(53 days)
No
The summary describes a physical medical device (catheter) used for sensing and mapping electrical activity in the heart. There is no mention of software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies focus on the physical and functional aspects of the reprocessed device.
No
The device is described for "sensing, recording, stimulation, and electrophysiology mapping," which are diagnostic and mapping functions, not therapeutic functions like treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the catheters are intended for "sensing, recording, stimulation, and electrophysiology mapping of cardiac structures," which are diagnostic functions. The "Device Description" also refers to them as "Diagnostic Electrophysiology (EP) Catheters."
No
The device description clearly details physical components like a hand piece, flexible shaft, distal tip, electrodes, and control mechanisms, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Device Function: The description clearly states that these catheters are used for "temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures." This is a procedure performed inside the body (in vivo). They are used to interact directly with the heart's electrical activity, not to analyze samples taken from the body.
The device is an in vivo diagnostic and therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
74 NLH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracardiac (cardiac structures, atrial regions of the heart, high right atrium, right ventricular apex, HIS bundle)
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
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. Performance testing demonstrates that Reprocessed Electrophysiology Catheters perform as originally intended.
Key Metrics
Not Found
Predicate Device(s)
K081329, K060757, K042775, K010471, K990958, K982232, K961924, K946333
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
:
SECTION 5: 510(k) SUMMARY
| Submitter: | Stryker Sustainability Solutions
10232 South 51st Street
Phoenix, Arizona 85044 | SEP 26 2011 | | | | |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|--|--|--|--|
| Contact: | Amanda Babcock
Senior 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 Electrophysiology
Catheters
Classification Name: Electrode recording catheter or electrode
recording probe | | | | | |
| | | | | | | |
| Predicate Device | 510(k) Title | Manufacturer | | | | |
| K081329 | Reprocessed Electrophysiology
Catheters | Ascent Healthcare
Solutions | | | | |
| K060757 | Inquiry Optima Plus Steerable
Electrophysiology Catheter | Irvine Biomedical | | | | |
| K042775 | Inquiry™ AFocus™, Inquiry™
AFocusII™, or Inquiry™ Optima™
Steerable Electrophysiology Catheter | Irvine Biomedical | | | | |
| K010471 | Inquiry™ AFocus™ Steerable
Electrophysiology Catheter | Irvine Biomedical | | | | |
| K990958 | Orthogonal™ Steerable
Electrophysiology Catheter | Irvine Biomedical | | | | |
| K982232 | IBI-1100 Bi-directional Steerable
Electrophysiology Catheter | Irvine Biomedical | | | | |
| K961924 | IBI-1100 Steerable Electrophysiology
Catheter | Irvine Biomedical | | | | |
| K946333 | IBI-1000™ Electrophysiology
Catheter | Irvine Biomedical | | | | |
| Device description: | 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 | | | | | |
| | | | | | | |
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 | French
Size | 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 |
| Item
Number | Description | French
Size | 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 |
| Item
Number | Description | French
Size | 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 |
| Item
Number | Description | French
Size | 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 (20mm
Dia.) |
| 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 |
| Item
Number | Description | French
Size | 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 Connecting
Cables | n/a | n/a | 150 cm | n/a |
| 85953 | Inquiry Diagnostic Connecting
Cables | n/a | n/a | 150 cm | n/a |
| 85954 | Inquiry Diagnostic Connecting
Cables | n/a | n/a | 150 cm | n/a |
| 85955 | Inquiry Diagnostic Connecting
Cables | n/a | n/a | 150 cm | n/a |
| 85930 | Inquiry Diagnostic Connecting
Cables | 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)