(85 days)
The Vector Event Grid Architecture System is intended for use in data collection from bedside and point of care biomedical devices and clinical information management systems either directly or through networks with independent bedside devices. The Vector Event Grid Architecture System is not intended for monitoring purposes, nor is it intended to control any of the biomedical devices and information systems with which it interconnects.
The VEGA System permits the transfer of data from biomedical and patient care devices to existing hospital information technology and electronic medical record systems. The VEGA System connects directly to biomedical devices and aggregates the data from multiple biomedical devices for transmission to electronic medical record systems. The VEGA System may also translate native biomedical device data into the HL7 standard as necessary.
The provided text is a 510(k) summary for the Nuvon, Inc. Vector Event Grid Architecture (VEGA) System, a device for collecting data from biomedical devices and clinical information management systems. It is not a detailed study report with specific acceptance criteria and performance metrics for a diagnostic or AI-driven device in the typical sense.
Therefore, much of the requested information cannot be extracted directly from this document. The document describes a data retrieval system rather than a device with diagnostic or analytical performance claims that would typically involve sensitivity, specificity, or other statistical measures.
However, I can extract the following information:
1. A table of acceptance criteria and the reported device performance:
The document does not provide a table of quantitative acceptance criteria or statistical performance metrics (e.g., sensitivity, specificity, AUC) because it's a data collection and transmission system, not a diagnostic one. Instead, it states qualitative performance outcomes.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Communication of biomedical device data from source devices | "Results of verification and validation activities have shown that the VEGA System biomedical device data are communicated from the source devices through the system in a manner consistent with the expected performance." |
| Functionality as intended | "In all instances the VEGA System functioned as intended..." |
| Fidelity of results | "...and the fidelity of the results observed was as expected." |
| Equivalence to predicate device for safety and effectiveness | "The minor technological differences between the VEGA System and its predicate devices raise no new issues of safety or effectiveness." |
| Substantially equivalent performance to predicate device | "Performance data demonstrate that the VEGA System has substantially equivalent performance to the Data Captor System." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document. The document refers to "verification and validation activities" but does not specify the sample size, type of data used (e.g., specific biomedical device models, patient data), or its provenance.
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):
This information is not applicable/not provided. The device is a data retrieval system, not one that makes clinical diagnoses requiring expert ground truth for its performance evaluation in the traditional sense. Its evaluation would focus on data integrity, transmission accuracy, and interoperability.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable/not provided. Adjudication methods are typically used for establishing ground truth in diagnostic studies, which is not the primary purpose of this device's performance evaluation as described.
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:
This information is not applicable/not provided. The VEGA System is a data retrieval and transmission system, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant to its function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The document describes the VEGA System as functioning independently to collect and transmit data. The performance section implies a standalone evaluation of the system's ability to communicate data accurately from source devices. However, the term "standalone" in the context of an "algorithm" is more typically associated with AI-driven diagnostic tools. Here, the device's function as a data intermediary is evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The concept of "ground truth" in the diagnostic sense (e.g., pathology, expert consensus) is not applicable to this device. For this type of system, the "ground truth" would likely be the actual data generated by the biomedical devices, and the performance would be validated by comparing the transmitted data to the source data for accuracy, completeness, and fidelity. The document states "the fidelity of the results observed was as expected," implying such a comparison.
8. The sample size for the training set:
This information is not applicable/not provided. The VEGA system is described as a data retrieval architecture, not a machine learning or AI algorithm that would typically require a "training set" in the context of supervised learning.
9. How the ground truth for the training set was established:
This information is not applicable/not provided for the same reasons as point 8.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 17, 2024
Nuvon, Inc. c/o Jonathan S. Kahan Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, DC 20004
Re: K102135
Trade/Device Name: Vector Event Grid Architecture (VEGA) System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II Product Code: MWI
Dear Jonathan S. Kahan:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated October 22, 2010. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code MWI.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact LCDR Stephen Browning, OHT2: Office of Cardiovascular Devices, 240-402-5241, Stephen.Browning@fda.hhs.gov.
Sincerely,
Stephen C. Browning -S
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Image /page/1/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered in the image and is the only element present. The image is likely a header or title for a document or website related to the Department of Health & Human Services.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Nuvon, Inc. c/o Mr. Jonathan S. Kahan Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, DC 20004
QCT 2 2 2010
Re: K102135
.
Trade/Device Name: Vector Event Grid Architecture (VEGA) System Regulation Number: Unclassified Regulation Name: None Regulatory Class: Unclassified Product Code: LNX Dated: March 12, 2010 Received: March 15, 2010
Dear Mr. Kahan:
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. Iisting 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.
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Page 2 - Mr. Jonathan S. Kahan
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 (OS) 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,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Enclosure
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Indications for Use Statement
OCT 2 2 2010
510(k) Number (if known):
AND/OR
Device Name: Vectored Event Grid Architecture (VEGA) System
Indications for Use:
The Vector Event Grid Architecture System is intended for use in data collection from bedside and point of care biomedical devices and clinical information management systems either directly or through networks with independent bedside devices. The Vector Event Grid Architecture System is not intended for monitoring purposes, nor is it intended to control any of the biomedical devices and information systems with which it interconnects.
Prescription Use X (Part 21 C.F.R. 801 Subpart D)
Over-The-Counter Use . (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence
of CDRH, Office of Device Evaluation (ODE)
W.M.D.
Division Sign-Off) ivision of Cardiovascular Devices
510(k) N
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車
OCT 2 2 2010
510(k) SUMMARY VEGA System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Nuvon, Inc One Rincon Center 101 Spear Street. Suite 255 San Francisco, CA 94105 Phone: 1-215-966-6142 Facsimile: 1-267-499-2001 Contact Person: John R. Zaleski July 20th, 2010 Date Prepared:
Name of Device and Name/Address of Sponsor
VEGA System
Nuvon, Inc.
One Rincon Center
101 Spear Street, Suite 255
San Francisco, CA 94105
Common or Usual Name
Physiological and biomedical device data retrieval system and standard industry format (e.g.: XML, HL7) translator.
Classification Name/Product Code/CFR Reference
Software, transmission and storage, patient data
Product Code: NSX, MWI
CRF Reference: Not classified
Predicate Device
Data Captor, K032142, developed by Capsule Technologie, Inc.
Intended Use / Indications for Use
The VEGA System is intended to be used for data collection from bedside and point of care biomedical devices and clinical information management systems either directly or through networks with independent bedside devices. The Vector Event Grid Architecture System is not intended for monitoring purposes, nor is it intended to control any of the biomedical devices and information systems with which it interconnects."
Technological Characteristics
The VEGA System permits the transfer of data from biomedical and patient care devices to existing hospital information technology and electronic medical record systems. The VEGA System connects directly to biomedical devices and aggregates the data from multiple biomedical
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devices for transmission to electronic medical record systems. The VEGA System may also translate native biomedical device data into the HL7 standard as necessary.
Performance Data
Results of verification and validation activities have shown that the VEGA System biomedical device data are communicated from the source devices through the system in a manner consistent with the expected performance. In all instances the VEGA System functioned as intended and the fidelity of the results observed was as expected.
Substantial Equivalence
The VEGA System is substantially equivalent to the Capsule Technologie Data Captor product. The VEGA System has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the VEGA System and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the VEGA System has substantially equivalent performance to the Data Captor System. Thus, the VEGA System is substantially equivalent.
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§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).