(205 days)
Not Found
No
The description focuses on data transfer, storage, review, and reporting of oximetry data, with no mention of AI or ML capabilities. The software is described as an "adjunct system requiring human interpretation."
No
The device is described as data management software that helps healthcare professionals review and manage pulse oximetry data and generate reports. It explicitly states that it "does not suggest a course of treatment or generate a diagnosis," indicating it is not intended for direct therapeutic use.
No
The device description explicitly states: "nVISION® software is an adjunct system requiring human interpretation of results; it does not suggest a course of treatment or generate a diagnosis." This indicates it is not a diagnostic device itself, but rather a tool to help healthcare professionals review and interpret data, with the ultimate diagnostic responsibility resting with the human user.
Yes
The device description explicitly states "nVISION® software runs on a personal computer" and describes its function as processing data from external hardware (Nonin oximeters). It does not include any hardware components itself.
Based on the provided information, the nVISION® Data Management Software is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- nVISION's function: nVISION processes data from pulse oximeters, which are external devices measuring physiological parameters (oxygen saturation and pulse rate) non-invasively. It does not analyze biological specimens.
- Intended Use: The intended use is for managing and reviewing data collected by the oximeters, not for analyzing biological samples.
- Device Description: The description confirms it's software that displays and manages data from the oximeters.
- Lack of mention of biological samples: There is no mention of the software interacting with or analyzing any biological specimens.
Therefore, nVISION falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
nVISION® Data Management Software (nVISION) is an optional accessory for compatible Nonin oximeters with memory playback. nVISION® software is indicated for use with the following Nonin oximeters: 9700, 3100, 9600, 2120, 2500, 8500, 8600, 8800, and 9840. It is intended for use by healthcare professionals when (1) transferring data from pulse oximeters to computers in order to maintain individual records of pulse oximetry data, (2) reviewing that data according to user-selected parameters, and (3) generating reports.
Product codes
DQA
Device Description
nVISION® Data Management Software (nVISION) is an an optional accessory for compatible Nonin oximeters with memory playback. nVISION® software is indicated for use with the following Nonin oximeters: 9700, 3100, 9600, 2120, 2500, 8500, 8600, 8800, and 9840. nVISION® software runs on a personal computer and provides a graphical display of downloaded oximetry data for review and interpretation by a clinician. This software also allows oximetry data and patient information to be saved in a "library" for future retrieval and analysis. The healthcare professional using nVISION® software is solely responsible for selecting the analysis criteria used to calculate summary statistics included in the reports. nVISION® software is an adjunct system requiring human interpretation of results; it does not suggest a course of treatment or generate a diagnosis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals
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)
Representative samples of nVISION® software successfully underwent performance testing to demonstrate appropriate functional characteristics.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).
0
MAY - 6 2004
.
KA33307
SECTION 2. Summary and Certification
A. 510(K) Summary
| Submitter: | Nonin Medical, Inc. |
|---|---|
| Contact Person: | John R. Dalpee |
| Director of Regulatory Affairs | |
| Nonin Medical, Inc. | |
| 2605 Fernbrook Lane N. | |
| Plymouth, MN 55447 | |
| Phone: (763) 577-3166 | |
| Fax: (763) 553-7807 | |
| Date Prepared: | 10 October, 03 |
| Trade Name: | nVISION® Data Management Software (K033307). Class II, 21 |
| CRF 870.2700. | |
| Classification Name | |
| And Number: | Pulse Oximeter Data Management Software |
| Product Code: | DQA |
| Predicate Devices: | nVISION® Data Management Software is substantially equivalent |
| to Respironics' Profox Software (K001708) and Nellcor's Score | |
| Software (K961450). | |
| Device Description: | nVISION® Data Management Software (nVISION) is an optional |
| accessory for compatible Nonin oximeters with memory playback. | |
| nVISION® software is indicated for use with the following Nonin | |
| oximeters: 9700, 3100, 9600, 2120, 2500, 8500, 8600, 8800, and |
- nVISION® software runs on a personal computer and
provides a graphical display of downloaded oximetry data for
review and interpretation by a clinician. This software also allows
oximetry data and patient information to be saved in a "library" for
future retrieval and analysis. The healthcare professional using
nVISION® software is solely responsible for selecting the analysis
criteria used to calculate summary statistics included in the reports.
nVISION® software is an adjunct system requiring human
interpretation of results; it does not suggest a course of treatment or
generate a diagnosis. |
1
| Intended Use: | nVISION® Data Management Software (nVISION) is an optional
accessory for compatible Nonin oximeters with memory playback.
nVISION® software is indicated for use with the following Nonin
oximeters: 9700, 3100, 9600, 2120, 2500, 8500, 8600, 8800, and
9840. It is intended for use by healthcare professionals when (1)
transferring data from pulse oximeters to computers in order to
maintain individual records of pulse oximetry data, (2) reviewing
that data according to user-selected parameters, and (3) generating
reports. |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Functional and
Safety Testing: | Representative samples of nVISION® software successfully
underwent performance testing to demonstrate appropriate
functional characteristics. |
| Conclusion: | nVISION® Data Management Software is substantially equivalent
to Respironics' Profox Software (K001708) and Nellcor's Score
Software (K961450).
This conclusion is based on the fact that nVISION® software is
equivalent to the predicate devices in terms of functional design,
indications for use, principles of operation, software platform, and
hardware requirements. |
:
:
--(
2
Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a bird or a stylized human figure.
MAY - 6 2004
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
John R. Dalpee Director of Regulatory Affairs Nonin Medical, Incoporated 2605 Fernbrook Lane, North Minneapolis, MN 55447-4755
Re: K033307
Trade/Device Name: nVision Data Management Software Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: March 12, 2004 Received: March 15, 2004
Dear Mr. Dalpee:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 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); good manufacturing practice requirements as set forth in the quality
3
Page 2 - John R. Dalpee
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Qul
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications For Use Page
510(K) Number : 033307
Device Name: nVISION® Data Management Software
Indications for Use:
nVISION® Data Management Software (nVISION) is an optional accessory for compatible Nonin oximeters with memory playback. nVISION Is Indicated for use with the following Nonin oximeters: 9700, 3100, 9600, 2120, 2500, 8500, 8600, 8800, and 9840. It is intended for use by healthcare professionals when (1) transferring data from pulse oximeters to computers in order to maintain Individual records of pulse oximetry data, (2) reviewing that data according to user-selected parameters, and (3) generating reports.
Prescription Use
(Part 21 CFR 801 Subpart D)
And/Or
Over-The Counter Use (21 CFR 807 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cain Taylor
(Division Sigh-Off) Division of Anesthealology, General Hospital, Infection Control, Dental Devices
510(k) Number: