(24 days)
Not Found
No
The document explicitly states that the software update only includes a service menu and bug fixes, with "No other changes to the system were made." There is no mention of AI or ML in the description or the "Mentions AI, DNN, or ML" section.
No.
The device is described as a monitoring and recording system for ECG, which aids in diagnosis rather than providing direct therapy.
Yes
The device records subcutaneous ECG and monitors for cardiac arrhythmias, which are a form of diagnosis.
No
The device description explicitly states it includes an "implantable component" (Implantable Loop Recorder) and a "Base Station," indicating it is a system with hardware components, not solely software.
Based on the provided information, the Sleuth AT system 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 the body.
- Sleuth AT System: The Sleuth AT system is an implantable device that records subcutaneous ECG. This means it is placed inside the body and directly monitors electrical activity of the heart.
The Sleuth AT system is a medical device used for monitoring physiological signals in vivo (within the living body), not for analyzing samples in vitro (in a test tube or lab setting).
N/A
Intended Use / Indications for Use
The Transoma Medical Sleuth AT Implantable Cardiac 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 AT Implantable Cardiac 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 AT Implantable Cardiac System comprises three interrelated components: Implantable Loop Recorder (ILR), Personnel Diagnostic Manager (PDM) and Base Station,
The PDM software was updated from Version 4.2 to Version 4.3. The Version 4.3 software incorporates a Service Menu in the PDM and minor software bug fixes. The Service Menu includes time zone set-up, data review option and transfer log. No other changes to the system were made.
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 Sleuth AT System has been demonstrated via software design verification and validation testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Sleuth AT Implantable Cardiac Monitoring System (K083828)
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
SECTION 012 - SUMMARY OF SAFETY AND EFFECTIVENESS
General Information
l
Submitter's Name and Address:
Transoma Medical, Inc. 119 14th Street NW Suite 200 St. Paul, MN 55112 Phone: 651-414-5521 Fax: 651-481-7415
Lisa Stone Phone: 651-414-5521 Fax: 651-481-7415 Email: Istone(@transomamedical.com
Date of Summary:
Contact Person:
Proprietary Name of Device:
Common/Usual Name:
Classification Name:
April 23, 2009
Sleuth AT Implantable Cardiac Monitoring System
Implantable ECG Monitoring System
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 AT Implantable Cardiac Monitoring System (K083828)
Device Description 2
The Sleuth AT Implantable Cardiac 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 AT Implantable Cardiac System comprises three interrelated components: Implantable Loop Recorder (ILR), Personnel Diagnostic Manager (PDM) and Base Station,
The PDM software was updated from Version 4.2 to Version 4.3. The Version 4.3 software incorporates a Service Menu in the PDM and minor software bug fixes. The Service Menu includes time zone set-up, data review option and transfer log. No other changes to the system were made.
MAY 18 2009
K091206 1/2
1
SECTION 012 - SUMMARY OF SAFETY AND EFFECTIVENESS
3 Intended Use
The Transoma Medical Sleuth AT Implantable Cardiac 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 .
4 Summary of Technological Characteristics
The Sleuth AT System 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 Sleuth AT System has been demonstrated via software design verification and validation testing.
Q Conclusion
대한 도 12: 11 :: ,在线上
Based on the information provided above, the Sleuth AT System incorporating the Service Menu is substantially equivalent to the predicate Sleuth AT System.
Transoma Medical Special 510(k) - Sleuth AT System Confidential and Proprietary Information
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized eagle with its wings spread, facing to the right. The eagle is rendered in a thick, black line. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
MAY 18 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Transoma Medical, Inc. c/o Ms. Lisa Stone Regulatory Affairs Manager 119 14th Street NW Suite 200 St. Paul, MN 55112
Re: K091206
Trade/Device Name: Sleuth AT Implantable Cardiac Monitoring System Regulation Number: 21 CFR 870.2800 Regulation Name: Cardiac Implantable Event Recorder Regulatory Class: Class II (two) Product Codes: MXC Dated: April 23, 2009 Received: April 24, 2009
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, 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 Stone
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" (21 CFR 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 yours,
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 (if known):
Device Name: Sleuth AT Implantable Cardiac Monitoring System
Indications for Use:
The Sleuth AT 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 X (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)
| (Division Sign-Off) |
|---|
| --------------------- |
Division of Cardiovascular Devices
| 510(k) Number | K09/206 |
|---|---|
| --------------- | --------- |
Transoma Medical Special 510(k) - Sleuth AT System Confidential and Proprietary Information Page 008-2