(83 days)
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Not Found
No
The summary describes a standard nuclear imaging system and does not mention any AI or ML components or capabilities.
No
The device is used to detect and image the distribution of a gamma-emitting radionuclide, which indicates a diagnostic function rather than therapeutic.
Yes
The "Intended Use" clearly states the device is to "detect and image the distribution of the gamma emitting radionuclide in the patient's breast and the surrounding area," which is a process used to gather information for diagnosis.
No
The device description explicitly mentions "two rectangular fields of view detector heads," which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body. They are used to detect diseases, conditions, or infections.
- Device Function: This device is described as a "nuclear imaging system" that "DETECTS AND IMAGES THE DISTRIBUTION of THE GAMMA EMITTING RADIONUCLIDE IN THE PATIENT 'S BREAST AND THE SURROUNDING AREA". This involves administering a substance into the patient's body and then using external equipment to image its distribution.
- Direct Patient Interaction: The device interacts directly with the patient's body to acquire images, rather than analyzing a sample taken from the patient.
Therefore, based on the provided information, this device falls under the category of medical imaging equipment used for in-vivo (within the living body) procedures, not in-vitro diagnostics.
N/A
Intended Use / Indications for Use
The intended use of BCC is to detect the location and distribution of gamma ray emitting radionuclides in the body and store the data for analysis. This device includes accessories such as signal analysis and display . equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.
Product codes
90 KPS
Device Description
The BCC nuclear imaging system has two rectangular fields of view detector heads.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Gamma Camera
Anatomical Site
Body, Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
NuCamma Bi90 camera
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.
0
JAN 2 8 2002
510(K) SUMMARY
SUBMITTER IDENTIFICATION
Applicant's Name and Street Address: IS2 Research Inc. 20 Gurdwara Road, Units 3 - 6, Nepean, Ontario, Canada K2E 8B3
Contact Person: Victor Woodburn, Manager Quality and Regulatory
T - (613) 228-8755, F - (613) 228-8228 Telephone and Fax Numbers of Contact Person:
same as Applicant's address above Address of Manufacturing Site:
October 2001 Date of Submission:
DEVICE NAME
Device Name (common): Gamma Camera Proprietary Name: BCC Planar Scintillation Camera Imaging Classification Name:
INTRODUCTION
This 510(k) Premarket Notification has been prepared to demonstrate that the BCC, manufactured by IS2 Research Inc., is substantially equivalent to the NuCamma Bi90 camera, which has previously, underwent the 510(k) premarket notification process. The BCC nuclear imaging system has two rectangular fields of view detector heads.
INTENDED USE
The intended use of BCC is to detect the location and distribution of gamma ray emitting radionuclides in the body and store the data for analysis. This device includes accessories such as signal analysis and display . equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.
DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The intended use of the BCC is a reduced range of studies of NuCamma Bi90 can perform the identical studies to the BCC. The detector heads are identical in hardware and software. The ganty of the BCC is optimized for clinical study of the breast and does not have the range of automatic motions of the NuCamma Bi90
The BCC has been deemed safe and effective and is certified to the same electrical safety standards as the predicate device by a third party organization prior to use on patients. A matrix was constructed comparing the features and intended use of the BCC with the predicate device. We conclude that the BCC is substantially equivalent to the predicate device and that no new safety or effectiveness concerns are raised.
1
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. The central image is a stylized eagle with three horizontal lines above it, representing the three branches of government.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 8 2002
Mr. Victor Woodburn Manager, Quality and Regulatory IS4 Research Inc. 20 Gurdwara Road, Bays 3-6 Nepean, Ontario, Canada K2E 8B3
Re: K013667
Trade/Device Name: Breast Cancer Camera (BCC) Regulation Number: 21 CFR 892.1100 Regulation Name: Scintillation (gamma) camera Regulatory Class: I Product Code: 90 KPS Dated: October 31, 2001 Received: November 6, 2001
Dear Mr. Woodburn:
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 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 (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.
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.
2
This letter will allow you to begin marketing your device as described in your 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 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:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.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
3
Page _ of _
510(k) Number (if known):_KQ13 667
CANERA Device Name: BREAST CANCER
Indications for Use:
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IMAGES
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEBDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Seymann
(Division Sign-Off) Division of Reproductive, Abdom and Radiological Device 510(k) Number
Prescription Use √
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formal 1-2-96)