(169 days)
Not Found
No
The description focuses on centrifugal force for blood separation and does not mention any AI/ML components or functionalities.
Yes
The device is used for therapeutic plasma exchange and therapeutic plasma therapy, which aim to treat medical conditions by processing the patient's blood.
No
The device is a blood component separator used for therapeutic plasma exchange and plasma treatment, which are therapeutic procedures, not diagnostic ones.
No
The device description clearly states it is a "blood component separator which utilizes centrifugal force as the basis of operation," indicating it is a physical hardware device. The performance studies also mention "software and hardware validation and verification."
Based on the provided information, the COM.TEC Blood Cell Separator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use/Indications for Use: The intended uses are "plasma exchange" and "plasma treatment." These are therapeutic procedures performed directly on the patient's blood outside the body, but the purpose is to treat the patient, not to diagnose a condition.
- Device Description: The description reinforces the therapeutic nature of the device, explaining its use in replacing or treating plasma before returning it to the patient.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze blood components for diagnostic purposes, such as identifying biomarkers, measuring levels of substances, or detecting the presence of diseases.
IVD devices are specifically designed to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The COM.TEC Blood Cell Separator's function is to physically separate and treat blood components for therapeutic purposes, not to perform diagnostic tests.
N/A
Intended Use / Indications for Use
The COM.TEC Blood Cell Separator is a blood component separator, which utilizes centrifugal force as the basis of operation. The fields of application are as follows:
-
- Therapeutic plasma exchange - In plasmapheresis, the blood cell separator is used for the replacement of the blood plasma in the blood circuit by a plasma substitution solution or the reinfusion of the plasma after appropriate processing.
-
- Therapeutic plasma therapy- In plasmapheresis therapy additional plasma treatment is performed through specific commercially available separation columns prior to return to the patient.
Product codes (comma separated list FDA assigned to the subject device)
LKN
Device Description
The COM.TEC Blood Cell Separator is a blood component separator, which utilizes centrifugal force as the basis of operation.
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 COM.TEC blood cell separator has undergone rigorous software validation and performance testing, including clinical testing, software and hardware validation and verification, and biocompatibility testing of disposables. The results of this testing indicate that the Fresenius COM.TEC and associated disposables are safe and effective for their intended use and perform as expected.
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
Fresenius Medical Care
Fresenius COM.TEC Blood Cell Separator 510(k) Premarket Notification
SEP - 5 2006
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 |
| Lexington, MA 02420 | |
| Phone: | 1-781-402-4475 |
| Fax: | 1-781-402-9635 |
| Contact Person: | Janet C. Kay, Sr. Regulatory Affairs Specialist |
| Date of Preparation: | March 9, 2006 |
B. Device Name:
| Trade Name: | Fresenius COM.TEC Blood Cell Separator |
|---|---|
| Common/Usual Name: | Separator, Automated, Blood Cell, Diagnostic, |
| Therapeutic | |
| Classification Name: | Separator, Automated, Blood Cell, Diagnostic |
| Unclassified: | Separator, Automated, Blood Cell, Therapeutic |
C. Predicate Device
The predicate devices for the Fresenius COM.TEC are the following:
- Fresenius AS104 Blood Cell Separator #K895435 (11/02/90) and; .
- Fresenius P1R Plasma Treatment Set for use in plasmapheresis #K961706 . (7/31/96).
D. Device Description/Indications for Use:
The intended use for the Fresenius COM.TEC blood cell separator is equivalent to that for the Fresenius AS104 blood cell separator, and is as tollows:
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Fresenius Medical Care
Fresenius COM.TEC Blood Cell Separator 510(k) Premarket Notification
Summary of Safety and Effectiveness
The COM.TEC Blood Cell Separator is a blood component separator, which utilizes , centrifugal force as the basis of operation. The fields of application are as follows:
-
- Therapeutic plasma exchange - In plasmapheresis, the blood cell separator is used for the replacement of the blood plasma in the blood circuit by a plasma substitution solution or the reinfusion of the plasma after appropriate processing.
-
- Therapeutic plasma therapy- In plasmapheresis therapy additional plasma treatment is performed through specific commercially available separation columns prior to return to the patient.
E. Substantial Equivalence:
510(k) Substantial Equivalence Decision Making Process
-
- Is the product a device?
- YES The Fresenius COM.TEC is a device pursuant to 21 CFR §201 [321] (h),
-
- Does the new device have the same intended use?
YES - The intended use for the Fresenius COM.TEC is equivalent to that for the Fresenius AS104 and is as follows:
Intended Use - COM.TEC
The COM.TEC Blood Cell Separator is a blood component separator, which utilizes centrifugal force as the basis of operation. The fields of application are as follows:
-
- Therapeutic plasma exchange In plasmapheresis, the blood cell separator is used for the replacement of the blood plasma in the blood circuit by a plasma substitution solution or the reinfusion of the plasma after appropriate processing.
-
- Therapeutic plasma therapy- In plasmapheresis therapy additional plasma treatment is performed through specific commercially available separation columns prior to return to the patient.
2
Image /page/2/Picture/0 description: The image contains a sequence of alphanumeric characters, specifically the text 'K060734'. The characters are written in a clear, legible font, and they appear to be handwritten. The text is the primary focus of the image, with a simple white background.
Fresenius Medical Care
Fresenius COM.TEC Blood Cell Separator 510(k) Premarket Notification
Summary of Safety and Effectiveness
Intended Use - Fresenius AS104
The Fresenius AS104 Cell Separator is intended for use in apheresis procedures involving donors and patients.
The fields of application are as follows:
- Platelet collection "
- r Plasma exchange
- Granulocyte (polymorphionuclear) cell removal -
- Mononuclear cell removal -
3. Does the device have technological characteristics that raise new types of safety or effectiveness questions?
NO - The features included in the Fresenius COM.TEC are equivalent to those present on the Fresenius AS104 and raise no new types of safety or effectiveness questions.
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 COM.TEC and demonstrates that it is substantially equivalent to other commercially available Centrifygal Blood Cell Separators.
F. Safety Summary
The Fresenius COM.TEC blood cell separator has undergone rigorous software validation and performance testing, including clinical testing, software and hardware validation and verification, and biocompatibility testing of disposables. The results of this testing indicate that the Fresenius COM.TEC and associated disposables are safe and effective for their intended use and perform as expected.
G. General Safety and Effectiveness Concerns
The device labeling contains an Operator's Manual, which includes indications for use, cautions and warnings, as well as the general operating instructions required for proper use of the device. This information promotes safe and effective use of the device.
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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
SEP - 5 2006
Ms. Janet C. Kay Sr. Regulatory Affairs Specialist Fresenius Medical Care North America 95 Hayden Avenue LEXINGTON MA 02420
Re: K060734
Trade/Device Name: COM.TEC Blood Cell Separator, TPE Set and P1R Set. for Therapeutic Plasma Exchange and Therapeutic Plasma Treatment Regulation Number: None Regulatory Class: Unclassified Product Code: LKN Dated: June 30, 2006 Received: July 3, 2006
Dear Ms. Kay:
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. 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 (Premarket Approval}, 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.
Image /page/3/Picture/10 description: The image shows a circular logo for the FDA Centennial, celebrating 100 years from 1906 to 2006. The logo features the letters 'FDA' in a stylized font above the word 'Centennial'. Three stars are arranged below the word 'Centennial'. The logo is surrounded by text that follows the circular shape.
Protecting and Promoting Public Health
4
Page 2 –
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 (QS) 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 fetter 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0111 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0111 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0126 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/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
Fresenius Medical Care
Indications for Use
510(k) Number (if known): _
Device Name: Fresenius COMTEC Blood Cell Separator
Indications for Use:
The COMTEC Blood Cell Separator is a blood component separator which utilizes centrifugal force as the basis of operation. The fields of application are as follows:
-
plasma exchange
-
plasma treatment
Prescription Use (Part 21 CFR 801 Subpart D)
ANDIOR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David R. Layson
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Page / of /
(Posted November 13, 2003)