(169 days)
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:
- plasma exchange
- plasma treatment
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.
This document is a 510(k) Premarket Notification for the Fresenius COM.TEC Blood Cell Separator. It seeks to demonstrate substantial equivalence to predicate devices, not to set or prove acceptance criteria for a new type of device. Therefore, much of the requested information regarding acceptance criteria and a study proving they are met is not present in this type of submission.
Here's a breakdown of what can be extracted and what is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
This document, being a 510(k) submission, focuses on demonstrating substantial equivalence to pre-existing predicate devices rather than defining and meeting specific quantitative acceptance criteria for a novel device performance study. The core claim is that the COM.TEC performs "as expected" and is "safe and effective for its intended use" based on various tests, but no specific performance metrics or acceptance thresholds are provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
The document states that the COM.TEC has undergone "performance testing, including clinical testing." However, it does not provide specific details on the sample size of this clinical testing, the country of origin of the data, or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. Ground truth establishment for a diagnostic device usually involves expert review. Since this is for a blood cell separator, the "ground truth" would likely relate to the effectiveness of separation and safety outcomes, which would be assessed through various clinical and laboratory measures, not expert interpretation of images or similar data.
4. Adjudication Method for the Test Set
Not applicable and not provided. Adjudication methods (like 2+1 or 3+1) are typically used for establishing ground truth in diagnostic accuracy studies where there's a subjective element, often with image interpretation. For a blood cell separator, performance would be measured objectively (e.g., cell yields, plasma purity, patient outcomes).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done, as this type of study is specifically designed for evaluating diagnostic imaging algorithms, not a blood cell separation device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical medical device (blood cell separator), not an AI algorithm. Its performance is inherent in its operation, not an algorithm's output.
7. The Type of Ground Truth Used
The document mentions "clinical testing" and implies that the device's performance was evaluated against its intended use for therapeutic plasma exchange and therapeutic plasma therapy. The "ground truth" would therefore be the actual performance and safety outcomes of the device in these applications, likely measured through:
* Laboratory analysis: Quantifying separation efficiency, cell yields, plasma purity.
* Patient outcomes data: Monitoring for adverse events, effectiveness of treatment.
* Biocompatibility testing: Ensuring safety of components.
* Software and hardware validation and verification: To confirm functional integrity.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.
Summary of Relevant Information from the Document:
While the detailed specifics of a performance study with acceptance criteria are not in this summary, the document states:
- Device Description: Fresenius COM.TEC Blood Cell Separator, which utilizes centrifugal force.
- Intended Use: Therapeutic plasma exchange and therapeutic plasma therapy.
- Predicate Devices: Fresenius AS104 Blood Cell Separator (#K895435) and Fresenius P1R Plasma Treatment Set (#K961706).
- Substantial Equivalence Claim: The COM.TEC is substantially equivalent to the predicate devices and raises no new types of safety or effectiveness questions.
- 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."
Conclusion:
This 510(k) summary provides a high-level overview of the device and its claimed equivalence to predicate devices, supported by general statements about testing. It does not provide the detailed acceptance criteria and study particulars typically found when a new device makes specific performance claims against predefined metrics. The FDA's letter ultimately confirms substantial equivalence, allowing the device to be marketed.
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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 AveLexington, 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.
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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.
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Protecting and Promoting Public Health
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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
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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)
N/A