(8 days)
No reference devices were used in this submission.
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and performance studies do not mention any AI/ML components or capabilities.
Yes.
The device is used to treat patients with acute and/or chronic renal failure, which is a medical condition, making it a therapeutic device.
No
The device description and intended use clearly state that the Tablo Hemodialysis System is for "dialysis therapy" and "treatment" of renal failure. There is no mention of diagnosing conditions or providing diagnostic information.
No
The device description explicitly lists multiple hardware components, including the "Tablo Console" and various accessories like "Tablo Straws," "Patient USB Stick," and "Hand Crank." While "Tablo Script" is mentioned as optional accessory software, the core device is a physical hemodialysis system.
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 directly on the patient, not a test performed on a sample taken from the patient.
- 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: There is no mention of analyzing biological samples (blood, urine, etc.) to provide diagnostic information. The system's function is to filter the patient's blood.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Tablo Hemodialysis System does not fit this definition.
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 Tablo Hemodialysis System is also indicated for use in the home.
Product codes (comma separated list FDA assigned to the subject device)
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. This premarket notification is an indication expansion to include home use of the device. The product described in this submission includes:
- . 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
- . The following accessories/components
- Tablo Script (optional accessory software) o
- Tablo Straws O
- O Outset Acid Concentrate 1K, 2K and 3K
- Outset Bicarbonate Concentrate O
- Patient USB Stick O
- Hand Crank O
- O Locking Power Cord
- Drain Line O
- O Water Line
- Disinfectant Straw O
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, home
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Studies: Outset Medical conducted the Tablo clinical study, a prospective, multicenter, open label, nonrandomized, cross-over study evaluating the use of the Tablo Hemodialysis System In-Center and In-Home by trained subjects with end stage renal disease (ESRD) who are on stable dialysis regimen. Use of the Tablo Hemodialysis System is associated with a low adverse event rate and can safely be used at home by ESRD patients. The recommended adequacy target of home hemodialysis (a weekly standardized Kt/V of 2.1) can consistently and effectively be delivered with the Tablo Hemodialysis System when used by End Stage Renal Disease patients in the home environment. Additionally, patients reliably achieve ultrafiltration goals using the System at home. The Tablo Hemodialysis System is safe and effective for home use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.”
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March 31, 2020
Outset Medical, Inc. Jennifer Mascioli-Tudor Vice President of Quality Assurance and Regulatory Affairs 1830 Bering Drive San Jose, CA 95112
Re: K200741
Trade/Device Name: Tablo Hemodialysis System Regulation Number: 21 CFR 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: II Product Code: KDI, FIP Dated: March 20, 2020 Received: March 24, 2020
Dear Jennifer Mascioli-Tudor:
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.
1
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 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 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.
Carolyn Y. Neuland, Ph.D. 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200741
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) |
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Page 1 of 4 Outset Medical, Inc.
510(k) Summary
I. SUBMITTER
| Name: | |
|---|---|
Outset Medical, Inc. 1830 Bering Drive San Jose, CA 95112
Phone: Primary Contact: Secondary Contact: Date Prepared:
(669) 231-8200 Jennifer Mascioli-Tudor Mara Marshak March 20, 2020
II. DEVICE
Name of Device:
Tablo® Hemodialysis System
Common or Usual Name: Hemodialysis delivery system and water purification system
Classification Name: High Permeability Hemodialysis System (21 CFR § 876.5860) Product Code: KDI Water Purification System for Hemodialysis - Product Code: FIP
Regulatory Class: II
III. PREDICATE DEVICE
Tablo Console, K160881 The predicate device has not been subject to a design related recall. No reference devices were used in this submission.
IV. 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. This premarket notification is an indication expansion to include home use of the device. The product described in this submission includes:
- . 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
- . The following accessories/components
- Tablo Script (optional accessory software) o
- Tablo Straws O
- O Outset Acid Concentrate 1K, 2K and 3K
- Outset Bicarbonate Concentrate O
- Patient USB Stick O
4
- Hand Crank O
- O Locking Power Cord
- Drain Line O
- O Water Line
- Disinfectant Straw O
V. INDICATIONS FOR USE
The indications for use statement was modified to include home 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.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
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 technological differences exist between the predicate and subject devices:
- Added Outset 1K acid concentrate
- Venous drip chamber level sensor change
- 1-way data transmission from the device to the cloud for home users ●
- . Software reliability improvements
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
No additional testing was conducted to support the modified device.
Electrical safety and electromagnetic compatibility (EMC)
Complies with ES 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-1-10, IEC 60601-1-11, and IEC 60601-2-16. RFID testing per AIM 7351731.
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
5
directly result in serious injury or death to the patient or operator. Completed software testing supports safety and effectiveness of the device.
Bench Performance Testing
The following test were completed to support the subject device.
| Test Performed | Acceptance Criteria | Result |
|---|---|---|
| AAMI Water and | ||
| AAMI Dialysate | ||
| Quality | ||
| Verification | The system shall meet ANSI/AAMI 13959:2014 and | |
| ANSI/AAMI 11663:2014 requirements for water and | ||
| dialysate under worst case input test conditions. | Pass | |
| 1K Concentrate | ||
| Compatibility | ||
| Verification | The system shall be compatible with the Outset | |
| branded 1K acid concentrate | Pass | |
| Drip Chamber | ||
| Level Sensor | ||
| Verification | The modified sensors shall meet pre-specified | |
| functional and performance requirements. | Pass | |
| Suitability Test - | ||
| USP | ||
| Microbial | ||
| Enumeration Test | The system shall not inhibit detection and/or the | |
| recovery of potential organisms. | 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, issued March 17, |
- | Pass |
Human Factors
Human factors validation conducted in accordance with the FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices", issued February 3, 2016.
Animal Study
No animal studies were conducted to support the modified device.
Clinical Studies
Outset Medical conducted the Tablo clinical study, a prospective, multicenter, open label, nonrandomized, cross-over study evaluating the use of the Tablo Hemodialysis System In-Center and In-Home by trained subjects with end stage renal disease (ESRD) who are on stable dialysis regimen. Use of the Tablo Hemodialysis System is associated with a low adverse event rate and can safely be used at home by ESRD patients. The recommended adequacy target of home hemodialysis (a weekly standardized Kt/V of 2.1) can consistently and effectively be delivered with the Tablo Hemodialysis System when used by End Stage Renal Disease patients in the home environment. Additionally, patients reliably achieve ultrafiltration goals using the System at home. The Tablo Hemodialysis System is safe and effective for home use.
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VIII. CONCLUSION
The clinical and non-clinical data support that the modified Tablo Hemodialysis System, when used in the home environment, is as safe and effective and therefore, is substantially equivalent to the predicate device, K160881.