(230 days)
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 prescribing physician.
The Tablo™ Console is a self-contained hemodialysis system (Console) intended for acute and chronic dialysis therapy with or without ultrafiltration, in an acute or chronic care facility. The console consists of fluidic systems that perform the activities of a Water Purification System (WPS) and a conventional Dialysis Delivery System (DDS). Since the original 510(k) clearance, the Tablo Console has incorporated design and corresponding labeling updates whose purpose was to improve ease of manufacturing, increase reliability, simplify the design, and optimize performance.
This document is a 510(k) summary for the Tablo Console, a hemodialysis system. The primary purpose of this submission is to describe expanded wireless communication capabilities and other design updates.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" in the typical sense of quantitative thresholds for a specific diagnostic performance metric. Instead, it details various types of performance testing against established standards and internal requirements. The "reported device performance" is a general statement of compliance rather than specific numerical results.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility Standards | No specific criteria or numerical results provided. Statement: "Design updates to the fluidic system have been made to the modified device and biocompatibility has been evaluated. There were no changes to the material type, formulation, chemical composition, material processing or contact duration. No additional testing was required." |
| Electrical Safety Standards | Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, and IEC 60601-2-16. Performance: "The Tablo Console with Wireless Capability has been evaluated against the requirements for Electromagnetic Compatibility and Electrical Safety." (Implied compliance) |
| Electromagnetic Compatibility (EMC) Standards | Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, and IEC 60601-2-16. Performance: "The Tablo Console with Wireless Capability has been evaluated against the requirements for Electromagnetic Compatibility and Electrical Safety." (Implied compliance) |
| Software Verification and Validation | Criteria: Functional and performance software requirements. Performance: "For all software modifications, system level software verification testing demonstrated that the Tablo meets functional and performance software requirements." |
| System Performance Testing | Criteria: Verification of design updates specific to: Fluidic System Optimization, Front Panel Interface, Console External and Internal Design, System Accessories, Dialyzer Prime, Heat Disinfection. Performance: Testing demonstrated compliance with performance specifications. (Implied compliance) |
| Overall Conclusion | "The performance testing demonstrates that the Tablo Console with expanded wireless capability meets all performance specifications and complies with applicable standards and FDA Guidance Documents." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of diagnostic performance involving patient data. The various tests performed (biocompatibility, electrical safety, EMC, software, system performance) would have used devices or components of the device as the test "samples." No information is provided regarding the specific number of devices tested for each type of engineering or software verification test.
Since no clinical studies were performed, there is no patient data, and therefore no information on country of origin or whether data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
Not applicable. This submission concerns device modifications and engineering verification, not a diagnostic algorithm requiring ground truth established by medical experts from patient data.
4. Adjudication Method
Not applicable, as there is no diagnostic algorithm performance evaluation against ground truth from patient data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "No clinical studies were performed in support of the modifications." Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted.
6. Standalone Performance Study
Yes, in a sense. The entire submission focuses on the standalone performance of the device and its modified components (hardware, software, wireless capabilities) against engineering and safety standards. There is no AI component that would have distinct "standalone algorithm performance" versus "human-in-the-loop performance." The device itself is the "algorithm" in terms of its operational functionality.
7. Type of Ground Truth Used
The "ground truth" for the various performance tests was based on:
- Established international and national standards (e.g., IEC 60601 series).
- Internal functional and performance requirements for software and system operation.
- Design specifications for hardware and fluidic systems.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set of patient data. The "training" for the device would be its initial design, development, and iterative testing/refinement phases.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no AI/ML training set in the context of this device. The "ground truth" for the device's design and functionality would stem from engineering principles, medical device regulatory requirements, and user needs for hemodialysis.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 15, 2016
Outset Medical, Inc. Julie Newsome Vice President of Quality and Regulatory Operations 1830 Bering Drive San Jose, CA 95112
Re: K160881 Trade/Device Name: Tablo Console Regulation Number: 21 CFR§ 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: II Product Code: KDI, FIP Dated: October 13, 2016 Received: October 14, 2016
Dear Julie Newsome:
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 (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 contact the Division of Industry and Consumer Education 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. 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
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 Industry and Consumer Education 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 yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160881
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 trained individual available as needed who is considered competent in the use of the prescribing physician.
| 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) |
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K160881 - 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.
| Submitter's Name: | Julie NewsomeVice President, Quality and Regulatory OperationsOutset Medical, Inc.1830 Bering Drive, San Jose, CA 95112 |
|---|---|
| Company: | Vice President, Quality and Regulatory Operations |
| Address: | 1830 Bering Drive, San Jose, CA 95112 |
| Contact Person: | Julie NewsomeVice President, Quality and Regulatory OperationsOutset Medical, Inc. |
| Phone: | 650.521.2245 |
| Facsimile: | 669.231.8201 |
| Email: | jnewsome@outsetmedical.com |
| Date of Summary Preparation: |
Submitter's Information
Device Information
| Trade Name: | Tablo™ Console | |
|---|---|---|
| Common Name: | Hemodialysis Delivery System | Portable Water Treatment System |
| Classification Name: | High Permeability HemodialysisDelivery System | Water Purification System forHemodialysis |
| ClassificationNumber: | Class II per 21 CFR 876.5860 | Class II per 21 CFR 876.5665 |
| Product Code: | KDI | FIP |
| Classification Panel: | Gastroenterology/Urology | Gastroenterology/Urology |
Predicate Device Information
The Tablo Console was originally cleared under K140866 and most recently cleared under K150880 for the addition of one-way Wireless Capability.
Device Description
The Tablo™ Console is a self-contained hemodialysis system (Console) intended for acute and chronic dialysis therapy with or without ultrafiltration, in an acute or chronic care facility. The console consists of fluidic systems that perform the activities of a Water Purification System (WPS) and a conventional Dialysis Delivery System (DDS). Since the original 510(k) clearance, the Tablo Console has incorporated design and corresponding labeling updates whose purpose was
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to improve ease of manufacturing, increase reliability, simplify the design, and optimize performance.
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.
Key Performance Specifications/Characteristics of the Device
The proposed Tablo Console with Expanded Wireless Data Transmission Capability and the predicate device (K150880) are equivalent in technological characteristics:
- Design and Construction
- Water Purification Method
- Dialysate Preparation ●
- Disinfection - Heat and chemical disinfection
- . Materials (patient and non-patient contacting)
- Electrical safety and associated testing
- Compatibility - Interface with the Tablo Cartridge (Blood Tubing Set)
- Off the shelf components - Dialyzers and non-invasive blood pressure cuffs (NIBP).
- Standards - Electrical and electromagnetic safety, Water Purification, and Hemodialysis System standards.
- Software - Software controlled, and utilizes Graphic User Interface (GUI)
- Software verification and validation ●
- Wireless data transmission capability
The principal purpose of this 510(k) is to describe the expanded wireless communication capabilities for the Tablo Console. The changes made to the device since the last 510(k) clearance K150880 are also covered within this 510(k) submission.
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Comparison of Technological Characteristics with the Predicate Device
Performance testing completed on the proposed device to support the determination of substantial equivalence is summarized below and has been developed in accordance with appropriate FDA guidance documents and relevant standards.
Since the original clearance, the Tablo Console has incorporated design and corresponding labeling updates whose purpose was to improve ease of manufacturing, increase reliability, simplify the design, and optimize performance. The complete list of changes implemented and included in the Tablo Console Roll-Up attachment are included in the summary of performance data below.
Biocompatibility Testing
Design updates to the fluidic system have been made to the modified device and biocompatibility has been evaluated. There were no changes to the material type, formulation, chemical composition, material processing or contact duration. No additional testing was required.
Electrical Safety and Electromagnetic Compatibility (EMC)
The Tablo Console with Wireless Capability has been evaluated against the requirements for Electromagnetic Compatibility and Electrical Safety. The evaluation of the device was conducted in accordance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, and IEC 60601-2-16.
Software Verification and Validation Testing
For all software modifications, system level software verification testing demonstrated that the Tablo meets functional and performance software requirements.
System Performance Testing
System Performance Testing included verification of design updates specific to the roll-up changes in the following areas:
- Fluidic System Optimization
- Front Panel Interface
- Console External and Internal Design ●
- System Accessories
- Dialyzer Prime
- . Heat Disinfection
Animal Studies
No animal studies were performed in support of the modifications.
Clinical Studies
No clinical studies were performed in support of the modifications.
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Conclusion
The performance testing demonstrates that the Tablo Console with expanded wireless capability meets all performance specifications and complies with applicable standards and FDA Guidance Documents. The proposed Tablo Console with expanded Wireless Capability is substantially equivalent to the predicate device, and the minor differences in the technological characteristics of the proposed and the predicate devices do not raise any new or different questions of safety or effectiveness.
§ 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.”