(182 days)
The reprocessed electrophysiology diagnostic catheters are indicated for temporary use during electrophysiology studies for intracardiac sensing, cardiac stimulation, and for the electrophysiological mapping and evaluation of cardiac structures and arrhythmias.
SterilMed Reprocessed Reflexion EP diagnostic catheters consist of a shaft with a handle at the proximal end, and are considered to be steerable. These catheters have an outer diameter of either 6 or 7F and are either 99 or 105cm in length, with 2 - 20 platinum, radiopaque tip electrodes and a variety of inter-electrode spacing's and curve styles at the distal tip. The distal tip is steerable and cables connect to the handle and interface between the catheter and an external stimulator and/or an electrophysiological recorder.
Note: Only the catheter is the subject of this submission, the external stimulator and/or electrophysiological recorder and any other related equipment are not included in the scope of this submission.
The provided text is related to a 510(k) submission for reprocessed electrophysiology diagnostic catheters, demonstrating substantial equivalence to a predicate device. It focuses on the safety and functional testing of the reprocessed device, rather than the performance of a software algorithm or AI.
Therefore, the requested information regarding acceptance criteria and a study proving a device meets acceptance criteria in the context of AI/software performance (e.g., sample size for test set, ground truth experts, MRMC studies, standalone algorithm performance, training set details) is not applicable to this document.
The document describes the functional and safety testing performed on the reprocessed catheters to demonstrate appropriate functional characteristics and validate cleaning and sterilization procedures. However, it does not provide specific acceptance criteria or detailed results in a structured table or outline a study comparing algorithmic performance to established metrics for AI/software devices.
Here's the relevant information that can be extracted, framed within the limitations of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state numerical acceptance criteria in a table format for reprocessed catheter performance that would be directly comparable to a software algorithm's output. Instead, it broadly states:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional Characteristics | "demonstrate appropriate functional characteristics" |
| Cleaning Procedures | "Process validation testing was performed to validate the cleaning... procedures" |
| Sterilization Procedures | "Process validation testing was performed to validate the ... sterilization procedures" |
| Device Packaging | "Process validation testing was performed to validate the ... device packaging" |
| Manufacturing Process (Visual & Functional Testing) | "manufacturing process includes visual and validated functional testing of all products produced" |
| Substantial Equivalence | "substantially equivalent to the St. Jude Medical Reflexion™ electrophysiology diagnostic catheters" based on "functional design (principle of operation), materials, indications for use and methods of construction." |
2. Sample size used for the test set and the data provenance:
- Sample Size: "Representative samples of reprocessed EP diagnostic catheters were tested." The exact number of samples is not specified in the provided text.
- Data Provenance: The testing was "performed to validate the cleaning and sterilization procedures as well as device packaging" and includes "visual and validated functional testing of all products produced" by SterilMed, Inc. This implies the data is prospective and generated internally during the reprocessing and manufacturing process. The country of origin of the data is implicitly the USA given the submission to the FDA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This document concerns physical device reprocessing and testing, not AI/software performance requiring expert-established ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are typically for subjective expert review in AI/software performance studies. The testing described is objective functional and validation testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is not an AI or imaging device, so no MRMC study or AI assistance comparison was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. There is no algorithm described in this document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the functional and safety testing, the "ground truth" would be established by engineering specifications, validated test protocols, and performance standards for electrophysiology diagnostic catheters, ensuring they meet pre-defined criteria for safety and efficacy after reprocessing. This is inherent in process and design validation, not typically referred to as "ground truth" in the same way as in AI studies.
8. The sample size for the training set:
- Not Applicable. There is no "training set" for an AI model described.
9. How the ground truth for the training set was established:
- Not Applicable. There is no "training set" for an AI model described.
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Image /page/0/Picture/0 description: The image shows the logo for SterilMed INC. The text "SterilMed INC." is in a bold, sans-serif font. Below the logo, in a smaller font, is the text "Medical Device Reprocessing" and "Small Equipment & Instrument Repair."
II. SUMMARY AND CERTIFICATION
- A. 510(k) Summary
JAN 1 4 2010
| Submitter: | SterilMed, Inc. |
|---|---|
| Contact Person: | Dennis Toussaint |
| 11400 73rd Avenue North | |
| Maple Grove, MN 55369 | |
| Ph: 763-488-3410 | |
| Fax: 763-488-2051 |
| Date Prepared: | July 14, 2009 |
|---|---|
| Trade Name: | Reprocessed Electrophysiology Diagnostic Catheters |
| Classification Name: | Electrode Recording Catheter or Electrode Recording Probe |
| Classification Number: | Class II, 21 CFR 870.1220 |
| Product Code: | NLH |
| PredicateDevices: | The reprocessed EP diagnostic catheters are substantially equivalent to St. Jude MedicalReflexion™ catheters. |
|---|---|
| DeviceDescription: | SterilMed Reprocessed Reflexion EP diagnostic catheters consist of a shaft with a handle at theproximal end, and are considered to be steerable. These catheters have an outer diameter ofeither 6 or 7F and are either 99 or 105cm in length, with 2 - 20 platinum, radiopaque tipelectrodes and a variety of inter-electrode spacing's and curve styles at the distal tip. The distaltip is steerable and cables connect to the handle and interface between the catheter and anexternal stimulator and/or an electrophysiological recorder. |
| Note: Only the catheter is the subject of this submission, the external stimulator and/orelectrophysiological recorder and any other related equipment are not included in the scope ofthis submission. | |
| Intended Use: | The reprocessed EP diagnostic catheters are intended for temporary use duringelectrophysiology studies for intracardiac sensing, recording, cardiac stimulation, and for theelectrophysiological mapping and evaluation of cardiac structures and arrhythmias. |
| Functional andSafety Testing: | Representative samples of reprocessed EP diagnostic catheters were tested to demonstrateappropriate functional characteristics. Process validation testing was performed to validate thecleaning and sterilization procedures as well as device packaging. In addition, themanufacturing process includes visual and validated functional testing of all products produced. |
| Conclusion: | The reprocessed EP diagnostic catheters are substantially equivalent to the St. Jude MedicalReflexion™ electrophysiology diagnostic catheters. |
| This conclusion is based upon the devices' similarities in functional design (principle ofoperation), materials, indications for use and methods of construction. |
PAGE 1 OF 1
CONFIDENTIAL CEROPRIETARY INFORMATION OF STEBILMED, INC.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it, representing medicine and health. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
SterilMed, Inc c/o Mr. Garrett Ahlborg Regulatory Affairs Manager, 1400 73td Avenue North, Suite 100 Maple Grove, MN 55369
JAN 1 4 2010
Re: K092158
Reprocessed Electrophysiology Catheters (See Enclosed List) Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II (two) Product Code: NLH Dated: December 22, 2009 Received: December 23, 2009
Dear Mr. Ahlborg:
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 - Mr. Garrett Ahlborg
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Dina R. Vahuner
A 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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Image /page/3/Picture/0 description: The image shows the logo for SterilMed, INC. The logo is in black and white and features the company name in a bold, sans-serif font. Below the company name, there is smaller text that reads "Medical Device Reprocessing" and "Small Equipment & Instrument Repair". The logo is simple and professional, and it conveys the company's focus on medical device reprocessing and repair.
Indications for Use
K092/58.
510(k) Number (if known):
Device Name: Reprocessed Electrophysiology Diagnostic Catheters
Indications for Use:
The reprocessed electrophysiology diagnostic catheters are indicated for temporary use during electrophysiology studies for intracardiac sensing, cardiac stimulation, and for the electrophysiological mapping and evaluation of cardiac structures and arrhythmias.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
wnad. vclmes
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number_ko-92158
Page 1 of 1
CONFIDENTIAL & PROPRIETARY INFORMATION OF STERILMED, INC.
§ 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).