(29 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard cardiac monitoring technology.
No.
The device is described as a "diagnostic monitoring device" used for evaluating symptoms and identifying cardiac arrhythmias, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section states, "The Jot Dx™ ICM is indicated for the monitoring and diagnostic evaluation of patients..." Additionally, the "Device Description" calls it an "implantable diagnostic monitoring device."
No
The device description explicitly lists an "Implantable Device" and "Implant Tools," indicating significant hardware components beyond software.
Based on the provided information, this device 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 to examine these samples outside of the body.
- Device Description: The Jot Dx™ ICM is described as a "minimally invasive, implantable diagnostic monitoring device with subcutaneous electrodes." This means it is placed inside the body to monitor electrical activity of the heart.
- Intended Use: The intended use is for monitoring and diagnostic evaluation of patients experiencing symptoms related to cardiac arrhythmias. This monitoring happens in vivo (within the living body).
- Anatomical Site: The device is implanted subcutaneously, which is under the skin, inside the body.
The device collects physiological data (EGM - electrogram) directly from within the patient's body, rather than analyzing a sample taken from the body. This clearly distinguishes it from an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Jot Dx™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arthythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.
The Jot Dx™ ICM has not been specifically tested for pediatric use.
Product codes
MXC, DSI
Device Description
The candidate Jot Dx™ ICM DM4500 System, predicated on the Confirm Rx™ ICM DM3500 System, consists of the following key features and components:
- Jot Dx™ ICM Model DM4500 Implantable Device (Figure 2): The ICM is intended as a minimally invasive, implantable diagnostic monitoring device, with subcutaneous electrodes, looping memory, and automatic as well as patient-activated EGM storage capability, which help physicians monitor, diagnose, and document patients who are susceptible to cardiac arrhythmias. Specific features include:
- Patient-initiated triggering of EGM storage using the myMerlin™ mobile application. o This includes capability for the patient to identify symptoms, which are stored with the EGM for physician review.
- Automate d triggering of EGM storage when tachycardia, bradycardia, or pauses are detected; with physician-programmable values for pause duration, bradycardia rate, tachycardia rate, and number of tachycardia intervals.
- Automated triggering of EGM storage when atrial fibrillation (AF) is detected, with o physician programmable values for AF duration.
- The ability to identify EGM anomalies as a consequence of noise or vigorous activity o and inhibit EGM storage as applicable.
- Remote monitoring capabilities. O
- Implant Tools: Incision tool (Model DM3520; Figure 2, a) and Insertion tool (Model ■ DM3510; Figure 2, b) are used to implant the device subcutaneously. The implantable device is pre-loaded into the insertion tool and packaged together with the incision tool.
- The DM3520 incision tool is used to make an angled cut to the skin during the insertion O procedure.
- The blunt dissection tip of the DM3510 insertion tool is inserted just past the skin o creating a subcutaneous pocket parallel to the skin (Figure 3). With the insertion tool in place as far as it can go, until the flared edge contacts the incision site, the plunger is withdrawn to drop the pre-loaded device into the insertion channel. The plunger is advanced to insert the device into the subcutaneous pocket (Figure 3). This completes insertion (implantation) of the ICM, and the incision is closed per standard of care.
- Confirm Rx ICM Accessory Kit DM3500A: The Confirm Rx™ ICM Accessory Kit Model DM3500A (originally cleared via 510(k) K202876) is a sterilized, standalone, onetime use convenience kit containing the Insertion Tool DM3510 and the Incision Tool DM3520. The contents of this package include implant tools which are used for both the candidate Jot Dx™ ICM DM4500 and the predicate Confirm Rx™ ICM DM3500 (K202888) and allow for availability of the implant tools separately in a convenience kit, without the pre-loaded ICM in the insertion tool.
- Magnet: The magnet facilitates faster startup of Bluetooth connection and provides user authentication (required for programmer sessions).
- Clinician Programmer (Merlin PCS Programmer Model 3650): The Merlin PCS 3650 Programmer operates using Model 3330 software. The clinician programmer provides the means for the physician to program device parameters and retrieve diagnostic information from the device, including electrograms, heart rate history, episode duration, and trend information. The clinician programmer, using a Bluetooth® dongle, a device-MDDS component, communicates with the Jot Dx™ ICM DM4500 device with Bluetooth® telemetry (also referred to as Bluetooth® Low Energy or Bluetooth® LE). Programmer software Model 3330 v25.3.1 or higher contains support for the Jot Dx™ ICM device and include tabs within the user interface for Implant View and Reason for Monitoring features.
- Implant View is designed to streamline programming at the time of implant. Upon o initial interrogation at implant, the programmer automatically displays the Implant View in which the user can immediately input device and patient information to be stored onto the device, as well as set the Reason for Monitoring.
- Reason for Monitoring allows the user to select from a list of possible conditions for o which the patient is receiving the device (such as Syncope. Ventricular Tachycardia, Palpations, etc). The programmer then sets the AF duration parameter and EGM storage priority based on the reason selected. These parameters can be manually adjusted by the user later, if customization is preferred.
- myMerlin™ Mobile Application (Model APP1000 (Android) and APP1001 (iOS)): The ■ mobile application provides the means for the patient to activate EGM recording in the Jot DxTM ICM DM4500 device. with data pass-through functionality to enable physician follow-up via the Merlin.net Patient Care Network. Software v1.0.6000 or higher contain support for the Jot Dx™ ICM device. Patients who do not supply their own mobile device may be provided with an Abbott-issued off the shelf Android mobile device, which is not part of the medical device.
- Remote Care/Clinician Portal (Merlin.net MN5000 Report Generator): The Merlin.net system allows physicians to remotely monitor and diagnose patients' cardiac events. The Merlin.net MN5000 v7.8 or higher software contains support for the Jot Dx™ ICM DM4500 device.
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
The Jot Dx™ ICM has not been specifically tested for pediatric use.
Intended User / Care Setting
Clinician, Physician, Patient
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 TEST SUMMARY
The candidate Jot Dx™ ICM DM4500 is identical to the predicate Confirm Rx™ ICM DM3500 (K202888), aside from name, model number, and corresponding laser marking. The risk analysis method used to assess the impact of the addition of the candidate Jot Dx™ ICM DM4500 documents the investigation of hazards and mitigation of associated risks and reports the result of the investigation. The risk analysis method used to assess the impact of the modifications was a Failure Mode and Effects Analysis (FMEA/FMECA). It was determined that the overall risk is acceptable. Completion of all verification and validation activities demonstrated that the candidate Jot Dx™ ICM DM4500 meets its predetermined design and performance specifications and that the product is substantially equivalent to the predicate device (Model DM3500, K202888).
TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
All necessary device and system verification testing conducted on the candidate Jot Dx ICM DM4500 System supports a determination of substantial equivalence to the predicate Confirm Rx™ ICM DM3500 System.
Completion of all verification activities demonstrated the candidate Jot Dx™ ICM DM4500 device meets its predetermined design and performance specifications and that the product is substantially equivalent to the predicate Confirm Rx™ ICM device (K202888). The results of the testing show that the candidate Jot Dx ICM DM4500 system performs as intended and is safe for its intended use.
CONCLUSION (SUBSTANTIAL EQUIVALENCE)
The results of the verification and validation tests and the risk analysis have demonstrated the candidate Jot Dx™ ICM DM4500 system functions in accordance with product specifications. The candidate Jot Dx™ ICM DM4500 system is substantially equivalent in terms of safety and technological characteristics to the identified predicate device (Confirm RxTM ICM System; K202888). Product verification and validation testing demonstrate that the candidate Jot Dx ICM system is as safe and as effective and performs as well as the predicate system (K202888). The indications for use are not changed for the candidate Jot Dx™ ICM DM4500. The fundamental scientific technology of the candidate Jot Dx™ ICM DM4500 system remains the same as the predicate Confirm RxTM ICM DM3500 system (K202888). Thus, the candidate Jot DxTM ICM DM4500 System is deemed to be substantially equivalent to the predicate Confirm Rx™ ICM DM3500 cleared via 510(k) K202888.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the full name written out in blue text.
August 13, 2021
Abbott (St. Jude Medical) Juni Sarkar Sr. Regulatory Affairs Specialist 15900 Valley View Ct. Sylmar, California 91342
Re: K212206
Trade/Device Name: Jot Dx Insertable Cardiac Monitor Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: MXC, DSI Dated: July 14, 2021 Received: July 15, 2021
Dear Juni Sarkar:
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jennifer W. Shih -S
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212206
Device Name Jot Dx™ ICM DM4500
Indications for Use (Describe)
The Jot Dx™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arthythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.
The Jot Dx™ ICM has not been specifically tested for pediatric use.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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| Date Prepared: | July 14, 2021 | |
|---|---|---|
| Submitter: | Abbott (formerly St. Jude Medical) | |
| Cardiac Rhythm Management Division | ||
| Address: | 15900 Valley View Ct. | |
| Sylmar, CA 91342 | ||
| USA | ||
| Phone: | (818) 362-6822 | |
| Establishment Registration: | 2017865 | |
| Contact Person: | Juni Sarkar | |
| Senior Regulatory Affairs Specialist | ||
| (818) 294-3429 | ||
| juni.sarkar@abbott.com | Jennifer Dunham | |
| Sr. Manager, Regulatory Affairs | ||
| (818) 383-1630 | ||
| jennifer.dunham@abbott.com | ||
| Trade Name/Proprietary | ||
| Name: | Jot DxTM Insertable Cardiac Monitor | |
| Common Name: | Insertable Cardiac Monitor | |
| Model Number: | DM4500 | |
| Classification Name: | 21 CFR 870.2800, Medical magnetic tape recorder | |
| Product Code: | MXC, DSI | |
| Classification: | Class II | |
| Pediatric Use: | The Jot DxTM Insertable Cardiac Monitor has not been specifically tested | |
| in pediatric patients. |
LEGALLY MARKETED DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED
510(k) K202888: Confirm RxTM Insertable Cardiac Monitor System
INDICATIONS FOR USE
The are no changes to the Indications for Use as a result of this submission. The Indications for Use for the Jot Dx™ Insertable Cardiac Monitor (ICM) system are as follows:
The Jot Dx™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.
The Jot Dx ICM has not been specifically tested for pediatric use.
4
PRODUCT DESCRIPTION
The candidate Jot Dx™ ICM DM4500 System, predicated on the Confirm Rx™ ICM DM3500 System, consists of the following key features and components:
- . Jot Dx™ ICM Model DM4500 Implantable Device (Figure 2): The ICM is intended as a minimally invasive, implantable diagnostic monitoring device, with subcutaneous electrodes, looping memory, and automatic as well as patient-activated EGM storage capability, which help physicians monitor, diagnose, and document patients who are susceptible to cardiac arrhythmias. Specific features include:
- Patient-initiated triggering of EGM storage using the myMerlin™ mobile application. o This includes capability for the patient to identify symptoms, which are stored with the EGM for physician review.
- o Automated triggering of EGM storage when tachycardia, bradycardia, or pauses are detected; with physician-programmable values for pause duration, bradycardia rate, tachycardia rate, and number of tachycardia intervals.
- Automated triggering of EGM storage when atrial fibrillation (AF) is detected, with o physician programmable values for AF duration.
- The ability to identify EGM anomalies as a consequence of noise or vigorous activity o and inhibit EGM storage as applicable.
- Remote monitoring capabilities. O
- Implant Tools: Incision tool (Model DM3520; Figure 2, a) and Insertion tool (Model ■ DM3510; Figure 2, b) are used to implant the device subcutaneously. The implantable device is pre-loaded into the insertion tool and packaged together with the incision tool.
- The DM3520 incision tool is used to make an angled cut to the skin during the insertion O procedure.
- The blunt dissection tip of the DM3510 insertion tool is inserted just past the skin o creating a subcutaneous pocket parallel to the skin (Figure 3). With the insertion tool in place as far as it can go, until the flared edge contacts the incision site, the plunger is withdrawn to drop the pre-loaded device into the insertion channel. The plunger is advanced to insert the device into the subcutaneous pocket (Figure 3). This completes insertion (implantation) of the ICM, and the incision is closed per standard of care.
5
Image /page/5/Picture/3 description: The image shows a gray Abbott Jot Dx DM4500 device. The device has a rectangular shape with rounded edges. The Abbott logo and the text "Jot Dx" are printed on the device. The serial number "S/N 1234567" is also printed on the device. The model number "DM4500" is printed on the right side of the device.
Figure 1: Jot Dx ICM DM4500
Image /page/5/Figure/5 description: The image contains two different medical instruments. The instrument in image (a) is a white, thin, curved tool with a sharp, silver blade at the end. The instrument in image (b) is a white, plastic tool with a handle and a long, thin extension.
Figure 2: Implant tool DM3520 and Incision tool DM3510
Image /page/5/Figure/7 description: The image contains two figures labeled (a) and (b). Both figures show a hand holding a medical instrument and using it on a surface. In figure (b), there is an arrow pointing to the left, indicating the direction of movement.
Figure 3: Insertion Process
- Confirm Rx ICM Accessory Kit DM3500A: The Confirm Rx™ ICM Accessory Kit Model DM3500A (originally cleared via 510(k) K202876) is a sterilized, standalone, onetime use convenience kit containing the Insertion Tool DM3510 and the Incision Tool DM3520. The contents of this package include implant tools which are used for both the candidate Jot Dx™ ICM DM4500 and the predicate Confirm Rx™ ICM DM3500 (K202888) and allow for availability of the implant tools separately in a convenience kit, without the pre-loaded ICM in the insertion tool.
6
Image /page/6/Picture/3 description: The image shows a Jot Dx ICM kit with two tools inside a clear plastic container. The tool on the left is labeled as the "Insertion Tool" and has a black handle. The tool on the right is labeled as the "Incision Tool" and has a white handle.
Figure 4: Jot Dx™ ICM DM4500 and Accessories in the Sterile Packaging
- 트 Magnet: The magnet facilitates faster startup of Bluetooth connection and provides user authentication (required for programmer sessions).
- 트 Clinician Programmer (Merlin PCS Programmer Model 3650): The Merlin PCS 3650 Programmer operates using Model 3330 software. The clinician programmer provides the means for the physician to program device parameters and retrieve diagnostic information from the device, including electrograms, heart rate history, episode duration, and trend information. The clinician programmer, using a Bluetooth® dongle, a device-MDDS component, communicates with the Jot Dx™ ICM DM4500 device with Bluetooth® telemetry (also referred to as Bluetooth® Low Energy or Bluetooth® LE). Programmer software Model 3330 v25.3.1 or higher contains support for the Jot Dx™ ICM device and include tabs within the user interface for Implant View and Reason for Monitoring features.
- Implant View is designed to streamline programming at the time of implant. Upon o initial interrogation at implant, the programmer automatically displays the Implant View in which the user can immediately input device and patient information to be stored onto the device, as well as set the Reason for Monitoring.
- Reason for Monitoring allows the user to select from a list of possible conditions for o which the patient is receiving the device (such as Syncope. Ventricular Tachycardia, Palpations, etc). The programmer then sets the AF duration parameter and EGM storage priority based on the reason selected. These parameters can be manually adjusted by the user later, if customization is preferred.
- myMerlin™ Mobile Application (Model APP1000 (Android) and APP1001 (iOS)): The ■ mobile application provides the means for the patient to activate EGM recording in the Jot
7
DxTM ICM DM4500 device. with data pass-through functionality to enable physician follow-up via the Merlin.net Patient Care Network. Software v1.0.6000 or higher contain support for the Jot Dx™ ICM device. Patients who do not supply their own mobile device may be provided with an Abbott-issued off the shelf Android mobile device, which is not part of the medical device.
- Remote Care/Clinician Portal (Merlin.net MN5000 Report Generator): The Merlin.net system allows physicians to remotely monitor and diagnose patients' cardiac events. The Merlin.net MN5000 v7.8 or higher software contains support for the Jot Dx™ ICM DM4500 device.
Image /page/7/Figure/5 description: This image shows a diagram of a cardiac monitoring system. The diagram includes several components, such as a clinician, programmer, external magnet, ICM insertable cardiac monitor, heart, patient application, clinician portal, and patient. The diagram shows the flow of information between these components, including telemetry communications, sensing, and internet connectivity. The patient application includes a patient activator and a patient transmitter.
Figure 5: Block Diagram of Jot Dx™ ICM System
TECHNOLOGICAL CHARACTERISTICS
The candidate Jot DxTM ICM DM4500 and the predicate Confirm Rx™ ICM DM3500 (K202888) are 49 x 94 x 3.1 mm in dimension and use Bluetooth® wireless telemetry to communicate with external devices, including the clinician programmers and the myMerlin™ mobile application. An external magnet facilitates faster startup of Bluetooth® connection and provides user authentication (required for programmer sessions). The remote monitoring equipment for the candidate Jot Dx™ ICM DM4500 and the predicate Confirm Rx™ ICM DM3500 (K202888) is the myMerlin™ mobile application, installed on a patient's or Abbottprovided mobile device, using built-in cellular or Wi-Fi connectivity. The candidate Jot Dx™ ICM DM4500 will continue to use the same technology as the predicate Confirm Rx™ ICM DM3500 (K20288). The myMerlin™ mobile application provides the means for the patient to activate EGM recording in the Jot Dx™ ICM device, with data pass-through functionality to enable physician follow-up via the Merlin.net Patient Care Network (clinician portal). See Figure 5 for a block diagram of the Jot DxTM ICM system.
8
The subject of this premarket notification is the candidate Abbott-branded Jot Dx™™ ICM DM4500 System to be added to Abbott's ICM device portfolio, which is identical to the predicate Confirm Rx™ ICM DM3500 (K202888) system aside from name, model number, and corresponding laser marking. There are no changes to the predicate (K202888) Confirm RxTM Insertable Cardiac Monitor DM3500, the insertion tool DM3510, the incision tool DM3520, or the myMerlin™ mobile applications within the scope of this premarket notification. The Merlin PCS 3650 programmer software model 3330 v25.3.1 or higher and Merlin.net MN5000 v7.8 or higher include support for Jot DxTM ICM. The magnet is Class I exempt device-MDDS.
The fundamental technological characteristics of the candidate Jot Dx™ ICM DM4500 are not changing in comparison to the predicate device, the current Confirm Rx™ ICM DM3500 (510(k) K202888). The candidate Jot Dx™ ICM DM4500 system has the same:
- Intended Use and Indications for Use
- Operating rules ●
- Device/tool functionality ●
- Packaging materials and process
- Shelf life
- . Device Longevity
- Software
NON-CLINICAL TEST SUMMARY
The candidate Jot Dx™ ICM DM4500 is identical to the predicate Confirm Rx™ ICM DM3500 (K202888), aside from name, model number, and corresponding laser marking. The risk analysis method used to assess the impact of the addition of the candidate Jot Dx™ ICM DM4500 documents the investigation of hazards and mitigation of associated risks and reports the result of the investigation. The risk analysis method used to assess the impact of the modifications was a Failure Mode and Effects Analysis (FMEA/FMECA). It was determined that the overall risk is acceptable. Completion of all verification and validation activities demonstrated that the candidate Jot Dx™ ICM DM4500 meets its predetermined design and performance specifications and that the product is substantially equivalent to the predicate device (Model DM3500, K202888).
SUBSTANTIAL EQUIVALENCE
The candidate Jot Dx™ ICM system is an Abbott-branded Insertable Cardiac Monitoring device which is identical to the predicate Confirm Rx™ ICM DM3500 (K202888) aside from name, model number, and corresponding laser marking (as shown Figure 1). The candidate Jot Dx™ ICM DM4500 is identical in design and function and has the same indications and intended use as the predicate Confirm Rx™ ICM DM3500 (K202888). Both the candidate Jot Dx™ ICM DM4500 and the predicate Confirm Rx ICM DM3500 (K20288) have the same function and fundamental scientific technology. The minor differences in name, model number, and laser marking do not raise new issues of safety and effectiveness. Thus, the candidate Jot DxTM ICM
9
DM4500 system is substantially equivalent to the predicate Confirm Rx™ ICM DM3500 system (K202888).
TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
All necessary device and system verification testing conducted on the candidate Jot Dx ICM DM4500 System supports a determination of substantial equivalence to the predicate Confirm Rx™ ICM DM3500 System.
Completion of all verification activities demonstrated the candidate Jot Dx™ ICM DM4500 device meets its predetermined design and performance specifications and that the product is substantially equivalent to the predicate Confirm Rx™ ICM device (K202888). The results of the testing show that the candidate Jot Dx ICM DM4500 system performs as intended and is safe for its intended use.
CONCLUSION (SUBSTANTIAL EQUIVALENCE)
The results of the verification and validation tests and the risk analysis have demonstrated the candidate Jot Dx™ ICM DM4500 system functions in accordance with product specifications. The candidate Jot Dx™ ICM DM4500 system is substantially equivalent in terms of safety and technological characteristics to the identified predicate device (Confirm RxTM ICM System; K202888). Product verification and validation testing demonstrate that the candidate Jot Dx ICM system is as safe and as effective and performs as well as the predicate system (K202888). The indications for use are not changed for the candidate Jot Dx™ ICM DM4500. The fundamental scientific technology of the candidate Jot Dx™ ICM DM4500 system remains the same as the predicate Confirm RxTM ICM DM3500 system (K202888). Thus, the candidate Jot DxTM ICM DM4500 System is deemed to be substantially equivalent to the predicate Confirm Rx™ ICM DM3500 cleared via 510(k) K202888.