(95 days)
The Stereo Navigator Accessory is an optional accessory to the PEM Flex® PET Scanner. It is intended for the localization of lesions in female breasts, as identified on a PET image. By using the Stereo Navigator, the physician is able to guide compatible interventional devices towards the PET abnormality as medically indicated. The Stereo Navigator also provides a means to confirm localization of the lesion in advance of the interventional procedure.
The Stereo Navigator determines the three dimensional coordinates of a userdefined target for an imaged abnormality (e.g. lesion) displayed on the PEM Flex PET Scanner. Since PEM Flex tomographic images are displayed as a series of 2D planar slices, the user must define a target on two orthogonal images to define all three axis coordinates of the target location. These coordinates are processed into stereotactic information by the Stereo Navigator software which is used by the healthcare provider to position a stereotactic frame for guiding the trajectory of an interventional device and for determining the depth to which the interventional device should be inserted along the trajectory.
Additionally, the Stereo Navigator provides a means for the user to confirm that localization has been achieved during the interventional procedure and prior to sampling or marking. This is accomplished by placing an encapsulated positronemitting line source (radioactive line source) through the tissue access port (cannula) of the interventional device to the intended sampling or marking site, acquiring an image and comparing the location of the line source relative to the lesion (in at least two orthogonal image planes).
This 510(k) summary for the Naviscan Stereo Navigator Accessory (K082354) provides a high-level overview of the device and its claimed substantial equivalence. However, it does not detail specific acceptance criteria or a comprehensive study demonstrating direct adherence to such criteria. Instead, it relies on demonstrating substantial equivalence to predicate devices based on intended uses, technological characteristics, principles of operation, and overall safety and effectiveness, supported by preclinical (phantom) and confirmatory clinical studies.
Therefore, a direct table of acceptance criteria vs. device performance as would be expected for a specific performance study is not available in the provided text. The information below is extracted from the provided text, and where specific details are not present, this is noted.
1. Table of Acceptance Criteria and Reported Device Performance
As specific, quantitative acceptance criteria and corresponding reported performance metrics are not explicitly stated in the 510(k) summary, the table below reflects the general claims of the device and the nature of the studies conducted. The document focuses on demonstrating substantially equivalent performance rather than meeting predefined numerical acceptance thresholds directly.
| Acceptance Criterion (Implied/General) | Reported Device Performance (as stated or implied in the 510(k)) |
|---|---|
| Accuracy of Lesion Localization (for guiding interventional devices) | "The Stereo Navigator determines the three dimensional coordinates of a user defined target for an imaged abnormality... These coordinates are processed into stereotactic information by the Stereo Navigator software which is used by the healthcare provider to position a stereotactic frame for guiding the trajectory of an interventional device and for determining the depth to which the interventional device should be inserted along the trajectory." (Implies sufficient accuracy for intended use). "Preclinical (phantom) studies" were conducted. These studies "demonstrated that the device is substantially equivalent to the predicates with respect to safety and effectiveness." |
| Confirmation of Localization (prior to sampling/marking) | "The Stereo Navigator provides a means for the user to confirm that localization has been achieved during the interventional procedure and prior to sampling or marking. This is accomplished by placing an encapsulated positron-emitting line source... acquiring an image and comparing the location of the line source relative to the lesion (in at least two orthogonal image planes)." (Implies functionality and ability to confirm). "Confirmations clinical studies" were conducted. These studies "demonstrated that the device is substantially equivalent to the predicates with respect to safety and effectiveness." |
| Safety and Effectiveness (general performance relative to predicates) | "The Stereo Navigator was subject to preclinical (phantom) studies and confirmatory clinical studies. These studies demonstrated that the device is substantially equivalent to the predicates with respect to safety and effectiveness." "The Stereo Navigator is as safe and effective as the [Predicate Devices]... The minor technological differences between the Stereo Navigator and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Stereo Navigator is as safe and effective as the Predicate Devices." |
| Compatibility with PEM Flex® PET Scanner | "The Stereo Navigator Accessory is an optional accessory to the PEM Flex® PET Scanner." |
| Localization of Lesions in Female Breasts from PET Images (intended use) | "It is intended for the localization of lesions in female breasts, as identified on a PET image." Demonstrated implicitly through the "confirmatory clinical studies" in the context of its intended use. |
The provided 510(k) summary does not include the following details for a thorough acceptance criteria and study description:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not specified. The document mentions "confirmatory clinical studies" but does not provide details on sample size for the test set, country of origin, or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable/Not specified. This device is described as an accessory for stereotactic guidance, not an AI software intended to improve human reader performance in image interpretation. The focus is on its ability to localize physical coordinates.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Partially applicable. The device's function to "determine the three dimensional coordinates of a user-defined target" and process them into stereotactic info by the software is a standalone algorithmic function. However, the overall system is human-in-the-loop, as the user defines the target and utilizes the output for guidance. The "preclinical (phantom) studies" would likely assess the standalone accuracy of the measurement and calculation aspect.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For "preclinical (phantom) studies": Physical ground truth from a phantom, likely measured precisely.
- For "confirmatory clinical studies": Not explicitly stated, but for lesion localization, ground truth could involve surgical pathology, follow-up imaging, or other established clinical methods for confirming lesion presence and location.
8. The sample size for the training set
- Not specified. This device is a localization system, not a machine learning algorithm in the typical sense that requires a training set for model development (though software development would involve internal testing).
9. How the ground truth for the training set was established
- Not specified/Not applicable in the context of machine learning training, as it's not described as an AI/ML device that learns from a training set. If 'training set' refers to internal development data for the software, the ground truth would typically be established through engineering specifications and precision measurement techniques.
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NOV 1 8 2008
Image /page/0/Picture/2 description: The image shows the word "NAVISCAN" in a bold, sans-serif font. There is a curved line above the word that starts from the left and extends over the "N". The letters are all capitalized and evenly spaced. The overall design is simple and modern.
Naviscan, Inc. 11180 Roselle Street, Suite 100 San Diego, CA 92121 +1.858.587.3641 Direct +1.858.587.2596 Fax www.naviscan.com
510(k) SUMMARY
As required by section 807.92(c)
Naviscan, Inc.'s Stereotactic Navigation Accessory
Stereo Navigator Accessory for the PEM Flex® PET Scanner
| Company Name: | Naviscan, Inc. |
|---|---|
| Address: | 11180 Roselle Street, Suite 100 |
| San Diego, CA 92121 | |
| Contact Person: | Heather Jalisi |
| Phone: | 858.332.0942 |
| Fax: | 858.857.2596 |
| Date Prepared: | August 12, 2008 |
| Trade name: | Stereo Navigator Accessory for the PEM Flex® PET Scanner |
| Classification Name: | Accessory to Emission Computed Tomography System |
| 21 CFR 892.1200, Product Code 90-KPS, Device Class II | |
| Predicate Devices: | Stereotactic Localization Device (SLD), Philips Medical Systems |
| Confirma Breast MRI Interventional Components, Confirma, Inc | |
| SureLoc® CADstream 4.0 System, Confirma, Inc. |
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Intended Use / Indications for Use:
The Stereo Navigator Accessory is an optional accessory to the PEM FIcx® PET Scanner. It is intended for the localization of lesions in female breasts, as identified on a PET image. By using the Stereo Navigator, the physician is able to guide compatible interventional devices towards the PET abnormality as medically indicated. The Stereo Navigator also provides a means to confirm localization of the lesion in advance of the interventional procedure.
Technological Characteristics:
The Stereo Navigator determines the three dimensional coordinates of a userdefined target for an imaged abnormality (e.g. lesion) displayed on the PEM Flex PET Scanner. Since PEM Flex tomographic images are displayed as a series of 2D planar slices, the user must define a target on two orthogonal images to define all three axis coordinates of the target location. These coordinates are processed into stereotactic information by the Stereo Navigator software which is used by the healthcare provider to position a stereotactic frame for guiding the trajectory of an interventional device and for determining the depth to which the interventional device should be inserted along the trajectory.
Additionally, the Stereo Navigator provides a means for the user to confirm that localization has been achieved during the interventional procedure and prior to sampling or marking. This is accomplished by placing an encapsulated positronemitting line source (radioactive line source) through the tissue access port (cannula) of the interventional device to the intended sampling or marking site,
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510(k) Summary, Stereo Navigator Accessory
acquiring an image and comparing the location of the line source relative to the lesion (in at least two orthogonal image planes).
Performance Data:
The Stereo Navigator was subject to preclinical (phantom) studies and confirmatory clinical studies. These studies demonstrated that the device is substantially equivalent to the predicates with respect to safety and effectiveness. Substantial Equivalence:
The Stereo Navigator is as safe and effective as the 1) Stereotactic Localization Device (SLD), 2) Confirma Breast MRI Interventional Components, and 3) SureLoc® CADstream 4.0 System, ("Predicate Devices"). The Stereo Navigator has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the Stereo Navigator and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Stereo Navigator is as safe and effective as the Predicate Devices. Thus, the Stereo Navigator is substantially equivalent.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 8 2008
Ms. Heather Jalisi Director, Quality and Regulatory Naviscan, Inc. 11180 Roselle Street, Suite 100 SAN DIEGO CA 92121
Re: K082354
Trade/Device Name: Stereo Navigator Accossory for the PEM Flex® PET Scanner Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: August 12, 2008 Received: August 26, 2008
Dear Ms. Jalisi:
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.
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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.
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 this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
loque M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): Kod 2354
Device Name: Stereo Navigator Accessory for the PFM Flex® PET Scanner
Indications for Use:
The Stereo Navigator Accessory is an optional accessory to the PEM Flex® PET Scanner. It is intended for the localization of lesions in female breasts, as identified on a PET image. By using the Stereo Navigator, the physician is able to guide compatible interventional devices towards the PFT abnormality as medically indicated. The Stereo Navigator also provides a means to confirm localization of the lesion in advance of the interventional procedure.
Prescription Use ______________ AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
ર-Σ
§ 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.