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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and the supporting study:

The provided document describes a 510(k) submission for the OxiprobE Pulse Oximetry Sensors (model BM-500). The submission focuses on demonstrating substantial equivalence to a predicate device (BMT Sensors, K092549) rather than a comprehensive, de novo clinical study proving novel performance.

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Predicate Device)	Reported Device Performance (Subject Device - BM-500)
SpO2 Accuracy (%)	70 - 100 ± 2 (BM-200), 70 - 100 ± 3 (BM-400)	70 - 100 ± 3
Pulse Rate Accuracy (bpm)	50 - 150 ± 2 (BM-200), 50 - 150 ± 2 (BM-400)	50 - 150 ± 2
Usage Type	Single Use Disposable	Single Use Disposable
Sterility	Non-Sterile	Non-Sterile
Adhesive Tape Type	Tan Woven (BM-200), Clear Woven (BM-400)	Tan Woven
Emitter - Detector Spacing	26mm (BM-200), 20mm (BM-400)	20mm
Tape Length	110mm (BM-200), 81mm (BM-400)	80mm

Note: The reported device performance for the subject device (BM-500) is presented as being "Same" or "SE" (Substantially Equivalent) to the predicate device's specifications, implying it meets or is comparable to the predicate's acceptance criteria. For SpO2 and Pulse Rate accuracy, the BM-500 aligns with the specifications of one of the predicate models (BM-400 for SpO2 and both for Pulse Rate).

2. Sample Size for the Test Set and Data Provenance

The document states, "Nonclinical Bench Testing (No new clinical data was required to support this 510(k)) was included to support substantial equivalence." This indicates that no human clinical test set was used for this particular submission. The "test set" consisted of the device itself undergoing various bench tests.

Sample Size: Not applicable in the context of a human test set. For bench testing, the sample sizes would refer to the number of devices or components tested, which is not specified in this summary.
Data Provenance: Not applicable for clinical study provenance as no clinical data was generated for this submission. The performance assessment relied on bench testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable as no human clinical test set was used to establish ground truth from patient data. The "ground truth" for the non-clinical tests would be the established international standards and internal specifications the device was tested against.

4. Adjudication Method for the Test Set

Not applicable as no human clinical test set or subjective expert evaluation was involved for this submission requiring an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. A MRMC comparative effectiveness study was not performed. The submission explicitly states "No new clinical data was required" and focuses on bench testing to establish substantial equivalence with a predicate device. This type of study is more relevant for diagnostic aids involving human interpretation of images or data.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, in essence, standalone non-clinical performance was evaluated. The "Pulse and SpO2 accuracy" testing, along with other bench tests (EMC/EMI, electrical safety, durability), evaluated the device's inherent performance without a human in the loop interpreting its output. The device itself (the sensor) is a measurement tool, and its accuracy is inherent to its design and function. The output of the device (SpO2 and pulse rate readings) is the standalone performance.

7. Type of Ground Truth Used

For the accuracy parameters (SpO2 and Pulse Rate accuracy), the ground truth would have been established by a reference standard or validated measurement method during the original development and testing of the predicate device and likely followed established physiological measurement standards for oximetry. The current submission relies on the established accuracy of the predicate and demonstrates that the new device meets similar specifications via bench testing.

For the other performance tests (e.g., EN ISO 60601-1, EN ISO 80601-2-61, EMC/EMI), the ground truth is defined by the specific requirements and limits set forth in these international technical standards. The device's performance is compared against these normative requirements.

8. Sample Size for the Training Set

Not applicable. This device, an oximetry sensor, does not involve machine learning or an "algorithm" that requires a training set in the conventional sense for diagnostic image analysis or similar AI applications. Its function is based on established optical and physiological principles, and its parameters are set by design, not by learning from labeled data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

{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 #431-17Shindang-dong, Jung-guSeoul, 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:

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 fornon-invasive, continuous, beat-by-beat monitoring of oxygensaturation of functional arterialhemoglobin, pulse rate, andpulse amplitude. Individualmodels are labeled for theintended use. It is forprescription use only.	The OxiprobE is indicated for non-invasive, continuous, beat-by-beatmonitoring of oxygen saturation offunctional arterial hemoglobin, pulserate, and pulse amplitude. Individualmodels 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 WovenBM-400 Clear Woven	BM-500: Tan Woven	SE
Emitter - Detector Spacing	BM-200 = 26mmBM-400 = 20mm	BM-500 = 20mm	Same
Tape Length	BM-200 = 110mmBM-400 = 81mm	BM-500 = 80mm	Same
SpO2 Accuracy(%)	BM-200: 70 - 100 ± 2BM-400: 70 - 100 ± 3	BM-500 : 70 - 100 ± 3	Same
Pulse Rate Accuracy (bpm)	BM-200: 50 - 150 ± 2BM-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}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the United States. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the bird symbol.

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:

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.

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).