(69 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description points to a standard photo-optical coagulation analyzer.
No.
This device is an in vitro diagnostic device used to determine coagulation profiles of plasma specimens, which aids in diagnosis and monitoring, rather than directly treating a condition.
Yes
The device determines the coagulation profile to diagnose conditions like disseminated intravascular coagulation (DIC), assess disease severity (acute phase response), and monitor patients receiving anticoagulant therapy, which are all diagnostic applications.
No
The device is described as a "Semi-automated system for in vitro coagulation studies, clot based and photo-optical," indicating it includes hardware components for optical measurement and clot detection, not just software.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that POTENS+ is an "in vitro medical device to determine the coagulation profile of citrated human plasma specimens." This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens taken from the human body.
- Specimen Type: The device analyzes "citrated human plasma specimens," which are biological samples taken from a human.
- Purpose: The purpose is to "determine the coagulation profile," which involves analyzing the properties of the specimen to provide diagnostic information about the patient's health (specifically, their blood clotting ability).
- Setting: The device is intended for use by a "medical professional in a laboratory setting," which is a typical environment for IVD testing.
The rest of the information, such as the device description, performance studies, and key metrics, further supports its classification as an IVD by detailing how it performs the in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
POTENS+ is a multipurpose system for use in performing clot based, photo-optical in-vitro coagulation studies including Prothrombin Time (PT) derived Fibrinogen (FBG), and the International Normalization Ratio (INR).
POTENS+ is an in vitro medical device to determine the coagulation profile of citrated human plasma specimens to be used by a medical professional in a laboratory setting. This profile includes Prothrombin Time (PT) derived Fibrinogen (FBG), and the International Normalization Ratio (INR).
Prothrombin Time is used to determine the status of the extrinsic clotting pathway for Clotting Factors I, II, V, VII and X, and to assist in monitoring oral anticoagulants.
Fibrinogen is used to diagnose disseminated intravascular coagulation (DIC), as a representation of acute disease - part of the "acute phase response," and it is an independent risk variable in heart attack and stroke prediction.
INR is used to monitor the patients receiving anticoagulation therapy.
Product codes
JPA
Device Description
Semi-automated system for in vitro coagulation studies, clot based and photo-optical.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical measurement of direct light transmission during clot formation.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professional in a laboratory setting.
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
A comparison study was conducted using patent specimens over the normal, diagnostic and therapeutic range. Correlation coefficients (r-values) ranged from for 0.973 to 0.980 for Fibrinogen, 0.95 to 0.974 for PT and 0.919 to 0.963 for INR results. Total precision for Fibrinogen was well within NCCLS recommendations using human based and bovine based control plasmas. Total precision for PT and INR using human based control plasmas were also well within NCCLS recommendations.
Key Metrics
Correlation coefficients (r-values) ranged from for 0.973 to 0.980 for Fibrinogen, 0.95 to 0.974 for PT and 0.919 to 0.963 for INR results. Total precision coefficient of variations (CVs) were less than 6% for fibrinogen using normal and abnormal control plasma, less than 5% for PT using normal and abnormal human control plasma and less than 8% for INR using normal and abnormal human control plasma.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
0
DEC - 8 2003
510(k) SUMMARY Section D. Section D.
POTENS+
This summary of safety and effectiveness information is being submitted in accordance with the requirement of SMDA 1990 and the final rule under 21 CFR 807.92 published December 14, 1994.
(A)(1) The submitter's name, address, telephone number, a contact person, and the date the summary was prepared:
Submitter's Name: WADA, Inc
Submitter's Address: 1556 San Leandro Lane, Montecito, CA 93108
Submitter's Telephone: 805-969-2758
Submitter's Contact: Gail Rodrick-Highberg (510-792-1527)
Date 510(k) Summary Prepared: September 19, 2003
(a)(2) The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known.
Trade or Proprietary Name: POTENS+
Common or usual Name: Multipurpose System for In Vitro Coagulation Studies:
Classification Name: Multipurpose System for In Vitro Coagulation Studies.
(a)(3) An identification of the legally marketed device to which the submitter claims substantial equivalence.
Device equivalent to:
Organon Tecknika Coag-A-Mate MTX (K962857) for Fibrinogen Organon Tecknika MDA-180 (K924453) for PT & INR
(a)(4) A description of the device
Device description: Semi-automated system for in vitro coagulation studies, clot based and photo-optical.
(a)(5) A statement of the intended use of the device
Device Intended Use: POTENS+ is a multipurpose system for use in performing clot based, photo-optical in-vitro coagulation studies including Prothrombin Time (PT) derived Fibrinogen (FBG), and the International Normalization Ratio (INR).
(a)(6) The summary of the technological characteristics of the new device in comparison to those of the predicate device.
POTENS+. MTX and MDA-180 are multipurpose systems capable of performing in-vitro coagulation studies; all three perform clot-based assays.
1
Table 1 below outlines the similarities/differences between the POTENS+, MTX and MDA-180.
Table 1
| | POTENS+
(Test Device) | CAM-MTX
(Predicate Device) | MDA-180
(Predicate Device) |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Analytes | PT, FBG and INR | FBG | PT, FBG and INR |
| Methodology | Fibrin Clot based assay;
optical measurement of
direct light transmission
during clot formation. | Clauss method: Fibrin Clot
based assay; optical
measurement of relative
light transmission to the
time of clot formation. | Clauss method: Fibrin Clot
based assay; optical
measurement of relative
light transmission to the
time of clot formation. |
| Instrument
system | Potentiophotometer ,
Reagent Dispenser,
Pipettor, Heating block,
computer and printer | Analyzer (measuring rotor
and photometer), computer
and printer | Multi-Channel Discrete
Analyzer |
| Principles of
operation | Detects change in light
transmittance at 660nm | Detects change in light
transmittance at 405 nm | Detects change in light
transmittance in the
spectral range 405 to 710
nm.
FBG @ 425 nm
PT @ 580 nm |
| Method of
Detection | Optical (LED with silicon
photovoltaic cell) | Optical using a photometer
and detectors | Optical (tungsten lamp)
using photodiode detectors |
| Signal
Processing | Linear handling of light
transmission using digital
electronics | Logarithmic conversion of
light transmission using
analog electronics | Logarithmic handling of
light transmission using
analog electronics |
| Reagents/
Accessories | Calibration Standards (2)
Controls (3)
Reagent Water
Test Cuvettes
Cuvette rack
Normal saline
Thromboplastin (Dade®
Thromboplastin C Plus) | Reference Plasma (for
calibration)
Verify Controls:
Veronal Buffer
Sample cups
Cuvette Rotor
Fibriquik (Thrombin) | VeriCal Calibrator Set
Verify Controls
Reagent Water
Probe Cleaner
Buffer
Test Cuvettes
Clauss Reagents
(Thrombin, Imidiazole
buffer) |
| Operating
Temp | 37 ± 0.3°C | 37°C | 37 ± 1°C |
| Test Sample | Citrated plasma | Citrated plasma | Citrated plasma |
| Test Sample
Dilution | Not required | Required | Required |
Similaritics and Difference Between POTENS+, MTX and the MDA-180
2
(b)(1) A brief discussion of the nonclinical tests submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalency.
Testing was performed to determine correlation and bias, precision and interfering substances. Interfering substances, and specimen collection and preparation are well documented for these type of assays are in accordance with NCCLS standards and recommendations of the International Society of Thrombosis and Hemostasis.
(b)(2) A brief discussion of the clinical tests submitted, reference, or relied in the premarket notification submission for a determination of substantial equivalency.
A comparison study was conducted using patent specimens over the normal, diagnostic and therapeutic range. Correlation coefficients (r-values) ranged from for 0.973 to 0.980 for Fibrinogen, 0.95 to 0.974 for PT and 0.919 to 0.963 for INR results. Total precision for Fibrinogen was well within NCCLS recommendations using human based and bovine based control plasmas. Total precision for PT and INR using human based control plasmas were also well within NCCLS recommendations.
(b)(3) The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performed as well or better that the legally marketed device identified in (a)(3),
The performance characteristics of the POTENS+ are comparable to those of the predicate devices. The data presented in the premarket notification demonstrate that the POTENS+ performs substantially equivalent to the predicate devices. Comparison studies were performed to demonstrate that POTENS+ is equivalent to the MTX for determining Fibrinogen concentration and to the MDA-180 for determining PT and INR results.
Equivalence was demonstrated using commercially available methods/product along with patient specimens covering the normal, therapeutic and diagnostic range. Correlation coefficients (r-values) ranged from for 0.973 to 0.980 for Fibrinogen, 0.95 to 0.974 for PT and 0.919 to 0.963 for INR results.
Precision studies were performed following the guidelines in NCCL EP5A "Evaluation of Precision Performance of Clinical Chemistry Devices". Total precision coefficient of variations (CVs) were less than 6% for fibrinogen using normal and abnormal control plasma, less than 5% for PT using normal and abnormal human control plasma and less than 8% for INR using normal and abnormal human control plasma.
3
Image /page/3/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a stylized lower portion representing the body.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Wada Inc.
DEC - 8 2003
c/o Ms. Gail Rodrick-Highberg Regulatory Consultant Highberg Associates 35949 Nicolet Court Fremont, California 94536
Re: K033137
Trade/Device Name: POTENS+ Regulation Number: 21 CFR § 864.5425 Regulation Name: Multipurpose System for in vitro Coagulation Studies Regulatory Class: II Product Code: JPA Dated: September 29, 2003 Received: September 30, 2003
Dear Ms. Rodrick-Highberg:
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 such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
4
Page 2 -
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
STATEMENT OF INDICATIONS FOR USE Section C. ...
Page 1 of 1
510(k) Number (if known) _K 033137
Device Name: POTENS+
Indications for Use:
POTENS+ is an in vitro medical device to determine the coagulation profile of citrated human plasma specimens to be used by a medical professional in a laboratory setting. This profile includes Prothrombin Time (PT) derived Fibrinogen (FBG), and the International Normalization Ratio (INR).
Prothrombin Time is used to determine the status of the extrinsic clotting pathway for Clotting Factors I, II, V, VII and X, and to assist in monitoring oral anticoagulants.
Fibrinogen is used to diagnose disseminated intravascular coagulation (DIC), as a representation of acute disease - part of the "acute phase response," and it is an independent risk variable in heart attack and stroke prediction.
INR is used to monitor the patients receiving anticoagulation therapy.
Josephine Bautista
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) KU33137
Rx
✓