(123 days)
Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheters can be used for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies. The catheters are commonly placed in the high right atrium, right ventricular apex, and the HIS bundle.
The Medline ReNewal Reprocessed Inquiry Steerable Diagnostic Electrophysiology Catheters are flexible, insulated catheters constructed of thermoplastic elastomer material and noble metal electrodes. The tip of the steerable catheters may be manipulated with the control mechanism located in the handle of the proximal end of the catheter.
The provided text is a 510(k) Premarket Notification from the FDA regarding a reprocessed medical device: the Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through extensive clinical studies with specific acceptance criteria as you would see for an AI/ML powered device.
Therefore, the document does not contain the information requested regarding acceptance criteria, study details, sample sizes for training/test sets, expert adjudication, MRMC studies, standalone algorithm performance, or ground truth establishment in the context of an AI/ML device.
Instead, the document details physical and functional performance testing to ensure the reprocessed device is equivalent to the original predicate devices. This typically involves:
-
Table of Acceptance Criteria and Reported Device Performance: This document does not present a formal table of acceptance criteria and reported device performance in the way one would for an AI/ML algorithm. Instead, it states that "The functional characteristics of the subject device have been evaluated and found to be substantially equivalent to the predicate device based on the following tests." The tests listed are:
- Visual inspection
- Dimensional measurement
- Electrical safety
- Mechanical characteristics (continuity, isolation, resistance)
- Corrosion resistance
- Cleaning validation
- Biocompatibility
- Packaging and shelf life validation
- Sterilization validation
- Product stability
The acceptance criterion for these tests is that the reprocessed device performs comparably to the new, original predicate devices.
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Sample size used for the test set and the data provenance: The document does not specify exact sample sizes for each of the non-clinical tests listed. It indicates the tests were performed on the reprocessed devices. The "data provenance" is implied to be from Medline ReNewal's internal testing of their reprocessed catheters. This is not medical imaging data from patients.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For reprocessed medical devices, "ground truth" relates to engineering specifications and performance standards established by the original manufacturer and industry standards, rather than expert human interpretation of medical data.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically associated with human interpretation of complex data (like medical images) to establish ground truth, which is not the type of data or evaluation performed for this device.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical medical device, not an AI-powered diagnostic tool. MRMC studies are for AI/ML devices to assess human reader performance with and without AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this device would be based on engineering specifications, material properties, functional performance benchmarks (e.g., electrical resistance within a specified range, mechanical integrity under stress, sterility), and established safety standards. It does not involve medical, pathological, or outcomes data in the way an AI/ML diagnostic would.
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The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no "training set."
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How the ground truth for the training set was established: Not applicable. As there is no training set.
In summary, the provided document is a 510(k) clearance letter for a reprocessed physical medical device, not an AI/ML enabled device. Therefore, the questions related to AI/ML model evaluation (training/test sets, ground truth methodology, expert adjudication, MRMC studies) are not relevant to this submission. The "study" proving the device meets acceptance criteria refers to a series of non-clinical, bench-top functional and material property tests to ensure the reprocessed device performs equivalently to its new predicate.
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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: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a symbol of the agency's mission to protect and promote public health through the regulation and supervision of food safety, tobacco, pharmaceuticals, medical devices, and other related products.
November 29, 2024
Surgical Instrument Service and Savings Inc. (dba Medline ReNewal) Stephanie Boyle Mays Senior Regulatory Affairs Specialist, QA/RA 1500 NE Hemlock Ave. Redmond, Oregon 97756
Re: K242225
Trade/Device Name: Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: NLH Dated: November 1, 2024 Received: November 1, 2024
Dear Stephanie Boyle Mays:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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).
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Sincerely,
Aneesh S. Deoras -S
Aneesh Deoras Assistant Director 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
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| OEM ModelNo. | Diameter(Fr) | Length(cm) | Electrodes | Curve | |
|---|---|---|---|---|---|
| Qty. | Spacing(mm) | ||||
| 81102 | 6 | 110 | 10 | 2-5-2 | M |
| 81104 | 6 | 110 | 10 | 2-5-2 | L |
| 81105 | 6 | 110 | 10 | 2-5-2 | XL |
| 81107 | 6 | 110 | 10 | 5 | L |
| 81171 | 5 | 110 | 10 | 2 | M |
| 81172 | 5 | 110 | 10 | 2-5-2 | M |
| 81174 | 5 | 110 | 10 | 2-5-2 | L |
| 81202 | 7 | 110 | 20 | 2-10-2 | XXL |
| 81207 | 7 | 110 | 20 | 5 | SL |
| 81209 | 7 | 110 | 20 | 2-5-2 | SL |
| 81223 | 5 | 110 | 10 | 2(50)3 | XL |
| 81224 | 5 | 110 | 10 | 2(30)3 | M |
| 81402 | 6 | 110 | 4 | 2-5-2 | M |
| 81403 | 6 | 110 | 4 | 5 | M |
| 81404 | 6 | 110 | 4 | 2-5-2 | L |
| 81405 | 6 | 110 | 4 | 5 | L |
| 81417 | 6 | 110 | 4 | 5 | XL |
| 81418 | 6 | 110 | 4 | 2-5-2 | XL |
| 81472 | 5 | 110 | 4 | 2-5-2 | M |
| 81473 | 5 | 110 | 4 | 5 | M |
| 81474 | 5 | 110 | 4 | 2-5-2 | L |
| 81483 | 5 | 110 | 4 | 5 | E(HIS) |
| 81504 | 6 | 110 | 10 | 5 | M |
| 81520 | 6 | 110 | 10 | 2 | XL |
| 81521 | 5 | 110 | 5 | 5(170) | M/L |
| 81524 | 6 | 110 | 10 | 2 | L |
| 81526 | 5 | 95 | 10 | 2-170-170 | C1(HIS) |
| 81530 | 4 | 110 | 10 | 2 | M |
| 81531 | 4 | 110 | 10 | 2-5-2 | M |
| 81532 | 4 | 110 | 10 | 2-5-2 | L |
| 81534 | 4 | 110 | 10 | 5 | L |
| 81537 | 4 | 60 | 10 | 2-5-2 | M(SC) |
| 81540 | 4 | 110 | 4 | 2-5-2 | M |
| 81542 | 4 | 110 | 4 | 5 | M |
| 81543 | 4 | 110 | 4 | 2-5-2 | L |
| 81557 | 5 | 110 | 10 | 3(170)50 | M |
| 81721 | 5 | 110 | 10 | 2-5-2 | M(SC) |
| 81730 | 5 | 110 | 10 | 2-8-2 | M/L |
| 81734 | 5 | 110 | 10 | 2-5-2 | L |
| 81735 | 5 | 110 | 10 | 5 | L |
| 81736 | 5 | 110 | 10 | 5(22)5 | M/L |
| 81801 | 6 | 110 | 8 | 2 | M |
| 81802 | 6 | 110 | 8 | 2-5-2 | M |
| 81807 | 6 | 110 | 8 | 2 | L |
| 81809 | 6 | 110 | 8 | 2-5-2 | L |
| 81871 | 5 | 110 | 8 | 2 | M |
| 81872 | 5 | 110 | 8 | 2-5-2 | M |
| 81945 | 6 | 110 | 10 | 2-5-2 | L |
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter
Indications for Use (Describe)
Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheters can be used for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies. The catheters are commonly placed in the high right atrium, right ventricular apex, and the HIS bundle.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/5/Picture/0 description: The image contains the Medline Renewal logo. The Medline logo is on the left side of the image and consists of a blue square with a white star-like symbol and the word "MEDLINE" in white letters. To the right of the Medline logo is the word "Renewal" in green and blue letters. Below the word "Renewal" is the phrase "Full Circle Reprocessing" in smaller, blue letters.
Traditional 510(k) Notification Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheters
510(k) 242225 Summary
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR § 807.92.
| Submitter/Owner | Surgical Instrument Service and Savings Inc. (dba Medline ReNewal)1500 NE Hemlock Ave., Redmond, OR 97756 | |
|---|---|---|
| Contact/Prepared by | Stephanie Boyle MaysSenior Regulatory Affairs Specialist, Regulatory AffairsP: 541-516-4205 • F: 541-923-3375 • smays@medline.com | |
| Date Prepared | July 26, 2024 | |
| Device NameandClassification | Proprietary/Trade Name: | Medline ReNewal Reprocessed Abbott InquirySteerable Diagnostic Catheter |
| Common or Usual Name | Catheter, recording, electrode, reprocessed | |
| Regulatory Name/Reference | Electrode recording catheter or electrode recordingprobe/21 CFR § 870.1220 | |
| Regulatory Class | 2 | |
| Product Code | NLH | |
| Panel | Cardiovascular | |
| Predicatesselection | Rationale | The predicate models in K982232 and K961924include the subject device models of this submission. |
| 510(k) Number | K982232 | |
| PredicateDevice (1) | Proprietary orTrade Name | Modification of the IBI-1100 SteerableElectrophysiology Catheter System |
| Common or UsualName | Catheter, recording, or probe electrode recording | |
| RegulatoryName/Reference | Electrode recording catheter or electrode recordingprobe/21 CFR § 870.1220 | |
| Regulatory Class | 2 | |
| Product Code | DRF | |
| Panel | Cardiovascular | |
| 510(k) applicant | Irvine BioMedical, Inc.,2146-A Michelson Dr., Irvine, CA 92612 | |
| 510(k) Number | K961924 | |
| PredicateDevice (2) | Proprietary orTrade Name | IBI-1100 Steerable Electrophysiology CatheterSystem |
| Common or UsualName | Catheter, recording, or probe electrode recording | |
| RegulatoryName/Reference | Electrode recording catheter or electrode recordingprobe/21 CFR § 870.1220 | |
| Regulatory Class | 2 | |
| Product Code | NLH | |
| Panel | Cardiovascular | |
| 510(k) applicant | Irvine BioMedical, Inc.,2146-A Michelson Dr., Irvine, CA 92612 | |
| DeviceDescription/Intended Use | The Medline ReNewal Reprocessed Inquiry Steerable DiagnosticElectrophysiology Catheters are flexible, insulated catheters constructed ofthermoplastic elastomer material and noble metal electrodes. The tip of thesteerable catheters may be manipulated with the control mechanismlocated in the handle of the proximal end of the catheter. | |
| Indications forUse | Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnosticcatheters can be used for electrogram recording and cardiac stimulationduring diagnostic electrophysiologic studies. The catheters are commonlyplaced in the high right atrium, right ventricular apex, and the HIS bundle. | |
| TechnologicalCharacteristics | The technological characteristics, materials, and the fundamental scientifictechnology of the subject device is equivalent to the predicate andreference devices. The proposed devices are reprocessed versions of thepredicate devices. Each device undergoes a validated process that includescleaning, inspections and functional tests, packaging and sterilization.Devices are tracked to ensure they do not exceed the number of validatedreprocessing cycles (2). Devices that have reached the maximum numberof cycles or do not meet inspection criteria are rejected and disposed ofappropriately. The predicate devices were used to support intended use,technological characteristics, and functional performance specifications. | |
| Non-clinicalTestingSummary | The functional characteristics of the subject device have been evaluatedand found to be substantially equivalent to the predicate device based onthe following tests:Functional performance studies: visual inspection; dimensional measurement; electrical safety; mechancial characteristics continuity, isolation, resistance; and corrosion resistance. Cleaning validation Biocompatibility Packaging and shelf life validation Sterilization validation Product stability |
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Image /page/6/Picture/0 description: The image contains the Medline Renewal Full Circle Reprocessing logo. The Medline logo is on the left side of the image and consists of a blue square with a white star-like symbol and the word "MEDLINE" in white letters. To the right of the Medline logo is the word "Renewal" in green and blue letters, with the words "Full Circle Reprocessing" in blue letters below it. The TM symbol is in the upper right corner of the word "Renewal".
Traditional 510(k) Notification Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheters
Summary Table follows
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Image /page/7/Picture/0 description: The image contains the Medline Renewal logo. The Medline logo is on the left side of the image and consists of a blue square with a white cross inside. The word "MEDLINE" is written in white letters above the cross. To the right of the Medline logo is the word "Renewal" in large, bold letters, with "Re" in green and "Newal" in blue. Below the word "Renewal" is the phrase "Full Circle Reprocessing" in smaller, blue letters.
| Summary Table: Predicates and Proposed Device Comparison Chart | |||
|---|---|---|---|
| PREDICATE 1Modification of theIB-1100 SteerableElectrophysiologyCatheter System | PREDICATE 2IBI-1100 SteerableElectrophysiologyCatheter System | PROPOSEDMedline ReNewalReprocessed AbbottInquiry SteerableDiagnostic Catheter | Comparison |
| 510(k) number | |||
| K982232 | K961924 | TBD | N/A |
| Model number | |||
| Not listed in K982232Summary | Not listed in K961924Summary | 81102, 81104, 81105,81107, 81171, 81172,81174, 81202, 81207,81209, 81223, 81224,81402, 81403, 81404,81405, 81417, 81418,81472, 81473, 81474,81483, 81504, 81520,81521, 81524, 81526,81530, 81531, 81532,81534, 81537, 81540,81542, 81543, 81557,81721, 81730, 81734,81735, 81736, 81801,81802, 81807, 81809,81871, 81872, 81945,81947 | As stated |
| Classification Name | |||
| Catheter, electroderecording, or probeelectrode recording | Catheter, electroderecording, or probeelectrode recording | Catheter, recording,electrode recording,reprocessed | As stated |
| Regulation No. | |||
| 21 CFR § 870.1220 | 21 CFR § 870.1220 | 21 CFR § 870.1220 | Same |
| Regulatory Class | |||
| 2 | 2 | 2 | Same |
| Product Code | |||
| DRF | DRF | NLH | As stated |
| Indications for Use | |||
| Electrogram recordingand cardiac stimulationduring diagnosticelectrophysiologicstudies. The cathetersare commonly placed inthe high right atrium, rightventricular apex, and theHIS bundle | Electrogram recordingand cardiac stimulationduring diagnosticelectrophysiologicstudies. The catheters arecommonly placed in thehigh right atrium, rightventricular apex, and theHIS bundle | Electrogram recordingand cardiac stimulationduring diagnosticelectrophysiologicstudies. The catheters arecommonly placed in thehigh right atrium, rightventricular apex, and theHIS bundle | Same |
| Technological Characteristics | |||
| The catheters containvarious numbers ofelectrodes and electrodespacings and a steerabledesign with a tip that areavailable in variouscurves. | The catheters containvarious numbers ofelectrodes and electrodespacings and a steerabledesign with a tip that areavailable in variouscurves. | The Medline ReNewalReprocessed AbbottInquiry SteerableDiagnostic Catheterscontain various numbersof electrodes andelectrode spacings and asteerable design with a tipthat are available invarious curves. | Same |
| Reprocessing | |||
| Each catheter is reprocessed no more than two times. Medline ReNewal does not reprocess the | |||
| Inquiry Steerable Diagnostic Catheters of other reprocessors. | |||
| Conclusion | |||
| The predicates and proposed devices in this application have the same indications for use andtechnological characteristics. Based on this and the non-clinical testing data presented in this510(k) submission, the Medline ReNewal Reprocessed Abbott Inquiry Steerable DiagnosticCatheters within the scope of this submission are substantially equivalent to the predicatedevices. |
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Image /page/8/Picture/0 description: The image contains the Medline and Renewal logos. The Medline logo is on the left and consists of the word "MEDLINE" in white text inside of a blue square with a white star-like symbol. To the right of the Medline logo is the Renewal logo, which consists of the word "Renewal" in green and blue text, with the letters "Re" in green and the rest of the word in blue. Below the word "Renewal" is the phrase "Full Circle Reprocessing" in blue text.
Traditional 510(k) Notification Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheters
§ 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).