(292 days)
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No
The description focuses on mechanical and disposable components for blood collection and reinfusion, with no mention of AI or ML capabilities.
Yes
The device is described as an "autologous blood recovery system intended for the post-operative collection and filtration of blood from a surgical wound in order to transfuse the whole blood back to the patient," which is a therapeutic intervention.
No
The device is an autologous blood recovery and reinfusion system, designed to collect and reinfuse blood, not to diagnose a condition.
No
The device description clearly outlines multiple hardware components including a wound drain, evacuator tube, blood collection reservoir, vacuum mechanism, and reinfusion bag.
Based on the provided information, the Stryker ConstaVac Blood Conservation System II (CBCII) is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the post-operative collection and filtration of blood from a surgical wound in order to transfuse the whole blood back to the patient. This is a therapeutic procedure involving the patient's own blood, not a diagnostic test performed on a sample outside the body to provide information about a disease or condition.
- Device Description: The device is described as an autotransfusion apparatus used for collecting and reinfusing blood. This aligns with a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing the blood for diagnostic purposes, detecting specific substances, or providing information for diagnosis.
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. The CBCII system's function is to collect and return the patient's own blood, which is a therapeutic intervention.
N/A
Intended Use / Indications for Use
The Stryker ConstaVac Blood Conservation System II (CBCII) is an autologous blood recovery system intended for the post-operative collection and filtration of blood from a surgical wound in order to transfuse the whole blood back to the patient.
The Stryker ConstaVac Blood Conservation System II (CBCII) Disposal Blood Bag is used with the previously cleared CBC II System to provide a disposal Blood Bag is used with in the CBCII reservoir in the CBCII reservoir.
Product codes
CAC
Device Description
The Stryker CBCII System is a single patient use, sterile, disposable, autotransfusion apparatus. The system consists of a wound drain and evacuator tube, an 800cc blood collection reservoir, a means for providing a vacuum in which to drain the blood from the wound site, a means for transferring the blood to a reinfusion bag and a reinfusion The blood disposal bag provides a means for the user to dispose of wound baq. drainage collection once reinfusion has been discontinued.
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
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Key Metrics
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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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§ 868.5830 Autotransfusion apparatus.
(a)
Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.(b)
Classification. Class II (performance standards).
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Stryker® K90714
4100 East Milham Avenue Kalamazoo, MI 49001-6197 (616) 323-7700 (800) 253-3210
DEC 1 6 1997
Device Name:
| Classification Name: | Autotransfusion Apparatus: 21 CFR 868.5830,
Class II |
|----------------------|-------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Postoperative Autotransfusion Device |
| Proprietary Name: | Stryker ConstaVac Blood Conservation System I
(CBCII) |
| Device Sponsor: | Stryker Corporation
Instruments Division
4100 E. Milham Avenue
Kalamazoo, MI 49001
Registration No: 1811755 |
Regulatory Class:
Summary of Safety and Effectiveness:
The Stryker ConstaVac Blood Conservation System II (CBCII) is an autologous blood recovery system intended for the post-operative collection and filtration of blood from a surgical wound in order to transfuse the whole blood back to the patient.
Class II
The Stryker CBCII System is a single patient use, sterile, disposable, autotransfusion apparatus. The system consists of a wound drain and evacuator tube, an 800cc blood collection reservoir, a means for providing a vacuum in which to drain the blood from the wound site, a means for transferring the blood to a reinfusion bag and a reinfusion The blood disposal bag provides a means for the user to dispose of wound baq. drainage collection once reinfusion has been discontinued.
1
This reinfusion device has been tested and does meet the applicable sections of the American National Standard for Auto Transfusion Devices, ANSI/AAMI AT6-1981 as well as the biocompatibility guidelines set forth in the Tripartite Guidance.
The CBCII System is equivalent to existing marketed products by companies such as Baxter V. Mueller. Power modality, intended use, and safety risks are all substantially equivalent. The CBCII Blood Disposal Bag is equivalent to existing marketed products by companies such as Zimmer. Intended use and safety risks are substantially equivalent.
The Stryker CBC II System, including the blood disposal bag, does not raise any new safety and efficacy concerns when compared to similar legally marketed devices. Therefore, the Stryker CBC II System is substantially equivalent to these existing devices.
Tammy Founds
Tammy Loui Assoc. Manager, Regulatory Affairs Stryker Instruments
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes, positioned to the right of a circular emblem. The emblem contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circle's perimeter.
Public Health Service
Rockville MD 20857
Mr. Rodney Parker Microbologist and Supervisor of Regulatory Affairs Stryker Instruments 4100 East Milham Avenue Kalamazoo, MI 49001
DEC I 6 1997
Re: K970714 Stryker Constavac Blood Conservation System II Requlatory Class: II (Two) Product Code: CAC October 15, 1997 Dated: Received: October 22, 1997
Dear Mr. Parker:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Rodney Parker
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
868 · 5830 CAC II -Autorbransfosion eratus
Page_l
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ k 97074
Device Name: CBCII Blood Disposal Bag_
Indications For Use:
The Stryker ConstaVac Blood Conservation System II (CBCII) Disposal Blood Bag is used with the previously cleared CBC II System to provide a disposal Blood Bag is used with
in the CBCII reservoir in the CBCII reservoir.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The- Counter Use _
(Optional Format 1-2-96)