(27 days)
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
The St. Jude Medical IS4 Flushing/funneling tool Accessory kit Model DS0A002 is an individually packaged accessory kit containing one IS4 flushing/funneling tool.
This submission document pertains to the St. Jude Medical IS4 Flushing/Funneling Tool Accessory Kit. The information provided heavily emphasizes the substantial equivalence to a predicate device and does not describe a study involving detailed acceptance criteria and performance metrics typically associated with new or significantly modified medical devices that would involve AI or advanced analytical capabilities.
Based on the provided text, there is no mention of an AI-powered device, acceptance criteria, or a study that evaluates device performance against specific metrics.
The document is a 510(k) summary for a Class II medical device (Continuous Flush Catheter, product code KRA) that is an accessory kit. The core of the submission is to demonstrate substantial equivalence to a previously approved predicate device.
Here's how the requested information relates to the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present. The submission focuses on substantial equivalence to a predicate device, implying that the new device meets the same performance standards as the predicate, but these standards are not explicitly detailed here.
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): No test set, sample size, or data provenance information is provided as this is a substantial equivalence claim for an accessory kit, not a performance study as described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable. No ground truth establishment or expert involvement in this context is mentioned.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication process is described.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-powered device, nor is it a comparative effectiveness study involving human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm, but a physical accessory kit.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable. This is not a machine learning model.
- How the ground truth for the training set was established: Not applicable.
Summary of the document's content:
- Device: St. Jude Medical IS4 Flushing/Funneling Tool Accessory Kit (Model DS0A002).
- Intended Use: To provide a means of flushing the lead and facilitate the insertion of a guidewire or stylet into the connector pin of an over-the-wire left heart lead with an IS4 connector.
- Classification: Class II, regulated under 21 CFR 870.1210 (Continuous Flush Catheter).
- Predicate Device: St. Jude Medical IS4 Flushing/Funneling tool (approved under P030054/S173).
- Conclusion: The device is considered substantially equivalent to the predicate device based on similarities in design, technological characteristics, principle of operation, materials, and indications for use.
In essence, the provided text describes a regulatory submission for a medical device accessory kit, where the primary justification for market approval is its substantial equivalence to an already approved product, rather than presenting a performance study against specific acceptance criteria.
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Section 4- 510(k) Summary
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| Submitter : | St Jude Medical, CRMD15900 Valley View CourtSylmar, CA 91324Establishment Registration Number: 2017865 | JAN 1 8 2012 | ||
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| Contact Person : | Geena GeorgeRegulatory Affairs SpecialistPhone (818) 493 2629Fax (818) 493 3615 | |||
| Date Prepared : | December 21, 2011 | |||
| Trade Name : | St Jude Medical IS4 Flushing/Funneling tool Accessory kitDS0A002 | |||
| Classification : | Class II-21 CFR 870.1210Continuous Flush Catheter | |||
| Product Code : | KRA | |||
| Predicate Device: | The subject device is equivalent to the following St Jude MedicalDeviceIS4 Flushing/Funneling tool (approved under P030054/S173) | |||
| Device Description : | The St. Jude Medical IS4 Flushing/funneling tool Accessory kitModel DS0A002 is an individually packaged accessory kitcontaining one IS4 flushing/funneling tool. | |||
| Intended Use: | The IS4 Flushing/Funneling tool is to provide a means of flushingthe lead and facilitate the insertion of either a guidewire or styletinto the connector pin of the over the wire left heart lead with anIS4 connector. | |||
| Comparison toPredicate Devices | The St Jude Medical IS4 Flushing/Funneling tool Accessory kitModel DS0A002 has an identical intended use and the samefundamental scientific technology as the predicate device which iscommercially available. | |||
| Conclusion : | St Jude Medical considers the IS4 Flushing/Funneling toolAccessory kit Model DS0A002 to be equivalent to the predicatedevice listed above. This conclusion is based upon the devicesimilarities in design, technological characteristics, principle ofoperation, materials and indications for use. |
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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.
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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
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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
§ 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).