(261 days)
Not Found
No
The description details an automated process for calculating ABI using a conventional algorithm based on measured pressures. There is no mention of AI or ML techniques for data analysis, pattern recognition, or decision support beyond the direct calculation.
No.
The device is intended for diagnosis and screening of peripheral arterial disease (PAD), not for providing therapy or treatment.
Yes
The device is intended for the "rapid measurement of ankle-brachial pressure index (ABP), or ankle-brachial index (ABI), and pulse volume recording (PVR) / volume plethysmography in adults," and is described as being "suitable for use in wound care assessing symptomatic PAD, and as a screening device for PAD." This clearly indicates its use in identifying and assessing medical conditions, which is the definition of a diagnostic device.
No
The device description explicitly states that the system comprises "Σ USB plug and play hardware" in addition to the software. This indicates the presence of physical hardware components necessary for the device's function, making it a hardware-software system, not a software-only device.
Based on the provided information, the TM-ABI system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed outside of the living body (in vitro).
- TM-ABI System Function: The TM-ABI system directly measures physiological parameters (blood pressure and pulse volume) from the patient's limbs using cuffs and pneumo-plethysmography. This is a non-invasive measurement performed on the living body.
- Lack of Specimen Analysis: The description does not mention the collection or analysis of any biological specimens.
Therefore, the TM-ABI system falls under the category of a medical device used for physiological measurement and diagnosis, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The TM-ABI system is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD).
TM-ABI system is intended for the rapid measurement of ankle-brachial pressure index (ABP), or ankle-brachial index (ABI), and pulse volume recording (PVR) / volume plethysmography in adults. It is suitable for use in wound care assessing symptomatic PAD, and as a screening device for PAD. It may also be used on patients with venous or arterial ulcers prior to the application of compression therapy.
TM-ABI system can be used on patients with unilateral lower limb amputation.
The TM-ABI System is intended to be used to spot-check patients. The TM-ABI provides information regarding patient risk. The physician has the responsibility of making proper judgments based on this information.
Product codes (comma separated list FDA assigned to the subject device)
JOM
Device Description
TM-ABI System is a programmable electro medical system (PEMS). The system comprises:
- USB plug and play hardware.
- Software installed on a computer
It is intended to measure a patient's Ankle Brachial Pressure Index (ABPI) and Ankle brachial Index (ABI) and provides Pulse Volume Recording (PVR) / volume plethysmography.
This is done through an automated process.
The operator places the three color coded cuffs on the right or left arm, and on each ankle as described in the instructions for use, and connects to the device.
When connected, the operator clicks start on the software to begin measurement. The device will then automatically control the inflation of the cuffs and monitor variations in individual pressures to determine values to be used for the calculation of the ABI values for both the left and right of the patient.
TM-ABI uses pneumo-plethysmography in order to obtain physiologic measurements from patient's limbs. Measurements are conducted as a single occurrence on the three liminating any requirement to rest the patient between measurements. The test period takes approximately 3 minutes. The ABPI or ABI are calculated using the conventional algorithm: The device measures systolic pressures on arm and 2 ankles and then calculates the ABIs as follows:
Left ABI = Left ankle pressure / Arm pressure
Right ABI = Right ankle pressure / Arm pressure
ABPI values, as well as the Pulse Volume recording (PVR), are displayed on the LCD, and on a software installed in a computer. The results are saved in a backup and can also be printed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
arm, ankles, lower limb
Indicated Patient Age Range
adult subjects / adults
Intended User / Care Setting
physician / Clinical environment
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)
- CRC (Cyclic redundancy check) Coding was performing to demonstrate the software performance to accurately capture, store, and analyze the data measured by the hardware.
- Testing comprises:
- Calibration tests
- Software verification (SRS/SDS/STD/STR)
- Clinical Study comparing the device results and standard Doppler method results to assess the Ankle Brachial Index.
- The TM-ABI use 3 cuffs and therefore 3 blood pressure measurements at same time and the > predicate device use 4 cuffs and therefore 4 blood pressure measurements in same time.
- TM-ABI uses the same cuffs during the inflation/deflation to display the Pulse volume , and the predicate device use different cuffs at constant pressure of 45 mmHg Do not affect the performances and the effectiveness of the TM-ABI system comparing to the predicate device as shown by the clinical studies of TM-ABI and the predicate device versus. The standard Doppler probe method.
- ABI results: Coefficient of correlation r with the standard Doppler probe method: r= 0.88
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Ankle brachial pressure index: ± 0.1
ABI results: Coefficient of correlation r with the standard Doppler probe method: r= 0.88
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.
Not Found
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
§ 870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.
(a)
Identification. A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 22, 2015
LD Technology LLC Albert Maarek Quality Manager 100 N. Biscayne Blvd., Suite 502 Miami, Florida 33132
Re: K143152
Trade/Device Name: TM-ABI System Regulation Number: 21 CFR 870.2780 Regulation Name: Hydraulic, Pneumatic, Or Photoelectric Plethysmographs Regulatory Class: Class II Product Code: JOM Dated: June 23, 2015 Received: June 24, 2015
Dear Albert 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 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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 yours,
Mitchell Stein
forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number: K143152
Device Name: TM-ABI system
Indications for Use:
The TM-ABI system is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD).
TM-ABI system is intended for the rapid measurement of ankle-brachial pressure index (ABP), or ankle-brachial index (ABI), and pulse volume recording (PVR) / volume plethysmography in adults. It is suitable for use in wound care assessing symptomatic PAD, and as a screening device for PAD. It may also be used on patients with venous or arterial ulcers prior to the application of compression therapy.
TM-ABI system can be used on patients with unilateral lower limb amputation.
The TM-ABI System is intended to be used to spot-check patients. The TM-ABI provides information regarding patient risk. The physician has the responsibility of making proper judgments based on this information.
*Prescription Use: Federal law restricts the use of 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________________________________________________________________________________________________________________________________________________________________________
3
510(k) Premarket Notification Number: date: May 27, 2015
510(k) Summary TM-ABI device
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92
1. 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-ABI system Regulation number: 21CFR 870.2780 Product Code: JOM Device Class: Class II Classification Name: Hydraulic, pneumatic, or photoelectric plethysmograph Classification Panel: Cardiology
3. Predicate legally marketed devices
Dopplex Ability K121108. Applicant: Huntleigh Healthcare Limited - Diagnostic Products Division. Product Code: JOM.
4. Device Description
TM-ABI System is a programmable electro medical system (PEMS). The system comprises:
- Σ USB plug and play hardware.
- Software installed on a computer
It is intended to measure a patient's Ankle Brachial Pressure Index (ABPI) and Ankle brachial Index (ABI) and provides Pulse Volume Recording (PVR) / volume plethysmography.
This is done through an automated process.
The operator places the three color coded cuffs on the right or left arm, and on each ankle as described in the instructions for use, and connects to the device.
When connected, the operator clicks start on the software to begin measurement. The device will then automatically control the inflation of the cuffs and monitor variations in individual pressures to determine values to be used for the calculation of the ABI values for both the left and right of the patient.
TM-ABI uses pneumo-plethysmography in order to obtain physiologic measurements from patient's limbs. Measurements are conducted as a single occurrence on the three liminating any requirement to rest
4
the patient between measurements. The test period takes approximately 3 minutes. The ABPI or ABI are calculated using the conventional algorithm: The device measures systolic pressures on arm and 2 ankles and then calculates the ABIs as follows:
Left ABI = Left ankle pressure Arm pressure
Right ABI = Right ankle pressure Arm pressure
ABPI values, as well as the Pulse Volume recording (PVR), are displayed on the LCD, and on a software installed in a computer. The results are saved in a backup and can also be printed.
5. Intended use and indications for use
The TM-ABI system is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD).
TM-ABI system is intended for the rapid measurement of ankle-brachial pressure index (ABPI), or anklebrachial index (ABI), and pulse volume recording (PVR) / volume plethysmography in adults. It is suitable for use in wound care assessment, for assessing symptomatic PAD, and as a screening device for PAD. It may also be used on patients with venous or arterial ulcers prior to the application of compression therapy.
TM-ABI system can be used on patients with unilateral lower limb amputation.
The TM-ABI System is intended to be used to spot-check patients. The TM-ABI provides information regarding patient risk. The physician has the responsibility of making proper judgments based on this information.
*Prescription Use: Federal law restricts the use of this device to sale by or on the order of a physician
6. Performances, technical specifications and materials Performances
TM-ABI system measures simultaneous 3 blood pressure values using the oscillometic method. It is portable medical device, powered by internal Li-Po battery and/or by an AC/DC converter. It has two electrical inlets - power inlet and USB type B inlet, used for a connection with the software installed in a computer. TM-ABI system has three pressure inlets to connect three cuffs with specially designed connectors on both sides. These connectors are separated by indication color, also traceable on the colored hoses and colored cuffs.
The front panel foil indicates the device's name and manufacturer. It has an on/off button, start/stop/enter button, three function buttons, and LED power indicator. The color LCD screen is protected by a front panel foil.
The main purpose of the device is to measure ABPI, It also allows for checking measurement history.
Technical specifications i.e. table of comparison with the predicate device Patient contact materials:
The materials in contact with the patient are the cuffs, tubes and bladders.
The Cuff material is nylon, and the Tube and Bladder material are PVC and latex free.
5
7. Contra-indications
- Patients undergoing external defibrillation.
- Patients connected to electronic life support devices, or any implanted electronic device.
- Bilateral mastectomy
- Patients moving or undergoing long term monitoring.
- Do not use this device in the presence of:
- A Magnetic resonance imaging (MR or MRI) equipment. MRI equipment may deliver induced current to the device.
- A Strong electromagnetic sources, such as electro surgery equipment.
-
Computed Tomography (CT) equipment.
- 2 Arterial catheters (access or therapy) on arm or leg or an arterio-venous (AV) fistula or shunt. The temporary interference of the blood flow could result in injury to the patient.
- ) Venous pulsations may cause erroneous reading in blood pressure (e.g. tricuspid valve regurgitation).
- Take caution with patients that have low perfusion. Using the blood pressure device may cause skin erosion and/or pressure necrosis.
8. Undesirable side effects:
No side effects or adverse reactions are known to date.
9. Substantial equivalence
Predicate legally marketed device: Dopplex Ability K121108. Applicant: Huntleigh Healthcare Limited - Diagnostic Products Division. Product Code: JOM.
Similarities
- The TM-ABI hardware has same intended use , same technology (oscillometric method) , and > same performances and effectiveness (clinical study comparing to the standard Doppler probe method)
Differences:
Hardware Technological characteristics
-
The TM-ABI uses 3 cuffs. The predicate device uses 4 cuffs
-
The TM-ABI displays the Pulse volume/plethysmography from the cuffs during the process inflation/deflation. The predicate device displays the Pulse volume /Plethysmography from different cuffs at a constant pressure of 45 mmHg.
6
Table of comparison
| Information | TM-ABI | Dopplex Ability K121108 |
|---|---|---|
| Intended use | The TM-ABI is indicated for use on adult | |
| subjects at risk of having or developing | ||
| peripheral arterial disease (PAD). | ||
| TM-ABI is intended for the rapid | ||
| measurement of ankle-brachial pressure | ||
| index (ABPI), or ankle-brachial index | ||
| (ABI), and provides pulse volume | ||
| recording (PVR) / volume | ||
| plethysmography in adults. It is suitable for | ||
| use in wound care assessment, for | ||
| assessing symptomatic PAD, and as a | ||
| screening device for PAD. It may also be | ||
| used on patients with venous or arterial | ||
| ulcers prior to the application of | ||
| compression therapy. | ||
| TM-ABI can be used on patients with | ||
| unilateral lower limb amputation. | The Dopplex Ability is indicated for use on | |
| adult subjects at risk of having or developing | ||
| peripheral arterial disease (PAD). | ||
| Dopplex Ability is intended for rapid | ||
| measurement of ankle-brachial pressure index | ||
| (ABPI), or ankle-brachial index (ABI), and | ||
| pulse volume recording (PVR) / volume | ||
| plethysmography in adults. | ||
| It is suitable for use in wound care | ||
| assessment, for assessing symptomatic PAD, | ||
| and as a screening device for PAD. It may | ||
| also be used on patients with venous or | ||
| arterial ulcers prior to the application of | ||
| compression therapy. | ||
| Dopplex Ability can be used on patients with | ||
| unilateral lower limb amputation. | ||
| Dimensions/weight | width: 250 mm, height: 730mm, depth: 200 mm, | |
| weight: 0.60kg | Width: 260mm, height: 160mm, depth: | |
| 240mm weight: 3 kg | ||
| Display | 4.3" color LCD screen with 16-bit color | |
| depth resolution: 480 x 272 pixels | B/W Analog display | |
| Power Supply | Output: 5V DC/3.0A. Battery type: | |
| rechargeable lithium polymer | ||
| AC/DC converter 5 V. | ||
| Capacity: 2,300mAh, | ||
| number of measurements per charge: 30 | Output: 5VDC/3.0 A. Integral NiMH Battery | |
| Direct connection to the wall plug | ||
| Capacity: 2,300 mAh | ||
| Number of measurements per charge: 50 | ||
| Applied parts in contact | ||
| with the patient | 3 cuffs, tubes and bladders | 4 cuffs, tubes and bladders |
| Testing Bench | Type of protection against electric shock: | |
| Class II. BF | ||
| Compliant with standards: | ||
| 60601-1, | ||
| 60601-1-2 | ||
| 80601-2-30. | Type of protection against electric shock: | |
| Class II. BF | ||
| Compliant with standards: | ||
| 60601-1, | ||
| 60601-1-2 | ||
| 60601-2-30 | ||
| Measurement types | Right and left Ankle brachial pressure | |
| index : Left ABI = $\frac{\text{Left ankle pressure}}{\text{Arm pressure}}$ |
Right ABI = $\frac{\text{Right ankle pressure}}{\text{Arm pressure}}$ | Right and left Ankle brachial pressure index
Left ABI = $\frac{\text{Left ankle pressure}}{\text{Highest Arm pressure}}$
Right ABI = $\frac{\text{Right ankle pressure}}{\text{Highest Arm pressure}}$ |
7
| Measurement ranges | Pressures range : Diastolic 40 to 180 mmHg Systolic 39 to 242 mmHg | Arm systolic pressures in the range 80 to 205mmHg and leg systolic pressures in the range 55 to 205mmHg. |
|---|---|---|
| Limit values of | ||
| measurement errors | Ankle brachial pressure index: $\pm$ 0.1 | Ankle brachial pressure index: $\pm$ 0.1 |
| Cuffs inflation and | ||
| deflation | Automatic inflation using an air pump and deflation using an electromagnetic valve. | Automatic inflation using an air pump and deflation using an electromagnetic valve. |
| Pulse Volume | ||
| /Plethysmography | Pneumo-plethysmography method using the cuffs measuring the blood pressure values : Plethysmography displayed at the inflammation and deflation pressure | Pneumo-plethysmography method using additional cuffs at constant pressure of 45 mmHg. |
| Temperature and | ||
| humidity range | working environment: 10 to 40°C, 30 to 85% relative air humidity, IPX0 protection, transport and storage: 0 to 60°C, up to 85% relative air humidity. | working environment: 10 to 40°C, 30 to 85% relative air humidity, IPX0 protection, transport and storage: 0 to 60°C, up to 85% relative air humidity. |
| Target population | Adult | Adult |
| Where used | Clinical environment | Clinical environment |
| PC Data transmission | USB | USB |
| ABI results: | ||
| Coefficient of | ||
| correlation r with the | ||
| standard Doppler | ||
| probe method | r= 0.88 | r=0.89 |
10. Performances and Effectiveness
CRC (Cyclic redundancy check) Coding was performing to demonstrate the software performance to accurately capture, store, and analyze the data measured by the hardware.
Testing comprises:
-
- Calibration tests
-
- Software verification (SRS/SDS/STD/STR)
-
- Clinical Study comparing the device results and standard Doppler method results to assess the Ankle Brachial Index.
The following facts:
- The TM-ABI use 3 cuffs and therefore 3 blood pressure measurements at same time and the > predicate device use 4 cuffs and therefore 4 blood pressure measurements in same time.
8
-
TM-ABI uses the same cuffs during the inflation/deflation to display the Pulse volume , and the predicate device use different cuffs at constant pressure of 45 mmHg
Do not affect the performances and the effectiveness of the TM-ABI system comparing to the predicate device as shown by the clinical studies of TM-ABI and the predicate device versus.
The standard Doppler probe method. In addition, the manufacturer of the predicate device states: "The pulse volume recording / Volume plethysmography can be used as an adjunct to the Ankle Brachial Index (ABI), and an alternative to Doppler waveforms." And therefore, it is not the primary intended use of the device which is a rapid measurement of ankle-brachial pressure index (ABPI), or ankle-brachial index (ABI).
11. General Safety Concerns
The laboratory tests reports of the TM-ABI System have demonstrated the general safety of the system compared to the legally marketed predicate device.
NOTES! The performed laboratory tests are updated compared to the predicate device.
12. Standards
- V IEC 60601-1: Medical electrical equipment Part 1: General requirements for basic safety and essential performance. Third Edition December 2006
- V IEC60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests. Third Edition 05/17/2007
-
IEC 80601-2-30: Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers. 10/31/2010 Second Edition
-
Guidance for: Industry; FDA staff; and Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005
- V ISO 14971: Medical devices - Application of risk management to medical devices. March 01 2007
Conclusion
TM-ABI system is equivalent in performance, technology, safety and efficacy to the legally marketed predicate device.
Signature:
Albert MAAREK
Premarket notification [510K] Number: K143152