(89 days)
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No
The document describes a standard pulse oximetry device and does not mention any AI or ML components or capabilities.
No.
The device is for monitoring physiological parameters (oxygen saturation, pulse rate, and pulse amplitude) and does not treat or cure any 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 aid in diagnosis. It also mentions "prescription use only," further implying its role in clinical assessment.
No
The device description explicitly states it consists of "Pulse Oximetry sensors and cables" and includes physical components like "Connector, Cable and sensor," which are hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The OxiprobE is described as a pulse oximetry sensor and cable used for non-invasive measurement of blood oxygen saturation and pulse rate. It works by placing a sensor on the patient's body (likely a finger or toe) and using light to measure these parameters.
- Lack of Sample Analysis: The description does not mention taking any samples from the patient for analysis. The measurement is done externally and directly on the patient.
Therefore, the OxiprobE falls under the category of a non-invasive medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The OxiprobE is indicated for non-invasive, continuus, beat-by-beat monitoring of oxygen saturation of functional arterial hemoglobin, pulse rate and pulse amplitude. Individual models are labeled specifically for either adult or pediatric use. It is for prescription use only.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
The Oxiproble is Pulse Oximetry sensors and cables used for non-invasive measurement of blood oxygen saturation and pulse rute measurement. It consists of Connector, Cable and sensor. Bio Medical Technologies Co., Ltd. supplies both disposable and reusable sensors. 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. Adhesive sensors are patient-dedicated and can travel with your patients. Single-use sensors do not present the risk of cross-contamination caused by products that are reused from patient up patient. Reusable sensors are designed to monitor various sizes of relatively immobile patients. When short-term or intermittent monitoring is necessary, these reusable, nonsterile sensors are an effective monitoring alternative.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
The Oxiproble models BM-100, BM-200 and BM-300 are indicated for adult patients. The Oxiproble model BM-400 is indicated for pediatric patients.
The Oxiproble models BM-300s is indicated for adult patients over 30 kg. The OxiproblE models BM -600p is indicated for pediatric patients over 10 kg and less than 50 kg.
Intended User / Care Setting
prescription use only.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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).
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§ 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
Image /page/0/Picture/1 description: The image shows a diagram of a molecule. The molecule is made up of three atoms, labeled as M, B, and M. The atoms are connected by lines, indicating that they are bonded together. The text below the diagram says 'Bimetallic homogeneous molecular catalyst'.
Medical Technologies Co., Ltd 1 Bldg. #431-17. Shindang-dong, Jung-gu,Seoul, 100-452. Korea cl.822.2234.0780~2 Fax: 822.2234.0748
NOV 1 6 2009
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92(c).
Date: Aunistrator 6, 2009
- Company and Correspondent making the submission:
| Company | |
|---|---|
| Name | Bio Medical Technologies Co., Ltd. |
| Address | Megu Bldg. #431-17. Shindang-dong, Jung- |
| gu, Seoul, 100-452, Republic of Korea | |
| Phone | |
| Fax | +82 2 2234-0780-2 |
| +82 2 2234-0748 | |
| Contact | K.N. Kim |
2. Device:
Proprietary Name - OxiprobE Common Name - Oximetry Sensor Classification Name - Oximeter
3. Predicate Device:
Model D-25, N-25, D-20, Nellcor Puritan Bennett Inc., K993637 Philips Reusable SpO2 Sensors-M1191T, M1192T, Philips Medical Systems, K063783
4. Classifications Names & Citations:
Regulation Number: 21 CFR 870.2700 Regulatory Class: Class II
Regulation Name: Oximeter Product Code: DQA
- Description:
The Oxiproble is Pulse Oximetry sensors and cables used for non-invasive measurement of blood oxygen saturation and pulse rute measurement. It consists of Connector, Cable and sensor. Bio Medical Technologies Co., Ltd. supplies both disposable and reusable sensors. 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
1
Image /page/1/Picture/0 description: The image shows a logo with three circles connected by lines. The top circle contains the letters 'm' and 'm', the left circle contains the letters 'b' and 'b', and the right circle contains the letters 't' and 't'. Below the circles, the text 'An Medical Technologies' is written, followed by 'www.am-tech.co.kr'.
Bio Medical Technologies Co.,Ltd legu Bldg. #431-17. Shindang-dong, Jung-gu,Seoul, 100-452, Korea Tel.822.2234.0780~2 Fax.822.2234.0748
these important optical components and provides a comfortable fit. Adhesive sensors are patient-dedicated and can travel with your patients. Single-use sensors do not present the risk of cross-contamination caused by products that are reused from patient up patient. Reusable sensors are designed to monitor various sizes of relatively immobile patients. When short-term or intermittent monitoring is necessary, these reusable, nonsterile sensors are an effective monitoring alternative.
The Oxiproble models BM-100, BM-200 and BM-300 are indicated for adult patients. The Oxiproble model BM-400 is indicated for pediatric patients.
The Oxiproble models BM-300s is indicated for adult patients over 30 kg. The OxiproblE models BM -600p is indicated for pediatric patients over 10 kg and less than 50 kg.
- ర్. Indication for use:
The OxiprobE is indicated for non-invasive, continuus, beat-by-beat monitoring of oxygen saturation of functional arterial hemoglobin, pulse rate and pulse amplitude. Individual models are labeled specifically for either adult or pediatric use. It is for prescription use only.
7. Review:
The OXIPROBE has the same device characteristics as the predicate device, the intended use, materials, design and use concept are similar.
Based on the comparison of intended use and technical features, the OXIPROBE is substantially equivalent to the predicate device.
8. Conclusions:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Bio Medical Technologics Co., Ltd. concludes that the OXIPROBE are safe and effective and substantially equivalent to predicate devices as described herein.
-
- Bio Medical Technologies Co., Ltd. will update and include in this summary any other information deemed reasonably necessary by the FDA.
END
- Bio Medical Technologies Co., Ltd. will update and include in this summary any other information deemed reasonably necessary by the FDA.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird, with its wings forming a flowing, abstract design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Bio Medical Technologies Company, Limited C/O Ms. Cathryn Cambria Arkin Consulting Group, L.L.C. 5536 Trowbridge Drive Dunwoody, Georgia 30338
NOV 1 6 2009
Re: K092549
Trade/Device Name: OxiprobE Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II . Product Code: DQA Dated: August 6. 2009 Received: August 19, 2009
Dear Ms. Cambria:
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.
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. Cambria
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,
for
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number K
Device Name: OxiprobE
Indication for use:
The OxiprobE is indicated for non-invasive, continuus, beat-by-beat monitoring of oxygen saturation of functional arterial hemoglobin, pulse rate and pulse amplitude. Individual models are labeled specifically for either adult or pediatric use. It is for prescription use only.
Prescription Use N ાર (Per 21CFR801 Subpart D)
Over-The-Counter Use (Per 21CFR807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schultheis
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: k 092549