(136 days)
Not Found
Not Found
No
The device description and intended use focus on mechanical blood transfer and reinfusion, with no mention of AI or ML capabilities.
No.
The device is described as a blood transfer device, and its intended use is for blood evacuation and reinfusion, not for treating a disease or condition. It acts as an accessory to an autotransfusion system.
No
The device description indicates its use for blood evacuation and reinfusion, which are therapeutic actions, not diagnostic ones. It helps in the process of autotransfusion rather than detecting or identifying a medical condition.
No
The device description clearly states it is a "flexible vinyl bag with a rigid frame" and an "actuator handle," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the evacuation and reinfusion of shed blood from the mediastinal and pleural spaces. This is a process performed on the patient's body, not on a sample in vitro (outside the body).
- Device Description: The description details a physical device for transferring blood, not a test or reagent used to analyze a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on the analysis of a sample.
IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely mechanical for blood handling during a medical procedure.
N/A
Intended Use / Indications for Use
The Rapid Transfer Blood Bag is intended for use as a blood evacuation and reinfusion device for shed mediastinal and pleural drainage when used in conjunction with the Pleur-evac Continuous Reinfusion Autotransfusion Systems.
Product codes
73 CAC
Device Description
The Rapid Transfer Blood Bag is a flexible vinyl bag with a rigid frame that can be expanded using an actuator handle to cause transfer of blood from a Continuous Reinfusion Autotransfusion System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
mediastinal and pleural drainage
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
- Genzyme Surgical Products Pleur-evac Autotransfusion Blood a. Recovery Bag
- b Atrium Medical Corporation ATS Blood Bag
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
DEC 18 1998
K982712 510(K) SUMMARY
1. SUBMITTER:
Genzyme Surgical Products 600 Airport Road Fall River, MA 02720 Telephone: 508-677-6600
Contact: Stephen M. Page, Director of Regulatory Affairs Date Prepared: July 31, 1998
2. DEVICE:
Genzyme Surgical Products Rapid Transfer Blood Bag Classification Name: Autotransfusion Apparatus Trade Name: Rapid Transfer Blood Bag
3. PREDICATE DEVICE:
- Genzyme Surgical Products Pleur-evac Autotransfusion Blood a. Recovery Bag
- b Atrium Medical Corporation ATS Blood Bag
4. DEVICE DESCRIPTION:
The Rapid Transfer Blood Bag is a flexible vinyl bag with a rigid frame that can be expanded using an actuator handle to cause transfer of blood from a Continuous Reinfusion Autotransfusion System.
5. INTENDED USE:
The Rapid Transfer Blood Bag is intended for use as a blood evacuation and reinfusion device for shed mediastinal and pleural drainage when used in conjunction with the Pleur-evac Continuous Reinfusion Autotransfusion Systems.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus-like symbol, which is a staff with a serpent entwined around it, representing medicine and health. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 8 1998
Mr. Stephen M. Page Genzyme Surgical Products Corp. 600 Airport Road Fall River, MA 02720-4740
K982712 Re: Rapid Transfer Blood Bag Regulatory Class: II (two) Product Code: 73 CAC Dated: November 19, 1998 November 23, 1998 Received:
Dear Mr. Page:
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 Regulations, 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 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 Failure to comply with the GMP regulation may result in assumptions. In addition, FDA may publish further announcements regulatory action. 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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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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Allelson
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE Rapid Transfer Blood Bag
The Rapid Transfer Blood Bag is intended for use as a blood evacuation and reinfusion device for shed mediastinal and pleural drainage when used in conjunction with the Pleur-evac Continuous Reinfusion Autotransfusion Systems.
Mark Kramer
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K182712
Prescriptions use
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