(72 days)
Not Found
No
The description focuses on the physical components and function of a disposable blood tubing set for hemodialysis, with no mention of AI or ML capabilities.
No
The device is a blood tubing set used during hemodialysis to provide extracorporeal access to the patient's blood. It facilitates the procedure but does not directly treat a disease or condition; rather, it is a component used within a therapeutic procedure.
No
Explanation: The device description states it includes components like tubing, drip chambers, and filters used to pump blood, retain debris, infuse medications, sample blood, and monitor pressure during hemodialysis. This functionality is for therapy and monitoring during a procedure, not for diagnosing a condition.
No
The device description explicitly lists physical components such as tubing, drip chambers, and filters, indicating it is a hardware medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide extracorporeal access to the patient's blood during Hemodialysis." This describes a device used outside the body to process blood, not a device used to test or analyze samples in vitro (in a lab setting).
- Device Description: The description details components like tubing, drip chambers, filters, etc., which are consistent with a bloodline for hemodialysis. It also explicitly states it's a "non-implanted blood access device" and is described in 21 CFR 876.5820, which is the regulation for Hemodialysis blood access device and accessories. IVD devices fall under different regulatory classifications (typically 21 CFR Part 866 or 864).
- No mention of testing or analysis: The text focuses on the physical process of moving and filtering blood, not on analyzing blood components or characteristics to diagnose a condition.
Therefore, this device is a medical device used in the process of hemodialysis, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Nipro® Set - Blood Tubing Set with Transducer Protector and Priming Set are disposable bloodlines intended to provide extracorporeal access to the patient's blood during hemodialysis. The compatibility of available configurations is the responsibility of the physician in charge.
Product codes
FJK, FIB
Device Description
The Nipro® Blood Tubing Set with Transducer Protector and Priming Set includes arterial and venous dialysis blood tubing with transducer protectors and priming set (non-implanted blood access device) as described in 21 CFR 876.5820.
The devices are packaged together for convenient use during hemodialysis procedures. There are 13 different configurations of the arterial line and 6 different configurations of the venous line. The various blood set models are being manufactured for application with various models of dialysis machines. 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 and monitor pressure.
The devices are packaged sterile and labeled for single use only. There is no ability to clean and reuse these devices. 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
patient's blood (extracorporeal access)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician in charge
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)
Performance testing was conducted to verify that the device is safe and effective for its intended use. Those tests along with their associated results and conclusions are included in this submission. Biocompatibility testing was also conducted. Those tests include pyrogenicity, acute toxicity. intracutaneous reactivity, hemolysis testing, implantation testing and bacterial endotoxin testing.
The results of the performance testing and the comparison of technological characteristics with the predicate device demonstrate that the Nipro® Blood Tubing Set with Transducer Protector and Priming Set performs equivalent to the predicate device and is safe and effective when used as intended.
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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K072024
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Image /page/0/Picture/1 description: The image shows the logo for Nipro. The logo consists of a stylized, intertwined symbol resembling two overlapping letter "N" shapes, followed by the word "NIPRO" in bold, sans-serif font. The logo is black and white.
3150 N.W. 107 Avenue Miami, Florida 33172 Tel .: (305) 599-7174 Fax: (305) 599-8454
2007
510(k) Summary of Safety and Effectiveness for Nipro® Set
Blood Tubing Set with Transducer Protector and Priming Set
807.92(a)(1)
Applicant: Establishment Reg.: Nipro Medical Corporation 1056186
Contact Person: Jessica Oswald Regulatory Affairs Specialist
July 19, 2007 Date of summary preparation:
807.92(a)(2)
Trade Name: Nipro@ Set - Blood Tubing Set with Transducer Protector and Priming Set
Common Name: Blood tubing set
Classification Name: set, tubing, blood, with and without anti-regurgitation valve
Requlation Number: 21 CFR 876.5820 Panel: 78 Product Code: FJK
Product Code: FIB
807.92(a)(3)
Legally marketed substantial equivalent device: K010264 - NIPRO Set Blood Tubing Set with transducer protector and priming set.
807.92(a)(4)
Description of device:
The Nipro® Blood Tubing Set with Transducer Protector and Priming Set includes arterial and venous dialysis blood tubing with transducer protectors and priming set (non-implanted blood access device) as described in 21 CFR 876.5820.
The devices are packaged together for convenient use during hemodialysis procedures. There are 13 different configurations of the arterial line and 6 different configurations of the venous line. The various blood set models are being manufactured for application with various models of dialysis machines. The components of the device include tubing, drip chambers, infusion tubing, pressure monitoring lines, ports, clamps and filters which are used to pump
1
K072024
PAGE 2 OF 2
Image /page/1/Picture/1 description: The image shows the logo for Nipro. The logo consists of a stylized, abstract symbol to the left of the word "NIPRO" in bold, sans-serif font. The symbol appears to be two overlapping shapes, creating an infinity-like or double helix design.
3150 N.W. 107 Avenue Miami, Florida 33172 Tel.: (305) 599-7174 Fax: (305) 599-8454
blood, retain and capture blood debris, infuse medications or fluids, sample blood and monitor pressure.
The devices are packaged sterile and labeled for single use only. There is no ability to clean and reuse these devices. They are restricted for sale by or on the order of a physician.
807.92(a)(5)
Indications for Use:
The Nipro® Set - Blood Tubing Set with Transducer Protector and Priming Set are disposable bloodlines intended to provide extracorporeal access to the patient's blood during hemodialysis. The compatibility of available configurations is the responsibility of the physician in charge.
807.92(a)(6)
Comparison of technological characteristics:
The Nipro® Blood Tubing Set with Transducer Protector and Priming Set is substantially equivalent to the predicate device in the following technological characteristics -
- Design .
- Physical characteristics .
- . Basic Scientific Technology
- Intended Use .
807.92(b)(1)
Non-clinical tests submitted :
Performance testing was conducted to verify that the device is safe and effective for its intended use. Those tests along with their associated results and conclusions are included in this submission. Biocompatibility testing was also conducted. Those tests include pyrogenicity, acute toxicity. intracutaneous reactivity, hemolysis testing, implantation testing and bacterial endotoxin testing.
807.92(b)(3)
Conclusions drawn from non-clinical and clinical tests:
The results of the performance testing and the comparison of technological characteristics with the predicate device demonstrate that the Nipro® Blood Tubing Set with Transducer Protector and Priming Set performs equivalent to the predicate device and is safe and effective when used as intended.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 4, 2007
Ms. Jessica Oswald Regulatory Affairs Specialist NIPRO® Medical Corporation 3150 NW 107th Avenue MIAMI FL 33172
Re: K072024
Trade/Device Name: NIPRO® Blood Tubing Set with Transducer Protector and Priming Set; Models A201-A219, V801-V806, 5M9634 and -93 Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: FJK Dated: August 28, 2007 Received: September 4, 2007
Dear Ms. Oswald:
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, 1796, 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely vours.
Nancy Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number:
Device Name: Nipro® Set - Blood Tubing Set with Transducer Protector and Priming Set
Indications for Use:
The Nipro® Set - Blood Tubing Set with Transducer Protector and Priming Set are disposable bloodlines intended to provide extracorporeal access to the patient's blood during Hemodialysis. The compatibility of available configurations is the responsibility of the physician in charge.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use
(21 CFR 801 Subpart C)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal and | |
| Radiological Devices | K072024 |
| 510(k) Number |