(205 days)
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.
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. 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the nVISION® Data Management Software:
Acceptance Criteria and Device Performance for nVISION® Data Management Software (K033307)
Based on the provided documentation, the nVISION® Data Management Software is a Class II medical device (21 CRF 870.2700), classified as Pulse Oximeter Data Management Software. The primary method for demonstrating its acceptance and effectiveness is through a substantial equivalence claim to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) summary for software seeking substantial equivalence, specific quantitative "acceptance criteria" and "reported device performance" in the traditional sense (e.g., sensitivity, specificity, accuracy against a gold standard) are not explicitly detailed in the document. Instead, the acceptance is based on demonstrating equivalence in terms of functionality, safety, and intended use.
| Acceptance Criterion (Based on Substantial Equivalence to Predicates) | Reported Device Performance (Summary of Evidence) |
|---|---|
| Functional Design | nVISION® software successfully underwent performance testing to demonstrate appropriate functional characteristics, which align with the predicate devices. |
| Indications for Use | Intended for use by healthcare professionals for transferring, reviewing (according to user-selected parameters), and generating reports of pulse oximetry data, consistent with the predicates. |
| Principles of Operation | Operates on the same principles as the predicate devices, involving the display and management of downloaded oximetry data. |
| Software Platform | Developed on a software platform comparable to the predicate devices. |
| Hardware Requirements | Compatible with standard personal computer hardware, similar to the predicate devices. |
| Safety Testing | Representative samples successfully underwent performance testing to demonstrate appropriate functional characteristics, ensuring safe operation. |
| Adjunct System Requiring Human Interpretation | Explicitly states it is an "adjunct system requiring human interpretation of results; it does not suggest a course of treatment or generate a diagnosis," mirroring the expected use model of predicate data management software. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a specific "test set" sample size in terms of patient data or clinical cases. The performance testing appears to be functional and safety testing of the software itself rather than a clinical trial with a cohort of patients. The data provenance (country of origin, retrospective/prospective) is therefore not applicable in the context of this software's evaluation as described.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. Given the nature of the software (data management rather than diagnostic interpretation), a traditional "ground truth" derived from expert consensus on patient cases is unlikely to have been the primary method of evaluation. The evaluation focused on the software's ability to accurately handle and display data from the oximeters and match the functionality of predicate devices.
4. Adjudication Method for the Test Set
An adjudication method (e.g., 2+1, 3+1) for a test set is not applicable and therefore not mentioned, as there isn't a stated clinical test set requiring expert adjudication for ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not conducted or described in the provided summary. The device is data management software, not an AI interpretation tool intended to directly improve human reader performance on a diagnostic task.
6. Standalone Performance Study
A standalone performance study in the sense of an algorithm's diagnostic accuracy without human-in-the-loop was not performed for this software. The software's role is to present data for human review and interpretation, not to make independent diagnoses. The "performance testing" mentioned refers to functional and safety testing of the software itself.
7. Type of Ground Truth Used
The "ground truth" concept is not directly applicable in the typical clinical sense for this software. The evaluation relied on demonstrating that the software accurately processed and displayed data from compatible Nonin oximeters and performed functions comparable to predicate data management software. The implicit "ground truth" would be the accurate, raw data from the oximeters and the established functionality of the predicate devices.
8. Sample Size for the Training Set
This information is not applicable and not provided. As "nVISION® Data Management Software" is described as a data management tool, not an AI/ML diagnostic algorithm, there isn't a "training set" in the context of machine learning. The software's development likely involved standard software development methodologies and testing, rather than an AI training paradigm.
9. How Ground Truth for the Training Set Was Established
This information is not applicable as there is no mention of a training set for an AI/ML algorithm.
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MAY - 6 2004
.
KA33307
SECTION 2. Summary and Certification
A. 510(K) Summary
| Submitter: | Nonin Medical, Inc. |
|---|---|
| Contact Person: | John R. DalpeeDirector of Regulatory AffairsNonin Medical, Inc.2605 Fernbrook Lane N.Plymouth, MN 55447Phone: (763) 577-3166Fax: (763) 553-7807 |
| Date Prepared: | 10 October, 03 |
| Trade Name: | nVISION® Data Management Software (K033307). Class II, 21CRF 870.2700. |
| Classification NameAnd Number: | Pulse Oximeter Data Management Software |
| Product Code: | DQA |
| Predicate Devices: | nVISION® Data Management Software is substantially equivalentto Respironics' Profox Software (K001708) and Nellcor's ScoreSoftware (K961450). |
| Device Description: | nVISION® Data Management Software (nVISION) is an optionalaccessory for compatible Nonin oximeters with memory playback.nVISION® software is indicated for use with the following Noninoximeters: 9700, 3100, 9600, 2120, 2500, 8500, 8600, 8800, and9840. nVISION® software runs on a personal computer andprovides a graphical display of downloaded oximetry data forreview and interpretation by a clinician. This software also allowsoximetry data and patient information to be saved in a "library" forfuture retrieval and analysis. The healthcare professional usingnVISION® software is solely responsible for selecting the analysiscriteria used to calculate summary statistics included in the reports.nVISION® software is an adjunct system requiring humaninterpretation of results; it does not suggest a course of treatment orgenerate a diagnosis. |
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| Intended Use: | nVISION® Data Management Software (nVISION) is an optionalaccessory for compatible Nonin oximeters with memory playback.nVISION® software is indicated for use with the following Noninoximeters: 9700, 3100, 9600, 2120, 2500, 8500, 8600, 8800, and9840. It is intended for use by healthcare professionals when (1)transferring data from pulse oximeters to computers in order tomaintain individual records of pulse oximetry data, (2) reviewingthat data according to user-selected parameters, and (3) generatingreports. |
|---|---|
| Functional andSafety Testing: | Representative samples of nVISION® software successfullyunderwent performance testing to demonstrate appropriatefunctional characteristics. |
| Conclusion: | nVISION® Data Management Software is substantially equivalentto Respironics' Profox Software (K001708) and Nellcor's ScoreSoftware (K961450).This conclusion is based on the fact that nVISION® software isequivalent to the predicate devices in terms of functional design,indications for use, principles of operation, software platform, andhardware requirements. |
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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
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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
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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:
§ 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).