(84 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other information suggesting the use of AI/ML.
No
The device is described as an "imaging tool" for "evaluation of human tissue microstructure" and provides "cross sectional, real-time depth visualization," which are diagnostic functions, not therapeutic.
Yes
The device is indicated as an "imaging tool in the evaluation of human tissue microstructure," which aims to provide information for diagnosis or assessment of medical conditions.
No
The device description explicitly states it is comprised of a console, catheter, and inflation accessory kit, which are hardware components.
Based on the provided information, the Nvision VLE Imaging System is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is described as "an imaging tool in the evaluation of human tissue microstructure by providing two-dimensional, cross sectional, real-time depth visualization." This describes a device that directly images tissue within the body (in vivo), not a device that analyzes samples outside the body (in vitro).
- Device Description: The components listed (Console, Catheter, Inflation Accessory Kit) are consistent with an imaging system used for internal examination.
- Input Imaging Modality: Optical Coherence Tomography (OCT) and Optical Frequency Domain Imaging (OFDI) are imaging techniques used to visualize structures within living tissue.
- Anatomical Site: The device is used on "human tissue," which further supports its use within the body.
IVDs are typically used to examine samples such as blood, urine, tissue biopsies, etc., outside of the living organism to diagnose diseases or conditions. The Nvision VLE Imaging System's function is to provide real-time visualization of tissue structure in situ.
N/A
Intended Use / Indications for Use
The Nvision VLE Imaging System is indicated for use as an imaging tool in the evaluation of human tissue microstructure by providing two-dimensional, cross- sectional, real-time depth visualization.
Product codes (comma separated list FDA assigned to the subject device)
NQQ
Device Description
The NinePoint Medical Nvision VLE Imaging System is a general imaging system comprised of the Nvision VLE Console, Nvision VLE Catheter and the Nvision VLE Inflation Accessory Kit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Coherence Tomography (OCT), Optical Frequency Domain Imaging (OFDI)
Anatomical Site
human tissue microstructure
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)
In-vitro and clinical testing have been performed and all components, subassemblies and/or full devices and systems have met the required specifications for the completed tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K033783, K042894, K041077, K102599
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
DEC 1 6 2011
Image /page/0/Picture/2 description: The image shows the logo for NinePoint Medical. The logo consists of the word "NinePoint" in a large, bold font, with the word "MEDICAL" in a smaller font underneath. Above the word "NinePoint" is a circle made up of small dots. The logo is simple and professional, and the use of the circle of dots adds a touch of visual interest.
One Kendall Square, Suite B7501 Cambridge, Massachusetts 02139 ninepointmedical.com
510(k) Summary
- Basic Information-Submitter:
| 510(k) Owner: | NinePoint Medical Inc. |
|---|---|
| Address: | One Kendall Square, Suite B7501 |
| Cambridge, MA 02139 | |
| (617) 250-7190 (main number) | |
| (617) 250-7199 (fax) | |
| Official Contact: | Cindy Domecus, R.A.C. (US & EU) |
| Principal, Domecus Consulting Services LLC | |
| Consultant to NinePoint Medical, Inc. | |
| (650) 343-4813 | |
| (650) 343-7822 (fax) | |
| DomecusConsulting@comcast.net |
Date Summary Prepared: 21 September 2011
-
- Device Name:
Trade Name: Nvision VLE Imaging System (OCT) Common Name: Optical Coherence Tomography Imaging System/Optical Frequency Domain Imaging Classification Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1560 Product Code: NQQ Classification: Class II
- Device Name:
Premarket Notification, Nvision VLE Imaging System Proprietary and Confidential Information of NinePoint Medical Inc.
1
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Image /page/1/Picture/1 description: The image shows the logo for NinePoint Medical. The logo features the word "NinePoint" in a bold, sans-serif font, with the word "MEDICAL" in a smaller font below it. Above the word "NinePoint" is a circular design made up of nine dots. The dots are evenly spaced around the circle.
One Kendall Square, Suite B7501 ambridge. Massachusetts 02139 nine point medical. com
-
- Device Description:
The NinePoint Medical Nvision VLE Imaging System is a general imaging system comprised of the Nvision VLE Console, Nvision VLE Catheter and the Nvision VLE Inflation Accessory Kit.
- Device Description:
-
- Indications for Use Statement:
The Nvision VLE Imaging System is indicated for use as an imaging tool in the evaluation of human tissue microstructure by providing two-dimensional, cross- sectional, real-time depth visualization.
- Indications for Use Statement:
-
- Technological Characteristics:
Optical coherence tomography (OCT) is an imaging technique analogous to ultrasound; however, instead of producing an image from the scattering of sound waves, it utilizes optical scattering based on differences in tissue composition to form two-dimensional images. OCT systems use the principles of low coherence interferometry to generate high-resolution images of tissue microstructures. Interferometry and OCT enable the measurement of the optical back-reflected signals, and therefore the morphology of the internal microstructures can be determined by the back-reflected signal from the different depths of the tissue.
- Technological Characteristics:
All of the predicate OCT systems employ low coherence interferometry as the basis of the system. The systems use broadband optical sources with either superluminescent diodes or swept sources, high dynamic range detection and either fixed or scanning reference arms. The scanned reference arms were utilized in the Imalux, time domain OCT systems, while the advent of fixed reference arm and swept source OCT technology (Tomophase and NinePoint Medical) has permitted high speed and high sensitivity image capability. The Tomophase predicate device (K102599) and the Nvision VLE Imaging System use a derivative of OCT utilizing swept source technology, referred to as SS-OCT or optical frequency domain imaging, OFDI. OFDI is a derivative
Premarket Notification, Nvision VLE Imaging System Proprietary and Confidential Information of NinePoint Medical Inc.
2
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Image /page/2/Picture/1 description: The image shows the logo for NinePoint Medical. Above the word "NinePoint" is a circle made of nine dots. Below the word "NinePoint" is the word "MEDICAL" in smaller, capitalized letters.
One Kendall Square, Suite B7501 Cambridge, Massachusetts 02139 ninepointmedical.com
development of the time-domain OCT imaging modality, which enables high speed, two-dimensional, cross-sectional, real-time imaging.
7. Performance data:
The NinePoint Medical Nvision VLE Imaging System will be tested against and comply with the following voluntary standards:
IEC 60601-1, General Safety IEC 60601-1-2, Electromagnetic Compatibility IEC 60601-1-4, Programmable Electrical Medical Systems IEC 60601-2-18, Endoscope IEC 60601-2-22, Laser Safety IEC 60825-1, Laser Safety ISO 10993-1, Biological Evaluation of Medical Devices ISO 10993-7, Biological Evaluation of Medical Devices, Ethylene Oxide Sterilization residual testing
ISO 11135-1, Sterilization of Health Care Products, Ethylene Oxide
In-vitro and clinical testing have been performed and all components, subassemblies and/or full devices and systems have met the required specifications for the completed tests.
- 510(k) Summary:
NinePoint Medical Inc. has demonstrated that the Nvision VLE Imaging System is substantially equivalent to the predicate devices listed above.
3
Image /page/3/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged around the circumference of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC 1 6 2011
NinePoint Medical, Inc. % Domecus Consulting Services, LLC Ms. Cindy Domecus 1171 Barroihet Avenue Hillsborough, California 94010
Re: K112770
Trade/Device Name: Nvision VLE Imaging System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: NOO Dated: December 09, 2011 Received: December 12, 2011
Dear Ms. Domecus:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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
4
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours, Mark N. Melkerso Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
5
112770
Section 5 Indications for Use Statement
510(k) Number (if known):
K112770 This application
Device Name:
Indications for Use:
Nvision VLE Imaging System
The Nvision VLE Imaging System is indicated for use as an imaging tool in the evaluation of human tissue microstructure by providing twodimensional, cross sectional, real-time depth visualization.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
(21CFR 807
Nil RPOglen
for mxm |
|--------------------------------------------------------|---------------------------------------------------------------------------------|
| (Division Sign-Off) | |
| Division of Surgical, Orthopedic, | |
| and Restorative Devices | |
510(k) Number_ Premarket Notification, Nvision VLE Imaging System Proprietary and Confidential Information of NinePoint Medical Inc.