K Number
K233335
Device Name
Tablo® Hemodialysis System
Date Cleared
2023-12-05

(67 days)

Product Code
Regulation Number
876.5860
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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 include Intermittent Hemodialysis (IHD), Sustained Low Efficiency Dialysis (SLED/ SLEDD), Prolonged Intermittent Renal Replacement Therapy (PIRRT), and Isolated Ultrafiltration.
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 consist of: 1. Tablo Console 2. Tablo Cartridge
More Information

No
The summary does not mention AI, ML, or any related terms, and the performance studies focus on standard medical device testing (biocompatibility, electrical safety, bench performance, etc.) without indicating any AI/ML-specific validation.

Yes
The device is indicated for use in patients with renal failure and offers various treatment types such as Intermittent Hemodialysis (IHD) and Isolated Ultrafiltration, which are therapeutic interventions.

No

The Tablo Hemodialysis System is indicated for use in patients with renal failure to provide dialysis therapy, not to diagnose a condition.

No

The device description explicitly states that the Tablo Hemodialysis System consists of a "Tablo Console" and a "Tablo Cartridge," which are physical hardware components.

Based on the provided information, the Tablo Hemodialysis System is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • Intended Use: The intended use is for treating patients with renal failure through hemodialysis, which is a direct treatment of the patient's blood. IVD devices are used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
  • Device Description: The system consists of a console and a cartridge, which are components of a machine that performs a physical process on the patient's blood. This is not consistent with the typical components of an IVD device (e.g., reagents, test strips, analyzers that process samples).
  • Lack of IVD Characteristics: The description does not mention any analysis of biological samples, use of reagents, or generation of diagnostic information from patient specimens.

The Tablo Hemodialysis System is a therapeutic device used for extracorporeal blood treatment.

N/A

Intended Use / Indications for Use

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 include Intermittent Hemodialysis (IHD), Sustained Low Efficiency Dialysis (SLED/ SLEDD), Prolonged Intermittent Renal Replacement Therapy (PIRRT), and Isolated Ultrafiltration.

Product codes

KDI, FIP

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 consist of:

    1. Tablo Console
    1. Tablo Cartridge

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Acute or chronic care facility or in the home. Treatments must be administered under physician's prescription and observed by a trained individual who is considered competent in the use of the device.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The following performance data were provided in support of the substantial equivalence determination:

  • Biocompatibility Testing: Conducted in accordance with ISO 10993-1:2018 and FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process", dated September 8, 2023. Evaluated endpoints: Cytotoxicity, Sensitization (Guinea Pig Maximization), Intracutaneous Irritation, Material-Mediated Pyrogenicity, Hemocompatibility (ASTM Hemolysis - direct contact), Chemical Characterization, Toxicological Risk Assessment.
  • Electrical safety and electromagnetic compatibility (EMC): No additional testing conducted as changes to hydraulics do not impact electrical safety or EMC.
  • Software Verification and Validation Testing: Not required as no software modifications were made.
  • Sterilization and Shelf Life: Tablo Console is reusable, non-sterile. Disinfection methods are the same as predicate and described in labeling. No changes to the Table Cartridge.
  • Bench Performance Testing: Conducted in accordance with FDA guidance document, "Guidance for the Content of Premarket Notifications for Hemodialysis Delivery System", dated August 7, 1998. Tests conducted: Dialysate Temperature Accuracy, Fluid Removal Accuracy, Chemical Disinfection, Heat Disinfection, Related Alarms.
  • Human Factors Validation Testing: Not deemed necessary as modifications to hydraulics do not impact usability.
  • Animal Study: No animal studies conducted.
  • Clinical Studies: No clinical studies conducted.

Key results: The completed verification and validation of the device supports the safety and effectiveness of the subject Tablo Hemodialysis System. The results demonstrate that the Tablo Hemodialysis System is substantially equivalent to the predicate, legally marketed device, cleared under K223248.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Tablo Hemodialysis System, K223248

Reference Device(s)

K190793, K210782

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 876.5860 High permeability hemodialysis system.

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

0

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 4, 2023

Outset Medical, Inc. Claire Bao Senior Regulatory Affairs Specialist 3052 Orchard Drive San Jose, California 95134

Re: K233335

Trade/Device Name: Tablo® Hemodialysis System Regulation Number: 21 CFR 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: Class II Product Code: KDI, FIP Dated: September 28, 2023 Received: September 29, 2023

Dear Claire Bao:

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.

1

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-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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-devicereporting-mdr-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/medical-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn).

2

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/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumereducation-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Digitally signed by Maura Maura Rooney Rooney -S Date: 2023.12.05 09:53:57 -ટ -05'00'

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

3

Indications for Use

510(k) Number (if known) K233335

Device Name Tablo® Hemodialysis System

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 and observed by a trained individual who is considered competent in the Tablo Hemodialysis System is also indicated for use in the home. Treatment types available intermittent Hemodialysis (IHD), Sustained Low Efficiency Dialysis (SLED/ SLED), Prolonged Intermittent Renal Replacement Therapy (PIRRT), and Isolated Ultrafiltration.

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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K233335 Page 1 of 5

Outset Medical, Inc.

510(k) Summary

(21 CFR 807.92)

I. SUBMITTER

| Name: | Outset Medical, Inc.
3052 Orchard Drive
San Jose, CA 95134 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Claire Bao
Senior Regulatory Affairs Specialist
Outset Medical, Inc.
+1 (213) 610-3589 |
| Date Prepared: | September 28, 2023 |
| II. DEVICE | |
| Trade/Proprietary Name: | Tablo® Hemodialysis System |
| Common /Generic Name: | Hemodialysis delivery system and water purification system |
| Classification Regulations: | 21 CFR § 876.5860 – High permeability hemodialysis system
21 CFR § 876.5655 – Water purification system for hemodialysis |
| Product Codes: | KDI; FIP |
| Regulatory Class: | II |

III. PREDICATE DEVICE

The predicate device to which substantial equivalence is claimed is: Tablo Hemodialysis System, K223248

IV. INDICATION FOR USE

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 include Intermittent Hemodialysis (IHD), Sustained Low Efficiency Dialysis (SLED/ SLEDD), Prolonged Intermittent Renal Replacement Therapy (PIRRT), and Isolated Ultrafiltration.

V. DEVICE DESCRIPTION

5

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 consist of:

    1. Tablo Console
    1. Tablo Cartridge

Figure 5-1 below provides an overview of the Tablo Hemodialysis System consisting of the Tablo Console and Cartridge.

Image /page/5/Picture/7 description: The image shows a Tablo hemodialysis machine. The machine is dark blue and has a boxy shape with rounded edges. It has the word "tablo" printed on the side. The machine is on wheels, which makes it portable.

Console with Integrated Dialysis Delivery and Water Purification

Image /page/5/Picture/9 description: The image shows a medical device with a cartridge installed on the console front panel. The device is on wheels and has a screen on top. The device has a door that is open, revealing the cartridge and other components. The device is likely used for medical treatments.

Figure 5-1: Tablo Hemodialysis System with Cartridge Inserted

The Tablo Hemodialysis System with updated hydraulics does not affect the functionality of the Tablo cartridge, which was cleared under K190793 and K210782.

Accessories:

| List of Accessories Supplied by Outset
Medical: | List of Dialysis Treatment Accessories Supplied by
OEMs: |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Straws Patient Key Outset Acid jug (Optional) Outset Bicarbonate jug (Optional) Non-invasive Blood Pressure Cuff (NIPB) kit, adult size medium. Small and large sizes are not shipped with the Console but can be ordered from Outset Medical. Hand-Crank Power Cord | High Flux Dialyzer (prescription required) Acid jug (If not using Outset Supplied Acid jug) Bicarbonate jug (If not using Outset Supplied Acid jug) Minncare HD or Minncare Cold Sterilant Chlorine/Chloramine test kit Saline bags Heparin Syringes and needles Gloves and mask |

6

Drain Line Water Line Disinfectant Straws (Adapter)Biohazard container Disinfectant, gauze pads, and tape for access site
-----------------------------------------------------------------------------------------------------------------------------

VI. SUBSTANTIAL EQUIVALENCE

In accordance with the 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications 510(k) Outset Medical reached the conclusion that the Tablo Hemodialysis System with updated hydraulic material and the predicate device are substantially equivalent. No new issues of safety or effectiveness were raised by the changes to the hydraulics of Tablo Hemodialysis System.

Substantial Equivalence Section provides a 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 and effectiveness of the device.

The completed verification and validation of the device supports the safety and effectiveness of the subject Tablo Hemodialysis System. The results demonstrate that the Tablo Hemodialysis System is substantially equivalent to the predicate, legally marketed device, cleared under K223248.

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Testing

Biocompatibility testing for the modified Tablo Hemodialysis System was conducted in accordance with ISO 10993-1:2018 and FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process", dated September 8, 2023. The following endpoints were evaluated to support the biological safety of the Tablo Hemodialysis System:

  • Cytotoxicity
  • Sensitization, Guinea Pig Maximization .
  • Intracutaneous Irritation
  • Material-Mediated Pyrogenicity
  • Hemocompatibility, ASTM Hemolysis (direct contact)
  • Chemical Characterization
  • Toxicological Risk Assessment

Electrical safety and electromagnetic compatibility (EMC)

The changes to the hydraulics do not impact the electrical safety or EMC of the Tablo Hemodialysis System. Therefore, no additional electrical safety or EMC testing was conducted to support the modified device.

Software Verification and Validation Testing

7

No software modifications were made as a result of the changes to the Tablo Console hydraulics. No new software verification and validation testing is required to support the change.

Sterilization and Shelf Life

Tablo Console is a reusable, non-sterile device. The components are disinfected using either heat disinfection or chemical disinfection using the pre-programmed machine disinfection cycle. Cleaning and disinfection methods are the same as predicate Tablo Hemodialysis System K223248 and have been described in device labeling and User manuals in Section 13 Labeling of this submission. No changes were made to the Table Cartridge within this submission.

Bench Performance Testing

The bench performance testing for the subject Tablo Hemodialysis System was conducted in accordance with FDA guidance document, "Guidance for the Content of Premarket Notifications for Hemodialysis Delivery System", dated August 7, 1998.

Following nonclinical bench performance tests were conducted to demonstrate that the modified Tablo Hemodialysis System meets the system requirements and performs as intended. The performance characterization of the subject device is the same as the predicate Tablo Hemodialysis System (cleared under K223248):

  • Dialysate Temperature Accuracy
  • Fluid Removal Accuracy ●
  • . Chemical Disinfection
  • Heat Disinfection
  • Related Alarms

Human Factors Validation Testing

The modifications to the hydraulics do not impact the usability of the Tablo Hemodialysis System. No new Human Factors validation study is deemed necessary to support the modifications to the material used in the hydraulics of the Tablo Hemodialysis System (Console).

Animal Study

No animal studies were conducted to support the modifications to the material used in the hydraulics of the Tablo Hemodialysis System (Console).

Clinical Studies

No clinical studies were conducted to support the modifications to the material used in the hydraulics of the Tablo Hemodialysis System (Console).

VIII. CONCLUSION

The Tablo Hemodialysis System's intended use including its indication for use, fundamental technological characteristics, performance specifications, principle of operation, functionality, intended patient population, anatomical location of use, user interface, clinical conditions and use environments have remained the same. The completed verification and validation of the device supports the safety and effectiveness of the subject Tablo Hemodialysis System. The results demonstrate that the Tablo

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K233335
Page 5 of 5

Hemodialysis System is substantially equivalent to the predicate, legally marketed device, cleared under K223248.