(53 days)
Reprocessed Diagnostic Electrophysiology (EP) Catheters are intended for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures. The reprocessed IBI AFocus 100 Steerable and the Inquiry TM Optima™ catheters are to be used to map the atrial regions of the heart. The reprocessed Inquiry™ fixed curve and steerable catheters are commonly placed at the high right atrium, right ventricular apex, and HIS bundle.
The Reprocessed Diagnostic Electrophysiology (EP) Catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Diagnostic EP catheters incorporate a hand piece, a flexible shaft and a distal tip section containing diagnostic electrodes. The distal tip of deflectable catheters can be deflected into a curve by manipulating the hand piece. Specific to the Inquiry™ Optima™, Optima™ Plus steerable electrophysiology catheters: The catheter incorporates both a deflectable shaft steering mechanism and a distal end with a variable loop diameter, which allows selection of diameters within a specific range. The distal shaft may be deflected by pushing and pulling the thumb control and the distal loop diameter may be expanded or contracted by turning the rotating knob. Specific to the AFocus™ steerable and the Inquiry™ fixed curve and steerable electrophysiology catheters: The catheters are flexible and insulated catheters constructed of noble metal electrodes and thermoplastic elastomer material. The control mechanism located in the handle at the proximal end of the catheter manipulates the tip of the steerable catheters. The distal tip on the AFocus™ catheter has been designed to expedite the collection of electrogram recordings of a circumferential area.
The provided text describes a 510(k) summary for "Reprocessed Electrophysiology Catheters" by Stryker Sustainability Solutions. It details the device, its intended use, and the performance data submitted to demonstrate substantial equivalence to predicate devices.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly list quantitative acceptance criteria in a numerical table format for device performance. Instead, it states that "Performance testing demonstrates that Reprocessed Electrophysiology Catheters perform as originally intended." This implies that the acceptance criterion is that the reprocessed devices function equivalently to the original, new devices. The reported performance is that this equivalence has been demonstrated through various tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device performs as originally intended (i.e., equivalent to new predicate devices) | "Performance testing demonstrates that Reprocessed Electrophysiology Catheters perform as originally intended." |
The performance data listed includes:
- Biocompatibility
- Validation of reprocessing
- Sterilization Validation
- Function test(s)
- Packaging Validation
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify the sample size used for the test set for any of the performance tests (Biocompatibility, Reprocessing Validation, Sterilization Validation, Function Tests, Packaging Validation). It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.
3. 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):
This information is not provided in the document. The type of device (reprocessed catheters) and the nature of the tests (biocompatibility, sterilization, function) suggest that ground truth would likely be established through standardized laboratory methods and measurements, rather than human expert interpretation of images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable and is not provided in the document. Adjudication methods are typically used in clinical studies involving human interpretation or subjective endpoints. The tests described are primarily objective bench and laboratory tests.
5. 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:
This is not applicable to the device described. The device is a reprocessed electrophysiology catheter, and the studies mentioned are bench and laboratory tests. There is no AI component, no human readers involved in interpreting results in the way an MRMC study would assess, and therefore no effect size relating to AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is a reprocessed medical instrument, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the performance tests mentioned (Biocompatibility, Validation of reprocessing, Sterilization Validation, Function test(s), Packaging Validation), the ground truth would be established by:
- Biocompatibility: Adherence to ISO standards (e.g., ISO 10993) and established toxicological profiles.
- Validation of reprocessing: Verification that the reprocessing steps (cleaning, disinfection, inspection) meet predefined criteria to render the device clinically safe and functional. This would involve testing for residual soil, microbial load, and material integrity.
- Sterilization Validation: Demonstrating a specified sterility assurance level (SAL), typically 10^-6, through established sterilization methodologies (e.g., ethylene oxide or steam sterilization validation protocols).
- Function test(s): Comparison of critical performance parameters (e.g., electrical conductivity, steerability, mechanical integrity, electrode adhesion) of the reprocessed device against predetermined specifications (often based on the original new device's specifications).
- Packaging Validation: Ensuring package integrity and maintenance of sterility through simulated shipping and environmental challenges (e.g., according to ISO 11607).
These forms of ground truth are based on objective, measurable criteria and established scientific standards, rather than expert consensus on subjective findings, pathology, or long-term outcomes data.
8. The sample size for the training set:
This is not applicable. The device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
This is not applicable. The device is not an AI/ML algorithm that requires a training set.
{0}------------------------------------------------
:
SECTION 5: 510(k) SUMMARY
| Submitter: | Stryker Sustainability Solutions10232 South 51st StreetPhoenix, Arizona 85044 | SEP 26 2011 | ||||
|---|---|---|---|---|---|---|
| Contact: | Amanda BabcockSenior Regulatory Affairs Specialist(480) 763-5300 (o)(863) 904-2312 (f)amanda.babcock@stryker.com | |||||
| Date of preparation: | August 3, 2011 | |||||
| Name of device: | Trade/Proprietary Name: Reprocessed ElectrophysiologyCathetersClassification Name: Electrode recording catheter or electroderecording probe | |||||
| Predicate Device | 510(k) Title | Manufacturer | ||||
| K081329 | Reprocessed ElectrophysiologyCatheters | Ascent HealthcareSolutions | ||||
| K060757 | Inquiry Optima Plus SteerableElectrophysiology Catheter | Irvine Biomedical | ||||
| K042775 | Inquiry™ AFocus™, Inquiry™AFocusII™, or Inquiry™ Optima™Steerable Electrophysiology Catheter | Irvine Biomedical | ||||
| K010471 | Inquiry™ AFocus™ SteerableElectrophysiology Catheter | Irvine Biomedical | ||||
| K990958 | Orthogonal™ SteerableElectrophysiology Catheter | Irvine Biomedical | ||||
| K982232 | IBI-1100 Bi-directional SteerableElectrophysiology Catheter | Irvine Biomedical | ||||
| K961924 | IBI-1100 Steerable ElectrophysiologyCatheter | Irvine Biomedical | ||||
| K946333 | IBI-1000™ ElectrophysiologyCatheter | Irvine Biomedical | ||||
| Device description: | The Reprocessed Diagnostic Electrophysiology (EP) Cathetersare specially designed electrode catheters that transmitelectrical impulses and can be positioned for endocardialrecording or stimulation. Diagnostic EP catheters incorporate ahand piece, a flexible shaft and a distal tip section containingdiagnostic electrodes. The distal tip of deflectable catheters canbe deflected into a curve by manipulating the hand piece.Specific to the Inquiry™ Optima™, Optima™ Plus steerableelectrophysiology catheters: The catheter incorporates both adeflectable shaft steering mechanism and a distal end with a | |||||
{1}------------------------------------------------
variable loop diameter, which allows selection of diameters within a specific range. The distal shaft may be deflected by pushing and pulling the thumb control and the distal loop diameter may be expanded or contracted by turning the rotating knob.
Specific to the AFocus™ steerable and the Inquiry™ fixed curve and steerable electrophysiology catheters: The catheters are flexible and insulated catheters constructed of noble metal electrodes and thermoplastic elastomer material. The control mechanism located in the handle at the proximal end of the catheter manipulates the tip of the steerable catheters. The distal tip on the AFocus™ catheter has been designed to expedite the collection of electrogram recordings of a circumferential area.
Indications for Use: Reprocessed Diagnostic Electrophysiology (EP) Catheters are intended for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures. The reprocessed IBI AFocus™ Steerable and the Inquiry™ Optima™ catheters are to be used to map the atrial regions of the heart. The reprocessed Inquiry™ fixed curve and steerable catheters are commonly placed at the high right atrium, right ventricular apex, and HIS bundle.
Technological The design, materials, and intended use of Reprocessed characteristics: Electrophysiology Catheters are identical to the predicate devices. The mechanism of action of Reprocessed Electrophysiology Catheters is identical to the predicate devices in that the same standard mechanical design, materials, and sizes are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation. In addition, Stryker Sustainability Solutions' reprocessing of Electrophysiology Catheters includes removal of adherent visible soil and decontamination. Each individual Electrophysiology Catheter is tested for appropriate function of its components prior to packaging and labeling operations.
Performance data: Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Electrophysiology Catheters. This included the following tests:
- Biocompatibility ●
- Validation of reprocessing .
- Sterilization Validation ●
- Function test(s) ●
- Packaging Validation .
Stryker Sustainability Solutions Reprocessed Electrophysiology Catheters Traditional 510(k)
{2}------------------------------------------------
Performance testing demonstrates that Reprocessed Electrophysiology Catheters perform as originally intended.
Conclusion: Stryker Sustainability Solutions concludes that the modified devices (Reprocessed Electrophysiology Catheters) are safe, effective, and substantially equivalent to the predicate devices as described herein.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three lines representing its wings. The eagle is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the border of the circle.
Food and Drug Administration 16903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Stryker Sustainability Solutions c/o Amanda Babcock Senior Regulatory Affairs Specialist 10232 South 513 Street . Phoenix, AZ 85044
SEP 2 6 2011
Re: K112232
Trade/Device Name: Reprocessed Electrophysiology Catheters (See Enclosed List of Models) Regulatory Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: II (two)
Product Code: 74 NLH Dated: August 3, 2011
Received: August 4, 2011
Dear Ms. Babcock:
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 10 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.
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.
{4}------------------------------------------------
Page 2 - Ms. Amanda Babcock
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.
1f you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutfDA/CentersOffices/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,
Blam D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Page 3 – Ms. Amanda Babcock
List of Models Found SE:
| Item Number | Description | FrenchSize | Electrodes | Spacing | Curve |
|---|---|---|---|---|---|
| 80001 | IBI Inquiry Fixed Curve | 6F | 10 | 2-5-2mm | Josephson |
| 80002 | IBI Inquiry Fixed Curve | 6F | 10 | 2-5-2mm | Cournand |
| 80003 | IBI Inquiry Fixed Curve | 6F | 10 | 2-8-2mm | Special Curve |
| 80051 | IBI Inquiry Fixed Curve | 5F | 10 | 2mm | Josephson |
| 80052 | IBI Inquiry Fixed Curve | 5F | 10 | 2-5-2mm | Josephson |
| 80055 | IBI Inquiry Fixed Curve | 5F | 10 | 2-5-2mm | Cournand |
| 80063 | IBI Inquiry Fixed Curve | 5F | 10 | 2-8-2mm | Special Curve |
| 80064 | IBI Inquiry Fixed Curve | 5F | 10 | 2-8-2mm | Special Curve |
| 80065 | IBI Inquiry Fixed Curve | 5F | 10 | 2-5-2mm | Special Curve |
| 80116 | IBI Inquiry Fixed Curve | 6F | 10 | 2mm | Josephson |
| 80131 | IBI Inquiry Fixed Curve | 4F | 10 | 5mm | Cournand |
| 80132 | IBI Inquiry Fixed Curve | 4F | 10 | 2-5-2mm | Cournand |
| 80133 | IBI Inquiry Fixed Curve | 4F | 10 | 2mm | Josephson |
| 80134 | IBI Inquiry Fixed Curve | 4F | 10 | 5mm | Josephson |
| 80135 | IBI Inquiry Fixed Curve | 4F | 10 | 2-5-2mm | Josephson |
| 80137 | IBI Inquiry Fixed Curve | 4F | 10 | 5-50-5mm | Josephson i |
| 80138 | IBI Inquiry Fixed Curve | 4F | 10 | 5-10-5mm | Josephson 1. |
| 80139 | IBI Inquiry Fixed Curve | 6F | 10 | 2-8-2mm | Special Curve |
| 80404 | IBI Inquiry Fixed Curve | 6F | 4 | 2-2-2mm | Josephson |
| 80405 | IBI Inquiry Fixed Curve | 6F | 4 | 2-5-2mm | Josephson |
| 80406 | IBI Inquiry Fixed Curve | 6F | 4 | 5mm | Josephson |
| 80407 | IBI Inquiry Fixed Curve | 6F | 4 | 2mm | Cournand |
| 80408 | IBI Inquiry Fixed Curve | 6F | 4 | 2-5-2mm | Cournand |
| 80409 | IBI Inquiry Fixed Curve | 6F | 4 | 5mm | Cournand |
| 80411 | IBI Inquiry Fixed Curve | 6F | 4 | 2-5-2mm | Damato |
| 80412 | IBI Inquiry Fixed Curve | 6F | 4 | 5mm | Damato |
| 80413 | IBI Inquiry Fixed Curve | 6F | 4 | 10mm | Josephson |
| 80414 | IBI Inquiry Fixed Curve | 6F | 4 | 10mm | Cournand |
| 80415 | IBI Inquiry Fixed Curve | 6F | 4 | 10mm | Damato |
| 80440 | IBI Inquiry HIS Fixed Curve | 5F | 4 | 5mm | Cournand(HIS) |
| 80451 | IBI Inquiry Fixed Curve | 5F | 4 | 2mm | Josephson |
| 80452 | IBI Inquiry Fixed Curve | 5F | 4 | 2-5-2mm | Josephson |
| 80453 | IBI Inquiry Fixed Curve | 5F | 4 | 5mm | Josephson |
| 80455 | IBI Inquiry Fixed Curve | 5F | 4 | 2-5-2mm | Cournand |
| 80456 | IBI Inquiry Fixed Curve | 5F | 4 | 5mm | Cournand |
| 80458 | IBI Inquiry Fixed Curve | 5F | 4 | 2-5-2mm | Damato |
| 80459 | IBI Inquiry Fixed Curve | 5F | 4 | 5mm | Damato |
| 80463 | IBI Inquiry Fixed Curve | 5F | 4 | 10mm | Cournand |
| ItemNumber | Description | FrenchSize | Electrodes | Spacing | Curve |
| 80465 | IBI Inquiry Fixed Curve | 4F | 4 | 5mm | Cournand |
| 80466 | IBI Inquiry Fixed Curve | 4F | 4 | 2-5-2mm | Cournand |
| 80467 | IBI Inquiry Fixed Curve | 4F | 4 | 2mm | Josephson |
| 80468 | IBI Inquiry Fixed Curve | 4F | 4 | 5mm | Josephson |
| 80469 | IBI Inquiry Fixed Curve | 4F | 4 | 2-5-2mm | Josephson |
| 80473 | IBI Inquiry Fixed Curve | 5F | 4 | 5mm | Josephson |
| 80476 | IBI Inquiry Fixed Curve | 5F | 4 | 5mm | Cournand |
| 80479 | IBI Inquiry Fixed Curve | 5F | 4 | 5mm | Damato |
| 80484 | IBI Inquiry Fixed Curve | 5F | 4 | 5mm | Josephson 1 |
| 80485 | IBI Inquiry Fixed Curve | 4F | 4 | 5mm | Josephson 1 |
| 80501 | IBI Inquiry Fixed Curve | 6F | 5 | 2-5-2mm | Cournand |
| 80508 | IBI Inquiry Fixed Curve | 6F | 5 | 2-5-2mm | Josephson |
| 80516 | IBI Inquiry Fixed Curve | 6F | 4 | 2mm | Cournand |
| 80517 | IBI Inquiry Fixed Curve | 6F | 4 | 2-5-2mm | Josephson |
| 80518 | IBI Inquiry Fixed Curve | 6F | 4 | 10mm | Josephson 1 |
| 80519 | IBI Inquiry Fixed Curve | 6F | 4 | 10mm | Damato |
| 80520 | IBI Inquiry Fixed Curve | 6F | 4 | 10mm | Cournand |
| 80533 | IBI Inquiry Fixed Curve | 5F | 10 | 2-8-2mm | Special Curve |
| 80534 | IBI Inquiry Fixed Curve | 5F | 10 | 5-30-5mm | Cournand |
| 80535 | IBI Inquiry Fixed Curve | 4F | 4 | 2-5-2mm | Josephson 1 |
| 80536 | IBI Inquiry Fixed Curve | 4F | 4 | 5mm | Damato |
| 80537 | IBI Inquiry Fixed Curve | 6F | 4 | 10mm | Josephson |
| 80544 | IBI Inquiry Fixed Curve | 5F | 10 | 2-8-2mm | Cournand |
| 80567 | IBI Inquiry HIS Fixed Curve | 4F | 4 | 5mm | Cournand(HIS) |
| 80602 | IBI Inquiry Fixed Curve | 6F | 6 | 2-5-2mm | Josephson |
| 80603 | IBI Inquiry Fixed Curve | 6F | 6 | 5mm | Josephson |
| 80604 | IBI Inquiry Fixed Curve | 6F | 6 | 2mm | Cournand |
| 80606 | IBI Inquiry Fixed Curve | 6F | 6 | 5mm | Cournand |
| 80627 | IBI Inquiry Fixed Curve | 5F | 6 | 5mm | Josephson I |
| 80803 | IBI Inquiry Fixed Curve | 6F | 8 | 5mm | Josephson |
| 80804 | IBI Inquiry Fixed Curve | 6F | 8 | 2mm | Cournand |
| 80806 | IBI Inquiry Fixed Curve | 6F | 8 | 5mm | Damato |
| 80810 | IBI Inquiry Fixed Curve | 6F | 8 | 5mm | Cournand |
| 80820 | IBI Inquiry HIS Fixed Curve | 5F | 8 | 20-5mm | Cournand(HIS) |
| 80900 | IBI Inquiry Fixed Curve | 7F | 14 | 3-3-3-3-3-3-70-3-3-3-3-3-3mm | Cournand |
| 80945 | IBI Inquiry Fixed Curve | 7F | 14 | 3(70)3mm | Cournand |
| 81101 | IBI Inquiry Steerable | 6F | 10 | 2mm | Medium 3.2cm |
| 81102 | IBI Inquiry Steerable | 6F | 10 | 2-5-2mm | Medium 3.2cm |
| 81104 | IBI Inquiry Steerable | 6F | 10 | 2-5-2mm | Large 4.1cm |
| 81105 | IBI Inquiry Steerable | 6F | 10 | 2-5-2mm | X-Large 5.0cm |
| 81106 | IBI Inquiry Steerable | 6F | 10 | 2-5-2mm | Far Reach |
| 81107 | IBI Inquiry Steerable | 6F | 10 | 5mm | Large 4.1cm |
| 81108 | IBI Inquiry Steerable | 6F | 10 | 2mm | Large 4.1cm |
| 81109 | IBI Inquiry Steerable | 6F | 10 | 2mm | Large 4.1cm |
| 81110 | IBI Inquiry H Steerable | 6F | 10 | 1-7-1mm | H |
| 81120 | IBI Inquiry H Steerable | 7F | 20 | 1-7-1mm | H |
| 81121 | IBI Inquiry H Steerable | 7F | 21 | 1-7-1mm | H-SC |
| ItemNumber | Description | FrenchSize | Electrodes | Spacing | Curve |
| 81124 | IBI Inquiry H Steerable | 7F | 24 | 2-7-1mm | H |
| 81125 | IBI Inquiry H Steerable | 7F | 10 | 2-9-1mm | H |
| 81126 | IBI Inquiry H Steerable | 7F | 10 | 2-9-1mm | H-Large |
| 81128 | IBI Inquiry H Steerable | 7F | 21 | 5mm | H |
| 81130 | IBI Inquiry H Steerable | 7F | 20 | 1-9-1mm | H-Large |
| 81131 | IBI Inquiry H Steerable | 7F | 21 | 1-9-1mm | H-Large |
| 81134 | IBI Inquiry H Steerable | 7F | 24 | 2-9-1mm | H-Large |
| 81136 | IBI Inquiry H Steerable | 7F | 20 | 5mm | H-Large |
| 81142 | IBI Inquiry H Steerable | 6F | 6 | 2-7-2mm | H-Large |
| 81150 | IBI Inquiry H Steerable | 7F | 24 | 2-7-1mm | H-SCE |
| 81171 | IBI Inquiry Steerable | 5F | 10 | 2mm | Medium 3.2cm |
| 81172 | IBI Inquiry Steerable | 5F | 10 | 2-5-2mm | Medium 3.2cm |
| 81174 | IBI Inquiry Steerable | 5F | 10 | 2-5-2 mm | Large 4.1cm |
| 81176 | IBI Inquiry Steerable | 5F | 10 | 2-5-2 mm | Far Reach |
| 81177 | IBI Inquiry Steerable | 5F | 10 | 5mm | Large 4.1cm |
| 81178 | IBI Inquiry Steerable | 5F | 10 | 2mm | Large 4.1cm |
| 81179 | IBI Inquiry Steerable | 5F | 10 | 2mm | Extended Reach |
| 81202 | IBI Ten-Ten Duodecapolar | 7F | 20 | 2-10-2mm | XX Large 4.8cm |
| 81203 | IBI Inquiry Soft Tip Steerable | 5F | 10 | 2-5-2mm | Medium 3.2cm |
| 81207 | IBI Ten-Ten Duodecapolar | 7F | 20 | 5mm | Super Large 5.1cm |
| 81209 | IBI Ten-Ten Duodecapolar | 7F | 20 | 2-5-2mm | Super Large 5.1cm |
| 81211 | IBI Ten-Ten Duodecapolar | 7F | 20 | 2-20-2-25-2mm | Super Large 5.1cm |
| 81223 | IBI Inquiry Steerable | 5F | 10 | 2-50-3mm | X-Large 5.0cm |
| 81224 | IBI Inquiry Steerable | 5F | 10 | 2(30)3mm | Medium 3.2cm |
| 81401 | IBI Inquiry Steerable | 6F | 4 | 2mm | Small 2.7cm |
| 81402 | IBI Inquiry Steerable | 6F | 4 | 2-5-2mm | Medium 3.2cm |
| 81403 | IBI Inquiry Steerable | 6F | 4 | 5mm | Medium 3.2cm |
| 81404 | IBI Inquiry Steerable | 6F | 4 | 2-5-2mm | Large 4.1cm |
| 81405 | IBI Inquiry Steerable | 6F | 4 | 5mm | Large 4.1cm |
| 81406 | IBI Inquiry Steerable | 6F | 4 | 2-5-2mm | Extended Reach |
| 81407 | IBI Inquiry Steerable | 6F | 4 | 2-5-2mm | Far Reach |
| 81412 | IBI Inquiry Steerable | 6F | 4 | 2mm | Extended Reach |
| 81417 | IBI Inquiry Steerable | 6F | 4 | 5mm | X-Large 5.0cm |
| 81418 | IBI Inquiry Steerable | 6F | 4 | 2-5-2mm | X-Large 5.0cm |
| 81471 | IBI Inquiry Steerable | 5F | 4 | 5mm | Small 2.7cm |
| 81472 | IBI Inquiry Steerable | 5F | 4 | 2-5-2mm | Medium 3.2cm |
| 81473 | IBI Inquiry Steerable | 5F | 4 | 5mm | Medium 3.2cm |
| 81474 | IBI Inquiry Steerable | 5F | 4 | 2-5-2mm | Large 4.1cm |
| 81478 | IBI Inquiry Steerable | 5F | 4 | 2mm | Small 2.7cm |
| 81479 | IBI Inquiry Steerable | 5F | 4 | 2-5-2mm | Small 2.7cm |
| 81483 | IBI Inquiry HIS Steerable | 5F | 4 | 5mm | Extended (HIS) |
| 81484 | IBI Inquiry HIS Steerable | 5F | 4 | 5mm | L (EX-HIS) |
| 81485 | IBI Inquiry HIS Steerable | 5F | 4 | 5mm | Extended (EX-HIS) |
| 81503 | IBI Inquiry Bi-Directional | 6F | 4 | 5mm | Large 4.1cm |
| 81504 | IBI Inquiry Bi-Directional | 6F | 10 | 5mm | Medium 3.2cm |
| 81511 | IBI Inquiry Steerable | 6F | 6 | 2-5-2mm | Medium 3.2cm |
| ItemNumber | Description | FrenchSize | Electrodes | Spacing | Curve |
| 81520 | IBI Inquiry Steerable | 6F | 10 | 2mm | X-Large 5.0cm |
| 81521 | IBI Inquiry Soft Tip Steerable | 5F | 5 | 5-170mm | Medium/Large |
| 81524 | IBI Inquiry Steerable | 6F | 10 | 2mm | Large 4.1cm |
| 81530 | IBI Inquiry Steerable | 4F | 10 | 2mm | Medium 3.2cm |
| 81531 | IBI Inquiry Steerable | 4F | 10 | 2-5-2mm | Medium 3.2cm |
| 81532 | IBI Inquiry Steerable | 4F | 10 | 2-5-2mm | Large 4.1cm |
| 81534 | IBI Inquiry Steerable | 4F | 10 | 5mm | Large 4.1cm |
| 81536 | IBI Inquiry Steerable | 4F | 10 | 2-5-2mm | Medium 3.2cm |
| 81537 | IBI Inquiry Steerable | 4F | 10 | 2-5-2mm | Medium 3.2cm |
| 81540 | IBI Inquiry Steerable | 4F | 4 | 2-5-2mm | Medium 3.2cm |
| 81541 | IBI Inquiry Steerable | 4F | 4 | 2mm | Medium 3.2cm |
| 81542 | IBI Inquiry Steerable | 4F | 4 | 5mm | Medium 3.2cm |
| 81543 | IBI Inquiry Steerable | 4F | 4 | 2-5-2mm | Large 4.1cm |
| 81545 | IBI Inquiry Steerable | 4F | 4 | 5mm | Large 4.1cm |
| 81578 | AFocus Steerable | 5F | 10 | 5mm | AF Curve (20mmDia.) |
| 81587 | IBI A-Focus II Steerable | 7F | 20 | 1-2.5mm | 20mm (A-Focus) |
| 81589 | IBI A-Focus II Steerable | 7F | 14 | 1-5-1mm | 20mm (A-Focus) |
| 81591 | IBI A-Focus II Steerable | 7F | 14 | 1-3-1mm | 15mm (A-Focus) |
| 81594 | IBI A-Focus II Steerable | 7F | 10 | 3.5mm | 15mm (A-Focus) |
| 81595 | IBI A-Focus II Steerable | 7F | 10 | 5mm | 20mm (A-Focus) |
| 81596 | IBI A-Focus II Steerable | 7F | 10 | 2-7mm | 20mm (A-Focus) |
| 81597 | IBI A-Focus II Steerable | 7F | 10 | 2-11mm | 25mm (A-Focus) |
| 81599 | IBI A-Focus II Steerable | 7F | 10 | 8mm | 25mm (A-Focus) |
| 81601 | IBI Inquiry Steerable Curve | 6F | 6 | 5mm | Medium 3.2cm |
| 81602 | IBI Inquiry Steerable Curve | 6F | 6 | 5mm | Large 4.1cm |
| 81603 | IBI Inquiry Steerable Curve | 6F | 6 | 5mm | Extended Reach |
| 81604 | IBI Inquiry Steerable Curve | 6F | 6 | 5mm | Far Reach |
| 81605 | IBI Inquiry Steerable Curve | 6F | 6 | 5mm | X-Large 5.0cm |
| 81659 | IBI Optima Steerable Lasso | 7F | 20 | 1-4.5mm | 25mm-15mm(Optima) |
| 81670 | IBI A-Focus I Steerable | 5F | 12 | 2-10mm | 25mm (A-Focus) |
| 81671 | IBI A-Focus I Steerable | 5F | 14 | 2-9mm | 30mm (A-Focus) |
| 81672 | IBI A-Focus II Steerable | 5F | 10 | 2-7-2mm | 20mm (A-Focus) |
| 81673 | IBI A-Focus II Steerable | 5F | 10 | 5mm | 20mm (A-Focus) |
| 81676 | IBI A-Focus 1 Steerable | 5F | 10 | 3.5mm | 15mm (A-Focus) |
| 81680 | IBI A-Focus II Steerable | 5F | 10 | 3.5mm | 15mm (A-Focus) |
| 81687 | IBI Optima Steerable Lasso | 7F | 10 | 7mm | 25mm-15mm(Optima) |
| 81703 | IBI Inquiry Soft Tip Steerable | 5F | 10 | 2-8-2mm | Medium/Large SC |
| 81704 | IBI Inquiry Soft Tip Steerable | 5F | 10 | 5mm | Medium/Large SC |
| 81705 | IBI Inquiry Soft Tip Steerable | 5F | 10 | 2-8-2mm | Medium SC |
| 81706 | IBI Inquiry Soft Tip Steerable | 5F | 10 | 5mm | Medium/Large XS |
| 81711 | IBI Inquiry HIS Steerable | 5F | 8 | 5-20-5mm | Extended (HIS) |
| 81717 | IBI Optima Steerable Lasso | 7F | 24 | 1-4.5mm | 25mm-15mm(Optima) |
| 81721 | IBI Inquiry Soft Tip Steerable | 5F | 10 | 2-5-2mm | Medium SC |
| ItemNumber | Description | FrenchSize | Electrodes | Spacing | Curve |
| 81730 | IBI Inquiry Soft Tip Steerable | 5F | 10 | 2-8-2mm | Medium/Large |
| 81732 | IBI Inquiry Soft Tip Steerable | 5F | 10 | 2-5-2mm | Medium 3.2cm |
| 81733 | IBI Inquiry Soft Tip Steerable | 5F | 10 | 2mm | Large 4.1cm |
| 81734 | IBI Inquiry Soft Tip Steerable | 5F | 10 | 2-5-2mm | Large 4.1cm |
| 81735 | IBI Inquiry Soft Tip Steerable | 5F | 10 | 5mm | Large 4.1cm |
| 81738 | IBI Inquiry Soft Tip Steerable | 5F | 10 | 1mm | Large 4.1cm |
| 81742 | IBI Inquiry Soft Tip Steerable | 5F | 4 | 2-5-2mm | Medium 3.2cm |
| 81743 | IBI Inquiry Soft Tip Steerable | 5F | 4 | 5mm | Medium 3.2cm |
| 81745 | IBI Inquiry Soft Tip Steerable | 5F | 4 | 2-5-2mm | Large 4.1cm |
| 81750 | IBI Inquiry Soft Tip Steerable | 5F | 10 | 2-5-2mm | Large 4.1cm |
| 81751 | IBI Inquiry Soft Tip Steerable | 5F | 8 | 2mm | Medium 3.2cm |
| 81767 | IBI Optima Steerable Lasso | 7F | 10 | 7mm | 25mm-15mm(Optima) |
| 81801 | IBI Inquiry Steerable | 6F | 8 | 2mm | Medium 3.2cm |
| 81802 | IBI Inquiry Steerable | 6F | 8 | 2-5-2mm | Medium 3.2cm |
| 81807 | IBI Inquiry Steerable | 6F | 8 | 2mm | Large 4.1cm |
| 81809 | IBI Inquiry Steerable | 6F | 8 | 2-5-2mm | Large 4.1cm |
| 81823 | IBI Inquiry Soft Tip Steerable | 6F | 8 | 2mm | Medium 3.2cm |
| 81871 | IBI Inquiry Steerable | 5F | 8 | 2mm | Medium 3.2cm |
| 81872 | IBI Inquiry Steerable | 5F | 8 | 2-5-2mm | Medium 3.2cm |
| 81873 | IBI Inquiry Steerable | 5F | 8 | 5mm | Medium 3.2cm |
| 81877 | IBI Inquiry Steerable | 5F | 8 | 2mm | Large 4.1cm |
| 81879 | IBI Inquiry Steerable | 5F | 8 | 2-5-2 mm | Large 4.1cm |
| 81901 | IBI Ten-Ten Duodecapolar | 7F | 20 | 1-3-1mm | Medium 3.2cm |
| 81902 | IBI Ten-Ten Duodecapolar | 7F | 20 | 1-3-1mm | Large 4.1cm |
| 81940 | IBI Inquiry Soft Tip Steerable | 6F | 10 | 2mm | Medium 3.2cm |
| 81943 | IBI Inquiry Soft Tip Steerable | 6F | 10 | 2mm | Large 4.1cm |
| 81945 | IBI Inquiry Soft Tip Steerable | 6F | 10 | 2-5-2mm | Large 4.1cm |
| 81947 | IBI Inquiry Soft Tip Steerable | 6F | 10 | 5mm | Medium/Large |
| 81951 | IBI Inquiry Soft Tip Steerable | 6F | 4 | 5mm | Medium 3.2cm |
| 81954 | IBI Inquiry Soft Tip Steerable | 6F | 4 | 5mm | Large 4.1cm |
| 87000 | IBI Inquiry Steerable | 7F | 10 | 2.5-4-2.5 | Medium 3.2cm |
| 240mm | |||||
| 87006 | IBI Inquiry Steerable | 6F | 10 | 2-5-2mm | M/L |
| 85931 | Inquiry Diagnostic ConnectingCables | n/a | n/a | 150 cm | n/a |
| 85953 | Inquiry Diagnostic ConnectingCables | n/a | n/a | 150 cm | n/a |
| 85954 | Inquiry Diagnostic ConnectingCables | n/a | n/a | 150 cm | n/a |
| 85955 | Inquiry Diagnostic ConnectingCables | n/a | n/a | 150 cm | n/a |
| 85930 | Inquiry Diagnostic ConnectingCables | n/a | n/a | 150 cm | n/a |
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SECTION 4: INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
K//2232
Device Name: Reprocessed Electrophysiology Catheters
Indications For Use: Reprocessed Diagnostic Electrophysiology (EP) Catheters are intended for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures. The reprocessed IBI AFocus 100 Steerable and the Inquiry TM Optima™ catheters are to be used to map the atrial regions of the heart. The reprocessed Inquiry™ fixed curve and steerable catheters are commonly placed at the high right atrium, right ventricular apex, and HIS bundle.
Prescription Use × (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE),
(Division Sign-Off)
Division of Cardiovascular Devi
Division of Cardiovascular Devices
510(k) Number K112232
Stryker Sustainability Solutions Reprocessed Electrophysiology Catheters Traditional 510(k)
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).