The Tablo Cartridge is a single use, disposable arterial and venous bloodline set intended to provide extra-corporeal access during hemodialysis. The Tablo Cartridge is compatible only with the Tablo Hemodialysis System.

Device Description

The Tablo Cartridge is a single use blood tubing set attached to an organizer tray. The E-beam sterilized and disposable cartridge is inserted onto the front panel of the console for each dialysis treatment.

AI/ML Overview

The provided document is a 510(k) summary for the Tablo Cartridge, a medical device used in hemodialysis. It outlines the performance data submitted to the FDA to demonstrate substantial equivalence to a predicate device. However, this document does not describe a study involving an AI/machine learning device, nor does it detail acceptance criteria and a study proving an AI device's performance in the way implied by the prompt's structured questions.

Specifically, the device in question is a physical "blood tubing set" for hemodialysis, and the changes discussed are related to manufacturing processes (sterilization method) and minor design improvements. The "performance data" refers to validation tests for sterilization, shelf-life, biocompatibility, and bench performance of the physical cartridge, not the performance metrics of an AI algorithm.

Therefore, many of the questions asked in the prompt, such as "Number of experts used to establish the ground truth for the test set," "Adjudication method," "MRMC comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the-loop performance)," and "How the ground truth for the training set was established," are not applicable to the information provided in this 510(k) summary.

Based on the provided document, here's what can be extracted, acknowledging that it does not fit the typical AI/ML device study format requested:

Device: Tablo® Cartridge (Hemodialysis blood tubing set)
Nature of Submission: 510(k) for a modified device (change in sterilization method from Ethylene Oxide (EO) gas to E-beam radiation, and minor design changes).

Given the nature of the device and the modification, the "acceptance criteria" and "study proving the device meets the acceptance criteria" are related to the safety and performance of the physical medical device and its manufacturing process, not an AI algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a single table with explicit "acceptance criteria" alongside "reported device performance" values in a quantitative, pass/fail format in terms of algorithm accuracy (e.g., sensitivity, specificity, AUC). Instead, it lists various types of tests conducted to ensure the device's safety and functionality after the modification. The acceptance criteria for these tests are implied to be compliance with relevant ISO standards, USP standards, and FDA guidance documents.

Test Category	Implied Acceptance Criteria (Compliance with)	Reported Device Performance (Summary of Study Outcome)
E-Beam Sterilization Validation	ISO 11137-1:2006, ISO 11137-2:2013, ISO 11737-1:2018, ISO 11737-2:2019, USP <71>, ANSI/AAMI ST72:2019. (Ensuring the device is sterile post-treatment and biocompatible with human contact).	Conducted comprehensive tests including Bioburden Recovery, Bioburden Determination, Verification Dose Determination, Dose Map Study, Method Suitability Determination, and Test of Sterility. The outcome stated: "The E-beam sterilization process validation testing... was conducted in accordance with FDA guidance documents" and "complies with following standards." This implies successful validation demonstrating effective sterilization.
Shelf-Life Testing	ISO 11607-1:2019, ISO 11607-2:2019. (Ensuring the device maintains functionality, sterility, and package integrity over its intended shelf-life under various conditions).	Included Accelerated aging testing, Climatic conditioning testing, Gross leak detection (Bubble) testing, Seal strength (Peel) testing, Package performance testing, and Product functional testing. The outcome stated: "The shelf-life verification testing included the following tests to ensure that the Tablo Cartridge complies with the ISO 11607-1:2019 and ISO 11607-2:2019 standards." This implies successful demonstration of shelf-life stability.
Biocompatibility Testing	ISO 10993-1:2018. (Ensuring the device does not cause unacceptable adverse biological reactions when in contact with the patient's blood path). Specific tests: Cytotoxicity, Sensitization, Irritation, Acute systemic toxicity, Hemocompatibility, Genotoxicity, Pyrogenicity.	Conducted a battery of tests for an external communicating device with prolonged direct and indirect contact (>24 hours to 30 days) with the blood path. The outcome stated: "The battery of testing included the following tests and continues to be supportive for the modified device, per ISO 10993-1:2018." This implies successful demonstration of biocompatibility.
Bench Performance Testing	Meeting system requirements and performing as intended (Implied to be aligned with the predicate device's performance and/or internal specifications for flow rates, pressure handling, etc., relevant to hemodialysis blood tubing sets).	"Nonclinical bench performance tests were conducted to demonstrate that the Tablo Cartridge meets the system requirements and performs as intended." The outcome stated: "The performance testing demonstrates that the Tablo Cartridge meets all performance specifications and complies with applicable standards and FDA Guidance Documents." This indicates successful functional performance.

Overall Conclusion: "The Tablo Cartridge (Modified Device) is substantially equivalent to the Predicate Device, and the minor difference between the Modified and the Predicate Device do not raise any new or different questions of safety or effectiveness."

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated numerically (e.g., number of cartridges tested). For sterilization validation, often a statistically significant sample size based on standards like ISO 11137 is used, but the exact number isn't provided here. The same applies to shelf-life and bench performance testing.
Data Provenance: Not specified regarding country of origin or whether it was retrospective/prospective. This is typical for device performance testing performed by the manufacturer, rather than clinical trial data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This is not an AI/imaging device requiring expert interpretation for ground truth. The "ground truth" for this device would be objective measurements and laboratory test results demonstrating physical, chemical, and biological properties.

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

Not Applicable. There's no human interpretation or subjective assessment that would require an adjudication method.

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. This is a physical medical device, not an AI/ML algorithm that assists human readers.

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

Not Applicable. This is a physical medical device.

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

For this device, the "ground truth" is established through objective laboratory testing, established chemical/biological assays, and physical performance measurements against predefined specifications and internationally recognized standards (e.g., ISO, USP). It's based on empirical measurements of device properties rather than human diagnostic interpretation.

8. The sample size for the training set:

Not Applicable. There is no "training set" as this is not an AI/ML model.

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

Not Applicable. There is no "training set" or corresponding ground truth establishment process in the context of AI/ML.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and name on the right. The FDA acronym and name are in blue, with the acronym in a larger font size than the name. The name is written as "U.S. FOOD & DRUG ADMINISTRATION".

November 26, 2021

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

Re: K210782

Trade/Device Name: Tablo® Cartridge Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: FJK Dated: October 27, 2021 Received: Ocobter 28, 2021

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 (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

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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

Sincerely,

for Glenn B. Bell, Ph.D. 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) K210782

Device Name Tablo Cartridge

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)|X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

(21 CFR 807.92)

I. SUBMITTER

Name:	Outset Medical, Inc.3052 Orchard DriveSan Jose, CA 95134
Phone:	(669) 231-8200
Primary Contact:	Jennifer Mascioli-Tudor
Prepared by:	Claire Bao
Date Prepared:	March 24, 2021

II. DEVICE

Trade/Device Name:	Tablo Cartridge
Common or Usual Name:	Blood tubing set
Regulation Name:	Hemodialysis system and accessories
Regulation Number:	21 CFR § 876.5820
Product Code:	FJK
Regulatory Class:	II

III. PREDICATE DEVICE

Tablo Cartridge (K190793) The predicate device has not been subjected to a design related recall. No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

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Image /page/4/Picture/2 description: The image shows a medical device with a cartridge installed on the console front panel. The device has a screen on top and a door that opens to reveal the cartridge and other components. The cartridge is connected to the device with tubes and wires. The device is on wheels, making it easy to move around.

Figure 1. Tablo Cartridge Inserted into Tablo Hemodialysis Delivery System

V. INDICATIONS FOR USE

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The modified Tablo Cartridge has the same fundamental technology, principle of operation, and principal functionality as the predicate device. The Tablo Cartridge is a blood tubing set which functions as part of the extracorporeal blood system of the Tablo Hemodialysis machine.

The Tablo Cartridge with E-beam sterilization (Modified Device) and the Predicate Device are equivalent in technological characteristics:

. Intended use - To provide extra-corporeal access during hemodialysis.
Operating principle – Inserted onto Tablo Console as part of the extracorporeal blood system.
. Compatibility - Interface with the Tablo Console (Hemodialysis System).

The following differences exist between the subject and predicate device:

Sterilization method changed from Ethylene Oxide (EO) gas to E-beam radiation.
. Minor design changes for improvement.

VII. PERFORMANCE DATA

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

E-Beam Sterilization Process Validation Testing

The E-beam sterilization process validation testing for the Tablo Cartridge was conducted in accordance with FDA guidance document, "Hemodialysis Blood Tubing Sets – Premarket Notification [510(k)] Submissions," dated April 23, 2008 and "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," dated January 21, 2016.

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The Tablo Cartridge complies with following standards:

ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for ● development, validation and routine control of a sterilization process for medical devices
. ISO 11137-2:2013 Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose
ISO 11737-1:2018 Sterilization of health care products – Microbiological methods – Part 1: Determination of a population of microorganisms on products
. ISO 11737-2:2019 Sterilization of health care products – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
. USP <71> Sterility Tests standard
. ANSI/AAMI ST72:2019 Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing

The E-beam sterilization validation included the following tests to support the sterilization validation:

Bioburden Recovery Test
Bioburden Determination
Verification Dose Determination
Dose Map Study
Method Suitability Determination
Test of Sterility

Shelf-Life Testing (Accelerated Aging and Transit)

The shelf-life verification for the Tablo Cartridge was conducted as recommended by FDA's guidance document, "Hemodialysis Blood Tubing Sets – Premarket Notification [510(k)] Submissions," dated April 23, 2008.

The shelf-life verification testing included the following tests to ensure that the Tablo Cartridge complies with the ISO 11607-1:2019 and ISO 11607-2:2019 standards:

. Accelerated aging testing
Climatic conditioning testing
Gross leak detection (Bubble) testing
. Seal strength (Peel) testing
Package performance testing
Product functional testing

Biocompatibility Testing

The biocompatibility evaluation for the Tablo Cartridge was conducted in accordance with the FDA guidance document, "Hemodialysis Blood Tubing Sets – Premarket Notification [510(k)] Submissions," dated April 23, 2008.

The battery of testing included the following tests and continues to be supportive for the modified device, per ISO 10993-1:2018, as an external communicating device with prolonged direct and indirect contact (>24 hours to 30 days) with the blood path:

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Cytotoxicity
Sensitization
Irritation
Acute systemic toxicity
Hemocompatibility
Genotoxicity
Pyrogenicity

Bench Performance Testing

The bench performance testing for the Tablo Cartridge was conducted in accordance with the FDA guidance document, "Hemodialysis Blood Tubing Sets – Premarket Notification [510(k)] Submissions," dated April 23, 2008.

Nonclinical bench performance tests were conducted to demonstrate that the Tablo Cartridge meets the system requirements and performs as intended.

Animal Study

No animal studies were performed in support of the modifications.

Clinical Studies

No clinical studies were performed in support of the modifications.

VIII. CONCLUSION

The performance testing demonstrates that the Tablo Cartridge meets all performance specifications and complies with applicable standards and FDA Guidance Documents. The Tablo Cartridge (Modified Device) is substantially equivalent to the Predicate Device, and the minor difference between the Modified and the Predicate Device do not raise any new or different questions of safety or effectiveness.

Regulation Number and Section

§ 876.5820 Hemodialysis system and accessories.

(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.