(86 days)
Not Found
No
The description focuses on standard ECG recording, display, printing, and communication features. While it mentions an "optional interpretation," there is no indication that this interpretation is generated using AI/ML. The lack of mention of AI/ML terms, training/test data, or performance metrics related to algorithmic interpretation further supports this conclusion.
No
The device is used to record the electrical activity of the heart for diagnostic purposes, not to treat it.
Yes.
The device's intended use is to record the electrical activity of the heart to correlate waveforms with heart muscle tissue health, and it's used for evaluating patients with cardiac abnormalities. While it does not produce a definitive interpretation, it provides an "effective beginning for evaluation," indicating its role in the diagnostic process.
No
The device description explicitly details hardware components such as a keyboard, display, storage, and communication options (Ethernet, wireless, modem), indicating it is a physical medical device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the living body (in vitro).
- Device Function: The Atria 3100 and 6100 are electrocardiographs. They record the electrical activity of the heart by placing electrodes on the patient's skin. This is a measurement taken from the living body (in vivo).
- Intended Use: The intended use is to record the electrical activity of the heart for correlation with the health of the heart muscle tissue structures. This is a diagnostic process performed on the patient directly.
Therefore, since the device operates by taking measurements directly from the patient's body rather than analyzing samples taken from the body, it falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Under the supervision of a qualified physician trained in ECG interpretation, Atria can be used to record the electrical activity of the heart for the purpose of correlating the resultant waveforms with the health of the heart muscle tissue structures.
This equipment is not designed to produce a definitive interpretation nor exhaustive evaluation of the patient's heart but rather provide an effective beginning for evaluation of adult and pediatric patients with cardiac abnormalities.
Product codes
DPS
Device Description
The Atria 3100 and 6100 are 12 lead electrocardiographs designed to record the electrical activity of the heart. They can display, print, electronically send and save ECG recordings. The Atria 6100 features a full alpha numeric keyboard and color display for data entry, waveform review and editing machine settings. The unit provides the ability to store 150 ECGs, print rhythm strips manually or automatically, and provides an optional interpretation. Advanced communications options allow the unit to fax, email and upload results to shared network drives via wired Ethernet, wireless 802.11 and modem.
The differences between the Atria 3100 and 6100 are as follows:
-
- Screen Size:
- Atria 3100 = 2 x 40 character display for data entry only (no waveform . viewing)
- Atria 6100 = 640 x 480 color TFT VGA preview screen for waveform . viewing
-
- Storage:
- . Atria 3100 = 50 records
- Atria 6100 = 150 records .
-
- The Atria 6100 has a slightly different keyboard to accommodate navigation in the User Interface.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
Under the supervision of a qualified physician trained in ECG interpretation
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
K060167 Page 1
Cardiac Science Corporation Bothell, WA Abbreviated Premarket Notification January 20, 2006
APR 1 9 2006
II. 510(k) Summary
A. Name of Device
| Trade name: | Atria 3100 |
|---|---|
| Atria 6100 | |
| Common name: | Electrocardiograph |
| Classification name: | Electrocardiograph |
B. Predicate Devices
| Device Name | Premarket
Notification |
|------------------------------------------------------------------|---------------------------|
| PageWriter Trim Series Cardiograph - Phillips Medical
Systems | K031422 |
| CP 100 and CP 200 - Welch Allyn, Inc. | K050074 |
C. Device description
The Atria 3100 and 6100 are 12 lead electrocardiographs designed to record the electrical activity of the heart. They can display, print, electronically send and save ECG recordings. The Atria 6100 features a full alpha numeric keyboard and color display for data entry, waveform review and editing machine settings. The unit provides the ability to store 150 ECGs, print rhythm strips manually or automatically, and provides an optional interpretation. Advanced communications options allow the unit to fax, email and upload results to shared network drives via wired Ethernet, wireless 802.11 and modem.
The differences between the Atria 3100 and 6100 are as follows:
-
- Screen Size:
- Atria 3100 = 2 x 40 character display for data entry only (no waveform . viewing)
- Atria 6100 = 640 x 480 color TFT VGA preview screen for waveform . viewing
-
- Storage:
- . Atria 3100 = 50 records
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Page 4 of 39
Confidential
1
zcbuiot Page 2
Cardiac Science Corporation Bothell, WA Abbreviated Premarket Notification January 20, 2006
- Atria 6100 = 150 records .
-
- The Atria 6100 has a slightly different keyboard to accommodate navigation in the User Interface.
D. Intended use
Under the supervision of a qualified physician trained in ECG interpretation, Atria can be used to record the electrical activity of the heart for the purpose of correlating the resultant waveforms with the health of the heart muscle tissue structures.
This equipment is not designed to produce a definitive interpretation nor exhaustive evaluation of the patient's heart but rather provide an effective beginning for evaluation of adult and pediatric patients with cardiac abnormalities.
E. Summary
The intended use, indication for use and principle of operation are substantially equivalent to the predicate devices, and do not raise any new types of safety and effectiveness questions.
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Page 5 of 39
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 9 2006
Cardiac Science Corporation c/o Ms. Cheryl L. Shea Vice President. RA/QA 3303 Monte Villa Parkway Bothell, Washington 98021-8969
Re: K060167
Trade Name: Atria 3100 and Atria 6100 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: March 22, 2006 Received: March 24, 2005
Dear Ms. Shea:
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. Iisting 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). 11 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
3
Page 2 -- Ms. Cheryl L. Shea
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour 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 (OS) 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), please contact the Office of Compliance at (240) 276-0120. 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/cdrl/industry/support/index.html.
Sincerely vours,
Bfumtemon for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number: KoloOlo 7
Device Name: Atria 3100 and Atria 6100
Indications for Use:
Under the supervision of a qualified physician trained in ECG interpretation, Atria can be used to record the electrical activity of the heart for the purpose of correlating the resultant waveforms with the health of the heart muscle tissue structures.
This equipment is not designed to produce a definitive interpretation nor exhaustive evaluation of the patient's heart but rather provide an effective beginning for evaluation of adult and pediatric patients with cardiac abnormalities.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bifumblona
Off
lovascular Devices
K060667
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