the Tablo Water Purification System. The cart with prefiltration also includes backflow prevention and a booster pump to help transport water from the incoming supply to the Tablo System.
4 The Tablo® Hemodialysis System may be referenced synonymously throughout supporting documentation as "Tablo System" | "System" | "Console" | "Tablo X".
² The TabloCart™ with Prefiltration Drawer may be referenced synonymously throughout supporting documentation as "TabloCart" | "cart" | "accessory cart" | "Fluid Motion" | "prefiltration cart"
V. INDICATION FOR USE
There is no change to the intended use or indication for use for the subject device when compared to the predicate device cleared under K223248. The optional accessory cart has the same indications for use as the predicate device with the addition of "and TabloCart" to the statement, as listed below.
Indications for Use (Tablo Hemodialysis System, K223248):
The Tablo® Hemodialysis 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 and observed by a trained individual who is considered competent in the use of the device. The Tablo Hemodialysis System is also indicated for use in the home. Treatment types available intermittent Hemodialysis (IHD), Sustained Low Efficiency Dialysis (SLED/ SLEDD), Prolonged Intermittent Renal Replacement Therapy (PIRRT), and Isolated Ultrafiltration.
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Indications for Use (TabloCart with Prefiltration Drawer):
The Tablo® Hemodialysis System and TabloCart 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 and observed by a trained individual who is considered competent in the use of the device. The Tablo Hemodialysis System is also indicated for use in the home. Treatment types available include Intermittent Hemodialysis (IHD), Sustained Low Efficiency Dialysis (SLED), Prolonged Intermittent Renal Replacement Therapy (PIRRT), and Isolated Ultrafiltration.
Use, or non-use, of the TabloCart with Prefiltration Drawer has no impact to the Tablo Hemodialysis System's intended use or indications for use.
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VI. INTENDED USE
There is no change to the intended use for the Tablo Console, cleared under K223248. Addition of the optional accessory cart does introduce a modified intended use specific to the cart, as listed below.
Intended Use (Tablo Hemodialysis System, K223248):
The intended use of the Tablo Hemodialysis System is for treatment of patients with end stage renal disease (ESRD) who require hemodialysis, with or without ultrafiltration, through a vascular access (i.e., fistula, graft, catheter).
Intended Use (TabloCart with Prefiltration Drawer):
The TabloCart with Prefiltration Drawer is intended to serve as an optional accessory to the Tablo Hemodialysis System, when increased height, improved mobility or additional, large capacity filters for sediment and/or chlorine/chloramine reduction are desired.
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VII. DEVICE DESCRIPTION
The Tablo® Hemodialysis System is a self-contained hemodialysis system intended for acute and chronic dialysis therapy, with or without ultrafiltration, in an acute, chronic care facility or in the home.
The Tablo Hemodialysis System consists of:
- Tablo Console and Software
- Tablo Cartridge
The TabloCart™ is an optional accessory to the Tablo Hemodialysis System that raises the height of the Tablo console and includes larger wheels that rotate and lock in more functional directions than the Tablo console without a cart, aiding in overall system mobility. When configured with a Prefiltration Drawer, the cart has replaceable, large-capacity cartridge filters (sediment and/or carbon) that serve as "prefilters" to help remove major sediment and chlorine/chloramines from supply water before it enters the Tablo console's water purification system. The cart with prefiltration also includes backflow prevention and a booster pump to transport water from the incoming water supply to the Tablo console.
The TabloCart with Prefiltration Drawer consists of:
- Tablo Cart Wheeled Platform, Fluidics Drawer and Software o
Figure 5-1 provides an overview of the Tablo Hemodialysis System mounted to the optional TabloCart with Prefiltration Drawer. The TabloCart is designed for compatibility with the Tablo Hemodialysis System only.
Image /page/8/Picture/11 description: The image shows a Tablo System and TabloCart with Prefiltration Drawer. The Tablo System is a medical device used for hemodialysis. The TabloCart is a cart that is used to transport the Tablo System. The Prefiltration Drawer is a drawer that is used to store prefiltration supplies.
Figure 5-1: Tablo Hemodialysis System mounted to optional accessory, the TabloCart with Prefiltration Drawer
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The Tablo Hemodialysis System is designed to operate as intended with or without use of the optional cart and the cart is compatible only with the Tablo Hemodialysis System. The proposed accessory cart does not affect the functionality of the Tablo Hemodialysis System, cleared under K223248.
Accessories supplied by Outset Medical is unchanged from those described in K223248 (See 11.1 Device Variant and Accessories) with the exception of the accessory TabloCart. The list of dialysis treatment accessories supplied by OEMs also remains unchanged from those identified in K223248.
VII. SUBSTANTIAL EQUIVALENCE
In accordance with The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications 510(k), Outset Medical, Inc. (Outset) has reached the conclusion that the Tablo Hemodialysis System and TabloCart with Prefiltration Drawer is substantially equivalent to the predicate Tablo Hemodialysis System (without accessory cart). The predicate device is legally marketed and the system with and without the TabloCart have the same intended use. No new issues of safety or effectiveness were raised by the minor differences in technological characteristics.
Section 12- Substantial Equivalence provides a detailed comparison of the technological characteristics for the predicate and subject device. The comparison table also provides a discussion for why any differences between the predicate and subject device do not impact the safety or effectiveness of the device. A summary of this comparison is provided below in Table 5.1.
Completed verification and validation of the device supports the safety and effectiveness of the subject Tablo Hemodialysis System and TabloCart with Prefiltration Drawer. The results demonstrate that the Tablo console with optional cart is substantially equivalent to the predicate, legally marketed device, cleared under K223248.
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| Parameter | Tablo Hemodialysis System(Predicate, K223248) | Tablo Hemodialysis System andTabloCart with Prefiltration Drawer(Subject Device) |
|---|---|---|
| Indications forUse | The Tablo® Hemodialysis System is indicatedfor use in patients with acute and/or chronicrenal failure, with or without ultrafiltration, inan acute or chronic care facility. Treatmentsmust be administered under physician'sprescription and observed by a trainedindividual who is considered competent in theuse of the device. The Tablo HemodialysisSystem is also indicated for use in the Home.Treatment types available include:Intermittent Hemodialysis (IHD), SustainedLow Efficiency Dialysis (SLED/ SLEDD),Prolonged Intermittent Renal ReplacementTherapy (PIRRT), and Isolated Ultrafiltration. | The Tablo® Hemodialysis System andTabloCart is indicated for use in patients withacute and/or chronic renal failure, with orwithout ultrafiltration, in an acute or chroniccare facility. Treatments must beadministered under physician's prescriptionand observed by a trained individual who isconsidered competent in the use of thedevice. The Tablo Hemodialysis System is alsoindicated for use in the Home. Treatmenttypes available include: IntermittentHemodialysis (IHD), Sustained Low EfficiencyDialysis (SLED/ SLEDD), ProlongedIntermittent Renal Replacement Therapy(PIRRT), and Isolated Ultrafiltration. |
| Class | II | II |
| CommonName | High Permeability Hemodialysis System | High Permeability Hemodialysis System |
| Product Code | KDI, FIP | KDI, FIP |
| ClassificationPanel | Gastroenterology / Urology | Gastroenterology / Urology |
| RegulationNumber | 21 CFR § 876.5860 High PermeabilityHemodialysis System21 CFR § 876.5665 Water Purification Systemfor Hemodialysis | 21 CFR § 876.5860 High PermeabilityHemodialysis System21 CFR § 876.5665 Water Purification Systemfor Hemodialysis |
| Intended Use | The intended use of the Tablo HemodialysisSystem is for treatment of patients with endstage renal disease (ESRD) who requirehemodialysis, with or without ultrafiltration,through a vascular access (i.e., fistula, graft,catheter). | The intended use of the Tablo HemodialysisSystem is for treatment of patients with endstage renal disease (ESRD) who requirehemodialysis, with or without ultrafiltration,through a vascular access (i.e., fistula, graft,catheter).The TabloCart with Prefiltration is intended toserve as an optional accessory to the TabloHemodialysis System, when increased height,improved mobility or additional, largecapacity filters for sediment and/orchlorine/chloramine reduction are desired. |
| Parameter | Tablo Hemodialysis System(Predicate, K223248) | Tablo Hemodialysis System andTabloCart with Prefiltration Drawer(Subject Device) |
| ConfigurationComparison | Tablo Hemodialysis System: | Tablo Hemodialysis System mounted tooptional TabloCart with Prefiltration Drawer(configured as 2S, 2C or SC): |
| Tablo Console Physical Dimensions:• Floor Space: 19 in. x 17.5 in.• System Height: 35.2 in.• Dry Weight: 195 lbs. | Tablo Console Physical Dimensions:• Floor Space: 19 in. x 17.5 in.• System Height: 35.2 in.• Dry Weight: 195 lbs. | |
| Accessory Cart Physical Dimensions: N/A | Accessory Cart Physical Dimensions:• Floor Space: 30 in. x 22.5 in.• Height: 11.1 in.• Dry Weight: 34 lbs. (15.42 kg) | |
| Mobility:• Four (4) rolling wheels• Two (2) roll-locking wheels (front)and• Two (2) 360° swiveling wheels (rear) | Mobility:• Four (4) 360° swiveling wheels• Two (2) directional-locking and roll-locking wheels (front)and• Two (2) directional locking (rear) | |
| Supply Water FiltrationConsole:• Two (2) carbon filters• One (1) sediment filter• One (1) Water Ultrafilter | Supply Water FiltrationConsole:• Two (2) carbon filters• One (1) sediment filter• One (1) Water Ultrafilter | |
| Accessory Cart with Prefiltration:N/A | Accessory Cart with Prefiltration:• 2S: two (2) sediment filtersor• 2C: two (2) carbon filtersor• SC: one (1) sediment filter andone (1) carbon filter | |
| Parameter | Tablo Hemodialysis System(Predicate, K223248) | Tablo Hemodialysis System and TabloCartwith Prefiltration Drawer(Subject Device) |
| ConsoleImage | Image: Tablo Hemodialysis System | Image: Tablo Hemodialysis System and TabloCart with Prefiltration Drawer |
| Filtration,Volume | TabloHemodialysisSystemImage: Filtration System | Tablo Hemodialysis System andTabloCart with Prefiltration DrawerCombined Carbon and SedimentImage: Filtration System+Image: Prefiltration Drawer |
Table 5.1 Summarized Comparison Table
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Table 5.1 Summarized Comparison Table (Continued)
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Table 5.1 Summarized Comparison Table (Continued)
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VIII. PERFORMANCE DATA
The following performance data has been provided in support of the substantial equivalence determination.
Biocompatibility Testing
Comparative evaluation of the materials used for the Tablo Hemodialysis System and the TabloCart with Prefiltration Drawer are considered equivalent to the predicate Tablo Hemodialysis System cleared under K223248. Biocompatibility evidence is detailed in Section 15.
Electromagnetic Compatibility (EMC) and Electrical Safety
The subject device has no difference in the EMC and electrical safety from the predicate device, cleared in K223248. EMC and electrical safety evidence provided in K223248 included the Tablo Hemodialysis System and TabloCart with Prefiltration. Therefore, no additional electrical safety or EMC testing was conducted to support modified device. Current evidence is provided in Section 17 – Electromagnetic Compatibility and Electrical Safety.
Software Verification and Validation Testing
The software for the Tablo Hemodialysis System is not impacted by use, or non-use, of the TabloCart with Prefiltration. The cart is a water pre-filtration system for processing water before entry into the Tablo's water purification system, and its software functions independently from the Console. The software for the TabloCart with Prefiltration Drawer does not directly interact with the software installed on the Tablo Console. If any failure of the cart's software occurs, the cart will enter bypass mode, with operation of the Tablo Console uninterrupted.
Software verification and validation testing was conducted and passed at the system level for the Tablo Hemodialysis System connected to the optional TabloCart with Prefiltration Drawer accessory. The Documentation provided is per FDA's Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, with the TabloCart software assessed as a Minor Level of Concern. Completed software testing, including evaluation of cybersecurity risks, supports that the safety and effectiveness of the system with optional cart is substantially equivalent to the predicate. Software evidence is detailed in Section 16.
Sterilization and Shelf Life (Cleaning, Disinfection)
The TabloCart with Prefiltration is a reusable, non-sterile accessory to the Tablo Hemodialysis System. Cleaning and disinfection methods for the optional cart are the same as for the predicate Tablo Hemodialysis System (K223248) and have been described in the device labeling, for Tablo Console and TabloCart Instructions for Use in Section 13 - Labeling.
Table Hemodialysis System (Console) labeling cleared under K223248 has not been modified by the addition of the TabloCart with Prefiltration Drawer, except for the addition of standalone labeling and instructions for use specific to the TabloCart.
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Bench Performance Testing
Additional bench testing was conducted to support the accessory TabloCart with Prefiltration. The performance characterization of the subject device is the predicate Tablo Hemodialysis System (cleared under K223248).
No new Human Factors validation study was deemed necessary for the updated Tablo Hemodialysis System and TabloCart with Prefiltration Drawer.
Animal Study
No animal studies were conducted to support the Tablo Hemodialysis System and TabloCart.
Clinical Studies
No clinical studies were conducted to support the updated Tablo® Hemodialysis System and TabloCart with Prefiltration Drawer.
IX. CONCLUSION
The completed verification and validation of the device supports the safety and effectiveness of the subject Tablo® Hemodialysis System mounted atop the optional TabloCart™ with Prefiltration Drawer. The results demonstrate that the addition of the TabloCart™ with Prefiltration Drawer to the Tablo Hemodialysis System is substantially equivalent to the predicate, legally marketed device cleared under K223248.
§ 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.”