(90 days)
No
The summary describes a standard gamma camera system for image acquisition and explicitly states that the acquisition is performed in the same manner as the predicate device, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is described as an "acquisition" system for Nuclear Medicine SPECT and Planar Gamma Camera images, and its purpose is to "acquire" gamma camera output data. It is for imaging and data acquisition, not for treating or diagnosing.
No
The device is described as an "acquisition" system for gamma camera images, rather than directly providing diagnostic interpretations. It is intended to acquire data, which is then used for imaging but not necessarily for direct diagnosis by the device itself.
No
The device description explicitly states that the APEX XL-4 is a "Gamma Camera - SPECT Imaging System" and mentions "detector electronics, mechanical components, software, and the manufacturing specifications," indicating it includes hardware components in addition to software.
Based on the provided information, the Apex XL-4 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "acquisition of Nuclear Medicine SPECT and Planar Gamma Camera images." This describes a device that captures images from a patient after they have been administered a radioactive tracer.
- Device Description: The description confirms it's a "Gamma Camera - SPECT Imaging System" and its function is to "acquire nuclear medicine gamma camera output data."
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a person's health. The Apex XL-4 operates in vivo (within the living body) by detecting radiation emitted from the patient.
Therefore, the Apex XL-4 is a medical imaging device used for nuclear medicine procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the APEX XL-4 is to acquire nuclear medicine gamma camera output data for previously-approved Elscint APEX Gamma Camera systems. This acquisition is performed in the same manner as the corresponding components of the equivalent device, K021823.
The Apex XL-4 is intended for use as an acquisition of Nuclear Medicine SPECT and Planar Gamma Camera images.
Product codes (comma separated list FDA assigned to the subject device)
90KPS
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Nuclear Medicine SPECT and Planar Gamma Camera images
Anatomical Site
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The conclusion of tests performed and clinical images obtained demonstrate that the subject device (APEX XL-4) is as safe and effective as the legally marketed device (CardioSPECT SC).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Ko33001
Image /page/0/Picture/1 description: The image shows the word "Photon" in a stylized font. The "P" is large and ornate, with a small design to the left of it. The rest of the word is written in a cursive style, and there is a star-like symbol to the right of the word.
14350 S.W. 142nd Ave., Micomi, FI. 33186 Phone: 305-234-0836
SECTION G 510(K) SUMMARY
21CFR 807.92
1.0 Introduction
DEC 2 4.2003
This 510(k) Premarket Notification has been prepared to demonstrate that the APEX XL-4, manufactured by Photon2, is substantially equivalent to the NC Systems, Inc. CardioSPECT SC which has previously been reviewed and approved via the 510(k) premarket notification process (K021823).
Submitter Identification 2.0
- 2.1 Applicant Name & Address. Transphoton Corporation (dba Photon") 14350 S.W. 142nd Avenue Miami, FL 33186 Phone: 305-234-0836 305-234-2398 Fax:
2.2 Contact Person:
Scott Jennings IBIS, Inc. 37 Electric Avenue Lunenburg, MA 01462 Phone: 978-985-2532 978-582-4544 Fax:
- 2.3 Manufacturing Site: Mediso, Ltd. Alsotorokvesz 14 H-1022 Budapest, Hungary
- 2.4 Date of Submission: September 30, 2003
3.0 Device Identification
- 3.1 Device Proprietary Name: Photon2 APEX XL-4
3.2 Common Name: Gamma Camera - SPECT Imaging System
3.3 Classification Name Emission Computed Tomography System (ECT)
1
$\xi$Photon$^2$+
3.4 Classification Panel: Radiological
3.5 Regulatory Class Class II
3.6 Regulation Number: 21CFR 892.1200
3.7 Product Code: 90KPS
Identification of Equivalent Device 4.0
- 4.1 Predicate Device 510(k) Number: K021823
4.2 Predicate Device Identification:
Proprietary Name: NC Systems, Inc. CardioSPECT SC Device Name (common): Gamma Camera-SPECT Gamma Camera Classification Name: Emission Computed Tomography System (ECT) Regulation Number: 21CFR 892.1200 Regulatory Class: II Product Code: 90KPS
-
4.3 Predicate Device Description:
The predicate device, NC Systems, Inc. CardioSPECT SC, is a device with components that have substantially equivalent specifications, safety, effectiveness, and intended use as the Photon2 APEX XL-4: -
The CardioSPECT SC is a scintillation detector, NaI, system with . PMT light gathering capacity. The CardioSPECT SC has one detector both with the ability to rotate these detectors around the patient. The system uses a collimator on the detector to permit spatial image resolution of the gamma photons emitted from the patient. The collimators lock in place. There is no built-in radioactive scanning source and none is required. The CardioSPECT SC is capable of both Planar (Class I) and SPECT or ECT (Class II) operation. The acquisition/processing computer is an approved system sold and supported by NC Systems, Inc. but manufactured by Segami Corporation.
-
The detector electronics, mechanical components, software, and the . manufacturing specifications of the applicant system (the APEX XL-4) are substantially equivalent to the CardioSPECT SC, the legally marketed device.
-
Detailed specifications for the predicate device are provided in Section . く.
2
Image /page/2/Picture/0 description: The image shows the word "Photon" written in a stylized font. The "P" is large and ornate, with a floral design incorporated into its upper left portion. The rest of the word, "hoton", is written in a smaller, cursive font. There are also some small decorative elements to the right of the word.
Intended Use 5.0
The intended use of the APEX XL-4 is to acquire nuclear medicine gamma camera output data for previously-approved Elscint APEX Gamma Camera systems. This acquisition is performed in the same manner as the corresponding components of the equivalent device, K021823.
Determination of Substantial Equivalence 6.0
The APEX XL-4 Interface has been compared to the corresponding components of the legally marketed CardioSPECT SC System and been determined to be substantially equivalent:
- The intended use of the applicable components in the two devices is . identical.
- The specifications for each device are compared in Section C. .
- The labeling for each device are equivalent. Refer to Section D. .
- The conclusion of tests performed and clinical images obtained . demonstrate that the subject device (APEX XL-4) is as safe and effective as the legally marketed device (CardioSPECT SC). Refer to Section E.
Thus, we conclude that the APEX XL-4 is substantially equivalent to the predicate device and that no new safety or effectiveness concerns are raised.
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 4 2003
Transphoton Corporation % Mr. Scott Jennings IBIS, Inc. 37 Electric Avenue LUNENBURG MA 01462 Re: K033001 Trade/Device Name: APEX XL-4 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS Dated: September 24, 2003 Received: September 30, 2003
Dear Mr. Jennings:
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 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 (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.
4
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 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 the 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" (21CFR Part 807.97) you may obtain. 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
5
| Page | of |
|---|---|
| ------ | ---- |
| 510(k) Number (if known): | K 03 30 01 |
|---|---|
| Device Name: | APEX XL-4 |
Indications For Use:
The Apex XL-4 is intended for use as an acquisition of Nuclear Medicine SPECT and Planar Gamma Camera
images.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel R. Lyman
(Division Sign-510kl N
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Usc
(Optional Formal 1-2-96)