(99 days)
Not Found
No
The 510(k) summary describes a disposable bicarbonate concentrate set for hemodialysis. The description focuses on the chemical composition, physical form, and interface with a hemodialysis machine. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is described as "intended for extracorporeal bicarbonate hemodialysis for chronic renal failure," which directly indicates its use in treating a medical condition.
No
The device, a Bicarbonate Concentrate Set, is indicated for use in the preparation of dialysate for hemodialysis therapy for chronic renal failure, not for diagnosing a condition.
No
The device description clearly states it consists of powdered sodium bicarbonate in a single-use cartridge with an integrated tubing assembly, indicating it is a physical medical device, not software only.
Based on the provided information, the HemoCare Bicarbonate Concentrate Set (BCS) is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for the preparation of dialysate for extracorporeal bicarbonate hemodialysis. This process involves treating blood outside the body, not analyzing samples of bodily fluids or tissues in vitro (in a test tube or lab setting) to diagnose or monitor a medical condition.
- Device Description: The device is a cartridge containing powdered sodium bicarbonate used to create a solution for dialysis. It's a component of a hemodialysis system, which is a therapeutic device.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of analytes, or diagnostic purposes.
Therefore, the HemoCare Bicarbonate Concentrate Set is a component of a therapeutic medical device (hemodialysis system) used for treating chronic renal failure, not an IVD.
N/A
Intended Use / Indications for Use
The HemoCare Bicarbonate Concentrate Set (BCS) is indicated for use in the preparation of dialysate in a 3-stream proportioning hemodialysis machine with a compatible mechanical interface, such as the HemoCare Hemodialysis System. The BCS is intended for extracorporeal bicarbonate hemodialysis for chronic renal failure, according to a physician's prescription.
Product codes
KPO
Device Description
The HemoCare Bicarbonate Concentrate Set (BCS) is the Subject Device of this submission. It consists of powdered sodium bicarbonate in a single use cartridge with an integrated tubing assembly for interfacing with hemodialysis systems with compatible three-stream proportioning connector ports such as the HemoCare Hemodialysis System. The HemoCare System uses the bicarbonate concentrate in 3-stream, 45x proportioning to generate dialysate for bicarbonate hemodialysis therapy.
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
Not Found
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 data were provided to support the substantial equivalence determination:
Biocompatibility Testing was performed in accordance with ISO 10993-1:2018 and FDA Guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (2023). The following endpoints were evaluated to support the biological safety of the HemoCare BCS:
- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic Toxicity
- Subacute System Toxicity
- Pyrogenicity
- Genotoxicity
- Hemocompatibility
Bench Performance Testing was performed to verify specified performance across the following areas:
- Dialysate Quality
- Microbial Safety
- Distribution, Storage and Shelf Life
The results of non-clinical testing demonstrate that the HemoCare Bicarbonate Concentrate Set meets all performance specifications and is safe and effective. The minor differences between the HemoCare Bicarbonate Concentrate Set and the predicate device do not raise any new or different questions of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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 12, 2024
DEKA Research and Development Paul Smolenski Regulatory Affairs 340 Commercial Street Manchester, NH 03101
K240920 Re:
Trade/Device Name: HemoCare Bicarbonate Concentrate Set (BCS) Regulation Number: 21 CFR§ 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: KPO Dated: May 24, 2024 Received: May 28, 2024
Dear Paul Smolenski:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-
devices/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,
Maura Rooney -S
Maura Rooney 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
3
Indications for Use
510(k) Number (if known) K240920
Device Name HemoCare Bicarbonate Concentrate Set (BCS)
Indications for Use (Describe)
The HemoCare Bicarbonate Concentrate Set (BCS) is indicated for use in the preparation of dialysate in a 3-stream proportioning hemodialysis machine with a compatible mechanical interface, such as the HemoCare Hemodialysis System. The BCS is intended for extracorporeal bicarbonate hemodialysis for chronic renal failure, according to a physician's prescription.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/1 description: The image shows the logo for DEKA Research & Development Corp. The logo is in black and white and features the word "DEKA" in a bold, sans-serif font. Below the logo is the text "DEKA Research & Development Corp." in a smaller font. The logo is simple and modern.
510(k) Summary
This 510(k) Summary of Safety and Effectiveness information is prepared in accordance with the requirements of 21 CFR Part 807.92.
| 1 | Submitter | |
|---|---|---|
| Name: | DEKA Research and Development, Corp. | |
| 340 Commercial Street | ||
| Manchester, NH 03101 | ||
| USA | ||
| Primary Contact: | Paul Smolenski | |
| Regulatory Affairs | ||
| DEKA Research & Development Corporation | ||
| Phone: 603-669-5139 | ||
| Fax: 603-624-0573 | ||
| psmolenski@dekaresearch.com | ||
| Alternate Contact: | William Calhoun | |
| Regulatory Affairs | ||
| DEKA Research & Development Corporation | ||
| Phone: 603-669-5139 | ||
| Fax: 603-624-0573 | ||
| wcalhoun@dekaresearch.com | ||
| Date Prepared: | July 10, 2024 | |
| 2 | Device | |
| Trade Name: | HemoCare Bicarbonate Concentrate Set (BCS) |
| Trade Name: | HemoCare Bicarbonate Concentrate Set (BCS) | |
|---|---|---|
| Common Name: | Sodium Bicarbonate for Hemodialysis | |
| Classification Regulation: | 21 CFR § 876.5820 - Hemodialysis system and accessories | |
| Product Codes: | KPO | |
| Regulatory Class: | Class II |
3 Predicate Device
The Predicate Device for which Substantial Equivalence is claimed is the Gambro BiCart, cleared on January 8, 2002 under premarket notification K013724.
510(k) Summary
5
Image /page/5/Picture/1 description: The image shows the word "DEKA" in a bold, sans-serif font. The letters are all capitalized and black. The letters are close together, and the "K" has a unique design with a sharp angle in the middle.
DEKA Research & Development Corp.
Device Description ব
The HemoCare Bicarbonate Concentrate Set (BCS) is the Subject Device of this submission. It consists of powdered sodium bicarbonate in a single use cartridge with an integrated tubing assembly for interfacing with hemodialysis systems with compatible three-stream proportioning connector ports such as the HemoCare Hemodialysis System. The HemoCare System uses the bicarbonate concentrate in 3-stream, 45x proportioning to generate dialysate for bicarbonate hemodialysis therapy.
5 Indications for Use
The HemoCare Bicarbonate Concentrate Set (BCS) is indicated for use in the preparation of dialysate in a 3-stream proportioning hemodialysis machine with a compatible mechanical interface, such as the HemoCare Hemodialysis System. The BCS is intended for extracorporeal bicarbonate hemodialysis for chronic renal failure, according to a physician's prescription.
Substantial Equivalence Discussion 6
Comparison of Indications for Use 6.1
The Subject and Predicate Devices are both indicated for bicarbonate hemodialysis for chronic renal failure.
Comparison of Technical Characteristics 6.2
A summary of the technological similarities and differences between the Subject and Predicate Devices is provided in following table.
| Characteristic | HemoCare BCS
(Subject Device) | Gambro BiCart
(Predicate Device K013724) | Comparison |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|------------|
| Product Code | KPO | KPO | Same |
| Regulation Number | 876.5860 | 876.5860 | Same |
| Device Description | Powdered sodium
bicarbonate concentrate
housed in a disposable
cartridge with connections
for a hemodialysis system. | Powdered sodium
bicarbonate concentrate
housed in a disposable
cartridge with connections
for a hemodialysis system. | Same |
| Intended Use | Bicarbonate concentrate
intended for use in
bicarbonate hemodialysis. | Bicarbonate concentrate
intended for use in
bicarbonate hemodialysis. | Same |
6
Image /page/6/Picture/1 description: The image shows the word "DEKA" in a bold, sans-serif font. The letters are black, and the background is white. The letters are stylized, with the "K" having a unique shape that resembles an arrow pointing to the left.
DEKA Research & Development Corp.
| Characteristic | HemoCare BCS
(Subject Device) | Gambro BiCart
(Predicate Device K013724) | Comparison |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The HemoCare Bicarbonate
Concentrate Set (BCS) is
indicated for use in the
preparation of dialysate in a
3-stream proportioning
hemodialysis machine with a
compatible mechanical
interface, such as the
HemoCare Hemodialysis
System. The BCS is
intended for extracorporeal
bicarbonate hemodialysis for
chronic renal failure,
according to a physician's
prescription. | Gambro BiCart is intended
for use in a bicarbonate
hemodialysis for acute and
chronic renal failure, or acute
intoxication with dialyzable
substances. | Substantially
Equivalent.
Both devices
supply
powdered
sodium
bicarbonate
concentrate
for use in
hemodialysis
systems
having 3-
stream, 45x
dialysate
proportioning |
| Prescription Use | Yes | Yes | Same |
| Single Use | Yes | Yes | Same |
| Use-life | 2 years | 2 years | Same |
| Disposable | Yes | Yes | Same |
| Dialysate
Proportioning | three stream proportioning | three stream proportioning | Same |
| Acid Dilution Ratio | 1:44 (45x) | 1:44 (45x) | Same |
| Sodium Bicarbonate
Grade | USP grade dry sodium
bicarbonate powder | USP grade dry sodium
bicarbonate powder | Same |
| Bicarbonate powder
quantity | 720 g | 650 g, 720 g and 1150 g | Substantially
Equivalent |
| Storage Temperature | Store 15°C to 30°C | Store below 40 °C | Substantially
Equivalent |
| Housing material | Polypropylene | Polypropylene | Same |
7 Performance Data
The following performance data were provided to support the substantial equivalence determination:
Biocompatibility Testing
Biocompatibility testing was performed in accordance with ISO 10993-1:2018 and FDA Guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (2023). The following endpoints were evaluated to support the biological safety of the HemoCare BCS:
- Cytotoxicity
- Sensitization ●
7
Image /page/7/Picture/0 description: The image shows the word "DEKA" in a bold, sans-serif font. The letters are all capitalized and black. The letters are spaced closely together, and the overall impression is one of strength and stability. The background is white.
DEKA Research & Development Corp.
- Irritation
- Acute Systemic Toxicity
- Subacute System Toxicity ●
- . Pyrogenicity
- Genotoxicity ●
- Hemocompatibility
Bench Performance Testing
Benchtop verification testing was performed to verify specified performance across the following areas:
- . Dialysate Quality
- Microbial Safety
- . Distribution, Storage and Shelf Life
Conclusion 8
The results of non-clinical testing demonstrate that the HemoCare Bicarbonate Concentrate Set meets all performance specifications and is safe and effective. The minor differences between the HemoCare Bicarbonate Concentrate Set and the predicate device do not raise any new or different questions of safety or effectiveness. The HemoCare Bicarbonate Concentrate Set is substantially equivalent to the predicate device.