(25 days)
Not Found
No
The 510(k) summary describes a modification to an existing implantable ECG monitoring system, specifically the addition of a longer antenna. The description focuses on the hardware components and bench testing related to the antenna's performance and safety. There is no mention of AI, ML, or any algorithms that would process the ECG data using such technologies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is for monitoring and recording ECG, not for treating a condition.
Yes
The device is described as an "Implantable ECG Monitoring System" that "records subcutaneous ECG" and is indicated for "patients with clinical syndromes or situations at increased risk of cardiac arrhythmias" and "patients who experience transient symptoms that may suggest a cardiac arrhythmia." These uses are consistent with diagnosing cardiac arrhythmias.
No
The device description explicitly states it includes an "implantable component" and an "Implantable Monitoring Device (IMD)", which are hardware components. The modification also involves a physical antenna accessory kit.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes monitoring subcutaneous ECG and identifying cardiac arrhythmias. This is a physiological measurement taken directly from the patient's body.
- Device Description: The device is an implantable system that records ECG. This involves interacting directly with the patient's body.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide diagnostic information. IVDs are specifically designed for testing samples in vitro.
The device is clearly designed for in vivo (within the living body) monitoring and recording of physiological signals.
N/A
Intended Use / Indications for Use
The Transoma Medical Sleuth Implantable ECG Monitoring System is an implantable, patient- and automatically-activated monitoring system that records subcutaneous ECG and is indicated for:
- Patients with clinical syndromes or situations at increased risk of cardiac . arrhythmias
- Patients who experience transient symptoms that may suggest a cardiac . arrhythmia
Product codes
MXC
Device Description
The Sleuth Implantable ECG System is an electrocardiogram (ECG) monitoring system that includes an implantable component and that provides continuous ECG monitoring and episodic or segmented ECG recording. The Sleuth Implantable ECG System comprises three interrelated components: Implantable Monitoring Device (IMD), Activator and Base Station.
The modification described in this Special 510(k) is the addition of an 8 cm Antenna Accessory Kit option (Model 3000-08) for use with the IMD, Model 2010.
The 8 cm antenna gives the physician an additional option. The Accessory Kit contains an 8 cm antenna and torque wrench. No changes have been made to the torque wrench.
The only difference between the original 6 cm antenna and the 8 cm antenna is the length. The antenna measures 8 cm from the IS-1 connector to tip.
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
Not Found
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 substantial equivalence of the 8 cm Antenna Accessory Kit has been demonstrated via bench testing, including:
- Visual/dimensional inspection -
- IS-1 testing -
- Resistance testing -
- Impedance testing *
- Tensile/flexural strength testing =
- Protection of the device from external defibrillation and high-power electrical fields testing
- -Radiated immunity testing
- ESD immunity testing -
- Electrical environmental effects (E3) testing -
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
Image /page/0/Picture/0 description: The image shows a handwritten sequence of numbers and letters. The sequence starts with the letter 'K', followed by the numbers '073147'. Below this sequence, there is another handwritten notation that appears to be 'R 1/2'. The handwriting is bold and clear, making the characters easily distinguishable.
510(k) Summary of Safety and Attachment 7: Effectiveness
| 1
| General Information | DEC 0 3 2007 |
|---|---|
| Submitter's Name and Address: | Transoma Medical, Inc. |
| 4358 West Round Lake Road | |
| Arden Hills, MN 55112 | |
| Phone: 651-481-7444 | |
| Fax: 651-481-7413 | |
| Contact Person: | Lisa Stone |
| Phone: 651-414-5521 | |
| Fax: 651-481-7415 | |
| Email: Istone@transomamedical.com | |
| Date of Summary: | November 7, 2007 |
| Proprietary Name of Device: | Model 3000-08 Antenna Accessory Kit |
| Common/Usual Name: | Implantable ECG Monitoring System |
| Classification Name: | Cardiac Implantable Event Recorder |
| Product Code - MXC | |
| 21 CFR Part 870.2800 | |
| Device Class II | |
| Legally Marketed Device to | |
| Which Substantial Equivalence | |
| is Claimed: | Sleuth Implantable ECG System |
| K063035 |
2 Device Description
The Sleuth Implantable ECG System is an electrocardiogram (ECG) monitoring system that includes an implantable component and that provides continuous ECG monitoring and episodic or segmented ECG recording. The Sleuth Implantable ECG System comprises three interrelated components: Implantable Monitoring Device (IMD), Activator and Base Station.
The modification described in this Special 510(k) is the addition of an 8 cm Antenna Accessory Kit option (Model 3000-08) for use with the IMD, Model 2010.
The 8 cm antenna gives the physician an additional option. The Accessory Kit contains an 8 cm antenna and torque wrench. No changes have been made to the torque wrench.
1
K073147
p 2/2
The only difference between the original 6 cm antenna and the 8 cm antenna is the length. The antenna measures 8 cm from the IS-1 connector to tip.
3 Intended Use
The Transoma Medical Sleuth Implantable ECG Monitoring System is an implantable, patient- and automatically-activated monitoring system that records subcutaneous ECG and is indicated for:
- Patients with clinical syndromes or situations at increased risk of cardiac . arrhythmias
- Patients who experience transient symptoms that may suggest a cardiac . arrhythmia
Summary of Technological Characteristics 4
The 8 cm Antenna Accessory Kit incorporates substantially equivalent technology, comparable features, labeling, and intended use, and is similar to the predicate device currently available on the market.
Non-clinical Test Summary 5
The substantial equivalence of the 8 cm Antenna Accessory Kit has been demonstrated via bench testing, including:
- Visual/dimensional inspection -
- IS-1 testing -
- Resistance testing -
- Impedance testing *
- Tensile/flexural strength testing =
- Protection of the device from external defibrillation and high-power electrical fields testing
- -Radiated immunity testing
- ESD immunity testing -
- Electrical environmental effects (E3) testing -
6 Conclusion
Based on the information provided above, the 8 cm Antenna Accessory Kit is substantially equivalent to the 6 cm Antenna Accessory Kit.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines that form the silhouette of a person's head and shoulders.
DEC 0 3 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Transoma Medical, Inc. c/o Ms. Lisa J. Stone, RAC Principal Regulatory Affairs Specialist 4211 Lexington Ave. North, Suite 2244 St. Paul, MN 55126-6164
Re: K073147
Trade/Device Name: Sleuth Implantable ECG System 8 cm Antenna Accessory Kit Regulation Number: 21 CFR 870.2800 Regulation Name: Implantable Cardiac Event Recorder (without Arrhythmia Detection) Regulatory Class: Class II (two) Product Code: MXC Dated: November 7, 2007 Received: November 8, 2007
Dear Ms. Stone:
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), 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 J. Stone, RAC
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.
Bzimmerma 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 Statement Attachment 4:
K073147 510(k) Number ____
Device Name: Transoma Medical Sleuth Implantable ECG Monitoring System
Indications for Use:
The Transoma Medical Sleuth Implantable ECG Monitoring System is an implantable, patient- and automatically-activated monitoring system that records subcutaneous ECG and is indicated for:
- Patients with clinical syndromes or situations at increased risk of cardiac . arrhythmias
- Patients who experience transient symptoms that may suggest a cardiac . arrhythmia
Prescription Use_ ____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart D)
OR
Over the Counter Use (21 CFR 801 Subpart C)
THE COLLECTION COLLECTION COLLECTION COLLECTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSU
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Bhummon
Division Sign Off
Devices Division of Cardlove 510iki Number