(15 days)
No
The document describes a nuclear imaging system and its hardware and software components, focusing on mechanical movements, acquisition parameters, and standard image processing. There is no mention of AI or ML technologies.
No
The device is described as an "Imaging System" intended to "produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body". Its function is diagnostic, providing visual information, rather than therapeutic, which would involve treating a condition.
Yes
The "Intended Use / Indications for Use" states that the device is "intended to produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel." The act of interpreting these images to understand the anatomical distributions of radioisotopes in the body directly supports diagnosis. Additionally, the "Device Description" mentions various clinical studies like "bone statics and lung scan," "renal, gastric emptying, hepatobiliary, flow studies, GI bleed, thyroid," which are diagnostic procedures.
No
The device description explicitly details numerous hardware components including a gantry frame, detector arms, collimator storage structure, patient imaging table, and remote hand controller. While it includes software for acquisition and processing, it is an integral part of a larger hardware system.
Based on the provided information, the SK YLight Imaging System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel." This describes an in vivo imaging system, meaning it is used to image inside the living body.
- Device Description: The description details a nuclear imaging system with detectors, a gantry, a patient table, and software for acquiring and processing images of radioisotopes administered to a patient. This is consistent with a nuclear medicine imaging system used for in vivo studies.
- Input Imaging Modality: The input is "single photon and positron emitting radioisotopes," which are administered to the patient and then detected by the system. This is characteristic of nuclear medicine imaging, not in vitro testing.
- Anatomical Site: The imaging is performed "within the human body." IVD devices are used to test samples taken from the human body (e.g., blood, urine, tissue).
In Vitro Diagnostic devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease or injury. The SK YLight Imaging System operates by detecting radiation from radioisotopes within the patient's body, which is the definition of an in vivo imaging system.
N/A
Intended Use / Indications for Use
The SK YLight Imaging System is intended to produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.
Product codes
90 KPS
Device Description
The modified SKYLight Imaging System offers all the features of the existing SKYLight Imaging System (K000908) while adding an optional feature that provides the used option or ability to acquire a single head acquisition studies on two separate but simultaneous planar patients. The SKYLight is designed to provide extended imaging functionality relative to a ring style gantry. The SKYLight was designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography (ECT) studies. The device includes a gantry frame, two detector arms (with detectors), a collimator storage structure with an acquisition computer unit, a patient imaging table, and a remote hand controller. The modified SKYLight is capable of accommodating two separate patient tables. The gantry is "open" so that a high degree of imaging flexibility is available to image patients sitting, standing or lying down, with or without the included patient imaging table. The patient imaging tables are mechanized to allow for patient loading access and then raised to an imaging height. The tables do not move during imaging since the gantry is flexible enough to perform all required motions for noncircular orbits. The imaging pallet includes removable arm, leg, breast, and headrest supports for patient positioning during studies that require support.
SK YLight is an 'open frame' imaging system, the 'open frame' consisting of an overhead rectangular structure that is supported by 4 (or more) columns that are bolted to the imaging room floor. A detector arm support structure is mounted onto the open frame which allows for the detector arm support structure (and both detector arms) to move in the longitudinal motion (X-axis). Arms that can telescope up and down (Z-axis) support the detectors. These detector arms are supported by a structure that allows for each detector arm to move toward or away from each other (Y-axis). Each detector has the ability to rotate and acquire images independently The combination of these four motions (Z, Y, X, and detector rotate), permit the detectors to perform all standard non-circular and circular ECT studies in both the 90-degree and 180-degree relative position. The SkyLight uses the EPIC HP+ detectors. The detectors use standard EPIC collimators, or MCD shields, which may be exchanged using an automatic exchange unit.
The modified SKYLight acquisition computer uses the same acquisition software (subsystem) as existing SKYLight to acquire ECT imaging studies and interfaces with a Pegasys computer system (workstation). The acquisition CPU is used to install the camera software and to archive and restore acquisition parameters and correction tables. The acquisition software is used to complete pre-programmed gantry motions for setup of imaging studies and exchange of collimators; to perform quality assurance tests on the SK YLight system; and to program image parameters and gantry for clinical studies.
When using either a single detector or dual detectors placed in a relative 90-degree or relative 180-degree positions (as study appropriate), SKYLight can be used to perform static, dynamic, gated, total body, circular-orbit and non-circular orbit SPECT studies, coincidence studies, gated SPECT (circular and non-circular) studies, computerprogrammed protocol strings, and reference scans (dual detectors only). SPECT and total body acquisitions are routinely acquired with two detectors. There are some planar procedures such as bone statics and lung scan also use two detectors. There are many additional nuclear medicine procedures that only use one detector at a time. These single detector procedures are typically renal, gastric emptying, hepatobiliary, flow studies, GI bleed, thyroid, and delayed static views. This acquisition sub-system interfaces with a Pegasys computer system for entry into the database. The Pegasys workstation also includes software used for image processing, database utilities, and archiving utilities.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Emission Computed Tomography (ECT), SPECT
Anatomical Site
Within the human body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical personnel
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SKYLight Imaging System (K000908)
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
510(k) SUMMARY
| A. | Submitted By:
ADAC Laboratories
540 Alder Dr.
Milpitas, CA 95035 | Contact: David Kolesar
Tel: (408) 468-3455
Fax: (408) 468-3050 |
|----|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| B. | Device Trade Name:
Common Name:
Classification Name:
Device Class:
Product Code: | SKYLight Imaging System
Gamma Camera Systems
Emission Computed Tomography System
21 CFR 892.1200, Class II
90 KPS |
| C. | Date prepared: | September 28, 2001 |
| D. | Predicate Device: | SKYLight Imaging System (K000908) |
| E. | Intended Use: | |
The SK YLight Imaging System is intended to produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.
F. Device Description:
The modified SKYLight Imaging System offers all the features of the existing SKYLight Imaging System (K000908) while adding an optional feature that provides the used option or ability to acquire a single head acquisition studies on two separate but simultaneous planar patients. The SKYLight is designed to provide extended imaging functionality relative to a ring style gantry. The SKYLight was designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography (ECT) studies. The device includes a gantry frame, two detector arms (with detectors), a collimator storage structure with an acquisition computer unit, a patient imaging table, and a remote hand controller. The modified SKYLight is capable of accommodating two separate patient tables. The gantry is "open" so that a high degree of imaging flexibility is available to image patients sitting, standing or lying down, with or without the included patient imaging table. The patient imaging tables are mechanized to allow for patient loading access and then raised to an imaging height. The tables do not move during imaging since the gantry is flexible enough to perform all required motions for noncircular orbits. The imaging pallet includes removable arm, leg, breast, and headrest supports for patient positioning during studies that require support.
SK YLight is an 'open frame' imaging system, the 'open frame' consisting of an overhead rectangular structure that is supported by 4 (or more) columns that are bolted to the imaging room floor. A detector arm support structure is mounted onto the open frame which allows for the detector arm support structure (and both detector arms) to move in the longitudinal motion (X-axis). Arms that can telescope up and down (Z-axis) support the detectors. These detector arms are supported by a structure that allows for each detector
1
arm to move toward or away from each other (Y-axis). Each detector has the ability to rotate and acquire images independently
The combination of these four motions (Z, Y, X, and detector rotate), permit the detectors to perform all standard non-circular and circular ECT studies in both the 90-degree and 180-degree relative position. The SkyLight uses the EPIC HP+ detectors. The detectors use standard EPIC collimators, or MCD shields, which may be exchanged using an automatic exchange unit..
The modified SKYLight acquisition computer uses the same acquisition software (subsystem) as existing SKYLight to acquire ECT imaging studies and interfaces with a Pegasys computer system (workstation). The acquisition CPU is used to install the camera software and to archive and restore acquisition parameters and correction tables. The acquisition software is used to complete pre-programmed gantry motions for setup of imaging studies and exchange of collimators; to perform quality assurance tests on the SK YLight system; and to program image parameters and gantry for clinical studies.
When using either a single detector or dual detectors placed in a relative 90-degree or relative 180-degree positions (as study appropriate), SKYLight can be used to perform static, dynamic, gated, total body, circular-orbit and non-circular orbit SPECT studies, coincidence studies, gated SPECT (circular and non-circular) studies, computerprogrammed protocol strings, and reference scans (dual detectors only). SPECT and total body acquisitions are routinely acquired with two detectors. There are some planar procedures such as bone statics and lung scan also use two detectors. There are many additional nuclear medicine procedures that only use one detector at a time. These single detector procedures are typically renal, gastric emptying, hepatobiliary, flow studies, GI bleed, thyroid, and delayed static views. This acquisition sub-system interfaces with a Pegasys computer system for entry into the database. The Pegasys workstation also includes software used for image processing, database utilities, and archiving utilities.
G. Technological Comparison:
The modified SK YLight Imaging System and existing SKYLight Imaging System have identical intended use and indications for use. The modified SKYLight and the existing SKYLight are technologically identical. They share the identical mechanical and electrical components. No changes or modifications have been made to the mechanical or electrical components. All the features provided on the existing SKYLight are provided on the modified SKYLight. The only change has been to the acquisition software which provides the modified SKYLight Imaging System an optional feature that allows the user the to acquire a single head acquisition on two separate but simultaneous planar patients.
H. Conclusion
The modified SKYLight Imaging System is substantially equivalent to the predicate device SK YLight based upon identical indications for use, technological comparison and overall system performance.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three parallel lines that curve upwards and to the right, resembling a stylized bird or wing. The caduceus is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 6 2001
ADAC Laboratories % Michael Kwan, Ph.D. Underwriters Laboratories, Inc. 1655 Scott Boulevard SANTA CLARA CA 95050-4169 Re: K013496
Trade/Device Name: SKYLight Imaging System Gamma Camera System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS Dated: October 19, 2001 Received: October 22, 2001
Dear Dr. Kwan:
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.
3
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
4
NOV 0 6 2001 INDICATIONS FOR USE STATEMENT
KO13496 510 (k) NUMBER (IF KNOWN): _
DEVICE NAME:
SKYLight Imaging System
ADAC Laboratories SPONSOR NAME:
INDICATIONS FOR USE:
The SK Y Light Imaging System is intended to produce images depicting the anatomical I the UN I Light ining. Boton and positron emitting radioisotopes within the body for interpretation by medical personnel.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use_ (Optional Format 1-2-96)
David G. Syverson