Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard photoelectric technology for measuring SpO2 and pulse rate, with no mention of AI, ML, or related concepts.

Therapeutic

No.
The device is stated to be for "spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate," which are diagnostic measurements and not a therapeutic function.

Diagnostic

Yes

The device is intended for the spot-checking of oxygen saturation and pulse rate, which are measurements used to assess a patient's physiological state and contribute to a diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly details hardware components like LEDs, a photoelectric cell, and electronics to interface with the sensor, indicating it is a hardware device with embedded software, not a software-only medical device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
SB100II Function: The SB100II Fingertip Pulse Oximeter is a non-invasive device that measures oxygen saturation and pulse rate directly from the finger. It does not involve the collection or analysis of any bodily specimens.

The device description clearly states it's a "non-invasive device" and measures parameters "in a translucent part of the body, in this case the finger." This is a direct measurement on the body, not an in vitro test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The SB100II Fingertip Pulse Oximeter is a non-invasive device intended for the spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult and pediatric patients in home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care etc.). The SB100II is not intended for continuous monitoring.

Product codes (comma separated list FDA assigned to the subject device)

DQA

Device Description

The SB10011 pulse oximeter is an instrument for photoelectrically determining the oxygenation of blood in a translucent part of the body, in this case the finger.

This SB1001 contains the electronics to interface to the integral sensor. This sensor consists of a light emitting diode and a photoelectric cell placed on either side of the finger. Red and infrared light are transmitted through oxyhemoglobin and are sensed in the photoelectric cell. The red and infrared light is absorbed in different amounts depending on the oxygenation of the blood.

The SB10011 has the ability to determine both the percent of saturated hemoglobin and the pulse rate. It performs these functions on adult and pediatric patient populations. It is designed for spot checking both the SpO2 and Pulse rate information. To perform this, the SB100Il display digital values for both the SpO2 and Pulse.

Pulse amplitude is displayed graphically by means of a vertical bar, which elevates in synch with the pulse cycle. The SB1001 is powered by two "AAA" batteries. The wavelength of red LED is 660nm and Infrared LED is 905/880nm with maximum optical output power of 4mW.

The device incorporates a battery state indicator and provides a visual indication of low battery.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Finger

Indicated Patient Age Range

Adult and pediatric patients

Intended User / Care Setting

Home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care etc.).

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)

The following performance tests were done and the SB100II meet all requirements.

ISO 9919 including clinical testing
IEC 60601-1-2
IEC 60601-1

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Accuracy: +/-3% 70-99% (SpO2), ±3 bpm (Pulse)
SpO2 Range: 35-99%
SpO2 Resolution: 1%
Pulse Range: 30-250 bpm
Pulse Resolution: 1 bpm

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Contec Medical Systems, K082641, CMS-50DL, Smith's Medical, K013171, BCI3420

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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).

Summary

0

| | Page 1 of 6
02-Jun-2010 | |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Official Contact: | CY Wang - RD VP
Atlantean
1F, No. 789, Bo-ai Street
Chubay City, TAIWAN
Tel - 886-3-555-8340
Fax - 886-2-2736-3250 | K10156
SEP 20 2010 |
| Proprietary or Trade Name: | SB100II Finger Pulse Oximeter | |
| Common/Usual Name: | Pulse oximeter | |
| Classification Name: | Oximeter
DQA - 870.2700 | |
| Predicate Devices: | Contec Medical Systems, K082641, CMS-50DL
Smith's Medical, K013171, BCI3420 | |

510(k) Summary

Device Description:

The SB10011 pulse oximeter is an instrument for photoelectrically determining the oxygenation of blood in a translucent part of the body, in this case the finger.

This SB1001 contains the electronics to interface to the integral sensor. This sensor consists of a light emitting diode and a photoelectric cell placed on either side of the finger. Red and infrared light are transmitted through oxyhemoglobin and are sensed in the photoelectric cell. The red and infrared light is absorbed in different amounts depending on the oxygenation of the blood.

The SB10011 has the ability to determine both the percent of saturated hemoglobin and the pulse rate. It performs these functions on adult and pediatric patient populations. It is designed for spot checking both the SpO2 and Pulse rate information. To perform this, the SB100Il display digital values for both the SpO2 and Pulse.

Pulse amplitude is displayed graphically by means of a vertical bar, which elevates in synch with the pulse cycle. The SB1001 is powered by two "AAA" batteries. The wavelength of red LED is 660nm and Infrared LED is 905/880nm with maximum optical output power of 4mW.

The device incorporates a battery state indicator and provides a visual indication of low battery.

Summary Description:

The SB10011 is not life-supporting or life-sustaining, not for implant. .
The SB100II is not sterile .
◆ The SB100H is reusable.
The SB10011 is for prescription use. .
The SB100II does not contain drug or biological products ●
The SB100H is a class II device, product code DQA regulation 21 CFR 870.2700. .

1

510(k) Summarv Page 2 of 6 02-Jun-2010

The SB100II is a standalone device it is not part of a multi-parameter module and does . not connect to any other devices
The SB100H is for use in spot-checking it is not intended for continuous monitoring. .
The SB10011 is not intended for out of hospital transport .
. The SB100II can be used in homes.
The SB10011 is a transmittance device that calculates functional SpO2 .
. The SB100II does not provide audio or visual alarms
The SB100I1 has only one control the On / Off key. When the device is on it can . display the following:
- ୍ତ SpO2 values
- Pulse Rate o
- An indication of pulse amplitude. O
. There are no accessories for use with the SB1001. The sensor is integral to the device and is spring loaded so that it does not need to be adhered to the skin by tape or other measures.
The SB100H is a standalone device that does not interface to any other devices so there . are no patient cables, extender cables, sensors or external power supplies.
. The SB100II is not provided sterile is not intended to be sterilized.
. The SB100II is not a reprocessed device.
. The SB10011 does not have multiple modes. It is on or off, when it is on, it measures SpO2 and pulse rate as described above.
. There are no claims relative to motion tolerance
. There are no claims relative to low perfusion

Indications for Use:

The SB10011 Fingertip Pulse Oximeter is a non-invasive device intended for the spot-checking of oxygen saturation of arterial hemoglobin (SpO-) and the pulse rate of adult and pediatric patients in home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care etc.). The SB10011 is not intended for continuous monitoring.

Patient Population:

Adult and pediatric patient populations

Environment of Use: Home and hospital

Contraindications: None

2

Premarket Notification 510(k)
Section 5 -- 510(k) Summary

510(k) Summary

.

| Attribute | Smiths Medical
BC13420
510(k) K013171 | Contee Medical Systems
CMS50 DL
510(k) K082641 | Atlantean SB10011
(This submission) | Discussion of
Differences |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The BCI 3420 Digit Pulse Oximeter is
a handheld, finger mounted pulse
oximeter that combines the monitor
and sensor into one assembly that
measures SpO2, pulse rate and pulse
strength. It may be used as a spot
check device in the home, hospital or
clinical environments, including
patient ground transport in clinical and
EMS (Emergency Medical Services)
settings. The BCI 3420 Digit Pulse
Oximeter will provide reliable
measurements on patient ranging from
pediatric to adults. | The Fingertip Pulse Oximeter is
a non-invasive device intended
for the spot-check of oxygen
saturation of arterial hemoglobin
(SpO2) and the pulse rate of
adult and pediatric patients in
home and hospital environments
(including clinical use in
internist/surgery, anesthesia,
intensive care etc.). This device
is not intended for continuous
monitoring. | The SB10011 Fingertip Pulse Oximeter is
a non-invasive device intended for the
spot-checking of oxygen saturation of
arterial hemoglobin (SpO2) and the pulse
rate of adult and pediatric patients in
home and hospital environments
(including clinical use in internist /
surgery, anesthesia, intensive care etc.).
The SB10011 is not intended for
continuous monitoring. | Same as K082641 |
| Environments of use | home, hospital or clinical
environments, including patient
ground transport in clinical and EMS
(Emergency Medical Services)
settings | home and hospital environments
(including clinical use in
internist/surgery, anesthesia,
intensive care etc. | home and hospital environments
(including clinical use in
internist/surgery, anesthesia, intensive
care etc. | Same as K082641 |
| Intended application
site | Finger | Finger | Finger | Same |
| Low perfusion claims | No | No | No | Same |
| Motion Claims | No | No | No | Same |
| Prescriptive | Yes | Yes | Yes | Same as K082641 |
| Patient population | Pediatric / adult | Pediatric / adult | Pediatric / adult | Same |
| Reusable | Yes | Yes | Yes | Same |
| Display Type | LED | LED | LED | Same |
| Attribute | Smiths Medical
BC13420
510(k) K013171 | Contec Medical Systems
CMS50 DL
510(k) K082641 | Atlantean SB10011
(This submission) | Discussion of
Differences |
| Display Parameter | SpO2, Pulse Rate, Pulse Strength | SpO2, Pulse Rate, Pulse Strength | SpO2, Pulse Rate, Pulse Strength | Same |
| Controls | On | On | On / off | Same |
| Alarms | Unknown | Unknown | None | No alarms on SB10011 |
| SpO2
Range | 0-99% | 35-99% | 35-99% | Same as K082641 |
| Resolution | 1% | 1% | 1% | Same |
| Accuracy | +/-2% 70-99% | +/-2% 70-99% | +/-3% 70-99% | Similar, actual Arms 2.5
Meets FDA guidance for
non-motion ≤ 3.0 %
Meets ISO 9919 for non-
motion