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.

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.

AI/ML Overview

The provided text describes the COBE® Angel Whole Blood Separation System and its 510(k) submission, focusing on establishing substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria in the way envisioned by the prompt's request for performance metrics (e.g., sensitivity, specificity, accuracy).

The document is a regulatory submission for a medical device that processes blood, not an AI/algorithm-based diagnostic device where typical AI acceptance criteria would apply. Therefore, many of the requested items (like ground truth, expert opinions, MRMC studies, AI assistance) are not relevant to this type of device and are not present in the provided text.

Based on the available information:

A table of acceptance criteria and the reported device performance:
The document states: "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."
However, specific quantitative acceptance criteria (e.g., minimum purity of plasma, recovery rate of platelets) and the exact reported performance values are not detailed in the provided text. The assessment for this type of device focuses on demonstrating "substantial equivalence" to a predicate device, which implies that its performance is comparable and safe/effective for its intended use, but doesn't typically involve the same kind of detailed performance metrics as a diagnostic algorithm.
Sample size used for the test set and the data provenance:
The document mentions "in-vitro test data" but does not specify the sample size, the type of test set (e.g., number of blood samples), or data provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided as the device is a blood separation system, not an AI diagnostic system requiring expert-established ground truth for image or diagnostic interpretation.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable and not provided.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable and not provided as the device is a blood separation system, not an AI diagnostic system.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable and not provided.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The concept of "ground truth" as typically used for AI diagnostic devices (e.g., pathology for cancer detection) is not directly applicable here. For a blood separation system, "ground truth" would likely relate to objective measurements of the separated components (e.g., cell counts, protein concentrations) determined by laboratory techniques rather than expert consensus on diagnostic interpretation. The document does not detail these specific "ground truth" methods.
The sample size for the training set:
The document does not mention a "training set" as this is not an AI/machine learning device.
How the ground truth for the training set was established:
This information is not applicable and not provided.

In summary, the provided 510(k) summary focuses on demonstrating "substantial equivalence" through "comparison of device features and in-vitro test data" rather than providing a detailed breakdown of acceptance criteria and performance study results specific to AI/algorithm validation.

Summary

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510(k) Pre-Market Notification: COBE® Angel Whole Blood Separation System

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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 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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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

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Indications For Use

Ko42413 510(k) Number (If known):

COBE® Angel Whole Blood Separation System Device Name:

Indications For Use:

The plasma and concentrated platelets can be used for diagnostic tests.

Prescription Use X (Per 21 CFR 801.109)

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

Regulation Number and Section

§ 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.