(30 days)
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No
The summary describes a blood collection reservoir, a mechanical accessory, and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device is described as an accessory for the sterile collection and filtration of recovered blood for autotransfusion, which is a processing step, not a therapeutic application itself.
No
The device is described as an accessory for the collection and filtration of blood for autotransfusion, which is a therapeutic rather than a diagnostic purpose. There is no mention of it being used to identify or analyze diseases or conditions.
No
The device is described as a "Blood Collection Reservoir," which is a physical component used in autotransfusion. The description does not mention any software functionality.
Based on the provided information, the XRES Blood Collection Reservoir is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the sterile collection and filtration of recovered blood for subsequent processing for autotransfusion. This is a process that happens outside the body, but it's about preparing blood for reinfusion, not for diagnostic testing on the blood itself.
- Device Description: It's described as a "Blood Collection Reservoir," which aligns with its collection and filtration function.
- Lack of Diagnostic Elements: There is no mention of analyzing the blood for diagnostic purposes, detecting diseases, or providing information about a patient's health status based on the blood sample.
- Accessory to Autotransfusion: It's an accessory to an autotransfusion device, which is a therapeutic process, not a diagnostic one.
IVDs are devices intended to be used in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality. The XRES Blood Collection Reservoir does not fit this definition.
N/A
Intended Use / Indications for Use
The XRES Blood Collection Reservoir is an accessory to an autotransfusion device and is intended for the sterile collection and filtration of recovered blood for subsequent processing for autotransfusion.
Product codes
DTN
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.4400 Cardiopulmonary bypass blood reservoir.
(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
MAR 2 4 2010
Sorin Group Italia s.r.l. c/o Mr. Barry Sall Principal Consultant Parexel International Consulting 195 West Street Waltham, WA 02451
Re: K100507
XRES Blood Collection Reservoir Regulation Number: 21 CFR 870.4400 Regulation Name: Reservoir, Blood, Cardiopulmonary Bypass Regulatory Class: Class II Product Code: DTN Dated: February 19, 2010 Received: February 22, 2010
Dear Mr. Sall:
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 (PMA), it may be subject to 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.
1
Page 2 - Mr. Barry Sall
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 ligting (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm11.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/defaylt.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Duane R. Vachner
ABram D. Zuckerman, M.D. -Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): _长100507
Device Name: XRES Blood Collection Reservoir Indication for Use:
The XRES Blood Collection Reservoir is an accessory to an autotransfusion device and is intended for the sterile collection and filtration of recovered blood for subsequent processing for autotransfusion.
Prescription Use X (Part 21CFR 801 Subpart D)
Over-the- Counter Use AND/OR (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
unn R. Vimer
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_KIU0607