(42 days)
Not Found
No
The device is described as a manually operated cable switch with no active circuits or power sources, designed to interface between existing devices for manual signal switching. There is no mention of any computational or algorithmic processing that would indicate AI/ML.
No.
The device is a cable switch used during lead implants for PSA measurements and does not directly treat or prevent a disease or condition.
No
The device is a Pacing Vector Selector Cable Switch, which is explicitly described as interfacing with a Pacing System Analyzer and enabling the switching of signals for PSA measurements. It does not perform analysis or diagnosis itself, but rather facilitates the measurement process for a diagnostic device (the Pacing System Analyzer).
No
The device is described as a "manually operated unit" and a "3-channel Patient Adapter Cable" with a "2-pole, 5 position switch integrated into the 3-channel molded connector housing." This description clearly indicates a physical hardware device, not software.
Based on the provided information, the Model 6149 Pacing Vector Selector Cable Switch is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Model 6149 is a manually operated cable switch used during lead implants for PSA (Pacing System Analyzer) measurements. It facilitates switching electrical signals from implanted leads to a Pacing System Analyzer.
- No Specimen Analysis: The device does not interact with or analyze any specimens taken from the human body. It works with electrical signals from implanted medical devices (leads).
- Intended Use: The intended use is to assist with the implantation of a pacing or defibrillation lead system by providing different electrical measurement configurations. This is a procedural aid, not a diagnostic test performed on a biological sample.
Therefore, the Model 6149 falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Model 6149 Pacing Vector Selector Cable Switch is a manually operated unit used during lead implants for PSA measurements and provides the capability to switch RV and LV tip and ring signals to five possible electrode combinations.
Product codes
DTA, DTC, DTE
Device Description
The Model 6149 Pacing Vector Selector Cable Switch was designed to interface between the Guidant Model 3105 or 3106 Pacing System Analyzer and Guidant 6697 Patient Cables. It is manually operated and has no active circuits or power sources. It is a 3-channel Patient Adapter Cable, easily switchable between PSA vector measurements on implanted leads without relocating alligator clips on the lead terminal. A 2-pole, 5 position switch is integrated into the 3-channel molded connector housing on the distal end of the cable. The pacing vectors options provided are: Left Ventricle Tip to Right Ventricle Coil, Left Ventricle Ring to Right Ventricle Coil, Left Ventricle Ring to Left Ventricle Tip, Left Ventricle Tip to Left Ventricle Ring, Right Ventricle Tip to Right Ventricle Coil. It is indicated for use during chronic implantation of a pacing or defibrillation lead system.
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 physicians and hospital staff will use the Model 6149 to assist with the implantation of a pacing or defibrillation lead system.
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)
Not Found
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
§ 870.3720 Pacemaker electrode function tester.
(a)
Identification. A pacemaker electrode function tester is a device which is connected to an implanted pacemaker lead that supplies an accurately calibrated, variable pacing pulse for measuring the patient's pacing threshold and intracardiac R-wave potential.(b)
Classification. Class II (performance standards).
0
Korssy
Image /page/0/Picture/1 description: The image shows the logo for Remington Medical, Inc. The logo consists of two parts: a geometric shape on the left and the company name on the right. The geometric shape is a black hexagon with the letters 'R', 'M', and 'I' arranged inside. The company name, 'Remington Medical, Inc.', is written in a bold, serif font.
MAY 1 9 2005
510(k) SUMMARY of SAFETY and EFFECTIVENESS
A. General Information 1. Submitter's Name: Remington Medical Inc. 6830 Meadowridge Court 2. Address: Alpharetta, Georgia 30005 770-888-8520 3. Telephone: Don Rosvold 4. Contact Person: March 31, 2005 5. Date Prepared: 6. Registration Number: 1056553 B. Device Guidant Model 6149 Pacing Vector Selector Patient 1. Name: Adapter Cable 2. Trade Name: Adapter Cable Adapter Cable 3. Common Name: External Pulse Generator, Electrode Function Analyzer, and 4. Classification Name: Generator Function Analyzer DTA, DTC, and DTE 5. Product Code: 6. Class: III 870.3600, 870.3630, and 870.3720 7. Regulation Number: C. Identification of Legally Marketed Devices
l. Name: ERA 300 K032613 and K964190 2. K Number: December 8, 2003 and July 10, 1997 3. Date Cleared:
1
Image /page/1/Picture/0 description: The image shows the logo for Remington Medical, Inc. The logo consists of a black geometric shape on the left, with the letters "RMI" in white inside. To the right of the geometric shape is the text "Remington Medical, Inc." in a bold, serif font. The text is arranged in two lines, with "Remington" on the top line and "Medical, Inc." on the bottom line.
D. Description of the Device
The Model 6149 Pacing Vector Selector Cable Switch was designed to interface between the Guidant Model 3105 or 3106 Pacing System Analyzer and Guidant 6697 Patient Cables. It is manually operated and has no active circuits or power sources.
It is a 3-channel Patient Adapter Cable, easily switchable between PSA vector measurements on implanted leads without relocating alligator clips on the lead terminal.
A 2-pole, 5 position switch is integrated into the 3-channel molded connector housing on the distal end of the cable. The pacing vectors options provided are:
- · Left Ventricle Tip to Right Ventricle Coil
- · Left Ventricle Ring to Right Ventricle Coil
- · Left Ventricle Ring to Left Ventricle Tip
- · Left Ventricle Tip to Left Ventricle Ring
- · Right Ventricle Tip to Right Ventricle Coil
It is indicated for use during chronic implantation of a pacing or defibrillation lead system.
Trained physicians and hospital staff will use the Model 6149 to assist with the implantation of a pacing or defibrillation lead system. No customer interaction will be required.
The Model 6149 is not intended to be part of the sterile field and has no sterilization requirements: It is for repeated use during implant procedures.
E. Intended Use Statement
The Model 6149 Pacing Vector Selector Cable Switch is a manually operated unit that connects to the Pacing System Analyzer (PSA) (3105) using a Redel connector.
It is used during lead implants for PSA measurements and provides the capability to switch RV and LV tip and ring signals to five possible electrode combinations.
F. Technological Characteristics Summary
As the Model 6149 is an accessory to ERA 300, the only difference is the Model 6149. The original and subsequent 510(k's) for the ERA 300 did not have and do not have an accessory such as the Model 6149.
In the same view, there are no similarities as the ERA 300 did not have such an accessory.
The addition of the Model 6149 to be used with Guidant's PSA Model 3105 is considered minor and does not raise any safety concerns or effectiveness concerns.
2
Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the snake and staff. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the caduceus. The seal is black and white.
Food and Drug Administr. 9200 Corporate Boulevard Rockville MD 20850
MAY 1 9 2005
Remington Medical, Inc. c/o Mr. Don Rosvold President 6830 Meadowridge Court Alpharetta, GA 30005
Re: K050884
R02000 !
Guidant Model 6149 Pacing Vector Selector Patient Adapter Cable Regulation Number: 21 CFR 870.3600 Regulation Name: External Pacemaker Pulse Generator Regulatory Class: III (three) Product Code: DTA Dated: March 31, 2005 Received: April 7, 2005
Dear Mr. Rosvold:
We have reviewed your Section 510(k) premarket notification of intent to market the device in we nave reviewed your becamined the device is substantially equivalent (for the indications felerenced above and nave determined we are and and devices marketed in interstate for use stated in the cherosury to regally to regally the Medical Device Amendments, or to commerce provided to May 26, 1976, the encordance with the provisions of the Federal Food. Drug. devices that have been recalismed in acceraation will of a premarket approval application (PMA). and Cosment Act (Act) that do not require species the general controls provisions of the Act. The Y ou may, therefore, market the device, solo, solo, excepted on the manual registration, listing of the general controls provisions of the rist leveling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classifica (see above) the existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controlions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Our neements concerning your device in the Federal Register.
3
Page 2 - Mr. Don Rosvold
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 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bhirminum for
Bram D. Zuckerman, M.D. Division of Cardiovacsular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): To be determined
050884
Device Name: Model 6149
Indications for Use:
- The Model 6149 Pacing Vector Selector Cable Switch is a manually operated unit . I he Model 0149 Facting Vector Belocer Creek Brovides the capability to switch
used during lead implants for PSA measurements and provides the capability to switch used during icad implains for x to five possible electrode combinations.
Prescription Use X_
AND/OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D)
(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)
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on Sign-Of Aslon Sign-Om
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