(378 days)
The Medline ReNewal Reprocessed Supreme and Response Electrophysiology Catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
Medline ReNewal Reprocessed St. Jude 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 electrophysiology catheters are manufactured in various fixed curves and electrode spacings for electrophysiological mapping for the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text.
It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than proving independent efficacy or safety through clinical trials typically associated with AI/software devices. Therefore, the "study" described herein is a series of performance tests to show the reprocessed device functions similarly to the original predicate device. It does not involve human readers, AI assistance, or complex ground truth establishment in the way AI/ML devices do.
Acceptance Criteria and Device Performance Study for Medline ReNewal Reprocessed Supreme and Response Electrophysiology Catheters (K161272)
This document describes the regulatory submission for reprocessed electrophysiology catheters, not an AI or software device. The "acceptance criteria" and "study" are therefore focused on the physical and functional performance of the reprocessed medical devices, demonstrating that they are substantially equivalent to their original, legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various performance tests conducted to demonstrate substantial equivalence. It implies that the test results met the internal acceptance criteria for each test, thereby proving the reprocessed device performs as intended and is equivalent to the predicate. Specific numerical acceptance criteria values are not explicitly stated in this summary document, but the statement "found to be substantially equivalent to the predicate device based on the following tests" implies successful completion against pre-defined criteria.
| Test Category | Specific Tests Conducted | Reported Device Performance |
|---|---|---|
| Functional Performance | Simulated use and artificial soiling | Met acceptance criteria (implied by "found to be substantially equivalent") |
| Bond strength (tensile testing) | Met acceptance criteria (implied) | |
| Torsional strength | Met acceptance criteria (implied) | |
| Leakage current | Met acceptance criteria (implied) | |
| Catheter/handle joint flexibility and continuity (flex fatigue) | Met acceptance criteria (implied) | |
| Electrode adherence | Met acceptance criteria (implied) | |
| Shaft flexibility | Met acceptance criteria (implied) | |
| Tip buckling | Met acceptance criteria (implied) | |
| Direct current resistance | Met acceptance criteria (implied) | |
| Impedance at 5 kHz | Met acceptance criteria (implied) | |
| Corrosion resistance | Met acceptance criteria (implied) | |
| Cleaning | Protein, total organic carbon, and endotoxins | Met acceptance criteria (implied) |
| Visual inspection under magnification | Met acceptance criteria (implied) | |
| Cleaning performance qualification | Met acceptance criteria (implied) | |
| Biocompatibility | Cytotoxicity | Met acceptance criteria (implied) |
| Sensitization | Met acceptance criteria (implied) | |
| Irritation | Met acceptance criteria (implied) | |
| Acute systemic toxicity | Met acceptance criteria (implied) | |
| Pyrogenicity | Met acceptance criteria (implied) | |
| Hemocompatibility (hemolysis, thrombogenicity, & complement activation) | Met acceptance criteria (implied) | |
| Other | Packaging and shelf life validation | Met acceptance criteria (implied) |
| Sterilization validation (bioburden testing; ethylene oxide and ethylene chlorohydrin residuals) | Met acceptance criteria (implied) | |
| Product stability | Met acceptance criteria (implied) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of reprocessed catheters used for each test. Medical device testing typically involves statistically significant sample sizes to ensure reliability, but these specific numbers are not disclosed in this summary.
- Data Provenance: The testing was performed internally by the manufacturer, Medline ReNewal, based in Redmond, Oregon, USA. The data is prospective in the sense that the tests were conducted specifically for this 510(k) submission on reprocessed devices. The "origin" of the devices themselves would be from healthcare facilities where they were initially used, then collected by Mecline ReNewal for reprocessing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Given this is a physical medical device (catheter) rather than a diagnostic AI/ML device, the concept of "ground truth" and "experts" in the context of interpreting medical images is not directly applicable. The "ground truth" here is established through objective engineering and laboratory measurements against predefined specifications and comparisons to the performance of the predicate device. The experts involved would be engineers, scientists, and quality assurance personnel with expertise in medical device testing, materials science, biocompatibility, and sterilization, rather than clinical experts like radiologists. The number and specific qualifications of these personnel are not detailed in this public summary.
4. Adjudication Method for the Test Set
Not applicable in the context of physical medical device performance testing. Results are generated through objective measurement and comparison to specifications, not through human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI/ML or diagnostic imaging device. Its function is to perform electrophysiology procedures, and the study focuses on its physical and functional equivalence to a predicate catheter.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is not an algorithm. The "performance" is of the physical device itself.
7. Type of Ground Truth Used
The "ground truth" is based on objective, quantitative measurements of the catheter's physical and functional properties (e.g., tensile strength, leakage current, resistance, biocompatibility characteristics, cleanliness) compared against:
- Engineering specifications.
- Performance characteristics of the original, new predicate device.
- Relevant industry standards (e.g., for sterilization, biocompatibility).
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem is a stylized representation of three human profiles facing right, layered on top of each other. The profiles are connected and form a single, flowing shape.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 18, 2017
Medline ReNewal Brandi Panteleon Director, Quality Assurance and Regulatory Affairs 2747 SW 6th St. Redmond, Oregon 97756
Re: K161272
Trade/Device Name: Medline ReNewal Reprocessed Supreme and Response Electrophysiology Catheters Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: NLH Dated: May 12, 2017 Received: May 16, 2017
Dear Brandi Panteleon:
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
M.A. Willemsen
for
for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| Table 1a: K161272 List of Models in ScopeSupreme EP Catheters | ||||
|---|---|---|---|---|
| Manufacturer Model No. | Electrodes | Spacing | Curve | Size |
| 401430 | 4 | 5 | JSNa | 6 Fr x 120 cm |
| 401433 | 4 | 10 | CRDb | 5 Fr x 120 cm |
| 401434 | 4 | 10 | CRD | 6 Fr x 120 cm |
| 401435 | 4 | 10 | JSN | 5 Fr x 120 cm |
| 401436 | 4 | 10 | JSN | 6 Fr x 120 cm |
| 401438 | 4 | 10 | DAOc | 6 Fr x 120 cm |
| 401441 | 4 | 5 | CRD | 5 Fr x 120 cm |
| 401442 | 4 | 5 | CRD | 6 Fr x 120 cm |
| 401443 | 4 | 5 | JSN | 5 Fr x 120 cm |
| 401444 | 4 | 5 | DAO | 5 Fr x 120 cm |
| 401445 | 4 | 5 | DAO | 6 Fr x 120 cm |
| 401448 | 4 | 2-5-2 | CRD | 5 Fr x 120 cm |
| 401449 | 4 | 2-5-2 | CRD | 6 Fr x 120 cm |
| 401450 | 4 | 2-5-2 | JSN | 5 Fr x 120 cm |
| 401451 | 4 | 2-5-2 | JSN | 6 Fr x 120 cm |
| 401453 | 4 | 2-5-2 | DAO | 6 Fr x 120 cm |
| 401466 | 4 | 5 | DAO-1d | 5 Fr x 120 cm |
| 401468 | 4 | 2-5-2 | DAO-1 | 5 Fr x 120 cm |
| 401474 | 4 | 5 | CRD-1e | 6 Fr x 120 cm |
| 401475 | 4 | 5 | JSN-1f | 6 Fr x 120 cm |
| 401859 | 4 | 10 | CRD-2g | 5 Fr x 120 cm |
| 401860 | 4 | 5 | CRD-2 | 5 Fr x 120 cm |
| 401863 | 10 | 2-8-2 | CSLh | 5 Fr x 120 cm |
| 401864 | 10 | 2-8-2 | CSL | 5 Fr x 65 cm |
| 401865 | 10 | 5-5-5 | CSL | 5 Fr x 120 cm |
| 401871 | 4 | 2 | CRD-1 | 5 Fr x 120 cm |
| 401872 | 6 | 2-2-2 | CRD-1 | 5 Fr x 120 cm |
| 401876 | 6 | 5-5-5-175-175 | CRD-1 | 6 Fr x 120 cm |
| 401877 | 6 | 5-5-5-175-175 | JSN | 6 Fr x 120 cm |
| 401878 | 6 | 5-5-5-175-175 | JSN | 5 Fr x 120 cm |
| 401950 | 4 | 5 | CRD | 6 Fr x 120 cm |
| 401951 | 4 | 5 | JSN | 6 Fr x 120 cm |
| 401952 | 4 | 10 | CRD | 6 Fr x 120 cm |
| 401956 | 2 | 10 | CRD | 6 Fr x 120 cm |
| 401957 | 2 | 10 | CRD | 5 Fr x 120 cm |
| 402004 | 4 | 5 | CRD-2 | 6 Fr x 120 cm |
| 402008 | 6 | 2-5-2 | CRD-2 | 5 Fr x 120 cm |
| 402009 | 6 | 5-5-5 | CRD-2 | 5 Fr x 120 cm |
| 402010 | 6 | 2-5-2 | CRD-2 | 6 Fr x 120 cm |
| 402011 | 6 | 5-5-5 | CRD-2 | 6 Fr x 120 cm |
| Table 1b: K161272 List of Models in ScopeResponse EP Catheters | ||||
| Manufacturer Model No. | Electrodes | Spacing | Curve Size | |
| 401150 | 6 | 2-1-1-10-1-1-1-1-1- | CRD 6 Fr x 120 cm | |
| 401154 | 4 | 5 | CRD 6 Fr x 120 cm | |
| 401155 | 4 | 5 | JSN 6 Fr x 120 cm | |
| 401156 | 4 | 5 | DAO-1 6 Fr x 120 cm | |
| 401158 | 4 | 10 | CRD 6 Fr x 120 cm | |
| 401206 | 4 | 10 | CRD 5 Fr x 120 cm | |
| 401207 | 4 | 10 | JSN 5 Fr x 120 cm | |
| 401210 | 4 | 10 | CRD 6 Fr x 120 cm | |
| 401211 | 4 | 10 | JSN 6 Fr x 120 cm | |
| 401212 | 4 | 10 | DAO 6 Fr x 120 cm | |
| 401222 | 4 | 5 | CRD 5 Fr x 120 cm | |
| 401223 | 4 | 5 | JSN 5 Fr x 120 cm | |
| 401226 | 4 | 5 | CRD 6 Fr x 120 cm | |
| 401227 | 4 | 5 | JSN 6 Fr x 120 cm | |
| 401228 | 4 | 5 | DAO 6 Fr x 120 cm | |
| 401260 | 4 | 2-5-2 | CRD 6 Fr x 120 cm | |
| 401261 | 4 | 2-5-2 | JSN 6 Fr x 120 cm | |
| 401271 | 6 | 2-5-2 | JSN 6 Fr x 120 cm | |
| 401275 | 6 | 2-2-2 | CRD 6 Fr x 120 cm | |
| 401276 | 6 | 2-2-2 | JSN 6 Fr x 120 cm | |
| 401278 | 6 | 2-2-2 | CRD 6 Fr x 120 cm | |
| 401282 | 6 | 5-5-5 | JSN 6 Fr x 120 cm | |
| 401305 | 10 | 2-5-2 | CRD 6 Fr x 120 cm | |
| 401306 | 10 | 2-5-2 | JSN 6 Fr x 65 cm | |
| 401308 | 10 | 2-5-2 | CRD 6 Fr x 120 cm | |
| 401309 | 10 | 2-5-2 | JSN 6 Fr x 120 cm | |
| 401310 | 10 | 2-5-2 | DAO 6 Fr x 120 cm | |
| 401311 | 10 | 2-2-2 | CRD 6 Fr x 120 cm | |
| 401312 | 10 | 2-2-2 | JSN 6 Fr x 120 cm | |
| 401317 | 2 | 10 | CRD 6 Fr x 120 cm | |
| 401318 | 2 | 10 | JSN 6 Fr x 120 cm | |
| 401353 | 10 | 2-8-2 | CSL 6 Fr x 120 cm | |
| 401356 | 4 | 5 | CRD-1 6 Fr x 120 cm | |
| 401357 | 4 | 5 | JSN-1 6 Fr x 120 cm | |
| 401360 | 6 | 2-5-2 | JSN 5 Fr x 120 cm | |
| 401381 | 10 | 2-8-2 | CSL 6 Fr x 120 cm | |
| 401386 | 6 | 5-5-5 | CSL 6 Fr x 120 cm | |
| 401392 | 10 | 2-2-2 | CSL 6 Fr x 120 cm | |
| 401399 | 10 | 5-5-5 | CSL 6 Fr x 120 cm | |
| 401400 | 10 | 5-5-5 | CSL 6 Fr x 120 cm | |
| 401425 | 6 | 5-5-5-150-5 | CRD 6 Fr x 120 cm |
Table 1a: K161272 List of Models in Scope
(List of models continued on next page)
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Table 1b: K161272 List of Models in Scope
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Indications for Use
510(k) Number (if known) K161272
Device Name
Medline ReNewal Reprocessed Supreme and Response Electrophysiology Catheters
Indications for Use (Describe)
The Medline ReNewal Reprocessed Supreme and Response Electrophysiology Catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/5/Picture/0 description: The image contains the logos for Medline and Renewal. The Medline logo is on the left and features the company name in a stylized font with a blue star-like symbol. To the right of the Medline logo is a vertical line, followed by the Renewal logo. The Renewal logo has the word "Renewal" in a combination of green and blue, with the words "Full Circle Reprocessing" underneath in a smaller font.
510(k) Summary — K161272
| Submitter/Owner | Medline ReNewal2747 SW 6th St.Redmond, OR 97756 |
|---|---|
| Contact Name | Brandi PanteleonDirector, Quality Assurance and Regulatory AffairsP: 541-923-3310F: 541-923-3375E: bpanteleon@medline.com |
| Prepared by | Stephanie Boyle MaysRegulatory Affairs SpecialistP: 541-516-4205F: 541-923-3375E: smays@medline.com |
| Date Prepared | May 2, 2015 |
| Device Names | Proprietary Name: Medline ReNewal Reprocessed Supreme and ResponseElectrophysiology CathetersCommon Name: Diagnostic Electrophysiology Catheter, Reprocessed |
| Classification | Classification: Class IIRegulation Number: 21 CFR § 870.1220Product Code: NLH |
| PredicateDevice | K002976 St. Jude Medical Response Electrophysiology Catheter, SupremeElectrophysiology Catheter |
| ReferenceDevice | K151617 Medline ReNewal Reprocessed St. Jude Medical LivewireElectrophysiology Catheters |
| DeviceDescription/Intended Use | Medline ReNewal Reprocessed St. Jude Supreme and ResponseElectrophysiology Catheters are commonly placed at the high right atrium,right ventricular apex and His bundle, and in the coronary sinus, and areused for electrogram recording and cardiac stimulation during diagnosticelectrophysiology studies.The electrophysiology catheters are manufactured in various fixed curvesand electrode spacings for electrophysiological mapping for the evaluationof a variety of cardiac arrhythmias from endocardial and intravascularsites. 1 |
| Indications forUse | The Medline ReNewal Reprocessed Supreme and ResponseElectrophysiology Catheters can be used in the evaluation of a variety ofcardiac arrhythmias from endocardial and intravascular sites. |
l
Device Description and Intended Use were the same category in predicate K002976.
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Image /page/6/Picture/0 description: The image is a logo for Medline Renewal Full Circle Reprocessing. The Medline logo is on the left, and the Renewal Full Circle Reprocessing logo is on the right. The Medline logo is a blue stylized image of a medical symbol. The Renewal logo is in green and blue, and the Full Circle Reprocessing logo is in a smaller font below the Renewal logo.
| TechnologicalCharacteristics | The technological characteristics of the proposed devices and thefundamental scientific technology of the subject device are identical to thepredicate device. The proposed devices are a reprocessed version of thepredicate devices. Only Medline ReNewal reprocesses the MedlineReNewal Reprocessed St. Jude Supreme and Response ElectrophysiologyCatheters. Catheters are reprocessed a maximum of two times. Cathetersare marked and taken out of service after the maximum number of cycles isreached. | ||||
|---|---|---|---|---|---|
| PerformanceTesting | 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: simulated use and artificial soiling; bond strength (tensile testing); torsional strength; leakage current; catheter/handle joint flexibility and continuity (flex fatigue); electrode adherence; shaft flexibility; tip buckling; direct current resistance; impedance at 5 kHz; and corrosion resistance. Cleaning: protein, total organic carbon, and endotoxins; visual inspection under magnification; and cleaning performance qualification. Biocompatibility: cytotoxicity; sensitization; irritation; acute systemic toxicity; pyrogenicity; and hemocompatibility (hemolysis, thrombogenicity; & complement activation). Packaging and shelf life validation; sterilization validation: bioburden testing; and ethylene oxide and ethylene chlorohydrin residuals testing. Product stability | ||||
| Model | Electrodes | Spacing | Curve | Size | |
| 401430 | 4 | 5 | JSN | 6 Fr x 120 cm | |
| 401433 | 4 | 10 | CRD | 5 Fr x 120 cm | |
| 401434 | 4 | 10 | CRD | 6 Fr x 120 cm | |
| Device Models- Supreme | 401435 | 4 | 10 | JSN | 5 Fr x 120 cm |
| 401436 | 4 | 10 | JSN | 6 Fr x 120 cm | |
| 401438 | 4 | 10 | DAO | 6 Fr x 120 cm | |
| 401441 | 4 | 5 | CRD | 5 Fr x 120 cm | |
| 401442 | 4 | 5 | CRD | 6 Fr x 120 cm | |
| 401443 | 4 | 5 | JSN | 5 Fr x 120 cm | |
| Model | Electrodes | Spacing | Curve | Size | |
| 401444 | 4 | 5 | DAO | 5 Fr x 120 cm | |
| 401445 | 4 | 5 | DAO | 6 Fr x 120 cm | |
| 401448 | 4 | 2-5-2 | CRD | 5 Fr x 120 cm | |
| 401449 | 4 | 2-5-2 | CRD | 6 Fr x 120 cm | |
| 401450 | 4 | 2-5-2 | JSN | 5 Fr x 120 cm | |
| 401451 | 4 | 2-5-2 | JSN | 6 Fr x 120 cm | |
| 401453 | 4 | 2-5-2 | DAO | 6 Fr x 120 cm | |
| 401466 | 4 | 5 | DAO-1 | 5 Fr x 120 cm | |
| 401468 | 4 | 2-5-2 | DAO-1 | 5 Fr x 120 cm | |
| 401474 | 4 | 5 | CRD-1 | 6 Fr x 120 cm | |
| 401475 | 4 | 5 | JSN-1 | 6 Fr x 120 cm | |
| 401859 | 4 | 10 | CRD-2 | 5 Fr x 120 cm | |
| 401860 | 4 | 5 | CRD-2 | 5 Fr x 120 cm | |
| 401863 | 10 | 2-8-2 | CSL | 5 Fr x 120 cm | |
| 401864 | 10 | 2-8-2 | CSL | 5 Fr x 65 cm | |
| 401865 | 10 | 5-5-5 | CSL | 5 Fr x 120 cm | |
| 401871 | 4 | 2 | CRD-1 | 5 Fr x 120 cm | |
| 401872 | 6 | 2-2-2 | CRD-1 | 5 Fr x 120 cm | |
| 401876 | 6 | 5-5-5-175-175 | CRD-1 | 6 Fr x 120 cm | |
| 401877 | 6 | 5-5-5-175-175 | JSN | 6 Fr x 120 cm | |
| 401878 | 6 | 5-5-5-175-175 | JSN | 5 Fr x 120 cm | |
| 401950 | 4 | 5 | CRD | 6 Fr x 120 cm | |
| 401951 | 4 | 5 | JSN | 6 Fr x 120 cm | |
| 401952 | 4 | 10 | CRD | 6 Fr x 120 cm | |
| 401956 | 2 | 10 | CRD | 6 Fr x 120 cm | |
| 401957 | 2 | 10 | CRD | 5 Fr x 120 cm | |
| 402004 | 4 | 5 | CRD-2 | 6 Fr x 120 cm | |
| 402008 | 6 | 2-5-2 | CRD-2 | 5 Fr x 120 cm | |
| 402009 | 6 | 5-5-5 | CRD-2 | 5 Fr x 120 cm | |
| 402010 | 6 | 2-5-2 | CRD-2 | 6 Fr x 120 cm | |
| 402011 | 6 | 5-5-5 | CRD-2 | 6 Fr x 120 cm | |
| 401893 | 10 | 2-8-2 | CSL | 5 Fr x 65 cm | |
| Model | Electrodes | Spacing | Curve | Size | |
| 401150 | 10 | 2-1-1-10-1-1-1-1-1- | CRD | 6 Fr x 120 cm | |
| 401154 | 4 | 5 | CRD | 6 Fr x 120 cm | |
| 401155 | 4 | 5 | JSN | 6 Fr x 120 cm | |
| 401156 | 4 | 5 | DAO-1 | 6 Fr x 120 cm | |
| 401158 | 4 | 10 | CRD | 6 Fr x 120 cm | |
| 401206 | 4 | 10 | CRD | 5 Fr x 120 cm | |
| 401207 | 4 | 10 | JSN | 5 Fr x 120 cm | |
| 401210 | 4 | 10 | CRD | 6 Fr x 120 cm | |
| 401211 | 4 | 10 | JSN | 6 Fr x 120 cm | |
| 401212 | 4 | 10 | DAO | 6 Fr x 120 cm | |
| 401222 | 4 | 5 | CRD | 5 Fr x 120 cm | |
| 401223 | 4 | 5 | JSN | 5 Fr x 120 cm | |
| 401226 | 4 | 5 | CRD | 6 Fr x 120 cm | |
| 401227 | 4 | 5 | JSN | 6 Fr x 120 cm | |
| 401228 | 4 | 5 | DAO | 6 Fr x 120 cm | |
| 401260 | 4 | 2-5-2 | CRD | 6 Fr x 120 cm | |
| 401261 | 4 | 2-5-2 | JSN | 6 Fr x 120 cm | |
| 401271 | 6 | 2-5-2 | JSN | 6 Fr x 120 cm | |
| 401275 | 6 | 2-2-2 | CRD | 6 Fr x 120 cm | |
| 401276 | 6 | 2-2-2 | JSN | 6 Fr x 120 cm | |
| 401278 | 6 | 2-2-2 | CRD | 6 Fr x 65 cm | |
| 401282 | 6 | 5-5-5 | JSN | 6 Fr x 120 cm | |
| 401305 | 10 | 2-5-2 | CRD | 6 Fr x 120 cm | |
| 401306 | 10 | 2-5-2 | JSN | 6 Fr x 120 cm | |
| 401308 | 10 | 2-5-2 | CRD | 6 Fr x 65 cm | |
| 401309 | 10 | 2-5-2 | JSN | 6 Fr x 65 cm | |
| 401310 | 10 | 2-5-2 | DAO | 6 Fr x 65 cm | |
| 401311 | 10 | 2-2-2 | CRD | 6 Fr x 120 cm | |
| 401312 | 10 | 2-2-2 | JSN | 6 Fr x 120 cm | |
| 401317 | 2 | 10 | CRD | 6 Fr x 120 cm | |
| 401318 | 2 | 10 | JSN | 6 Fr x 120 cm | |
| 401353 | 10 | 2-8-2 | CSL | 6 Fr x 65 cm | |
| 401356 | 4 | 5 | CRD-1 | 6 Fr x 120 cm | |
| 401357 | 4 | 5 | JSN-1 | 6 Fr x 120 cm | |
| Response(concluded) | Model | Electrodes | Spacing | Curve | Size |
| 401360 | 6 | 2-5-2 | JSN | 5 Fr x 120 cm | |
| 401381 | 10 | 2-8-2 | CSL | 6 Fr x 120 cm | |
| 401386 | 6 | 5-5-5 | CSL | 6 Fr x 120 cm | |
| 401392 | 10 | 2-2-2 | CSL | 6 Fr x 120 cm | |
| 401399 | 10 | 5-5-5 | CSL | 6 Fr x 120 cm | |
| 401400 | 10 | 5-5-5 | CSL | 6 Fr x 65cm | |
| 401425 | 6 | 5-5-5-150-5 | CRD | 6 Fr x 120 cm | |
| Based on comparisons of the indications for use, intended use,technological characteristics, and performance data to the predicatedevices, Medline ReNewal Reprocessed St. Jude Medical Supreme andResponse Electrophysiology Catheters are substantially equivalent to thepredicate device. |
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Image /page/7/Picture/0 description: The image contains the logos for Medline and Renewal. The Medline logo is on the left and features the company name in blue with a stylized blue symbol below it. To the right of the Medline logo is the Renewal logo, with "Re" in green and "Newal" in blue. Below Renewal is the text "Full Circle Reprocessing" in a smaller font size.
Device Models
- Supreme
(concluded)
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Image /page/8/Picture/0 description: The image shows the Medline Renewal logo. The word "Renewal" is in large font, with "Re" in green and "newal" in blue. Below "Renewal" is the phrase "Full Circle Reprocessing" in a smaller font. To the left of the word "Renewal" is the word "Medline" in blue with a blue star below it.
- vice Models Response
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Image /page/9/Picture/0 description: The image shows the Medline Renewal logo. The Medline logo is on the left, and the Renewal logo is on the right. The Medline logo is a blue star with the word "MEDLINE" in blue letters next to it. The Renewal logo is in green and blue letters, with the words "Full Circle Reprocessing" in smaller letters below it.
§ 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).