(39 days)
Not Found
Not Found
No
The device description and intended use clearly describe a simple extension cable for connecting a pacing analyzer, with no mention of AI/ML terms, image processing, or data analysis capabilities.
No
The device is an extension cable used to connect a pacing system analyzer to a patient's cardiac pacing lead system. It facilitates the analysis process but does not directly provide therapy.
No
The device is an extension cable used to connect a pacing analyzer to a patient's cardiac pacing lead system, allowing the analyzer to be at a distance. It facilitates the use of a diagnostic device (the pacing analyzer), but is not a diagnostic device itself.
No
The device description explicitly states "Disposable Extension Cables," which are hardware components. The intended use also describes connecting a hardware analyzer to a hardware pacing lead system using an adapter and these cables.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for connecting a pacing system analyzer to a patient's cardiac pacing lead system. This involves interacting with the patient's body and electrical signals, not analyzing samples in vitro (outside the body).
- Device Description: The device is described as disposable extension cables, which are physical connectors.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
The device's function is to facilitate the connection of a pacing analyzer to a patient, which is a medical device used for monitoring and evaluating the performance of a cardiac pacing system.
N/A
Intended Use / Indications for Use
"For use in conjunction with a Model 4815 Adapter for connecting a non-sterile pacing (system) analyzer to a patient's cardiac pacing lead system, allowing the analyzer to be located at some distance from the patient, outside of the sterile field."
Product codes
74 DSA
Device Description
Model 4255 or Model 4260 Disposable Extension Cables
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's cardiac pacing lead system
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2900 Patient transducer and electrode cable (including connector).
(a)
Identification. A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 4 2001
Mr. Robert C. Mace Manager Quality Assurance and Regulatory PACE Medical, Inc. 391 Totten Pond Road Waltham, MA 02451
K012392 Re:
Model 4255 or Model 4260 Disposable Extension Cables Regulation Number: 870.3600 Regulatory Class: II (two) Product Code: 74 DSA Dated: July 25, 2001 Received: July 27, 2001
Dear Mr. Mace:
We have reviewed your Section 510(k) notification of intent to market the device referenced w onewed your betermined the device is substantially equivalent (for the indications for use above and we nave acteriment of the marketed predicate devices marketed in interstate commerce surved in the energians, to regarment 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). You may, therefore, market the device, subject to the general controls Cosmotic Pro (110). I The general controls provisions of the Act include requirements for annual provibions of itis Prod - Prod - Process, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations (Freniance in provide can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to maportion the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. Robert C. Mace
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nodicate 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 and n you deelie specific and vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, (2017) 591 10. 1 runners at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mionination on your respeal and Consumer Assistance (DSMICA) 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,
James E. Dillard III
Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number:________________________________________________________________________________________________________________________________________________________________
Device Name: Model 4255 or Model 4260 Disposable Extension Cables
INDICATIONS FOR USE
"For use in conjunction with a Model 4815 Adapter for connecting a non-sterile pacing (system) analyzer to a patient's cardiac pacing lead system, allowing the analyzer to be located at some distance from the patient, outside of the sterile field."
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use / (Per 21 CFR 801.109)
Over-The-Counter-Use (Optional Format 1-2)
Dakitah
Division of Cardiovascular & Respiratory Devices
510(k) Number K012392