(451 days)
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on fluidic systems and conventional dialysis delivery.
Yes
The device is indicated for use in patients with renal failure, performing hemodialysis, which is a therapeutic treatment to remove waste products from the blood.
No
The Tablo® Hemodialysis System is described as a treatment device for renal failure, not a device used to diagnose a medical condition. Its intended use is for dialysis therapy.
No
The device description explicitly states it includes a "Tablo Console" and a "Table Cartridge," which are physical hardware components. While software is mentioned in the performance studies, the device is clearly a system with both hardware and software.
Based on the provided information, the Tablo Hemodialysis System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for treating patients with renal failure through hemodialysis. This is a therapeutic treatment performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a system for performing hemodialysis, including water purification and dialysis delivery. This aligns with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples (blood, urine, etc.) to provide diagnostic information. IVDs are designed to detect, measure, or identify substances in these samples to aid in diagnosis or monitoring.
Therefore, the Tablo Hemodialysis System is a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for 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.
Product codes
KDI, FIP
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
- Syringes and needles
- Gloves and mask
- Biohazard container
- Disinfectant, gauze pads, and tape for access site
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
acute or chronic care facility or in the home. Treatments must be administered under physician's prescription and observed by a trained individual who is considered competent in the use of the device.
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
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:
- 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:
- Fungistasis and Bacteriostasis: The system shall not inhibit detection and/or the recovery of potential organisms as per USP 61. Result: Pass.
- Reprocessing Disinfection Validation: The system shall be labeled with cleaning instructions in accordance with FDA guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" dated March 2015. Result: Pass.
- Human Factors Validation: The system shall be assessed for usability with representative home users in accordance with its intended use/indication for use. The FDA guidance document used is "Applying Human Factors and Usability Engineering to Medical Devices" dated February 2016. Result: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Tablo Hemodialysis System, K200741
Reference Device(s)
Tablo Hemodialysis System, K190793
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5860 High permeability hemodialysis system.
(a)
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).
(b)
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.”
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
K211370 Page 1 of 4
Outset Medical, Inc.
510(k) Summary
(21 CFR 807.92)
I. SUBMITTER
| Name: | Outset Medical, Inc.
3052 Orchard Drive
San Jose, CA 95134 |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Phone:
Contact:
Date Prepared: | (408) 701-7319
Saket Bhatt
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
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
4
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
5
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
6
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 | ||
| Bacteriostasis | The system shall not inhibit detection and/or the | |
| recovery of potential organisms as per USP 61. | Pass | |
| Reprocessing | ||
| Disinfection Validation | The system shall be labeled with cleaning | |
| instructions in accordance with FDA guidance, | ||
| "Reprocessing Medical Devices in Health Care | ||
| Settings: Validation Methods and Labeling" dated | ||
| March 2015. | Pass | |
| Human Factors | ||
| Validation | The system shall be assessed for usability with | |
| representative home users in accordance with its | ||
| intended use/indication for use. The FDA guidance | ||
| document used is "Applying Human Factors and | ||
| Usability Engineering to Medical Devices" dated | ||
| 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.