(107 days)
Not Found
Not Found
No
The provided 510(k) summary does not contain any keywords or descriptions related to AI, ML, image processing, or performance studies typically associated with AI/ML-powered devices. The description focuses solely on the device's function as a blood component separator for therapeutic plasma exchange.
Yes
The device is described as a "blood component separator" intended for "therapeutic plasma exchange," which directly implies its use in treating a medical condition.
No
The device description states it is a "blood component separator," and the intended use is for "therapeutic plasma exchange." Neither of these functions involves diagnosing a condition; instead, they describe a therapeutic procedure.
No
The device description explicitly states it is a "Spectra Optia Apheresis System, a blood component separator," which is a hardware system.
Based on the provided information, the Spectra Optia Apheresis System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "therapeutic plasma exchange," which is a medical procedure performed on a patient's blood outside the body, but the purpose is to treat the patient directly, not to diagnose a condition based on analyzing the blood components.
- Device Description: It's described as a "blood component separator." While it processes blood, its function is to separate components for therapeutic purposes, not for diagnostic testing.
- Lack of Diagnostic Indicators: There is no mention of the device being used to analyze blood for markers, substances, or characteristics that would lead to a diagnosis.
IVD devices are specifically designed to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Spectra Optia's function is therapeutic, not diagnostic.
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
Spectra Optia Apheresis System, a blood component separator
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Food and Drug Administration . 9200 Corporate Boulevard Rockville MD 20850
AUG - 2 2007
Ms. Patti L. Arndt Senior Regulatory Affairs Specialist Gambro BCT, Inc. 10810 West Collins Avenue LAKEWOOD CO 80215
Re: K071079
Trade/Device Name: Spectra Optia Apheresis System Regulation Number: None Regulatory Class: Unclassified Product Code: LKN Dated: July 17, 2007 Received: July 18, 2007
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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
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.
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Page 2 - Ms. Patti Arndt
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 (21 CFR Part 807); listing (21 CFR Part 807), labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally 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 the labeling regulation, please contact the Office of Compliance at (240) 276-0115. 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/industry/support/index.html.
Sincerely yours,
Hebert Lewin Jr.
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/1 description: The image shows the text "GAMBRO.BCT." in a simple, sans-serif font. The text is black and appears to be printed on a white background. There is a small, stylized graphic to the left of the word GAMBRO, which may be a logo.
Spectra Optia Apheresis System 510(k) Notification
Indications for Use/Intended Use Statement 4
510(k) Number:
K07/079
Device Name:
Spectra Optia Apheresis System
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 [Part 21 CRF 801 Subpart C]
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herberl Leun
(Division Sign-Off)
(Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
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