(71 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 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 80 to 115 cm, with 4-10 platinum, 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.
The provided text describes a 510(k) summary for SterilMed Reprocessed Deflectable Electrophysiology Diagnostic Catheters. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through a standalone study with detailed performance metrics.
Therefore, the requested information elements related to acceptance criteria, detailed study design, ground truth, sample sizes for training/test sets, expert qualifications, and specific performance effect sizes (like MRMC) are not fully available or directly applicable in this type of submission document.
However, I can extract information about the functional and safety testing that was performed to support the substantial equivalence claim.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table with specific quantitative acceptance criteria (e.g., minimum tensile strength, maximum leakage current, etc.) and corresponding reported device performance values. Instead, it broadly states that "Representative samples... underwent design testing to demonstrate appropriate functional characteristics, and biocompatibility testing to demonstrate compatibility of the device materials."
The "reported device performance" is implicitly that the device performs equivalently to the predicate devices, allowing for the conclusion of "substantial equivalence."
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated. The document mentions "Representative samples" were used for testing without specifying the number of units or lot sizes.
- Data Provenance: Not explicitly stated (e.g., country of origin). The testing was conducted by SterilMed, Inc. (Minneapolis, MN, USA).
- Retrospective or Prospective: Not applicable. The testing described is functional and safety testing of the reprocessed devices themselves, not a clinical study on patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable. Ground truth as typically defined for AI/diagnostic studies (e.g., expert consensus on images) is not relevant here. The "ground truth" for the device's functionality would be established by engineering specifications and objective test methods.
- Qualifications of Experts: Not applicable. The testing would have been conducted by qualified engineers and technicians, but their specific qualifications are not detailed.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. This concept (e.g., 2+1, 3+1) is typically used for resolving discrepancies in expert interpretations in AI/diagnostic studies. For functional device testing, methods would involve comparing test results against predefined specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating human reader performance with and without AI assistance, which is not the scope of this device (a reprocessed electrophysiology catheter).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done:
- Standalone Study: Not applicable. This device is a physical catheter, not an algorithm. The "standalone" performance here refers to the device's direct functional testing in isolation from human use, which was indeed performed as "design testing."
7. The Type of Ground Truth Used:
The "ground truth" for this medical device (reprocessed catheter) is based on established engineering specifications, performance standards, and comparison to the characteristics of the original (new) predicate devices.
Specifically from the text:
- "Functional characteristics" (e.g., torque, steerability, electrode function).
- "Biocompatibility" (compatibility of materials with the body).
- "Cleaning and sterilization procedures" (validated to eliminate contaminants and ensure sterility).
- "Manufacturing process includes visual and functional testing of all products produced."
8. The Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable. This is not an AI/machine learning device that uses a "training set." The training for the manufacturing process would refer to employee training, not data-based model training.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth for Training Set: Not applicable, as there is no "training set" in the context of an AI model for this device. The "ground truth" for the manufacturing process quality would be based on validated process parameters and established quality control standards.
Summary of Available Information from the Document:
The study proving the device meets the (unspecified quantitative) acceptance criteria is described as "Functional and Safety Testing."
- Acceptance Criteria (General): Appropriate functional characteristics, biocompatibility, validated cleaning/sterilization, and packaging integrity. The overall acceptance criterion is "substantial equivalence" to the predicate devices.
- Reported Device Performance: The device performs equivalently to the predicate devices, as stated in the conclusion: "These devices are identical to the predicate devices in terms of their design, materials, indications for use, and construction."
- Sample Size & Data Provenance: "Representative samples" were used. No specific numbers or geographic origin are given for the testing. Testing is of the physical device, not patient data.
- Experts / Ground Truth for Testing: Functional and safety testing would be against engineering specifications and industry standards. No explicit "expert consensus" or "pathology" ground truth as defined for diagnostic studies is relevant.
- Adjudication / MRMC: Not applicable to this type of device submission.
- Standalone Testing: Yes, "design testing" was performed on the reprocessed catheters themselves.
- Ground Truth for Testing: Established engineering specifications, performance standards, and the characteristics of the predicate devices.
- Training Set: Not applicable.
This 510(k) submission establishes substantial equivalence through a combination of design review, functional testing, biocompatibility testing, and validation of reprocessing procedures, rather than a clinical trial or AI performance study typically associated with the detailed questions provided.
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MAR 1 - 2005
043513
Page 1 of 2
SECTION 2. SUMMARY AND CERTIFICATION
2.A. 510(K) SUMMARY
| Submitter: | SterilMed, Inc. |
|---|---|
| Contact Person: | Dr. Bruce R. LesterSterilMed, Inc.11400 73rd Avenue NorthMinneapolis, MN 55369Ph: 763-488-3400Fax: 763-488-3350 |
| Date Prepared: | December 17, 2004 |
| Trade Name: | SterilMed Reprocessed Deflectable ElectrophysiologyDiagnostic Catheter |
| Classification Name:and Number: | Electrode Recording CatheterClass II, 21 CFR 870.1220 |
| Product Code: | NLH |
| Predicate Device(s): | The SterilMed reprocessed deflectable electrophysiologydiagnostic catheter is substantially equivalent to: the A20(K953768), manufactured by Biosense Webster (formerlyknown as Cordis Webster); the Bard Dynamic Tip Catheter(K912213), manufactured by C.R. Bard Inc.; and theircounterparts from the original manufacturers. |
| Device Description: | The 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 lengthranging from 80 to 115 cm, with 4-10 platinum, radiopaqueelectrodes along the tip shaft and a variety of inter-electrodespacings 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 anexternal stimulator and/or an electrophysiologic recorder. Itshould be noted that this submission pertains to the catheteronly. It does not include any other components in a systemsuch as connector cables, external stimulators, orelectrophysiologic recorders. |
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page 2 of 2
| Intended Use: | The SterilMed Reprocessed Electrophysiology 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. |
|---|---|
| Functional andSafety Testing: | Representative samples of reprocessed deflectable electrophysiology diagnostic catheters underwent design testing to demonstrate appropriate functional characteristics, and biocompatibility testing to demonstrate compatibility of the device materials. Process validation testing was done to validate the cleaning and sterilization procedures as well as the device's packaging. In addition, the manufacturing process includes visual and functional testing of all products produced. |
| Conclusion: | The deflectable electrophysiology diagnostic catheters reprocessed by SterilMed are substantially equivalent to the A20 (K953768) manufactured by Biosense Webster (formerly known as Cordis Webster) and the Bard Dynamic Tip Catheter (K912213) manufactured by C.R. Bard Inc., and their counterparts from the original manufacturers. This conclusion is based upon the fact that these devices are identical to the predicate devices in terms of their design, materials, indications for use, and construction. |
:
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Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird with three wing-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 - 2005
SterilMed, Inc. Bruce Lester, Ph.D. Vice President Research and Development 11400 73rd Avenue North Minneapolis, MN 55369
Re: K043513
R043313
Trade Name: Sterilmed Reprocessed Deflectable Electrophysiology Diagnostic Catheters (See Enclosed List) Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: NLH Dated: December 17, 2004 Received: December 20, 2004
Dear Dr. Lester:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becaren b r (x) pe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the encreased of 76, the enactment date of the Medical Device Amendments, or to commerce proct to may 20, 1773, in accordance with the provisions of the Federal Food, Drug, de nec.s mat have been room do require approval of a premarket approval application (PMA). and Costietle Act (110.) that the device, subject to the general controls provisions of the Act. The r ou may, mererore, mains 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 may oc subject to back as a sateral 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 and mean Please be advised that FDA s issuance of a cevice complies with other requirements of the Act
that FDA has made a determination that your device complies with other may that FDA has made a decemmanen and Jointistered by other Federal agencies. You must or any Federal Statules and regulations adminities. by registration and listing (21 comply with an the Act 31equirements, newally, good manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (becares over device as described in your Section 510(k) I mis letter will anow you to begin manteang your antial equivalence of your device to a legally premarket notification. The PDA mixing of basification 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 If you desire specific at not its you (240) 276-0120 Also, please note the regulation entitled, Comact the Office of Complance at (210) = 10 = 10 = 10 = 10 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = = = Misoranuing by telefono to promazion ibilities under the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-2041 or Manufacturers, micriational and Soless http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours,
Blairimmar for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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1
List of Model numbers
| No. | BiosenseWebster (47 Models) | Bard (18 Models) |
|---|---|---|
| 1 | D5-08D-P10-FS | 200131 |
| 2 | D5-08D-P10-RT | 200344 |
| 3 | D5-DL-005-PS | 200345 |
| 4 | D5S-06AL-252-FS | 200443 |
| 5 | D5S-270L-B02-PS | 201101 |
| 6 | D5S-AL-252-PS | 201102 |
| 7 | D6-06DR-002-FS | 201103 |
| 8 | D6-08DR-002-FS | 201104 |
| 9 | D6-08DR-002-RT | 201105 |
| 10 | D6-08DR-252-RT | 201106 |
| 11 | D6-10DR-282-RT | 201107 |
| 12 | D6-10DR-P10-FS | 201108 |
| 13 | D6-10DR-P10-RS | 201109 |
| 14 | D6-10DR-P10-RT | 201110 |
| 15 | D6-DR-005-PS | 201112 |
| 16 | D6-DR-010-PS | 201113 |
| 17 | D6-DR-231-PS | 201114 |
| 18 | D6-DR-252-PS | 201115 |
| 19 | D6-QA-005-PS | - |
| 20 | D6-QD-010-PS | - |
| 21 | D6-QF-005-PS | - |
| 22 | D6S-08DR-PRY-FS | - |
| 23 | D6S-270L-252-PS | - |
| 24 | D7-06DL-002-FS | - |
| 25 | D7-08DL-002-FS | - |
| 26 | D7-08DR-002-FS | - |
| 27 | D7-08DR-002-RT | - |
| 28 | D7-08DR-005-FS | - |
| 29 | D7-08DR-252-RT | - |
| 30 | D7-08R-HIS-FS | - |
| 31 | D7-08R-HIS-RT | - |
| 32 | D7-10DR-282-RT | - |
| 33 | D7-10DR-P10-FS | - |
| 34 | D7-10DR-P10-RS | - |
| 35 | D7-10DR-P10-RT | - |
| 36 | D7-10FR-252-RT | - |
| 37 | D7-270RG-252-PS | - |
| 38 | D7-270RL-252-PS | - |
| 39 | D7-DL-005-PS | - |
| 40 | D7-DL-010-PS | - |
| 41 | D7-DL-252-RT | - |
| 42 | D7-DR-005-PS | - |
| 43 | D7-DR-010-PS | - |
| 44 | D7-DR-252-PS | - |
| 45 | D7-PSL-252-PS | - |
| 46 | OD7-3X4D-010-FS | - |
| 47 | OD7-8X2D-005-FS | - |
.
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Indications for Use
510(k) Number (if known): K043513
Reprocessed Deflectable Electrophysiology Diagnostic Catheters Device Name:
Indications For Use:
The SterilMed Reprocessed Electrophysiological Diagnostic Catheters are intended for The Dierminou resproosescophysiology studies for intracardiac sensing, recording, and stimulation. They also provide temporary pacing for the evaluation of cardiac armulation. - They 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)
Blumme
(Division Sign-Off)
Division of Cardiovascular Devices 510(k) Number
Page 1 of 1
0
§ 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).