(190 days)
K001317 Aria Digital Holter Recorder®
Not Found
No
The device description explicitly states that it "does not perform any analysis on the ECG data" and the "Mentions AI, DNN, or ML" section is marked as "Not Found".
No
The device is strictly for acquiring and storing ECG signals for diagnostic purposes and does not perform any therapeutic function.
Yes.
The device acquires and stores ECG signals for later analysis, which is a key step in diagnosing heart conditions. Although it "does not perform any analysis on the ECG data" itself, the data it collects is intended to be used for diagnostic purposes by a healthcare practitioner.
No
The device description explicitly states it is a "Digital Holter Recorder" and describes hardware components like "on-board flash memory," "infra-red communications," and cable connections for data transfer. It also mentions "hardware testing" in the performance studies summary.
Based on the provided information, the SEER Light Compact Digital Holter Recorder is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The SEER Light Compact Digital Holter Recorder acquires ECG signals directly from the chest surface of a patient. This is a non-invasive measurement of electrical activity within the body, not an analysis of a biological specimen.
The device is a medical device used for physiological monitoring, specifically for recording ambulatory ECG data.
N/A
Intended Use / Indications for Use
The intended use of the SEER Light Compact Digital Holter Recorder is to acquire ambulatory 2 or 3 channels of ECG signal from the chest surface of pediatric or adult patients for no longer than 24 hours. The device stores this data along with patient demographic information to on board flash memory. It does not perform any analysis on the ECG data.
The SEER Light Compact Digital Holter Recorder is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.
Product codes (comma separated list FDA assigned to the subject device)
MWJ
Device Description
The SEER Light Compact Digital Holter Recorder is designed to acquire ambulatory 2 or 3 channels of ECG signal from the chest surface for no longer than 24 hours. The device stores the acquired ECG data in its on-board 32 megabytes of flash memory. Additionally, the SEER Light controller downloads patient demographic information into the SEER Light recorder and checks the signal quality of the ECG data at hookup time via isolated, infra-red communications. At the end of the recording the SEER Light controller is connected to the SEER Light recorder by cable and the stored ECG data is transferred to it and onto a standard compact flash memory card.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chest surface
Indicated Patient Age Range
pediatric or adult patients
Intended User / Care Setting
used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.
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)
The SEER Light complies with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the system:
- Requirements specification review .
- Code inspections ●
- Software and hardware testing ●
- Safety testing ●
- Environmental testing .
- Final validation .
The results of these measurements demonstrated that the SEER Light Compact Digital Holter Recorder is as safe, as effective, and performs as well as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K001317 Aria Digital Holter Recorder®
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.
Not Found
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
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).
0
K021470
| Date: | NOV 1 4 2002 |
|---|---|
| Date: | November 12, 2002 |
| Submitter: | GE Medical Systems Information Technologies |
| 8200 West Tower Avenue | |
| Milwaukee, WI 53223 USA | |
| Contact Person: | Lisa Lee Michels |
| Regulatory Affairs Specialist | |
| GE Medical Systems Information Technologies | |
| Phone: (262) 293-1609 | |
| Fax: (414) 918-8203 | |
| Device: Trade Name: | SEER Light Compact Digital Holter Recorder or (SEER Light) |
| Common/Usual Name: | Digital Ambulatory Monitor |
| Classification Names: | 21 CFR 870.2800 Electrocardiograph, Ambulatory (without |
| Analysis) MWJ | |
| Predicate Devices: | K001317 Aria Digital Holter Recorder® |
| Device Description: | The SEER Light Compact Digital Holter Recorder is designed to |
| acquire ambulatory 2 or 3 channels of ECG signal from the chest | |
| surface for no longer than 24 hours. The device stores the | |
| acquired ECG data in its on-board 32 megabytes of flash | |
| memory. Additionally, the SEER Light controller downloads | |
| patient demographic information into the SEER Light recorder | |
| and checks the signal quality of the ECG data at hookup time via | |
| isolated, infra-red communications. At the end of the recording | |
| the SEER Light controller is connected to the SEER Light | |
| recorder by cable and the stored ECG data is transferred to it and | |
| onto a standard compact flash memory card. | |
| Intended Use: | The intended use of the SEER Light Compact Digital Holter |
| Recorder is to acquire ambulatory 2 or 3 channels of ECG signal | |
| from the chest surface of pediatric or adult patients for no longer | |
| than 24 hours. The device stores this data along with patient | |
| demographic information to on board flash memory. It does not | |
| perform any analysis on the ECG data. | |
| The SEER Light Compact Digital Holter Recorder is intended to | |
| be used under the direct supervision of a licensed healthcare | |
| practitioner, by trained operators in a hospital or medical | |
| professional's facility. | |
| Technology: | The proposed SEER Light employs the same technology as the |
| predicate device. |
510(k) Summary of Safety and Effectiveness
1
Test Summary:
The SEER Light complies with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the system:
- Requirements specification review .
- Code inspections ●
- Software and hardware testing ●
- Safety testing ●
- Environmental testing .
- Final validation .
Conclusion:
The results of these measurements demonstrated that the SEER Light Compact Digital Holter Recorder is as safe, as effective, and performs as well as the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its head, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
GE Medical Systems Information Technologies c/o Ms. Lisa Lee Michels Regulatory Affairs Specialist 8200 West Tower Avenue Milwaukee, WI 53223
Re: K021470
Trade Name: SEER Light Compact Digital Holter Recorder and Controller Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II (two) Product Code: MWJ Dated: August 23, 2002 Received: August 26, 2002
Dear Ms. Michels:
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.
3
Page 2 - Ms. Lisa Lee Michels
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), 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,
Elio Mallis
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
5 10(k) Number (if known):
1021470
Device Name:
SEER Light Compact Digital Holter Recorder
Indications For Use:
The intended use of the SEER Light Compact Digital Holter Recorder is to acquire ambulatory 2 or 3 channels of ECG signal from the chest surface of pediatric or adult patients for no longer than 24 hours. The device stores this data along with patient demographic information to on board flash memory. It does not perform any analysis on the ECG data.
The SEER Light Compact Digital Holter Recorder is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K021470
Elias Mallis
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)