Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical medical device (catheter) used for electrogram recording and stimulation, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on physical and electrical characteristics.

Therapeutic

No
The device is described as a "diagnostic" catheter used for "electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies," indicating a diagnostic rather than therapeutic purpose.

Diagnostic

Yes
The "Intended Use / Indications for Use" states that the catheters "can be used for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies." The term "diagnostic" explicitly indicates its purpose.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical catheter constructed of thermoplastic elastomer material and noble metal electrodes, with a control mechanism in the handle. This indicates a hardware device, not software only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for "electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies." This involves interacting directly with the patient's body (in vivo) to record electrical signals and stimulate the heart.
Device Description: The description details a physical catheter designed to be inserted into the body.
Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis on bodily specimens.

The device is a medical device used for diagnostic procedures performed within the patient's body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

NLH

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

high right atrium, right ventricular apex, and the 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

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: 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

Key Metrics

Not Found

Predicate Device(s)

K982232, K961924

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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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"

1

(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).

2

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

3

| OEM Model
No. | Diameter
(Fr) | Length
(cm) | Electrodes | |------------------|-- | | (mm) | |
| 81102 | 6 | 81104 | 6 | 81105 | 6 | 81107 | 6 | 81171 | 5 | 81172 | 5 | 81174 | 5 | 81202 | 7 | 81207 | 7 | 81209 | 7 | 81223 | 5 | 81224 | 5 | 81402 | 6 | 81403 | 6 | 81404 | 6 | 81405 | 6 | 81417 | 6 | 81418 | 6 | 81472 | 5 | 81473 | 5 | 81474 | 5 | 81483 | 5 | 81504 | 6 | 81520 | 6 | 81521 | 5 | 81524 | 6 | 81526 | 5 | 81530 | 4 | 81531 | 4 | 81532 | 4 | 81534 | 4 | 81537 | 4 | 81540 | 4 | 81542 | 4 | 81543 | 4 | 81557 | 5 | 81721 | 5 | 81730 | 5 | 81734 | 5 | 81735 | 5 | 81736 | 5 | 81801 | 6 | 81802 | 6 | 81807 | 6 | 81809 | 6 | 81871 | 5 | 81872 | 5 | 81945 | 6 | Curve |
----------------|----------------|------------|-----------------|---------|
| | Qty. | Spacing
| 110 | 10 | 2-5-2 | M |
| 110 | 10 | 2-5-2 | L |
| 110 | 10 | 2-5-2 | XL |
| 110 | 10 | 5 | L |
| 110 | 10 | 2 | M |
| 110 | 10 | 2-5-2 | M |
| 110 | 10 | 2-5-2 | L |
| 110 | 20 | 2-10-2 | XXL |
| 110 | 20 | 5 | SL |
| 110 | 20 | 2-5-2 | SL |
| 110 | 10 | 2(50)3 | XL |
| 110 | 10 | 2(30)3 | M |
| 110 | 4 | 2-5-2 | M |
| 110 | 4 | 5 | M |
| 110 | 4 | 2-5-2 | L |
| 110 | 4 | 5 | L |
| 110 | 4 | 5 | XL |
| 110 | 4 | 2-5-2 | XL |
| 110 | 4 | 2-5-2 | M |
| 110 | 4 | 5 | M |
| 110 | 4 | 2-5-2 | L |
| 110 | 4 | 5 | E(HIS) |
| 110 | 10 | 5 | M |
| 110 | 10 | 2 | XL |
| 110 | 5 | 5(170) | M/L |
| 110 | 10 | 2 | L |
| 95 | 10 | 2-170-170 | C1(HIS) |
| 110 | 10 | 2 | M |
| 110 | 10 | 2-5-2 | M |
| 110 | 10 | 2-5-2 | L |
| 110 | 10 | 5 | L |
| 60 | 10 | 2-5-2 | M(SC) |
| 110 | 4 | 2-5-2 | M |
| 110 | 4 | 5 | M |
| 110 | 4 | 2-5-2 | L |
| 110 | 10 | 3(170)50 | M |
| 110 | 10 | 2-5-2 | M(SC) |
| 110 | 10 | 2-8-2 | M/L |
| 110 | 10 | 2-5-2 | L |
| 110 | 10 | 5 | L |
| 110 | 10 | 5(22)5 | M/L |
| 110 | 8 | 2 | M |
| 110 | 8 | 2-5-2 | M |
| 110 | 8 | 2 | L |
| 110 | 8 | 2-5-2 | L |
| 110 | 8 | 2 | M |
| 110 | 8 | 2-5-2 | M |
| 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)

K242225

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"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."

5

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 Mays
Senior Regulatory Affairs Specialist, Regulatory Affairs
P: 541-516-4205 • F: 541-923-3375 • smays@medline.com | |
| Date Prepared | July 26, 2024 | |
| Device Name
and
Classification | Proprietary/Trade Name: | Medline ReNewal Reprocessed Abbott Inquiry
Steerable Diagnostic Catheter |
| | Common or Usual Name | Catheter, recording, electrode, reprocessed |
| | Regulatory Name/Reference | Electrode recording catheter or electrode recording
probe/21 CFR § 870.1220 |
| | Regulatory Class | 2 |
| | Product Code | NLH |
| | Panel | Cardiovascular |
| Predicates
selection | Rationale | The predicate models in K982232 and K961924
include the subject device models of this submission. |
| | 510(k) Number | K982232 |
| Predicate
Device (1) | Proprietary or
Trade Name | Modification of the IBI-1100 Steerable
Electrophysiology Catheter System |
| | Common or Usual
Name | Catheter, recording, or probe electrode recording |
| | Regulatory
Name/Reference | Electrode recording catheter or electrode recording
probe/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 |
| Predicate
Device (2) | Proprietary or
Trade Name | IBI-1100 Steerable Electrophysiology Catheter
System |
| | Common or Usual
Name | Catheter, recording, or probe electrode recording |
| | Regulatory
Name/Reference | Electrode recording catheter or electrode recording
probe/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 | |
| Device
Description/
Intended Use | 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. | |
| Indications for
Use | 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. | |
| Technological
Characteristics | The technological characteristics, materials, and the fundamental scientific
technology of the subject device is equivalent to the predicate and
reference devices. The proposed devices are reprocessed versions of the
predicate devices. Each device undergoes a validated process that includes
cleaning, inspections and functional tests, packaging and sterilization.
Devices are tracked to ensure they do not exceed the number of validated
reprocessing cycles (2). Devices that have reached the maximum number
of cycles or do not meet inspection criteria are rejected and disposed of
appropriately. The predicate devices were used to support intended use,
technological characteristics, and functional performance specifications. | |
| Non-clinical
Testing
Summary | 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:
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 | |

6

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 1
Modification of the
IB-1100 Steerable
Electrophysiology
Catheter System	PREDICATE 2
IBI-1100 Steerable
Electrophysiology
Catheter System	PROPOSED
Medline ReNewal
Reprocessed Abbott
Inquiry Steerable
Diagnostic Catheter	Comparison
510(k) number
K982232	K961924	TBD	N/A
Model number
Not listed in K982232
Summary	Not listed in K961924
Summary	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, electrode
recording, or probe
electrode recording	Catheter, electrode
recording, or probe
electrode 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 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	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	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	Same
Technological Characteristics
The catheters contain
various numbers of
electrodes and electrode
spacings and a steerable
design with a tip that are
available in various
curves.	The catheters contain
various numbers of
electrodes and electrode
spacings and a steerable
design with a tip that are
available in various
curves.	The Medline ReNewal
Reprocessed Abbott
Inquiry Steerable
Diagnostic Catheters
contain various numbers
of electrodes and
electrode spacings and a
steerable design with a tip
that are available in
various 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 and
technological characteristics. Based on this and the non-clinical testing data presented in this
510(k) submission, the Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic
Catheters within the scope of this submission are substantially equivalent to the predicate
devices.

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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