(405 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on hardware components and imaging technology.
No.
The device is indicated for use as an imaging tool in the evaluation of human tissue microstructure and does not provide any therapeutic benefit or treatment.
Yes
The device is described as an "imaging tool in the evaluation of human tissue microstructure" and performs "two-dimensional, cross-sectional, real-time depth visualization." This functionality directly supports the assessment and interpretation of tissue characteristics, which is a core aspect of diagnosis.
No
The device description explicitly states it is comprised of a console, catheter, and inflation accessory kit, indicating it includes hardware components.
Based on the provided information, the Nvision VLE Imaging System is not an IVD (In Vitro Diagnostic).
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 used in vivo (within the living body) for imaging, not a device used in vitro (outside the body) to examine specimens like blood, urine, or tissue samples.
- Device Description: The description mentions a console, catheter, and inflation accessory kit. This aligns with an imaging system used internally, not a laboratory-based diagnostic device.
- Anatomical Site: The anatomical site is "human tissue microstructure, including esophageal tissue microstructure," which is an in vivo location.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or performing tests on specimens outside the body, which are hallmarks of IVD devices.
Therefore, the Nvision VLE Imaging System is an in vivo imaging device, not an in vitro diagnostic device.
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, including esophageal 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), SS-OCT or optical frequency domain imaging (OFDI)
Anatomical Site
human tissue microstructure, including esophageal 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.
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
Image /page/0/Picture/0 description: The image shows the logo for NinePoint Medical. Above the company name is a circle made of nine dots. The word "NinePoint" is in a large font, and the word "MEDICAL" is in a smaller font below it.
K 120 800
One Kendall Square, Suite B7501 Cambridge, Massachusetts 02139 ninepointmedical.com
510(k) Summary
APR 2 5 2013
-
- Basic Information-Submitter:
510(k) Owner:
- Basic Information-Submitter:
Address: '
NinePoint Medical Inc.
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:
March 15, 2012
-
- Device Name:
Trade Name: Nvision VLE Imaging System 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:
-
- Predicate Device: Nvision VLE Imaging System, K112770
-
- Device Description:
Premarket Notification, Nvision VLE Imaging System NinePoint Medical Inc.
1
Image /page/1/Picture/0 description: The image shows the logo for NinePoint Medical. The logo consists of the words "NinePoint" in a large, bold font, with the word "MEDICAL" in a smaller font below. Above the word "NinePoint" is a circle made up of nine small, star-like shapes. The logo is simple and professional, and the use of the circle of stars may be a reference to the company's name.
One Kendall Square, Suite B7501 Cambridge, Massachusetts 02139 ninepointmedical.com
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.
-
- Indications for Use Statement:
The Nvision VLE Imaging System is indicated for use as an imaging tool in the evaluation of human tissue microstructure, including esophageal 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:
The Nvision VLE Imaging System uses a derivative of OCT utilizing swept source technology, referred to as SS-OCT or optical frequency domain imaging, OFDI. OFDI is a derivative development of the time-domain OCT imaging modality, which enables high speed, two-dimensional, cross-sectional, real-time imaging.
2
Image /page/2/Picture/0 description: The image shows the logo for NinePoint Medical. The logo consists of the word "NinePoint" in a serif font, with the word "MEDICAL" in a smaller sans-serif font underneath. Above the word "NinePoint" is a circle made up of nine small circles or dots.
One Kendall Square, Suite B7501 Cambridge, Massachusetts 02139 ninepointmedical.com
-
- Performance data:
The NinePoint Medical Nvision VLE Imaging System will be tested against and comply with the following voluntary standards:
- Performance data:
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 device listed above.
- 510(k) Summary:
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized design resembling a human figure embracing or supporting another, with flowing lines suggesting movement or care.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Ninpoint Medical, Incorporated % Domecus Consulting Sevices, LLC Ms. Cindy Domecus. RAC (US & EU) 1171 Barroilhet Avenue Hillsborough, California-94010-
APR 2 5 2013
Re: K120800
Trade/Device Name: Nine Pointe Medical Inc. Nvision VLE Imaging System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: NOQ Dated: March 11, 2013 Received: March 12, 2013
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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of select one Device Evaluation or In Vitro Diagnostic Device Evaluation and Safety] has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:
-
- The Nvision VLE Imaging System is intended to provided an image of the tissue microstructure. The safety and effectiveness of this device for diagnostic analysis (i.e. differentiating normal versus specific abnormalities) in any tissue microstructure or specific disease has not been evaluated.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
- The Nvision VLE Imaging System is intended to provided an image of the tissue microstructure. The safety and effectiveness of this device for diagnostic analysis (i.e. differentiating normal versus specific abnormalities) in any tissue microstructure or specific disease has not been evaluated.
4
Page 2 - Ms. Cindy Domecus, RAC (US & EU)
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
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-eode of-Federal-Regulations, Title-21, Parts-800-to-898-In-addition-FDA-maypublish 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); 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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Christy foreman
Christy Foreman Director Office of Device Evaluation Center for Devices and Radiological Health Food and Drug Administration
Enclosure
5
Indications for Use
510(k) Number: K120800
Device Name: Nine Pointe Medical Inc. Nvision-VLE-Imaging system
Indications For Use: The Nvision VLE Imaging System is indicated for use as an imaging tool in the evaluation of human tissue microstructure, including esophageal tissue microstructure, by providing two-dimensional, cross sectional, real-time depth visualization.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Neil R Oqdena 2013.03.27 17:00:29 04'00'
(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K120800
Page 1 of 1_