(92 days)
Contec 08A K110774
No
The document describes a system that integrates existing cleared devices and software for data management and analysis, but there is no mention of AI or ML technologies being used for data processing, interpretation, or any other function. The analysis is based on standard data display and review by healthcare professionals.
No
The device is used for non-invasively measuring and displaying physiological parameters (SpO2, PR, NIBP) and for data management, not for treating any condition.
No
The text explicitly states: "The TM-Oxi system does not report any diagnosis but provides values."
No
The device description explicitly states that the system comprises both hardware (Non-invasive blood pressure components, USB HUB, power supply, converters) and software. It is described as a "programmable electro medical system using one oximeter and one noninvasive blood pressure device (NIBP)".
Based on the provided information, the TM-Oxi device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens from the human body. The TM-Oxi device measures physiological parameters (SpO2, pulse rate, NIBP) directly from the patient's body (finger and arm) using non-invasive methods. It does not analyze blood, urine, tissue, or other biological samples.
- The intended use is for non-invasive measurement of vital signs. The description clearly states the device measures and displays SpO2, pulse rate, and NIBP. These are vital signs, not results of in vitro analysis.
- The software manages and displays data from the device. The software's purpose is to upload, display, and manage the data collected by the hardware, which are the vital sign measurements. It does not perform any analysis on biological specimens.
The TM-Oxi is a non-invasive physiological monitoring device.
N/A
Intended Use / Indications for Use
The TM-Oxi device indicated for use in non-invasively measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Non-invasive measurement of blood pressure (NIBP) of adult patients.
The TM-Oxi software uploads the data of the device and displays the data into a computer for enhanced data management. The TM-Oxi software is intended for use in clinical settings as an aid for health care professionals to review, analyze and evaluate the historical tests results. The TM-Oxi device is intended for spot-checking of patients.
The TM-Oxi system does not report any diagnosis but provides values. It is the physician's responsibility to make proper judgments based on these numbers.
Prescription Use: Federal law restricts this device to sale by or on the order of a physician.
Product codes (comma separated list FDA assigned to the subject device)
MWI, DXN, DQA
Device Description
The TM-Oxi is a programmable electro medical system using one oximeter and one noninvasive blood pressure device (NIBP). The system comprises:
- a. Hardware:
- Non- invasive blood pressure, pump and valve boards and connections, tube, bladder ● and cuff 510k cleared (K093013) not modified.
- USB HUB DC converter with 3 features .
- ✔ Power supply of NIBP board via USB hub connected to USB port of the PC and microchip converter 5V to 6 V.
- microchip converter 510k cleared (K090671) not modified via USB hub > connected to USB port of the PC.
- connected to USB port of the connected to USB port of the PC. >
b. Software:
The used software are ESO software 510k K102442 for data analysis and ES Complex software 510k number k 113264 for data management.
software 310k humber K 115204 for addinations of the data from oximeter (ESO) and blood pressure device (Contec 08A K110774).
Therefore the TM-Oxi system will be a combination of the 2 separate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Finger (for oximeter), arm (for blood pressure cuff)
Indicated Patient Age Range
adult patients
Intended User / Care Setting
clinical settings, health care professionals
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 OEM subcontractor for MD 200A K093013 provided the PCB boards (blood pressure, pump and valve), tube and bladder, cuff and they were cleared for use together.
Therefore, ISO 9919 report from OEM oximeter and ANSI/AAMI SP10:2002 & ANSI/AAMI SP10:2002/A1:2003/A2: 2006 report from OEM blood pressure can be used for TM-Oxi.
Testing comprises:
-
- Integration tests for oximeter and blood pressure device
-
- Integration tests for oxinceler and over (Cyclic redundancy check) Coding was performing to Soltware structurar testing using Gree ( ) ) ecurately capture, store, and analyze the data measured by the hardware.
-
- Laboratory testing for electrical safety (60601-1-1) and EMC (60601-1-2)
-
- Software verification (SRS/SDS/STD/STR)
Since the TM-Oxi is using 510K cleared devices clinically tested (ISO 9919 and SP10) and with regard of the testing describe above, the TM-Oxi do not required additional clinical test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2% Accuracy: 70%~100%: ±2%, Below 70% unspecified
Pulse rate accuracy: ± 2 bpm during the pulse rate range of 3099 bpm and 2% during the pulse rate range of 100250 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.
MD2000BVital Sign Monitor K100740, ESO Software K 102442, ES Complex Software K1 13264, CMS 50E K090671, MD 200A K093013
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.
Contec 08A K110774
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
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0
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P1/7
510(k) Premarket Notification Number: K130056 Date of revision: 03/15/2013
APR 1 1 2013
510(k) Summary TM-Oxi device
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92
- Submitter's Identification: Manufacturer: L.D TECHNOLOGY Address: 100 N.Biscayne Blvd, Suite 502 Miami, FL, 33132, USA Tel: 305-379-9900 E mail: albert.ldteck@gmail.com
2. Device Name / Classification
Trade name: Patient monitor Device Name and Model: TM-Oxi Regulation number: 21CFR 870.2300 Product Code: MWI Subsequent Product codes: DXN, DQA Classification: Class II Classification Name: monitor, physiological, patient
3. Predicate legally marketed devices
- MD2000BVital Sign Monitor K100740.Applicant: Beijing Choice Electronic Technology Co., Ltd. Product . Code MWI. Subsequent Product codes: DXN, DQA
- ESO Software K 102442. Applicant: LD Technology LLC .Product code DQA
- ES Complex Software K1 13264. Applicant: LD Technology LLC. Product Code DXN, DQA, GZO, MNW ◆
- CMS 50E K090671 Applicant: Contec Medical Systems Co., Ltd Product Code DQA .
- MD 200A K093013 Applicant: Beijing Choice Electronic Technology Co., Ltd Product Codes DXN
4. Device Description
The TM-Oxi is a programmable electro medical system using one oximeter and one noninvasive blood pressure device (NIBP). The system comprises:
- a. Hardware:
- Non- invasive blood pressure, pump and valve boards and connections, tube, bladder ● and cuff 510k cleared (K093013) not modified.
- USB HUB DC converter with 3 features .
- ✔ Power supply of NIBP board via USB hub connected to USB port of the PC and
1
microchip converter 5V to 6 V.
- microchip converter 510k cleared (K090671) not modified via USB hub > connected to USB port of the PC.
- connected to USB port of the connected to USB port of the PC. >
b. Software:
Software:
The used software are ESO software 510k K102442 for data analysis and ES Complex software 510k number k 113264 for data management.
software 310k humber K 115204 for addinations of the data from oximeter (ESO) and blood pressure device (Contec 08A K110774).
pressure device (Contect 687 ATT 10777).
Therefore the TM-Oxi system will be a combination of the 2 separate devices.
5. Intended use and indications for use
- Intended use and indications for use in non-invasively measuring and displaying functional The I M-Oxi device indicated for use in non invasively measurement of the sive measurement of blood pressure (NIBP) of adult patients.
blood pressure (NIBP) of adult patients.
The TM-Oxi software uploads the data of the device and displays in olinical settings as an The TM-Oxi sollware uploads the data of the do rooms' in clinical settings as an
enhanced data management. The TM-Oxi software is intended for use in clinical settings as an enhanced data management. The TW On sentives to review, and evaluate the historical tests results. and for neath caree is intended for spot-checking of patients.
The TM-Oxi system does not report any diagnosis but provides values. It is the physician's THC TM-OXT Systeake proper judgments based on these numbers.
responsibility to make propel judgments based on areas any or on the order of a physician.
6. Performances, technical specifications and materials Performances
Block Diagram TM-Oxi /system
Image /page/1/Figure/15 description: The image shows a block diagram of a system with both software and hardware components. The software side includes modules for pulse rate, SpO2%, pulse wave, temporary storage, status report, data analysis and management, and blood pressure values. The hardware side includes components such as MD200A K093013, BP PCB + Pump, CMS50E K090671, USB Hub DC Converter, Microchip Converter (5V to 6V), and Hub USB ports.
2
2
Technical specifications I.e. Device description Patient contact materials:
Patient contact materials.
The materials in contact with the patient are the cuff, tube, blader and oximely from the first The materials in contact with the particul are PVC and they are latex free Cull material is inylon and Didustic may beauting in the material and latex free.
7. Contra-indications
- Patients undergoing external defibrillation .
- r atients undergoing external delife support devices, or any implanted electronic device.
- Patients moving or long term monitoring
- Do not use this device in the presence of :
- Ilor use inis device in the praging (MR or MRI) equipment. MRI equipment may cause induced current to the device
- Strong electromagnetic sources, such as electro surgery equipment.
-
Computed tomography (CT) equipment.
- When using the oximeter finger probe, utilize the arm not in use for blood pressure,
- arterial catheter, or having an AV fistula or pressure dressing.
- arterial catherer, of having an Arream, such as methylene blue, indocyanine green, indigo carmine, and fluorescein
- earmine, and freerer of dysfunctional hemoglogins, such as carboxyhemoglobin or . methemoglobin, will affect the accuracy of the SpO2 measurement.
- mentemogiobin, will arrestricts blood flow, such as use of a blood pressure cuff or extremes Ally condition that resistance, may cause an inability to determine accurate pulse rate and SpO2 readings
- and Spolish or false fingernails: Fingernail polish or false fingernails may cause . inaccurate SpO2 readings
- maccurate 5px2 readings . regurgitation)
- Caution with low perfused patient. Using the blood pressure device may cause skin erosion and/or pressure necrosis.
8. Undesirable side effects:
Side effects or adverse reactions are none known to date.
3
K130056 P4/7
9. Substantial equivalence Predicate legally marketed devices
- are legally marketed devices
MD2000BVital Sign Monitor K100740.Applicant: Beijing Choice Electronic Technology
MD2000BVital Sign Monitor K100740.Applicant: Beijing DNDL DOA . MD2000D Vital Bigh Monitor . Subsequent Product codes: DXN, DQA - Co., Ltd. Product 00042. Applicant: LD Technology LLC .Product_code DQA .
- ESO Software K113264. Applicant: LD Technology LLC. Product Code DXN, DQA, GZO, MNW
Similarities
- Illarities
✔ The TM-Oxi hardware has same intended use and same performances and effectiveness - V The TM-Oxi software used the same source codes than ESO and ES Complex software
✔ The TM-Oxi software used the same source codes than ESO and ES Complex software The TM-OXI Software used the same source of the data of the oximeter and blood . pressure device. - And Children Children Children
Hardware Differences:
Hardware Technological characteristics
- V The predicate device has an internal Oximeter PCB board connected to a SpO2 probe. The TM-Oxi uses 510k cleared oximeter which has PCB board and Spx2 probe in one The TM-OXF ases of the reast of the other provided by the OEM subcontractor.
- The blood pressure device is powered by the USB port of a PC and microchip The blood pressure do rooms in and AC DC converter, measurements are managed by software and the results are directly display to a PC screen.
Hardware table of comparison
4
| Name device (510k
| number | TM-Oxi hardware | MD2000B Vital sign monitor K100740 |
|---|---|---|
| Intended use and features | ||
| Intended use | The TM-Oxi device indicated for use in non- | |
| invasively measuring and displaying functional | ||
| oxygen saturation of arterial hemoglobin (SpO2), | ||
| pulse rate (PR), Non-invasive measurement of | ||
| blood pressure (NIBP) of adult patients in | ||
| medical facilities. | ||
| TheTM-Oxi device is intended for spot-checking | ||
| of patients. | The vital signs monitor is a portable device | |
| indicated for use in non-invasively | ||
| measuring and displaying functional oxygen | ||
| saturation of arterial hemoglobin | ||
| (SpO2), pulse rate (PR), Non-invasive | ||
| measurement of blood pressure (NIBP) of | ||
| adult and pediatric patients in hospitals, | ||
| medical facilities, and sub-acute | ||
| environments. The vital sign monitor is | ||
| intended for spot-checking and/or continuous | ||
| monitoring of patients. | ||
| SpO2 % | YES | YES |
| Oximeter Wave form | ||
| and Pulse rate | YES | YES |
| Systolic pressure | YES | YES |
| Diastolic pressure | YES | YES |
| Output | ||
| Output current | 100 mA | 75 mA |
| Output Power | 25VA | 25VA |
| Voltage | 5V DC | 7.2 V DC |
| Oximeter Technical Specifications | ||
| SpO2% Measuring | ||
| range | 0 to 100% | 0 to 100% |
| SpO2% Accuracy | 70%~100%: ±2%, Below 70% unspecified | 80-100%:±2%; 70-79%±3%;0-69% |
| Unspecified | ||
| Pulse rate measuring | ||
| range | 30 to 250bpm | 30 to 235bpm |
| Pulse rate accuracy | ± 2 bpm during the pulse rate range of 30~99 | |
| bpm and 2% during the pulse rate range of | ||
| 100~250 bpm | 30-100, ±2bpm; 101-235±2%;0-29 | |
| Unspecified | ||
| LEDS | Wavelength Red : 660 nm | |
| Wavelength IR : 880 nm | ||
| Radiant Power Red : 1.8 mW | ||
| Radiant Power IR : 2 mW | Wavelength Red : 660 nm | |
| Wavelength IR : 940 nm | ||
| Radiant Power Red : 1.8 mW | ||
| Radiant Power IR : 2 mW | ||
| BP Technical Specifications | ||
| Measuring principle | Oscillometric | Oscillometric |
| Measurement mode | Controlled by software | Manual/Automatic/STAT |
| Measuring range | ||
| Systolic | 30-255 mmHg | 30-255 mmHg |
| Measuring range | ||
| Diastolic | 15-220 mmHg | 15-220 mmHg |
| Other specifications | ||
| Target population | Adult | Adult and pediatric |
| Application site | Finger | Finger |
| Display | LCD (oximeter) and PC screen | LCD, LED PC Screen |
| Power supply | USB | Battery, Converter |
| Safety Class | BF | BF |
| Data transmission | USB | USB or flash key (optional) |
| Testing bench | 60601-1-1 | |
| 60601-1-2 | 60601-1-1 | |
| 60601-1-2 | ||
| ISO 9919 |
5
K130056 P6/7
10. Performances and Effectiveness
-
- The OEM subcontractor for MD 200A K093013 provided the PCB boards (blood pressure, The OEM subcomractor to: ladder, cuff and they were cleared for use together.
- punip allu valve), tuoc and bladder, can bladel, career sensor, USB cable The OLM subcomments and they were cleared for use together.
Therefore, ISO 9919 report from OEM oximeter and ANSI/AAMI SP10:2002 I herefore, ISO 9919 report nom OEM onlines. and read.
& ANSI/AAMI SP10:2002/A1:2003/A2: 2006 report from OEM blood pressure can be used for TM-Oxi
Testing comprises:
-
- Integration tests for oximeter and blood pressure device
-
- Integration tests for oxinceler and over (Cyclic redundancy check) Coding was performing to Soltware structurar testing using Gree ( ) ) ecurately capture, store, and analyze the data measured by the hardware.
-
- Laboratory testing for electrical safety (60601-1-1) and EMC (60601-1-2)
-
- Software verification (SRS/SDS/STD/STR)
Discussion of requirements of additional Clinical Test
Since the TM-Oxi is using 510K cleared devices clinically tested (ISO 9919 and SP10) and with regard of the testing describe above, the TM-Oxi do not required additional clinical test.
. .
The following facts:
- The predicate device has an internal Oximeter PCB board connected to a SpO2 probe. The products as not the cleared oximeters which have PCB board and SpO2 probe in
- one block, USB port, specific USB cable and software provided by the OEM subcontractor.
- The blood pressure device is powered by the USB port of a PC and microchip The blood pressure are active and not AC DC converter, measurements are managed by software and the results are directly display to a PC screen.
Do not affect the performances and the effectiveness of the TM-Oxi system as shown in the Integration tests.
11. General Safety Concerns
General Safety Concerns
General Salety Collectilis
The laboratory tests reports of the components of TM-Oxi System (IEC 60601-1-2 and IEC The laboratify tosts reports of the componsible of the system comparing to the legally marketed predicate device.
6
6
K130056 P7/7
7
The following facts:
- The predicate device has an internal Oximeter PCB board connected to a SpO2 probe. > The predioute de roo simeters which have PCB board and SpO2 probe in The TM-OXI uses broxesific USB cable and software provided by the OEM : subcontractor. .
- subcomination.
The blood pressure device is powered by the USB port of a PC and microchip The blood pressure are act not AC DC converter, measurements are managed by software and the results are directly display to a PC screen.
Do not affect the general safety of the TM-Oxi.
12. Standards
ndards
ANSI/AAMI SP10:2002/A1:2003/A2:2006/(R)2008 Issued 2008/12/18.Consolidated ANSWARNHT Of Feetronic or Automated Sphygmomanometers.
version. Manual, Licetionic of Pracedia.org +1 -1. General requirements for safety -ILC00001 - 1 1 155de Safety requirements for medical electrical systems Conateral standard: Safecy requirement 2 Medical Electrical Equipment Part 1-2: General
IEC 60001-1-2 133ded: 2001/07/90 Standard: Electromagnetic Compatibility - Req. and Tests -- Including Section 6 manual review
Tests = Including Section o manadi 107.07
IEC 60601-2-30: Issued: 1999/12/22 Ed: 2 Medical electrical equipment: Part 2: IEC 60001-2-30. Issued: 1777 12225, including essential performance, of automatic cycling non- invasive blood pressure monitoring equipment.
cycling noti- first.ive blood pressure montaining on including was conducted to validate and Perify that the Blood Pressure Monitor met all design specifications. (OEM subcontractor) vertly that the Diood Fressure Medical electrical equipment Particular requirements
ISO9919 Issued: 2005/03/15 Ed: 2 Medical electrical equipment Particular requirements ISO9919 ISSued. 2005/05/15 Date: 2 Nefarmance of pulse oximeter equipment for medical use (OEM subcontractor)
use (OEM Subcontractor)
Guidance for: Industry; FDA staff; and Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005
Contained in Medical devices -------------------------------------------------------------------------------------------------------------------------------------------------. March 01 2007
Conclusions
Conclusions
TM-Oxi is equivalent in performances, technology, safety and efficacy to the legally marketed predicate device.
7
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three wavy lines extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 11, 2013
LD Technology, Inc. c/o Mr. Albert Maarek Regulatory Consultant 100 North Biscayne Ave, Suite 502 Miami, FL 33132
Re: K130056
Trade/Device Name: TM-Oxi System Regulatory Number: 21 CFR 870.2300 Regulation Name: Physiological Patient Monitor (without arrhythmia detection or alarms) Regulatory Class: II (two) Product Code: 74 MWI Dated: March 4, 2013 Received: March 5, 2013
Dear Mr. Maarek:
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.
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
8
Page 2 - Mr. Albert Maarek
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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Image /page/8/Picture/6 description: The image contains the text "Owen 2 Earis -S". The text is written in a bold, sans-serif font. The letters are black, and the background is white. The text is slightly distorted, as if it were scanned from a document.
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
K130056
Indications for Use
510(k) Number:
Device Name: TM-Oxi system
Indications for Use:
The TM-Oxi device indicated for use in non-invasively measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Non-invasive measurement of blood pressure (NIBP) of adult patients.
The TM-Oxi software uploads the data of the device and displays the data into a computer for enhanced data management. The TM-Oxi software is intended for use in clinical settings as an aid for health care professionals to review, analyze and evaluate the historical tests results. TheTM-Oxi device is intended for spot-checking of patients.
The TM-Oxi system does not report any diagnosis but provides values. It is the physician's responsibility to make proper judgments based on these numbers.
Prescription Use: Federal law restricts this device to sale by or on the order of a physician.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Owen P. Faris -S
2013.04.11 10:32:16
-04'00'