(267 days)
This device is indicated for hemodialysis prescribed by physicians for adult patients with acute and chronic renal failure, treated in hospitals and dialysis clinics by qualified operators. This device is not indicated for pediatric patients. It is not for home use.
This device is made up of disposable bloodlines intended to provide extracorporeal access to a patient's blood during hemodialysis. It is the responsibility of the physician or other licensed practitioner to ensure compatibility with the available configurations.
The BLOOD TUBING LINES FOR HEMODIALYSIS AL series (Sterilized by Steam) includes arterial and venous dialysis blood tubing.
The devices are packaged together for convenient use during hemodialysis procedures. They are manufactured for application with the DBB-06 PRO Hemodialysis Delivery System.
The components of the device include tubing, drip chambers, infusion tubing, pressure monitoring lines, ports, clamps and filters which are used to pump blood, retain and capture blood debris, infuse medications or fluids, sample blood as well as monitor pressure.
The devices are packaged sterile and labeled for single use only. These devices cannot be cleaned and reused. They are restricted for sale by or on the order of a physician.
The BLOOD TUBING LINES FOR HEMODIALYSIS C18 series is one part of a blood tubing lines for hemodialysis. The devices are packaged together for convenient use during hemodialysis procedures. They are manufactured for application with the DBB-06 PRO Hemodialysis Delivery System. The devices are packaged sterile and labeled for single use only.
These devices cannot be cleaned or reused. They are restricted for sale by or on the order of a physician.
Based on the provided FDA 510(k) Clearance Letter for "BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) and C18 Series," the device in question is blood tubing lines, not an AI/software device. Therefore, many of the typical acceptance criteria and study components associated with AI-powered medical devices (like those requiring test sets, expert ground truth, MRMC studies, standalone performance, and extensive training data) are not applicable to this product.
The document primarily focuses on demonstrating substantial equivalence to a predicate device through:
- Technological Characteristics: Same intended use, design, configuration, scientific technology, and principles of operation.
- Material Equivalence: Similar materials, with no new or additional materials posing unaddressed risks.
- Performance Testing: Bench testing, sterilization validation, shelf-life testing, and biological safety testing.
- Compatibility: Ensuring compatibility with the intended hemodialysis delivery system.
Given that this is a physical medical device (blood tubing lines) and not a software/AI device, the request for a table of acceptance criteria and study details as typically applied to AI devices cannot be fully fulfilled from the provided document. The document confirms that no clinical performance data and no animal performance data were submitted for this 510(k). This is typical for Class II devices demonstrating substantial equivalence where bench and preclinical testing are sufficient based on established predicate devices and known risks.
However, I can extract the types of performance testing and safety evaluations that were conducted to "prove the device meets acceptance criteria" for a physical medical device:
Acceptance Criteria and Study for BLOOD TUBING LINES FOR HEMODIALYSIS (K242479)
Context: This device is a physical medical device (blood tubing lines) used in hemodialysis, not an AI or software-based device. Therefore, the "acceptance criteria" and "study" described below relate to the physical and biological performance of the tubing lines themselves, demonstrating their safety and effectiveness through substantial equivalence to a legally marketed predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Criterion | Reported Device Performance/Conclusion in 510(k) Summary |
|---|---|---|
| Material Safety | Cytotoxicity (Unaged & Aged) | Completed, confirmed safety. |
| Sensitization | Completed, confirmed safety. | |
| Intracutaneous Reactivity | Completed, confirmed safety. | |
| Acute Systemic Toxicity | Completed, confirmed safety. | |
| Pyrogenicity | Completed, confirmed safety. (Guidance ref: Pyrogen and Endotoxins Testing) | |
| Subchronic Systemic Toxicity | Completed, confirmed safety. | |
| Genotoxicity (BRM & MLA) | Completed, confirmed safety. | |
| Hemocompatibility (Hemolysis Unaged & Aged, Complement Activation, Thrombogenicity, Mechanical Hemolysis) | Completed, confirmed safety. | |
| Chemical Characterization (Extractable Analysis) | Completed, confirmed safety. | |
| Biological Risk Assessment | Completed, confirmed safety. | |
| Sterilization & Shelf Life | Sterilization Validation | Completed using subject device. |
| Shelf Life Testing | Completed using subject device. | |
| Bench Performance | Structural Integrity | Completed, confirmed substantial equivalence. |
| Pump Segment Performance | Completed, confirmed substantial equivalence. | |
| Needle Access Ports | Completed, confirmed substantial equivalence. | |
| Needleless Access Ports | Completed, confirmed substantial equivalence. | |
| Blood Pathway Volume | Completed, confirmed substantial equivalence. | |
| Tensile Strength | Completed, confirmed substantial equivalence. | |
| Transducer Protectors | Completed, confirmed substantial equivalence. | |
| Tubing Compliance | Completed, confirmed substantial equivalence. | |
| Mechanical Hemolysis | Completed, confirmed substantial equivalence. | |
| Resist Kinking After Repeated Clamping | Completed, confirmed substantial equivalence. | |
| Simulated Treatment | Completed, confirmed substantial equivalence. | |
| Connector to Haemodialyser | Completed, confirmed substantial equivalence. | |
| Connectors to Vascular Access Device | Completed, confirmed substantial equivalence. | |
| Connectors to Ancillary Components | Completed, confirmed substantial equivalence. | |
| Colour Coding | Completed, confirmed substantial equivalence. | |
| Air-Capture Chamber Fill Level | Completed, confirmed substantial equivalence. | |
| Blood Pathway Flow Dynamics | Completed, confirmed substantial equivalence. | |
| Compatibility | Compatibility with DBB-06 PRO Hemodialysis Delivery System | Performance tests confirmed compatibility. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify exact sample sizes for each bench, biological, sterilization, or shelf-life test. This information is typically detailed in the full submission, not the summary.
- Data Provenance: The studies are described as "completed" by the submitter, NIKKISO CO., LTD. The typical provenance for such tests would be internal lab testing or accredited third-party labs where the devices are manufactured or tested. No country of origin for the data itself is specified beyond the applicant being from Japan. These are pre-market, prospective tests performed specifically for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This is a physical device clearance based on engineering performance and biological safety tests, not an AI device requiring expert-labeled medical imaging or clinical data. Ground truth for these types of tests is established through standardized methodologies (e.g., ISO standards, ASTM standards, AAMI standards) and quantitative measurements rather than expert consensus on subjective findings.
4. Adjudication Method for the Test Set
- Not Applicable. As above, no "test set" in the context of expert adjudication for AI models exists for this device. Performance is determined by meeting pre-defined quantitative thresholds and qualitative observations in laboratory settings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size
- No. An MRMC comparative effectiveness study is designed to evaluate the impact of an AI system on human reader performance for diagnostic tasks. This device is blood tubing lines, not an AI diagnostic tool.
- The 510(k) summary explicitly states: "No clinical performance data is submitted in this 510(k)." and "No animal performance data is submitted in this 510(k)."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not a software algorithm. The "standalone performance" of the blood tubing refers to its ability to perform its function (e.g., maintain structural integrity, prevent kinking, ensure blood flow pathways) independently, which is covered by the extensive bench testing listed.
7. The Type of Ground Truth Used
- For Physical Performance/Bench Testing: Ground truth is defined by objective engineering specifications, performance standards (e.g., ISO, AAMI, ASTM), and quantitative measurements (e.g., tensile strength values, flow rates, volume measurements, pressure limits). These are often derived from predicate device performance and established medical device standards.
- For Biological Safety Testing: Ground truth is established by the results of standardized biological assays conforming to ISO 10993 series and FDA guidance, where specific chemical or biological reactions (e.g., cytotoxicity, hemolysis, pyrogenicity) are measured against predefined safety limits.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" in the context of machine learning for this physical medical device. The device itself is manufactured, not "trained."
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set for an AI/software model, no ground truth needed to be established for it. The design and manufacturing process for the blood tubing lines are validated through the various tests described above, ensuring they meet the specified performance and safety characteristics.
§ 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.