(141 days)
No
The summary describes a reprocessed electrophysiology catheter and its functional and performance testing, with no mention of AI or ML capabilities.
No.
The device is used for diagnostic purposes (electrogram recording and cardiac stimulation during diagnostic electrophysiology studies) to evaluate cardiac arrhythmia, not to treat or provide therapy for it.
Yes
The device is used for "electrogram recording" and during "diagnostic electrophysiology studies" to evaluate "cardiac arrhythmia," indicating its role in identifying and understanding medical conditions.
No
The device description clearly states it is a catheter constructed of polyurethane and incorporates platinum electrodes, indicating it is a physical hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "evaluation of a variety of cardiac arrhythmia from endocardial and intravascular sites" and "electrogram recording and cardiac stimulation during diagnostic electrophysiology studies." This describes a device used within the body for diagnostic procedures, not a device used to test samples outside the body (which is the definition of an IVD).
- Device Description: The description details a catheter with electrodes placed within the heart and blood vessels for recording electrical signals and stimulation. This is consistent with an in-vivo diagnostic tool, not an in-vitro one.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside the body.
Therefore, the Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheters and Supreme Electrophysiology Catheters are not IVDs. They are invasive diagnostic devices used within the patient's body.
N/A
Intended Use / Indications for Use
The Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheters and Supreme Electrophysiology Catheters can be used in the evaluation of a variety of cardiac arrhythmia from endocardial and intravascular sites.
Product codes
NLH
Device Description
Medline ReNewal Reprocessed St. Jude Medical Supreme and Response Electrophysiology Catheters are commonly placed at the high right atrium, right ventricular apex and His bundle, and in the coronary sinus, and are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The Medline ReNewal Reprocessed St. Jude Medical Supreme and Response Electrophysiology Catheters are fixed electrode catheters constructed of a polyurethane insulation/shaft and incorporate platinum electrodes. Each device is marked and tracked and will be taken out" of service once the maximum number of cycles has been reached.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
endocardial and intravascular sites
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;
- Mechanical characteristics
- continuity, isolation, resistance;
- Corrosion resistance.
- Cleaning :
- protein, total organic carbon
- visual inspection under magnification; and
- Cleaning qualification.
- Biocompatibility:
- sensitization;
- irritation;
- acute systemic toxicity;
- materials-mediated pyrogen;
- complement activation;
- thrombosis; and.
- hemocompatibility.
- Packaging and shelf life validation.
- Sterilization validation:
- bioburden;
- ethylene oxide/ ethylene chlorohydrin residuals;
- bacteriostasis/fungistasis; and
- endotoxin.
- Product stability
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 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 includes the letters "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font size.
September 14, 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: K241156
Trade/Device Name: Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme 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: August 19, 2024 Received: August 19, 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.
1
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" (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 QS 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 Rule"). 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-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-regulatory
2
assistance/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
3
The item numbers included in the scope of this submission are as follows:
| OEM
Part No. | Description | Electrodes
(Qty.) | Electrode
Spacing
(mm) | Curve | Size
(diameter/length) | |
|-------------------------------------|-------------------------|----------------------|------------------------------|---------|----------------------------|--|
| | | | Response Catheter Models | | | |
| 401150 | Decapolar | 10 | 2-10-2 | CRD™ | 6 Fr, 120 cm | |
| 401206 | Quadripolar | 4 | 10 | CRD™ | 5 Fr, 120 cm | |
| 401207 | Quadripolar | 4 | 10 | JSN™ | 5 Fr, 120 cm | |
| 401210 | Quadripolar | 4 | 10 | CRD™ | 6 Fr, 120 cm | |
| 401211 | Quadripolar | 4 | 10 | JSN™ | 6 Fr, 120 cm | |
| 401212 | Quadripolar | 4 | 10 | DAO ™ | 6 Fr, 120 cm | |
| 401222 | Quadripolar | 4 | 5 | CRD™ | 5 Fr, 120 cm | |
| 401223 | Quadripolar | 4 | 5 | JSN™ | 5 Fr, 120 cm | |
| 401226 | Quadripolar | 4 | 5 | CRD™ | 6 Fr, 120 cm | |
| 401227 | Quadripolar | 4 | 5 | JSN™ | 6 Fr, 120 cm | |
| 401228 | Quadripolar | 4 | 5 | DAO™ | 6 Fr, 120 cm | |
| 401260 | Quadripolar | 4 | 2-5-2 | CRD™ | 6 Fr, 120 cm | |
| 401261 | Quadripolar | 4 | 2-5-2 | JSN™ | 6 Fr, 120 cm | |
| 401271 | Hexapolar | 6 | 2-5-2 | JSN™ | 6 Fr, 120 cm | |
| 401305 | Decapolar | 10 | 2-5-2 | CRD™ | 6 Fr, 120 cm | |
| 401306 | Decapolar | 10 | 2-5-2 | JSN™ | 6 Fr, 120 cm | |
| 401309 | Decapolar | 10 | 2-5-2 | JSN™ | 6 Fr, 65 cm | |
| 401310 | Decapolar | 10 | 2-5-2 | DAO™ | 6 Fr, 65 cm | |
| 401311 | Decapolar | 10 | 2-2-2 | CRD™ | 6 Fr, 120 cm | |
| 401312 | Decapolar | 10 | 2-2-2 | JSN™ | 6 Fr, 120 cm | |
| 401317 | Bipolar | 2 | 10 | CRD™ | 6 Fr, 120 cm | |
| 401353 | Decapolar | 10 | 2-8-2 | CSL™ | 6 Fr, 65 cm | |
| 401357 | Quadripolar | 4 | 5 | JSN-1 ™ | 6 Fr, 120 cm | |
| 401381 | Decapolar | 10 | 2-8-2 | CSL ™ | 6 Fr, 120 cm | |
| 401392 | Decapolar | 10 | 2-2-2 | CSL ™ | 6 Fr, 120 cm | |
| 401399 | Decapolar | 10 | 5-5-5 | CSL™ | 6 Fr, 120 cm | |
| 401400 | Decapolar | 10 | 5-5-5 | CSL ™ | 6 Fr, 65 cm | |
| 401425 | Hexapolar | 6 | 5-5-5-150-5 | CRD™ | 6 Fr, 120 cm | |
| OEM
Part No. | Description | Electrodes
(Qty.) | Electrode
Spacing (mm) | Curve | Size (diameter,
length) | |
| | Supreme Catheter Models | | | | | |
| 401430 | Quadripolar | 4 | 5 | JSN™ | 6 Fr, 120 cm | |
| 401433 | Quadripolar | 4 | 10 | CRD™ | 5 Fr, 120 cm | |
| 401434 | Quadripolar | 4 | 10 | CRD™ | 6 Fr, 120 cm | |
| 401435 | Quadripolar | 4 | 10 | JSN™ | 5 Fr, 120 cm | |
| 401436 | Quadripolar | 4 | 10 | JSN™ | 6 Fr, 120 cm | |
| 401438 | Quadripolar | 4 | 10 | DAO™ | 6 Fr, 120 cm | |
| 401441 | Quadripolar | 4 | 5 | CRD™ | 5 Fr, 120 cm | |
| 401442 | Quadripolar | 4 | 5 | CRD™ | 6 Fr, 120 cm | |
| 401443 | Quadripolar | 4 | 5 | JSN™ | 5 Fr, 120 cm | |
| 401444 | Quadripolar | 4 | 5 | DAO™ | 5 Fr, 120 cm | |
| 401445 | Quadripolar | 4 | 5 | DAO™ | 6 Fr, 120 cm | |
| 401448 | Quadripolar | 4 | 2-5-2 | CRD™ | 5 Fr, 120 cm | |
| 401449 | Quadripolar | 4 | 2-5-2 | CRD™ | 6 Fr, 120 cm | |
| 401450 | Quadripolar | 4 | 2-5-2 | JSN™ | 5 Fr, 120 cm | |
| 401451 | Quadripolar | 4 | 2-5-2 | JSN™ | 6 Fr, 120 cm | |
| 401453 | Quadripolar | 4 | 2-5-2 | DAO™ | 6 Fr, 120 cm | |
| 401466 | Quadripolar | 4 | 5 | DAO-1™ | 5 Fr, 120 cm | |
| 401468 | Quadripolar | 4 | 2-5-2 | DAO-1™ | 5 Fr, 120 cm | |
| 401474 | Quadripolar | 4 | 5 | CRD-1™ | 6 Fr, 120 cm | |
| 401475 | Quadripolar | 4 | 5 | JSN-1™ | 6 Fr, 120 cm | |
| 401859 | Quadripolar | 4 | 10 | CRD-2™ | 5 Fr, 120 cm | |
| 401860 | Quadripolar | 4 | 5 | CRD-2™ | 5 Fr, 120 cm | |
| 401863 | Decapolar | 10 | 2-8-2 | CSL™ | 5 Fr, 120 cm | |
| 401864 | Decapolar | 10 | 2-8-2 | CSL™ | 5 Fr, 65 cm | |
| 401865 | Decapolar | 10 | 5-5-5 | CSL™ | 5 Fr, 120 cm | |
| 401876 | Hexapolar | 6 | 5-5-5-175-175 | CRD-1™ | 6 Fr, 120 cm | |
| 401877 | Hexapolar | 6 | 5-5-5-175-175 | JSN™ | 6 Fr, 120 cm | |
| 401878 | Hexapolar | 6 | 5-5-5-175-175 | JSN™ | 5 Fr, 120 cm | |
| 401890 | Quadripolar | 4 | 5-5-5 | JSN™ | 4 Fr, 120 cm | |
| 401891 | Quadripolar | 4 | 5-5-5 | CRD™ | 4 Fr, 120 cm | |
| 401892 | Quadripolar | 4 | 5-5-5 | DAO™ | 4 Fr, 120 cm | |
| 401893 | Decapolar | 10 | 2-8-2 | CSL™ | 4 Fr, 65 cm | |
| OEM
Part No. | Description | Electrodes
(Qty.) | Electrode
Spacing (mm) | Curve | Size (diameter,
length) | |
| Supreme Catheter Models (concluded) | | | | | | |
| 401966 | Hexapolar | 6 | 5-5-5 | CRD-2™ | 4 Fr, 120 cm | |
| 401967 | Hexapolar | 6 | 2-2-2 | CRD-2™ | 4 Fr, 120 cm | |
| 401979 | Decapolar | 10 | 2-5-2 | CSL™ | 4 Fr, 65 cm | |
| 401994 | Quadripolar | 4 | 2-5-2 | JSN™ | 4 Fr, 120 cm | |
| 401996 | Quadripolar | 4 | 2-5-2 | CRD™ | 4 Fr, 120 cm | |
| 402004 | Quadripolar | 4 | 5 | CRD-2™ | 6 Fr, 120 cm | |
| 402008 | Hexapolar | 6 | 2-5-2 | CRD-2™ | 5 Fr, 120 cm | |
| 402009 | Hexapolar | 6 | 5-5-5 | CRD-2™ | 5 Fr, 120 cm | |
| 402010 | Hexapolar | 6 | 2-5-2 | CRD-2™ | 6 Fr, 120 cm | |
| 402011 | Hexapolar | 6 | 5-5-5 | CRD-2™ | 6 Fr, 120 cm | |
| 402012 | Quadripolar | 4 | 5-5-5 | CRD-2™ | 4 Fr, 120 cm | |
4
5
6
Indications for Use
510(k) Number (if known) K241156
Device Name
Medine ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology Catheter
Indications for Use (Describe)
The Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheters and Supreme Electrophysiology Catheters can be used in the evaluation of a variety of cardiac arrhythmia from endocardial and intravascular sites.
| 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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7
Image /page/7/Picture/1 description: The image contains the logo for Medline Renewal Full Circle Reprocessing. The Medline logo is on the left side of the image and consists of a blue square with a white star inside. To the right of the Medline logo is the word "Renewal" in green and blue lettering. Below the word "Renewal" is the phrase "Full Circle Reprocessing" in a smaller, blue font.
Traditional 510(k) Notification Medline ReNewal Reprocessed SJM Supreme and Response EP Catheters
510(k) 241156
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, Quality Assurance/Regulatory Affairs
P: 541-516-4205 • F: 541-923-3375 • smays@medline.com | | | |
| Date Prepared | April 25, 2024 | | | |
| Device Name
and
Classification | Proprietary/Trade
Name: | Medline ReNewal Reprocessed St. Jude Medical Response
Electrophysiology Catheter, Supreme Electrophysiology 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 | | |
| | Predicate
selection rationale | The predicate models in K151622 include the subject
device models of this submission. | | |
| | 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 | 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 | St. Jude Medical,
14901 DeVeau Place, Minnetonka, MN 55345 | | |
| Reference
Device | Reference device
rationale | Reference and proposed devices share original
equipment manufacturer, predicate device, similar
materials, indications for use, intended use, and
processes. | | |
| | 510(k) Number | K221067 | | |
8
Image /page/8/Picture/1 description: The image contains the logo for Medline Renewal Full Circle Reprocessing. The Medline logo is on the left side of the image and consists of a blue square with a white cross inside. To the right of the Medline logo is the word "Renewal" in large, bold, green letters. Below the word "Renewal" is the phrase "Full Circle Reprocessing" in smaller, blue letters.
Traditional 510(k) Notification
Medline ReNewal Reprocessed SJM Supreme and Response EP Catheters
| | Proprietary or
Trade Name | Medline ReNewal Reprocessed St. Jude Medical
Livewire Steerable Electrophysiology Catheter |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| | Common or Usual
Name | Catheter, recording, or probe electrode recording |
| | Regulatory
Name/Reference | Electrode recording catheter or electrode recording
probe/21 CFR § 870.1220 |
| Reference
device
concluded | Regulatory Class | 2 |
| | Product Code | NLH |
| | Panel | Cardiovascular |
| | 510(k) applicant | Surgical Instrument Service and Savings (dba
Medline ReNewal)
1500 NE Hemlock Ave., Redmond, OR 97756 |
| Device
Description/
Intended Use | Medline ReNewal Reprocessed St. Jude Medical Supreme and Response
Electrophysiology Catheters are commonly placed at the high right atrium,
right ventricular apex and His bundle, and in the coronary sinus, and are
used for electrogram recording and cardiac stimulation during diagnostic
electrophysiology studies. The Medline ReNewal Reprocessed St. Jude
Medical Supreme and Response Electrophysiology Catheters are fixed
electrode catheters constructed of a polyurethane insulation/shaft and
incorporate platinum electrodes.
Each device is marked and tracked and will be taken out" of service once
the maximum number of cycles has been reached. | |
| Indications for
Use | The Medline ReNewal Reprocessed St. Jude Medical Response
Electrophysiology Catheters and Supreme Electrophysiology Catheters can
be used in the evaluation of a variety of cardiac arrhythmia from
endocardial and intravascular sites. | |
| 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
Supreme and Response predicate devices. K151622 was used as the
primary predicate to support intended use, technological characteristics,
and functional performance specifications. K221067 was used as a
reference device to further demonstrate substantial equivalency. | |
| 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;
● Mechanical characteristics
● continuity, isolation, resistance;
● Corrosion resistance.
● Cleaning :
● protein, total organic carbon
● visual inspection under magnification; and
● Cleaning qualification.
● Biocompatibility:
| |
9
Image /page/9/Picture/1 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 inside. The words "ReNewal" are in large green and blue letters, and the words "Full Circle Reprocessing" are in smaller blue letters below the word Renewal.
Traditional 510(k) Notification
Medline ReNewal Reprocessed SJM Supreme and Response EP Catheters
- sensitization; ●
- irritation;
- acute systemic toxicity; ●
- materials-mediated pyrogen;
- complement activation; ●
- thrombosis; and .
- hemocompatibility .
- Packaging and shelf life validation .
- Sterilization validation: ●
- bioburden; ●
- ethylene oxide/ ethylene chlorohydrin residuals; ●
- bacteriostasis/fungistasis; and
- . endotoxin
- Product stability
Summary Table: Predicate, Reference and Proposed Device Comparison Chart
| PREDICATE
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 | REFERENCE
Medline ReNewal
Reprocessed St. Jude
Medical Livewire
Steerable
Electrophysiology
Catheter | PROPOSED
Medline ReNewal
Reprocessed St. Jude
Medical Supreme and
Response
Electrophysiology
Catheters | Comparison |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510(k) number | | | |
| K151622 | K221067 | K241156 | N/A |
| Model number | | | |
| 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 | 401150, 401206, 401207,
401210, 401211, 401212,
401222, 401223, 401226,
401227, 401228, 401260,
401261, 401271, 401305,
401306, 401309, 401310,
401311, 401312, 401317,
401353, 401357, 401381,
401392, 401399, 401400,
401425, 401430, 401433,
401434, 401435, 401436,
401438, 401441, 401442,
401445, 401443, 401444 | Same |
| | | | |
| | 401448, 401449, 401450,
401451, 401453, 401466,
401468, 401474, 401475,
401859, 401860, 401863,
401864, 401865, 401876,
401877, 401878, 401890,
401891, 401892, 401893,
401966, 401967, 401979,
401994, 401996, 402004,
402008, 402009, 402010,
402011, 402012 | | |
| | Classification Name | | |
| Catheter, electrode
recording, or probe
electrode recording | Catheter, recording,
electrode recording,
reprocessed | 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 | NLH | NLH | As stated |
| | Indications for Use | | |
| St. Jude Medical
Electrophysiology
Catheters can be used in
the evaluation of a variety
of cardiac arrhythmias
from endocardial and
intravascular sites. | Medline ReNewal
Reprocessed Livewire
Electrophysiology
Catheters can be used in
the evaluation of a variety
of cardiac arrhythmias
from endocardial and
intravascular sites. | Medline ReNewal
Reprocessed St. Jude
Medical Response
Electrophysiology
Catheters and Supreme
Electrophysiology
Catheters can be used in
the evaluation of a variety
of cardiac arrhythmia
from endocardial and
intravascular sites. | Same |
| | Technological Characteristics | | |
| The SJM
Electrophysiology
Supreme and Response
Catheters contain various
fixed curves and
electrode spacings. | The Medline ReNewal
Reprocessed St. Jude
Medical Livewire
Electrophysiology
Catheters contain various
electrode spacings and a
steerable design with a tip
that can be shaped into a
user-desired curve | The Medline ReNewal
Reprocessed St. Jude
Medical Supreme and
Response
Electrophysiology
Catheters contain various
fixed curves and
electrode spacings. | As stated |
| | Reprocessing | | |
| | Each subject catheter is reprocessed no more than one time. Medline ReNewal does not | | |
| | reprocess the Supreme and Response Electrophysiology Catheters of other reprocessors. | | |
| | Conclusion | | |
| | | | |
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Image /page/10/Picture/1 description: The image contains the logo for Medline Renewal Full Circle Reprocessing. The word "Renewal" is in a larger font, with "Re" in green and "newal" in navy blue. Below that is the phrase "Full Circle Reprocessing" in a smaller navy blue font. To the left of the text is the Medline logo, which is a navy blue square with a white cross and the word "MEDLINE" in white.
Traditional 510(k) Notification Medline ReNewal Reprocessed SJM Supreme and Response EP Catheters
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Image /page/11/Picture/1 description: The image is a logo for Medline Renewal Full Circle Reprocessing. The Medline logo is on the left side of the image and is a blue square with a white star and the word "MEDLINE" in white letters. To the right of the Medline logo is the word "Renewal" in large 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 SJM Supreme and Response EP Catheters
The predicate, reference 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 Supreme and Response Electrophysiology Catheters within the scope of this submission are substantially equivalent to the predicate device.