(272 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard software-controlled functions for fluid management and monitoring.
Yes
The device is intended for "Continuous Renal Replacement Therapy (CRRT) for patients... with acute renal failure and/or fluid overload" and "Therapeutic Plasma Exchange (TPE) therapy for patients... where removal of plasma components is indicated," which are both therapeutic interventions.
No
The device is described as a "CRRT Unit" and is used for Continuous Renal Replacement Therapy (CRRT) and Therapeutic Plasma Exchange (TPE), which are treatments, not diagnostic procedures. Its functions involve pumping fluids and controlling fluid removal, not diagnosing conditions.
No
The device description explicitly states it is a "software controlled device" that performs physical functions like pumping blood, delivering solutions, and controlling fluid removal. It also mentions a "touchscreen interface" and is used with a "tubing set" (the S.A.M Cassette). This indicates the device includes significant hardware components beyond just software.
Based on the provided information, the S.A.M CRRT Unit is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes a device used for treating patients with acute renal failure and/or fluid overload through Continuous Renal Replacement Therapy (CRRT) and Therapeutic Plasma Exchange (TPE). These are therapeutic procedures performed directly on the patient's blood, not tests performed on samples outside the body to diagnose or monitor a condition.
- Device Description: The description details a system that pumps blood, delivers solutions, controls fluid removal, and monitors the process. These are all functions related to a therapeutic intervention, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, etc.) to provide diagnostic information. The device is focused on processing the patient's blood for therapeutic purposes.
IVD devices are typically used 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 S.A.M CRRT Unit does not fit this description.
N/A
Intended Use / Indications for Use
The S.A.M CRRT Unit is intended for:
- Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload.
- Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated.
For all treatments performed utilizing the S.A.M CRRT Unit, use of the treatment device must be carried out as per the manufacturers' specifications.
All treatments administered via the S.A.M unit must be prescribed by a physician and are intended in the environment of the Intensive Care Unit or Emergency Department of the hospital.
Rx Only.
The S.A.M Cassette CRRT is intended for single use in continuous renal replacement and therapeutic plasma exchange therapies using the S.A.M CRRT Unit. The S.A.M Cassette for CRRT is indicated for patients weighing 20 kg or more. Rx Only.
Product codes (comma separated list FDA assigned to the subject device)
KDI
Device Description
The S.A.M CRRT Unit is a software controlled device that performs the following functions:
- Primes the SAM disposable cassette automatically.
- Pumps blood through the blood flow path of the disposable cassette.
- Delivers anticoagulant into the blood flow path.
- Pumps sterile infusion solutions into the blood flow path of the disposable according to therapy in use.
- Pumps sterile dialysate into the fluid compartment of the filter in CRRT therapies.
- Controls the patient fluid removal or plasma loss according to the therapy in use.
- Monitors the system and alerts the operator to abnormal situations through alarms.
The S.A.M CRRT Unit has a touchscreen interface that provides operating instructions to the user. The system is used in conjunction with the S.A.M Cassette tubing set.
Physical Characteristics:
Height 1600 mm Width 720 mm Depth 660 mm Weight 50kg
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 - indicated patients weighing 20 kilograms or more.
Intended User / Care Setting
All treatments administered via the S.A.M unit must be prescribed by a physician and are intended in the environment of the Intensive Care Unit or Emergency Department of the hospital.
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)
The SAM unit is tested against and conforms to the FDA recognized consensus standards:
- 9-80: IEC 60601-2-16 Edition 4.0 2012-03, Medical Electrical Equipment Part 2-16: -Particular Requirements For The Basic Safety And Essential Performance Of Haemodialysis, Haemodiafiltration And Haemofiltration Equipment.
- 19-4: AAMI ANSI ES60601-1:2005/(R) 2012 and A1:2012 C1:2009/(R)2012 And -A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD).
- 19-1: IEC 60601-1-2 Edition 3 2007-03 Medical Electrical Equipment Part 1-2: General -Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests.
The SAM Cassette bloodlines are tested for biocompatibility as per ISO 10993.
The performance data, specifically the data derived from IEC60601-2-16, indicates that the SAM CRRT Unit is suitable for the intended use of the unit and is therefore substantially equivalent to the predicate device.
The successful testing of the S.A.M CRRT Unit demonstrates safety and effectiveness when used for the defined indications for use and is substantially equivalent to the predicate devices.
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.
Not Found
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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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 & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
December 13, 2017
Spectral Medical Inc. % Olga Pavlova, Ph.D. Regulatory Manager Amarex Clinical Research 20201 Century Boulevard, 4th Floor Germantown, MD 20874
Re: K170790
Trade/Device Name: S.A.M CRRT Unit Regulation Number: 21 CFR§ 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: II Product Code: KDI Dated: November 10, 2017 Received: November 13, 2017
Dear Olga Pavlova:
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.
1
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.
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a simple, sans-serif font. The text is black and appears to be against a light background. The letters are clear and easy to read, with a slight shadow effect on some parts of the text.
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
2
Indications for Use
510(k) Number (if known) K170790/S001
Device Name S.A.M CRRT Unit
Indications for Use (Describe) The S.A.M CRRT Unit is intended for:
-
Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload.
-
Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated.
For all treatments performed utilizing the S.A.M CRRT Unit, use of the treatment device must be carried out as per the manufacturers' specifications.
All treatments administered via the S.A.M unit must be prescribed by a physician and are intended in the environment of the Intensive Care Unit or Emergency Department of the hospital.
Rx Only.
The S.A.M Cassette CRRT is intended for single use in continuous renal replacement and therapeutic plasma exchange therapies using the S.A.M CRRT Unit. The S.A.M Cassette for CRRT is indicated for patients weighing 20 kg or more. Rx Only.
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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3
Image /page/3/Picture/0 description: The image shows the logo for Spectral Medical Inc. The word "SPECTRAL" is in large, bold, black font. Below the right side of "SPECTRAL" is the word "Medical" in a smaller, gray font. To the right of "Medical" is a red vertical line, and then the letters "INC" in a black font.
510(k) Summary
The content in this 510(k) summary has been provided in conformance with 21 CFR Part 807.92.
Submitter's Information
| Name: | Spectral Medical, Inc. |
|---|---|
| Address: | 135 The West Mall, Unit 2 |
| Toronto, Ontario M9C 1C2 | |
| Phone: | 416 626 3233 |
| Fax: | 416 626 7383 |
| Contact Person: | Danijela Domljanovic |
| Director, Quality Assurance | |
| Date of Preparation: | November 20, 2017 |
Device Name
Trade/Device Name: S.A.M CRRT Unit Regulation Number: 21 CFR 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: Class II Product Code: KDI Classification Panel: Gastroenterology/Urology
Legally Marketed Predicate Devices (unmodified devices)
Prismaflex™ 510(k) K110823
Device Description
The S.A.M CRRT Unit is a software controlled device that performs the following functions:
- -Primes the SAM disposable cassette automatically.
- Pumps blood through the blood flow path of the disposable cassette. -
- -Delivers anticoagulant into the blood flow path.
- -Pumps sterile infusion solutions into the blood flow path of the disposable according to therapy in use.
- -Pumps sterile dialysate into the fluid compartment of the filter in CRRT therapies.
- Controls the patient fluid removal or plasma loss according to the therapy in use. -
4
- -Monitors the system and alerts the operator to abnormal situations through alarms.
The S.A.M CRRT Unit has a touchscreen interface that provides operating instructions to the user. The system is used in conjunction with the S.A.M Cassette tubing set.
Physical Characteristics:
Height 1600 mm Width 720 mm Depth 660 mm Weight 50kg
Indications for Use
The S.A.M CRRT unit is intended for:
-
Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload.
-
Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated.
For all treatments performed utilizing the S.A.M CRRT Unit, use of the treatment device must be carried out as per the manufacturers' specifications.
All treatments administered via the S.A.M unit must be prescribed by a physician and are intended to be performed in the environment of the Intensive Care Unit or Emergency Department of the hospital.
Rx Only.
The SAM Cassette CRRT is intended for single use in continuous renal replacement and therapeutic plasma exchange therapies using the SAM CRRT Unit. The SAM Cassette for CRRT is indicated for patients weighing 20 kg or more. Rx Only.
Patient Population:
The intended patient population of the SAM control unit are patients requiring extracorporeal blood purification by convection, diffusion or adsorption including, or not, compensation of the components extracted from the blood. Specifically the unit is intended to deliver the continuous renal replacement therapies (CRRT) continuous veno-venous – Hemofiltration (CVVH or HF), - Hemodialysis (CVVHD or HD), and - Hemodiafiltration (CVVHDF or HDF). The unit will also deliver Therapeutic Plasma Exchange (TPE).
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Image /page/5/Picture/0 description: The image shows the logo for Spectral Medical INC. The word "SPECTRAL" is in large, bold, black font. Below this word, the word "Medical" is in a smaller, gray font. To the right of the word "Medical" is a red vertical line, followed by the letters "INC" in a large, bold, black font.
Technological Characteristics (design, material, chemical composition, energy source, etc.)
| Parameter | Prismaflex
K110823 | SAM |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Prismnaflex® control unit is
intended for:
- Continuous Renal Replacement
Therapy (CRRT) for patients weighing
20 kilograms or more with acute renal
failure and/or fluid overload. - Therapeutic Plasma Exchange (TPE)
therapy for patients weighing 20
kilograms or more with diseases where
removal of plasma components is
indicated.
All treatments administered via the
Prismaflex® control unit must be
prescribed by a physician | The S.A.M CRRT Unit is intended for: - Continuous Renal Replacement Therapy
(CRRT) for patients weighing 20 kilograms
or more with acute renal failure and/or fluid
overload. - Therapeutic Plasma Exchange (TPE)
therapy for patients weighing 20 kilograms
or more with diseases where removal of
plasma components is indicated.
For all treatments performed utilizing the
S.A.M CRRT Unit, use of the treatment
device must be carried out as per the
manufacturers' specifications.
All treatments administered via the S.A.M
unit must be prescribed by a physician and
are intended to be performed in the
environment of the Intensive Care Unit or
Emergency Department of the hospital.
Rx Only.
The S.A.M Cassette CRRT is intended for
single use in continuous renal replacement
and therapeutic plasma exchange therapies
using the S.A.M CRRT Unit. The S.A.M
Cassette for CRRT is indicated for patients
weighing 20 kg or more. Rx Only. |
| Technology /
Components:
Pumps | 5 Peristaltic Pumps | 4 piston/membrane pumps |
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Image /page/6/Picture/0 description: The image shows the logo for Spectral Medical Inc. The word "SPECTRAL" is in large, bold, black letters. Below the word "SPECTRAL" is the word "Medical" in a smaller, gray font. To the right of the word "SPECTRAL" is a red vertical line, followed by the letters "INC" in black.
| Clamps/Valves | One Venous Electroclamp | 8 Cam driven pinch clamps (2 per pump chamber)
3 stepper motor actuated pinch clamps
(Venous, purge, waste) |
|----------------------------------------------------------------------------|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Air / fluid
detectors Blood
leak detector
Pressure
transducers | 1 Air Detector
1 Optical Blood Leak Detector
4 Pressure Sensors | 1 ultrasonic air/ fluid detectors
1 optical blood leak detector
5 electronic pressure transducers |
| Temperature
sensors | No. | 4 electronic temperature sensors (one per
plate of heater, one for fluid inlet and one
for outlet) |
| Flow Rates:
Blood | 10-450 ml/min | 0-300ml/min |
| Prescription
Fluid /Dialysate
Flow | 0-8000 ml/h | 0-6000 ml/h |
| Ultrafiltration
Flow | 0-10000 ml/hr | 0-6000ml/hr |
| Transmembrane
Pressure
Monitoring
Specification | 70 to 350mmHg | 0-400mmHg |
| Venous
Pressure
Monitor | -50 to 350 mmHg | -120 to 300 mmHg |
| Effluent fluid
Pressure
Monitor | -350 to 400 mmHg | -50 to 500 mmHg |
| Air Detector | Yes | Yes |
| Blood Leak
Detector | Yes | Yes |
| Effluent Volume
Accuracy | (+/- 30ml/hr)
(+/- 70ml/3hr)
(+/- 300ml/24hr) | (+/- 25mL/hr) |
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Image /page/7/Picture/0 description: The image shows the logo for Spectral Medical INC. The word "SPECTRAL" is written in large, black, serif font. Below the "RAL" in Spectral, the word "Medical" is written in a smaller, gray, serif font. To the right of "SPECTRAL Medical", there is a red vertical line, and then the letters "INC" are written in a large, black, serif font.
Performance Data
The SAM unit is tested against and conforms to the FDA recognized consensus standards:
- 9-80: IEC 60601-2-16 Edition 4.0 2012-03, Medical Electrical Equipment Part 2-16: -Particular Requirements For The Basic Safety And Essential Performance Of Haemodialysis, Haemodiafiltration And Haemofiltration Equipment.
- 19-4: AAMI ANSI ES60601-1:2005/(R) 2012 and A1:2012 C1:2009/(R)2012 And -A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD).
- 19-1: IEC 60601-1-2 Edition 3 2007-03 Medical Electrical Equipment Part 1-2: General -Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests.
The SAM Cassette bloodlines are tested for biocompatibility as per ISO 10993.
The performance data, specifically the data derived from IEC60601-2-16, indicates that the SAM CRRT Unit is suitable for the intended use of the unit and is therefore substantially equivalent to the predicate device.
Conclusion
The successful testing of the S.A.M CRRT Unit demonstrates safety and effectiveness when used for the defined indications for use and is substantially equivalent to the predicate devices.