ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336

K090296 · Biodex Medical Systems, Inc. · KPT · Feb 19, 2009 · Radiology

Device Facts

• Record ID: K090296
• Device Name: ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336
• Applicant: Biodex Medical Systems, Inc.
• Product Code: KPT · Radiology
• Decision Date: Feb 19, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1360
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

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.

Device Story

Atomlab 400 and 500 are radionuclide dose calibrators; used in nuclear medicine departments, clinics, and pharmacies. Device consists of a display unit and argon gas-filled pressurized ionization chamber detector. Input: radioactive samples; device measures radioactivity levels. Operation: chamber detects radiation; display unit processes signal to verify dose accuracy before patient administration. Calibration data stored within chamber unit, allowing interchangeability between displays. Used by nuclear medicine technologists or pharmacists to ensure correct dosage. Benefits: ensures patient safety by verifying radioactivity levels prior to administration.

Clinical Evidence

Bench testing only. Physicists at Northwestern Memorial Hospital and Stony Brook University Hospital verified device accuracy, linearity, constancy, and geometry performance metrics.

Technological Characteristics

Argon gas-filled pressurized ionization chamber detector; display unit; interchangeable chamber-display architecture with calibration data stored in chamber. Complies with UL60601-1, CAN/CSA C22.2 No. 601-1-1, IEC 60601-1, IEC 60601-1-4, IEC 60601-1-2, IEC 1303, and IEC 61145.

Indications for Use

Indicated for use in nuclear medicine departments, clinics, and pharmacies to calibrate and verify radioactivity of radionuclides prior to patient administration.

Regulatory Classification

Identification

A radionuclide dose calibrator is a radiation detection device intended to assay radionuclides before their administration to patients.

Predicate Devices

• Atomlab 100 (K884312/A)
• Atomlab 200 (K884312/A)
• Capinter 25 (K071396)

Submission Summary (Full Text)

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K090296

#### 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: [phone] ext. 2343 Fax: [phone] Email: [e-mail]

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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) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

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 [phone] or [phone] 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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