Tablo Console with Wireless Capability

K150880 · Outset Medical · KDI · May 1, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K150880
• Device Name: Tablo Console with Wireless Capability
• Applicant: Outset Medical
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: May 1, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Tablo 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, with a trained individual available as needed who is considered competent in the use of the device by the prescribing physician.

Device Story

Tablo Console is a self-contained hemodialysis system integrating water purification and dialysis delivery. Used in acute or chronic care facilities for renal failure treatment. Operates via fluidic systems to perform dialysis and ultrafiltration. Managed by trained individuals under physician prescription. Features a graphical user interface (GUI) for operation. Includes one-way wireless data transmission for medical informatics. Benefits patients by providing integrated, self-contained dialysis therapy.

Clinical Evidence

Bench testing only. Performance testing verified wireless compatibility, electrical safety, electromagnetic compatibility, and software verification. No clinical data presented.

Technological Characteristics

Self-contained hemodialysis system integrating water purification and dialysis delivery. Uses heat and chemical disinfection. Interfaces with Tablo Cartridge (blood tubing set). Includes GUI and one-way wireless data transmission. Complies with electrical/electromagnetic safety, water purification, and hemodialysis system standards.

Indications for Use

Indicated for patients with acute and/or chronic renal failure requiring hemodialysis, with or without ultrafiltration, in acute or chronic care facilities. Requires physician prescription and supervision by a trained individual.

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™ Console (K140866)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a series of overlapping profiles. The symbol is composed of three curved lines that create the impression of faces or heads in profile.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 1, 2015

Outset Medical Nancy Gallo Sr. Vice President, Regulatory Affairs and Quality Assurance 1830 Bering Drive San Jose, CA 95112

Re: K150880

Trade/Device Name: Tablo Console Regulation Number: 21 CFR§ 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: March 31, 2015 Received: April 1, 2015

Dear Nancy Gallo,

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation 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) K150880

Device Name Tablo Console

### Indications for Use (Describe)

The Tablo 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, with a trained individual available as needed who is considered competent in the use of the device by the prescribing physician.

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)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

## FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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### 510(k) Summary 7

This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR Part 807.92.

| Submitter's Name: | Nancy Gallo |
|---------------------------------|-----------------------------------------------------------------------------|
| Company: | Outset Medical |
| Address: | 1830 Bering Drive<br>San Jose, CA 95112 |
| Contact Person: | Nancy Gallo<br>Sr. Vice President, Regulatory Affairs and Quality Assurance |
| Phone: | 510.682.6505 |
| Facsimile: | 669.231.8201 |
| Email: | [e-mail] |
| Date of Summary<br>Preparation: | March 31, 2015 |

#### 7.1 Submitter's Information

#### 7.2 Device Information

| Trade Name: | Tablo™ Console | |
|------------------------|---------------------------------------------------|-----------------------------------------------|
| Common Name: | Hemodialysis Delivery System | Portable Water Treatment<br>System |
| Classification Name: | High Permeability Hemodialysis<br>Delivery System | Water Purification System for<br>Hemodialysis |
| Classification Number: | Class II per 21 CFR 876.5860 | Class II per 21 CFR 876.5665 |
| Product Code: | KDI | FIP |
| Classification Panel: | Gastroenterology/Urology | Gastroenterology/Urology |

#### 7.3 Predicate Device Information

Tablo™ Console (K140866)

#### 7.4 Device Description

The Tablo™ Console is a self-contained hemodialysis system (Console) intended for acute and chronic dialysis therapy with or without ultrafiltration, in an acute or chronic care facility. The console consists of fluidic systems that perform the activities of a Water Purification System (WPS) and a conventional Dialysis Delivery System (DDS).

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#### 7.5 Indications for Use

The Tablo 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, with a trained individual available as needed who is considered competent in the use of the device by the prescribing physician.

#### 7.6 Technological Characteristics

The Tablo Console (Modified Device) and the Predicate Device are equivalent in technological characteristics:

- Intended use - To deliver hemodialysis to patients with renal disease.
- Off the shelf components - Dialyzers and non-invasive blood pressure cuffs (NIBP).
- . Standards - Electrical and electromagnetic safety, Water Purification, and Hemodialysis System standards.
- Software - Software controlled, and utilizes Graphic User Interface (GUI).
- Design and Construction
- Water Purification Method
- Dialysate Preparation
- Disinfection - Heat and chemical disinfection.
- Compatibility – Interface with the Tablo Cartridge (Blood Tubing Set)
- System Level Specifications

There is one difference between the Modified and Predicate Devices. The difference is limited to the inclusion of one-way wireless data transmission capability for medical informatics.

#### 7.7 Performance Data

The following performance testing, developed in accordance with appropriate FDA guidance documents and relevant standards, has been performed on the Modified Device to support the determination of substantial equivalence:

- Performance testing to verify wireless compatibility of the system with other communication devices
- . Performance testing to verify maintenance of the Electrical Safety and Electromagnetic Compatibility profiles
- Software verification

#### 7.8 Conclusion

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