(161 days)
Not Found
No
The document describes a standard hemodialysis system with mechanical and electronic components, sensors, and disposable elements. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies.
Yes.
The device is indicated for use in patients with acute and/or chronic renal failure, which is a medical condition, and it removes waste products from the blood, acting as a therapy.
No
The device is a hemodialysis system used for treating renal failure by filtering blood, not for diagnosing a medical condition.
No
The device description clearly outlines hardware components like the SC+ Machine (containing pumps, sensors, etc.), a disposable Dialysate Cartridge, and a disposable Blood Tubeset. This is not a software-only device.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The description of the SC+ Hemodialysis System clearly states its purpose is to treat patients with renal failure by filtering their blood extracorporeally (outside the body). It does not involve the analysis of samples taken from the patient for diagnostic purposes.
- The device description focuses on the mechanical and fluid handling aspects of hemodialysis. It details the machine's components, the dialysate cartridge, and the blood tubeset, all of which are involved in the physical process of blood filtration and fluid removal.
- The intended use is for treatment, not diagnosis. The indication for use is "for use in patients with acute and/or chronic renal failure," which describes a patient population for whom the treatment is intended, not a diagnostic test.
Therefore, the SC+ Hemodialysis System is a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
SC+ Hemodialysis Machine/ SC+ Dialysate cartridge
The SC+ 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, by a trained person who is considered competent in the use of the device.
SC+ Blood Tubeset
The SC+ Blood Tubeset is a single use, disposable arterial and venous bloodline set intended to provide extracorporeal access during hemodialysis. The Blood Tubeset is compatible only with the SC+ Hemodialysis System.
Product codes (comma separated list FDA assigned to the subject device)
KDI, FJK
Device Description
The SC+ is a hemodialysis delivery system intended for acute and chronic dialysis therapy with or without ultrafiltration in an acute of chronic care facility. The system consists of the SC+ Machine, a single use disposable Dialysate Cartridge, and a sterile, single use, disposable Blood Tubeset.
1.4.1 SC+ Hemodialysis System
The SC+ Hemodialysis System is intended for acute and chronic dialysis therapy, with or without ultrafiltration, utilizing Dialysis Water (from standalone Reverse Osmosis (RO) units or a central RO ring main) to produce dialysate. The SC+ Hemodialysis system is for use in patients with arteriovenous (AV) fistula or central venous catheter access.
The system consists of the SC+ Machine, a single use disposable Dialysate Cartridge, and a sterile, single use, disposable Blood Tubeset.
The SC+ Machine consists of a water circuit (heater, de-aeration module, etc) blood leak detector, air in blood detector, a pneumatic interface for the dialysate cartridges, a peristaltic blood pump and various other sensors. The dialysate cartridge contains the following; conductivity monitors, interfaces for pressure and temperature measurement, membrane pumps to perform mixing/proportioning in order to produce dialysis fluid and the controlled removal of fluid from a patient with acute and/or chronic renal failure based on a physician's prescription. The dialysate fluid is manufactured using dialysis water purified externally by reverse osmosis that is heated to approximately 37℃ and subsequently deaerated within the machine before entering the cartridge.
The SC+ Blood Tubeset is a single use, sterile device consisting of an arterial line, a venous line, connections to a standard dialyzer, a saline line, three pressure transducer pods integrated into a single unit, a venous drip chamber, and a line for heparin infusion.
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. Treatments must be administered under physician's prescription, by a trained person 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance testing, developed in accordance with appropriate FDA guidance documents and relevant standards, has been performed on the Modified Device to support the determination of substantial equivalence:
- Performance testing to verify maintenance of the Electrical Safety and Electromagnetic Compatibility profiles
- Software verification
- Human Factors validation testing •
- Biological safety testing •
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.”
0
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August 12, 2021
Quanta Dialysis Technologies Ltd Sam Drew Risk and Regulatory Manager 1-3 Tything Road Alcester, Warwickshire B49 6EU UNITED KINGDOM
K210661 Re:
Trade/Device Name: SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset Regulation Number: 21 CFR 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: Class II Product Code: KDI, FJK Dated: July 12, 2021 Received: July 13, 2021
Dear Sam Drew:
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
1
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,
Carolyn Y. Neuland, Ph.D. Assistant Division 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
Indications for Use
510(k) Number (if known) K210661
Device Name SC+ Hemodialysis Machine SC+ Dialysate Cartridge SC+ Blood Tubeset
Indications for Use (Describe) SC+ Hemodialysis Machine/ SC+ Dialysate cartridge
The SC+ 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, by a trained person who is considered competent in the use of the device.
SC+ Blood Tubeset
The SC+ Blood Tubeset is a single use, disposable arterial and venous bloodline set intended to provide extracorporeal access during hemodialysis. The Blood Tubeset is compatible only with the SC+ 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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K210661 510(k) Summary Date of preparation: 12th July 2021
510(k) Summary
The content of this 510(k) summary is provided in conformance with 21 CFR Part 807.92
1.1 Manufacturer
Quanta Dialysis Technologies Ltd Tything Road, Alcester, Warwickshire, B49 6EU, United Kingdom
1.2 Contact
Sam Drew Sam.drew@quantadt.com +44 01789 400043
1.3 Device information
The SC+ Hemodialysis system comprises of the SC+ Hemodialysis Machine, the SC+ Dialysate Cartridge and the SC+ Blood Tubeset.
1.3.1 SC+ Machine & Dialysate Cartridge
General Device Information 1.3.1.1
| Trade Name | SC+ Machine & SC+ Dialysate Cartridge |
|---|---|
| Common Name | Hemodialysis Delivery System |
| Product Code | KDI |
| Device | Dialyzer, High Permeability With Or Without |
| Sealed Dialysate System | |
| Classification Name | High permeability hemodialysis system |
| Regulation Number | 21 CFR §876.5860 |
| Device Class | Class II |
| Review Panel | Gastroenterology/Urology |
Table 1: SC+ Device and Dialysate Cartridge general device information
4
1.3.1.2 Predicate Device Information:
| Trade Name | SC+ Machine & SC+ Dialysate Cartridge |
|---|---|
| Common Name | Hemodialysis Delivery System |
| Product Code | KDI |
| Device | Dialyzer, High Permeability With Or Without |
| Sealed Dialysate System | |
| Classification Name | High permeability hemodialysis system |
| Regulation Number | 21 CFR §876.5860 |
| Device Class | Class II |
| Review Panel | Gastroenterology/Urology |
| 510(k) reference | K193670 |
| Date of Clearance | 2020-12-23 |
Table 2: SC+ device and Dialysate Cartridge predicate device information
SC+ Blood Tubeset 1.3.2
1.3.2.1 General Device Information
| Trade Name | SC+ Blood Tubeset |
|---|---|
| Common Name | Blood Tubing Set |
| Product Code | FJK |
| Device | SC+ Blood Tubeset |
| Classification Name | Set, tubing, blood, with and without anti-regurgitation valve |
| Regulation Number | 21 CFR §876.5820 |
| Device Class | Class II |
| Review Panel | Gastroenterology/Urology |
Table 3: SC+ Blood Tubeset general device information
1.3.2.2 Predicate Device Information:
| Trade Name | SC+ Blood Tubeset |
|---|---|
| Common Name | Blood Tubing Set |
| Product Code | FJK |
| Device | SC+ Blood Tubeset |
| Classification Name | Set, tubing, blood, with and without anti- |
| regurgitation valve | |
| Regulation Number | 21 CFR §876.5820 |
| Device Class | Class II |
| Review Panel | Gastroenterology/Urology |
| 510(k) reference | K193670 |
| Date of Clearance | 2020-12-23 |
Table 4: SC+ Blood Tubeset predicate device information
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1.4 Device Description
The SC+ is a hemodialysis delivery system intended for acute and chronic dialysis therapy with or without ultrafiltration in an acute of chronic care facility. The system consists of the SC+ Machine, a single use disposable Dialysate Cartridge, and a sterile, single use, disposable Blood Tubeset.
1.4.1 SC+ Hemodialysis System
The SC+ Hemodialysis System is intended for acute and chronic dialysis therapy, with or without ultrafiltration, utilizing Dialysis Water (from standalone Reverse Osmosis (RO) units or a central RO ring main) to produce dialysate. The SC+ Hemodialysis system is for use in patients with arteriovenous (AV) fistula or central venous catheter access.
The system consists of the SC+ Machine, a single use disposable Dialysate Cartridge, and a sterile, single use, disposable Blood Tubeset.
The SC+ Machine consists of a water circuit (heater, de-aeration module, etc) blood leak detector, air in blood detector, a pneumatic interface for the dialysate cartridges, a peristaltic blood pump and various other sensors. The dialysate cartridge contains the following; conductivity monitors, interfaces for pressure and temperature measurement, membrane pumps to perform mixing/proportioning in order to produce dialysis fluid and the controlled removal of fluid from a patient with acute and/or chronic renal failure based on a physician's prescription. The dialysate fluid is manufactured using dialysis water purified externally by reverse osmosis that is heated to approximately 37℃ and subsequently deaerated within the machine before entering the cartridge.
The SC+ Blood Tubeset is a single use, sterile device consisting of an arterial line, a venous line, connections to a standard dialyzer, a saline line, three pressure transducer pods integrated into a single unit, a venous drip chamber, and a line for heparin infusion.
1.5 Device Modifications
This 510(k) covers the following modifications:
- Addition of two-way wireless transmission capability for machine data ●
- Updated user workflows and interface for ease of use and streamlining ●
1.6 Indications for Use
1.6.1 SC+ Hemodialysis Machine & Dialysate Cartridge
The SC+ 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, by a trained person who is considered competent in the use of the device.
1.6.2 SC+ Blood Tubeset
The SC+ Blood Tubeset is a single use, disposable arterial and venous bloodline
6
set intended to provide extracorporeal access during hemodialysis. The Blood Tubeset is compatible only with the SC+ Hemodialysis System.
1.7 Technological Characteristics
Changed SC+ device vs SC+ device as cleared in K193670 1.7.1
The technological characteristics of the SC+ Machine and SC+ Dialysate Cartridge are considered to be equivalent to the predicate device, SC+ device and dialysate cartridge (K193670). A summary of the similarities and differences is provided in the table below.
| | Subject Device | Predicate
Device |
|------------------------------------------------------------------------------------------------------------------------------------------------|----------------|---------------------|
| | SC+ (K210661) | SC+ (K193670) |
| Indicated for use in patients with acute and/or chronic renal failure, with
or without ultrafiltration in an acute or chronic care facility | ✓ | ✓ |
| Use of purified water for dialysate production | ✓ | ✓ |
| Use of third-party accessories, including dialyzers, endotoxin retentive
filters, acid and bicarbonate | ✓ | ✓ |
| Application of consensus standards | ✓ | ✓ |
| Device is software controlled and utilize Graphic User Interface (GUI). | ✓ | ✓ |
| Design and Construction - Blood pump, alarms, alerts, air detector
mechanism, and blood leak detectors. | ✓ | ✓ |
Table 5: Technological Characteristics of the SC+ Machine and predicate
Differences between the subject device and the predicate device:
- The subject device utilizes 3G/4G cellular communications to transmit machine . data (non-clinical) to the Quanta Service Portal and download software updates (duplicating the predicate device's ethernet connectivity as cleared in K193670)
- The subject device has streamlined process with regards to air in venous line removal and priming
7
Changed SC+ Blood Tubeset vs SC+ Blood Tubeset device as cleared in 1.7.2 K193670
The technological characteristics of the SC+ Blood Tubeset are considered to be equivalent to the predicate device, SC+ Blood Tubeset (K193670). A summary of the similarities and differences is provided in the table below.
| | Subject
Device | Predicate
Device |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|-----------------------------------|
| | SC+ Blood
Tubeset
(K210661) | SC+ Blood
Tubeset
(K193670) |
| Intended Use: To provide extracorporeal access
during hemodialysis | ✓ | ✓ |
| Materials: Primary fluid path materials are Polyvinyl
Chloride (PVC) and Polypropylene (PP). | ✓ | ✓ |
| Design & Construction: Polyvinyl Chloride (PVC)
tubing of various lengths and diameters, with color
coded pinch clamps, color coded injection ports,
heparin line, saline line, and pressure monitoring
components. | ✓ | ✓ |
| Sterility: Sterile, single use, non-pyrogenic. | ✓ | ✓ |
| Priming Volume: | ≤165ml | ≤165ml |
| Needle configuration: Double needle | ✓ | ✓ |
Table 6: Technological Characteristics of the SC+ Blood Tubeset and predicate
Differences between the subject device and the predicate device:
- . The subject device includes a luer activated valve (needless valve/ air removal port) on the venous bloodline for streamlined air removal
- . The saline spike preconnected to the arterial bloodline is replaced with a recirculation luer (this recirculation luer is a component as cleared in K193670)
1.8 Summary of Verification and Validation Activities
The following performance testing, developed in accordance with appropriate FDA guidance documents and relevant standards, has been performed on the Modified Device to support the determination of substantial equivalence:
8
- Performance testing to verify maintenance of the Electrical Safety and Electromagnetic Compatibility profiles
- Software verification
- Human Factors validation testing •
- Biological safety testing •
1.9 Conclusion
The modified devices are substantially equivalent to the predicate devices