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

The provided document is a 510(k) summary for the Tablo® Hemodialysis System, specifically for a new software version. This document focuses on demonstrating substantial equivalence to a predicate device (K211370), rather than a study defining acceptance criteria for AI or a detailed performance study as would be required for a novel AI device.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI performance metrics (like sensitivity, specificity, etc.) is not directly applicable to this document. The document primarily discusses verification and validation of software changes and bench performance testing to support the extension of treatment duration.

However, I can extract the relevant information from the document regarding the device's performance data and the types of studies conducted to support its substantial equivalence.

Here's a breakdown based on the provided text, reinterpreting "acceptance criteria" as the deemed "substantial equivalence" established through various tests:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for a software update to an existing device, the "acceptance criteria" are implicitly tied to maintaining or improving the safety and effectiveness of the device as cleared under the predicate (K211370) and extending the treatment duration. The "reported device performance" is primarily about the successful completion of various tests to demonstrate this.

Acceptance Criteria (Implicit)	Reported Device Performance
Biocompatibility: No change in material or manufacturing/processing from predicate.	Materials and manufacturing/processing are identical to the predicate Tablo Hemodialysis System (K211370). No additional biocompatibility data deemed necessary.
Electrical Safety and EMC: No difference in EMC and electrical safety from predicate.	The subject device has no difference in EMC and electrical safety from the predicate device (K211370). No additional EMC testing conducted.
Software Verification and Validation (V&V): Software V&V conducted and passed, meeting FDA guidance for "major" level of concern.	Software verification and validation testing were conducted and passed. Documentation provided per FDA guidance. Testing supports safety and effectiveness.
Sterilization and Shelf Life: Console is reusable, non-sterile; cleaning/disinfection methods are same as predicate. No changes to cartridge.	Tablo Console is reusable, non-sterile. Cleaning and disinfection methods are the same as predicate (K211370). No changes to the Tablo Cartridge within this submission.
Bench Performance Testing: Performance characterization same as predicate; human factors validated for software updates; ability to provide safe/effective treatment up to 24 hours demonstrated.	No additional bench testing was deemed necessary as performance characterization is the same as the predicate (K211370). Additional Human Factors validation data was provided for software updates. Performance testing demonstrated the device can provide safe and effective treatment for a duration of up to 24 hours. A summary of system-level, essential performance, alarms, software V&V, mechanical hemolysis, and protective systems testing is presented.

Information not directly applicable or available from the provided text, as it relates to AI-specific studies:

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

This information is not provided as the document describes a 510(k) for a software update to a hemodialysis system, not an AI/ML device with a distinct "test set" in the context of an algorithm's performance. The "test set" would implicitly be the entire system undergoing the verification and validation processes.

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 to the type of device and study described. Ground truth in this context would be defined by engineering specifications, regulatory standards, and established medical safe use practices for hemodialysis machines.

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

Not applicable, as there's no "ground truth" derived from expert consensus for an AI algorithm's output.

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 MRMC study was conducted. This device is a hemodialysis system, not an imaging or diagnostic AI tool. The "Human Factors validation data" mentioned relates to the usability and safety of the system's interface for operators, not to AI-assisted interpretation by human readers.

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

Standalone performance in the AI sense is not explicitly discussed. The device itself (Tablo Hemodialysis System) performs its function either autonomously or with user interaction, but it's not described as an AI algorithm in the context of image analysis or diagnostic support. The software performance here refers to the operating system controlling the device's functions.

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

The "ground truth" for the performance of the hemodialysis system software and hardware would be based on engineering specifications, adherence to ISO/IEC standards, regulatory requirements, and safe operational parameters for dialysis treatment. For the extended 24-hour treatment capability, the ground truth would be the ability to maintain specified performance (e.g., fluid removal, solute clearance, alarm responsiveness) over that duration without compromise to safety.

8. The sample size for the training set

This information is not applicable to a traditional software update for a hemodialysis machine. "Training set" typically refers to data used to train AI/ML models, which is not the subject of this 510(k). Verification and validation are performed against requirements, not a "training set" in the AI sense.

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

Not applicable, see point 8.

Summary

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June 21, 2023

Outset Medical, Inc. Saket Bhatt VP. Global Regulatory Affairs 3052 Orchard Drive San Jose, CA 95134

Re: K223248

Trade/Device Name: Tablo® Hemodialysis System Regulation Number: 21 CFR§ 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI, FIP Dated: May 19, 2023 Received: May 22, 2023

Dear Saket Bhatt:

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.

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 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-regulatoryinformation/postmarketing-safety-reporting-combination-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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Gema Gonzalez -S

Gema Gonzales, MS Acting 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)

K223248

Device Name Tablo® Hemodialysis System

Indications for Use (Describe)

The Tablo® Hemodialysis System is indicated for use in patients with acute and 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 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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K223248 Page 1 of 4

510(k) Summary

(21 CFR 807.92)

I. SUBMITTER

Name:	Outset Medical, Inc.3052 Orchard DriveSan Jose, CA 95134
Phone:	(330) 261-7717
Primary Contact:	Keshu Nso
Date Prepared:	June 21, 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 AND REFERENCE DEVICES

The predicate device to which substantial equivalence is claimed is: Tablo Hemodialysis System, K211370

For Tablo specification change for intermittent therapy up to a maximum of 24 hours, Outset has identified two reference devices.

. NxStage System OneS, K133547
Quanta SC+ Hemodialysis System, K222067

IV. INDICATION FOR USE

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

V. DEVICE DESCRIPTION

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/4/Picture/7 description: The image shows a blue Tablo dialysis machine on wheels. The machine is boxy and has a handle on the left side. The word "tablo" is written in white on the front of the machine. The machine appears to be in a studio setting.

Console with Integrated Dialysis Delivery and Water Purification

Cartridge installed on
Console front panel

Figure 5-1: Tablo Hemodialysis System with Cartridge Inserted

The proposed new software version for Tablo Hemodialysis System (Console) 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:
-------------------------------------------------	----------------------------------------------------------

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• Straws	• High Flux Dialyzer (prescription required)
• Patient Key	• Acid jug (If not using Outset Supplied Acid jug)
• Outset Acid jug (Optional)	• Bicarbonate jug (If not using Outset Supplied Acid jug)
• Outset Bicarbonate jug (Optional)	• Minncare HD or Minncare Cold Sterilant
• 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.	• Chlorine/Chloramine test kit
• Hand-Crank	• Saline bags
• Power Cord	• Heparin
• Drain Line	• Syringes and needles
• Water Line	• Gloves and mask
• 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 new Tablo Hemodialysis System (Console) software version and the predicate device are substantially equivalent. No new issues of safety or effectiveness were raised by the minor differences in technological characteristics.

Section 12- Substantial Equivalence provides a comparison of the technological characteristics for the predicate, reference and subject device. The comparison table also provides a discussion for why any differences between the predicate, reference 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 K211370.

VII. PERFORMANCE DATA

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

Biocompatibility Testing

Materials and manufacturing/processing are identical to the predicate Tablo Hemodialysis System cleared under K211370. Therefore, no additional biocompatibility data is deemed necessary for this submission.

Electrical safety and electromagnetic compatibility (EMC)

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The subject device has no difference in the EMC and electrical safety from the predicate device, cleared by FDA in K211370. Therefore, no additional EMC testing was conducted to support modified device.

Software Verification and Validation Testing

Software verification and validation testing were conducted and passed for the subject device. Documentation provided is per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software for this device is considered 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. Completed software testing supports safety and effectiveness of the device.

Sterilization and Shelf Life

Tablo Console is a reusable, non-sterile device. Cleaning and disinfection methods are the same as predicate Tablo Hemodialysis System K211370 and have been described in device labeling and User manuals in Section 13 – Labeling. No changes were made to the Table Cartridge within this submission.

Bench Performance Testing

No additional bench testing was deemed necessary to support the new Tablo Hemodialysis System (Console) software version. The performance characterization of the subject device is the same as the predicate Tablo Hemodialysis System (cleared under K211370). Additional Human Factors validation data was provided for the updates made to the Tablo Hemodialysis System (Console) software version.

Performance testing conducted to demonstrate that the Tablo device can provide safe and effective treatment for a duration of up to 24 hours is presented. A summary of system-level testing, essential performance testing, alarms testing, software verification testing, mechanical hemolysis testing, and protective systems testing is presented.

Animal Study

No animal studies were conducted to support the updated Tablo Hemodialysis System (Console) software version.

Clinical Studies

No clinical studies were conducted to support the updated Tablo Hemodialysis System (Console) software version.

VIII. CONCLUSION

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.”