Tablo Hemodialysis System

K211370 · Outset Medical, Inc. · KDI · Jul 29, 2022 · Gastroenterology, Urology

Device Facts

• Record ID: K211370
• Device Name: Tablo Hemodialysis System
• Applicant: Outset Medical, Inc.
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Jul 29, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Tablo Hemodialysis System is a self-contained, integrated hemodialysis delivery system (DDS) and water purification system (WPS). It processes water and dialysate for extracorporeal blood treatment. The system consists of a console and a disposable cartridge. It is used in acute/chronic care facilities or home environments. Treatments are prescribed by physicians and monitored by trained individuals. The system manages fluidic circuits, water purification, and dialysis delivery. It provides therapy for renal failure patients, potentially improving access to care. The device includes software to manage treatment parameters and restrict functionality based on professional or self-care modes. Healthcare providers use the system interface to set prescriptions and monitor therapy. The device is reusable, with disposable cartridges and various accessories (e.g., NIPB cuff, concentrates).

Clinical Evidence

No clinical studies were conducted. Evidence consists of bench performance testing, including fungistasis/bacteriostasis validation (USP 61), reprocessing/disinfection validation, and human factors usability testing for home users per FDA guidance.

Technological Characteristics

Integrated WPS and DDS console. Complies with ES 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1-11, IEC 60601-2-16, and AIM 7351731 (RFID). Reusable console with disposable cartridge. Software-controlled fluidic systems. Major level of concern software.

Indications for Use

Indicated for patients with acute and/or chronic renal failure, with or without ultrafiltration, in acute/chronic care facilities or home settings. Contraindications include very low blood pressure, shock, active uncontrollable bleeding, or lack of vascular access.

Regulatory Classification

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).

Special Controls

*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.”

Predicate Devices

• Tablo Hemodialysis System (K200741)

Reference Devices

• Tablo Hemodialysis System (K190793)

Submission Summary (Full Text)

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July 29, 2022

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

Re: K211370

> Trade/Device Name: Tablo® Hemodialysis System (software version 4.8) Regulation Number: 21 CFR 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: Class II Product Code: KDI, FIP Dated: July 29, 2022 Received: July 29, 2022

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. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting (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 (OS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Gema Gonzalez, 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) K211370

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 use of the Tablo Hemodialysis System is also indicated for use in the home.

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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K211370 Page 1 of 4

Outset Medical, Inc.

# 510(k) Summary

(21 CFR 807.92)

## I. SUBMITTER

| Name: | Outset Medical, Inc.<br>3052 Orchard Drive<br>San Jose, CA 95134 |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Phone:<br>Contact:<br>Date Prepared: | [phone]<br>Saket Bhatt<br>July 29, 2022 |
| 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<br>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, K200741

Additionally, the following device is used as a reference device to support the device differences: Tablo Hemodialysis System, K190793

## IV. INDICATION FOR USE

The labeled indication for use statement is as follows:

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.

## V. CONTRAINDICATIONS

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Prescribing physicians should consider the following contraindications for hemodialysis: very low blood pressure, shock, active, uncontrollable bleeding condition, or lack of vascular access. The passing of a patient's blood through an extracorporeal circuit may require anticoagulation to prevent blood clotting. In addition, the parameters of dialysis should be optimized to avoid discomfort to the patient.

The use of third-party external infusion pump is contraindicated with the Tablo System for home users for all fluid infusions including heparin infusion.

## VI. 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 or chronic care facility or in the home. The device includes the:

- Tablo Console, a single module consisting of multiple fluidic systems that perform the activities of a water purification system (WPS) and a conventional dialysis delivery system (DDS), and
- Table Cartridge

The following are accessories available from Outset:

- Tablo Straws
- · Patient Key (USB)
- Outset Acid Concentrate 1K, 2K and 3K (Optional)
- · Outset Bicarbonate Concentrate jug (Optional)
- Non-invasive Blood Pressure Cuff (NIPB) kit
- Hand-Crank
- · Locking Power Cord
- Drain Line
- Water Line
- Insert and straw for Minncare Cold Sterilant
- Tablo Script

Field Replaceable Units:

- · Filter, Chlorine/Chloramines (Carbon Filter)
- · Filter, Sediment
- · Filter, RO Membrane
- · Ultrafilter (Water and Dialysate Ultrafilter)

The following are dialysis treatment recommended accessories which are commercially available by other manufacturers:

- High Flux Dialyzer
- Acid jug (If not using Outset Supplied Acid Concentrates jug)
- Bicarbonate jug (If not using Outset Supplied Bicarbonate jug)
- Minncare Cold Sterilant ●
- Chlorine/Chloramine test kit
- Saline bag

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K211370 Page 3 of 4

Outset Medical, Inc.

- Syringes and needles
- Gloves and mask
- Biohazard container
- Disinfectant, gauze pads, and tape for access site

## VII. SUBSTANTIAL EQUIVALENCE

The modified Tablo Hemodialysis System has the same fundamental technology, principle of operation, and principle functionality as the predicate. The device is a high permeability hemodialysis system, which combines a water purification system and dialysate delivery system as one device system.

The following differences exist between the predicate and subject device:

- . Hardware changes: these features are the same as those in the cleared reference device,
- . Software changes: these changes align the subject device software to that of the cleared reference device,
- . Updated software to restrict functionality by use settings (professional and self-care mode).

## VIII. PERFORMANCE DATA

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

### Biocompatibility Testing

In accordance with the FDA Guidance for the Content of Premarket Notifications for Hemodialysis Delivery Systems, issued August 7, 1998, Section VII, C, Outset Medical followed the alternative path and conducted leachable testing in lieu of biocompatibility tests. Toxicological assessment was performed. Device materials are considered safe for use as intended.

### Electrical safety and electromagnetic compatibility (EMC)

The device was tested against and complies with ES 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1-11, and IEC 60601-2-16. RFID testing per AIM 7351731 was also conducted.

### Software Verification and Validation Testing

Software verification and validation testing were conducted and passed for the incremental software changes. 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

N/A, Tablo Console is reusable, non-sterile. No changes were made to the Table Cartridge within this submission.

### Bench Performance Testing

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K211370 Page 4 of 4

Bench testing to support the updated Tablo Console is as described in the reference device 510(k) K190793 and additional testing was conducted as described below:

| Test Performed | Acceptance Criteria | Result |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Fungistasis and<br>Bacteriostasis | The system shall not inhibit detection and/or the<br>recovery of potential organisms as per USP 61. | Pass |
| Reprocessing<br>Disinfection Validation | The system shall be labeled with cleaning<br>instructions in accordance with FDA guidance,<br>"Reprocessing Medical Devices in Health Care<br>Settings: Validation Methods and Labeling" dated<br>March 2015. | Pass |
| Human Factors<br>Validation | The system shall be assessed for usability with<br>representative home users in accordance with its<br>intended use/indication for use. The FDA guidance<br>document used is "Applying Human Factors and<br>Usability Engineering to Medical Devices" dated<br>February 2016. | Pass |

#### Animal Study

No animal studies were conducted to support the modified device.

#### Clinical Studies

No clinical studies were conducted to support the modified device.

### IX. CONCLUSION

Non-clinical testing supports the safety and effectiveness of the Tablo Hemodialysis System. The results from these tests demonstrate that the device system performs comparably to the predicate device and is substantially equivalent to the legally marketed device, K200741.