(327 days)
Not Found
No
The device description and intended use clearly define it as disposable bloodlines for hemodialysis, made of standard medical-grade plastics. There is no mention of any computational or analytical capabilities, let alone AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
This device is a bloodline intended to provide extracorporeal access to the patient's blood during hemodialysis, which is a supportive treatment, not a therapeutic device itself.
No
Explanation: The device description states its purpose is to provide extracorporeal access to the patient's blood during hemodialysis and includes components for functions like pumping blood, capturing debris, infusing medications, and sampling blood, but it does not mention any diagnostic capabilities.
No
The device description explicitly details physical components made of materials like PVC, PE, PP, ABS, and PC, which are hardware.
Based on the provided information, 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 to facilitate a medical procedure (hemodialysis) by managing blood flow outside the body.
- Device Description: The description details components like tubing, drip chambers, ports, etc., all related to the physical handling and flow of blood during dialysis.
- 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 health status. IVDs are specifically designed for testing samples in vitro (outside the body) to diagnose, monitor, or screen for diseases or conditions.
The device is a blood tubing set, which is a component used in the hemodialysis process, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The JMS Blood Tubing Sets are disposable bloodlines, intended to transfer blood from patients' vascular access system to the hemodialyzer through an arterial tubing, and from the hemodialyzer to the patient vascular system via a venous tubing. JMS Blood Tubing set is for Single use only.
The JMS Blood Tubing Sets with transducer protector and priming sets are disposable bloodlines intended to provide extracorporeal access to the patient's blood during hemodialysis.
Product codes
78 FJK, KOC
Device Description
The tubing sets that JMS intended to market include arterial and venous dialysis blood tubing as described in 21 CFR 876.5820. Various models of blood tubing sets are being manufactured for application with different dialysis machines, such as Baxter, Fresenius, Althin, etc.
All components of blood tubing set, including drip chambers, infusion tubing, monitoring lines, ports, and segments which are use to pump blood, retain and capture air and blood debris, infuse medications or fluid, sampling blood, pressure monitoring and making connections to other devices, are all included.
The materials used are mainly, polyvinylchloride (PVC), polyethylene (PE), polypropylene (PP), acrylonitrite butadiene styrene (ABS), and polycarbonate (PC).
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K001465, K001971, K852605, K001107, K953823
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
510(k) Summary of Safety and Effectiveness
Manufacturer and contact Information 1.
-
1.1 Manufacturer
JMS Singapore Pte Ltd 440 Ang Mo Kio Industrial Park 1 Singapore 569620 -
1.2 Sponsor
JMS North America Corperation 22320 Foothill Blvd., Suite 350 Hayward, CA 94541 USA -
1.3 Contact Information
Swee Cheau, Chong Manager of RA & QA JMS North America Corperation 22320 Foothill Blvd., Suite 350 Hayward, CA 94541 Telephone: (510) 888-9090 Fax: (510) 888-9099
Device Classification Name 2.
Gastroenterology Devices Panel has classified Hemodialysis System and accessories as Class II. Reference 21 CFR 876.5820
3. Predicate Device Name
JMS Blood Tubing Sets which are substantially equivalent to the following predicate devices which are legally marketed in market in intended use, design, safety and effectiveness:
- . Nipro® Blood Tubing Set (K001465)
- OFI Biomedica SpA Blood Tubing Set (K001971) .
- Nextron medical Technologies Blood Tubing Set (K852605) .
- Fresenius Blood Tubing Set (K001107) .
- Medisystems Blood Tubing Set (K953823) .
1
Device Intended use 4.
The JMS Blood Tubing Sets are disposable bloodlines, intended to transfer blood from patients' vascular access system to the hemodialyzer through an arterial tubing, and from the hemodialyzer to the patient vascular system via a venous tubing. JMS Blood Tubing set is for Single use only.
Device Description 5.
The tubing sets that JMS intended to market include arterial and venous dialysis blood tubing as described in 21 CFR 876.5820. Various models of blood tubing sets are being manufactured for application with different dialysis machines, such as Baxter, Fresenius, Althin, etc.
All components of blood tubing set, including drip chambers, infusion tubing, monitoring lines, ports, and segments which are use to pump blood, retain and capture air and blood debris, infuse medications or fluid, sampling blood, pressure monitoring and making connections to other devices, are all included.
The materials used are mainly, polyvinylchloride (PVC), polyethylene (PE), polypropylene (PP), acrylonitrite butadiene styrene (ABS), and polycarbonate (PC).
Technological Characteristics and Substantial Equivalence 6.
The configuration, labeling, packaging, materials and mode of sterilizations of the subject device are similar to legally marketed predicate devices. The subject device and all other predicate devices are used for hemodialysis, which are labeled sterile, non-pyrogenic and for single use only. JMS Blood Tubing Set and predicate devices are all composed of various tube sizes, connectors and clamps for connection to all arterial or venous access system.
The JMS Blood Tubing Set complies with AAMI/ANSI RD 17 : 1994 standard for . The JMS Blood Tubing Set has also been tested for its biocompatibility as accordance to ISO 10993.
JMS believes that the information provided in this submission clearly describes the JMS Blood Tubing Sets and demonstrates that they are substantially equivalent to the said predicate devices with regards to intended use, material, biocompatibility, and overall performance characteristics.
2
Image /page/2/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized image of three birds in the center. The text is small and difficult to read, but it appears to be the name of an organization or agency. The birds are depicted in a simple, abstract style, with flowing lines suggesting movement and flight. The logo has a clean and professional look.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 6 2004
Swee Cheau, Chong Manager of Regulatory Affairs & Quality Assurance JMS North America Corporation 22320 Foothill Blvd., Suite 350 HAYWARD CA 94541
Re: K032975
Trade/Device Name: JMS Blood Tubing Sets Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Codes: 78 FJK and KOC Dated: August 5, 2004 Received: August 9, 2004
Dear Ms. Chong:
We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your Section 910(x) premained in substantially equivalent (for the indications referenced above and nave uctemined the actrose aredicate devices marketed in interstate for use stated in the enclosite) to regally management date of the Medical Device Ameralments, or to commerce prior to May 26, 1776, the enaoutions with the provisions of the Federal Food. Drug, devices that have been receasined in aoost require approval approval application (PMA). and Cosment Act (Act) that do not require approvine the general controls provisions of the Act. The Y ou may, utcrefore, market the devices, soloje requirements for annual registration, listing of general controls provisions of the free morals can and prohibitions against misbranding and adultcration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), IT your device is classified (see above) into eting major regulations affecting your device can be It may be Subject to additional controls. - Emile - Sats 800 to 898. In addition, FDA may found in the Code of I ederal resgueening your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a bacean.
that FDA has made a determination that your device complies with other requirements of the Act that TDA has made a decertimation that Josener Federal agencies. You must of any rederal statutes and regulations annimating, but not limited to: registration and listing comply with an the Act STequirences, monday, good manufacturing practice requirements as sch
(21 CFR Parl 807); labeling (21 CFR Part 801); good manufacturing dia dia dia des (21 CFR Part 807), labelling (21 CFR Part 820); and 820); and If applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 11 and 1000; 1 forth in the quanty 35 stems (QD) regarding 531-542 of the Act); 21 CFR 1000-1050.
3
Pare 2
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin marketing your acence of your device of your device to a legaliyalize premarket notification - The FDA Inding of substantial of your device and this, 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 If you desire specific advice for your device on on table good on the regulation
contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advice, please contact the seculaci the Additionally, for questions on the promote the regulation entitled, "Misbranding
Office of Compliance at (301) 594-4639. Also, please mote of test. Other general Office of Compliance at (301) 594-4057. Tass, part 807.97) you may obtain. Other general by reference to premarket notification (21 cc r x an or obtained from the Division of Small
information on your responsibilities under the Act may be obtained from the 1800) information on your responsibilites this reserved its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Associated analysmamain html Manufacturers, International and Coulsumer rissistance anno control of the comment.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATION FOR USE STATEMENT
| 510(k) Number: | K032975 |
|---|---|
| Device Name : | JMS Blood Tubing Sets |
| Indication for use: | The JMS Blood Tubing Sets with transducer protector and |
| priming sets are disposable bloodlines intended to provide | |
| extracorporeal access to the patient's blood during | |
| hemodialysis. |
:
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrently of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (per 21 CFR 801-109) | |
|---|---|
| or | Over The-counter use |
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K032975 |