(85 days)
The 3444 Reusable Finger Sensor is used with BCI oximetry to noninvasively measure oxygen saturation (SpOz), pulse rate and plethysmographic pulse waves. The 3444 sensor is recommended for patients weighing more than 15 kg and patients with limited activity.
The 3444 Reusable Finger Sensor is not recommended for prolonged use unless skin integrity is checked frequently and the measurement site is changed accordingly.
The Reusable Finger Sensor is for use with BCI International monitors and with monitors that contain BCI International oximelry or are licensed to use BCI International sensors.
The BCI 3444 Reusable Oximetry Finger Sensor is an updated version of an existing finger sensor, the 3044, legally marketed by BCI International. This updated finger sensor is designed to work with all BCI oximeters. The sensor is made up of three major parts, the cable with the molded connector, the top part of the shell containing the LEDs and the bottom part of the shell containing the photo detector.
This submission describes the BCI 3444 Reusable Finger Sensor, an updated version of an existing finger sensor (BCI 3044), designed to work with BCI oximeters for noninvasive measurement of oxygen saturation (SpO2), pulse rate, and plethysmographic pulse waves.
Here's a breakdown of the requested information:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|
| Standard deviation for SpO2 measurement range of 70-100% ≤ 2 | 1.73 |
| Standard deviation for SpO2 measurement range of 50-69% ≤ 3 | 2.50 |
| Sensor intensity (Red & IR light) | Passed (Performed the same as predicate device) |
| Drop test | Passed |
| 4 kV Hi-Pot test | Passed |
| Surface temperature test | Passed |
| Operational test at extreme temperatures (0°F & 140°F) | Passed |
| Maximum difference in readings when compared to predicate device (3044) | A count of one (maximum difference between 89 sets of measurements) |
2. Sample Size Used for the Test Set and Data Provenance
The document describes two main clinical/comparison studies for the test set:
- Clinically controlled desaturation studies: The sample size for these studies is not explicitly stated as a number of subjects. It mentions "data collected from the studies" but does not quantify the number of subjects or measurements.
- Comparison with predicate device (3044): 89 sets of measurements were compared on subjects. The provenance of this data (e.g., country of origin, retrospective or prospective) is not explicitly stated, but the context of "clinically controlled desaturation studies" suggests a prospective, controlled clinical setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish a "ground truth" in the traditional sense for the clinical studies. Instead, it relies on a co-oximeter (OSM-3) as the reference standard for blood oxygen level measurements during the controlled desaturation studies. Therefore, this section is not applicable as expert review was not the method for ground truth.
4. Adjudication Method for the Test Set
Since a co-oximeter was used as the reference standard and there's no mention of expert review, there was no adjudication method described for the test set. The comparison was statistical against the reference device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focuses on the device's accuracy against a reference standard and its equivalence to a predicate device, not on human reader performance with or without AI assistance.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The clinical desaturation studies and the comparison with the predicate device represent a standalone assessment of the BCI 3444 sensor (in conjunction with a BCI oximeter). The performance metrics (standard deviation) are for the device system's accuracy as compared to a co-oximeter, without human intervention in interpreting the output of the device under test beyond standard clinical usage.
7. The Type of Ground Truth Used
The primary ground truth used for the clinical desaturation studies was measurement from a co-oximeter (OSM-3), which is a gold standard for blood gas analysis. This is a form of direct physiological measurement providing objective outcome data.
8. The Sample Size for the Training Set
The document does not provide information regarding a training set. This is a medical device submission for an updated sensor, not an AI or machine learning algorithm. Therefore, the concept of a "training set" as typically understood in AI/ML is not applicable here. The performance evaluation relies on comparing the new device against a predicate and a reference standard.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set (as this is not an AI/ML device), this section is not applicable.
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K974697
1000
Summary of Safety and Effectiveness
| Submitter: | BCI International, Inc. |
|---|---|
| Address: | W238 N1650 Rockwood DriveWaukesha, WI 53188 |
| Telephone: | (414) 542-3100 |
| Contact: | VP Regulatory Affairs |
| Prepared: | December 15, 1997 |
| Proprietary Name: | 3444 Reusable Finger Sensor |
| Common/Classification Name: | Pulse Oximeter (accessory) |
| Predicate Devices: | BCI 3044 Reusable Finger Sensor |
MAR ||New Device Description:
The BCI 3444 Reusable Oximetry Finger Sensor is an updated version of an existing finger sensor, the 3044, legally marketed by BCI International. This updated finger sensor is designed to work with all BCI oximeters. The sensor is made up of three major parts, the cable with the molded connector, the top part of the shell containing the LEDs and the bottom part of the shell containing the photo detector.
Intended Use:
The 3444 Reusable Finger Sensor is used with BCI oximetry to noninvasively measure oxygen saturation (SpO2), pulse rate and plethysmographic pulse waves. The 3444 sensor is recommended for patients weighing more than 15 kg and patients with limited activity.
The 3444 Reusable Finger Sensor is not recommended for prolonged use unless skin integrity is checked frequently and the measurement site is changed accordingly.
The Reusable Finger Sensor is for use with BCI International monitors and with monitors that contain BCI International oximetry or are licensed to use BCI International sensors.
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Performance Data:
The design of this device utilizes currently available technology found in the predicate device and in many legally marketed devices. Testing was done to ensure that it would perform the same as the predicate device. This testing included sensor intensity (Red & IR light), drop test, 4 kV Hi-Pot test, surface temperature test and an operational test at extreme temperatures (0°F & 140°F). The 3444 sensor passed all the tests.
Clinically controlled desaturation studies were done to demonstrate that the 3444 with a BCI oximeter accurately displays the patient's blood oxygen level within the systems specified accuracy limits as compared to a co-oximeter (OSM-3). Statistical analysis on the data collected from the studies were compared to those from a co-oximeter during the controlled subject desaturation runs. The results from the clinical studies support the accuracy claims of the system (3444 with the oximeter), with a standard deviation of 1.73 for the measurement range of 70-100% (spec is 2) and 2.50 for the range of 50-69% (spec is 3).
Additional tests were run comparing the new 3444 sensor directly with the predicate 3044 sensor. These tests compared 89 sets of measurements on subjects where the two sensors (with oximeters) were used at the same time to take a reading. The maximum difference between readings was a count of one. The 3444 passed this set of tests.
On the basis of the above referenced testing it is our determination that the device is safe, effective, and performs as well as or better than the legally marketed predicate device.
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 Aliprand
Donald Alexander VP Regulatory Affairs
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 1 1998
Mr. Donald J. Alexander BCI International W238 N1650 Rockwood Drive Waukesha, WI 53188-1199
Re: K974697 BCI 3444 Pulse Oximeter Sensor Regulatory Class: II (two) Product Code: 74 DQH ...... December 15, 1997 Dated: Received: December 16, 1997
Dear Mr. Alexander:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) ------inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Donald J. Alexander
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications For Use
510(k) Number (if Known): _ 长ና 7 4 6 9 7
Device Name: BCI 3444 Reusable Finger Sensor, ( A Pulse Oximeter Accessory )
Indications For Use:
Intended Use
The 3444 Reusable Finger Sensor is used with BCI oximetry to noninvasively measure oxygen saturation (SpOz), pulse rate and plethysmographic pulse waves. The 3444 sensor is recommended for patients weighing more than 15 kg and patients with limited activity.
The 3444 Reusable Finger Sensor is not recommended for prolonged use unless skin integrity is checked frequently and the measurement site is changed accordingly.
The Reusable Finger Sensor is for use with BCI International monitors and with monitors that contain BCI International oximelry or are licensed to use BCI International sensors.
( PLFASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrence of CDRH, Office of Device Evaluation (ODE)
M. R
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular, Respiratory, | |
| and Neurological Devices510(k) Number | K974 697 |
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The_Counter Use _____________
§ 870.2310 Apex cardiograph (vibrocardiograph).
(a)
Identification. An apex cardiograph (vibrocardiograph) is a device used to amplify or condition the signal from an apex cardiographic transducer and to produce a visual display of the motion of the heart; this device also provides any excitation energy required by the transducer.(b)
Classification. Class II (performance standards).