(13 days)
No
The summary describes a standard dose calibrator with a display unit and ionization chamber, and there is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is used to measure the radioactivity of radionuclides before administration to patients, but it does not directly treat or diagnose a disease or condition. It is a measurement and calibration tool.
No
The device is used to verify the radioactivity of a radionuclide before administration to a patient, which is a measurement or calibration function for a therapeutic or diagnostic agent, not a diagnostic act for a patient.
No
The device description explicitly states it is comprised of a display unit and one or more connected argon gas filled pressurized ionization chamber detector units, indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to calibrate radioactive doses for administration to patients. This is an in vivo application, meaning it's used in the context of treating or diagnosing a living organism.
- Device Description: The device measures radioactivity of a radionuclide before administration to the patient. This is a quality control step for a substance that will be used in vivo.
- Lack of In Vitro Activities: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information about a physiological state, disease, or condition.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body. This device's function is related to preparing a substance for use within the body.
N/A
Intended Use / Indications for Use
The Atomlab dose calibrators are used in Nuclear Medicine departments, clinics and nuclear pharmacies for calibrating radioactive doses for administration to patients. The instrument is used to verify the radioactivity of a radionuclide before administration to the patient.
Product codes
KPT
Device Description
The Atomlab dose calibrator is comprised of a display unit and one or more connected argon gas filled pressurized ionization chamber detector unit. The calibration for the dose calibrator is contained in the chamber has a calibration certificate with it when it is shipped. Any of the Atomlab 400 and 500 displays can be connected to the chamber and will work correctly with the chamber since the calibration is stored in the chamber. The dose calibrators were independently tested and verified that they function correctly.
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
Nuclear Medicine departments, clinics and nuclear pharmacies. The user or a consulting physicist performs a series of tests for acceptance testing upon installation.
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
Testing has been done by physicists at Northwestern Memorial Hospital and Stony Brook University Hospital of device accuracy, linearity, constancy, and geometry to device performance is substantially equivalent to the predicate devices.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing has been done by physicists at Northwestern Memorial Hospital and Stony Brook University Hospital of device accuracy, linearity, constancy, and geometry to device performance is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Atomlab 100 (K884312/A), Atomlab 200 (K884312/A), Capinter 25 (K071396)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1360 Radionuclide dose calibrator.
(a)
Identification. A radionuclide dose calibrator is a radiation detection device intended to assay radionuclides before their administration to patients.(b)
Classification. Class II.
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510K SUMMARY
ATOMLAB 400 AND ATOMLAB 500, MODELS #086-330, 086-335, 086-336, 086-332
The Atomlab 400 and Atomlab 500 Radionuclide Dose Calibrator series from Biodex Medical Systems, Inc. is ETL listed for the Medical Device Safety Standards UL6060101, CAN/CSA C22.2 No .: 601-1-1-190, IEC 60601-1-4, IEC 60601-1 and is Retlif Certified to the EMC Medical Standard IEC 60601-1-2.
The radionuclide dose calibrators are Class II devices. Classification #: 90 KPT, 21 CFR #892.1360
The Atomilab dose calibrators comply with Performance Standard IEC 1303 and IEC 61145.
Predicate Devices: Atomlab 100 (K884312/A), Atomlab 200 (K884312/A), Capinter 25 (K071396),
The basic detection, measurement process, design concepts, functions and algorithms remain the same as the predicate devices. Testing has been done by physicists at Northwestern Memorial Hospital and Stony Brook University Hospital of device accuracy, linearity, constancy, and geometry to device performance is substantially equivalent to the predicate devices.
The intended use: The Atomlab dose calibrators are used in Nuclear Medicine departments, clinics and nuclear pharmacies for calibrating radioactive doses for administration to patients. The instrument is used to verify the radioactivity of a radionuclide before administration to the patient. The Atomlab dose calibrator is comprised of a display unit and one or more connected argon gas filled pressurized jonization chamber detector unit. The calibration for the dose calibrator is contained in the chamber has a callbration certificate with it when it is shipped. Any of the Atomlab 400 and 500 displays can be connected to the chamber and will work correctly with the chamber since the calibration is stored in the chamber. The dose calibrators were independently tested and verified that they function correctly.
Dose calibrators have been used in Nuclear Medicine departments and nuclear pharmacies for many years. When a dose calibrator is received, upon installation there is a series of tests that are performed by the user or a consulting physicist for acceptance testing of the dose calibrator.
The Atomlab 400 and Atomlab 500 will be manufactured to the product's specifications.
CERTIFICATION:
I hereby certify that this summary of safety and effectiveness applies for the above indicated Atomlab dose calibrators.
Date: Jan 6, 2009
Name:
Clyde Schlein
Director of Regulatory Affairs & Compliance Biodex Medical Systems, Inc. 20 Ramsay Road Shirley, New York USA 11967-4704 Phone: (631) 924-9000 ext. 2343 Fax: (631) 924-9502 Email: cschlein@biodex.com
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines extending from its head, representing the department's commitment to health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biodex Medical Systems, Inc. % Mr. Jay Y. Kogoma Responsible Third Party Official Intertek Testing Services 2307 E. Aurora Rd., Unit B7 TWINSBURG OH 44087 ·
FEB 1 9 2009
Re: K090296
Trade/Device Name: Atomlab 400 and Atomlab 500 Regulation Number: 21 CFR 892.1360 Regulation Name: Radionuclide dose calibrator Regulatory Class: II Product Code: KPT Dated: February 5, 2009 Received: February 6, 2009
Dear Mr. Kogoma:
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 unay, there interes market the device, subject to the general controls prossisions 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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; 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os 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 our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry.suppor/index.html.
Sincerely yours,
Janine M. Morris
anine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
| 510(k) Number (if known): | K090296 |
|---|---|
| --------------------------- | --------- |
Device Name:
Atomlab 400 Atomlab 500
Indications For Use:
The Atomlab dose calibrators are used in Nuclear Medicine Departments, clinics and nuclear pharmacies for calibrating radioactive doses for administration to patients.
The instrument is used to verify the radioactivity of a radionuclide before administration to the patient.
Prescription Use . X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
- (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANDRIGER.PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Torzal Martin
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
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