TABLO CARTRIDGE

K140841 · Home Dialysis Plus · FJK · Sep 11, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K140841
• Device Name: TABLO CARTRIDGE
• Applicant: Home Dialysis Plus
• Product Code: FJK · Gastroenterology, Urology
• Decision Date: Sep 11, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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

Device Story

Tablo™ Cartridge is a single-use, sterile blood tubing set mounted on an organizer for interface with the Tablo™ Hemodialysis System. Components include arterial/venous lines, saline line, pressure transducer protector, venous drip chamber, arterial pressure pod, and heparin syringe line. The organizer ensures correct placement of tubing on the hemodialysis machine. The device facilitates extracorporeal blood flow during hemodialysis procedures. It is intended for use by healthcare providers or trained users in a clinical or home setting as part of the Tablo Hemodialysis System. The cartridge provides the necessary fluid path for blood circulation between the patient and the dialyzer, enabling the hemodialysis process to remove waste products and excess fluid from the patient's blood.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including functional testing, biocompatibility, packaging/shelf-life validation, sterilization validation, and pyrogenicity testing of the blood fluid path.

Technological Characteristics

Single-use, sterile blood tubing set. Materials: Polyvinyl Chloride (PVC) and Polypropylene (PP). Components: arterial/venous lines, pressure transducer protector, venous drip chamber, arterial pressure pod, heparin line, saline line. Mounted on an organizer for machine interface. Non-pyrogenic. Priming volume ≤ 300 ml.

Indications for Use

Indicated for patients requiring extracorporeal access during hemodialysis.

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

• Fresenius Blood Tubing Set (K120823)

Submission Summary (Full Text)

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

September 10, 2014

Home Dialysis Plus Nancy Gallo Senior Vice President, Regulatory Affairs 257 Humboldt Court Sunnyvale, CA 94089

Re: K140841 Trade/Device Name: Tablo™ Cartridge Regulation Number: 21 CFR§ 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: FJK Dated: August 8, 2014 Received: August 11, 2014

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 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.

# Herbert P. Lerner -S

for

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) K140841

Device Name Tablo™ Cartridge

### Indications for Use (Describe)

The Tablo™ Cartridge is a single use, disposable arterial and venous bloodline set intended to provide extracorporeal 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)

### 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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This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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# 5. 510(k) Summary

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.

#### 5.1 Submitter's Information

| Submitter's Name: | Moshe Pinto, CEO |
|------------------------------|--------------------------------------------------------|
| Company: | HDPlus |
| Address: | 257 Humboldt Ct, Sunnyvale, CA 94089 |
| Contact Person: | Nancy Gallo, Senior Vice-President, Regulatory Affairs |
| Phone: | 510.682.6505 |
| Facsimile: | 408.329.9091 |
| Email: | [e-mail] |
| Date of Summary Preparation: | March 31, 2014 |

#### 5.2 Device Information

| Trade Name: | Tablo™ Cartridge |
|------------------------|-------------------------------------------------------------------------|
| Common Name: | Blood Tubing Set |
| Classification Name: | Hemodialysis system and accessories |
| Classification Number: | Class II per 21 CFR 876.5820 |
| Product Code: | FJK (Set, Tubing, Blood, With And Without Anti-<br>Regurgitation Valve) |
| Classification Panel: | Gastroenterology/Urology |

#### Predicate Device Information 5.3

Fresenius Blood Tubing Set (K120823)

#### 5.4 Device Description

The Tablo™ Cartridge comprises a single-use, sterile Blood Tubing Set attached to an Organizer. The Organizer ensures proper placement of the Blood Tubing Set with the Tablo Hemodialysis System. The Blood Tubing Set consists of an arterial line, a venous line, an adaptor to connect the two lines, a saline line, a pressure transducer protector, a venous drip chamber, an arterial pressure pod, and a heparin syringe line. The Tablo Cartridge is developed exclusively for use with the Tablo Hemodialysis System. It is single-use, offered in one configuration, and provided sterile.

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#### 5.5 Indications for Use

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

#### Technological Characteristics 5.6

The Tablo Cartridge (Subject Device) utilizes Fresenius Blood Tubing Set (K120823) as its Predicate.

### 5.6.1 Tablo Cartridge vs. Fresenius Blood Tubing Set (K120823):

The Subject and Predicate Devices have equivalent technological characteristics:

- Intended Use – To provide extracorporeal access during hemodialysis.
- Materials – Primary fluid path materials are Polyvinyl Chloride (PVC) and Polypropylene (PP).
- Design & Construction - Polyvinyl Chloride (PVC) tubing of various lengths and diameters, with color-coded pinch clamps, color-coded injection ports, heparin line, saline line, and pressure monitoring components.
- Sterility - Sterile, single use, non-pyrogenic.
- Priming Volume Priming Volume of ≤ 300 ml ●

Minor differences exist in the technological characteristics of the Subject and Predicate Devices. None of the minor differences raise any new or different questions of safety or effectiveness. The differences include:

- Subject Device is mounted on an organizer to facilitate interface with the machine's front panel. The Predicate does not have an organizer and the tubing is uncoiled and attached to the machine.
- . The Inner Diameter (ID) of the Blood Pump Segment of Subject Device is smaller than that of the Predicate Device.
- The default configuration of the access point used for both systems is a double needle configuration, though the Predicate is also equipped with the option of a single needle configuration.
- The pressure measuring component of the Tablo Cartridge is different from that of the Predicate.

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#### 5.7 Performance Data

The following Performance Testing, developed in accordance with appropriate guidance documents and relevant standards, has been performed on the Subject Device to support the determination of substantial equivalence:

- . Functional testing.
- . Biocompatibility testing.
- Packaging and shelf life testing.
- Sterilization validation.
- Pyrogenicity testing for the blood fluid path.

The results of all these tests demonstrated the Tablo Cartridge is safe and does not raise new or different questions of safety or effectiveness as compared to the Predicate.

#### 5.8 Conclusion

The Performance Testing demonstrated the Tablo Cartridge meets all performance specifications and complies with applicable standards and FDA Guidance Documents. The Tablo Cartridge is substantially equivalent to the Predicate, and the minor differences in the technological characteristics of the Subject and the Predicate Devices do not raise any new or different questions of safety or effectiveness.