Tablo Cartridge

K210782 · Outset Medical, Inc. · FJK · Nov 26, 2021 · Gastroenterology, Urology

Device Facts

• Record ID: K210782
• Device Name: Tablo Cartridge
• Applicant: Outset Medical, Inc.
• Product Code: FJK · Gastroenterology, Urology
• Decision Date: Nov 26, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Tablo Cartridge is single-use, disposable arterial/venous blood tubing set; functions as extracorporeal blood circuit for Tablo Hemodialysis System. Cartridge inserts onto console front panel for each treatment. Device facilitates blood flow between patient and hemodialysis machine. E-beam sterilized. Used in clinical or home settings where Tablo Hemodialysis System is operated. Healthcare providers or patients use the cartridge to establish blood access; output is the physical blood path for dialysis. Benefits include safe, disposable blood access for hemodialysis therapy.

Clinical Evidence

No clinical studies were performed. Substantial equivalence supported by bench performance testing, sterilization process validation (ISO 11137-1/2, ISO 11737-1/2, USP <71>, ANSI/AAMI ST72), shelf-life verification (ISO 11607-1/2), and biocompatibility testing (ISO 10993-1).

Technological Characteristics

Single-use, disposable blood tubing set; E-beam sterilized. External communicating device with prolonged contact (>24 hours to 30 days) with blood path. Complies with ISO 11137, ISO 11737, ISO 11607, ISO 10993-1, and USP <71> standards. Interfaces with Tablo Hemodialysis System console.

Indications for Use

Indicated for patients requiring hemodialysis; provides extracorporeal blood access via arterial and venous bloodline set. Compatible only with Tablo Hemodialysis System.

Regulatory Classification

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.

Predicate Devices

• Tablo Cartridge (K190793)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

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.<br>3052 Orchard Drive<br>San Jose, CA 95134 |
|------------------|------------------------------------------------------------------|
| Phone: | [phone] |
| 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

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 (Figure 1).

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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

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.

## 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.