(33 days)
The SterilMed Reprocessed Electrophysiological Diagnostic Catheters are intended for temporary use during electrophysiology studies for intracardiac sensing, recording, and stimulation. They also provide temporary pacing for the evaluation of cardiac arrhythmias, and are used for electrophysiology mapping of cardiac structures during these evaluations.
The subject device consists of a reprocessed catheter that has a high-torque shaft with a handle at the proximal end, and is steerable. These catheters have an outer diameter of 5F to 7F, a length ranging from 85 to 125 cm, with 4-20 platinum/iridium, radiopaque electrodes along the tip shaft and a variety of inter-electrode spacings and curve styles at the tip. The tip is deflectable. Specific cables, as recommended by the original manufacturer, connect to the handle and interface between the catheter and an external stimulator and/or an electrophysiologic recorder. It should be noted that this submission pertains to the catheter only. It does not include any other components in a system such as, connector cables, external stimulators, or electrophysiologic recorders.
Here's a breakdown of the acceptance criteria and study information for the SterilMed Reprocessed Deflectable Electrophysiology Diagnostic Catheters, based on the provided text:
Important Note: This document (K051220) is a 510(k) summary for a reprocessed device. 510(k)s primarily focus on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness or specific performance metrics against clinical acceptance criteria as would be typical for a de novo device or a significantly modified device. Therefore, the "acceptance criteria" here are geared towards demonstrating the reprocessed device is as safe and effective as the original, not establishing new clinical performance benchmarks. The study described focuses on functional and safety aspects, not clinical performance with human readers or standalone AI algorithms.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly) | Reported Device Performance |
|---|---|---|
| Functional Characteristics | Appropriate functional performance after reprocessing (e.g., steerability, electrical conductivity, tip deflection, electrode integrity) | "Representative samples... underwent design testing to demonstrate appropriate functional characteristics." |
| Biocompatibility | Compatibility of device materials after reprocessing (no new patient risks from materials) | "Biocompatibility testing to demonstrate compatibility of the device materials." |
| Manufacturing Process Quality | Visual integrity and functional performance of all individual reprocessed units | "The manufacturing process includes visual and functional testing of all products produced." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "Representative samples of reprocessed deflectable electrophysiology diagnostic catheters" were used. A specific number is not provided in this summary.
- Data Provenance: Not explicitly stated, but given it's a reprocessed device, the testing would involve commercially available used devices that then undergo the reprocessing cycle. The testing itself would be prospective in nature relative to the reprocessing process. The country of origin for the data is implicitly the United States, as the filing is with the FDA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not Applicable / Not Provided. This type of information is generally relevant for studies involving subjective assessments (e.g., image interpretation) where expert consensus establishes a "ground truth." For functional and biocompatibility testing of a medical device like a catheter, the "ground truth" is defined by objective engineering specifications and scientific testing methods, not by expert interpretation in the same way. The individuals conducting the testing would be qualified engineers, technicians, and scientists.
4. Adjudication Method for the Test Set
- Not Applicable / Not Provided. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human interpreters or reviewers to establish a consensus ground truth. As mentioned above, the testing here is objective functional and biocompatibility testing, not interpretative.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study was not conducted nor is it applicable to this device. This device is a reprocessed electrophysiology catheter, which is a physical medical instrument. MRMC studies are typically performed for diagnostic imaging devices or AI algorithms that assist human interpretation. There is no "human reader" involved in the "interpretation" of a catheter's function in the way an MRMC study evaluates.
6. Standalone (Algorithm Only) Performance Study
- No. A standalone performance study for an algorithm was not conducted nor is it applicable. This device is a physical medical instrument, not an AI algorithm.
7. Type of Ground Truth Used
- The ground truth for the functional testing was based on engineering specifications and performance parameters expected of a new, equivalent electrophysiology diagnostic catheter.
- The ground truth for biocompatibility was based on established biocompatibility standards and tests (e.g., ISO 10993 series) for medical device materials.
- The ground truth for manufacturing process quality was based on internal quality control specifications for visual and functional attributes.
8. Sample Size for the Training Set
- Not Applicable. This document describes a reprocessed medical device, not an AI or machine learning model that would require a "training set." The focus is on verifying the physical device's performance after reprocessing.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for an AI/ML model, this question is not relevant to this submission.
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K051220
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SECTION 3. 510(K) SUMMARY
JUN 1 4 2005
| Submitter: | SterilMed, Inc.11400 73rd Avenue NorthMinneapolis, MN 55369 |
|---|---|
| Contact Person: | Dr. Bruce LesterVP Research and DevelopmentPhone: (888) 856-4870Fax: (763) 488-3350blester@sterilmed.com |
| Date Prepared: | May 11, 2005 |
| Trade Name: | SterilMed Reprocessed Deflectable ElectrophysiologyDiagnostic Catheters |
| Classification Nameand Number: | Electrode Recording CatheterClass II, 21 CFR 870.1220 |
| Product Code: | NLH |
| Predicate Device: | SterilMed Reprocessed Deflectable ElectrophysiologyDiagnostic Catheters (K043513) |
| Device Description: | The subject device consists of a reprocessed catheter that has ahigh-torque shaft with a handle at the proximal end, and issteerable. These catheters have an outer diameter of 5F to 7F, alength ranging from 85 to 125 cm, with 4-20 platinum/iridium,radiopaque electrodes along the tip shaft and a variety of inter-electrode spacings and curve styles at the tip. The tip isdeflectable. Specific cables, as recommended by the originalmanufacturer, connect to the handle and interface between thecatheter and an external stimulator and/or an electrophysiologicrecorder. It should be noted that this submission pertains to thecatheter only. It does not include any other components in asystem such as, connector cables, external stimulators, orelectrophysiologic recorders. |
| Intended Use: | The SterilMed Reprocessed Electrophysiology DiagnosticCatheters are intended for temporary use duringelectrophysiology studies for intracardiac sensing, recording,and stimulation. They also provide temporary pacing for theevaluation of cardiac arrhythmias, and are used forelectrophysiology mapping of cardiac structures during theseevaluations. |
| Functional andSafety Testing: | Representative samples of reprocessed deflectableelectrophysiology diagnostic catheters underwent design testingto demonstrate appropriate functional characteristics, andbiocompatibility testing to demonstrate compatibility of thedevice materials. Process validation testing wa |
| addition, | the manufacturing process includes visual and functional testing of all products produced. |
| Conclusion: | The new models of deflectable electrophysiology diagnostic catheters reprocessed by SterilMed are substantially equivalent to the models in the original 510(k). This conclusion is based upon the fact that the modified devices have the same fundamental scientific technology and intended use as the predicate device. |
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure with outstretched arms. The symbol is composed of three curved lines that create a sense of movement and dynamism.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 4 2005
SterilMed, Inc. Bruce Lester, Ph.D. Vice President Research and Development 11400 73td Avenue North Minneapolis, MN 55369
Re: K051220
Trade Name: Sterilmed Reprocessed Deflectable Electrophysiology Diagnostic Catheters (See Enclosed List) Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: NLH Dated: May 11, 2005 Received: May 12, 2005
Dear Dr. Lester:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Bruce Lester, Ph.D.
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Bhimmon for
Bran D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 3 – Bruce Lester, Ph.D.
List of Model numbers
| Daig Livewire™ Electrophysiology Catheter | |||
|---|---|---|---|
| 401938 | 401606 | 401578 | 401581 |
| 401939 | 401933 | 401579 | 401917 |
| 401940 | 401934 | 401583 | 401582 |
| 401941 | 401575 | 401584 | 401904 |
| 401990 | 401915 | 401585 | 401905 |
| 401991 | 401923 | 401586 | 401914 |
| 401600 | 401926 | 401587 | 401908 |
| 401603 | 401576 | 401588 | - |
| 401572 | 401577 | 401580 | - |
| EPT Polaris DX TM Steerable Diagnostic Catheter | EPT Polaris DX TM Steerable Diagnostic Catheter Shielded Connector |
|---|---|
| 5570 | 5570S |
| 5571 | 5571S |
| 5572 | 5572S |
| 5573 | 5573S |
| 5574 | 5574S |
| 5575 | 5575S |
| 5576 | 5576S |
| 5577 | 5577S |
| 5578 | 5578S |
| 5579 | 5579S |
| 9663 | 9663S |
| 5427 | 5427S |
| EPT Polaris XTTM Steerable Decapolar Mapping Catheter | |
| 7000D | |
| 7001D | |
| 7003D | |
| 7004D | |
| 7005D | |
| 7006D | |
| EPT Polaris LETM Mapping Catheter | EPT Polaris LETM Mapping Catheter Shielded Connector |
| 5590 | 5590S |
| 5591 | 5591S |
| 5592 | 5592S |
| 5593 | 5593S |
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Page 4 – Bruce Lester, Ph.D.
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and the comments of the comments of the comments of
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| Bard EP-XT Steerable Catheter | |
|---|---|
| 200769 | 200771 |
| 200770 | 201009 |
| 201116 | 200740 |
| 200737 | 200738 |
| 200735 | 200739 |
| 200898 | 200736 |
| 200525 | 200794 |
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INDICATIONS FOR USE SECTION 2:
510(k) Number (if known):
Reprocessed Deflectable Electrophysiology Diagnostic Catheters Device Name:
Indications For Use:
The SterilMed Reprocessed Electrophysiological Diagnostic Catheters are intended for temporary use during electrophysiology studies for intracardiac sensing, recording, and stimulation. They also provide temporary pacing for the evaluation of cardiac arrhythmias, and are used for electrophysiology mapping of cardiac structures during these evaluations.
Prescription Use X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Вватимиров
vision Sian-Off Division of Cardiovascular Devices 510(k) Number
Page 1 of 1
§ 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).