(88 days)
No
The description focuses on combining test results with user-entered patient data to perform calculations for recommended dosages. There is no mention of learning from data, adapting algorithms, or using complex pattern recognition that would indicate AI/ML. The calculations appear to be based on predefined mathematical factors encoded on the test cards and user input.
No
The device provides information for heparin management and calculates recommended dosages, but it does not directly administer treatment or physically interact with the patient for therapeutic purposes. It is an accessory to an analyzer, which is a diagnostic tool.
Yes
The device is described as an "accessory to the Rapidpoint Coag Analyzer," which is "a point of care instrument designed to determine hemostatic parameters of blood and plasma samples." The device itself "generates information on heparin management" and calculates "recommended dosages of Heparin or Protamine" based on test results from the Analyzer and patient data, which is a diagnostic function to inform treatment.
No
The device description explicitly states that the Rapidpoint Accent includes hardware components such as an eight-inch diagonal touch screen, a built-in printer, an internal power supply, and a serial cable. It is also an accessory to the Rapidpoint Coag Analyzer, which is a point-of-care instrument.
Based on the provided information, the Rapidpoint Accent itself is not an IVD.
Here's why:
- Intended Use: The Rapidpoint Accent's intended use is to "generate information on heparin management" by combining test results from the Rapidpoint Coag Analyzer with patient data. It calculates recommended dosages.
- Device Description: The description clearly states the Rapidpoint Accent is an accessory to the Rapidpoint Coag Analyzer. It takes results from the Analyzer and user input to perform calculations and provide dosing information. It does not directly perform a diagnostic test on a biological sample.
- IVD Definition: An In Vitro Diagnostic (IVD) device is defined as a medical device intended to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, a congenital abnormality, a mental impairment, a disease or to monitor therapeutic measures.
While the Rapidpoint Coag Analyzer and the Heparin Management Panel Cards (Heparin Management Test, Heparin Titration Test, and Protamine Response Test) Cards are clearly IVDs because they perform tests on blood samples to determine hemostatic parameters and patient response to heparin/protamine, the Rapidpoint Accent is a computational and interface device that uses the results from these IVDs.
Think of it this way: The IVDs (Analyzer and Cards) perform the diagnostic tests on the blood sample. The Rapidpoint Accent takes the results of those tests and uses them in conjunction with other data to provide clinical decision support (dosing recommendations). It's a post-analytical processing unit, not a diagnostic test itself.
N/A
Intended Use / Indications for Use
The Rapidpoint Accent is an accessory to the Rapidpoint Coag Analyzer. When used in conjunction with the Rapidpoint Coag and the Heparin Management Panel Cards (Heparin Management Test, Heparin Titration Test, and Protamine Response Test) Cards, its intended use is to generate information on heparin management.
The HTT card is intended for use with the HMT card, the Rapidpoint™ Coag Analyzer (K933092; K990566) and the Accent to determine the potential response of a patient to heparin. The test helps identify patients who may be unusually sensitive or resistant to anticoagulation with unfractionated heparin. The test is based upon clotting time of citrated or noncitrated whole blood. The test is for in vitro diagnostic use, and is especially suited for professional use in the operating room, where higher levels of heparin are typically used.
The PRT card is intended for use with the HMT card, the Rapidpoint™ Coag Analyzer (K933092; K990566) and the Rapidpoint" Accent to recommend the dose of protamine sulfate required to neutralize the heparin in a patient. The test is based upon protamine titration of heparin. Citrated or noncitrated whole blood samples can be used for this test. The test is for in vitro diagnostic use, and is especially suited for professional use in the operating room, where higher levels of heparin are typically used.
Product codes (comma separated list FDA assigned to the subject device)
JOX
Device Description
The Rapidpoint Accent is an accessory to the Rapidpoint Coag Analyzer. The Analyzer is a point of care instrument designed to determine hemostatic parameters of blood and plasma samples. The Accent works in conjunction with the Analyzer to provide dosing information for heparin and protamine during cardiopulmonary bypass procedures. The Accent determines this information by combining test results from the Analyzer with patient data entered into the Accent by the user. During the course of a CPB procedure, the user must perform a series of tests using the Analyzer, The test cards that must be used include the Heparin Management Test (HMT™), the Heparin Titration Test (HTT™), and the Protamine Response Test (PRT™). The results of these tests provide the Accent with information on how the patient's blood will respond to the addition of Heparin and Protamine. The Accent uses this information to calculate recommended dosages of Heparin or Protamine to be given to the patient to reach a target value entered into the Accent by the user. The target value may be either a heparin concentration or a clotting time.
The Accent includes an eight-inch diagonal touch screen for user interface and a built in printer for recording test results. The case is designed with a protective front cover that doubles as a holder for the Analyzer when the system is in use. The Accent is powered by an internal power supply that also orovides power to the Analyzer. The Accent and the Analyzer communicate through a serial cable that must be plugged into the Analyzer and is permanently attached to the Accent.
The HTT provides a method to determine the response of a patient to heparin. Before heparin administration, baseline Heparin Management Test (HMT) and HTT values are determined for the patient with the Rapidpoint" Coag (formerly TAS) Analyzer. Using these values, the Rapidpoint ACCENT will calculate the dose of heparin necessary to produce a desired concentration or effect of this drug in the patient's blood. Both citrated or noncitrated whole blood samples can be used for these tests.
The test card has a magnetic stripe on the back, which encodes lot specific information such as number, expiration date, and mathematical factors specific to that lot. A room temperature test card is removed from the pouch and the card is passed through the card reader of the instrument to program the instrument to run a test. The instrument instructs the operator to insert a test card and then requests patient and sample information. The card is warmed and the operator is prompted to add a drop of blood to the card sample well. The sample is drawn into the card and rehydrates the reagent, which begins the reaction. As the reaction proceeds and clotting begins, the movement of the particles decreases, and the instrument signals the clotting time.
The PRT card is made for use with citrated or noncitrated blood samples containing heparin. The PRT is a modification of the HMT card and consists of a single test card that contains calcium chloride to initiate coagulation in citrated blood samples, celite as activator, stabilizers. and protamine sulfate. The test results will depend on heparin activity in the blood, which in turn depend on the levels of heparin, of coagulation factors, and of heparin inhibitors in the sample. The higher the level of heparin activity, the greater the protamine sulfate dosage required to inhibit it. The results of the PRT card are used with values produced on HMT cards with samples taken just before protamine administration, to determine the response of the individual to the agent. The values are stored by the ACCENT, which performs the calculations to determine dose recommended to neutralize the heparin present in the patient.
The test card has a magnetic stripe on the back, which encodes lot specific information such as number, expiration date, and mathematical factors specific to that lot. A room temperature test card is removed from the pouch and the card is passed through the card reader of the instrument to program the instrument to run a test. The instrument instructs the operator to insert a test card and then requests patient and sample information. The card is warmed and the operator is prompted to add a drop of blood to the card sample well. The sample is drawn into the card and rehydrates the reagent, which begins the reaction. As the reaction proceeds and clotting begins, the movement of the particles decreases, and the instrument signals the clotting time.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional use in the operating room
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)
Nonclinical Performance Data: Preclinical testing was done at CVDI with HTT cards and the Rapidpoint™ Analyzer to determine the performance characteristics of the system.
The HTT cards are stable at refrigerator temperatures or lower (
§ 864.5680 Automated heparin analyzer.
(a)
Identification. An automated heparin analyzer is a device used to determine the heparin level in a blood sample by mixing the sample with protamine (a heparin-neutralizing substance) and determining photometrically the onset of air-activated clotting. The analyzer also determines the amount of protamine necessary to neutralize the heparin in the patient's circulation.(b)
Classification. Class II (special controls).
0
| Document Mail Center (HFZ-401) |
|---|
| Center for Devices and Radiological Health |
| Food and Drug Administration |
| 9200 Corporate Blvd. |
| Rockville, Maryland 20850 |
| October, 1999 |
| JAN | 1 4 2000 |
|---|---|
| ----- | ---------- |
510(k) Summary of Safety and Effectiveness Information
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.
The assigned 510(k) number is 99 35 19.
- Greg Godlevski Submitted by: Director of Software Development (Accent) and Cynthia G. Pritchard Executive Director of R&D (HTT, PRT cards)
- Cardiovascular Diagnostics, Inc. Address: 5301 Departure Drive Raleigh, NC 27616
- Phone: 1-800-247-4234
- Fax: 1-919-954-9932
- Contact: Peter Scott VP of Quality Assurance and Regulatory Affairs
- Date of Summary: October, 1999
1
510(k) Summary of Safety and Effectiveness Information
Accent
Trade name: Rapidpoint™ Accent
Common Name: Rapidpoint™ Accent
Classification Name: systems for in vitro coagulation studies, automated or semi-automated instruments and associated reagents and controls used to perform a series of coagulation studies and coaqulation factor assays (Class II. 21 CFR864.5425)
Predicate Device: The proposed Accent, when used with the Rapidpoint™ Coag Analyzer, is substantially equivalent to the previously cleared Hepcon HMS produced by Medtronics Corporation. The 510(k) number for the Hepcon HMS submission is K911240.
Description of the Device: The Rapidpoint Accent is an accessory to the Rapidpoint Coag Analyzer. The Analyzer is a point of care instrument designed to determine hemostatic parameters of blood and plasma samples. The Accent works in conjunction with the Analyzer to provide dosing information for heparin and protamine during cardiopulmonary bypass procedures. The Accent determines this information by combining test results from the Analyzer with patient data entered into the Accent by the user. During the course of a CPB procedure, the user must perform a series of tests using the Analyzer, The test cards that must be used include the Heparin Management Test (HMT™), the Heparin Titration Test (HTT™), and the Protamine Response Test (PRT™). The results of these tests provide the Accent with information on how the patient's blood will respond to the addition of Heparin and Protamine. The Accent uses this information to calculate recommended dosages of Heparin or Protamine to be given to the patient to reach a target value entered into the Accent by the user. The target value may be either a heparin concentration or a clotting time.
The Accent includes an eight-inch diagonal touch screen for user interface and a built in printer for recording test results. The case is designed with a protective front cover that doubles as a holder for the Analyzer when the system is in use. The Accent is powered by an internal power supply that also orovides power to the Analyzer. The Accent and the Analyzer communicate through a serial cable that must be plugged into the Analyzer and is permanently attached to the Accent.
2
Summary of Safety and Effectiveness Information
HTT Card
Trade name: Heparin Titration Test (HTT)
Common Name: HTT
Classification Name: multipurpose system for in vitro coagulation studies (class II, 864.5425)
Predicate Device: The proposed HTT is substantially equivalent to the Heparin Dose Response Test (Medtronic, Inc), performed on the Hepcon HMS (Medtronic, Inc), used for determining individual responses to heparin.
Description of the Device: The HTT provides a method to determine the response of a patient to heparin. Before heparin administration, baseline Heparin Management Test (HMT) and HTT values are determined for the patient with the Rapidpoint" Coag (formerly TAS) Analyzer. Using these values, the Rapidpoint ACCENT will calculate the dose of heparin necessary to produce a desired concentration or effect of this drug in the patient's blood. Both citrated or noncitrated whole blood samples can be used for these tests.
The test card has a magnetic stripe on the back, which encodes lot specific information such as number, expiration date, and mathematical factors specific to that lot. A room temperature test card is removed from the pouch and the card is passed through the card reader of the instrument to program the instrument to run a test. The instrument instructs the operator to insert a test card and then requests patient and sample information. The card is warmed and the operator is prompted to add a drop of blood to the card sample well. The sample is drawn into the card and rehydrates the reagent, which begins the reaction. As the reaction proceeds and clotting begins, the movement of the particles decreases, and the instrument signals the clotting time.
Intended Use: The HTT card is intended for use with the HMT card, the Rapidpoint™ Coag Analyzer (K933092; K990566) and the Accent to determine the potential response of a patient to heparin. The test helps identify patients who may be unusually sensitive or resistant to anticoagulation with unfractionated heparin. The test is based upon clotting time of citrated or noncitrated whole blood. The test is for in vitro diagnostic use, and is especially suited for professional use in the operating room, where higher levels of heparin are typically used.
3
Summary of Safety and Effectiveness Information
HTT Card
Comparison of HTT and the Predicate Device
Heparin Dose Response (HDR) (Hepcon HMS; Medtronic, Inc)
| Characteristic | Predicate Device | Proposed Device |
|---|---|---|
| Intended Use | Determines potential response of | |
| an individual to heparin | same | |
| Format | Dry reagent in cuvette | lyophilized reagents in a flat |
| shallow reaction chamber | ||
| mounted on a thin plastic card | ||
| Reaction | one stage | one stage |
| Sample type | Noncitrated whole blood | citrated or noncitrated whole |
| blood | ||
| Reagent base | Kaolin | Celite |
| Reaction | Formation of a fibrin clot | Same |
| Instrument | Hepcon HMS | Rapidpoint™ Coag Analyzer, |
| Rapidpoint™ ACCENT | ||
| Endpoint monitored | coagulation time | same |
| Test interpretation | endpoint has direct correlation to | |
| heparin activity | same | |
| Quality control | None available; manufacture | |
| recommends using normal donor | self tests performed by analyzer | |
| at power up and throughout | ||
| operation, plus functional testing | ||
| of each test card with two levels | ||
| of quality control plasmas, | ||
| electronic QC |
4
Summary of Safety and Effectiveness Information
HTT Card
Nonclinical Performance Data: Preclinical testing was done at CVDI with HTT cards and the Rapidpoint™ Analyzer to determine the performance characteristics of the system.
The HTT cards are stable at refrigerator temperatures or lower (