(31 days)
LKN
Not Found
No
The description focuses on hardware modifications (air detector) and basic software logic for safety alarms and procedure termination, with no mention of AI or ML terms or concepts.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is "intended for use in therapeutic plasma exchange" and the 'Device Description' further elaborates that it is "used therapeutically to remove and exchange blood plasma in patients who suffer from adverse hematologic and other conditions."
No
The device is a therapeutic device used for plasma exchange, not for diagnosing conditions. Its function is to remove and exchange blood plasma, and it includes safety features for this therapeutic process.
No
The device description clearly states it is a "centrifugal system" that includes a "machine" and a "disposable Exchange Set," indicating it is a hardware-based medical device with embedded software, not a software-only device.
Based on the provided text, the Spectra Optia Apheresis System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "therapeutic plasma exchange," which is a treatment procedure performed on a patient. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states it's a "blood component separator" used "therapeutically to remove and exchange blood plasma in patients." This describes a therapeutic intervention, not a diagnostic test.
- Lack of Diagnostic Function: The device's function is to separate blood components and perform plasma exchange. It does not analyze blood components for diagnostic purposes. The modification described is a safety feature related to air detection during the procedure, not a diagnostic function.
Therefore, the Spectra Optia Apheresis System, as described, falls under the category of a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Spectra Optia Apheresis System, a blood component separator, is intended for use in therapeutic plasma exchange.
Product codes
LKN
Device Description
The Spectra Optia Apheresis System is a centrifugal system that separates whole blood into its cellular and plasma components. The system is used therapeutically to remove and exchange blood plasma in patients who suffer from adverse hematologic and other conditions.
The system includes a disposable Exchange Set through which the patient's blood passes. and a machine that controls the separation of blood into its components and monitors the exchange procedure for patient safety. The Spectra Optia machine and its embedded software have been modified to include and support a return line air detector, respectively. The return line air detector serves as a backup air detection system and represents an enhancement to the system's overall safety profile. This additional sensor actively monitors the return line and detects the presence of air, prior to its reaching the patient. In the unlikely event that the extracorporeal circuit is improperly anticoagulated and clotted material in the disposable set interferes with the system's primary air detection sensors, the modified device "alarms" when air is detected and instructs the operator to clear the return line. Because the operator must clear the line before the apheresis procedure can be continued, patients are protected from receiving potentially unsafe quantities of air - even when the operator has sub-optimally anticoagulated the circuit. In the further unlikely event that the operator disregards the system's instructions to clear air in the line, the software safely terminates the apheresis procedure.
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
Not Found
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)
Extensive laboratory testing was conducted to verify and validate the functionality and effectiveness of this additional air detection system. Clinical validation data were not necessary. as the modification did not impact the implementation. control, or effectiveness of the system's therapeutic apheresis protocols.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Spectra Optia Apheresis System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
K103090 page 1 of 2
Section 5 Page 2 of 3
NOV 1 9 2010
510(k) Summary
| Owner/Manufacturer: | CaridianBCT, Inc.
10811 W. Collins Avenue
Lakewood, Colorado 80215 |
|------------------------------|-------------------------------------------------------------------------------------|
| Contact Person: | Patti Arndt
Senior Regulatory Affairs Specialist
Office Phone: (303) 231-4823 |
| Date of Summary Preparation: | October 18, 2010 |
| Trade Name: | Spectra Optia® Apheresis System |
| Common Name: | Therapeutic Apheresis System |
| Classification Name: | Separator, Automated, Blood Cell and Plasma, Therapeutic |
| Product Code: | LKN |
| Predicate Device: | Spectra Optia Apheresis System |
Device Description:
The Spectra Optia Apheresis System is a centrifugal system that separates whole blood into its cellular and plasma components. The system is used therapeutically to remove and exchange blood plasma in patients who suffer from adverse hematologic and other conditions.
The system includes a disposable Exchange Set through which the patient's blood passes. and a machine that controls the separation of blood into its components and monitors the exchange procedure for patient safety. The Spectra Optia machine and its embedded software have been modified to include and support a return line air detector, respectively. The return line air detector serves as a backup air detection system and represents an enhancement to the system's overall safety profile. This additional sensor actively monitors the return line and detects the presence of air, prior to its reaching the patient. In the unlikely event that the extracorporeal circuit is improperly anticoagulated and clotted material in the disposable set interferes with the system's primary air detection sensors, the modified device "alarms" when air is detected and instructs the operator to clear the return line. Because the operator must clear the line before the apheresis procedure can be continued, patients are protected from receiving potentially unsafe quantities of air - even when the operator has sub-optimally anticoagulated the circuit. In the further unlikely event that the operator disregards the system's instructions to clear air in the line, the software safely terminates the apheresis procedure.
Intended Use:
The Spectra Optia Apheresis System, a blood component separator, is intended for use in therapeutic plasma exchange.
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K105090 page 2 of 2
Page 3 of 3
Technological Comparison:
The base technology of the Spectra Optia system is not changed by the presence of the return line air detector, and there is no change to the disposable Exchange Set.
The return line air detector is very similar to sensors that are currently used in other parts of the Spectra Optia system, as is the supporting software.
Discussion of Non-clinical Data:
The correct functioning of the return line air detector was verified through the following activities:
- Physical testing of the modified Spectra Optia machine to ensure that the ultrasonic . sensor does not interfere with the interaction between the Spectra Optia machine and the disposable Exchange Set.
- Software code reviews and unit tests to ensure that algorithms and other code were � written correctly and yield the expected results.
- Integration tests to ensure that the modified software and hardware function correctly. .
- Simulated use tests to ensure that the backup air detection system consistently functions . as expected.
Discussion of Clinical Data:
Extensive laboratory testing was conducted to verify and validate the functionality and effectiveness of this additional air detection system. Clinical validation data were not necessary. as the modification did not impact the implementation. control, or effectiveness of the system's therapeutic apheresis protocols.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Patti Arndt Sr. Regulatory Affairs Specialist CaridianBCT, Inc: 10811 W. Collins Avenue LAKEWOOD CO 80215
NOV 1 9 2010
Re: K103090
Trade/Device Name: Spectra Optia® Apheresis System Regulation Number: None
Regulatory Class: Unclassified
Product Code: LKN
Dated: October 18, 2010 Received: October 19, 2010
Dear Ms. Arndt:
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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability … warranties. We remind you, however, that device labeling must be truthful and not misleading.
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, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting of medical device-related
3
Page 2
adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcestoYou/Industry/default.htm.
Sincerely yours,
Hubert Humphrey
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K103090 page lot 1
Section 4 Page 1 of 1
Image /page/4/Picture/2 description: The image shows the logo for CaridianBCT. The logo consists of a stylized graphic to the left of the text "CaridianBCT". The graphic is composed of several curved lines that converge at a point, resembling a stylized wing or swoosh. The text is in a simple, sans-serif font and is horizontally aligned with the graphic.
NOV 1 9 2010
Spectra Optia®Apheresis System Additional Air Detection System Special 510(k) Submission
Intended Use Use Statement 4
510(k) Number: K103090
Device Name: Spectra Optia® Apheresis System
Intended Use
The Spectra Optia Apheresis System, a blood component separator, is intended for use in therapeutic plasma exchange.
Prescription Use: YES (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use: NO (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Carolyn Y Newland for. Herb Lerner
of Reproductive, Gastro-R enal, and