(414 days)
Not Found
No
The summary describes a reprocessed electrophysiology catheter with mechanical steering and standard performance testing. There is no mention of AI/ML in the intended use, device description, or performance studies.
No
The device is used for evaluation and diagnostic purposes (evaluating cardiac arrhythmias), not for treating conditions.
Yes
The device is described as being used in the "evaluation of a variety of cardiac arrhythmias," which indicates its purpose is to diagnose or assess a medical condition.
No
The device description clearly states it is a physical catheter constructed of polyurethane and platinum electrodes, with a manipulable tip. The performance studies also focus on physical and material properties, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites." This describes a device used within the body for diagnostic purposes, not a device used to test samples outside the body (which is the definition of an IVD).
- Device Description: The description details a flexible electrode catheter used for internal procedures. This aligns with an in-vivo diagnostic device, not an in-vitro one.
- Lack of IVD Characteristics: There is no mention of testing biological samples (blood, urine, tissue, etc.) or using reagents, which are hallmarks of IVD devices.
Therefore, the Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter is an in-vivo diagnostic device, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
Product codes (comma separated list FDA assigned to the subject device)
NLH
Device Description
The Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter is a flexible electrode catheter constructed of a polyurethane insulation/shaft and incorporates platinum electrodes. The active tip may be manipulated by a remote means located at 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
endocardial and intravascular sites (cardiac)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
simulated use and artificial soiling; tensile testing; torsional strength; leakage current; continuity; isolation resistance; three-point bend corrosion resistance.
Cleaning:
protein, total organic carbon, and endotoxins; visual inspection under magnification; and cleaning performance qualification.
Biocompatibility:
cytotoxicity; sensitization; irritation; acute systemic toxicity; materials-mediated pyrogen complement activation; hemolysis (direct and indirect) coagulation complement activation thrombosis.
Packaging and shelf life validation; sterilization validation:
bioburden testing; and ethylene oxide and ethylene chlorohydrin residuals testing
bacteriostasis/fungistatis
Product stability
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows 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 text logo on the right. The FDA text logo is in blue and consists of the letters "FDA" in a square and the words "U.S. Food & Drug Administration".
May 31, 2023
Surgical Instrument Service and Savings Inc. (dba Medline ReNewal) Stephanie Mays Senior Regulatory Affairs Specialist 1500 NE Hemlock Ave. Redmond, Oregon 97756
Re: K221067
Trade/Device Name: Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode recording catheter or electrode recording probe Regulatory Class: Class II Product Code: NLH Dated: May 4, 2023 Received: May 4, 2023
Dear Stephanie 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 (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.
1
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 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 (QS) 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 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).
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
2
| Model | Description | Electrodes | Curve | Size | |
|---|---|---|---|---|---|
| No. | Qty. | Spacing | (cm)a | ||
| 401572 | Quadripolar | 4 | 2-5-2 | M Sweep | 6 Fr x 115 |
| 401575 | Decapolar | 10 | 2-5-2 | M Sweep | 6 Fr x 115 |
| 401580 | Hexapolar | 6 | 2-5-2 | M Sweep | 7 Fr x 115 |
| 401581 | Octapolar | 8 | 2-5-2 | M Sweep | 7 Fr x 115 |
| 401582 | Decapolar | 10 | 2-5-2 | M Sweep | 7 Fr x 115 |
| 401600 | Quadripolar | 4 | 2-5-2 | M Sweep | 6 Fr x 115 |
| 401603 | Quadripolar | 4 | 2-5-2 | M Curl | 6 Fr x 115 |
| 401606 | Quadripolar | 4 | 2-5-2 | L Sweep | 6 Fr x 115 |
| 401648 | Quadripolar | 4 | 5-5-5 | L Curl | 5 Fr x 115 |
| 401652 | Octapolar | 8 | 2-2-2 | M Sweep CRD- | |
| 2 ™ | 5 Fr x 115 | ||||
| 401653 | Hexapolar | 6 | 2-5-2 | M Sweep CRD- | |
| 2™ | 5 Fr x 115 | ||||
| 401654 | Hexapolar | 6 | 5 | M Sweep CRD- | |
| 2 ™ | 5 Fr x 115 | ||||
| 401655 | Decapolar | 10 | 5-5-5 | XL Curl | 5 Fr x 115 |
| 401780 | Quadripolar | 4 | 5-5-5 | M sweep | 5 Fr x 115 |
| 401904 | Duo-Decapolar | 20 | 2-10-2 | Super L Curl | 7 Fr x 95 |
| 401905 | Duo-Decapolar | 20 | 5-5-5 | Super L Curl | 7 Fr x 95 |
| 401908 | Duo-Decapolar | 20 | 2-2-2 | M Curl | 7 Fr x 115 |
| 401914 | Duo-Decapolar | 20 | 2-5-2 | Super L Curl | 7 Fr x 95 |
| 401915 | Decapolar | 10 | 2-5-2 | XL Curl | 6 Fr x 115 |
| 401917 | Octapolar | 8 | 2-2-2 | M Sweep | 6 Fr x 115 |
| 401918 | Duo-Decapolar BDB™ | 20 | 2-20-2-2-2- | ||
| 2-2-2-2-2-2- | |||||
| 2-2-25-2-25- | |||||
| 2-25-2 | Super L Curl | 7 Fr x 95 | |||
| 401923 | Decapolar | 10 | 2-2-2 | XL Curl | 6 Fr x 115 |
| 401926 | Decapolar CSL™ Bi- | ||||
| directional | 10 | 2-8-2 | XL Sweep CSL | 6 Fr x 115 | |
| 401932 | Dual-Purpose Duo- | ||||
| Decapolar (20 | |||||
| Electrodes) | 20 | 2-8-2-(60)-2- | |||
| 8-2 | Super L Curl | 7 Fr x 95 | |||
| 401933 | Quadripolar | 4 | 5-5-5 | M Sweep | 6 Fr x 115 |
| 401934 | Quadripolar | 4 | 5-5-5 | L Sweep | 6 Fr x 115 |
| 401935 | Decapolar | 10 | 2 | XL Sweep | 7 Fr x 115 |
| 401938 | Decapolar | 10 | 5-5-5 | M Sweep | 5 Fr x 115 |
The model numbers included in the scope of this submission are listed in the following table.
3
Indications for Use
510(k) Number (if known) K221067
Device Name
Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheters
Indications for Use (Describe)
The Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the Medline Renewal logo. The Medline logo is on the left, with the word "MEDLINE" in white letters on a blue square. To the right of the Medline logo is the word "Renewal" in green and blue letters, 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 letters.
221067 510(k) 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 (dba Medline ReNewal)
1500 NE Hemlock Ave., Redmond, OR 97756 | | | |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Contact/Prepared by | Stephanie Boyle Mays
Senior Regulatory Affairs Specialist, Quality Assurance/Regulatory Affairs
P: 541-516-4205 • F: 541-923-3375 • smays@medline.com | | | |
| Date Prepared | April 8, 2022 | | | |
| Device Name and Classification | Proprietary/Trade Name: | Medline ReNewal Reprocessed St. Jude Medical
Livewire Steerable Electrophysiology Catheters | | |
| | Common or Usual Name | Diagnostic Electrophysiology Catheter, Reprocessed | | |
| | Regulatory Name/Reference | Electrode recording catheter or electrode recording
probe, 21 CFR § 870.1220 | | |
| | Regulatory Class | 2 | | |
| | Product Code | NLH | | |
| | Panel | Cardiovascular | | |
| | 510(k) Number | K151622 | | |
| | Proprietary or Trade Name | St. Jude Medical MediGuide Enabled Livewire
Steerable Electrophysiology Catheter, Livewire
Electrophysiology Catheter, Response
Electrophysiology Catheter with Lumen, Response
Electrophysiology Catheter and SJM Epicardial
Catheter System, Supreme Electrophysiology
Catheter | | |
| Predicate Device | Common or Usual Name | Diagnostic Electrophysiology Catheter | | |
| | Regulatory Name/Reference | Electrode recording catheter or electrode recording
probe, 21 CFR § 870.1220 | | |
| | Regulatory Class | 2 | | |
| | Product Code | DRF | | |
| | Panel | Cardiovascular | | |
| | Manufacturer | St. Jude Medical
14901 DeVeau Place, Minnetonka, MN 55345 | | |
| Device Description | The Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable
Electrophysiology Catheter is a flexible electrode catheter constructed of a
polyurethane insulation/shaft and incorporates platinum electrodes. The
active tip may be manipulated by a remote means located at the proximal
end of the catheter. | | | |
| Indications for use | The Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable
Electrophysiology Catheter can be used in the evaluation of a variety of
cardiac arrhythmias from endocardial and intravascular sites. | | | |
5
Image /page/5/Picture/0 description: The image contains the Medline and Renewal logos. The Medline logo is a blue square with the word "MEDLINE" in white letters and a white star-like symbol. The Renewal logo is in green and blue letters, with the words "Full Circle Reprocessing" in smaller letters below. The Renewal logo also has a trademark symbol.
| Technological
Characteristics | The technological characteristics and the fundamental scientific technology
of the subject devices are equivalent to the predicate device. The proposed
devices are a reprocessed version of the predicate devices. K151622 St.
Jude Medical Livewire Steerable Electrophysiology Catheter was used as
the primary predicate 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: | | |
| | | simulated use and artificial soiling; tensile testing; torsional strength; leakage current; continuity; isolation resistance; three-point bend corrosion resistance. | | |
| | | Cleaning: | | |
| | | protein, total organic carbon, and endotoxins; visual inspection under magnification; and cleaning performance qualification. | | |
| | | Biocompatibility: | | |
| | | cytotoxicity; sensitization; irritation; acute systemic toxicity; materials-mediated pyrogen complement activation; hemolysis (direct and indirect) coagulation complement activation thrombosis. | | |
| | | Packaging and shelf life validation; sterilization validation: | | |
| | | bioburden testing; and ethylene oxide and ethylene chlorohydrin residuals testing | | |
| | | bacteriostasis/fungistatis | | |
| | | Product stability | | |
| Summary Table: Predicate and Medline ReNewal Reprocessed St. Jude Medical
Livewire Reprocessed Electrophysiology Catheter device comparison
chart. | | | | |
| Predicate | Proposed | Comparison | | |
| Predicate | Proposed | Comparison | |
|---|---|---|---|
| Device | |||
| Characteristics | St. Jude Medical MediGuide | ||
| Enabled Livewire Steerable | |||
| Electrophysiology Catheter, | |||
| Livewire Electrophysiology | Medline ReNewal St. Jude | ||
| Medical Livewire Steerable | |||
| Electrophysiology Catheter | As Stated |
6
Image /page/6/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 the word "MEDLINE" in white text and a white star symbol. To the right of the Medline logo is the word "Renewal" in green text, with the words "Full Circle Reprocessing" in blue text below it. The Renewal logo also has a trademark symbol.
| | Catheter, Response
Electrophysiology Catheter
with Lumen, Response
Electrophysiology Catheter
and SJM Epicardial Catheter
System, Supreme
Electrophysiology Catheter | | |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| 510(k) | K151622 | TBD | N/A |
| Model Numbers | Not listed in K151622
Summary | 401572, 401575, 401580,
401581, 401582, 401600,
401603, 401606, 401648,
401652, 401653, 401654
401655, 401780, 401904,
401905, 401908, 401914,
401915, 401917, 401918,
401923, 401926, 401932,
401933, 401934, 401935,
401938, 401939, 401940,
401941, 401949, 401990,
401991, 402022, 402032 | As stated |
| Common Name | Diagnostic Electrophysiology
Catheter | Diagnostic Electrophysiology
Catheter, Reprocessed | As stated |
| Regulation No. | 21 CFR § 870.1220 | 21 CFR § 870.1220 | Same |
| Regulatory Class | 2 | 2 | Same |
| Product Code | DRF | NLH | As stated |
| Indications for
Use (Intended
Use) | The Livewire Steerable
Electrophysiology Catheter can
be used in the evaluation of a
variety of cardiac arrhythmias
from endocardial and
intravascular sites. | The Medline ReNewal
Reprocessed St. Jude Medical
Livewire Steerable
Electrophysiology Catheter
can be used in the evaluation
of a variety of cardiac
arrhythmias from endocardial
and intravascular sites. | Same |
7
Image /page/7/Picture/0 description: The image shows 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 inside. The Renewal logo is on the right side of the image and is written in green and blue. Below the Renewal logo is the text "Full Circle Reprocessing".
Summary Table: Predicate and Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable EP Catheters device comparison chart (concluded).
| Predicate | Proposed | Comparison | |
|---|---|---|---|
| Device | |||
| Characteristic | |||
| s | St. Jude Medical MediGuide | ||
| Enabled Livewire Steerable | |||
| Electrophysiology Catheter, | |||
| Livewire Electrophysiology | |||
| Catheter, Response | |||
| Electrophysiology Catheter | |||
| with Lumen, Response | |||
| Electrophysiology Catheter | |||
| and SJM Epicardial Catheter | |||
| System, Supreme | |||
| Electrophysiology Catheter | Medline ReNewal St. Jude | ||
| Medical Livewire Steerable | |||
| Electrophysiology Catheter | As stated | ||
| Technological | |||
| Characteristicsa | To operate, the Livewire | ||
| Steerable Electrophysiology | |||
| Catheters are connected to a | |||
| generator via a universal | |||
| cable. | To operate, the Medline | ||
| ReNewal Reprocessed | |||
| Livewire Steerable | |||
| Electrophysiology Catheters | |||
| are connected to a generator | |||
| via a universal cable. | As stated | ||
| a Neither K151622 nor the current submission included the universal cable or generators as part of their respective submissions. Only catheter models were included in the project scope. | |||
| Reprocessing | Each catheter is reprocessed no more than two times. Medline ReNewal does not reprocess the catheters of other reprocessors. | ||
| Conclusion | The predicate 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 St. Jude Medical Livewire Steerable Catheter device models listed in this summary table are substantially equivalent to the predicate devices. |