(7 days)
Yes
The device description explicitly states that the "Add-Ons" perform data analysis using a "machine learned detection algorithm" and the "Mentions AI, DNN, or ML" section lists multiple instances of "machine learning".
No.
The device's intended use is to aid in diagnosing the likelihood of significant coronary artery disease, not to treat or therapeutically intervene.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an aid in diagnosis." Furthermore, the "Device Description" clarifies that it "indicates the likelihood of specific diseases at point of care," and "The CAD Add-On indicates the likelihood of significant Coronary Artery Disease (CAD)." These phrases directly link the device's function to the diagnostic process.
No
The device description explicitly states that the CorVista System is comprised of "several hardware and software components" and includes a "CorVista Base System" which is a "combination of hardware, firmware, and software components."
Based on the provided information, the CorVista® System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, prevention, or treatment of a disease or condition.
- CorVista System's Function: The CorVista System analyzes sensor-acquired physiological signals from the patient's body (specifically, from the trunk and digits). It does not analyze specimens derived from the body.
- Input Data: The input data for the CorVista System is physiological signals acquired directly from the patient, not laboratory test results from biological samples.
Therefore, while the CorVista System is a medical device used as an aid in diagnosis, its method of data acquisition and analysis falls outside the scope of In Vitro Diagnostics.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
The CorVista® System analyzes sensor-acquired physiological signals of patients presenting with cardiovascular symptoms (such as chest pain, dyspnea, fatigue) to indicate the likelihood of significant coronary artery disease. The analysis is presented for interpretation by healthcare providers in conjunction with their clinical judgment, the patient's signs, symptoms, and clinical history as an aid in diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
QXX, DQK
Device Description
The CorVista® System is a non-invasive medical device system comprised of several hardware and software components that are designed to work together to allow a physician to evaluate the patient for the presence of cardiac disease, or cardiac disease indicators, using a static detection algorithm.
The CorVista System has a modular design, where disease-specific "Add-On Modules" will integrate with a single platform, the CorVista Base System, to realize its intended use. The CorVista Base System is a combination of hardware, firmware, and software components with the functionality to acquire, transmit, store, and analyze data, and to generate a report for display in a secure web-based portal. The architecture of the CorVista Base system allows for integration with indication-specific "Add-Ons" which perform data analysis using a machine learned detection algorithm to indicate the likelihood of specific diseases at point of care. The CAD Add-On indicates the likelihood of significant Coronary Artery Disease (CAD). The analysis is presented for interpretation by healthcare providers in conjunction with their clinical judgment, the patient's signs, symptoms, and clinical history as an aid in diagnosis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Cardiovascular machine learning-based notification software
The CorVista® System is intended to non-invasively analyze physiological signals using machine learning techniques to indicate the likelihood of a cardiovascular disease or condition
Viz HCM is intended to non-invasively analyze physiological signals using machine learning techniques to suggest the likelihood of a cardiovascular disease or condition
Machine learning-based algorithm
Input Imaging Modality
Not Found
Anatomical Site
Trunk & Digits
Indicated Patient Age Range
Adult patients presenting with cardiovascular symptoms
Intended User / Care Setting
Professional healthcare environment (i.e., local physician offices, clinics and hospital settings) with cellular or Wifi
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
The validation population (A and B) used for performance testing included symptomatic subjects with a range of cardiovascular symptoms and risks factors which prompted the use of ICA and CTA for CAD evaluation.
Sample Size: N=1,816
Data Source: prospective, multicenter, nonrandomized, repository study. Sensor-acquired physiological signals were collected from the subjects using the CorVista Capture™ device based on the scheduling of their diagnostic imaging procedure.
Annotation protocol: The actual CAD classification (CAD+ or CAD-) of each subject (as determined by their reference procedure) was compared to the algorithm prediction results derived from the CorVista System with CAD Add-On Module.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: prospective, multicenter, nonrandomized, repository study.
Sample Size: N=1,816
AUC: 0.80 AUC-ROC.
Standalone Performance: Not Found
Key results: The diagnostic performance of the CorVista System in this broad population was demonstrated to be 88% sensitivity and 51% specificity. These results are comparable to the rule out performance of coronary computed tomography angiography (CCTA). The CorVista System is designed to be used in conjunction with the healthcare provider's clinical judgment, the patient's signs, symotoms, and clinical history as an aid in diagnosis.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 88%
Specificity: 51%
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.
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
N/A
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 8, 2023
CorVista Health, Inc. Gabrielle Zaeska Vice President Regulatory Affairs 7144 13th Place NW. Suite 2200 Washington, District of Columbia 20012
Re: K232686
Trade/Device Name: CorVista® System Regulation Number: 21 CFR 870.2380 Regulation Name: Cardiovascular machine learning-based notification software Regulatory Class: Class II Product Code: QXX, DQK Dated: September 1, 2023 Received: September 1, 2023
Dear Gabrielle Zaeska:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Stephen G. Browning -S
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K232686
Device Name CorVista® System
Indications for Use (Describe)
The CorVista® System analyzes sensor-acquired physiological signals of patients presenting with cardiovascular symptoms (such as chest pain, dyspnea, fatigue) to indicate the likelihood of significant coronary artery disease. The analysis is presented for interpretation by healthcare providers in conjunction with their clinical judgment, the patient's signs, symptoms, and clinical history as an aid in diagnosis.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------ |
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3
Summary of 510(k)
CorVista Health, Inc. [510(k) Number - K232686]
This 510(k) Summary is in conformance with 21 CFR 807.92
| Submitter: | CorVista Health, Inc. (“CorVista Health”)
7144 13th Place NW, Suite 200
Washington, DC 20012
Phone: 919-619-7581
Fax: 919-573-9105 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Gabrielle Zaeska
Vice President, Regulatory Affairs & Quality
CorVista Health, Inc.
Email: gzaeska@corvista.com
Phone: 612-267-5004
Fax: 919-573-9105 |
| Alternate Contact: | Tom McDougal
Principal Regulatory Affairs Specialist
CorVista Health, Inc.
Email: tmcdougal@corvista.com
Phone: 919-813-2724 ext 1058
Fax: 919-573-9105 |
| Date Prepared: | 1 September 2023 |
| Trade Name: | CorVista® System |
| Common Name: | Cardiovascular machine learning-based notification software |
| Classification: | Class II |
| Regulation Number: | 21 CFR 870.2380 |
| Classification Panel: | Cardiovascular |
| Product Code: | QXX |
Subsequent Product Code: DQK
4
| Predicate | |
|---|---|
| Trade / Device Name | Viz HCM |
| 510(k) Submitter / Holder | Viz.ai, Inc. |
| 510(k) Number | DEN230003 |
| Regulation Number | 21 CFR 870.2380 |
| Classification Panel | Cardiovascular |
| Product Code | OXO |
The predicate device has not been subject to a design-related recall.
Device Description
The CorVista® System is a non-invasive medical device system comprised of several hardware and software components that are designed to work together to allow a physician to evaluate the patient for the presence of cardiac disease, or cardiac disease indicators, using a static detection algorithm.
The CorVista System has a modular design, where disease-specific "Add-On Modules" will integrate with a single platform, the CorVista Base System, to realize its intended use. The CorVista Base System is a combination of hardware, firmware, and software components with the functionality to acquire, transmit, store, and analyze data, and to generate a report for display in a secure web-based portal. The architecture of the CorVista Base system allows for integration with indication-specific "Add-Ons" which perform data analysis using a machine learned detection algorithm to indicate the likelihood of specific diseases at point of care. The CAD Add-On indicates the likelihood of significant Coronary Artery Disease (CAD). The analysis is presented for interpretation by healthcare providers in conjunction with their clinical judgment, the patient's signs, symptoms, and clinical history as an aid in diagnosis.
Indications for Use
The Cor Vista® System analyzes sensor-acquired physiological signals of patients presenting with cardiovascular symptoms (such as chest pain, dyspnea, fatigue) to indicate the likelihood of significant coronary artery disease. The analysis is presented for interpretation by healthcare providers in conjunction with their clinical judgment, the patient's signs, symptoms, and clinical history as an aid in diagnosis.
Substantial Equivalence
The CorVista System is substantially equivalent to its predicate device, Viz HCM (DEN230003).
The table below provides a detailed comparison of the CorVista System to the predicate device.
5
| Characteristic | Subject Device | Chosen Predicate Device with
Justification | Comparison |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The CorVista® System is
intended to non-invasively
analyze physiological signals
using machine learning
techniques to indicate the
likelihood of a cardiovascular
disease or condition | Viz HCM is intended to non-
invasively analyze physiological
signals using machine learning
techniques to suggest the
likelihood of a cardiovascular
disease or condition | Same |
| Indications for Use | The CorVista® System
analyzes sensor-acquired
physiological signals of patients
presenting with cardiovascular
symptoms (such as chest pain,
dyspnea, fatigue) to indicate the
likelihood of
significant coronary artery
disease. The analysis is
presented for interpretation by
healthcare providers in
conjunction with their clinical
judgment, the patient's signs,
symptoms, and clinical history
as an aid in diagnosis. | Viz HCM is intended to be used in
parallel to the standard of care to
analyze recordings of 12-lead
ECG made on compatible ECG
devices. Viz HCM is capable of
analyzing the ECG, detecting signs
associated with hypertrophic
cardiomyopathy (HCM), and
allowing the user to view the ECG
and analysis results. Viz HCM is
indicated for use on 12-lead ECG
recordings collected from patients
18 years of age or older. Viz HCM
is not intended for use on patients
with implanted pacemakers.
Viz HCM is limited to analysis of
ECG data and should not be used
in-lieu of full patient evaluation or
relied upon to make or confirm
diagnosis. Viz HCM identifies
patients for further HCM follow-
up and does not replace the current | Different - This difference does
not change the intended use of the
device. The safety and
effectiveness of the CorVista
System in its intended use
population has been confirmed
through testing.
Any differences in the indications
for use do not affect the safety and
effectiveness of the CorVista
System and have been addressed
through clinical and bench testing
and supported by general and
special controls. |
| Characteristic | Subject Device | Chosen Predicate Device with
Justification | Comparison |
| Product Codes | (primary) QXX
(21 CFR 870.2380)
(subsequent product code)
DQK
(21 CFR 870.1425) | standard of care methods for
diagnosis of HCM. The results of
the device are not intended to rule-
out HCM follow-up.
(primary predicate) QXO
(21 CFR 870.2380)
(reference predicates)
DQK
(21 CFR 870.1425) | Different – codes reflect the
disease state detected and
hardware components. This
difference does not change the
intended use of the device |
| Operation Mode | Spot-check | Viz HCM (DEN230003) | Same |
| Motion | Non-motion | Spot-check
HemoSphere Advanced
Monitoring Platform, HemoSphere
ClearSight Module (K201446) and
Workmate ClarisTM System v1.2
(K210392)
Both secondary predicates are
intended for non-motion. | Same |
| Patient Population | Adult patients presenting with
cardiovascular symptoms | Viz HCM (DEN230003)
Adult patients | Different - This difference does
not change the intended use of the
device. The safety and
effectiveness of the CorVista
System in its intended use
population has been confirmed
through testing |
| Characteristic | Subject Device | Chosen Predicate Device with
Justification | Comparison |
| Environment of Use | Professional healthcare
environment (i.e., local
physician offices, clinics and
hospital settings) with cellular
or Wifi | Viz HCM (DEN230003)
Hospital and pre-hospital settings | Same |
| Prescription vs. Off-
the-Shelf | Prescription | Viz HCM (DEN230003)
Prescription | Same |
| Technological Characteristics | | | |
| Algorithm | Machine learning-based
algorithm | Viz HCM (DEN230003)
Machine learning-based algorithm | Same |
| Algorithm Calculation
and Output | Likelihood of significant CAD
derived from calculated VCG
and PPG features and patient
demographics. | Viz HCM (DEN230003)
Presence of signs of HCM derived
from ECG signal. | Different – The output of the
CorVista System provides users
with the likelihood of significant
CAD for a given patient. The
primary predicate indicates the
presence of signs of HCM. These
signs are equivalent in concept to
the calculated features that are
used as the inputs to the CorVista
machine-learning process and
resultant algorithm. Both devices
process signals to provide
information to users on
cardiovascular disease and as such
the intended use is not impacted
by this difference. The safety and
effectiveness of the CorVista
System has been confirmed
through testing. |
| Characteristic | Subject Device | Chosen Predicate Device with
Justification | Comparison |
| Ground Truth for
Model Training and
Validation | Guideline-driven ground truth
via invasive catheterization or
core-lab adjudicated CTA | Viz HCM (DEN230003)
Cardiologist-adjudicated signs of a
disease from ECG waveform | Different – The validation of the
two devices differs in the level of
ground truth that is used to
validate performance. The
CorVista System has been
validated using the patient's
disease state as ground truth, while
the predicate device utilizes the
presence of signs that suggest
disease. This difference does not
impact the shared general intended
use of providing information on
cardiovascular status. The safety
and effectiveness of the CorVista
System has been confirmed
through testing. |
| Measured
Physiological
Parameters | Synchronously acquired cardiac
electrical signals (acquired in
orthogonal axes via VCG) and
hemodynamic signals (acquired
via photoplethysmography
(PPG)) | HemoSphere Advanced
Monitoring Platform, HemoSphere
ClearSight Module (K201446) and
Workmate Claris™ System v1.2
(K210392)
K210392:
Oximetry, heart rate, and
additional cardiovascular
parameters (e.g., blood pressure,
oxygen delivery, etc.)
K201446:
Electrocardiograph and
intracardiac electrical signals | Same – The measured
physiological parameters of the
CorVista System are a subset of
those measured by the secondary
predicate devices. The safety and
effectiveness of the CorVista
System has been confirmed
through testing. |
| Characteristic | Subject Device | Chosen Predicate Device with
Justification | Comparison |
| Data Displayed | Likelihood of significant
Coronary Artery Disease
(CAD) | Viz HCM (DEN230003)
Notification Flag for patients who
require further HCM follow-up | Different - Display of the
likelihood of disease is of superior
diagnostic value compared to a
notification flag used in the
predicate device, therefore the
safety and effectiveness is non-
inferior compared to the predicate.
The clinical performance of the
CorVista System for the intended
disease and output has been
confirmed through testing. |
| Application Site | Trunk & Digits | HemoSphere Advanced
Monitoring Platform, HemoSphere
ClearSight Module (K201446) and
Workmate Claris™ System v1.2
(K210392)
The secondary predicates have
application sites including the
Trunk (K210392) and Digits
(K201446). | Same – The CorVista System
utilizes a subset of the application
sites utilized by the secondary
predicate devices. |
| Data Output | Tablet easy-to-read display
(LCD), Mobile App, and Web
App | Viz HCM (DEN230003)
Mobile app | Different - This difference does
not change the intended use of the
device. The safety and
effectiveness of the CorVista
System has been confirmed
through testing. |
| Characteristic | Subject Device | Chosen Predicate Device with
Justification | Comparison |
| Hardware | Seven-Channel Lead Set,
PPG Sensor,
Capture Device (Tablet) | HemoSphere Advanced
Monitoring Platform, HemoSphere
ClearSight Module (K201446) and
Workmate ClarisTM System v1.2
(K210392)
The secondary predicates utilize
lead sets, oximeter cables,
computer systems, etc. | Different - This difference does
not change the intended use of the
device. The safety and
effectiveness of the CorVista
System has been confirmed
through testing. |
| Software | CorVista Health Proprietary
Algorithm,
CorVista Health Proprietary
Application | Viz HCM (DEN230003)
Viz.ai Proprietary Algorithm,
Viz.ai Proprietary Application | Different - This difference does
not change the intended use of the
device. The safety and
effectiveness of the CorVista
System has been confirmed
through testing. |
| Physical
Degree of Protection
Against Electric Shock | Type CF – Applied Part | HemoSphere Advanced
Monitoring Platform, HemoSphere
ClearSight Module (K201446) and
Workmate ClarisTM System v1.2
(K210392)
Type BF and CF Applied Parts
(K201446)
Type CF - Applied Part
(K210392) | Same - The degree of protection
against electrical shock is the same
as the secondary predicate devices
and is appropriate for the intended
use environment. The safety and
effectiveness of the CorVista
System has been confirmed
through testing. |
| Characteristic | Subject Device | Chosen Predicate Device with
Justification | Comparison |
| Functional and Safety
Testing | IEC 60601-1 | HemoSphere Advanced
Monitoring Platform, HemoSphere
ClearSight Module (K201446) and
Workmate Claris™ System v1.2
(K210392) | Different - This difference does
not change the intended use of the
device. All devices completed
Functional and Safety testing
pursuant to their design and
intended use. The safety and
effectiveness of the CorVista
System has been confirmed
through testing. |
| | IEC 60601-1-2 | | |
| | IEC 60601-2-25 | | |
| | IEC 80601-2-61 | | |
| | IEC 60259 | | |
| | IEC 62133 | K201446:
IEC 60601-1
IEC 60601-1-2
IEC 60601-1-6
IEC 60601-1-8
IEC 60601-2-34
IEC 60601-2-57
IEC 60601-2-49
IEC 80601-2-49
Wireless Co-existence
K210392:
IEC 60601-1
IEC 60601-1-2 | |
| | AIM 7351731 | | |
| | ANSI IEEE C63.27 | | |
| | FCC 47CFR Part 15 Subpart C | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| Biocompatibility | ISO 10993 | HemoSphere Advanced
Monitoring Platform, HemoSphere
ClearSight Module (K201446) and
Workmate Claris™ System v1.2
(K210392) | Different - This difference does
not change the intended use of the
device. All devices completed
biocompatibility testing pursuant
to their level of patient contact.
The safety and effectiveness of the
CorVista System has been
confirmed through testing. |
| | Surface contact | | |
| | Skin | | |
| | Limited duration (