(87 days)
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No
The description focuses on a non-invasive, real-time hematocrit measurement system based on multiple sampling, not AI/ML. There is no mention of AI, ML, or related concepts in the provided text.
No
The device, particularly the CRIT-LINE™ Hematocrit Sampling System, is described as measuring hematocrit and providing data for the user, not directly treating a medical condition. The COBE® BRAT® 2 Autologous Blood Salvage System is for the recovery and/or processing of autologous blood. Neither component is described as providing a therapeutic effect.
No
The description states that the CRIT-LINE™ Hematocrit Sampling System measures the hematocrit of the finished blood product. While this measurement provides information about the product itself, it does not diagnose a patient's condition. The primary indication is for recovery and/or processing of autologous blood.
No
The device description explicitly mentions a "CRIT-LINE™ Hematocrit Sampling System" which is a physical component used to measure hematocrit. The performance studies also include electrical safety and electromagnetic testing, which are relevant to hardware components, not just software.
Based on the provided text, the COBE® BRAT® 2 Autologous Blood Salvage System with the CRIT-LINE™ Hematocrit Sampling System option is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The primary intended use is for the recovery and processing of autologous blood. The CRIT-LINE™ option is used to measure the hematocrit of the finished product in the reinfusion bag. While it measures a blood parameter, it's doing so on a processed blood product within a system designed for blood salvage and reinfusion, not for diagnostic purposes on a patient sample.
- Device Description: The description emphasizes measuring the hematocrit of the red cell product as it is being emptied into the reinfusion bag. This is a quality control or process monitoring step within the blood salvage procedure, not a diagnostic test performed on a patient's blood sample to diagnose a condition.
- Lack of Diagnostic Context: The text does not mention using the hematocrit measurement for diagnosing any disease or condition in a patient. It's solely focused on characterizing the processed blood product.
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. While the CRIT-LINE™ measures a blood parameter, its context within the COBE® BRAT® 2 system is for monitoring the quality of the salvaged blood product before reinfusion, not for diagnosing a patient.
N/A
Intended Use / Indications for Use
The COBE® BRAT® 2 Autologous Blood Salvage System in indicated for use for the recovery and/or processing of autologous blood. The CRIT-LINE™ Hematocrit Sampling System option is used in conjunction with the COBE® BRAT® 2 Autologous Blood Salvage System to measure the hematocrit of the finished product in the reinfusion bag.
Product codes (comma separated list FDA assigned to the subject device)
CAC, KOC
Device Description
The COBE® BRAT® 2 Autologous Blood Salvage System is being modified to add the CRIT-LINE™ Hematocrit Sampling System, which will be used to measure the finished red cell product as it is being emptied into the reinfusion bag. The CRIT-LINE™ Hematocrit Sampling System will be offered as an option for the COBE® BRAT® 2 Autologous Blood Salvage System.
The purpose of the CRIT-LINE™ Hematocrit Sampling System is to give the user a noninvasive, real-time measurement of the hematocrit of the red cell product in the reinfusion bag. It eliminates exposure of the clinician to collection of a blood sample. Because the CR/T-L/NE™ Hematocrit Sampling System measures the hematocrit of the blood ten times per second as it is being collected in the reinfusion bag, the system is able to capture changes in hematocrit as the blood is exiting the centrifuge bowl, and is able to provide a more representative hematocrit result based upon multiple sampling of the blood product, rather than on a single sample.
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
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)
Testing of the COBE® BRAT® 2 Autologous Blood Salvage System with CRIT-LINE™ Hematocrit Sampling System consisted of:
- Electrical safety testing in accordance with EN 60601-1: International Standard for Medical 1. Electrical Equipment, Part 1
- Electromagnetic immunity testing in accordance with EN60601-1-2: International Standard for 2. Medical Electrical Equipment, Part 1.2
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- Electromagnetic emmisions testing in accordance with EN 55011: Limits and Methods of Measurement of Radio Distrubance Characteristics of Industrial, Scientific, and Medical Radio-Frequency Equipment
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- Hematocrit performance testing in accordance with the CRIT-LINE™ product specifications using human blood
These data support substantial equivalence of the COBE® BRAT® 2 Autologous Blood Salvage System with CRIT-LINE™ Hematocrit Sampling System to the predicate device.
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.
COBE® BRAT® 2 Autologous Blood Salvage System
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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).
0
a 1999
510(k) Summary
| SUBMITTER: | COBE Cardiovascular®, Inc.
14401 W. 65th Way
Arvada, CO 80004 |
|----------------------|---------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Lynne Leonard
Phone: (303) 467-6586
Fax: (303) 467-6429 |
| DATE PREPARED: | June 10, 1999 |
| DEVICE TRADE NAME: | COBE® BRAT® 2 Autologous Blood Salvage System with
CRIT-LINE™ Hematocrit Sampling System |
| COMMON/USUAL NAME: | Autologous Blood Salvage System with Hematocrit Sampling Option |
| CLASSIFICATION NAME: | Autotransfusion Apparatus |
| PREDICATE DEVICE: | COBE® BRAT® 2 Autologous Blood Salvage System |
DEVICE DESCRIPTION:
The COBE® BRAT® 2 Autologous Blood Salvage System is being modified to add the CRIT-LINE™ Hematocrit Sampling System, which will be used to measure the finished red cell product as it is being emptied into the reinfusion bag. The CRIT-LINE™ Hematocrit Sampling System will be offered as an option for the COBE® BRAT® 2 Autologous Blood Salvage System.
The purpose of the CRIT-LINE™ Hematocrit Sampling System is to give the user a noninvasive, real-time measurement of the hematocrit of the red cell product in the reinfusion bag. It eliminates exposure of the clinician to collection of a blood sample. Because the CR/T-L/NE™ Hematocrit Sampling System measures the hematocrit of the blood ten times per second as it is being collected in the reinfusion bag, the system is able to capture changes in hematocrit as the blood is exiting the centrifuge bowl, and is able to provide a more representative hematocrit result based upon multiple sampling of the blood product, rather than on a single sample.
INDICATIONS FOR USE
The COBE® BRAT® 2 Autologous Blood Salvage System in indicated for use for the recovery and/or processing of autologous blood. The CRIT-LINE™ Hematocrit Sampling System option is used in conjunction with the COBE® BRAT® 2 Autologous Blood Salvage System to measure the hematocrit of the finished product in the reinfusion bag.
STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON
The COBE® BRAT® 2 Autologous Blood Salvage System with CRIT-LINE™ Hematoorit Sampling System is substantially equivalent to the currently marketed COBE® BRAT® 2 Autologous Blood Salvage System. The two devices are identical with the exception of the CRIT-LINE™ Hematocrit Sampling System option with its associated hardware, software, and disposables. Otherwise, the intended use,
1
specifications, method of operation, accessories, design, and features, of the COBE® BRAT® 2 Autologous Blood Salvage System remain the same.
Testing of the COBE® BRAT® 2 Autologous Blood Salvage System with CRIT-LINE™ Hematocrit Sampling System consisted of:
- Electrical safety testing in accordance with EN 60601-1: International Standard for Medical 1. Electrical Equipment, Part 1
- Electromagnetic immunity testing in accordance with EN60601-1-2: International Standard for 2. Medical Electrical Equipment, Part 1.2
-
- Electromagnetic emmisions testing in accordance with EN 55011: Limits and Methods of Measurement of Radio Distrubance Characteristics of Industrial, Scientific, and Medical Radio-Frequency Equipment
-
- Hematocrit performance testing in accordance with the CRIT-LINE™ product specifications using human blood
These data support substantial equivalence of the COBE® BRAT® 2 Autologous Blood Salvage System with CRIT-LINE™ Hematocrit Sampling System to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the USA. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
SEP 9 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Lynne Leonard Manager, Regulatory Submissions COBE Cardiovascular, Inc. 14401 W. 65th Way Arvada, Colorado 80004-3599
Re: K991986
Trade Name: COBE® BRAT® 2 Autologous Blood Salvage System with CRIT-LINE™ Hematocrit Sampling System Option
Regulatory Class: II Product Code: CAC, KOC Dated: June 10, 1999 Received: June 14, 1999
Dear Ms. Leonard:
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 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. 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,
Steven Sutman
Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications For Use 1.
| 510(k) Number (If known): | K991198 |
|---|---|
| --------------------------- | --------- |
COBE® BRAT® 2 System with CRIT-LINE™ Hematocrit Sampling System Option Device Name:
Indications For Use:
The COBE BRAT 2 is indicated for use for the recovery and/or processing of autologous blood. The CODE BRAT 2 is Indication in add for the roter in conjunction with the BRAT 2 The ONY -EINE Homatoon. Sampling by Stomished product in the reinfusion bag.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter E. Myerson
Division Sign-Off Division of Clinical Laboratory De 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________