(29 days)
Not Found
No
The provided 510(k) summary does not mention AI, ML, deep learning, or any related terms in the device description, intended use, or performance studies. The focus is on the hardware and basic image acquisition capabilities.
No
The device is a diagnostic imaging system used to measure the distribution of radiopharmaceuticals for determining metabolic and physiologic functions, not for treating any medical condition.
Yes
The intended use explicitly states the purpose is "imaging and measuring the distribution of injected positron emitting radiopharmaceuticals in human beings for the purpose of determining various metabolic and physiologic functions within the human body," which is a diagnostic function.
No
The device description clearly outlines hardware components (partial-ring PET scanner, lutetium-containing gamma-ray detectors) and describes the physical process of collecting gamma rays. The performance studies also include testing for biocompatibility, electrical safety, and electromagnetic compatibility, which are relevant to hardware.
Based on the provided information, the Naviscan PEMFlex Solo II High Resolution PET Scanner 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 outside of the living body.
- Device Function: The description clearly states that the Solo II is a PET scanner that images and measures the distribution of injected radiopharmaceuticals within the human body. This is an in vivo (within the living body) imaging procedure, not an in vitro test.
- Intended Use: The intended use is to image and measure the distribution of radiopharmaceuticals in human beings for determining metabolic and physiologic functions. This is a diagnostic imaging purpose, not an in vitro diagnostic test.
Therefore, the Naviscan PEMFlex Solo II High Resolution PET Scanner falls under the category of medical imaging devices used for in vivo diagnosis, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Naviscan, Inc. PEMFlex Solo II High Resolution PET Scanner is intended for medical purposes to image and measure the distribution of injected positron emitting radiopharmaceuticals in human beings for the purpose of determining various metabolic and physiologic functions within the human body.
Product codes
KPS
Device Description
The Naviscan, Inc. (Naviscan) PEMFlex Solo II High Resolution PET Scanner (Solo II) is a high spatial resolution, small field-of-view PET imaging system specifically developed for close-range, spot, i.e. limited field, imaging. The Solo II is a partial-ring PET scanner, equipped with lutetium-containing gamma-ray detectors, which collects gamma rays emitted by injected positron-emitting radiopharmaceuticals, and generates images corresponding to concentration of these radiopharmaceuticals in the body. The Solo II is designed to collect gamma rays from a patient's body part with high efficiency. In order to achieve this high efficiency, the detectors should be positioned as close as possible to the body part under examination. Properly configured, the Solo II can display images obtained from other digital imaging modalities for correlative purposes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Positron Emission Tomography (PET)
Anatomical Site
human body / a patient's body part
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)
Biocompatibility: The patient contact material in the Solo II was tested for biocompatibility in accordance with applicable Standards. Test results indicated that the patient contact material in the Solo II complies with its predetermined specification and with the applicable Standards.
Electrical Safety: The Solo II was tested for patient safety in accordance with applicable Standards. Test results indicated that the Solo II complies with its predetermined specification and with the applicable Standards.
Electromagnetic Compatibility Testing: The Solo II was tested for EMC in accordance with applicable Standards. Test results indicated that the Solo II complies with its predetermined specification and with the applicable Standards.
Performance Testing: The Solo II was tested for performance in accordance with applicable Standards. Test results indicated that the Solo II complies with its predetermined specification and with the applicable Standards.
Software Testing: Software for the Solo II was designed and developed according to a robust software development process, and was rigorously verified and validated. Test results indicated that the Solo II complies with its predetermined specification.
Clinical Images: Three (3) clinical case images are provided from the Solo II to demonstrate the high resolution image capability of the Solo II. Image results indicated that the Solo II complies with its predetermined specification.
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
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
MAR 3 1 2009
510(k) Premarket Notification Naviscan, Inc. PEMFlex Solo II High Resolution PET Scanner 510(k) Summary
. .
,----
| Submission Date: | 27 February 2009 | |||
|---|---|---|---|---|
| Submitter: | Naviscan, Inc. | |||
| 6865 Flanders Drive, Suite B | ||||
| San Diego, CA 92121 USA | ||||
| Submitter Contact: | Ms. Heather Jalisi | |||
| Director, Quality and Regulatory Affairs | ||||
| 858 332 9042 | ||||
| hjalisi@naviscan.com | ||||
| Manufacturing Site: | Naviscan, Inc. | |||
| 6865 Flanders Drive, Suite B | ||||
| San Diego, CA 92121 USA | ||||
| Trade Name: | Naviscan, Inc. PEMFlex Solo II High Resolution PET Scanner | |||
| Common Name: | Positron Emission Tomography System | |||
| Classification Name: | System, Tomography, Computed, Emission | |||
| Classification | ||||
| Regulation: | 21 CFR §892.1200 | |||
| Product Code: | KPS | |||
| Substantially | ||||
| Equivalent Devices: | New Naviscan Model | Predicate | ||
| 510(k) Number | Predicate | |||
| Manufacturer / Model | ||||
| PEMFlex Solo II High | ||||
| Resolution PET Scanner | K032063 | Naviscan, Inc. PEM | ||
| 2400 PET Scanner |
Page 1 of 3 000C32
1
510(k) Premarket Notification Naviscan, Inc. PEMFlex Solo II High Resolution PET Scanner 510(k) Summary
ア
i
| Device Description: | The Naviscan, Inc. (Naviscan) PEMFlex Solo II High Resolution PET
Scanner (Solo II) is a high spatial resolution, small field-of-view PET
imaging system specifically developed for close-range, spot, i.e. limited
field, imaging. The Solo II is a partial-ring PET scanner, equipped with
lutetium-containing gamma-ray detectors, which collects gamma rays
emitted by injected positron-emitting radiopharmaceuticals, and
generates images corresponding to concentration of these
radiopharmaceuticals in the body. The Solo II is designed to collect
gamma rays from a patient's body part with high efficiency. In order to
achieve this high efficiency, the detectors should be positioned as close
as possible to the body part under examination. Properly configured, the
Solo II can display images obtained from other digital imaging
modalities for correlative purposes. | |
|-----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Intended Use: | The Naviscan, Inc. PEMFlex Solo II High Resolution PET Scanner is
intended for medical purposes to image and measure the distribution of
injected positron emitting radiopharmaceuticals in human beings for the
purpose of determining various metabolic and physiologic functions
within the human body. | |
| Technology
Comparison: | The Solo II employs the same technological characteristics as the
predicate devices to collect and generate radiological images. This
consists of lutetium-containing gamma-ray detectors that collect
gamma rays emitted by injected positron-emitting
radiopharmaceuticals, and generates images corresponding to
concentration of these radiopharmaceuticals in the body. | |
| Summary of Performance Testing: | | |
| Biocompatibility | The patient contact material in the Solo II was tested for
biocompatibility in accordance with applicable Standards. | |
| | Test results indicated that the patient contact material in the Solo II
complies with its predetermined specification and with the applicable
Standards. | |
| Electrical Safety | The Solo II was tested for patient safety in accordance with applicable
Standards. | |
| | Test results indicated that the Solo II complies with its predetermined
specification and with the applicable Standards. | |
| Electromagnetic
Compatibility
Testing | The Solo II was tested for EMC in accordance with applicable
Standards. | |
| Test results indicated that the Solo II complies with its predetermined
specification and with the applicable Standards. | | |
| Performance Testing | The Solo II was tested for performance in accordance with applicable
Standards. | |
| Test results indicated that the Solo II complies with its predetermined
specification and with the applicable Standards. | | |
| Software Testing | Software for the Solo II was designed and developed according to a
robust software development process, and was rigorously verified and
validated. | |
| Test results indicated that the Solo II complies with its predetermined
specification. | | |
| Clinical Images | Three (3) clinical case images are provided from the Solo II to
demonstrate the high resolution image capability of the Solo II. | |
| Image results indicated that the Solo II complies with its predetermined
specification. | | |
| Conclusion | Based upon a comparison of devices and performance testing results,
Solo II is substantially equivalent to the predicate device. | |
Page 2 of 3
2
510(k) Premarket Notification Naviscan, Inc. PEMFlex Solo II High Resolution PET Scanner 510(k) Summary
ﺬ
Page 3 of 3 000C34
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 1 2009
Ms. Heather Jalisi Director, Quality and Regulatory Affairs Naviscan, Inc. 6865 Flanders Drive, Suite B SAN DIEGO CA 92121
Re: K090553
Trade/Device Name: Naviscan PEMFlex Solo II High Resolution PET Scanner Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: February 27, 2009 Received: March 2, 2009.
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 devicecan 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.
4
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 os 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 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Manufactures, 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/cdrb/industry.suppot/index.html.
Sincerely yours,
Janine M. Morris
anine M. Morris Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Indications for Use
510(k) Number (if known):
090553 K
Device Name:
Indications for Use:
K 070553
Naviscan PEMFlex Solo II High Resolution PET Scanner
The Naviscan PEMFlex Solo II High Resolution PET Scanner is intended for medical purposes to image and measure the distribution of injected positron emitting radiopharmaceuticals in human beings for the purpose of determining various metabolic and physiologic functions within the human body.
Over-The-Counter Use
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hubluna
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Page 1 of 1 000025