(57 days)
Not Found
No
The device description and performance studies focus on the physical components and mechanical performance of blood tubing lines, with no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML algorithms.
Yes
The device is used for hemodialysis, which is a treatment for renal failure, thus making it a therapeutic device.
No
This device is used to provide extracorporeal access to a patient's blood during hemodialysis, which is a treatment, not a diagnostic process.
No
The device description explicitly lists physical components like tubing, drip chambers, ports, clamps, and filters, indicating it is a hardware device. The performance studies also focus on the physical properties and performance of these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for hemodialysis, which is a treatment for renal failure. It involves extracorporeal access to a patient's blood to filter waste products. This is a therapeutic procedure, not a diagnostic one.
- Device Description: The device is described as blood tubing lines with components like tubing, drip chambers, filters, etc., used to pump blood, capture debris, infuse fluids, and monitor pressure during hemodialysis. These are all components of a system used for blood treatment outside the body.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze blood or other biological samples to provide diagnostic information about a patient's condition. IVDs are specifically designed for in vitro examination of specimens derived from the human body.
The device is clearly intended for use in a therapeutic procedure (hemodialysis) and not for diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes
KOC
Device Description
The BLOOD TUBING LINES FOR HEMODIALYSIS AV06C-E 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 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.
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
Adult patients. Not indicated for pediatric patients.
Intended User / Care Setting
Qualified operators in hospitals and dialysis clinics. Not for home use.
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)
Study Type: Sterilization validation and Shelf Life test
Key Results: Completed using the subject device.
Study Type: Biological Safety testing
Key Results: Completed to confirm the safety of the subject device. (Appendix 5 Cytotoxicity Unaged, Appendix 6 Cytotoxicity Aged, Appendix 7 Sensitization, Appendix 8 Intracutaneous Reactivity, Appendix 9 Acute Systemic Toxicity, Appendix 10 Pyrogenicity, Appendix 11 Subchronic Systemic Toxicity, Appendix 12 Genotoxicity BRM, Appendix 13 Genotoxicity MLA, Appendix 14 Hemocompatibility Hemolysis Unaged, Appendix 15 Hemocompatibility Hemolysis Aged, Appendix 16 Hemocompatibility Complement Activation, Appendix 17 Hemocompatibility Thrombogenicity 1, Appendix 18 Hemocompatibility Thrombogenicity 2, Appendix 19 Hemocompatibility Mechanical Hemolysis, Appendix 20 Hemocompatibility Platelet and leukocyte count assay, Appendix 21 Chemical Characterization, Appendix 22 Degradation Test, Appendix 23 Biological Risk Assessment, Appendix 24 Cited Document of Biological Risk Assessment)
Study Type: Performance - Bench testing
Key Results: Completed to confirm the subject device is substantially equivalent to the predicate device in performance. (Appendix 25 Structural Integrity for AV06C-E, Appendix 26 Pump Segment Performance for AV06C-E, Appendix 27 Needle Access Ports AV06C-E, Appendix 28 Blood Pathway Volume for AV06C-E, Appendix 29 Tensile Strength AV06C-E, Appendix 30 Transducer Protectors AV06C-E, Appendix 31 Tubing Compliance AV06C-E, Appendix 32 Mechanical Hemolysis for AV06C-E, Appendix 33 Resist Kinking After Repeated Clamping for AV06C-E, Appendix 34 Simulated Treatment AV06C-E, Appendix 35 Connector to Haemodialyser AV06C-E, Appendix 36 Connectors to Vascular Access Device AV06C-E, Appendix 37 Connectors to Ancillary Components AV06C-E, Appendix 38 Colour Coding AV06C-E, Appendix 39 Air-Capture Chamber Fill Level for AV06C-E, Appendix 40 Blood Pathway Flow Dynamics AV06C-E)
Performance - Animal: No animal performance data is submitted in this 510(k).
Performance - Clinical: No clinical performance data is submitted in this 510(k).
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out next to it.
July 28, 2023
NIKKISO Co., Ltd. % Fumiaki Kanai President & CEO MIC International 4-32-16 Ryogoku Sumida-ku. Tokyo 130-0023 Japan
Re: K231589
Trade/Device Name: Blood Tubing Lines for Hemodialysis AV06C-E Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: Class II Product Code: KOC Dated: May 26, 2023 Received: June 1, 2023
Dear Fumiaki Kanai:
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.
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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 (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 mediation-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.
Gema Gonzalez -S
Gema Gonzalez, MS Acting 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
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
Indications for Use Statement 3.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K231589
Device Name
BLOOD TUBING LINES FOR HEMODIAL YSIS AV06C-E
Indications for Use (Describe)
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.
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)
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."
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5. 510(k) Summary
| 510(k) Number | TBD |
|---|---|
| Preparation Date | May 26, 2023 |
| Submitter | NIKKISO CO., LTD. |
| 20-3, Ebisu 4-Chome, Shibuya-ku | |
| Tokyo 150-6022, Japan | |
| Primary Contact | Satoko Hina |
| Quality Assurance Department | |
| Medical Division | |
| NIKKISO CO., LTD. | |
| 20-3, Ebisu 4-Chome, Shibuya-ku | |
| Tokyo 150-6022, Japan | |
| Phone: +81-3-3443-3754 | |
| Fax: +81-3-3473-4965 | |
| Email: MedicalRA@nikkiso.co.jp | |
| Subject Device | Device Name: |
| BLOOD TUBING LINES FOR | |
| HEMODIALYSIS AV06C-E | |
| Device Classification Name: | |
| Accessories, Blood Circuit, | |
| Hemodialysis Regulation Number: | |
| 21 CFR 876.5820 | |
| Regulation Description: | |
| Hemodialysis system and accessories | |
| Device Class: | |
| Class II | |
| Classification Product Code: | |
| KOC | |
| Regulation Medical Specialty: | |
| Gastroenterology/Urology | |
| 510(k) Review Panel: | |
| Gastroenterology/Urology | |
| Device Description | The BLOOD TUBING LINES FOR HEMODIALYSIS AV06C-E 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 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. | |
| Intended Use / Indications | |
| for Use | 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. |
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510(k) Summary (continued)
| Predicate Device | ||
|---|---|---|
| 510(k) Number: | K082719 | |
| Device Name: | NIKKLINE BLOOD TUBING LINES WITH | |
| TRANSDUCER PROTECTORS, MODELS | ||
| AV06A-P, AV06B-P, AV06C-P | ||
| Applicant: | NIKKISO CO. LTD. | |
| Device Classification Name: | Accessories, Blood Circuit, | |
| Hemodialysis Regulation Number: | 21 CFR 876.5820 | |
| Regulation Description: | Hemodialysis system and accessories | |
| Device Class: | Class II | |
| Classification Product Code: | KOC | |
| Regulation Medical Specialty: | Gastroenterology/Urology | |
| 510(k) Review Panel: | Gastroenterology/Urology | |
| Technological | ||
| Characteristics | The subject device and predicate device have substantially equivalent technological | |
| characteristics: | ||
| • | Similar intended use including similar indication for use | |
| • | Similar design and configuration | |
| • | Same scientific technology and principles of operation | |
| The followings are only minor differences: | ||
| • | EOG sterilization is adopted as the sterilization method | |
| • | Compliance with the latest standards and guidance | |
| FDA Guidance | ||
| Documents | The following FDA guidance documents were referenced in preparing this premarket | |
| notification: | ||
| • | eCopy Program for Medical Device Submissions, issued April 2020 | |
| • | Format for Traditional and Abbreviated 510(k)s, issued September 2019 | |
| • | Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers, | |
| issued June 2012 | ||
| • | Hemodialysis Blood Tubing Sets, issued April 2008 | |
| • | Labeling: Regulatory Requirements for Medical Devices, issued August 1989 | |
| • | Recommended Content and Format of Non-Clinical Bench Performance Testing | |
| Information in Premarket Submissions, issued December 2019 | ||
| • | Shelf Life of Medical Devices, issued April 1991 | |
| • | Submission and Review of Sterility Information in Premarket Notification (510(k)) | |
| Submissions for Devices Labeled as Sterile, issued January 2016 | ||
| • | Use of International Standard ISO 10993-1, "Biological evaluation of medical devices |
- Part 1: Evaluation and testing within a risk management process", issued June 2016 |
| Sterilization and
Shelf Life | Sterilization validation and Shelf Life test were completed using the subject device BLOOD
TUBING LINES FOR HEMODIALYSIS AV06C-E. | |
| Biological Safety | Biological safety testing was completed to confirm the safety of the subject device: | |
| | Appendix 5 Cytotoxicity Unaged Appendix 6 Cytotoxicity Aged Appendix 7 Sensitization Appendix 8 Intracutaneous Reactivity Appendix 9 Acute Systemic Toxicity Appendix 10 Pyrogenicity Appendix 11 Subchronic Systemic Toxicity Appendix 12 Genotoxicity BRM Appendix 13 Genotoxicity MLA Appendix 14 Hemocompatibility Hemolysis Unaged Appendix 15 Hemocompatibility Hemolysis Aged Appendix 16 Hemocompatibility Complement Activation Appendix 17 Hemocompatibility Thrombogenicity 1 Appendix 18 Hemocompatibility Thrombogenicity 2 Appendix 19 Hemocompatibility Mechanical Hemolysis Appendix 20 Hemocompatibility Platelet and leukocyte count assay Appendix 21 Chemical Characterization Appendix 22 Degradation Test Appendix 23 Biological Risk Assessment Appendix 24 Cited Document of Biological Risk Assessment | |
| Performance - Bench | Bench testing was completed to confirm the subject device is substantially equivalent to the predicate device in performance: Appendix 25 Structural Integrity for AV06C-E Appendix 26 Pump Segment Performance for AV06C-E Appendix 27 Needle Access Ports AV06C-E Appendix 28 Blood Pathway Volume for AV06C-E Appendix 29 Tensile Strength AV06C-E Appendix 30 Transducer Protectors AV06C-E Appendix 31 Tubing Compliance AV06C-E Appendix 32 Mechanical Hemolysis for AV06C-E Appendix 33 Resist Kinking After Repeated Clamping for AV06C-E Appendix 34 Simulated Treatment AV06C-E Appendix 35 Connector to Haemodialyser AV06C-E Appendix 36 Connectors to Vascular Access Device AV06C-E Appendix 37 Connectors to Ancillary Components AV06C-E Appendix 38 Colour Coding AV06C-E Appendix 39 Air-Capture Chamber Fill Level for AV06C-E Appendix 40 Blood Pathway Flow Dynamics AV06C-E | |
| Performance - Animal | No animal performance data is submitted in this 510(k). | |
| Performance - Clinical | No clinical performance data is submitted in this 510(k). | |
| Substantial Equivalence | The subject device is substantially equivalent to the predicate device when evaluating intended use and technological characteristics. The subject device has the same intended use as the predicate device. The subject device and predicate device are substantially equivalent with only minor technological differences. These differences do not raise new questions of safety and effectiveness. | |
| Conclusion | This comparison demonstrates the subject device is substantially equivalent to the predicate device. The subject device is as safe and effective as the predicate device and will perform as intended. | |
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