(30 days)
The ViewFlex™ Xtra ICE Catheter, part of the ViewMate™ System, is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures and blood flow within the heart.
The ViewFlex Xtra ICE Catheter is inserted into the heart via intravascular access. The ViewFlex Xtra is a sterile, single use, temporary, intracardiac ultrasound catheter indicated for use in adult and adolescent pediatric patients. The ViewFlex catheter shaft is a 9 French catheter constructed with radiopaque tubing with a useable length of 90 cm. The shaft is compatible with a 10 French or larger introducer for insertion into the femoral or jugular veins. The catheter tip is a 64-element linear phased array transducer housed in silicone. The distal portion of the shaft is deflectable in four directions allowing for left-to-right and anterior-to-posterior deflection. The handle of the device has two deflection mechanisms that correspond with the movement of the distal shaft in the four planes of movement. The ViewFlex Xtra is compatible with ViewMate II and ViewMate Z ultrasound consoles.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific, quantifiable acceptance criteria in the traditional sense of a performance study (e.g., a specific sensitivity or specificity threshold). Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device through various non-clinical tests.
The criteria can be inferred from the "Comparison to Predicate Devices" and "Summary on Non-Clinical Testing" sections.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Functional Equivalence: Same intended use and fundamental scientific technology as the predicate device. | "The ViewFlex™ Xtra ICE Catheter has the same intended use and fundamental scientific technology as the predicate device." |
| Technological Equivalence: Technological characteristics (packaging, biocompatibility, sterilization, labeling) are substantially equivalent to the predicate device. | "The technological characteristics of the ViewFlex™ Xtra ICE Catheter are substantially equivalent to the predicate device including packaging, biocompatibility, sterilization, and labeling." |
| Safety and Effectiveness (Design Modifications): Design modifications do not adversely affect safety and effectiveness. | "Through biocompatibility and bench performance testing it was demonstrated that the design modifications do not adversely affect the safety and effectiveness." |
| Performance Specifications (Bench Testing): Device meets established performance specifications. | "The results of bench testing demonstrated that the device meets the established performance specifications." |
| Biocompatibility Specifications: Modified design meets specifications in accordance with ISO 10993-1. | "The results of biocompatibility testing demonstrated that the modified design meets specifications in accordance with ISO 10993-1." |
| Overall Substantial Equivalence: Based on the above, the device is substantially equivalent to the predicate. | "Based on this and the data provided in this pre-market notification, the subject device and predicate device has been shown to be substantially equivalent." (FDA's letter further confirms this determination). |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical testing (bench testing and biocompatibility testing). There is no mention of a clinical test set involving human patient data being used to establish the device's performance regarding its primary indication (visualizing cardiac structures and blood flow). Therefore, there is:
- No sample size for a clinical test set.
- No data provenance (country of origin, retrospective/prospective) for a clinical test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
As there was no clinical test set described for the primary indication of visualizing cardiac structures and blood flow, this information is not applicable or provided. The "ground truth" for the non-clinical tests would be established by the physical and chemical properties measured during bench and biocompatibility testing, compared against predetermined engineering specifications and ISO standards, respectively.
4. Adjudication Method for the Test Set
Again, since no clinical test set for diagnostic performance is described, an adjudication method is not applicable or provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. The document does not describe an MRMC comparative effectiveness study, nor does it address human reader improvement with or without AI assistance. This device is an imaging catheter, not an AI-powered diagnostic tool requiring human interpretation comparison.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No. This is an intracardiac ultrasound catheter, a direct imaging device, not an algorithm or AI system for which standalone performance would be applicable. Its "performance" is its ability to acquire images, which is assessed through bench testing and its similarity to the predicate device.
7. The Type of Ground Truth Used
For the non-clinical testing described:
- Bench Testing: Engineering specifications and performance metrics derived from the device's design and intended function (e.g., deflection capabilities, ultrasound signal quality, physical dimensions).
- Biocompatibility Testing: Compliance with ISO 10993-1 standards for biological evaluation of medical devices.
- Substantial Equivalence: Comparison to the established characteristics and performance of the predicate device (ViewFlex Plus Catheter (K101239)).
8. The Sample Size for the Training Set
Not Applicable. This is a hardware device (an intracardiac ultrasound catheter), not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not Applicable. As no training set is relevant for this type of device.
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| 510(k) Summary | |
|---|---|
| 510(k) Number | To be assigned |
| Submitter Information: | |
| Date Prepared: | May 04, 2012 |
| Submitter Name &Address: | Irvine Biomedical, Inc.a St. Jude Medical Company2375 Morse AvenueIrvine, CA 92614 |
| Contact Person: | Loucinda BjorklundSr. Regulatory Affairs SpecialistPhone (651) 756-3230Fax (952) 930-9481LBjorklund@sjm.com |
| Device Information: | |
| Trade Name: | ViewFlex™ Xtra ICE Catheter |
| Common Name: | ICE Catheter |
| Class | II |
| Classification Name: | 892.1550, System, Imaging, Pulsed Doppler Ultrasonic; ITX 892.1570,Transducer, Ultrasonic;892.1560, System, Imaging, Pulsed Echo, Ultrasonic892.1200, Diagnostic Intravascular Catheter |
| Predicate Device: | ViewFlex Plus Catheter (K101239) |
| Device Description: | The ViewFlex Xtra ICE Catheter is inserted into the heart via intravascularaccess. The ViewFlex Xtra is a sterile, single use, temporary, intracardiacultrasound catheter indicated for use in adult and adolescent pediatricpatients. The ViewFlex catheter shaft is a 9 French catheter constructedwith radiopaque tubing with a useable length of 90 cm. The shaft iscompatible with a 10 French or larger introducer for insertion into thefemoral or jugular veins. The catheter tip is a 64-element linear phasedarray transducer housed in silicone. The distal portion of the shaft isdeflectable in four directions allowing for left-to-right and anterior-to-posterior deflection. The handle of the device has two deflectionmechanisms that correspond with the movement of the distal shaft in thefour planes of movement. The ViewFlex Xtra is compatible withViewMate II and ViewMate Z ultrasound consoles. |
| Intended Use:(Indications for Use) | The ViewFlex Xtra ICE Catheter, part of the ViewMate System, isindicated for use in adult and adolescent pediatric patients to visualizecardiac structures and blood flow within the heart. |
| Comparison to PredicateDevices | The ViewFlex™ Xtra ICE Catheter has the same intended use andfundamental scientific technology as the predicate device. Thetechnological characteristics of the ViewFlex™ Xtra ICE Catheter aresubstantially equivalent to the predicate device including packaging,biocompatibility, sterilization, and labeling. Through biocompatibility andbench performance testing it was demonstrated that the designmodifications do not adversely affect the safety and effectiveness. |
| Summary on Non-ClinicalTesting | The results of bench testing demonstrated that the device meets theestablished performance specifications. The results of biocompatibilitytesting demonstrated that the modified design meets specifications inaccordance with ISO 10993-1. |
| Statement of Equivalence | The ViewFlex Xtra ICE Catheter has the same indications for use andtechnological characteristics as the predicate device. Based on this and thedata provided in this pre-market notification, the subject device andpredicate device has been shown to be substantially equivalent. |
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Image /page/1/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized symbol that resembles three abstract shapes that could be interpreted as birds in flight or abstract human figures.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN - 7 2012
Irvine Biomedical, Inc. St. Jude Medical Company c/o Mrs. Loucinda Bjorklund Sr. Regulatory Affairs Specialist 2375 Morse Avenue Irvine, CA 92614
K121381 Re:
KT21561
Trade/Device Name: ViewFlex™ Xtra ICE Catheter Regulatory Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II (two) Product Code: IYO Dated: May 4, 2012 Received: May 8, 2012
Dear Mrs. Bjorklund:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section J ro(x) promatic is substantially equivalent (for the indications
referenced above and have determined the device is substantially interstate for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encry manatiment date of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date at answasions of the Federal Food. Drug commerce prior to May 28, 1970, the encomence with the provisions of the Federal Food, Drug, devices that have been reciassified in accordance the approval application (PMA).
and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The Act. The Act. The You may, therefore, market the device, sabject to annual registration, listing of
general controls provisions of the Act include requirements for annual registrating and general controls provisions of the rict mercials and prohibitions against misbranding and devices, good manufacturing placece, iaoonag information related to contract liability. adulteration. Please note: CDRFI does not evaluate international and not misleading.
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Page 2 - Mrs. Loucinda Bjorklund
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 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.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K121381
INDICATIONS FOR USE
510(k) Number (if known): Device Name: ViewFlexTM Xtra ICE Catheter
Indications for Use:
The ViewFlex™ Xtra ICE Catheter, part of the ViewMate™ System, is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures and blood flow within the heart.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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)
Division Sign Off
vision Sign-Off) vision of Cardiovascular Devices
510(k) Number K121381
Page 10 of 245
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.