VECTOR EVENT GRID ARCHITECTURE (VEGA) SYSTEM

K102135 · Nuvon, Inc. · MWI · Oct 22, 2010 · Cardiovascular

Device Facts

• Record ID: K102135
• Device Name: VECTOR EVENT GRID ARCHITECTURE (VEGA) SYSTEM
• Applicant: Nuvon, Inc.
• Product Code: MWI · Cardiovascular
• Decision Date: Oct 22, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

VEGA System collects data from bedside/point-of-care biomedical devices and clinical information management systems; connects directly or via networks to aggregate data from multiple sources; translates native device data into standard formats (e.g., XML, HL7); transmits aggregated data to hospital IT and electronic medical record (EMR) systems. Used in clinical settings; operated by healthcare staff. Device acts as a data retrieval and translation gateway; does not perform patient monitoring or control connected biomedical equipment. Benefits include streamlined data integration into EMRs.

Clinical Evidence

Bench testing only. Verification and validation activities confirmed that biomedical device data is communicated from source devices through the system with expected fidelity and performance consistent with intended use.

Technological Characteristics

Data retrieval and translation system; connects to biomedical devices and hospital IT/EMR networks. Translates native device data to HL7/XML standards. Functions as a data aggregator and transmission gateway. Software-based architecture.

Indications for Use

Indicated for data collection from bedside and point-of-care biomedical devices and clinical information management systems in clinical environments. Not for patient monitoring or device control.

Regulatory Classification

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.

Predicate Devices

• Data Captor (K032142)

Submission Summary (Full Text)

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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, [e-mail].

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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#### 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 [phone] or [phone] 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

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Enclosure

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Indications for Use Statement

OCT 2 2 2010

510(k) Number (if known):

K102135

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: [phone] 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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