(121 days)
Not Found
No
The description focuses on the mechanical and control aspects of blood and plasma flow and adsorption, with no mention of AI or ML technologies for analysis, control, or decision-making.
Yes
The device performs whole blood or plasma adsorption to remove undesired substances from the blood or plasma, which directly treats a medical condition.
No
The device is described as an "Art Hemoadsorption system" that "operates and monitors the extracorporeal blood circuit to perform whole blood or plasma adsorption." It removes "undesired substances from the blood or plasma" and returns the treated blood to the patient. This functionality describes a therapeutic treatment system rather than a diagnostic one.
No
The device description clearly outlines hardware components such as pumps, filters, adsorbers, and a bubble catcher, indicating it is a physical medical device system, 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 describes a system that operates and monitors an extracorporeal blood circuit for performing whole blood or plasma adsorption. This is a therapeutic procedure performed on the patient's blood outside the body, not a diagnostic test performed in vitro (in a lab setting) to analyze samples for diagnostic purposes.
- Device Description: The description details the mechanical components and processes involved in circulating and treating blood or plasma extracorporeally. It focuses on physical separation and adsorption, not on analyzing biological samples for diagnostic information.
- Lack of Diagnostic Language: The text does not mention analyzing biological samples, detecting biomarkers, providing diagnostic information, or any other activities typically associated with IVDs.
The device is clearly designed for a therapeutic purpose (removing undesired substances from blood or plasma) rather than a diagnostic one.
N/A
Intended Use / Indications for Use
The Art Hemoadsorption system operates and monitors the extracorporeal blood circuit to perform whole blood or plasma adsorption (when used with a commercially available plasma filter).
Product codes (comma separated list FDA assigned to the subject device)
LKN
Device Description
The indication for use for the Fresenius ART Hemoadsorption System is as follows: Hemoadsorption system operates and monitors the The Art extracorporeal blood circuit to perform whole blood or plasma adsorption (when used with a commercially available plasma filter). In the extracorporeal blood circuit, the blood is continuously anticoagulated with ACD-A solution. The ACD-A flow can be adjusted and is controlled in relation to the blood flow. The ACD-A flow is monitored by a drip counter. If a whole-blood adsorption treatment is performed, the blood pump transports blood from the inlet side of the patient's vascular access through the adsorber. If a plasma adsorption treatment is performed, the blood pump transports blood from the inlet side of the patient's vascular access through a plasma filter. The plasma filter separates the plasma from the whole blood. The plasma pump delivers the plasma through the adsorber. The adsorber removes undesired substances from the blood or plasma. Downstream of the adsorber, the blood or plasma flows into the bubble catcher. In case of plasma adsorption, the plasma is mixed with the blood components that have been separated in the plasma filter beforehand. The blood is then returned to the patient via the return line.
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)
The Fresenius ART Hemoadsorption System's software validation, functional the I rooonloo ART risting rigorously tested the features of the ART machine. The results of this testing indicate that the ART Hemoadsorption System is safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
N/A
0
Ko50273 page 1/3
Fresenius ART Hemoadsorption System 510(k) Premarket Notification
JUN 8 - 2005
Summary of Safety and Effectiveness
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990.
A. Submitter's Information:
| Name: | Fresenius Medical Care North America |
|---|---|
| Address: | 95 Hayden Ave |
| Two Ledgemont Center | |
| Lexington, MA 02420 | |
| Phone: | 1-781-402-4475 |
| Fax: | (781) 402-9082 |
| Contact Person: | Janet C. Kay, Senior Regulatory Affairs Specialist |
| Date of Preparation: | February 4, 2005 |
B. Device Name:
| Trade Name: | Fresenius ART Hemoadsorption System |
|---|---|
| Common/Usual Name: | Separator, Automated, Blood Cell, Diagnostic |
| Classification Name: | Automated blood cell separator |
C. Predicate Device Name:
Fresenius 2008K Dialysate Delivery System K994267
Fresenius AS104 Cell Separator, #K895435
D. Device Description/Indications for Use:
The indication for use for the Fresenius ART Hemoadsorption System is as follows:
Hemoadsorption system operates and monitors the The Art extracorporeal blood circuit to perform whole blood or plasma adsorption (when used with a commercially available plasma filter).
Brief device description
In the extracorporeal blood circuit, the blood is continuously anticoagulated with ACD-A solution. The ACD-A flow can be adjusted and is controlled in relation to the blood flow. The ACD-A flow is monitored by a drip counter.
1
Fresenius ART Hemoadsorption System 510(k) Premarket Notification
Summary of Safety and Effectiveness
If a whole-blood adsorption treatment is performed, the blood pump transports blood from the inlet side of the patient's vascular access through the adsorber.
If a plasma adsorption treatment is performed, the blood pump transports blood from the inlet side of the patient's vascular access through a plasma filter. The plasma filter separates the plasma from the whole blood. The plasma pump delivers the plasma through the adsorber. The adsorber removes undesired substances from the blood or plasma.
Downstream of the adsorber, the blood or plasma flows into the bubble catcher. In case of plasma adsorption, the plasma is mixed with the blood components that have been separated in the plasma filter beforehand. The blood is then returned to the patient via the return line.
E. Substantial Equivalence:
Substantial Equivalence Decision Making Process
-
- Is the product a device?
YES - The Fresenius ART Hemoadsorption System is a device pursuant to 21 CFR §201 [321] (h).
- Is the product a device?
2. Does the new device have the same intended use?
YES ~ The intended use for Fresenius ART Hemoadsorption System is as follows:
Intended Use
The Art Hemoadsorption system operates and monitors the extracorporeal blood circuit to perform whole blood or plasma adsorption (when used with a commercially available plasma filter).
The intended use for the Fresenius AS104 Cell Separator is as follows:
Intended Use
The Fresenius AS104 Cell Separator is intended for use in apheresis procedures involving donors and patients.
2
Summary of Safety and Effectiveness
3. Does the device have technological characteristics that raise new types of safety or effectiveness questions?
NO - The technological characteristics of the Fresenius ART Hemoadsorption No - The toonhological onarcolous 2008K and Fresenius AS104. See Table III-1 for a comparison of the components and features of the Fresenius ART Hemoadsorption and the Fresenius 2008K and AS104.
4. Does descriptive or performance information demonstrate equivalence?
- YES Fresenius Medical Care North America believes that the information . provided in this submission clearly describes the Fresenius ART provided in this cabiner and demonstrates that it is substantially equivalent to the Fresenius 2008K and AS104.
F. Safetv Summary
The Fresenius ART Hemoadsorption System's software validation, functional the I rooonloo ART risting rigorously tested the features of the ART machine. The results of this testing indicate that the ART Hemoadsorption System is safe and effective for its intended use.
G. General Safety and Effectiveness Concerns
The device labeling contains an Operator's Manual, which includes indications for rno dovio laboling connings, as well as the general operating instructions required for proper use of the device. In addition, training and support is provided to clinics that use the Fresenius ART Hemoadsorption System. This information promotes safe and effective use of the device.
3
- વ
Image /page/3/Picture/2 description: The image shows a logo with a stylized bird in flight. The bird is composed of three curved lines, suggesting movement and speed. The logo is encircled by text, which appears to be part of the organization's name. The overall design is simple and modern, conveying a sense of dynamism and purpose.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 8 - 2005
Janet C. Kay, RAC Sr. Regulatory Affairs Specialist Fresenius Medical Care North America 95 Hayden Avenue LEXINGTON MA 02420
Re: K050273 Trade/Device Name: Fresenius ART Hemoadsorption System Regulation Number: None Regulatory Class: Unclassified Product Code: LKN Dated: April 29, 2005 Received: May 2, 2005
Dear Ms. Kay:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have reviewed your becaled by (s) } } }
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 the enclosed to regary man date of the Medical Device Amendments, or to devices that have been May 20, 1770, the classinsitions of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accordal of a premarket approval application (PMA). You may, therefore, market the do not require approval of a premiums provisions of the Act. The general controls provisions of the Act device, subject to the general some is prior , 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 (Premarket If your device is oldssinia ( to such additional controls. Existing major regulations affecting your Apploval), it thay of subject to back aderal Regulations, Title 21, Parts 800 to 898. In addition, FDA at vice can be round ments concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Freast oc advised mart Dri 5 issualles it device complies with other requirements of the Act or any I DA has made a decemination ass your cred by other Federal agencies. You must comply with all the rederal statues and regulations and limited to registration and listing (21 CFR Part 807); labeling Act S requirements, moduling, but not mixed in the requirements as set forth in the quality systems (QS) (21 CFR Part 801); and 11 applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w you to organization of substantial equivalence of your device to a legally premaince notheation: "The PDF maciassification 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 If you desire specific at nee 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" (21 CFR Also, produse note the regaral information on your responsibilities under the Act from the 807.77). Tou may ootain ourers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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
5
Image /page/5/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a stylized funnel shape above the text "Fresenius Medical Care". The funnel is made up of several horizontal lines that decrease in width from top to bottom.
Indications for Use
510(k) Number (if known):
Device Name: Fresenius ART Hemoadsorption System
Indications for Use:
The Art Hemoadsorption system operates and monitors the extracorporeal blood The Art Tremoadsorption operation (when used with a commercially available clicult to penomi plasma adsorption (mmunosorba adsorption column).
V Prescription Use _ (Part 21 CFR 801 Subpart D)
ﺷ
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Colin K. Holland
(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devices 510(k) Number.
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