(92 days)
The BCI 1621 Oximetry Data Management Program analyzes data recorded using the BCI 3403 pulse oximeter and provides a printed oximetry data analysis report and graphical SpO2 trend. This information can aid in the analysis of pulse oximetry data from sleep screening, oxygen therapy validation, and/or related studies. Data from the BCI 3403 pulse oximeter are downloaded for analysis using a unique cable.
The BCI® 1621 Oximetry Data Management Program is a software program used as a pulse oximetry accessory.
The provided document is a 510(k) summary for the BCI® 1621 Oximetry Data Management Program. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a standalone clinical study for performance.
Here's a breakdown of the information requested, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it relies on demonstrating that the new device performs "within its specifications" and "as well as the legally marketed predicate device(s)."
| Acceptance Criteria (Explicit) | Reported Device Performance |
|---|---|
| Not explicitly stated in quantitative terms. The implicit criterion is to perform "as well as" predicate devices and "within its specifications." | "The results demonstrated that the BCI® 1621 Oximetry Data Management Program performed within its specifications." "Based on these results, it is our determination that the device is safe, effective, and performs as well as the legally marketed predicate device(s)." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document mentions "clinical testing of the desaturation identification algorithm and overall software validation using simulators." It does not provide the number of patients, cases, or simulator runs.
- Data Provenance: Not specified regarding country of origin. The testing is described generally as "clinical testing" and "overall software validation using simulators." It does not clarify if the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. The document describes "clinical testing of the desaturation identification algorithm" but does not detail how ground truth for this testing was established or who established it.
4. Adjudication Method for the Test Set
- This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No, an MRMC comparative effectiveness study was not done as described. This device is a "Pulse Oximeter Display Software" designed to provide analysis reports and graphical trends for healthcare professionals. It is not an AI-assisted diagnostic tool for human readers in the sense of improving their interpretation accuracy. Its function is to process and present oximetry data, which would then be interpreted by a healthcare professional. Therefore, the concept of improving human reader performance with AI assistance in this context is not applicable based on the device's stated function.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, a standalone evaluation of the algorithm's performance was implied. The document states: "Testing of device performance included clinical testing of the desaturation identification algorithm and overall software validation using simulators." This indicates that the algorithm's ability to identify desaturations and the overall software's functionality were tested independently of human interpretation of the raw data. The phrase "performed within its specifications" suggests a standalone evaluation against predefined criteria for the software's output.
7. The Type of Ground Truth Used
- The document states "clinical testing of the desaturation identification algorithm." While not explicitly detailed, the "ground truth" for identifying desaturations in this context would typically be established by established physiological definitions of desaturation events based on SpO2 measurements, potentially validated by expert review of raw oximetry waveforms or comparison to a gold standard measurement, though this is not specified. The "overall software validation using simulators" would use known, controlled inputs to verify the software's processing and output.
8. The Sample Size for the Training Set
- This information is not provided in the document. The document primarily discusses testing and validation, not the development or training of the "desaturation identification algorithm." Given the age of the document (2002) and the nature of the device (software for displaying and analyzing oximetry data), it is unlikely to involve machine learning in the contemporary sense requiring a "training set" in the way an AI diagnostic algorithm would. The "algorithm" likely refers to a predefined set of rules or calculations for identifying desaturation events.
9. How the Ground Truth for the Training Set Was Established
- This information is not provided as a "training set" in the context of machine learning is not discussed. If the "algorithm" refers to rule-based logic, its "training" would be inherent in its design based on established medical definitions and physiological principles for desaturation.
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Image /page/0/Picture/1 description: The image shows a logo with the letters 'BCI' in bold, sans-serif font. To the left of the letters, there is a circular graphic composed of vertical lines, resembling a stylized sun or a data visualization. A small circle is present to the upper right of the letters, possibly serving as a design element or a trademark symbol. The overall design is simple and modern, with a focus on clean lines and geometric shapes.
FFB 2 1 2002
BCI, Inc. N7 W22025 Johnson Road Waukesha, WI 53186-1856 USA Tel: 262-542-3100 Fax: 262-542-3325 www.smiths-bci.com
Summary of Safety and Effectiveness
| Submitter: | BCI, Inc. |
|---|---|
| Address: | N7 W22025 Johnson RoadWaukesha, WI 53186 |
| Telephone: | (262) 542-3100 |
| Contact: | VP Regulatory Affairs |
| Prepared: | November 15, 2001 |
| Proprietary Name: | BCI® 1621 Oximetry Data Management Program |
| Common/Classification Name: | Pulse Oximeter Display Software |
| Predicate Devices: | BCI® 3403 Sleep Screening Pulse Oximeter(K011156)Nellcor Score™ Software (K961450) |
New Device Description:
The BCI® 1621 Oximetry Data Management Program is a software program used as a pulse oximetry accessory.
Intended Use:
The BCI® 1621 Oximetry Data Management Program provides a printed oximetry data analysis report and graphical SpO2 trend. It is designed for health care professionals in environments such as hospitals, skilled nursing facilities, physician offices, and home care. It can aid in the analysis of pulse oximetry data from sleep screening, oxygen therapy validation, and/or related studies. A unique cable is used to download data from the BCI 3403 pulse oximeter or compatible device.
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Image /page/1/Picture/0 description: The image shows a logo with a circular design on the left and the letters 'BCI' on the right. The circular design is composed of vertical lines, creating a textured effect. The letters 'BCI' are in a bold, sans-serif font, with a small circle or dot above and to the right of the 'I'. The logo appears to be in black and white.
Performance Data:
The design of this device utilizes currently available technology found in legally marketed devices. The software performs the same analysis as the BCI 3403 pulse oximeter (K011156). In addition, it performs desaturation analysis, constructs histograms, and SpO2 graphs similar to the Nellcor Score™ software (K961450).
Software development and testing was conducted in accordance with the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, FDA, May 29, 1998. Testing of device performance included clinical testing of the desaturation identification algorithm and overall software validation using simulators. The results demonstrated that the BCI® 1621 Oximetry Data Management Program performed within its specifications.
Based on these results, it is our determination that the device is safe, effective, and performs as well as the legally marketed predicate device(s).
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Respectfully,
Donald Alexander
Donald Alexander VP Regulatory Affairs
BCI is a trademark of BCI, Inc.. The symbol ® indicates it is registered in the U.S. Patent and Trademark Office and certain other countries. Score is a trademark of Mallinckrodt Inc.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with flowing lines, suggesting movement or flight. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 1 2002
Mr. Donald J. Alexander BCI, Inc. N7 W22025 Johnson Road Waukesha, WI 53186-1856
Re: K013862
BCI 1621 Oximetry Data Management Program Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II (two) Product Code: 74 DQA Dated: February 8, 2002 Received: February 11, 2002
Dear Mr. Alexander:
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.
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Page 2 - Mr. Donald J. Alexander
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loast of advised that I Dri brisualite over device complies with other requirements of the Act that I DA has made a acterimalistions administered by other Federal agencies. You must or any I cacal statutes and regarments, including, but not limited to: registration and listing (21 Comply with an the 11et 81equirements)01); good manufacturing practice requirements as set CI'N in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality byticles (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) I mis letter will anow you to organization of substantial equivalence of your device to a legally premarket notification: "The Dr. I massification 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 and If you desire specific ad rise for in vitro diagnostic devices), please contact the Office of additionally 21 OF N F art 6646. Additionally, for questions on the promotion and advertising of Compination at (301) 597-1 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Other general informational 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,
Da V. Tellh
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications For Use
510(k) Number (if Known):___
613862
Device Name: BCI 1621 Oximetry Data Management Program
Indications For Use:
Intended Use:
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Division of Cardiovascular & Respiratory Devices | |
|---|---|
| 510(k) Number | K013862 |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| --------------------------------------- | ------------------------------------------ | ---------------------- |
§ 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).