RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST
Device Facts
| Record ID | K993519 |
|---|---|
| Device Name | RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST |
| Applicant | Cardiovascular Diagnostics, Inc. |
| Product Code | JOX · Hematology |
| Decision Date | Jan 14, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.5680 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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.
Device Story
Rapidpoint Accent is a point-of-care accessory for the Rapidpoint Coag Analyzer; used in operating rooms by clinicians during cardiopulmonary bypass. System inputs include patient data entered via touch screen and coagulation test results (HMT, HTT, PRT) from the Analyzer. The device processes these inputs to calculate recommended heparin or protamine dosages to reach user-defined target clotting times or concentrations. The system features an 8-inch touch screen, built-in printer, and serial connection to the Analyzer. It benefits patients by providing precise, real-time anticoagulation management, reducing risks associated with heparin sensitivity or resistance.
Clinical Evidence
Clinical testing conducted at three hospitals with 139 individuals. Citrated and noncitrated blood samples were tested using the Rapidpoint Accent/Analyzer system and the predicate Hepcon HMS system. Primary endpoint was the comparison of calculated heparin and protamine dosages. ANOVA testing showed no significant differences (p ≥ 0.05) between the two systems. Bench testing confirmed stability, sensitivity to heparin activity (0.4 to 8 U/ml), and lack of interference from lipids, nitroglycerin, or Dextran.
Technological Characteristics
Point-of-care coagulation management system. Uses lyophilized reagents (Celite, calcium chloride, protamine sulfate) on plastic test cards with magnetic stripe encoding. Sensing principle: optical detection of particle movement decrease during clot formation. Connectivity: serial cable to Rapidpoint Coag Analyzer. Power: internal supply. User interface: 8-inch touch screen. Software: performs dosage calculations based on user-entered targets and test results.
Indications for Use
Indicated for professional use in operating rooms to manage heparin and protamine dosing during cardiopulmonary bypass procedures. Used with Rapidpoint Coag Analyzer and HMT/HTT/PRT test cards to determine patient response to heparin, identify sensitivity/resistance, and calculate neutralization dosages for patients undergoing anticoagulation.
Regulatory Classification
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.
Special Controls
*Classification.* Class II (special controls).
Predicate Devices
- Hepcon HMS (K911240)
- Heparin Dose Response Test (Medtronic, Inc) performed on Hepcon HMS
- Heparin Assay Cartridges (Medtronic, Inc) performed on Hepcon HMS
Reference Devices
Submission Summary (Full Text)
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| 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 |
|-----|----------|
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## 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
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#### 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.
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#### 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.
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## 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<br>an individual to heparin | same |
| Format | Dry reagent in cuvette | lyophilized reagents in a flat<br>shallow reaction chamber<br>mounted on a thin plastic card |
| Reaction | one stage | one stage |
| Sample type | Noncitrated whole blood | citrated or noncitrated whole<br>blood |
| Reagent base | Kaolin | Celite |
| Reaction | Formation of a fibrin clot | Same |
| Instrument | Hepcon HMS | Rapidpoint™ Coag Analyzer,<br>Rapidpoint™ ACCENT |
| Endpoint monitored | coagulation time | same |
| Test interpretation | endpoint has direct correlation to<br>heparin activity | same |
| Quality control | None available; manufacture<br>recommends using normal donor | self tests performed by analyzer<br>at power up and throughout<br>operation, plus functional testing<br>of each test card with two levels<br>of quality control plasmas,<br>electronic QC |
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### 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 (<8℃) for at least six months. They are stable at room temperature (20 - 25℃) for about two weeks.
The HTT card is sensitive to inhibitors of heparin. The performance characteristics of the HTT cards with respect to factor sensitivity have not been established.
Lipid (to at least 15 mg/ml), nitroglycerin (to 1 ug/ml), and Dextran (to 6 mg/ml) had no effect on HTT card results in the presence of absence of polybrene (added to simulate resistance to heparin). There was no effect of sample temperature from 2°C to 37°C on HTT card results. Samples should not be drawn into acid citrate tubes.
Clinical Performance Data: "Normal ranges" (mean +/- 2 SD) were 477 to 693 seconds for both citrated and noncitrated whole blood samples. Field and clinical testing was done at three large hospitals to establish substantial equivalence of the HTT to the predicate device. Heocon Heparin Dose Response (Medtronic). Samples from 139 individuals were drawn and split to provide citrated and noncitrated blood samples. These samples were tested on several different lots of HTT cards on the Rapidpoint" (formerly TAS) Coag Analyzer/ Rapidpoint™ ACCENT and with the predicate device. The heparin dosages calculated from the HTT by the Accent for each patient were compared to the heparin dosages calculated by the Hepcon HDR at each test site. No significant differences (p = ≥0.05) in dosage were observed between the two systems by ANOVA testing.
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#### Summary of Safety and Effectiveness Information
PRT Card
Trade name: Protamine Response Test Card (PRT)
Common Name: PRT
Classification Name: multipurpose system for in vitro coagulation studies (class II, 864.5425)
Predicate Device: The proposed PRT is substantially equivalent to the Heparin Assay Cartridges (Medtronic, Inc), performed on the Hepcon HMS (Medtronic, Inc), used for determining heparin levels in individual patients by protamine sulfate titration.
Description of the Device: 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.
Intended Use: 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.
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## Summary of Safety and Effectiveness Information
PRT Card
#### Comparison of PRT and the Predicate Device
#### Heparin Assay Cartridges (Hepcon HMS; Medtronic, Inc)
| Characteristic | Predicate Device | Proposed Device |
|---------------------|---------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Determines the amount of<br>heparin in a blood sample by<br>protamine titration | same |
| Format | Dry reagent in cuvette | lyophilized reagents in a flat<br>shallow reaction chamber<br>mounted on a thin plastic card |
| Reaction | one stage | one stage |
| Sample type | noncitrated whole blood | citrated or noncitrated whole<br>blood |
| Reagent base | Thromboplastin; protamine<br>sulfate | Celite; protamine sulfate |
| Reaction | Formation of a fibrin clot | Same |
| Instrument | Hepcon HMS | Rapidpoint™ Coag Analyzer,<br>Rapidpoint™ ACCENT |
| Endpoint monitored | Clot formation | Same |
| Test interpretation | endpoint has direct correlation to<br>heparin activity | Same |
| Quality control | Heparinized Hepcon HMS<br>controls | self tests performed by analyzer<br>at power up and throughout<br>operation, plus functional testing<br>of each test card with two levels<br>of quality control plasmas,<br>electronic QC |
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#### Summary of Safety and Effectiveness Information
PRT Card
Nonclinical Performance Data: Preclinical testing was done at CVDI with PRT cards and the Rapidpoint™ Coag Analyzer to determine the performance characteristics of the system.
The PRT cards are stable for at refrigerator temperatures or lower (<8℃) for at least 11 months. They are stable at room temperature (20 - 25℃) for at least 2 weeks.
The PRT card is sensitive to levels of heparin activity from 0.4 to at least 8 U/ml. The performance characteristics of the PRT cards with respect to factor sensitivity have not been established.
Lipid (to at least 15 mg/ml), nitroglycerin (to 1 ug/ml), and Dextran (to 6 mg/ml) had no effect on PRT card results in the presence of heparin. There was no effect of sample temperature from 2 °C to 37°C) on PRT card results. Samples should not be drawn into acid citrate tubes.
Clinical Performance Data: Citrated and noncitrated samples from normal individuals produce results of less than 40 seconds on PRT cards, indicating the absence of heparin. Field and clinical testing was done at three large hospitals to establish substantial equivalence of the predicate device (Hepcon Heparin Assay cartridges). Samples from 139 individuals were drawn and split to provide citrated and noncitrated blood samples. These samples were tested on several different lots of PRT cards on the Rapidpoint™ (formerly TAS) Coag Analyzer/Rapidpoint™ ACCENT and with the predicate device. The protamine sulfate dosages calculated from the PRT by the Accent for each patient were compared to the protamine sulfate dosages calculated by the Hepcon Heparin Assay Cartridges at each test site. No significant differences (p = ≥0.05) in dosage were observed between the two systems by ANOVA testing.
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# JAN 1 4 2000
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Peter Scott Vice President of Quality Assurance and Regulatory Affairs Cardiovascular Diagnostics, Inc. 5301 Departure Drive Raleigh, North Carolina 27616
Re: K993519 Trade Name: Rapidpoint™ Accent Regulatory Class: II Product Code: JOX Dated: October 18, 1999 Received: October 18, 1999
Dear Mr. Scott:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrl/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): k993519
Device Name:
Rapidpoint Accent, Heparin Titration Test Card, Protamine Response Test Card
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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Qffice of Device Evaluation (ODE)
Peter E. Masini
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K933519
Prescription
(Optional Format 3-10-98)
