(100 days)
The GenesisCS Component Concentrating System is intended to be used in a clinical laboratory or intraoperatively at the point of care for the safe and rapid preparation of plasma and platelet concentrate from a small sample of blood and for a preparation of a cell concentrate from bone marrow. The safety and effectiveness of this device for in vivo indications for use has not been established.
Not Found
This document is a 510(k) premarket notification decision letter from the FDA for the GenesisCS Component Concentrating System. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
Here's why and what's typically found in such documents when performance data is included:
- 510(k) Premarket Notification: This type of submission primarily demonstrates "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive clinical trial data demonstrating novel safety and effectiveness.
- "Substantial Equivalence": The FDA determines if a new device is as safe and effective as a predicate device, often by comparing intended use, technological characteristics, and performance data if relevant differences exist. However, comprehensive performance studies with acceptance criteria are not always fully detailed in the publicly available decision letter itself, but rather in the submitted 510(k) summary or full submission.
- Missing Information: The provided text is a regulatory clearance letter. It clearly states, "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..."
Therefore, I cannot provide the requested information based solely on the provided text. The document does not describe:
- A table of acceptance criteria or reported device performance.
- Sample sizes for a test set, data provenance, or details of retrospective/prospective studies.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- MRMC comparative effectiveness studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
However, I can extract the following relevant information:
- Trade/Device Name: GenesisCS Component Concentrating System
- Regulation Number: 21 CFR 862.2050
- Regulation Name: General purpose laboratory equipment labeled or promoted for a specific medical use
- Regulatory Class: Class I
- Product Code: JQC
- Intended Use Statement: "The GenesisCS Component Concentrating System is intended to be used in a clinical laboratory or intraoperatively at the point of care for the safe and rapid preparation of plasma and platelet concentrate from a small sample of blood and for a preparation of a cell concentrate from bone marrow."
- Important Warning/Limitation: "The safety and effectiveness of this device for in vivo indications for use has not been established." This indicates that while the device is cleared for its stated in vitro laboratory preparation uses, it has not been proven safe or effective for direct use within a living organism.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three diagonal strokes representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Nancy Lord, MD, Esquire Perfusion Partners & Associates, Inc. 1970 North Leslie Road, Number 220 Pahrump, Nevada 89060
JUN 2 0 2007
Re: K070666
Trade/Device Name: GenesisCS Component Concentrating System Regulation Number: 21 CFR 862.2050 Regulation Name: General purpose laboratory equipment labeled or promoted for a specific medical use Regulatory Class: Class I Product Code: JQC Dated: November 26, 2006 Received: March 12, 2007
Dear Dr. Lord:
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.
The Office of In Vitro Diagnostic Device Evaluation and Safety has determined that there is reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings and Precautions section of the device's labeling:
The safety and effectiveness of this device for in vivo indications for use has not been established.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
|
{1}------------------------------------------------
Page 2 - Nancy Lord, MD, Esquire
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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. 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/dsma/dsmamain.html.
Sincerely yours,
Robert G. Becker
Robert L. Becker, Jr., MD, PhD Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
INDICATION FOR USE STATEMENT (As required by 21 CFR 801.109)
The GenesisCS Component Concentrating System is intended to be used in a clinical laboratory or intraoperatively at the point of care for the safe and rapid preparation of plasma and platelet concentrate from a small sample of blood and for a preparation of a cell concentrate from bone marrow. The safety and effectiveness of this device for in vivo indications for use has not been established.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use:
Over-the-Counter Use:
Auschine Bautista
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K070666
6
§ 862.2050 General purpose laboratory equipment labeled or promoted for a specific medical use.
(a)
Identification. General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.(b)
Classification. Class I (general controls). The device is identified in paragraph (a) of this section and is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.