(110 days)
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.
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.
Here's a breakdown of the acceptance criteria and the study information for the SB100II Finger Pulse Oximeter, based on the provided documents:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Attribute | Acceptance Criteria (Predicate or Regulatory Standard) | Reported Device Performance (SB100II) |
|---|---|---|
| SpO2 Accuracy | +/-2% 70-99% (from K082641, K013171) | +/-3% 70-99% |
| Pulse Accuracy | ±2% or 2 bpm whichever is greater (from K082641, K013171) | +/-3 bpm |
| SpO2 Range | 35-99% (from K082641) | 35-99% |
| SpO2 Resolution | 1% | 1% |
| Pulse Range | 30-250 bpm (from K082641) | 30-250 bpm |
| Pulse Resolution | 1 bpm | 1 bpm |
| Standards Compliance | IEC 60601-1, IEC 60601-1-2, ISO 9919 | Meets current revisions of IEC 60601-1:1988+A1+A2, IEC 60601-1-2:2001+A1, and ISO 9919:2005 |
| Ingress Protection | Meets FDA guidance for protection against ingress of water (not specified in predicates) | IPX1 and ISO 9919 Clause 44 |
| Electrical Safety | Unknown (for predicates) | Type BF |
Discussion of Performance vs. Criteria:
- SpO2 Accuracy: The SB100II reports an accuracy of +/-3% in the 70-99% range. The document states this is "Similar, actual Arms 2.5 Meets FDA guidance for non-motion ≤ 3.0 % Meets ISO 9919 for non-motion <4.0 %". This indicates that while it's numerically slightly less accurate than the predicate's reported +/-2%, it still meets the FDA guidance and ISO standards for non-motion pulse oximeters.
- Pulse Accuracy: The SB100II reports +/-3 bpm accuracy, which is described as "Similar" to the predicate's "±2% or 2 bpm whichever is greater". This suggests it is within acceptable limits.
- Other Parameters: SpO2 Range, SpO2 Resolution, Pulse Range, and Pulse Resolution are identical or directly comparable to the predicate devices and meet the criteria.
- Standards Compliance: The SB100II meets current revisions of the listed consensus standards (IEC 60601-1, IEC 60601-1-2, and ISO 9919), demonstrating compliance with recognized safety and performance standards.
- Ingress Protection & Electrical Safety: The SB100II reports specific compliance (IPX1, Type BF) which meets FDA guidance and suitable protection class, respectively. These were unknown for the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
The document states "ISO 9919 including clinical testing" was performed (Page 5, "Performance Testing").
- There is no explicit sample size mentioned for the clinical testing in the provided text.
- There is no specific data provenance (e.g., country of origin, retrospective/prospective) mentioned within the provided text, other than the general statement of "clinical testing" as part of ISO 9919.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- This information is not provided in the document. For pulse oximetry, the "ground truth" for SpO2 is typically established by arterial blood gas analysis, which is an objective measurement, not expert consensus.
4. Adjudication Method
- This information is not applicable and not provided. The "ground truth" for pulse oximetry is a direct physiological measurement, not an interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done or reported. This type of study focuses on human reader performance, which is not relevant for a standalone pulse oximeter device. The device provides a direct numerical reading.
6. Standalone Performance Study
- Yes, a standalone performance study was conducted. The "Performance Testing" section states: "The following performance tests were done and the SB100II meet all requirements. - ISO 9919 including clinical testing". The "Summary of Differences" table also directly compares the SB100II's performance attributes (SpO2 Accuracy, Pulse Accuracy, etc.) against predicate devices, indicating standalone evaluation. The device is explicitly stated as "a standalone device" (Page 2).
7. Type of Ground Truth Used for Test Set
- The ground truth for the clinical testing to establish SpO2 accuracy as per ISO 9919 (which is the relevant standard for pulse oximeters) involves comparing the device's readings against arterial blood gas analysis (functional oxygen saturation). This is considered an objective, gold-standard physiological measurement.
8. Sample Size for the Training Set
- Training set details are not provided. For this type of medical device (pulse oximeter), there typically isn't a "training set" in the sense of machine learning. The device's algorithms are based on established physiological principles and calibrated during development, rather than "trained" on a large dataset. The provided document focuses on performance verification rather than algorithm development.
9. How Ground Truth for the Training Set Was Established
- This information is not provided and generally not applicable for the type of device. The ground truth for calibration and design of pulse oximeters usually comes from extensive physiological studies and controlled desaturation studies where arterial blood gas measurements are the reference.
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| Page 1 of 602-Jun-2010 | ||
|---|---|---|
| Official Contact: | CY Wang - RD VPAtlantean1F, No. 789, Bo-ai StreetChubay City, TAIWANTel - 886-3-555-8340Fax - 886-2-2736-3250 | K10156SEP 20 2010 |
| Proprietary or Trade Name: | SB100II Finger Pulse Oximeter | |
| Common/Usual Name: | Pulse oximeter | |
| Classification Name: | OximeterDQA - 870.2700 | |
| Predicate Devices: | Contec Medical Systems, K082641, CMS-50DLSmith'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. .
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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
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Premarket Notification 510(k)
Section 5 -- 510(k) Summary
510(k) Summary
.
| Attribute | Smiths MedicalBC13420510(k) K013171 | Contee Medical SystemsCMS50 DL510(k) K082641 | Atlantean SB10011(This submission) | Discussion ofDifferences |
|---|---|---|---|---|
| Indications for Use | The BCI 3420 Digit Pulse Oximeter isa handheld, finger mounted pulseoximeter that combines the monitorand sensor into one assembly thatmeasures SpO2, pulse rate and pulsestrength. It may be used as a spotcheck device in the home, hospital orclinical environments, includingpatient ground transport in clinical andEMS (Emergency Medical Services)settings. The BCI 3420 Digit PulseOximeter will provide reliablemeasurements on patient ranging frompediatric to adults. | The Fingertip Pulse Oximeter isa non-invasive device intendedfor the spot-check of oxygensaturation of arterial hemoglobin(SpO2) and the pulse rate ofadult and pediatric patients inhome and hospital environments(including clinical use ininternist/surgery, anesthesia,intensive care etc.). This deviceis not intended for continuousmonitoring. | The SB10011 Fingertip Pulse Oximeter isa non-invasive device intended for thespot-checking of oxygen saturation ofarterial hemoglobin (SpO2) and the pulserate of adult and pediatric patients inhome and hospital environments(including clinical use in internist /surgery, anesthesia, intensive care etc.).The SB10011 is not intended forcontinuous monitoring. | Same as K082641 |
| Environments of use | home, hospital or clinicalenvironments, including patientground transport in clinical and EMS(Emergency Medical Services)settings | home and hospital environments(including clinical use ininternist/surgery, anesthesia,intensive care etc. | home and hospital environments(including clinical use ininternist/surgery, anesthesia, intensivecare etc. | Same as K082641 |
| Intended applicationsite | 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 MedicalBC13420510(k) K013171 | Contec Medical SystemsCMS50 DL510(k) K082641 | Atlantean SB10011(This submission) | Discussion ofDifferences |
| 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 |
| SpO2Range | 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 2.5Meets FDA guidance fornon-motion ≤ 3.0 %Meets ISO 9919 for non-motion <4.0 % |
| Type | <70% unspecified | <70% unspecified | 35-69% unspecified | Same as K082641 |
| PulseRange | 30-254 bpm | 30-250 bpm | 30-250 bpm | Same |
| Accuracy | ±2% or 2 bpm whichever is greater | ±2% or 2 bpm whichever isgreater | ±3 bpm | Similar |
| Resolution | 1 bpm | 1 bpm | 1 bpm | Same |
| Power | 2 "AAA" batteries | 2 "AAA" batteries | 2 "AAA" batteries | Same |
| Battery Life | 16 hours continuous1400 spot checks | 30 hours | 16 hours continuous | Same time duration asK013171 |
| Attribute | Smiths MedicalBC13420510(k) K013171 | Contec Medical SystemsCMS50 DL510(k) K082641 | Atlantean SB10011(This submission) | Discussion of Difference |
| Environmental | ||||
| Dimensions | 57.2 x 43.3 x 38.1 mm | unknown | 63.5x34x35mm | Similar to K013171 |
| Weight | 85g | Unknown | 37g | Lighter than K013171 |
| OperatingTemperature | 10°C-55°C | Unknown | 5°C to 40°C | Similar to K013171 |
| Storage Temperature | -40°C-75°C | Unknown | -20°C to 70°C | Similar toKk013171 |
| Operating Humidity | 15%-95% | Unknown | 15%-95% | Similar to K013171 |
| Storage Humidity | 10-95% | unknown | 15%-95% | Similar to K013171 |
| Standards | ||||
| IEC 60601-1 | Yes (undated) | Yes (undated) | Yes IEC 60601-1: 1988 +A1+A2 | SB10011 meets current revisionof the recognized consensusstandard |
| IEC 60601-1-2 | Yes EN 60601-1-2: 1993 | Yes (undated) | IEC 60601-1-2: 2001 +AI | SB100II meets currentrecognized consensus standard |
| ISO 9919 | Unknown | ISO 9919: 2005 | ISO 9919: 2005 | Same as K082641 (currentrevision of the recognizedconsensus standard) |
| General | ||||
| Protection againstingress of water | Unknown | Unknown | IPX1 and ISO 9919 Clause 44 | Meets FDA guidance |
| Protection Class(electrical safety) | Unknown | Unknown | Type BF | Protection class is suitable for |
Page 5.20
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Premarket Notification 510(k) Summary
510(k) Summary
Page 5.21
.
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Premarket Notification 510(k)
Section 5 = 510(k) Summary
510(k) Summary
Page 5.22
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510(k) Summary Page 6 of 6 . 02-Jun-2010
Performance Testing:
The following performance tests were done and the SB100II meet all requirements.
- . ISO 9919 including clinical testing
- 1EC 60601-1-2 .
- . IEC 60601-1
Substantial Equivalence:
The SB100II Pulse Oximeter is viewed as substantially equivalent to the predicate devices because it performs the same basic functionality by similar technical means.
Indications -
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.
Technology -
The SB100H 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 SB100II contains the electronics to interface to the integral sensor. This sensor consists of a light emitting diode and a photoelectric cell placed on cither 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.
Materials - - --
The materials in contact with the patient as common to medical devices.
Environment of Use -
Home and hospital environments (including clinical use in internist/surgerv, anesthesia, intensive care etc.).
Patient Population -Adult and pediatric
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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol on the right side. To the left of the bird symbol is a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Atlantean C/O Mr. Paul E. Dryden President ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134
SEP 2 0 2010
Re: K101568
Trade/Device Name: SB100II Finger Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: September 15, 2010 Received: September 16, 2010
Dear Mr. Dryden:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Dryden
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Jame O. Eastland
Anthony D. Watson, B.S., M.S., M.B.A. 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 Statement
SEP 2 0 2010
Page 1 of 1
510(k) Number:
(To be assigned)
Device Name:
SB100II Finger Pulse Oximeter
Indications for Use:
The SB100II Fingertip Pulse Oximeter is a non-invasive device intended for the spotchecking 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.
Prescription Use XX (Part 21 CFR 801 Subpart D)
or
Over-the-counter use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schuta
Division Sign-Off) Division of Anesthesiology. General Hospital Infection Control, Dental Devices
510(k) Number: K101568
§ 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).