(255 days)
No reference devices were used in this submission.
No
The document describes a disposable bloodline set and its performance testing, with no mention of AI or ML capabilities.
No
The device is described as a bloodline set for extra-corporeal access during hemodialysis, and its purpose is to provide access, not to treat a condition itself.
No.
The device is described as a bloodline set for extra-corporeal access during hemodialysis, and its "Intended Use" focuses on providing this access, not on diagnosing medical conditions.
No
The device description explicitly states it is a "single use blood tubing set attached to an organizer tray" and is a "disposable cartridge," indicating it is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide extra-corporeal access during hemodialysis. This involves circulating blood outside the body for treatment, not for diagnostic testing of samples.
- Device Description: The device is a blood tubing set, which is used for the physical process of hemodialysis, not for analyzing biological samples.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze blood or other biological samples to diagnose a condition, monitor a disease, or determine compatibility.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnostic purposes. This device's function is purely therapeutic (hemodialysis).
N/A
Intended Use / 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.
Product codes
FJK
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The following performance data were provided in support of the substantial equivalence determination.
- E-Beam Sterilization Process Validation Testing: Conducted in accordance with FDA guidance documents and various ISO and USP standards (ISO 11137-1:2006, ISO 11137-2:2013, ISO 11737-1:2018, ISO 11737-2:2019, USP , ANSI/AAMI ST72:2019). Tests included Bioburden Recovery, Bioburden Determination, Verification Dose Determination, Dose Map Study, Method Suitability Determination, and Test of Sterility.
- Shelf-Life Testing (Accelerated Aging and Transit): Conducted as recommended by FDA's guidance document, complying with ISO 11607-1:2019 and ISO 11607-2:2019. Tests included Accelerated aging, Climatic conditioning, Gross leak detection (Bubble), Seal strength (Peel), Package performance, and Product functional testing.
- Biocompatibility Testing: Conducted in accordance with the FDA guidance document and ISO 10993-1:2018. Tests included Cytotoxicity, Sensitization, Irritation, Acute systemic toxicity, Hemocompatibility, Genotoxicity, and Pyrogenicity.
- Bench Performance Testing: Conducted in accordance with the FDA guidance document to demonstrate the device meets system requirements and performs as intended.
- Animal Study: No animal studies were performed.
- Clinical Studies: No clinical studies were performed.
The performance testing demonstrates that the Tablo Cartridge meets all performance specifications and complies with applicable standards and FDA Guidance Documents.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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)
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.
3052 Orchard Drive
San 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
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 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.