(90 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the description focuses on quantitative analysis of physician-identified nodules using image processing, which is a common function in medical imaging software that doesn't necessarily involve AI/ML.
No
The device is described as a "diagnostic patient-imaging tool" intended to "provide quantitative information about lung nodules" from CT images, which clearly indicates it is for diagnosis and not therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended for use as a diagnostic patient-imaging tool."
Unknown
The provided text does not explicitly state whether the device is software-only. While it describes a "Lung Nodule Assessment and Comparison Option" used within a CT workstation, it doesn't clarify if this option is purely software or includes dedicated hardware components. The "Device Description" section is also missing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "diagnostic patient-imaging tool" that provides quantitative information about lung nodules identified on CT images. This involves analyzing medical images of the patient's body, not analyzing samples taken from the patient (like blood, urine, or tissue).
- Device Description (or lack thereof): While the description is "Not Found," the context of its use within a "Computed Tomography X-Ray System" strongly indicates it's part of an imaging system, not a laboratory testing device.
- Input Imaging Modality: The input is from a "Computed Tomography X-Ray System," which is an imaging modality, not a method for analyzing biological samples.
- Anatomical Site: The focus is on the "lungs," which are an organ within the body, not a sample taken from the body.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates on images of the body itself.
N/A
Intended Use / Indications for Use
The Lung Nodule Assessment and Comparison Option is intended for use as a diagnostic patient-imaging tool. It is intended to provide quantitative information about "physician- 1 wou nTEO" identified" lung nodules that are identified on high-resolution computed tomography images of the lung.
The Lung Nodule Assessment and Comparison Option is used in a workstation (Mx View) of a Computed Tomography X-Ray System intended to produce crosssectional images of the lungs by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
Product codes
90JAK
Device Description
Not Found
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography
Anatomical Site
lung
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professionals
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)
Reference Device(s)
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
§ 892.1750 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
FEB 1 0 2003
K023785 Lung Nodule Assessment and Comparison Option
The following information is being supplied in accordance with 21CFR 807.92(a).
1. Submitter
| Submitter: | Philips Medical Systems (Cleveland), Inc.
595 Miner Road
Highland Heights, OH 44143
(440) 483-3000 | | |
|------------------|-------------------------------------------------------------------------------------------------------------|--------------|--|
| Contact | Robert L. Turocy
Philips Medical Systems (Cleveland), Inc.
595 Miner Road | | |
| | Highland Heights, OH 44143 | | |
| | Telephone: | 440 483 3528 | |
| | FAX: | 440 483 2976 | |
| Date of Summary: | November 6, 2002 | | |
2. Device Name
| (Proprietary Name): | Lung Nodule Assessment and Comparison Option |
|---|---|
| Classification Name: | Computed Tomography X-Ray System |
| Common Name: | Computed Tomography X-Ray System |
The FDA has classified the Lung Nodule Assessment and Comparison Option as Class II in 21 CFR 892.1750 (Product Code 90JAK)
3. Intended Use
The Lung Nodule Assessment and Comparison Option is intended for use as a diagnostic patient-imaging tool. It is intended to provide quantitative information about "physician- 1 wou nTEO" identified" lung nodules that are identified on high-resolution computed tomography images of the lung.
The Lung Nodule Assessment and Comparison Option is used in a workstation (Mx View) of a Computed Tomography X-Ray System intended to produce crosssectional images of the lungs by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles
1
4. Predicate Device
In the opinion of Philips Medical Systems (Cleveland) Inc., the Lung Nodule Assessment and Comparison Option is of comparable type and substantially equivalent to the legally marketed devices currently in commercial distribution, namely the Image Processing Function on the Select CT/SP in CDRH Document Control No K961464 and K012009. See Appendix "G", Equivalent Device Comparison Matrix. This opinion is based on the fact that comparing the Image Processing Function on the Select CT/SP with the Lung Nodule Assessment and Comparison Option reveals that the devices comply with the same or equivalent standards and have the same or equivalent intended uses.
Functional specifications and operator's instructions (preliminary) are included in the Appendixes "B" and "C".
5. Safety and Effectiveness
Philips Medical Systems, Inc. adheres to FDA GMPs, 21 CFR 1020.30-33, and voluntary standards for safety/effectiveness (UL 2601) all of which mandate that components are tested to minimize hazards (electrical, mechanical, and radiation). The Lung Nodule Assessment and Comparison Option is under the control of health care professionals who are trained and responsible for computed tomography examinations.
Philips has reviewed known information available and performed an investigation as to the causes of safety and effectiveness concerning the Lung Nodule Assessment and Comparison Option.
6. Substantial Equivalence Statement
The Lung Nodule Assessment and Comparison Option is substantially equivalent to legally marketed devices. The Lung Nodule Assessment and Comparison Option will be certified to comply with Federal Diagnostic X-Ray Performance Standards. Labeling (Product Specification and Operator's Manual) will be provided to the user of the equipment.
This opinion is based on the fact that comparing the Image Processing Function on the Select CT/SP and the Mx8000IDT to the Lung Nodule Assessment and Comparison Option reveals that the devices comply with the same or equivalent standards and have the same or equivalent intended uses.
The Lung Nodule Assessment and Comparison Option and the Image Processing Function on the Select CT/SP and Mx8000IDT CT Systems 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.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
FEB 1 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert L. Turocy Regulatory Affairs Manager Philips Medical Systems (Cleveland), Inc. 595 Miner Road HIGHLAND HEIGHTS OH 44143
Re: K023785
Trade/Device Name: Lung Nodule Assessment and Comparison Option Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: November 6, 2002
Received: November 12, 2002
Dear Mr. Turocy:
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
Page 2
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
4
Lung Nodule Assessment and Comparison Option Device Name:
The Philips Medical Systems MxView Lung Indications for Use: Nodule Assessment and Comparison Option is intended for use as a diagnostic patient-imaging tool. It is intended to provide quantitative information about physician-indicated lung nodules that are identified on high-resolution computed tomography images of the lung.
The Lung Nodule Assessment and Comparison Option is used in a workstation (MxView) of a Computed Tomography X-Ray System intended to produce cross-sectional images of the lungs by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
(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)
Nancy C. Beagdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices