(158 days)
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No
The provided text describes a blood collection and reinfusion system and does not mention any AI or ML components or functionalities.
No
The device collects and reinfuses a patient's own blood (autotransfusion) during surgery to reduce the need for donor blood. While it contributes to patient well-being by reducing risks associated with homologous transfusions, its primary function is blood management within a surgical context rather than directly treating a disease or health condition.
No
The device is described as an "Intraoperative Autotransfusion System" designed for the "collection and reinfusion of intraoperative drainage blood." Its purpose is to "reduce or eliminate the need for transfusion of homologous blood." This functionality is therapeutic (collecting and reinfusing blood) rather than diagnostic (identifying or characterizing a disease or condition).
No
The intended use describes a "system" for collecting and reinfusing blood, which inherently involves hardware components for blood handling. The lack of a device description doesn't negate this.
Based on the provided information, the Betatrans Intraoperative Autotransfusion System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a system for collecting and reinfusing blood within the patient's body during surgery. This is a therapeutic procedure, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.) to diagnose a condition.
- Using reagents or assays.
- Providing information about a patient's health status based on laboratory analysis.
The Betatrans system is a medical device used for blood management during surgery, falling under the category of devices used for therapeutic or supportive purposes, not diagnostic ones.
N/A
Intended Use / Indications for Use
The Betatrans Intraoperative Autotransfusion System is designed for the collection and reinfusion of intraoperative drainage blood collected intraoperatively. The system is intended to reduce or eliminate the need for transfusion of homologous blood, which can carry a variety of infectious agent including Hepatitis or HIV.
Product codes
CAC
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): 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.
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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.
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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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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 30 1998
Mr. Robert M. Engler Director of Operations Duxbury Scientific, Inc. 80 Seabury Point Road Duxbury, MA 02332
K982241 Re : Betatrans Intraoperative I and II Autotransfusion Systems Regulatory Class: II (Two) Product Code: CAC September 19, 1998 Dated: Received: September 24, 1998
Dear Mr. Engler:
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 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). 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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 requlations.
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Page 2 - Mr. Robert M. Engler
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding acberibed in your ivalence 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/dsma/dsmamain.html."
Sincerely yours,
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE OPTIONAL FORMAT
510(k) Number (if known): __ K 982241
Device Name: BETATRANS INTRAOPERATIVE AUTOTRANSFUSION SYSTEM
Indications For Use:
The Betatrans Intraoperative Autotransfusion System is designed for the collection and reinfusion of intraoperative drainage blood collected intraoperatively. The system is intended to reduce or eliminate the need for transfusion of homologous blood, which can carry a variety of infectious agent including Hepatitis or HIV.
Bete L. Lamperle
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number_K 98 224 /
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription use (Per 21 CFR 801.109)
Over The Counter Use_________________
(Optional Format 1-2-96 Reproduced)