(67 days)
Not Found
No
The description focuses on mechanical and sensor-based separation processes, with no mention of AI or ML terms or functionalities.
No.
The device is used to prepare blood components for diagnostic tests, not to treat a disease or condition.
No
The device is intended for the preparation of plasma and concentrated platelets, which can be used for diagnostic tests, rather than performing the diagnostic tests itself.
No
The device description explicitly details hardware components such as a blood centrifugation device, disposable processing set, whole blood access kit, centrifuge well, roller pump, platelet sensor, valve assembly driver, touch screen user interface, and emergency stop switch.
Based on the provided text, the COBE® Angel Whole Blood Separation System is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states that the prepared plasma and concentrated platelets "can be used for diagnostic tests." This directly links the output of the device to diagnostic purposes, which is a key characteristic of IVD devices.
- Device Description: The device processes a sample of whole blood from the patient to prepare components (plasma and platelets) that are then used for diagnostic tests. This aligns with the definition of an IVD device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
While the device itself is a separation system and not a diagnostic test kit, its output is intended for use in diagnostic tests. This makes it a device that supports in vitro diagnostic procedures.
N/A
Intended Use / Indications for Use
The COBE® Angel Whole Blood Separation System is intended to be used at the patient's point-of-care for the safe and rapid preparation of platelet poor plasma and platelet rich plasma from a sample of whole blood.
The plasma and concentrated platelets can be used for diagnostic tests.
Product codes
JQC
Device Description
The COBE® Angel Whole Blood Separation System consists of a blood centrifugation device and associated disposable processing set and whole blood access kit. The device is intended to be used at the patient's point-of-care for the safe and rapid preparation of platelet poor plasma and platelet rich plasma from a sample of whole blood.
The Blood Access Kit contains syringes, needles, anticoagulant, and a site preparation kit for collecting the blood to be processed with the Angel System. The Processing Set utilizes a variable volume separation chamber that separates autologous whole blood cells, platelet poor plasma, and platelet rich plasma. The Processing Set is provided sterile with a non-pyrogenic fluid pathway, and is for single patient use only. The Processing Set consists of the pre-connected variable volume separation chamber, a tubing set with a platelet sensor/valve assembly, and a three-compartment reservoir bag to hold the blood products (whole blood, red blood cells, and platelet poor plasma). A syringe is provided to collect the platelet rich plasma.
The primary features of the Angel System hardware are the centrifuge well and lid, roller pump, platelet sensor, valve assembly driver, touch screen user interface, and emergency stop switch. The platelet sensor detects the presence of the separated blood components as they exit the variable volume separation chamber, and switches the position of a rotating valve in the Processing Set to channel the individual blood components into their respective collection containers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
patient's point-of-care
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
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)
Reference Device(s)
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).
Not Found
§ 862.2050 General purpose laboratory equipment labeled or promoted for a specific medical use.
(a)
Identification. General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.(b)
Classification. Class I (general controls). The device is identified in paragraph (a) of this section and is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
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510(k) Pre-Market Notification: COBE® Angel Whole Blood Separation System
Image /page/0/Picture/1 description: The image contains the number 042473 in a handwritten style. There is also the number 41 in the upper right corner of the image. The numbers are black against a white background. The image appears to be a close-up of the numbers.
510(k) Summary
NOV 1 9 2004
SUBMITTER:
COBE Cardiovascular, Inc. 14401 W. 65th Wav Arvada, CO 80004
CONTACT PERSON: Jack Ellison Director, Regulatory and Quality Phone: (303) 467-6306 (303) 467-6429 Fax:
DATE PREPARED: September 2, 2004
DEVICE TRADE NAME: COBE Angel Whole Blood Separation System
COMMON/USUAL NAME: General Purpose Centrifuge for Clinical Use
CLASSIFICATION NAME: General Purpose Laboratory Equipment Labeled or Promoted for a Specific Medical Use (21 CFR 862.2050)
PREDICATE DEVICE: Medtronic Magellan™ Autologous Platelet Separator System (K021902)
DEVICE DESCRIPTION:
The COBE® Angel Whole Blood Separation System consists of a blood centrifugation device and associated disposable processing set and whole blood access kit. The device is intended to be used at the patient's point-of-care for the safe and rapid preparation of platelet poor plasma and platelet rich plasma from a sample of whole blood.
The Blood Access Kit contains syringes, needles, anticoagulant, and a site preparation kit for collecting the blood to be processed with the Angel System. The Processing Set utilizes a variable volume separation chamber that separates autologous whole blood cells, platelet poor plasma, and platelet rich plasma. The Processing Set is provided sterile with a non-pyrogenic fluid pathway, and is for single patient use only. The Processing Set consists of the pre-connected variable volume separation chamber, a tubing set with a platelet sensor/valve assembly, and a three-compartment reservoir bag to hold the blood products (whole blood, red blood cells, and platelet poor plasma). A syringe is provided to collect the platelet rich plasma.
The primary features of the Angel System hardware are the centrifuge well and lid, roller pump, platelet sensor, valve assembly driver, touch screen user interface, and emergency stop switch. The platelet sensor detects the presence of the separated blood components as they exit the variable volume separation chamber, and switches the position of a rotating valve in the Processing Set to channel the individual blood components into their respective collection containers.
STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON
A comparison of device features and in-vitro test data demonstrate that the Angel Whole Blood Separation System is substantially equivalent to the currently marketed Medtronic Magellan Autologous Platelet Separator System.
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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Jack Ellison Director, Quality Assurance and Regulatory Affairs COBE Cardiovascular, Inc. 14401 West 65th Way, Field Service Arvada, CO 80004
NOV 1 9 2004
K042473 Re: Trade/Device Name: COBE® Angel Whole Blood Separation System Regulation Number: 21 CFR § 862.2050 Regulation Name: General purpose laboratory equipment labeled or promoted for a specific medical use Regulatory Class: I Product Code: JQC Dated: September 7, 2004 Received: September 13, 2004
Dear Mr. Ellison:
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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of In Vitro Diagnostic Device Evaluation and Safety has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act. the following limitation must appear in the Warnings and Precautions section of the device's labeling:
The safety and effectiveness of this device for in vivo indications for use has not been established.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to
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Page 2 - Mr. Jack Ellison
proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
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 (CFR), Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
If you desire specific information about the application of other labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Robert Baker/
Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
3
Indications For Use
Ko42413 510(k) Number (If known):
COBE® Angel Whole Blood Separation System Device Name:
Indications For Use:
The COBE® Angel Whole Blood Separation System is intended to be used at the patient's point-of-care for the safe and rapid preparation of platelet poor plasma and platelet rich plasma from a sample of whole blood.
The plasma and concentrated platelets can be used for diagnostic tests.
Prescription Use X (Per 21 CFR 801.109)
.
OR
Over-The-Counter Use
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Josephine Brutsker
Division Sigh-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
DEVICE
510(k) K042473