(239 days)
Not Found
No
The description focuses on data acquisition, storage, and transmission for analysis by separate software, explicitly stating the device itself does not perform diagnosis or interpretation. There is no mention of AI or ML in the provided text.
No.
The device is a Holter recorder designed to acquire, digitize, and store ECG data for later analysis by evaluation software, which assists in diagnosis. It does not provide any therapy or treatment.
No
The device description explicitly states: "This recorder is not capable of any diagnosis nor can it provide any interpretation of the data." It acquires, digitizes, and stores data for analysis by separate software, which is then used by medical personnel to assist in diagnosis.
No
The device description clearly outlines hardware components like a recorder, keypad, LCD screen, batteries, and a memory card, in addition to the software.
Based on the provided information, the CardioMem® CM 3000-12BT 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, or tissue) to provide information for diagnosis, monitoring, or screening. The CardioMem® CM 3000-12BT is a Holter recorder that records electrical signals from the heart (ECG) directly from the patient's body. It does not analyze biological specimens.
- The intended use and device description clearly state that it acquires, digitizes, and stores ECG data. This data is then analyzed by separate software (CardioDay®) to assist trained medical personnel in diagnosis. The device itself is a data acquisition tool, not a diagnostic test performed on a specimen.
Therefore, the CardioMem® CM 3000-12BT falls under the category of a medical device used for physiological monitoring and data recording, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CardioMem® CM 3000-12BT is a Hotter recorder which is indicated for patients who may benefit from a long-term continuous electrocardiographic (ECG) recording, including, but not limited to, those with complaints of palpitations, syncope, chest pain, shortness of breath, or those that need to be monitored to judge their current cardiac functionality.
Product codes
MWJ
Device Description
The CM 3000-12BT is a Holler recorder designed to be used in conjunction with the evaluation software GardioDay® (K051471). This recorder is not capable of any diagnosis nor can it provide any interpretation of the clata. The CM 3000-12BT acquires, digitizes and stores data to be analyzed by CardioDay®. The CM 3000-12BT uitlizes a 10-lead electrode hookup and placement to provide CardioDay" with 12 channels of full disclosure for Holler analysis. The cardiac data provided by CardioDay® is used by trained medical personnel to assist in the diagnosis of patients with various rhythm patterns. The CM 3000-12BT Holter recorder stores 12 ECG channels continuously for up to 48-hours including the detection of pacemaker pulses. A keyped is available to set up system contiguration, to enter patient's ID and name, to check lead quality during hook-up, and to start the recording. During the recording, the keypad can be used to enter event markers. The CM 3000-12BT has a LCD screen to allow ECG display during the hook-up, lead quality check, system configuration and various messages for the hock-up technician. The CM 3000-12BT uses one or two AA batterles, and a removable memory card for data storage.
ECG data and palient data can be Iransmitted via a Bluetooth connection (BT module from Amber wireless GmbH) from the CM 3000-12BT to CardidDay" and also from CardioDay® to the CM 3000-12BT
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical personnel
physician or other licensed medical professional
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)
Non-Clinical Testing:
Varilization and validation test plans were completed in accordance with geternad AG procedures and GMP guidelines. A Hazard Analysis was completed and hazards were ത്തിക്കുന്നു. അമേരിക്കുന്നതിനു
The CardioMem" CM 3000-12BT complies to the following standards:
· IEC 60601-1.
- · IEC 6001-1-1.
- · IEC (30601-1-2 (EMC),
- · IEC 60601-1-4.
- IEC 60601-2-47
- IEC 60601-2-51 (Part 50.101.2).
- ANSVAAMI EC 38.
- 150 14971.
- EN 980,
- 13Q 15223,
- · EN 1041
All system specifications were met and lesting performed to demonstrate substantial equivalence
Clinical Testing:
Clinical testing was not required to demonstrate substantial equivalence of safety and effectiveness
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
§ 870.2800 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
MAY 3 0 2007
| Special 510(k) Notification | |
|---|---|
| and the controlled on the manage of the many of the man more to the comments of the manufactures and the many of the many of the man | |
| CardioMem" CM 3000-12BT | Project ID: 0508H1 |
| assessment of the program as and and the program and of the first and the first and any and the manus a | |
| 510(k) · Summary | Section 16-0001-Rev A |
510(k) - Summary
| Name and address of the
manufacturer and sponsor
of the 510(k) submission: | getemed AG
Oderstr. 59
14513 Teltow
Germany
Tel.: +49 3328 - 3942-0
Fax: +49 3328 - 3942-99 |
|----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Official contact person
for all correspondence: | Dr. Bert Schadow
Regulatory Affairs Manager
E-mail: schadow@getemed.de |
| Manufacturing Facility: | getemed Medizin- und Informationstechnik AG
Oderstr. 59
14513 Teltow
Germany |
| Date of Preparation: | 2006-09-22 |
| Device Name / Trade Name: | CardioMem CM 3000-12BT Holter recorder |
| Generic name of the device: | Electrocardiograph, ambulatory (withou! Analysis) |
| Classification of new device: | Class II |
| Classification Panel: | Cardiovascular |
| Product Code and | MWJ |
| CFR Regulation Number: | 21 CFR 870.2800 |
| Predicate Devices Name and
510(k) Numbers: | CardioMem CM 3000-12 Holter recorder
K051686 |
| | CG-7000DX-BT ECG Recorder/Transmitter
K052556 |
Description of Device:
The CM 3000-12BT is a Holler recorder designed to be used in conjunction with the evaluation software GardioDay® (K051471). This recorder is not capable of any diagnosis nor can it provide any interpretation of the clata. The CM 3000-12BT acquires, digitizes and stores data to be analyzed by CardioDay®. The CM 3000-12BT uitlizes a 10-lead electrode hookup and placement to provide CardioDay" with 12 channels of full disclosure for Holler analysis. The cardiac data provided by CardioDay® is used by trained medical personnel to assist in the diagnosis of patients with various rhythm patterns. The CM 3000-12BT Holter recorder stores 12 ECG channels continuously for up to 48-hours including the detection of pacemaker pulses. A keyped is available to set up system contiguration, to enter patient's ID and name, to check lead quality during hook-up, and to start the recording. During the recording, the keypad can be used to enter event markers. The CM 3000-12BT has a LCD screen to allow ECG display during the hook-up, lead quality check, system configuration and various messages for the hock-up technician. The CM 3000-12BT uses one or two AA batterles, and a removable memory card for data storage.
ECG data and palient data can be Iransmitted via a Bluetooth connection (BT module from Amber wireless GmbH) from the CM 3000-12BT to CardidDay" and also from CardioDay® to the CM 3000-12BT
0608H1-Sec216-0007-ResvA-C142000-12BT-510k_Summerry.doc
Page 1 x4 3
1
| Special 510(k) Notification | Image: getemed logo |
|---|---|
| CardioMem® CM 3000-12BT | Project ID: 0608H1 |
| 510(k) - Summary | Section 16-0001-Rev A |
Comparison of Device Technological Characteristics to Predicate Device:
The CG-7000DX-BT, the CardleMem® CM 3000-12 Holler recorder, and the CardioMem® CM 3000-12 Holler recorder have the following technology specifications:
| Specification | Legally Marketed Device
CG-7000DX-AT ECG
Recorder/Transmitter (K052556) | Legally Marketed Device
CardioMem" CM 3000-12
(K051686) | New/ Modified Device
CardioMem" CM 3000-12BT |
|----------------------------------|-------------------------------------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Online data | Yes | No | No |
| Patient hookup | 10 ECG electrodes | 10 ECG electrodes | 10 ECG electrodes |
| Number of ECG channels desired | 12 | 12 | 12 |
| ECG lead names | RA, LA, LL, RL, V1, V2, V3, V4, V5, V6 | RA, LA, LL, RL, V1, V2, V3, V4, V5, V6 | RA, LA, LL, RL, V1, V2, V3, V4, V5, V6 |
| A to D sample rate | 720 samples/sec | 1024 samples/sec | 1024 samples/sec |
| A to D resolution | 12 bit | 12 bit | 12 bit |
| Pacemaker detection | Not specified | No | Yes |
| Open-Lead detection | Not specified | Yes | Yes |
| Memory type | Not specified | CompactFlash" Memory Card | CompactFlash" Memory Card |
| Data transfer method | Via Bluetooth connection | Via removable memory card | Via removable memory card |
| Online data transfer | Via Bluetooth connection | Via OptoLink cable OL1000 | Via Bluetooth connection or USB connection |
| Memory card data format | Not specified | Standard file system | Standard file system |
| Liquid crystal display (LCD) | Yes | Yes | Yes |
| Display purpose | Display ECG,
Device control | Display ECG,
check lead quality,
input patient ID,
display messages | Display ECG,
check lead quality,
input patient ID,
display messages |
| Keyboard | Protected touch keys (membrane) | Protected touch keys (membrane) | Protected touch keys (membrane) |
| System configuration | Not specified | Check lead quality,
input patient ID and name,
start recording | Check lead quality,
input patient ID and name,
start recording |
| System configuration method | Per keyboard and LCD display | Per keyboard and LCD display | Per keyboard and LCD display |
| Marker button | No | Yes | Yes |
| Size | Not specified | 108 * 66 * 22 mm | 108 * 66 * 22 mm |
| Weight | Not specified | o getemed |
|-----------------------------|---------------------------------------------------------|
| CardioMem ® CM 3000-12BT | Project ID: 0608H1 |
| 510(k) - Summary | Section 16-0001-Rev A |
Intended use:
The CardioMerri" digital Holler recorder is intended to continuously record up to 48 hours of ECG data on a digital flash mamory card. The CardioMem® performs no cardiac analysis by itself and is intended to be used with the analysis evaluation software CardioDay®. The recorded data are downloaded to a PC for analysis and following evaluation by a trained physician or bealth care professional
Federal law restricts CardioMent® to use on order of a physicien.
This device is available only upon the order of a physician or other licensed medical professional.
Non-Clinical Testing:
Varilization and validation test plans were completed in accordance with geternad AG procedures and GMP guidelines. A Hazard Analysis was completed and hazards were ത്തിക്കുന്നു. അമേരിക്കുന്നതിനു
The CardioMem" CM 3000-12BT complies to the following standards:
· IEC 60601-1.
- · IEC 6001-1-1.
- · IEC (30601-1-2 (EMC),
- · IEC 60601-1-4.
- IEC 60601-2-47
- IEC 60601-2-51 (Part 50.101.2).
- ANSVAAMI EC 38.
- 150 14971.
- EN 980,
- 13Q 15223,
- · EN 1041
All system specifications were met and lesting performed to demonstrate substantial equivalence
Clinical Testing:
Clinical testing was not required to demonstrate substantial equivalence of safety and effectiveness
Conclusion:
The CardioMem" CM 3000-12BT Holter recorder is substantially equivalent to the predicate device listed in this Summary and the device, as changed, does not raise any new issues of safely and effectiveness.
060841-Sec16-0001-RewA-CV13000-12BT-510K_Summary Soc
Page 3 of 3
3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 3 0 2007
Getemed AG c/o Sid Mathur Senior Regulatory Affairs Specialist MDI Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, NY 11021
Re: K063042
Trade/Device Name: CardioMem CM 3000-12BT Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: MWJ Dated: April 23, 2007 Received: May 3, 2007
Dear Mr. Mathur:
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, EDA may publish further announcements concerning your device in the Federal Register.
4
Page 2 - Mr. Mathur
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 agencics. 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 clectronic 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 cquivalence 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bran D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
F. 561 C. - 1000 - 10/1/71 - 1000 - 10/1/71 - 1000 - 10/1/71 - 1000 - 10/1/71 - 1000 - 10/1/71
Indications for Use
510(k) Number (if known):
Cavice Name:
CardioMem® CM 3000-12BT
Indications For Use:
The CardioMem® CM 3000-12BT is a Hotter recorder which is indicated for patients who may benefit from a long-term continuous electrocardiographic (ECG) recording, including, but not limited to, those with complaints of palpitations, syncope, chest pain, shortness of breath, or those that need to be monitored to judge their current cardiac functionality.
Prescription Use (Part 21 CFR 801 Subpert D) Over-The-Counter Use (21 CFR 801 Subpari C)
(IPLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of __ (
(Division Sign-Off)
Division of Cardiovetoulat payt
510(k) Number Ko6 3017