(21 days)
The CardioMem® CM 3000-12 digital Holter recorder is intended to continuously record up to 48 hours of ECG data on a digital flash memory card. The CardioMem® CM 3000-12 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 health care professional.
Federal law restricts CardioMem® CM 3000-12 to use on order of a physician.
This device is available only upon the order of a physician or other licensed medical professional.
The CardioMem® CM 3000-12 is a Holter 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.
The CM 3000-12 is a Holter recorder designed to be used in conjunction with the evaluation software CardioDay® (not included in this 510(k)). This recorder is not capable of any diagnosis nor can it provide any interpretation of the data. The CM 3000-12 acquires, digitizes and stores data to be analyzed by CardioDay". The CM 3000-12 uiliizes a 10-lead electrode hookup and placement to provide CardioDay® with 12 channels of full disclosure for H 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 3000-12 Holter recorder stores 12 ECG channels continuously for up to 48-hours. A keypad is available to set up system configuration, 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 3000-12 has a LCD screen to allow ECG display during the hook-up, lead quality check, system configuration and various messages for the hook-up technician. The CM 3000-12 uses one or two AA batteries, and a removable memory card for data storage.
The provided document is a 510(k) summary for the CardioMem® CM 3000-12 Holter recorder. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study.
The device, CardioMem® CM 3000-12, is a Holter recorder that acquires, digitizes, and stores ECG data. Crucially, the document states: "This recorder is not capable of any diagnosis nor can it provide any interpretation of the data." and "The CardioMem® CM 3000-12 performs no cardiac analysis by itself and is intended to be used with the analysis evaluation software CardioDay®."
Therefore, the "acceptance criteria" and "device performance" in this context do not refer to diagnostic accuracy or clinical effectiveness metrics, but rather to the recorder's technical specifications and compliance with regulatory standards for device safety and electrical performance. The study described is not a clinical performance study but a series of tests to confirm safety and efficacy based on technical standards.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document implicitly defines "acceptance criteria" through comparison with predicate devices and adherence to regulatory standards (IEC and AAMI). The "reported device performance" is essentially that the device meets these technical specifications and standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Devices: | |
| Continuous recording of ECG data | Records 12 ECG channels continuously for up to 48-hours |
| No online data monitoring & alarm | No |
| Patient Hookup (10 ECG electrodes) | 10 ECG electrodes |
| Number of ECG channels derived (12) | 12 |
| A to D sample rate (1024 samples/sec - matching one predicate) | 1024 samples/sec |
| A to D resolution (12 bit - matching one predicate) | 12 bit |
| Uses CompactFlash™ Memory Card | CompactFlash™ Memory Card |
| Data transfer via removable memory card | Via removable memory card |
| Standard file system for memory card data | Standard file system |
| Liquid Crystal Display (LCD) present | Yes |
| Display purposes (ECG, lead quality, patient ID, messages) | Display ECG, check lead quality, input patient ID, display messages |
| Keyboard type (Protected touch keys) | Protected touch keys (membrane) |
| System configuration method (keyboard/LCD) | Per keyboard and LCD display |
| Marker button present | Yes |
| External patient cable present | Yes |
| Record identification procedure | Yes |
| ECG channel preview | Yes |
| Safety and Efficacy Standards Compliance: | |
| Compliance with Quality System Regulation 21 CFR 820 | Basis for development |
| Environmental and safety tests (including EMC) | Tested according to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-25, IEC 60601-2-47 and ANSI/AAMI EC 38:1998 standards. |
| (Lack of Pacemaker Detection - deviation from some predicates) | No (Pacemaker detection) |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical "test set" in the traditional sense involving patient data for diagnostic evaluation. The "tests" mentioned are primarily engineering and electrical safety tests, not performance on a clinical dataset. Therefore, there is no sample size of patients or data provenance (country, retrospective/prospective) for a clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As this is not a clinical performance study involving diagnostic outputs, there was no ground truth for a test set established by medical experts. The device explicitly states it performs no analysis or diagnosis.
4. Adjudication method for the test set
Not applicable, as no clinical test set requiring adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a Holter recorder, not an AI analysis tool. It does not perform analysis itself, nor does it involve human readers interpreting AI-assisted outputs.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a data acquisition and storage tool, not an algorithm performing standalone analysis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device's acceptance is its adherence to technical specifications and safety standards, rather than diagnostic accuracy against clinical ground truth.
8. The sample size for the training set
Not applicable. This document is about a hardware device, a Holter recorder, not an AI or analytical algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
{0}------------------------------------------------
Abbreviated 510(k) Notification
♥ geter
CardioMem® CM 3000-12
510(k) - Summary
Project ID: 0404H1
Section 16-0001-Rev B
| Submitted By: | getemed AGOderstr. 5914513 TeltowGermanyTel.: +49 3328 - 3942-0Fax: +49 3328 - 3942-99 | JUL 1 4 2005 |
|---|---|---|
| Contact: | Dr. Bert SchadowRegulatory Affairs Manager | |
| Manufacturing Facility: | getemed Medizin- und Informationstechnik AGOderstr. 5914513 TeltowGermany | |
| Date of Preparation: | 2005-05-25 | |
| Trade Name: | CardioMem® CM 3000-12 Holter recorder | |
| Common Name: | Holter recorder | |
| Classification Name: | Electrocardiograph, ambulatory (without Analysis) | |
| Product Classification: | 21 CFR 870.2800, Class II | |
| Product Code: | MWJ | |
| Legally Marketed Devices: | DR180+ Holter recorder (K004007, NorthEastMonitoring, Inc.)H12+ Holter recorder (K021373, Mortara InstrumentInc.)CardioID+ (RZ 153+) Holter recorder (K022540,Rozinn Electronics. Inc.) |
Reason for Submission
510(k) - Summary
Premarket notification (Abbreviated 510(k)) for CardioMem® CM 3000-12, a New Device, seeking authority to market the device under Section 510(k) as a device that is substantially equivalent to the DR180+ Holter recorder (K004007, NorthEast Monitoring, Inc.), the H12+ Holter recorder (K021373, Mortara Instrument, Inc.) and CardioID+ (RZ 153+) Holter recorder (K022540, Rozinn Electronics, Inc.).
Device Description
The CM 3000-12 is a Holter recorder designed to be used in conjunction with the evaluation software CardioDay® (not included in this 510(k)). This recorder is not capable of any diagnosis nor can it provide any interpretation of the data. The CM 3000-12 acquires, digitizes and stores data to be analyzed by CardioDay". The CM 3000-12 uiliizes a 10-lead electrode
hookup and placement to provide CardioDay® with 12 channels of full disclosure for H 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 3000-12 Holter recorder stores 12 ECG channels continuously for up to 48-hours. A keypad is available to set up system configuration, 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 3000-12 has a LCD screen to allow ECG display during the hook-up, lead
{1}------------------------------------------------
| Abbreviated 510(k) Notification | ● getemed |
|---|---|
| CardioMem® CM 3000-12 | Project ID: 0404H1 |
| 510(k) - Summary | Section 16-0001-Rev B |
quality check, system configuration and various messages for the hook-up technician. The CM 3000-12 uses one or two AA batteries, and a removable memory card for data storage.
Intended use
The CardioMem® CM 3000-12 digital Holter recorder is intended to continuously record up to 48 hours of ECG data on a digital flash memory card. The CardioMem® CM 3000-12 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 health care professional.
Federal law restricts CardioMem® CM 3000-12 to use on order of a physician.
This device is available only upon the order of a physician or other licensed medical professional.
Indications for use
The CardioMem® CM 3000-12 is a Holter 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.
Comparison of Technology Characteristics
The CardioMem® CM 3000-12 Holter recorder, the DR180+ Holter recorder, the H12+ Holter recorder, and the CardiolD+ (RZ153+) Holter recorder have the following technology specifications:
| Specification | Legally MarketedDeviceDR180+ Holterrecorder | Legally MarketedDeviceH12+ Holter recorder | Legally MarketedDeviceCardiolD+ (R2153+) | New DeviceCardioMemCM3000-12 |
|---|---|---|---|---|
| Online datamonitoring &alarm | No | No | No | No |
| Patient hookup | 10 ECG electrodes | 10 ECG electrodes | 7 ECG electrodes | 10 ECG electrodes |
| Number of ECGchannels derived | 12 | 12 | 3 | 12 |
| ECG lead names | RA, LA, LL, RL, V1, V2,V3, V4, V5, V6 | RA, LA, LL, RL, V1, V2,V3, V4, V5, V6 | Holter configuration perAAMI EC38 | RA, LA, LL, RL, V1, V2,V3, V4, V5, V6 |
| A to D sample rate | 720 samples/sec. | 180 samples/sec. | 1024 samples/sec. | 1024 samples/sec. |
| A to D resolution | 12 bit | 20 bit | 12 bit | 12 bit |
| Pacemakerdetection | Yes | Yes | Yes | No |
| Open-Leaddetection | not specified | Yes | Yes | Yes |
| Memory type | CompactFlash™Memory Card | CompactFlash™Memory Card | CompactFlash™Memory Card | CompactFlash™Memory Card |
| Data transfermethod | Via removablememory card | Via removablememory card | Via removablememory card | Via removablememory card |
| Memory card dataformat | Standard file system | Standard file system | Standard file system | Standard file system |
| Liquid crystaldisplay (LCD) | Yes | Yes | Yes | Yes |
| Display purpose | Display ECG,check lead quality,input patient ID,display messages | Display ECG,check lead quality,input patient ID,display messages | Display ECG,check lead quality,input patient ID,display messages | Display ECG,check lead quality,input patient ID,display messages |
0404H1-Sec16-0001-RevB-CM3000-12-510k_Summary.doc CONFIDENTIAL AND PROPRIETARY
{2}------------------------------------------------
| Abbreviated 510(k) Notification | ||||||
|---|---|---|---|---|---|---|
| CardioMem® CM 3000-12 | Project ID: 0404H1 | |||||
| 510(k) - Summary | Section 16-0001-Rev B | |||||
| Specification | Legally MarketedDeviceDR180+ Holterrecorder | Legally MarketedDeviceH12+ Holter recorder | Legally MarketedDeviceCardiolD+ (RZ153+) | New DeviceCardioMemCM 3000-12 | ||
| Keyboard | Protected touch keys(membrane) | Protected touch keys(membrane) | Protected touch keys(membrane) | Protected touch keys(membrane) | ||
| Systemconfiguration | Check lead quality,input patient ID,recording mode,start recording | Check lead quality,input patient ID,start recording | Check lead quality,input patient ID andname,start recording | Check lead quality,input patient ID andname,start recording | ||
| Systemconfigurationmethod | Per keyboard and LCDdisplay | Per keyboard and LCDdisplay | Per keyboard and LCDdisplay | Per keyboard and LCDdisplay | ||
| Marker button | Yes | Yes | Yes | Yes | ||
| Size | 125 x 70 x 25 mm | 64 x 91 x 25 mm | 108 x 79 x 22 mm | 108 * 86 * 22 mm | ||
| Weight | 142 g (without battery) | 125 g (without battery) | <160 g (without battery) | <160 g (without battery) | ||
| Belt clip / Carrierpouch | not specified | Carrier bag (Pouch) | Carrier bag (Pouch) | Carrier bag (Pouch) | ||
| Battery | 1 or 2 x 1.5 V AAalkaline | 1 x 1.5 V AA alkaline | 1 or 2 x 1.5 V AAalkaline | 1 or 2 x 1.5 V AAalkaline | ||
| Battery checkprior to recording | Yes | Yes | Yes | Yes | ||
| External patientcable | Yes | Yes | Yes | Yes | ||
| Recordidentificationprocedure | Yes | Yes | Yes | Yes | ||
| ECG channelpreview | Yes | Yes | Yes | Yes |
Conclusion
The CardioMem® CM 3000-12 Holter recorder, the DR180+ Holter recorder, the H12+ Holter recorder, and the CardiolD+ (RZ153+) Holter recorder are intended to store continuously ECG Data for a period of at least 24 hours. The CM 3000-12, the DR180+, the H12+, and the RZ153+ do not analyze the data at the time of the recording. The recorded data of the mentioned recorders are downloaded to a PC for analysis and following evaluation by a trained physician or health care professional.
Quality system regulation 21 CFR 820 (outlined by the FDA) is a basis for the development of the CardioMem® CM 3000-12 Holter recorder. This recorder is safe and effective for the application for which it is intended and has been tested (environmental and safety tests, including EMC (Electromagnetic Compatibility) tests, according to the IEC 60601-1, IEC 60601-1-2, IEC 60601-2-25, IEC 60601-2-47 and ANSI/AAMI EC 38:1998 standards) to confirm the safety and efficacy of the recorder.
CardioMem® CM 3000-12 is found to be substantially equivalent to the DR180+ Holter recorder (K004007), the H12+ Holter recorder (K021373) and the CardiolD+ (RZ153+) Holter recorder (K022540).
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling a caduceus, with three abstract human figures connected by flowing lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 4 2005
Getemed Medizin-und Informationstechnik AG c/o Ms. Carolann Kotula MDI Consultants Inc. 55 Northern Blvd., Suite 200 Great Neck, NY 11021
Re: K051686
CardioMem® CM3000-12 Regulation Number: 21 CFR 870.2800 Regulation Name: Medical magnetic tape recorder Regulatory Class: Class II (two) Product Code: MWJ Dated: June 20, 2005 Received: June 27, 2005
Dear Ms. Kotula:
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.
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
{4}------------------------------------------------
Page 2 – Ms. Carolann Kotula
or any Federal statutes and regulations administered by other Federal agencies. You must of any I cuttin statures and regaranents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CITY art 6077, adomig (Dr CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product laulation control pro hasis (seems (seems ) our device as described in your Section 510(k) I mis letter will anow you to oegill maing of substantial equivalence of your device to a legally prematics notineation: The Pro Pressification 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 If you desire specific acreoliance at (240) 276-0295 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Iviliouraliums of reference to prour responsibilities under the Act may be obtained from the Other general miormation sturers, 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,
Bhimman for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use
510(k) Number (if known):
$\frac{1}{2}$
CardioMem® CM 3000-12 Device Name:
Indications For Use:
The CardioMem® CM 3000-12 is a Holter recorder which is indicated for patients who The GardioMeth® OM 5000 12 15 a NoRel Football Cooking including, including, a may belient from a long term continuede themitations, syncope, chest pain, shorthess of
but not limited to, those with complaints of palpitations, syncope functionslity but for limited to, those with oomplaints of pairms cardiac functionality.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use ____ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blummenston
asion Sign-Off Division of Cardiovascular Devices 510(k) Number
Page 1 of
§ 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).