Code 150 Blood Component Collection Set is intended for separation of Platelet-Poor Plasma (PPP) and Platelet-Rich Plasma (PRP) from whole blood collected into transfer bags.

Code 151 Blood Component Set with Direct Draw Line is intended for separation of Platelet-Poor Plasma (PPP) and Platelet-Rich Plasma (PRP) from whole blood collected from directly the patient.

The process of PRP/PPP is to be performed in the immediate preoperative period, prior to the surgical procedure and before the establishment of cardiopulmonary bypass. The collected PRP/PPP shall be administered during or after the operation to aid in the normalization of the patient's hemocoagulative state.

The Electronmedics PRP/PP Sequestration Kits are indicated for the same use as the Code 150 and Code 151 Blood Component Collection Sets.

Device Description

The Blood Components Collection Set consists of a four-way adapter, a bag spike assembly, and two (2) collection bags. The four way adapter is inserted between the wash bowl and waste bag components of a preassembled surgical wash. The collection bags are attached to the free arms of the adapter. Whole blood to be processed may be collected in the immediate preoperative period into a transfer bag, which is then attached to the inlet side of the wash set using the bag spike assembly. In addition, blood may be collected directly from the patient by utilization of a filtered burette assembly intended for the administration of anticoagulation solution during preoperative collection of patient blood for sequestration of PRP/PPP. Alternately, whole blood from the extracorporeal circuit (e.g. cardiotomy reservoir or oxygenator) may be processed during the intraoperative period in the same manner.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Sorin Biomedical Inc. Dideco Blood Component Collection Sets (Code 150 and Code 151). This notification focuses on demonstrating "substantial equivalence" to a predicate device, rather than providing detailed acceptance criteria and a study report as might be expected for novel devices or performance claims. Therefore, much of the requested information regarding detailed acceptance criteria, specific performance metrics, and study methodologies is not present in this document.

Here's an analysis of the available information:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or specific performance metrics for the device's clinical efficacy (e.g., PRP purity, platelet recovery). Instead, it focuses on demonstrating substantial equivalence based on physical and functional tests to an existing predicate device (Electromedics Plasma Sequestration Set and AT-1000 Sequestration Set).

The "acceptance criteria" can be inferred as successful completion of these nonclinical tests, indicating the device performs as intended and is safe.

Acceptance Criteria Category	Reported Device Performance	Comments
Physical Tests
Pull Testing	Secure connection established between blood components collection set and surgical wash set.	The device passed pull testing, ensuring secure attachment.
Volume Accuracy (Burette)	All burettes recorded accurately at specified volumes.	The device's burette accurately measures volume.
Leak Testing (Filtered Burette)	No leaks observed when pressurized to 15 ± 0.5 psi and submerged in water.	The device passed leak testing.
Biocompatibility	Blood contacting components are safe for intended use.	Testing performed per Tripartite Guidances for "externally communicating devices, blood path direct: with a short term contact duration (5 minutes to 29 days)".
Overall Equivalence (Implied Performance)	Substantially equivalent in intended use, materials, design, and performance characteristics to the Electromedics Plasma Sequestration Set.	The device is deemed to perform similarly to the predicate device for PRP/PPP separation.

Study Details

The provided document describes nonclinical (in vitro) tests rather than a clinical study.

Sample Size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for any of the nonclinical tests. The text mentions "All burettes" for volume accuracy and "Each unit" for leak testing, implying the testing of multiple units, but the exact number isn't provided. For biocompatibility, it states "Biocompatibility testing was performed on finished devices," again without a specific number.
- Data Provenance: The tests were performed "in vitro" by Sorin Biomedical Inc.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for these nonclinical tests would be defined by engineering specifications and direct measurements (e.g., known forces for pull tests, precise volumes for accuracy, direct observation of leaks). Experts were not involved in establishing the "ground truth" in the sense of clinical interpretation.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. These were objective physical and functional tests, not subjective assessments requiring expert adjudication.
If a multi-reader, multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done. The document describes nonclinical in vitro tests and a comparison of technological characteristics to a predicate device, not a human reader study.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical blood component collection set, not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the nonclinical tests, the ground truth was based on:
- Engineering specifications and objective measurements: For pull testing (force required to disconnect), volume accuracy (comparison to known volumes), and leak testing (absence of bubbles under pressure).
- Regulatory standards/guidances: For biocompatibility testing, adherence to "Tripartite Guidances for the category of 'externally communicating devices, blood path direct: with a short term contact duration (5 minutes to 29 days)'."
The sample size for the training set: Not applicable. This document does not describe the development or evaluation of an algorithm using a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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K963758

Sorin Biomedical Inc. Dideco Blood Component Collection Sets - Code 150 and Code 151 510(k) Notification

510(k) SUMMARY XIV.

A. Name and Address of Submitter

Sorin Biomedical Inc. 17600 Gillette Avenue P.O. Box 19503 Irvine, California 92713-9503

B. Telephone and Fax Numbers of Submitter

(714) 250-8322 Telephone: (714) 757-8644 Fax:

C. Name of Contact Person

Susan Reimers Manager, Clinical and Regulatory Affairs

Date Summary was Prepared: D. September 16, 1996
E. Device Name

Trade or Proprietary Name:

Dideco Compact-A Autotransfusion System

Common Name:

Autotransfusion Apparatus

Classification Name:

Autrotransfusion Devices

F. Summary of Substantial Equivalence

The Blood Component Collection set is substantially equivalent in intended use, materials, design, and performance characteristics to the Electromedics Plasma Sequestration Set.

SORIN BIOMEDICAL INC. CONFIDENTIAL

FEB 20 1998

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G. Device Description

H. Device Intended Use

Code 150 Blood Component Collection Set is intended for separation of Platelet-Poor Plasma (PPP) and Platelet-Rich Plasma (PRP) from whole blood collected into transfer bags.

Code 151 Blood Component Collection Set with Direct Draw Line is intended for separation of Platelet-Poor Plasma (PPP) and Platelet-Rich Plasma (PRP) from whole blood collected directly from the patient.

The process of PRP/PPP is to be performed in the immediate preoperative period, prior to the surgical procedure and before the establishment of cardiopulmonary bypass. The collected PRP/PP shall be administered during or after the operation to aid in the normalization of the patient's hemocoagulative state.

I. Summary of Comparison of Technological Characteristics

The technological characteristics of the Blood Component Collection sets are similar to the Electromedics Plasma Sequestration Set. Both sets are identical in respect to their process steps, method of operation, materials, and suggested flow rates. They are both indicated for separation of Platelet-Poor Plasma (PPP) and Platelet-Rich Plasma (PRP) from whole blood collected from the patient.

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Summary of Nonclinical Tests J.

Substantial equivalence was based on a comparison of test results from the following in vitro physical and functional tests:

Physical Tests

Pull Testing

Pull testing was performed to ensure the blood components collection set can be securely attached to the preassembled surgical wash set to prevent being inadvertently disconnected. The results of the physical testing demonstrate that a secure connection can be established between the blood components collection set and the reassembled surgical wash set.

Volume Accuracy

The purpose of this test was to verify the accuracy of the volume label on the burette assembly by recording the volume indication at specific volume levels. All burettes recorded accurately at the specified volumes.

Leak Testing of the Filtered Burette

Leak testing was conducted on the blood component burette assembly under pressure. Each unit was slowly pressurized to 15 ± 0.5 psi and submerged under water.

Biocompatibility

Biocompatibility testing was performed on finished devices in accordance with Tripartite Guidances for the category of "externally communicating devices, blood path direct: with a short term contact duration (5 minutes to 29 days) ". Results demonstrate that the blood contacting components of the Blood Component Collection Set are safe for their intended use.

K. Conclusions

Based upon the above information, Sorin Biomedical Inc. concludes that the blood component collection set is substantially equivalent to the Electromedics AT-1000 Sequestration Set for the plasma sequestration indication for use.

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FEB 20 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Sharon Thompson Director, Regulatory Affairs/Quality Sorin Biomedical, Inc. 17600 Gillette Avenue P.O. Box 19503 Irvine, CA 92713-9503

K963758 Re: Code 150 Blood Component Collection Set Code 151 Blood Component Collection Set with Direct Draw Line Requlatory Class: II (two) Product Code: 74 CAC Dated: January 30, 1998 Received: February 2, 1998

Dear Ms. Thompson:

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 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 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 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 leqally 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 requlation 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/dsmamain.html".

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

Enclosure

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Page 1 of 1

100212011

K963758 510(k) Number (if known):

Device Name: CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE

Indications For Use:

Code 150 Blood Component Collection Set is intended for separation of Platelet-Poor Plasma (PPP) and Platelet-Rich Plasma (PRP) from whole blood collected into transfer bags.

Code 151 Blood Component Set with Direct Draw Line is intended for separation of Platelet-Poor Plasma (PPP) and Platelet-Rich Plasma (PRP) from whole blood collected from directly the patient.

The Electronmedics PRP/PP Sequestration Kits are indicated for the same use as the Code 150 and Code 151 Blood Component Collection Sets.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Lise -(Per 21 CFR 801.109)

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Over-The-Counter Use

(Optional Format 1-2-96)

Bete a. Simper

Regulation Number and Section

§ 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).