(272 days)
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.
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.
The provided text describes the 510(k) premarket notification for the S.A.M CRRT Unit, a medical device for Continuous Renal Replacement Therapy (CRRT) and Therapeutic Plasma Exchange (TPE). However, the document does not contain information about an AI/ML-driven device, nor does it discuss acceptance criteria and performance data for such a device in the context of diagnostic accuracy, image analysis, or human-in-the-loop studies (MRMC, standalone performance, etc.).
The document focuses on the substantial equivalence of the S.A.M CRRT Unit to a predicate device (Prismaflex K110823) based on its intended use, technological characteristics, and conformance to electrical safety and biocompatibility standards.
Therefore, I cannot extract the requested information regarding AI/ML acceptance criteria and study details from the provided text. The questions posed in your prompt (e.g., sample size for test/training sets, expert qualifications, ground truth establishment, MRMC studies) are relevant to the evaluation of AI/ML-powered medical devices, but not to the S.A.M CRRT Unit as described in this 510(k) summary.
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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.
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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.
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
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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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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. -
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- -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 | PrismaflexK110823 | SAM |
|---|---|---|
| Intended Use | The Prismnaflex® control unit isintended for:* Continuous Renal ReplacementTherapy (CRRT) for patients weighing20 kilograms or more with acute renalfailure and/or fluid overload.* Therapeutic Plasma Exchange (TPE)therapy for patients weighing 20kilograms or more with diseases whereremoval of plasma components isindicated.All treatments administered via thePrismaflex® control unit must beprescribed by a physician | The S.A.M CRRT Unit is intended for:* Continuous Renal Replacement Therapy(CRRT) for patients weighing 20 kilogramsor more with acute renal failure and/or fluidoverload.* Therapeutic Plasma Exchange (TPE)therapy for patients weighing 20 kilogramsor more with diseases where removal ofplasma components is indicated.For all treatments performed utilizing theS.A.M CRRT Unit, use of the treatmentdevice must be carried out as per themanufacturers' specifications.All treatments administered via the S.A.Munit must be prescribed by a physician andare intended to be performed in theenvironment of the Intensive Care Unit orEmergency Department of the hospital.Rx Only.The S.A.M Cassette CRRT is intended forsingle use in continuous renal replacementand therapeutic plasma exchange therapiesusing the S.A.M CRRT Unit. The S.A.MCassette for CRRT is indicated for patientsweighing 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 / fluiddetectors Bloodleak detectorPressuretransducers | 1 Air Detector1 Optical Blood Leak Detector4 Pressure Sensors | 1 ultrasonic air/ fluid detectors1 optical blood leak detector5 electronic pressure transducers |
| Temperaturesensors | No. | 4 electronic temperature sensors (one perplate of heater, one for fluid inlet and onefor outlet) |
| Flow Rates:Blood | 10-450 ml/min | 0-300ml/min |
| PrescriptionFluid /DialysateFlow | 0-8000 ml/h | 0-6000 ml/h |
| UltrafiltrationFlow | 0-10000 ml/hr | 0-6000ml/hr |
| TransmembranePressureMonitoringSpecification | 70 to 350mmHg | 0-400mmHg |
| VenousPressureMonitor | -50 to 350 mmHg | -120 to 300 mmHg |
| Effluent fluidPressureMonitor | -350 to 400 mmHg | -50 to 500 mmHg |
| Air Detector | Yes | Yes |
| Blood LeakDetector | Yes | Yes |
| Effluent VolumeAccuracy | (+/- 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.
§ 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.”