(170 days)
Input does not contain "Predicate Device(s) K/DEN number".
Not Found
No
The summary describes a system for simulating and initiating interventional procedures using CT images and a stereotactic arm. There is no mention of AI, ML, deep learning, or any related concepts in the intended use, device description, or other sections. The software is described as providing interactive relation between image volume and target field, which is typical of image-guided intervention systems but does not inherently imply AI/ML.
No
The device is used for simulating and initiating interventional procedures and planning biopsies and drainage, which are diagnostic and procedural planning functions, not therapeutic applications.
No
The device is described as an accessory to a CT System for simulating and initiating interventional procedures, such as planning biopsies and fluid drainage, rather than for diagnosing medical conditions.
No
The device description explicitly states that the PinPoint accessory includes hardware components such as a stereotactic arm, flat panel monitor, cabling, and biopsy phantom, in addition to software.
Based on the provided information, the PinPoint device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- PinPoint's Function: The PinPoint is described as an accessory to a CT system used for simulating and initiating interventional procedures by relating CT images to the actual target field. It's a tool for planning and guiding procedures performed on the patient's body, not for analyzing samples from the patient's body.
- Lack of Sample Analysis: The description focuses on image processing, spatial guidance, and procedural planning. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
Therefore, the PinPoint falls under the category of a medical device used for image-guided intervention and planning, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PinPoint is an accessory to a CT System intended to provide the radiologist with a means of simulating and initiating interventional procedures by interactively relating the patient's CT image volume to the actual target field. This accessory includes mounting the stereotactic arm on a CT Gantry, a flat panel TV monitor, cabling, biopsy phantom, and software. In addition the CT is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angels. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
PinPoint is not limited to any particular region of the body. It is equally viable for planning head and spine interventions as it is in the abdomen. It is expected that its major use will be in the planning biopsies of abdominal organs and drainage of fluid collections in the abdomen. However, more complicated procedures such as Brachy therapy and bone pinnings will be planned using the PinPoint.
Product codes
90 JAK
Device Description
The PinPoint is an accessory to a CT System intended to provide the radiologist with a means of simulating and initiating interventional procedures by interactively relating the patient's CT image volume to the actual target field. This accessory includes mounting the stereotactic arm on a CT Gantry, a flat panel video monitor, cabling, biopsy phantom, and software. In addition the CT is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angels. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
CT (Computed Tomography)
Anatomical Site
Not limited to any particular region of the body, specifically mentioned head, spine, and abdomen (abdominal organs).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Health care professionals who are trained and responsible for computed tomography examinations.
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)
Effectiveness is established by Picker's evaluation throughout all phases of the PinPoint development. The product will perform in accordance with the development specifications. The PinPoint represents the current state-of-the-art technology, therefore, is equivalent to legally marketed devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Picker 510(k) Notice
MAY 20 1998
PinPoint
Summary of Safety and Effectiveness
This is a summary of the information submitted by Picker International, Inc. to the Office of Device Evaluation (ODE), specifically DRAERD of the FDA as required by the Federal Food, Drug, and Cosmetic Act as amended on November 18, 1990 in section 513(f)(3).
The PinPoint is an accessory to a CT System intended to provide the radiologist with a means of simulating and initiating interventional procedures by interactively relating the patient's CT image volume to the actual target field. This accessory includes mounting the stereotactic arm on a CT Gantry, a flat panel video monitor, cabling, biopsy phantom, and software. In addition the CT is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angels. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
Preliminary functional specifications and operator's instructions are included in the Attachments "B" and "C" respectively. Final documentation will be provided with production units.
The PinPoint is substantially equivalent to legally marketed devices and is under control of health care professionals who are trained and responsible for computed tomography examinations. Labeling (Product Specification and Operator's Manual) will be provided to the user of the equipment.
Picker adheres to FDA 21 CFR 820, 1020.30, and 33, and voluntary standards for safety and effectiveness (UL 187) all of which mandate that components are tested to minimize hazards (electrical, mechanical, and radiation). In addition, the system is designed to conform to IEC 601-1.
Effectiveness is established by Picker's evaluation throughout all phases of the PinPoint development. The product will perform in accordance with the development specifications. The PinPoint represents the current state-ofthe-art technology, therefore, is equivalent to legally marketed devices.
Picker has reviewed all known information and performed an investigation as to the causes of safety and effectiveness concerning the PinPoint. In addition, all information contained in this 510(k) Notice is accurate and complete.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re:
PinPoint CT Accessory Dated: April 3, 1998 Received: April 6, 1998 Regulatory Class: II 21 CFR 892.1750/Procode: 90 JAK
Dear Mr. Turocy:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of 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 (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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmam.html".
Sincerely yours,
Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Image /page/1/Picture/14 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine. The caduceus has a staff with two snakes coiled around it, and a pair of wings at the top.
MAY 2 0 1998
Robert L. Turocy
595 Miner Road
Picker International. Inc.
Cleveland, Ohio 44143
Regulatory Affairs and Compliance Manager
2
page 1 of 1
510(K) Number (if known): K97 45/3
Device Name: PinPoint
Indications for Use:
The PinPoint is an accessory to a CT System intended to provide the radiologist with a means of simulating and initiating interventional procedures by interactively relating the patient's CT image volume to the actual target field. This accessory includes mounting the stereotactic arm on a CT Gantry, a flat panel TV monitor, cabling, biopsy phantom, and software. In addition the CT is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angels. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
PinPoint is not limited to any particular region of the body. It is equally viable for planning head and spine interventions as it is in the abdomen. It is expected that its major use will be in the planning biopsies of abdominal organs and drainage of fluid collections in the abdomen. However, more complicated procedures such as Brachy therapy and bone pinnings will be planned using the PinPoint.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
David C. Ingram
Abdominal, EN Ivision of Reproducti and Radiological Dev
Radiographic
K974513
510(k) Number
Prescription Use
OR
Over-The Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)