(49 days)
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No
The document describes a radionuclide dose calibrator and does not mention any AI or ML capabilities.
No.
The device is a radionuclide dose calibrator used to measure radioactivity, not to provide therapy or treatment to a patient. Its function is to quantify radioactivity in samples before administration to patients.
No.
The device is a dose calibrator used to measure radioactivity of radiopharmaceuticals before administration to patients, not to diagnose medical conditions in patients. The text indicates its use in "PET diagnostics" but this refers to the type of radiopharmaceutical it measures, not its function as a diagnostic tool itself.
No
The description explicitly states the device is a "radionuclide dose calibrator designed to measure the amount of radioactivity," which implies a physical device with sensors and measurement capabilities, not solely software.
Based on the provided information, the PET-Dose device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves analyzing biological samples like blood, urine, tissue, etc.
- PET-Dose Function: The PET-Dose device measures the radioactivity of radiopharmaceuticals before they are administered to patients. It's used to ensure the correct dose is being prepared for injection or administration. It does not analyze biological specimens from the patient.
- Intended Use: The intended use clearly states it's for measuring radioactivity in vials, syringes, and capsules before administration. This is a quality control and preparation step, not a diagnostic test performed on a patient sample.
Therefore, the PET-Dose falls under the category of a medical device used in the preparation and handling of radiopharmaceuticals for in-vivo diagnostic or therapeutic procedures, but it is not an IVD itself.
N/A
Intended Use / Indications for Use
PET-Dose is a radionuclide dose calibrator designed to measure the amount of radioactity i Dr Dose is a racience and in any other user-defined geometry samples. It is intended to assay nr vials, syringos, and maily onlinistration to patients, by measuring the residual of radiopharmaceutical in vials, the activity of the injectable in syringes, the activity of capsules before they are administered to patients, etc. The best applications of PET-Dose are activity measurements of beta emitters used in PET diagnostics such as. 18F, 12N, 150, etc.
Product codes
90 KPT
Device Description
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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
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Indicated Patient Age Range
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Intended User / Care Setting
PET-Dose is best fitted for use in nuclear medicine departments and, particularly, in PET centers.
The PET-Dose is intended to be used by trained medical physicist or qualified experts or nuclear medicine technicians to perform activity measurements in the nuclear medicine departments and, particularly, in PET centers.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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
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§ 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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains 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.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 2 2004
COMECER S.r.l. ,% Mr. N. E. Devine, Jr. Responsible Third Party Official Entela, Inc. 3033 Madison Ave. SE GRAND RAPIDS MI 49548
Re: K042746 Trade/Device Name: PET-Dose
Regulation Number: 21 CFR 892.1360 Regulation Name: Radionuclide dose calibrator
Regulatory Class: II Product Code: 90 KPT Dated: November 11, 2004 Received: November 12, 2004
. Dear Mr. Devine:
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 reasy by 17 is, 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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.
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.
1
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 premarket nedicate 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 11 you atte Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/dsmaldsmamain.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K 042746
Device Name: PET-Dose
Indications for Use:
PET-Dose is a radionuclide dose calibrator designed to measure the amount of radioactity i Dr Dose is a racience and in any other user-defined geometry samples. It is intended to assay nr vials, syringos, and maily onlinistration to patients, by measuring the residual of radiopharmaceutical in vials, the activity of the injectable in syringes, the activity of capsules before they are administered to patients, etc. The best applications of PET-Dose are activity measurements of beta emitters used in PET diagnostics such as. 18F, 12N, 150, etc.
PET-Dose is best fitted for use in nuclear medicine departments and, particularly, in PET centers.
The PET-Dose is intended to be used by trained medical physicist or qualified experts or nuclear medicine technicians to perform activity measurements in the nuclear medicine departments and, particularly, in PET centers.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over the Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NIEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Gordon
(Division (Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K042746