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.
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.
The provided 510(k) summary for the NinePoint Medical Nvision VLE Imaging System indicates that this device is an Optical Coherence Tomography (OCT) system, which is a general imaging system. While the document mentions compliance with several general safety and performance standards (like IEC and ISO), it does not contain details about specific acceptance criteria related to a clinical performance study for image interpretation, nor does it present the results of such a study.
The "Performance data" section (Section 7) primarily states that:
- The device will be tested against and comply with a list of voluntary standards (related to general safety, electromagnetic compatibility, biological evaluation, sterilization, etc.).
- "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."
This statement is very general and does not provide any specific quantitative acceptance criteria or detailed results of these tests that would be relevant to evaluating the device's diagnostic performance (e.g., accuracy, sensitivity, specificity for identifying specific tissue microstructures).
Therefore, based solely on the provided text, the extensive information requested in the prompt regarding acceptance criteria and a study proving those criteria cannot be extracted.
Here's a breakdown of why and what information is missing:
- Table of acceptance criteria and reported device performance: This information is not provided. The document lists general manufacturing and safety standards but not performance criteria for image quality or diagnostic accuracy.
- Sample size used for the test set and data provenance: No details about a specific test set, its size, or provenance are mentioned for clinical performance.
- Number of experts used to establish the ground truth for the test set and their qualifications: No information is provided about expert readers or ground truth establishment for a diagnostic performance study.
- Adjudication method for the test set: No adjudication method is described.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: No such study is mentioned, nor is an effect size for human readers improving with AI assistance (which is not relevant as this is an imaging device, not an AI diagnostic tool in the context of what's described).
- Standalone performance (algorithm only without human-in-the-loop performance): This is an imaging system, not an algorithm being evaluated without human interpretation. No separate algorithm-only performance is described.
- Type of ground truth used: No ground truth type is specified as there's no detailed diagnostic performance study described.
- Sample size for the training set: The product is an imaging system, not an AI/ML algorithm that typically requires a "training set" in the same way. The document doesn't mention an AI component that would have a training set.
- How the ground truth for the training set was established: Not applicable, as no AI model training is described.
In summary: The provided 510(k) summary focuses on establishing substantial equivalence to predicate devices based on technological characteristics and compliance with general safety and voluntary standards. It does not contain the detailed clinical performance study data that would typically include specific acceptance criteria and detailed results related to diagnostic accuracy, which is what your questions are seeking.
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DEC 1 6 2011
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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 B7501Cambridge, MA 02139(617) 250-7190 (main number)(617) 250-7199 (fax) |
| Official Contact: | Cindy Domecus, R.A.C. (US & EU)Principal, Domecus Consulting Services LLCConsultant to NinePoint Medical, Inc.(650) 343-4813(650) 343-7822 (fax)DomecusConsulting@comcast.net |
Date Summary Prepared: 21 September 2011
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- 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.
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One Kendall Square, Suite B7501 ambridge. Massachusetts 02139 nine point medical. com
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- 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:
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- 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.
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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.
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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
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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
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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
</12770
Over-the -Counter Use
(Part 21 CFR 801 Subpart D) Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | 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.
§ 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.