(234 days)
The Burdick 200 Pulse Oximeter provides SpO2, Pulse Rate, and Pulse Strength measurements. It may be used in the hospital or clinical environment, during emergency land or air transport, or for in home use.
The intended patient population is neonates to adults. The oximeter permits patient monitoring with adjustable alarm limits as well as visual and audible alarm signals.
The Oximeter has three modes of operation: Clinician Mode, Home-use Mode, and Sleep Study Mode.
The Clinician Mode aids the health care professional in monitoring patient activity.
The Home Use Mode permits the home-use caregiver to monitor a patient within the home environment.
The Sleep Study Mode allows the health care professional to record sleep study data which may be later transferred to a PC and analyzed.
The Burdick 200 is a hand held stand alone Pulse Oximeter designed to detect (SpO2) Oxygen saturation, pulse rate, and pulse strength on any patient from neonates to adults and output the measurements.
The Burdick 200 consists of two units, a hand held pulse oximeter and a table top charger base. Nine probes of various sizes and configurations are available to accommodate the spectrum of body sizes and sites.
This 510(k) summary does not contain sufficient information to answer all the requested questions about acceptance criteria and device performance studies. The document primarily focuses on establishing substantial equivalence to a predicate device and briefly mentions some functional and environmental tests performed due to minor dimensional and material changes.
Here's an attempt to extract and infer information based on the provided text:
Acceptance Criteria and Device Performance Study Summary
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred from document) | Reported Device Performance (Inferred from document) |
|---|---|---|
| Functional Performance | Ability to correctly detect and display SpO2, Pulse Rate, and Pulse Strength. | "All test results were within normal established limits" (pre-environmental test). "all were found to be within established limits" (post-environmental test). |
| Environmental Performance | Withstand specified environmental conditions (e.g., temperature, humidity, vibration - details not provided). | "The laboratory Report indicated that all test results were acceptable, and no negative results were noted." |
| Equivalency | Be manufactured and tested to the same specifications as the BCI International 3302 Oximeter. | Stated that "The Burdick 200 Oximeter will be manufactured and tested to the same specifications as the BCI International 3302 Oximeter." The document is a 510(k) for equivalency to an existing device. |
Missing Information: Precise numerical acceptance criteria for SpO2 accuracy, pulse rate accuracy, or specific environmental limits are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
The document describes tests performed on "a modified unit" (singular).
- Sample Size: 1 unit (a modified Burdick 200 Oximeter).
- Data Provenance: Not explicitly stated, but the functional and environmental testing appears to be conducted on the Burdick 200 Oximeter itself, likely in a controlled laboratory environment. It is not patient or clinical data, but rather device performance data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The tests described are functional and environmental, likely based on engineering specifications and laboratory measurements rather than expert clinical assessment of patient data.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the nature of the tests (functional and environmental), an adjudication method in the context of expert review of clinical cases would not be applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This document describes a 510(k) for a standalone medical device (pulse oximeter), not an AI-assisted diagnostic tool. Therefore, a study to measure the effect size of human readers with vs. without AI assistance is not relevant or included.
6. Standalone (Algorithm Only) Performance Study
The document does describe functional tests of the device itself, which operates as a standalone algorithm/device.
- Standalone Performance Study Done: Yes, functional tests were performed as described under "TESTS."
- Details:
- A "functional test was performed on the unit prior to environmental testing to establish that the unit to be tested was operating properly."
- "Following the environmental test an expanded functional test was performed."
- The "software accomplishing these measurements and calculations was developed by BCI International for their model 3302 and is used by Burdick Inc. in their model 200 in an unaltered form." This implies reliance on the already established performance of the BCI 3302's algorithm.
However, detailed performance metrics (e.g., accuracy, precision, bias) of the SpO2 and pulse rate measurements against a gold standard are not reported in this summary. The summary focuses on showing that the modified unit functions properly and withstands environmental stress, preserving the performance characteristics of the predicate device.
7. Type of Ground Truth Used
For the functional tests, the ground truth would typically be established by comparison to:
- Known input signals: For SpO2 and pulse rate measurements, this would involve using calibrated simulators or reference devices that provide known oxygen saturation and pulse rate values.
- Engineering specifications/reference standards: For environmental tests, the "ground truth" is adherence to specified environmental conditions and the device's ability to maintain functionality within those conditions.
The document does not explicitly state the specific ground truth methods or devices used but implies comparison to "normal established limits" and "established limits." Given it's a 510(k) seeking equivalence, the ground truth for overall device performance is implicitly based on the predicate device's established performance.
8. Sample Size for the Training Set
This information is not applicable as the document describes a hardware device (pulse oximeter) with embedded software, not a machine learning model that requires a "training set" in the conventional AI sense. The software's calculations are based on established physiological principles and algorithms, not machine learning trained on large datasets.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as #8. The "ground truth" for the software's functionality would have been established during the development and validation of the BCI 3302 software, likely using physiological models and clinical studies, but these details are not provided here.
{0}------------------------------------------------
MAY - 3 1996
510(k) SUMMARY
September 7, 1995 DATE:
- SUBMITTOR: Burdick Inc. 15 Plumb St. Milton, Wisconsin 53563
Tel # (608) 868-6000 or (800) 777-1777 Fax # (608) 868-4840
OFFICIAL CORRESPONDENT: Paul E. Appel Manager Regulatory Affairs
Trade Name: Burdick 200 Oximeter Common Name: Oximeter Classification Name: Oximeter
Equivalency:
The Burdick 200 Oximeter is equivalent to the Model 3302 Oximeter manufactured by BCI International.
Description:
The Burdick 200 is a hand held stand alone Pulse Oximeter designed to detect (SpO2) Oxygen saturation, pulse rate, and pulse strength on any patient from neonates to adults and output the measurements.
The Burdick 200 consists of two units, a hand held pulse oximeter and a table top charger base. Nine probes of various sizes and configurations are available to accommodate the spectrum of body sizes and sites.
Intended Use:
The Burdick 200 Pulse Oximeter provides SpO2, Pulse Rate, and Pulse Strength measurements. It may be used in the hospital or clinical environment, during emergency land or air transport, or for in home use.
The intended patient population is neonates to adults. The oximeter permits patient monitoring with adjustable alarm limits as well as visual and audible alarm signals.
{1}------------------------------------------------
Page Two 510(k) Summary
The Oximeter has three modes of operation: Clinician Mode, Home-use Mode, and Sleep Study Mode.
The Clinician Mode aids the health care professional in monitoring patient activity.
The Home Use Mode permits the home-use caregiver to monitor a patient within the home environment.
The Sleep Study Mode allows the health care professional to record sleep study data which may be later transferred to a PC and analyzed.
Technological Characteristics
The Burdick 200 oximeter and the BCI model 3302 hand held oximeter measure (SpO2) Oxygen saturation, pulse rate, and pulse strength. The oximeter determines SpO2 and pulse rate by passing two wavelengths of light, one red and one infrared through body tissue to a photodetector. The strength of the detected signal resulting from each light source depends on the color and thickness of the body tissue, the probe placement, the intensity of the light source, and the absorption of the arterial and venous blood in the body tissues.
These signals are processed in the oximeter, separating the time invariant parameters from the time variant parameters to identify the pulse rate and calculate oxygen saturation. Oxygen saturation calculations can be performed because oxygen saturated blood predictably absorbs less red light than oxygen depleted blood.
Software accomplishing these measurements and calculations was developed by BCI International for their model 3302 and is used by Burdick Inc. in their model 200 in an unaltered form.
The oximeter contains the following display features: SpO2 Numeric Display, Pulse Rate Numeric Display, Pulse Strength Bar Graph, Probe Light, Batt Light, and Alarm Silenced Light.
The control panel includes the following keys: On, Off/Standby, Alarm Select, Alarm/Alert Silence, Arrow (up), Arrow (down), ID/Clear, Pulse Volume,
The AC adapter/charger base features a receptacle for insertion of the oximeter. The receptacle contains charging contacts, and infrared windows for data communication with the oximeter. The printer I/O and the AC input connectors can be found on the rear panel.
The charger base contains the following indicators: Line Power, Charging, Fully Charged.
{2}------------------------------------------------
Page Three 510(k) Summary
Equivalency:
The Burdick 200 Oximeter is equivalent to the BCI International Model 3200 Pulse Oximeter because through contractual agreement Burdick has obtained the rights to manufacture and market the BCI 3302 Oximeter under the Burdick 200 name.
The Burdick 200 Oximeter will be manufactured and tested to the same specifications as the BCI International 3302 Oximeter. Labeling will be altered to reflect the Burdick name, manufacturing location, and model number
Accessories will be manufactured by and purchased from BCI International, and marketed under their name without any labeling changes. This will be their standard product, currently manufactured.
TESTS
In order to ensure that the slight dimensional and material changes to the enclosure would not compromise the operation of the oximeter, three series of tests were performed on a modified unit.
A functional test was performed on the unit prior to environmental testing to establish that the unit to be tested was operating properly. All test results were within normal established limits.
The oximeter was submitted to an independent laboratory for environmental testing. The laboratory Report indicated that all test results were acceptable, and no negative results were noted.
Following the environmental test an expanded functional test was performed. After review of test results, all were found to be within established limits.
§ 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).