(458 days)
No
The description focuses on the physical characteristics and basic electrical functions of a diagnostic catheter, with no mention of AI/ML processing of the signals.
No
The device is indicated for sensing and diagnostic pacing, not for treatment.
Yes
The device is used for "electrophysiological mapping," "sensing of intracardiac signals," and "diagnostic pacing," which are all processes involved in identifying or characterizing a medical condition.
No
The device description explicitly details a physical catheter with electrodes and a connector, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "electrophysiological mapping of cardiac structures in adult patients; i.e., stimulation and recording only." This describes a procedure performed within the body (in vivo) to measure electrical activity.
- Device Description: The device is a catheter designed to be inserted into the heart to sense and stimulate cardiac signals. This is an invasive procedure.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (such as blood, urine, or tissue) outside of the body to provide information about a person's health.
This device is clearly designed for an in-vivo procedure, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
The catheter is indicated for electrophysiological mapping of cardiac structures in adult patients; i.e., stimulation and recording only.
Product codes
DRF
Device Description
The MultiCath* and the AcQRate Dx Fixed Curve Catheter are pre-shaped multipolar catheters for sensing of intracardiac signals and diagnostic pacing, in combination with an electrophysiological investigation and recording device.
The device consists of a catheter body with a distal curve, an array of platinum/iridium (PtIr) electrodes, and a proximal multipolar connector. Multiple electrode configurations are available with various numbers of electrodes and electrode spacing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac structures
Indicated Patient Age Range
adult patients
Intended User / Care Setting
medical personnel qualified to work with lab monitoring systems.
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
Nonclinical Testing Summary: The nonclinical bench testing included: Design Verification (Dimensional Inspection, Visual Inspection, Functional and Compatibility Testing, Mechanical Testing, Corrosion Testing), Design Validation (Usability Testing), Biocompatibility Testing. In addition, BIOTRONIK has performed sterilization, shelf life and packaging validations. The collective results demonstrate that the materials chosen, manufacturing processes, and design meet established specifications and do not introduce new issues of safety or effectiveness.
Tests performed include: Dimensional and Visual Inspection, Functional and Compatibility Testing, Electrical and Mechanical Testing, Shelf life, Packaging, Biocompatibility, Sterilization Validation for MultiCath.
For the MPK cable, functional testing (visual inspection, dimensional verification, electrical continuity and resistance, mechanical characteristics), Sterilization Validation, and Reprocessing Validation were performed. All tests passed.
Clinical Performance Data: No clinical performance data was submitted or relied upon in support of the substantial equivalence determination.
Key Metrics
Not Found
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.
September 2, 2021
BIOTRONIK, Inc. Jon Brumbaugh Vice President, Regulatory Affairs and Compliance 6024 Jean Road Lake Oswego, Oregon 97035
Re: K201445
Trade/Device Name: MultiCath, AcQRate Dx Fixed Curve Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: DRF Dated: July 30, 2021 Received: August 2, 2021
Dear Jon Brumbaugh:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Aneesh Deoras Assistant Director (Acting) Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201445
Device Name MultiCath AcQRate Dx Fixed Curve Catheter
Indications for Use (Describe)
The catheter is indicated for electrophysiological mapping of cardiac structures in adult patients; i.e., stimulation and recording only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
MULTICATH CATHETERS FOR ELECTROPHYSIOLOGICAL DIAGNOSTICS
510(K) NOTIFICATION K201445
| Date Prepared: | May 28, 2020 |
|---|---|
| Contact: | Jon Brumbaugh |
| Vice President, Regulatory Affairs & New Product Development | |
| BIOTRONIK, Inc. | |
| 6024 Jean Road | |
| Lake Oswego, OR 97035 USA | |
| Phone (888) 345-0374 | |
| Fax (800) 913-6993 | |
| Email: jon.brumbaugh@biotronik.com | |
| Manufacturer: | VascoMed GmbH |
| Hertzallee 1 | |
| 79589 Binzen, Germany | |
| Phone: +49 (0)7621 16011 0 | |
| Fax: +49 (0)7621 16011 9191 | |
| Trade Name: | MultiCath |
| AcQRate Dx Fixed Curve Catheter | |
| Generic/Common Name: | Catheters for Electrophysiological Diagnostics |
| Classification Name: | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Classification & Panel: | Class II / 21 CFR § 870.1220, Cardiovascular |
| Product Code: | DRF |
| Predicate Device: | Cordis Webster fixed curve catheters |
| (K992965, cleared November 26, 1999) |
Catheter
Device Description [807.92(a)(4)]
The MultiCath* and the AcQRate Dx Fixed Curve Catheter are pre-shaped multipolar catheters for sensing of intracardiac signals and diagnostic pacing, in combination with an electrophysiological investigation and recording device.
The device consists of a catheter body with a distal curve, an array of platinum/iridium (PtIr) electrodes, and a proximal multipolar connector. Multiple electrode configurations are available with various numbers of electrodes and electrode spacing.
- Unless otherwise noted, the term "MultiCath" is used throughout to represent either MultiCath or the AcQRate Dx Fixed Curve Catheter.
4
Indications for Use [807.92(a)(5)]
The indications for use for the MultiCath Catheter and the predicate are the same.
The catheter is indicated for electrophysiological mapping of cardiac structures in adult patients; i.e., stimulation and recording only.
Comparison of Technological Characteristics with the Predicate Devices [807.92(a)(6)]
The MultiCath Catheters are substantially equivalent to the predicate devices based on comparisons of the device functionality, technological characteristics, and intended use. The differences in tip curvature offerings are minor and do not raise new issues of safety and effectiveness. The diameter and number of electrodes have been evaluated through bench and biocompatibility testing. Bench testing demonstrated that the subject device is substantially equivalent to the predicate device.
| Comparison of Characteristics between Proposed and Predicate Devices | |||
|---|---|---|---|
| Subject Device | Predicate Device | ||
| Characteristics | BIOTRONIK | ||
| MultiCath Catheters | |||
| (K201445) | Cordis Webster | ||
| Fixed Curve | |||
| Catheters | |||
| (K992965) | Rationale for Substantial | ||
| Equivalence | |||
| Precurved tip | Yes | Yes | Identical |
| Electrode | |||
| material | Platinum/iridium | Platinum/iridium | Identical |
| Steerable | No | No | Identical |
| Tip type | Normal or soft tip | Normal or soft tip | Identical |
| Poles | |||
| (Electrodes) | 4, 5, or 10 electrodes | 10 electrodes | Substantially equivalent. The |
| MultiCath is available with as | |||
| few as 4 electrodes. The models | |||
| with fewer than 10 electrodes | |||
| do not introduce new issues of | |||
| safety and effectiveness. | |||
| Diameters | 6 F, 5 F and 4 F | ||
| versions | 6 F, 5 F and 4 F | ||
| versions | Identical | ||
| Curve Type | HIS, Josephson, | ||
| Damato, Courmand, | |||
| Josephson special, | |||
| Multi-purpose | HIS, Josephson, | ||
| Damato, Courmand, | |||
| Levine | Substantially equivalent. The | ||
| MultiCath is available in 6 tip | |||
| curvatures. The minor | |||
| differences in tip shapes do | |||
| not introduce new issues of | |||
| safety and effectiveness. | |||
| Insertion length | 80, 100, 110 cm | 60, 110, 115, 120 cm | Substantially equivalent. The |
| MultiCath has three different | |||
| lengths, which fall within the | |||
| range of lengths for the cleared | |||
| predicate. There is no new worst | |||
| case. Any difference in lengths | |||
| does not introduce new issues of | |||
| safety and effectiveness. |
5
| Comparison of Characteristics between Proposed and Predicate Devices | |||
|---|---|---|---|
| Subject Device | Predicate Device | ||
| Characteristics | BIOTRONIK | ||
| MultiCath Catheters | |||
| (K201445) | Cordis Webster | ||
| Fixed Curve | |||
| Catheters | |||
| (K992965) | Rationale for Substantial | ||
| Equivalence | |||
| Torque shaft | Yes | Yes | Identical |
| Tip electrode | |||
| size | 1.67 mm | 1 mm | Substantially equivalent. The |
| minor difference in tip size | |||
| does not introduce new issues | |||
| of safety and effectiveness. | |||
| Electrode | |||
| Spacing | Various electrode | ||
| spacings available: | |||
| 2-5-2 mm, 2-8-2 mm, | |||
| 2 mm, 5 mm, | |||
| 5-5-5-280 mm | Various electrode | ||
| spacings available: | |||
| 2-5-2 mm, 2-8-2 mm, | |||
| and 2-10-2 mm | Substantially equivalent. The | ||
| minor difference in electrode | |||
| spacing does not introduce | |||
| new issues of safety and | |||
| effectiveness. | |||
| Single Use | Yes | Yes | Identical |
| Supplied Sterile | Yes | Yes | Identical |
| Internal Braid | |||
| Design | Yes | Yes | Identical |
Performance Data [807.92(b)]
All bench testing was conducted on the MultiCath Catheters necessary for Electrophysiological Diagnostics to support a determination of substantial equivalence to the predicate device.
Nonclinical Testing Summary [807.92(b)(1)]
The nonclinical bench testing included:
- . Design Verification
- Dimensional Inspection o
- Visual Inspection O
- Functional and Compatibility Testing O
- Mechanical Testing O
- o Corrosion Testing
- Design Validation .
- Usability Testing
- . Biocompatibility Testing
6
In addition, BIOTRONIK has performed sterilization, shelf life and packaging validations. The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the MultiCath Catheters meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the MultiCath Catheters do not introduce new issues of safety or effectiveness when compared to the predicate device.
| Test performed | Device | Test method summary | Results |
|---|---|---|---|
| Dimensional and Visual | |||
| Inspection | MultiCath | Testing demonstrate that requirements of | |
| EN ISO 10555-1 have been met and | |||
| correspond to the defined specifications. | pass | ||
| Functional and | |||
| Compatibility Testing | MultiCath | Functional and compatibility testing was | |
| performed with FDA approved external | |||
| generators. The results of the leakage | |||
| currents testing revealed an outcome below | |||
| the limits given in the standard IEC 60601- | |||
| 1:2005, COR1:2006, COR2:2007,AMD1:2012. | pass | ||
| Electrical and | |||
| Mechanical Testing | MultiCath | Testing demonstrates that applicable | |
| requirements of EN ISO 10555-1, EN 62366-1 | |||
| and EN ISO 60601-1 have been met to ensure | |||
| that the catheter is safe. | pass | ||
| Shelf life | MultiCath | Confirmation of device functional performance | |
| and sterile barrier pouch integrity (seal | |||
| strength per ASTM F88 and bubble per | |||
| ASTM F2096) with accelerated aging and | |||
| simulated distribution per ASTM 4169-16. | pass | ||
| Packaging | MultiCath | The methods applied to evaluate the sterile | |
| barrier package integrity included transport | |||
| simulation, preconditioning, seal strength, | |||
| peel and bubble testing. | pass | ||
| Biocompatibility | ViaCath | The biocompatibility testing demonstrate that | |
| the requirements of ISO 10993 "Biological | |||
| evaluation of medical devices -Part 1: | |||
| "Evaluation and testing within a risk | |||
| management process" and the 2020 FDA | |||
| Biocompatibility guidance 2have been met. | pass | ||
| Sterilization Validation | MultiCath | Full Revalidation of Sterilization Process | |
| Performance Qualification | |||
| ISO 11135:2014 Sterilization of health care | |||
| products - Ethylene oxide: Requirements of | |||
| development, validation and routine control of | |||
| a sterilization process for medical devices. | pass | ||
| Test performed | Device | Test method summary | Results |
| Functional testing - | |||
| visual inspection, | |||
| dimensional verification, | |||
| electrical continuity and | |||
| resistance, mechanical | |||
| characteristics | MPK | For validation of the product properties after | |
| real time aging of 25 months following tests | |||
| are performed: | |||
| a) Visual inspection of the packaging and | |||
| product | |||
| b) Functional test of the product | |||
| c) Electrical measurement | a) pass | ||
| b) pass | |||
| c) pass | |||
| Sterilization Validation | MPK | Full Revalidation of Sterilization Process | |
| Performance Qualification ISO 11135:2014 | |||
| Sterilization of health care products - | |||
| Ethylene oxide: Requirements of | |||
| development, validation and routine control | |||
| of a sterilization process for medical devices. | pass | ||
| Reprocessing Validation | MPK | Testing demonstrates that the cable can be | |
| reprocessed up to 50 times. | pass |
Clinical Performance Data [807.92(b)(2)]
No clinical performance data was submitted or relied upon in support of the substantial equivalence determination.
7
Cable
Device description:
BIOTRONIK's MPK-4-R and MPK-10 patient cables are four or ten channel cables to connect electrophysiological diagnostic catheters distributed by BIOTRONIK (e.g., MultiCath, ViaCath) and Acutus Medical (AcQRate Dx Fixed Curve Catheter, AcQ Dx Steerable Catheter) with electrophysiological examination units and stimulators.
Intended use:
MPK-4-R and MPK-10-R are used to connect BIOTRONIK and Acutus Medical diagnostic catheters to a cardiac stimulator or a lab monitoring system for intracardiac diagnostics as part of an electrophysiological study. MPK-R and diagnostic catheters may only be used by medical personnel qualified to work with lab monitoring systems. Patient cables may not be physically modified, e.q., shortened.
Functional and Safety Testing:
Conclusions [807.92(b)(3)]
Based on the performance testing and the technological characteristics, it can be concluded that the MultiCath meets its established performance for its intended use and is substantially equivalent to the predicate device.