(520 days)
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No
The device description focuses on physical components and mechanical processes for blood separation, with no mention of AI/ML or related concepts.
Yes
The device collects and processes blood components (PRP/PPP) which are then administered to the patient during or after surgery to aid in normalizing their hemocoagulative state. This direct application to affect a change in the patient's physiological condition indicates a therapeutic purpose.
No
This device is intended for the collection and separation of blood components (Platelet-Poor Plasma and Platelet-Rich Plasma) for therapeutic use, not for diagnosing a condition or disease.
No
The device description clearly outlines physical components like bags, adapters, and a burette assembly, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The primary intended use is the separation of blood components (PPP and PRP) from whole blood. This is a processing step, not a diagnostic test performed on a sample to provide information about a patient's health or condition.
- Device Description: The device is a collection set with bags and adapters designed for physically separating blood components. It doesn't involve reagents, assays, or analytical procedures typically associated with IVDs.
- Lack of Diagnostic Claims: The document does not mention any diagnostic claims, measurements, or analysis of the blood components for diagnostic purposes. The separated components are intended for administration back to the patient.
- Performance Studies: The performance studies focus on physical and functional aspects of the device (pull testing, volume accuracy, leak testing, biocompatibility), not on the accuracy or reliability of a diagnostic result.
In summary, the device is a tool for processing blood for therapeutic use, not for performing a diagnostic test on a blood sample.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
74 CAC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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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)
Substantial equivalence was based on a comparison of test results from the following in vitro physical and functional tests:
Physical Tests
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.
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.
Electromedics Plasma Sequestration Set
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.
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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
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
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.
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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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
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 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.
(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)
ેને તે તે તે તે તે તે તે આ ગામનાં મુખ્યત્વે ખેત
Over-The-Counter Use
(Optional Format 1-2-96)
Bete a. Simper