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:

Tablo Console
Tablo Cartridge

AI/ML Overview

This appears to be a 510(k) summary for a medical device (Tablo Hemodialysis System) that has undergone a modification. The document states that the device has been found substantially equivalent to its predicate device (Tablo Hemodialysis System, K223248), specifically due to changes in the hydraulic material.

Crucially, this document is NOT a study report for a novel AI device or a device that required extensive clinical or human factors validation for its primary function. The modifications were related to material changes in the hydraulics, and the FDA determined that these changes did not impact the device's fundamental performance, safety, or effectiveness. Therefore, many of the typical acceptance criteria and study components you've listed for AI/human-in-the-loop devices are not applicable or were explicitly deemed unnecessary in this context.

I will address the questions based on the information provided, explicitly stating when a piece of information is not available or relevant to this specific submission.

Here's an analysis of the provided text in relation to your questions:

1. A table of acceptance criteria and the reported device performance

The document doesn't provide a direct "acceptance criteria" table in the format typically seen for novel device performance or AI algorithms. Instead, the acceptance criteria for this submission revolve around demonstrating substantial equivalence to the predicate device despite the hydraulic material changes. Performance was demonstrated through various non-clinical tests to confirm the new materials didn't negatively impact the established performance of the device.

Since this submission is about material changes validated through bench testing, the "performance" is about maintaining the original specifications rather than achieving a new performance threshold.

Acceptance Criteria (Implied for this 510(k) modification)	Reported Device Performance (Summary)
Biocompatibility: Meet ISO 10993-1:2018 and FDA guidance for new materials.	All evaluated endpoints (Cytotoxicity, Sensitization, Intracutaneous Irritation, Material-Mediated Pyrogenicity, Hemocompatibility, Chemical Characterization, Toxicological Risk Assessment) were met.
Electrical Safety & EMC: No negative impact due to hydraulic changes.	Changes to hydraulics do not impact electrical safety or EMC. No additional testing was conducted as it was deemed unnecessary.
Software Functionality: No software modifications were made.	No software modifications were made; no new software V&V testing required.
Sterilization & Shelf Life: No changes to these aspects for the Console.	Console remains reusable, non-sterile; disinfection methods unchanged. Cartridge unchanged within this submission.
Bench Performance: Maintain established performance of the predicate device for critical functions (e.g., dialysate temperature, fluid removal).	Bench tests confirmed the modified system meets system requirements and performs as intended, matching the predicate Tablo Hemodialysis System (K223248) for: - Dialysate Temperature Accuracy - Fluid Removal Accuracy - Chemical Disinfection - Heat Disinfection - Related Alarms
Human Factors/Usability: No negative impact on usability.	Modifications to hydraulics do not impact usability. No new Human Factors validation study deemed necessary.
Clinical Performance: No need for new clinical studies.	No clinical studies were conducted as the changes were deemed not to require them for substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This document describes bench testing, biocompatibility testing, electrical safety/EMC analysis, and software/human factors assessments for a modification to an existing device. It's not a typical "test set" in the sense of a dataset for an AI algorithm or a patient cohort for a clinical trial.

Sample Size for Bench Testing/Biocompatibility: The specific sample sizes for each type of bench test (e.g., number of units tested for dialysate temperature accuracy, number of samples for biocompatibility) are not provided in this 510(k) summary. These details would be in the full submission, but not in this public summary.
Data Provenance: Not applicable in the context of patient data provenance for a test set. The tests described are laboratory-based and engineering assessments.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. Ground truth, expert consensus, or clinical interpretation by medical experts are not detailed because this submission is about physical/material modificationsvalidated through non-clinical testing, not diagnostic performance or clinical outcomes directly assessed by experts interpreting data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods are typically used in studies where human readers or interpreters are involved in generating or confirming ground truth, such as in imaging studies. This document concerns engineering and material changes validated through bench testing.

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

No, an MRMC study was not conducted. This submission is for modifications to a hemodialysis system, not an AI-powered diagnostic or assistive tool where human reader performance would be a relevant metric. The document explicitly states "No clinical studies were conducted."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable in the context of an AI algorithm. The device is a hemodialysis system, not an AI algorithm. Its performance is inherent to its mechanical, electrical, and material properties.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" in this context refers to the established performance specifications and safety profiles of the predicate device (K223248) and the relevant regulatory standards (e.g., ISO 10993-1, FDA guidance for hemodialysis delivery systems). The studies conducted (bench testing, biocompatibility) aim to demonstrate that the modified device continues to meet these established performance and safety requirements.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As above, this is not an AI/machine learning device.

Summary

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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.

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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-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).

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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

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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 DriveSan Jose, CA 95134
Primary Contact:	Claire BaoSenior Regulatory Affairs SpecialistOutset 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 system21 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

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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 OutsetMedical:	List of Dialysis Treatment Accessories Supplied byOEMs:
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

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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

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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.

Regulation Number and Section

§ 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.”