(30 days)
Not Found
No
The summary describes a bloodline set for hemodialysis, a purely mechanical device, and contains no mention of AI, ML, or related concepts.
No
The device is described as an extracorporeal blood circuit for hemodialysis equipment, which is a component used during a medical procedure, not a device that itself provides direct therapeutic effect to the patient.
No
The device is described as an "extracorporeal blood circuit" used during hemodialysis, which is a treatment process, not a diagnostic one. It facilitates the movement of blood for filtering, rather than identifying a medical condition or disease.
No
The device is described as "Arterial Bloodline Sets," which are physical components used in hemodialysis. The description of "extracorporeal blood circuit" further confirms it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use as an extracorporeal blood circuit during hemodialysis. This involves handling blood outside the body for treatment, not for diagnostic testing of samples.
- Device Description (or lack thereof): While the description is "Not Found," the intended use is the primary indicator.
- Lack of IVD-related terms: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information.
- Predicate Devices: The predicate devices listed are also hemodialysis blood tubing sets, which are not IVDs.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. This device's function is to facilitate the physical process of hemodialysis, not to perform diagnostic tests on blood samples.
N/A
Intended Use / Indications for Use
The Fresenius Single use Arterial Bloodline Sets are intended for use as the extracorporeal blood circuit during hemodialysis. They are intended for single use only with Fresenius and high flux negative pressure hemodialyzer equipment.
Product codes
78FJK
Device Description
Not Found
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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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Koi 2242
Page 1 of 2
AUG 1 6 2001
Fresenius Hemodialysis Single Use Arterial Bloodline Sets with Alternate Pump Segment Material "Special" 510(k) Premarket Notification
Section II: General Device Summary
| Proprietary Name: | Fresenius Hemodialysis Single Use Arterial
Bloodline Sets |
|------------------------------------|----------------------------------------------------------------|
| Common Name: | Blood Tubing Set, with or without Anti-
regurgitation Valve |
| Product Code/Classification Panel: | 78FJK/Gastroenterology-Urology |
| Classification: | Class II per §876.5820. |
Establishment Registration
Manufacturing Facility Address:
Erika de Reynosa, S.A. de C.V. Brecha E-99 Parque Industrial Revnosa, Mexico C.D. Reynosa, Tamps FDA Establishment Registration Number: 8030665
Sterilization Site:
Cosmed of Texas 1175 Isuzu Parkway Grand Prairie, TX 75050 FDA Establishment Registration Number: 1650907
Submitter Information
Submitter's Name and Address:
Fresenius Medical Care North America 95 Hayden Avenue Lexington, MA 02420 FDA Establishment Registration Number: 1225714
"Special 510{k)" Submission
1
K012242
Page 2 of 2
Fresenius Hemodialysis Single Use Arterial Bloodline Sets with Alternate Pump Segment Material "Special" 510(k) Premarket Notification
Section II: General Device Summary
Contact Information:
Arthur E. Eilinsfeld, Director of Regulatory Affairs Telephone: (781) 402-9068 Fax: (781) 402-9635
Alternate Contact: Lorraine Calzetta Patrovic ,Senior Regulatory Affairs Specialist Telephone: (781) 402-9785 Fax: (781) 402-9635
Summary of Safety and Effectiveness
The 510(k) Summary of Safety and Effectiveness is provided in Appendix 1- Summary of Safety and Effectiveness.
Performance Standards
No applicable performance standards have been issued under section 514 of the Food, Drug and Cosmetic Act for Blood Tubing Sets with and without Anti-regurgitation Valves.
Compliance with ANSI/AAMI RD17-1994 .
The Fresenius Hemodialysis Arterial Blood Tubing Sets have been designed to meet the requirements for Hemodialyzer Blood Tubing as specified in ANSI/AAMI RD17-1994.
Predicate Device
The predicate device for the Fresenius Single use Arterial Bloodline Sets with Alternate Pump Segment Material is:
- Fresenius Hemodialysis Blood Tubing Sets cleared under K971313 (10/27/97) .
- Fresenius Combi Sets® cleared under #K962081 (11/01/96) and #K000451 . (05/09/00).
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 6 2001
Mr. Arthur E. Eilinsfeld Director, Regulatory Affairs Fresenius Medical Care North America 95 Hayden Avenue LEXINGTON MA 02420
Re: K012242
Fresenius Single Use Arterial Bloodline Sets with Alternate Pump Segment Material Dated: July 13, 2001 Received: July 17, 2001 Regulatory Class: II 21 CFR §876.5820/Procode: 78 FJK
Dear Mr. Eilinsfeld:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the We have reviewed your Section 210(x) noursalion of this. It is enclosure) to to in the enclosure) to in the enclosures and the device is substantially equivalent (of the matement date of the Medical Device Amendmants, or to devices marketed in interstate continetee provisions of the Federal Food, DTug, and Cometic Act (Act.). You may,
that have been reclassified in accordance with the provisions of the that have been reclassined in acconcal controls provisions of the Act. The general controls provisions of the Act therefore, market the device, subject on the general concess good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Prematet Approval) it may be subject If your device is classified (See above) nine chile) elass if (Special Obin the Code of Federal Regulations, to such additional controls. Existing major regulations areemes compliance with the Current Good Manufacturing I itte 21, Parts 800 to 693. A substanty equiration (QS) for Medical Devices: General regulation (21 CFR Party of C Practice requirements, as set form in the Quality of Son Rogation (FDA) will verify such assumptions. Failure 820) and mat, through periodic QS mspection. In egulatory action. In addition, FDA may publish further announcements to comply with the User regulation in regulatory ations on are to your premarket notification submission increase concerning your device in the Pederal Regiser. Trease notes with to the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding I his letter will and you to begally 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 and additionally 809.10 for in vitro If you desire specific advice to your de raze on our nabeing regarant (30 l) 594-4639. Additionally, for questions on the promotion diagnosite devices), please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation and advertising of your device, premarket notification" (21CFR 807.97). Other general information on your entified, "Misoraning by relection of the Division of Small Manufacturers Assistance at its toll-free number (800) 16300130011003 and its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely vours
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 (s)
Image /page/2/Picture/16 description: The image shows a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus. The image is simple and clean, with a focus on the department's name and symbol.
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K01-242
Page 1 of 11
Fresenius Hemodialysis Single Use Arterial Bloodline Sets with Alternate Pump Segment Material "Special" 510(k) Premarket Notification
Section II: General Device Summary
Indications for Use/Intended Use
The Fresenius Single use Arterial Bloodline Sets are intended for use as the The Fresentus Single use Archar Birdinas They are intended for single use only extractiploreal blood circuit daning nomoundly and high flux negative pressure hemodialyzer equipment.
The Indications for Use statement is provided in Appendix 2- Indications for Use Statement.
Nancy C. Broadon
(Division Sign-Off Division of Reproductive, Abdordi and Radiological D 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
(Per 21 CFR 801.109)