(352 days)
No
The summary describes a standard pulse oximetry sensor and does not mention any AI or ML components in its description, intended use, or performance studies.
No
This device is a diagnostic tool used for monitoring physiological parameters (oxygen saturation, pulse rate, and pulse amplitude), not for treating a condition.
Yes
The device is indicated for "non-invasive, continuous, beat-by-beat monitoring of oxygen saturation of functional arterial hemoglobin, pulse rate, and pulse amplitude," which are measurements used to assess a patient's physiological state and help diagnose conditions.
No
The device description explicitly states it is a "Pulse Oximetry Sensor" and describes physical components like "disposable sensors," "light source," "photo detector," and "adhesive." It also mentions compatibility with an "extension cable" and a "Pulse Oximeter," all of which are hardware components.
Based on the provided text, the OxiprobE is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states "non-invasive, continuous, beat-by-beat monitoring of oxygen saturation of functional arterial hemoglobin, pulse rate, and pulse amplitude." This describes a device that measures physiological parameters directly from the patient's body, not from a sample taken from the body (like blood, urine, or tissue).
- Device Description: The description reinforces the non-invasive nature, mentioning the sensor being positioned "on the patient" and measuring "blood oxygen saturation and pulse rate measurement."
- Lack of IVD Characteristics: The text does not mention any analysis of samples taken from the body, reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, the OxiprobE is a non-invasive medical device used for physiological monitoring, not an IVD.
N/A
Intended Use / Indications for Use
The OxiprobE is indicated for non-invasive, continuous, beat-by-beat monitoring of oxygen saturation of functional arterial hemoglobin, pulse rate, and pulse amplitude. Individual models are labeled for the intended use. It is for prescription use only.
Product codes
DQA
Device Description
The OxiprobE Pulse Oximetry Sensors are used for non-invasive measurement of blood oxygen saturation and pulse rate measurement. The disposable sensors are designed to enable the sensor's light source and photo detector to be securely and properly positioned on the patient. The adhesive stabilizes these important optical components and provides a comfortable fit. The adhesive sensors are patient-dedicated and can travel with the patients. The single-use, disposable sensors do not present the risk of cross-contamination caused by products that are reused from patient to patient. This 510(k) seeks premarket clearance for a line extension model BM-500, compatible with the BM-2070 extension cable and the Nellcor N-395 Pulse Oximeter (a legacy oximeter.). The BM-2070 extension cable was cleared for use with the predicate BMT sensors under K092549.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult / Infant
Infant/Adult
Intended User / Care Setting
Not Found
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)
Nonclinical Bench Testing (No new clinical data was required to support this 510(k)) was included to support substantial equivalence as listed below:
- EN ISO 60601-1:2006, 30 edition: including ●
- Humidity preconditioning treatment (sub-clause 5.7) -
- Accessible parts (sub-clause 5.9.2) -
- Legibility of markings (sub-clause 7.1.2) -
- -Durability of markings (sub-clause 7.1.3)
- Leakage Current Tests (sub-clause 8.7) -
- Temperature test (11.1) -
- -Interruption of the power supply (sub-clause 11.8)
- Power Limitation test (sub-clause 13.1.2) -
- Push test (sub-clause 15.3.2) -
- Drop Test (hand-held) (sub-clause 15.3.4.1 -
- With the exception of: Usability EN 60601-1-6, or "accuracy" which was tested elsewhere by the sponsor, and those clauses not applicable to pulse oximetry sensors as determined by the certified testing laboratory
- EN ISO 80601-2-61:2011, Medical electrical equipment Part 2-61 Particular requirements . for basic safety and essential performance of pulse oximeter equipment for all units subject of this submission with the exception of those parts which the laboratory determined to be not applicable to sensors.
- . Electromagnetic Compatibility and Interference testing (EMC / EMI) was performed on all of the BMT Pulse Oximetry Sensors which are the subject of this 510(k) was conducted to determine compliance with the applicable requirements of the ISO 80601-2-61:2011 Standard as discussed on the FDA's Pulse Oximeter Guidance.
- Pulse and SpO2 accuracy. .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 Accuracy (%): BM-500 : 70 - 100 ± 3
Pulse Rate Accuracy (bpm): BM-500 : 50 - 150 ± 2
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
510(K) SUMMARY
Date Summary Prepared: July 30. 2014
JUL 3 0 2014
| Sponsor Information: | |
|---|---|
| Company Name: | BIO Medical Technologies Co., Ltd.(BMT) |
| Address: | Megu Bldg #431-17 |
| Shindang-dong, Jung-gu | |
| Seoul, Republic of Korea 100-452 | |
| Contact: | Bruce Lee |
| Telephone: | +(82) 222340782 |
| FAX: | +(82) 222340748 |
Correspondent Contact Information:
| Company Name: | Paladin Medical, Inc. | |
|---|---|---|
| Address: | P.O. Box 560 | |
| Stillwater, MN 55082 | ||
| Contact: | Elaine Duncan, M.S.M.E., RAC | |
| Title: | President | |
| Telephone: | +(82) 222340782 | |
| FAX: | +(82 222340748 |
DEVICE INFORMATION:
- . Proprietary Name: OxiprobE
- Common Name: Oximetry Sensor .
- Classification Name: Oximeter .
- Regulation Number: 870.2700 .
- Classification Product Code: DQA .
- . Classification/Review Advisory Committee: Anesthesiology
DESCRIPTION of the DEVICE:
The OxiprobE Pulse Oximetry Sensors are used for non-invasive measurement of blood oxygen saturation and pulse rate measurement. The disposable sensors are designed to enable the sensor's light source and photo detector to be securely and properly positioned on the patient. The adhesive stabilizes these important optical components and provides a comfortable fit. The adhesive sensors are patient-dedicated and can travel with the patients. The single-use, disposable sensors do not present the risk of cross-contamination caused by products that are reused from patient to patient. This 510(k) seeks premarket clearance for a line extension model BM-500, compatible with the BM-2070 extension cable and the Nellcor N-395 Pulse Oximeter (a legacy oximeter.). The BM-2070 extension cable was cleared for use with the predicate BMT sensors under K092549.
INDICATION FOR USE:
The OxiprobE is indicated for non-invasive, continuous, beat-by-beat monitoring of oxygen saturation of functional arterial hemoclobin, pulse rate, and pulse amplitude. Individual models are labeled for the intended use. It is for prescription use only.
PREDICATE DEVICE USED FOR SUBSTANTIAL EQUIVALENCE:
| Device Feature | Predicate BMT Sensors
(K092549) | Subject BMT Sensors (K132516) | Comparison* |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Indication for Use | The OxiprobE is indicated for
non-invasive, continuous, beat-
by-beat monitoring of oxygen
saturation of functional arterial
hemoglobin, pulse rate, and
pulse amplitude. Individual
models are labeled for the
intended use. It is for
prescription use only. | The OxiprobE is indicated for non-
invasive, continuous, beat-by-beat
monitoring of oxygen saturation of
functional arterial hemoglobin, pulse
rate, and pulse amplitude. Individual
models are labeled for the intended use.
It is for prescription use only. | Same |
| Intended Use | BM-200: Adult / Infant | BM-500: Infant/Adult | Same |
1
510(k) Summary-Continued
| Device Feature | Predicate BMT Sensors
(K092549) | Subject BMT Sensors (K132516) | Comparison* |
|----------------------------|----------------------------------------------|-------------------------------|-------------|
| | BM-400 Pediatric | | |
| Usage Type | Single Use Disposable | Single Use Disposable | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Adhesive Tape Type | BM-200: Tan Woven
BM-400 Clear Woven | BM-500: Tan Woven | SE |
| Emitter - Detector Spacing | BM-200 = 26mm
BM-400 = 20mm | BM-500 = 20mm | Same |
| Tape Length | BM-200 = 110mm
BM-400 = 81mm | BM-500 = 80mm | Same |
| SpO2 Accuracy
(%) | BM-200: 70 - 100 ± 2
BM-400: 70 - 100 ± 3 | BM-500 : 70 - 100 ± 3 | Same |
| Pulse Rate Accuracy (bpm) | BM-200: 50 - 150 ± 2
BM-400: 50 - 150 ± 2 | BM-500 : 50 - 150 ± 2 | Same |
PERFORMANCE TESTING:
Nonclinical Bench Testing (No new clinical data was required to support this 510(k)) was included to support substantial equivalence as listed below:
- EN ISO 60601-1:2006, 30 edition: including ●
- Humidity preconditioning treatment (sub-clause 5.7) -
- Accessible parts (sub-clause 5.9.2) -
- Legibility of markings (sub-clause 7.1.2) -
- -Durability of markings (sub-clause 7.1.3)
- Leakage Current Tests (sub-clause 8.7) -
- Temperature test (11.1) -
- -Interruption of the power supply (sub-clause 11.8)
- Power Limitation test (sub-clause 13.1.2) -
- Push test (sub-clause 15.3.2) -
- Drop Test (hand-held) (sub-clause 15.3.4.1 -
- With the exception of: Usability EN 60601-1-6, or "accuracy" which was tested elsewhere by the sponsor, and those clauses not applicable to pulse oximetry sensors as determined by the certified testing laboratory
- EN ISO 80601-2-61:2011, Medical electrical equipment Part 2-61 Particular requirements . for basic safety and essential performance of pulse oximeter equipment for all units subject of this submission with the exception of those parts which the laboratory determined to be not applicable to sensors.
- . Electromagnetic Compatibility and Interference testing (EMC / EMI) was performed on all of the BMT Pulse Oximetry Sensors which are the subject of this 510(k) was conducted to determine compliance with the applicable requirements of the ISO 80601-2-61:2011 Standard as discussed on the FDA's Pulse Oximeter Guidance.
- Pulse and SpO2 accuracy. .
CONCLUSION
It can be concluded from the results that the model BM 500 for use with the Nellcor Model N395 Pulse Oximeter, compatible with the predicate BM-2070 extension cable is substantially equivalent to the predicate.
2
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 30, 2014
BIO Medical Technologies, Co. Ltd. c/o Elaine Duncan, M.S.M.E., RAC President Paladin Medical, Inc. P.O. Box 560 Stillwater, MN 55082
Re: K132516
Trade/Device Name: OxiprobE Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: July 18, 2014 Received: July 21, 2014
Dear Ms. Duncan:
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 read may merest 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.
3
Page 2 Ms. Elaine Duncan
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 (OS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.hum.
Sincerely yours.
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director
DAGRID/ODE/CDRI! FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K132516
Device Name: OxiprobE
Indications for Use:
The OxiprobE is indicated for non-invasive, continuous, beat-by-beat monitoring of oxygen saturation of functional arterial hemoglobin, pulse rate, and pulse amplitude. Individual models are labeled for the intended use. It is for prescription use only.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| AND/OR | |
| Over-The-Counter Use | |
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/4/Picture/7 description: The image shows the text 'Todd D. Courtney -S' at the top. Below that is the date and time '2014:07:30 13:19:01'. The timezone offset '-04'00'' is at the bottom left. The letters 'FDA' are in the center of the image.