SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200 by GAMBRO BCT, INC.

This document is a 510(k) clearance letter from the FDA for the Spectra Optia Apheresis System. It states that the device is substantially equivalent to legally marketed predicate devices for use in therapeutic plasma exchange.

However, the provided text does not contain any information about acceptance criteria or specific study data that proves the device meets such criteria. The letter is a regulatory approval document and not a performance study report.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance.
Sample sizes or data provenance.
Number and qualifications of experts for ground truth.
Adjudication method.
Multi-reader multi-case (MRMC) comparative effectiveness study information.
Standalone algorithm performance.
Type of ground truth used.
Training set sample size.
How ground truth for the training set was established.

The document only confirms the FDA's concurrence with the stated Indications for Use.

Summary

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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

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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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Regulation Number and Section

N/A