(121 days)
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Not Found
No
The provided 510(k) summary does not contain any mention of AI, ML, deep learning, or related concepts, nor does it describe functionalities typically associated with AI/ML in medical devices (like image processing or complex data analysis beyond standard ECG interpretation).
No
The device is used for evaluation and monitoring of cardiac conditions and for research, not for direct treatment or therapy.
Yes
The device is used for "Evaluation of Symptoms suggesting arrhythmia or myocardial ischemia," "Evaluation of ECG documentation therapeutic intervention," and "Evaluation of patients for ST segment Changes," all of which are activities involved in diagnosing medical conditions.
Unknown
The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only. Without this information, it's impossible to ascertain if the device includes hardware components or is purely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens taken from the human body. The intended use and indications for use described here focus on evaluating symptoms, therapeutic interventions, ST segment changes, patient response to activities, and clinical syndromes related to cardiac function within the patient. There is no mention of analyzing blood, urine, tissue, or other biological samples.
- The device is used for direct patient evaluation. The indications describe monitoring and evaluating patients directly, not analyzing samples in a laboratory setting.
The description strongly suggests this is a device used for cardiac monitoring or evaluation, likely involving the recording and analysis of electrical activity of the heart (ECG). This falls under the category of medical devices used for diagnosis and monitoring in vivo, not in vitro.
N/A
Intended Use / Indications for Use
- · Designed for Adult and Pediatric Patients. - · For Hospital and Clinic use only. - · For Prescription use only. Some of the conditions for use are as follows: - Evaluation of Symptoms suggesting arrhythmia or myocardial ischemia. . - Evaluation of ECG documentation therapeutic intervention in individual or groups of patients. . - Evaluation of patients for ST segment Changes t - . Evaluation of patients response after resuming occupational or recreational activities (e.g. after M.I. or cardiac surgery). - Evaluation of clinical syndromes or situations where arrhythmia may increase the risk of sudden death. . - Clinical and epidemiological research studies. ● Precaution: Computerized ECG Analysis should not replace diagnosis by a qualified physician. The physician should verify that the reported data is accurate before applying clinical conclusions.
Product codes
DPS
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Adult and Pediatric
Intended User / Care Setting
Hospital and Clinic use only. Prescription use only.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(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 circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 3 2001
Mr. James H. Brown Caird Technology, Inc. 205 Camden Chase Columbia, SC 29223
Re: K012686
Trade Name: Caird Technology Holter 2000 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: November 17, 2001 Received: November 21, 2001
Dear Mr. Brown:
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 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.
1
Page 2 - Mr. James H. Brown
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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
N. Oa. Telle
am D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K012686 510(k) Number:
DEC 1 3 2001 Holter 2000 Device Name:
Indications for use:
- · Designed for Adult and Pediatric Patients.
- · For Hospital and Clinic use only.
- · For Prescription use only.
Some of the conditions for use are as follows:
- Evaluation of Symptoms suggesting arrhythmia or myocardial ischemia. .
- Evaluation of ECG documentation therapeutic intervention in individual or groups of patients. .
- Evaluation of patients for ST segment Changes t
- . Evaluation of patients response after resuming occupational or recreational activities (e.g. after M.I. or cardiac surgery).
- Evaluation of clinical syndromes or situations where arrhythmia may increase the risk of sudden death. .
- Clinical and epidemiological research studies. ●
Precaution:
Computerized ECG Analysis should not replace diagnosis by a qualified physician. The physician should verify that the reported data is accurate before applying clinical conclusions.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Confidential
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
l'age 2 of 3
Caird Technology Inc. 205 Camden Chuse Columbia, S.C. 29223
Deddy Tudd