(27 days)
P030054/S173
Not Found
No
The summary describes a mechanical tool for flushing and inserting wires into a lead connector, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a "Flushing/funneling tool" used to "flush the lead and facilitate the insertion of either a guidewire or stylet into the connector pin." Its function is supportive for other medical procedures, not directly therapeutic itself.
No
Explanation: The device is described as a tool for flushing and facilitating the insertion of a guidewire or stylet, which are procedural functions rather than diagnostic ones. There is no mention of it being used for diagnosis or performing any diagnostic measurements.
No
The device description explicitly states it is an "accessory kit containing one IS4 flushing/funneling tool," which is a physical tool, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to facilitate the flushing of a lead and the insertion of a guidewire or stylet into a connector pin. This is a mechanical manipulation of a medical device (a lead) and not a test performed on a biological sample to diagnose a condition, monitor a treatment, or screen for a disease.
- Device Description: The device is described as a "flushing/funneling tool," which aligns with its mechanical function.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing diagnostic information
Therefore, the IS4 Flushing/Funneling Tool is a medical device used in a procedural context, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The IS4 Flushing/Funneling tool is to provide a means of flushing the lead and facilitate the insertion of either a guidewire or stylet into the connector pin of the over the wire left heart lead with an IS4 connector.
Product codes
KRA
Device Description
The St. Jude Medical IS4 Flushing/funneling tool Accessory kit Model DS0A002 is an individually packaged accessory kit containing one IS4 flushing/funneling tool.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
P030054/S173
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).
0
.
Section 4- 510(k) Summary
.
| Submitter : | St Jude Medical, CRMD
15900 Valley View Court
Sylmar, CA 91324
Establishment Registration Number: 2017865 | JAN 1 8 2012 | | |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|--|--|
| Contact Person : | Geena George
Regulatory Affairs Specialist
Phone (818) 493 2629
Fax (818) 493 3615 | | | |
| Date Prepared : | December 21, 2011 | | | |
| Trade Name : | St Jude Medical IS4 Flushing/Funneling tool Accessory kit
DS0A002 | | | |
| Classification : | Class II-21 CFR 870.1210
Continuous Flush Catheter | | | |
| Product Code : | KRA | | | |
| Predicate Device: | The subject device is equivalent to the following St Jude Medical
Device
IS4 Flushing/Funneling tool (approved under P030054/S173) | | | |
| Device Description : | The St. Jude Medical IS4 Flushing/funneling tool Accessory kit
Model DS0A002 is an individually packaged accessory kit
containing one IS4 flushing/funneling tool. | | | |
| Intended Use: | The IS4 Flushing/Funneling tool is to provide a means of flushing
the lead and facilitate the insertion of either a guidewire or stylet
into the connector pin of the over the wire left heart lead with an
IS4 connector. | | | |
| Comparison to
Predicate Devices | The St Jude Medical IS4 Flushing/Funneling tool Accessory kit
Model DS0A002 has an identical intended use and the same
fundamental scientific technology as the predicate device which is
commercially available. | | | |
| Conclusion : | St Jude Medical considers the IS4 Flushing/Funneling tool
Accessory kit Model DS0A002 to be equivalent to the predicate
device listed above. This conclusion is based upon the device
similarities in design, technological characteristics, principle of
operation, materials and indications for use. | | | |
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 1 8 2012
St. Jude Medical, CRMD c/o Ms. Geena George Regulatory Affairs Specialist. 15900 Valley View Court Sylmar, CA 91342
Re: K113773
Trade/Device Name: St. Jude Medical IS4 Flushing/Funneling Tool Accessory Kit DS0A002 Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II (two) Product Code: KRA Dated: December 21, 2011 Received: December 22, 2011
Dear Ms. George:
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. 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.
2
Page 2 - Ms. Geena George
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K113773
Device Name: St Jude Medical IS4 Flushing/Funneling Tool Accessory kit Model DS0A002
Indications for Use: The IS4 Flushing/Funneling Tool is to provide a means of flushing the lead and facilitate the insertion of either a guidewire or stylet into the connector pin of the over the wire left heart lead with an IS4 connector
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 OF NEEDED)
Concurrence of CDRA, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K113273