(259 days)
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, with a trained individual available as needed who is considered competent in the use of the prescribing physician.
The Tablo® Cartridge is a single use, disposable arterial and venous bloodline set intended to provide extra-corporeal access during hemodialysis. The Tablo Cartridge is compatible only with the Tablo Hemodialysis System.
The Tablo Hemodialysis System is a self-contained hemodialysis system intended for acute and chronic dialysis therapy, with or without ultrafiltration, in an acute or chronic care facility. The system's innovative design includes the:
- . Tablo Console, a single module consisting of multiple fluidic systems that perform the activities of a water purification system (WPS) and a conventional dialysis delivery system (DDS), and
- Tablo Cartridge, a single use blood tubing set attached to an organizer tray. The ethylene oxide (EO) sterilized and disposable cartridge is inserted onto the front panel of the console for each dialysis treatment (Figure 1).
- . Tablo Script, an accessory software to the Tablo Console, is designed for use by medical professionals to a) prepare, update and verify patient dialysis prescriptions b) view and export dialysis treatment information and billing activities and c) set and modify Tablo Console settings. Note: Tablo Script is optional, patient prescriptions can still be created or changed directly on the Tablo Console.
Here's a breakdown of the acceptance criteria and study findings for the Tablo Hemodialysis System and Tablo Cartridge, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria | Result |
|---|---|---|
| Biocompatibility testing (Tablo Cartridge) | Tests included Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, Hemocompatibility, Genotoxicity, as per FDA guidance "Hemodialysis Blood Tubing Sets - Premarket Notification [510(k)] Submissions." Results must be passing under individual test conditions. | Pass |
| Biocompatibility testing (Tablo Console fluid contact materials) | Leachable testing conducted in accordance with FDA Guidance for the Content of Premarket Notifications for Hemodialysis Delivery Systems. Toxicological assessment confirms materials are safe for intended use. | Pass |
| Electrical safety and electromagnetic compatibility (EMC) | System complies with ES 60601-1, main and its collateral standards. | Pass |
| Software Verification and Validation Testing | Documentation provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (Major level of concern: failure could result in serious injury or death). | Pass |
| Device Performance (Shelf Life and Sterilization) | Device meets performance requirements following 1 year accelerated aging. | Pass |
| Packaging integrity (Shelf Life and Sterilization) | Packaging system meets performance requirements following 1 year accelerated aging. | Pass |
| Sterilization (Shelf Life and Sterilization) | Device is EO sterilized, meets SAL of 10^-6. | Pass |
| EO residuals (Shelf Life and Sterilization) | Meets ISO 10993-7 for prolonged contact device. | Pass |
| Bacterial endotoxin (LAL) testing (Shelf Life and Sterilization) | Meets ANSI/AAMI ST72. | Pass |
| 1. Environmental Operation (Bench Performance Testing) | The device shall meet the system requirements for environmental operation. | Pass |
| 2. Transit (Bench Performance Testing) | The system shall operate within specification after transit. | Pass |
| 3. Prime Discard (Bench Performance Testing) | The Tablo Cartridge shall meet the requirements for prime discard. | Pass |
| 4. Pinch Valve (Bench Performance Testing) | The system shall meet requirements for the blood and saline pinch valves. | Pass |
| 5. Maximum Power (Bench Performance Testing) | The system shall meet requirements for maximum power and current. | Pass |
| 6. Dialyzer Compatibility (Bench Performance Testing) | The system shall be compatible with hemodialyzers of sizes with the following ranges: Major Diameter: 2.14 - 2.75", Minor Diameter: 1.45 - 2.05", Total Length: 11.55 - 13.15", Dialysate Port Distance: 8.15 - 9.55". | Pass |
| 7. External Device Compatibility (Bench Performance Testing) | The system shall be compatible with external devices (i.e., external infusion pump, manual syringe injection of saline bolus and Transonic sensors (Transonic part number H4FX)). | Pass |
| 8. Cartridge Hemolysis Testing, 12 Hours (Bench Performance Testing) | The increase in hemolysis in a sample of blood circulating through the fluidic path during treatment as compared to a control sample of blood idle for the same amount of time shall not exceed 1%. The system shall meet its hemolysis requirements with a Crit-Line blood chamber (Fresenius part number 191058) connected within the extracorporeal circuit. | Pass |
| 9. Various hardware (Bench Performance Testing) | The system shall meet the following requirements for various hardware. | Pass |
| 10. Water Ingress (IP21) (Bench Performance Testing) | The console enclosure shall have an IP21 ingress protection rating per IEC 60529. | Pass |
| 11. Mechanical (Bench Performance Testing) | The system shall meet requirements for labeled priming volume, be designed with an ultrafilter that removes microbial materials and particles > 5nm, shall be designed with the required ports so that sampling for monitoring can be taken. | Pass |
| 12. Front Panel Interface with Cartridge Installed (Bench Performance Testing) | The system shall meet the following requirements for front panel interface with the cartridge installed. | Pass |
| 13. Essential Performance per IEC 60601-2-16 (Bench Performance Testing) | The system shall meet Essential Performance per IEC 60601-2-16. | Pass |
| 14. Battery Failure (Bench Performance Testing) | The system shall prevent treatment initiation if it detects a low battery voltage. | Pass |
| 15. AAMI Water and Dialysate Quality (Bench Performance Testing) | The system shall meet ANSI/AAMI 13959:2014 and ANSI/AAMI 11663:2014 requirements for water and dialysate. | Pass |
| 16. Total Dissolved Solids (Bench Performance Testing) | - Water sample results meet ANSI/AAMI 13959 toxic contaminant standards and ISO 23500 trace element standards. - Water from the Post RO sample port meets ISO 23500 electrolyte concentration limits when prepared from water with hardness of 150 mg/L. | Pass |
| 17. Water Treatment System (Bench Performance Testing) | The system shall meet requirements for a water treatment system. | Pass |
| 18. Dialysate flow and Conductivity Monitoring (Bench Performance Testing) | The system shall meet requirements for dialysate flow, temperature, volume, and conductivity monitoring. | Pass |
| 19. Air-In-Line (Bench Performance Testing) | The system shall meet requirements related to the system's purging and detection of air bubbles in the extracorporeal circuit. | Pass |
| 20. Pre-Treatment Mode (Bench Performance Testing) | The system shall meet requirements for pre-treatment mode. | Pass |
| 21. Post-Treatment Mode (Bench Performance Testing) | The system shall meet requirements for post-treatment mode. | Pass |
| 22. Blood Pump and Pinch Valve Control, and Saline Delivery Performance (Bench Performance Testing) | The system shall meet requirements for operation, performance, and control of the peristaltic blood pump. | Pass |
| 23. Heat Disinfection Mode (Bench Performance Testing) | The system shall meet requirements for heat disinfection mode. | Pass |
| 24. Chemical Disinfection Mode (Bench Performance Testing) | The system shall meet requirements for chemical disinfection mode. | Pass |
| 25. Ultrafiltration Accuracy (Bench Performance Testing) | The system shall provide a treatment fluid removal accuracy of +/- 100 mL per hour of the treatment time. | Pass |
| 26. Maintenance and Service User (Bench Performance Testing) | The system shall meet requirements for maintenance and service user. | Pass |
| 27. Maintenance and Service User (Mock Treatments) (Bench Performance Testing) | The system shall allow the user to run mock treatments in Service Interface without the need of a Patient USB. | Pass |
| 28. Heat and Chemical Disinfection Effectiveness (Bench Performance Testing) | Disinfection validation was performed on n=3 consoles per organism, totaling n=6 consoles to demonstrate that chemical and heat disinfection cycles reduce vegetative bacterial species (e.g., Pseudomonas aeruginosa) by six logs and non-tuberculous Mycobacterium species (e.g., Mycobacterium terrae) by three logs. | Pass |
| 29. External Disinfectant Chemical Compatibility Testing (IEC 60601-2-16 Test) (Bench Performance Testing) | The system and its accessories shall be capable of withstanding daily cleaning, using specified chemicals (70% Isopropyl Alcohol, 10% bleach, PDI Super Sani Cloth Germicidal Wipes, CaviWipes, CaviWipes1 Disinfecting Wipe, Oxivir 5, Oxivir TB Wipes) over the service life of the device per the chemical manufacturer instructions. | Pass |
| 30. Bring Your Own Concentrate Conductivity Test (Bench Performance Testing) | The system shall be compatible with dialysis fluid concentrates intended for a 45X-proportioning ratio. When mixed at a 45X ratio, the acid concentrate should comply with the following labeled formulation range: Sodium 100 mEq/L, Potassium 0 - 4 mEq/L, Calcium 0 - 3.5 mEq/L, Acetate 4 mEq/L. | Pass |
| 31. Human Factors Validation (Bench Performance Testing) | The system shall be assessed for usability with representative users (i.e., nurses and patient care technicians in clinical settings and acute-care facilities) in accordance with its intended use/indications for use. | Pass |
The document states that "Non-clinical testing supports the safety and effectiveness of the Tablo Hemodialysis System and Tablo Cartridge. The bench testing demonstrates that the device systems comparably to the predicate device and is substantially equivalent to the legally marketed device." This implies that all listed acceptance criteria were met.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state a general "test set" sample size for all performance tests. Specific sample sizes are mentioned for certain tests:
- Shelf Life and Sterilization Testing: The specifics of how many cartridges were subjected to accelerated aging are not detailed, but it's implied that the testing was sufficient to justify a 12-month shelf life.
- Heat and Chemical Disinfection Effectiveness: n=3 consoles per organism, totaling n=6 consoles for disinfection validation.
- Data Provenance: The data is from non-clinical bench performance testing and biocompatibility testing. It is not patient-derived data. The country of origin is not specified but implicitly refers to testing performed by or for Outset Medical, Inc., a U.S. company. The studies are prospective in the sense that they were designed and executed to evaluate the device.
3. Number of Experts and Qualifications for Ground Truth
- Ground Truth for Biocompatibility: Not applicable in the sense of expert consensus on qualitative data. The ground truth here is derived from standardized laboratory tests and their established pass/fail criteria (e.g., cytotoxicity, sensitization, hemocompatibility). Interpretation of these results would be done by qualified laboratory personnel and toxicologists. The specific number and qualifications are not detailed.
- Ground Truth for Performance Testing: Not applicable. Performance tests (e.g., flow rates, pressures, temperatures, disinfection efficacy, ultrafiltration accuracy) are measured against predefined engineering and regulatory specifications and standards (e.g., IEC standards, AAMI standards). The ground truth is the objective measurement comparing the device's output to these quantitative standards.
- Ground Truth for Human Factors Validation: The "ground truth" here is the assessment of usability in accordance with intended use. While representative users (nurses and patient care technicians) are involved, the document does not specify the number of experts (e.g., human factors engineers) who established the protocol or interpreted the findings, nor their specific qualifications.
4. Adjudication Method for the Test Set
The concept of an "adjudication method" (like 2+1, 3+1) typically applies to studies where human readers are interpreting ambiguous data (e.g., medical images, clinical diagnoses) and discrepancies need to be resolved. This is not applicable to the non-clinical, objective functional and safety performance tests described for the Tablo Hemodialysis System. The results are based on direct measurements and adherence to engineering and biological standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study typically evaluates the diagnostic performance or interpretative accuracy of humans (with or without AI assistance) on a set of cases. The studies presented are non-clinical engineering and safety performance tests of a medical device.
6. Standalone Performance Study (Algorithm Only)
The term "standalone" performance usually refers to the algorithm's performance without human intervention, particularly in the context of AI/software. While "Software Verification and Validation Testing" was performed for the Tablo system, the documentation doesn't describe it as an isolated algorithm performance study in the way an AI diagnostic tool would be evaluated. The software is an integrated component controlling the physical device, and its validation is part of the overall system's functional assessment. Therefore, a standalone algorithm performance study, as typically understood for AI, was not explicitly detailed as such.
7. Type of Ground Truth Used
The ground truth used for these studies is primarily:
- Established industry standards and regulatory guidelines: Examples include ISO 10993-7, ANSI/AAMI ST72, ES 60601-1, IEC 60601-2-16, ANSI/AAMI 13959:2014, ANSI/AAMI 11663:2014, and ISO 23500.
- Engineering specifications and design requirements: These define the expected performance of various components and the system as a whole (e.g., maximum power, dialyzer compatibility dimensions, ultrafiltration accuracy of +/- 100 mL/hr, specified concentrate parameters).
- Biological and chemical pass/fail criteria: For biocompatibility, sterilization, and disinfection effectiveness tests, which are based on scientific principles and regulatory limits.
There are no mentions of expert consensus, pathology, or outcomes data being directly used to establish the ground truth for these specific non-clinical tests.
8. Sample Size for the Training Set
Not applicable. This document describes the performance testing of a physical medical device (hemodialysis system and cartridge), not an AI algorithm that requires a "training set" of data. The software within the device underwent verification and validation, but this is distinct from machine learning model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As mentioned above, this is not an AI algorithm document where a training set and its ground truth would be relevant.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 12, 2019
Outset Medical, Inc. Jennifer Mascioli-Tudor VP, Quality Assurance and Regulatory Affairs 1830 Bering Drive San Jose, CA 95112
Re: K190793
Trade/Device Name: Tablo® Hemodialysis System Tablo® Cartridge Regulation Number: 21 CFR 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: II Product Code: KDI, FIP, FJK Dated: April 16, 2019 Received: April 18, 2019
Dear Jennifer Mascioli-Tudor:
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. 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 located 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.
{1}------------------------------------------------
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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.
For comprehensive regulatory information about medical devices and radiation-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.
Carolyn Y. Neuland, Ph.D. 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 Ouality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K190793
Device Name
Tablo® Hemodialysis System, Tablo® Cartridge
Indications for Use (Describe)
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, with a trained individual available as needed who is considered competent in the use of the prescribing physician.
The Tablo® Cartridge is a single use, disposable arterial and venous bloodline set intended to provide extra-corporeal access during hemodialysis. The Tablo Cartridge is compatible only with the Tablo Hemodialysis System.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary
I. SUBMITTER
Outset Medical, Inc. 1830 Bering Drive San Jose, CA 95112
Phone: (669) 231-8200
| Primary Contact: | Jennifer Mascioli-Tudor |
|---|---|
| Secondary Contact: | Mara Marshak |
| Date Prepared: | November 8, 2019 |
II. DEVICE
Name of Device: Tablo® Hemodialysis System; Tablo® Cartridge
Common or Usual Name: Hemodialysis delivery system and water purification system; Blood tubing set
Classification Name: High Permeability Hemodialysis System (21 CFR § 876.5860) Product Code: KDI Water Purification System for Hemodialysis - Product Code: FIP Hemodialysis system and accessories – Product Code: FJK
Regulatory Class: II
III. PREDICATE DEVICE
Tablo Console, K160881; Tablo Cartridge, K140841
These predicates have not been subject to a design related recall.
No reference devices were used in this submission.
{4}------------------------------------------------
IV. 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 or chronic care facility. The system's innovative design includes the:
- . Tablo Console, a single module consisting of multiple fluidic systems that perform the activities of a water purification system (WPS) and a conventional dialysis delivery system (DDS), and
- Tablo Cartridge, a single use blood tubing set attached to an organizer tray. The ethylene oxide (EO) sterilized and disposable cartridge is inserted onto the front panel of the console for each dialysis treatment (Figure 1).
- . Tablo Script, an accessory software to the Tablo Console, is designed for use by medical professionals to a) prepare, update and verify patient dialysis prescriptions b) view and export dialysis treatment information and billing activities and c) set and modify Tablo Console settings. Note: Tablo Script is optional, patient prescriptions can still be created or changed directly on the Tablo Console.
Image /page/4/Picture/7 description: The image shows a Tablo Hemodialysis System. The machine is dark blue and has the word "tablo" printed on the side. The machine has wheels on the bottom, which makes it portable.
Console with Integrated Dialysis Delivery and Water Purification
Image /page/4/Picture/9 description: The image shows a medical device with a cartridge installed on the console front panel. The device has a screen on top that displays a tree graphic. The device is on wheels and has a door that is open, revealing the cartridge and other components. The device is likely used for some type of medical treatment or procedure.
Figure 1: Tablo Hemodialysis System with Cartridge Inserted
The following are accessories supplied by Outset for use with Tablo:
- Tablo Straws
- . Patient Key (USB)
- Outset Acid Concentrate 1K, 2K and 3K (Optional) ●
- Outset Bicarbonate Concentrate (Optional) ●
- Non-invasive Blood Pressure Cuff (NIPB) kit
- Hand-Crank
{5}------------------------------------------------
- Locking Power Cord
- . Drain Line
- Water Line
- Insert and straws for Minncare Cold Sterilant
Field Replaceable Units:
- Filter, Chlorine/Chloramines (Carbon Filter)
- Filter, Sediment
- Filter, RO Membrane
- . Ultrafilter (Water and Dialysate Ultrafilter)
The following are dialysis treatment recommended accessories which are commercially available by other manufacturers:
- High Flux Dialyzer
- Acid jug (If not using Outset Supplied Acid jug)
- Bicarbonate jug (If not using Outset Supplied Bicarbonate jug) ●
- Minncare Cold Sterilant
- . Chlorine/Chloramine test kit
- Saline bags
- Heparin
- Syringes and needles ●
- Gloves and mask
- Biohazard container
- Disinfectant, gauze pads, and tape for access site
V. INDICATIONS FOR USE
The identical indications for use statement, except for registered trademarks and clarified tradename, are as follows:
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, with a trained individual available as needed who is considered competent in the use of the device by the prescribing physician.
The Tablo® Cartridge is a single use, disposable arterial and venous bloodline set intended to provide extra-corporeal access during hemodialysis. The Tablo Cartridge is compatible only with the Tablo Hemodialysis System.
{6}------------------------------------------------
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The modified Tablo Hemodialysis System and Tablo Cartridge have the same fundamental technology, principle of operation, and principle functionality. The device is a high permeability hemodialysis system, which uses the same principle of reverse osmosis as its water purification system combined into one preconfigured integrated machine. The Tablo Cartridge is intended as the hemodialysis blood tubing set and has the same compatibility only with Tablo.
The subject and predicate devices are based on the following same technological elements:
- essential performance per IEC 60601-2-16
- internal water purification system
- dialysate delivery system
The following technological differences were described for the proposed device:
- Tablo Console Front Panel ●
- . Tablo Peristaltic Venous Air Pump (VAP)
- Tablo Active Conductivity
- Tablo Heaters and Thermal Management
- Tablo 60601-2-16 Sensor Changes
- Tablo Maintenance of AAMI Quality Water and Dialysate
- Tablo Thermistors
- Tablo Electrical Architecture
- . Tablo Diener Pumps
- Tablo Ultrafiltration Accuracy
- Tablo Chemical and Heat Validation
- . Cartridge Pouch as Prime Discard Receptacle
- Y Connector that attaches Arterial and Venous Lines together
- Minor Molded Organizer Tray Changes
- . Heparin Pump Removal and Infusion Line Minor ID Increase
- Tube Coiling and Length Increase
- Needleless Infusion Port Design ●
- . Shelf Life to 12 months
- Maximum Operating Pressure roll-up from Console
- Labeled Priming Volume
- Compatibility with Commercial Accessories
- Soft Power Switch
- Specification update for Treatment Time
- Allow the use of Non-Outset Branded Concentrates
- Allow entering patient prescription data directly on the console
- Improve reliability of wireless data transmission
{7}------------------------------------------------
VII. PERFORMANCE DATA
The following performance data were provided to support substantial equivalence of the device.
Biocompatibility testing
For the Tablo Cartridge, biocompatibility evaluation was conducted in accordance with the FDA guidance document, Hemodialysis Blood Tubing Sets - Premarket Notification [510(k)] Submissions, dated April 23, 2008. The battery of tests include the following tests for externally communicating devices, contacting circulating blood, prolonged contact Class II (Category B):
- Cytotoxicity
- Sensitization
- Intracutaneous reactivity
- Acute systemic toxicity
- Hemocompatibility
- Genotoxicity
Results were passing under the conditions of the individual tests.
For the fluid contact materials of the Tablo Console, in accordance with the FDA Guidance for the Content of Premarket Notifications for Hemodialysis Delivery Systems, issued August 7, 1998, Section VII, C, Outset Medical followed the alternative path and conducted leachable testing in lieu of biocompatibility tests. Toxicological assessment was performed and device materials are considered safe for use as intended.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Tablo Hemodialysis System, consisting of the blood tubing set cartridge and Tablo console. The system complies with the ES 60601-1, main and its collateral standards.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
| Test | Acceptance Criteria | Result |
|---|---|---|
| Device Performance | Device meets performance requirements following 1year accelerated aging | Pass |
| Packaging integrity | Packaging system meets performance requirementsfollowing 1 year accelerated aging. | Pass |
| Sterilization | Device is EO sterilized, meets SAL of 10-6 | Pass |
| EO residuals | Meets ISO 10993-7 for prolonged contact device | Pass |
| Bacterial endotoxin(LAL) testing | Meets ANSI/AAMI ST72 | Pass |
| Test Performed | Acceptance Criteria | Result |
| 1. EnvironmentalOperation | The device shall meet the system requirements forenvironmental operation. | Pass |
| 2. Transit | The system shall operate within specification after transit. | Pass |
| 3. Prime Discard | The Tablo Cartridge shall meet the requirements for primediscard. | Pass |
| 4. Pinch Valve | The system shall meet requirements for the blood andsaline pinch valves. | Pass |
| 5. Maximum Power | The system shall meet requirements for maximum powerand current. | Pass |
| 6. DialyzerCompatibility | The system shall be compatible with hemodialyzers ofsizes with the following ranges: | Pass |
| Major Diameter: 2.14 - 2.75"Minor Diameter: 1.45 - 2.05"Total Length: 11.55 - 13.15"Dialysate Port Distance: 8.15 - 9.55" | ||
| 7. External DeviceCompatibility | The system shall be compatible with external devices (i.e.,external infusion pump, manual syringe injection of salinebolus and Transonic sensors (Transonic part numberH4FX). | Pass |
| 8. CartridgeHemolysisTesting, 12 Hours | The increase in hemolysis in a sample of blood circulatingthrough the fluidic path during treatment as compared toa control sample of blood idle for the same amount oftime shall not exceed 1%. | Pass |
| The system shall meet its hemolysis requirements with aCrit-Line blood chamber (Fresenius part number 191058)connected within the extracorporeal circuit. | ||
| 9. Various hardware | The system shall meet the following requirements forvarious hardware. | Pass |
| 10. Water Ingress(IP21) | The console enclosure shall have an IP21 ingressprotection rating per IEC 60529. | Pass |
| 11. Mechanical | The system shall meet requirements for labeled primingvolume, be designed with an ultrafilter that removesmicrobial materials and particles > 5nm, shall be designedwith the required ports so that sampling for monitoringcan be taken. | Pass |
| 12. Front PanelInterface withCartridgeInstalled | The system shall meet the following requirements forfront panel interface with the cartridge installed. | Pass |
| 13. EssentialPerformanceper IEC 60601-2-16 | The system shall meet Essential Performance per IEC60601-2-16. | Pass |
| Test Performed | Acceptance Criteria | Result |
| 14. Battery Failure | The system shall prevent treatment initiation if it detects a low battery voltage. | Pass |
| 15. AAMI Waterand DialysateQuality | The system shall meet ANSI/AAMI 13959:2014 and ANSI/AAMI 11663:2014 requirements for water and dialysate. | Pass |
| 16. Total DissolvedSolids | The system shall meet the requirements for total dissolved solids:- Water sample results meet ANSI/AAMI 13959 toxic contaminant standards and ISO 23500 trace element standards- Water from the Post RO sample port meets ISO 23500 electrolyte concentration limits when prepared from water with hardness of 150 mg/L | Pass |
| 17. WaterTreatmentSystem | The system shall meet requirements for a water treatment system. | Pass |
| 18. Dialysate flowandConductivityMonitoring | The system shall meet requirements for dialysate flow, temperature, volume, and conductivity monitoring. | Pass |
| 19. Air-In-Line | The system shall meet requirements related to the system's purging and detection of air bubbles in the extracorporeal circuit. | Pass |
| 20. Pre-TreatmentMode | The system shall meet requirements for pre-treatment mode. | Pass |
| 21. Post-TreatmentMode | The system shall meet requirements for post-treatment mode. | Pass |
| 22. Blood Pumpand Pinch ValveControl, andSaline DeliveryPerformance | The system shall meet requirements for operation, performance, and control of the peristaltic blood pump. | Pass |
| 23. HeatDisinfectionMode | The system shall meet requirements for heat disinfection mode. | Pass |
| 24. ChemicalDisinfectionMode | The system shall meet requirements for chemical disinfection mode. | Pass |
| 25. UltrafiltrationAccuracy | The system shall provide a treatment fluid removal accuracy of +/- 100 mL per hour of the treatment time. | Pass |
Shelf Life and Sterilization Testing (Tablo Cartridge)
{8}------------------------------------------------
Bench Performance Testing
{9}------------------------------------------------
Bench Performance Testing
{10}------------------------------------------------
| Bench Performance Testing | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Test Performed | Acceptance Criteria | Result | ||||||||||
| 26. Maintenanceand ServiceUser | The system shall meet requirements for maintenance andservice user. | Pass | ||||||||||
| 27. Maintenanceand ServiceUser | The system shall allow the user to run mock treatments inService Interface without the need of a Patient USB (apatient-specific secured USB storage device that containsencrypted treatment and prescription details). | Pass | ||||||||||
| 28. Heat andChemicalDisinfectionEffectiveness | Disinfection validation was performed on n=3 consoles perorganism, totaling n=6 consoles to demonstrate thatchemical and heat disinfection cycles reduce vegetativebacterial species (i.e., Pseudomonas aeruginosa) by sixlogs and non-tuberculous Mycobacterium species (i.e.,Mycobacterium terrae) by three logs. | Pass | ||||||||||
| 29. ExternalDisinfectantChemicalCompatibilityTesting (IEC60601-2-16Test) | The system and its accessories shall be capable ofwithstanding daily cleaning, using the chemicals below,over the service life of the device per the chemicalmanufacturer instructions, with:- 70% Isopropyl Alcohol- 10% bleach (0.3% - 0.6 % hypochlorite)- PDI Super Sani Cloth Germicidal Wipes- CaviWipes- CaviWipes1 Disinfecting Wipe- Oxivir 5- Oxivir TB Wipes | Pass | ||||||||||
| 30. Bring Your OwnConcentrateConductivityTest | The system shall be compatible with dialysis fluidconcentrates intended for a 45X-proportioning ratio.When mixed at a 45X ratio, the acid concentrate shouldcomply with the following labeled formulation range:ParameterFormulationSodium100 mEq/LPotassium0 - 4 mEq/LCalcium0 - 3.5 mEq/LAcetate4 mEq/L | Pass | ||||||||||
| 31. Human FactorsValidation | The system shall be assessed for usability withrepresentative users (i.e., nurses and patient caretechnicians in clinical settings and acute-care facilities) inaccordance with its intended use/indications for use. | Pass |
{11}------------------------------------------------
Animal Study
No animal studies were performed in support of the modifications.
Clinical Studies
No clinical studies were performed in support of the modifications.
VIII. CONCLUSIONS
Non-clinical testing supports the safety and effectiveness of the Tablo Hemodialysis System and Tablo Cartridge. The bench testing demonstrates that the device systems comparably to the predicate device and is substantially equivalent to the legally marketed device.
§ 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.”