(112 days)
The reprocessed EP diagnostic catheters are intended for temporary use during electrophysiology studies for intracardiac sensing, recording, and pacing for the electrophysiological mapping and evaluation of cardiac structures and arrhythmias.
The EP diagnostic catheters are steerable, multi-electrode catheters with a deflectable tip designed to facilitate electrophysiological mapping of the heart. The catheters have a high-torque shaft with a braided bi-directional deflectable tip section containing an array of ten platinum electrodes that includes a 2 mm tip dome, which can be used for stimulation and recording. The catheters are 7 french with a usable length of 115 cm. The rocker lever located on the hand piece is used to deflect the tip section. A friction control knob is located on the opposite side of the rocker lever and can be rotated clockwise to lock both the tip curve and rocker lever in place. The high-torque shaft allows the plane of the curved tip to rotate, enabling accurate positioning of the catheter tip.
The provided text describes the 510(k) summary for Sterilmed, Inc.'s Reprocessed Electrophysiology Diagnostic Catheters. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria for a new AI or diagnostic device.
Therefore, many of the requested categories for a study proving acceptance criteria cannot be directly extracted from this document, as it outlines the regulatory pathway for a reprocessed medical device.
However, I can extract information related to the functional and safety testing performed, which serves a similar purpose of demonstrating the device's acceptable performance.
Acceptance Criteria and Study for Reprocessed Electrophysiology Diagnostic Catheters (K121158)
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria in a tabular format as would be typical for a new diagnostic device. Instead, the "acceptance criteria" are implied by demonstrating that the reprocessed device performs "as originally intended" and is "substantially equivalent" to the predicate device.
| Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Functional & Safety | Reprocessed catheters must demonstrate appropriate functional characteristics. | "Representative samples of reprocessed EP diagnostic catheters were tested to demonstrate appropriate functional characteristics." |
| Cleaning Validation | Demonstrated efficacy of cleaning procedures. | "Process validation testing was performed to validate the cleaning... procedures." Specific non-clinical tests included "cleaning validation." |
| Sterilization | Demonstrated efficacy of sterilization procedures (ISO 11135, USP <71>). | "Process validation testing was performed to validate the ... sterilization procedures." Specific non-clinical tests included "sterilization (ISO 11135, USP <71>)." |
| Biocompatibility | Demonstrated biocompatibility (ISO 10993-1). | Specific non-clinical tests included "biocompatibility testing (ISO 10993-1)." |
| Ethylene Oxide Residue | Demonstrated acceptable ethylene oxide residuals (ISO 10993-7). | Specific non-clinical tests included "ethylene oxide residual testing (ISO 10993-7)." |
| Packaging Validation | Demonstrated integrity and protection (ASTM D 4169, ASTM F 2096). | Specific non-clinical tests included "packaging validation (ASTM D 4169, ASTM F 2096)." |
| Shelf Life Validation | Demonstrated maintenance of product integrity over time (ASTM F 1980). | Specific non-clinical tests included "shelf life validation (ASTM F 1980)." |
| Functional Performance (Bench Testing) | Demonstrated performance as originally intended through simulated use, visual inspection, fatigue testing, and function testing. | "validation of functional performance (bench testing) was performed through simulated use, visual inspection, fatigue testing, and function testing. Performance testing shows the reprocessed EP diagnostic catheters to perform as originally intended." |
| Manufacturing Process | Includes visual and validated functional testing of 100% of reprocessed products. | "the manufacturing process includes visual and validated functional testing of 100% of products reprocessed." |
| Substantial Equivalence | Device is as safe and effective as the predicate device (Biosense Webster Coronary Sinus Catheters with EZ Steer Technology (K101345)). | "Sterilmed concludes that the reprocessed EP diagnostic catheters are safe, effective, and substantially equivalent to the predicate devices, Biosense Webster Coronary Sinus Catheters with EZ Steer Technology (K101345), as described in this premarket notification submission." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states that "Representative samples of reprocessed EP diagnostic catheters were tested." It also mentions "100% of products reprocessed" undergo visual and validated functional testing as part of the manufacturing process. However, specific numbers for the "representative samples" used in the validation studies (cleaning, sterilization, biocompatibility, etc.) are not provided.
- Data Provenance: The studies were conducted by Sterilmed, Inc. and are related to their reprocessing procedures. This would be considered prospective testing and validation of their reprocessed devices. The country of origin of the data is implicitly the United States, where Sterilmed, Inc. is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this 510(k) submission. Ground truth established by experts is typically relevant for diagnostic devices that analyze medical images or data requiring clinical interpretation. This submission is for a reprocessed electrophysiology diagnostic catheter, where the "truth" is its functional performance, safety, and sterility, verified through engineering and laboratory testing rather than expert clinical consensus.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in expert interpretations, typically in diagnostic studies. The safety and performance of a reprocessed medical device are determined by standardized physical, chemical, and biological testing methods.
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
This is not applicable. This submission is for a reprocessed medical device, not an AI or imaging diagnostic device. No human-in-the-loop diagnostic performance studies are mentioned or relevant for this type of product.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This is not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established through:
- Reference to predicate device specifications and intended performance.
- Validated engineering and laboratory testing (e.g., functional bench testing, cleaning validation, sterilization validation, biocompatibility studies, packaging integrity tests, shelf-life tests) against recognized industry standards (ISO, ASTM, USP).
- Visual inspection and functional testing of 100% of reprocessed products.
8. The Sample Size for the Training Set
This is not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set was Established
This is not applicable, as there is no training set for this device.
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K12 1158
Image /page/0/Picture/1 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."
II. SUMMARY AND CERTIFICATION
- 510(k) Summary A.
| Submitter: | Sterilmed, Inc. | AUG 6 20 |
|---|---|---|
| Contact Person: | Jason Skramsted11400 73rd Avenue NorthMaple Grove, MN 55369Phone: 763-488-3483Fax: 763-488-4491 | |
| Date Prepared: | 13 April 2012 | |
| 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 the Biosense Webster Coronary SinusCatheters with EZ Steer Technology (K101345). |
|---|---|
| DeviceDescription: | The EP diagnostic catheters are steerable, multi-electrode catheters with a deflectable tip designed to facilitateelectrophysiological mapping of the heart. The catheters have a high-torque shaft with a braided bi-directional deflectable tip section containing an array of ten platinum electrodes that includes a 2 mm tipdome, which can be used for stimulation and recording. The catheters are 7 french with a usable length of115 cm. The rocker lever located on the hand piece is used to deflect the tip section. A friction control knobis located on the opposite side of the rocker lever and can be rotated clockwise to lock both the tip curve androcker lever in place. The high-torque shaft allows the plane of the curved tip to rotate, enabling accuratepositioning of the catheter tip. |
| Intended Use: | The reprocessed EP diagnostic catheters are intended for temporary use during electrophysiology studies forintracardiac sensing, recording, and pacing for the electrophysiological mapping and evaluation of cardiacstructures and arrhythmias. |
| TechnologicalCharacteristics: | The reprocessed EP diagnostic catheters are identical to the predicate devices in design, materials ofconstruction, and intended use. There are no changes to the clinical applications, patient population,performance specifications, or method of operation. |
| Functional andSafety Testing: | Representative samples of reprocessed EP diagnostic catheters were tested to demonstrate appropriatefunctional characteristics. Process validation testing was performed to validate the cleaning and sterilizationprocedures as well as device packaging. In addition, the manufacturing process includes visual and validatedfunctional testing of 100% of products reprocessed. |
| Summary ofNon-clinicalTestsConducted: | Specific non-clinical tests performed included: cleaning validation, sterilization (ISO 11135, USP<71>), biocompatibility testing (ISO 10993-1), ethylene oxide residual testing (ISO 10993-7), packagingvalidation (ASTM D 4169, ASTM F 2096), and shelf life validation (ASTM F 1980). Inaddition, validation of functional performance (bench testing) was performed through simulated use, visualinspection, fatigue testing, and function testing. Performance testing shows the reprocessed EP diagnosticcatheters to perform as originally intended. |
| Conclusion: | Sterilmed concludes that the reprocessed EP diagnostic catheters are safe, effective, and substantiallyequivalent to the predicate devices, Biosense Webster Coronary Sinus Catheters with EZ Steer Technology(K101345), as described in this premarket notification submission. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized design featuring three curved shapes that resemble abstract human figures or flowing ribbons. The overall design is simple and conveys a sense of unity and service.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 6 2012
Sterilmed, Inc. c/o Mr. Jason Skramsted 11400 73rd Avenue North Maple Grove, MN 55369
Re: K121158
Trade Name:
Reprocessed Electrophysiology Diagnostic Catheters (4 models manufactured by Biosense - Webster: (4 "models" BD710FJ282CT, BD710DF282CT, BD710DF282CT)
BD710FJ282RTS,
Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode recording catheter or electrode recording probe Regulatory Class: Class II (two)
Product Codes: NLH Dated: July 18, 2012 Received: July 19, 2012
Dear Mr. Skramsted:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(x) premation is substantially equivalent (for the indications
referenced above and have determined the devices marketed in interstate referenced above and have determined the arrested predicate devices marketed in interstate for use stated in the enclosure) to tegally manated provice Americal Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the encordance with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance what as proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosmetic Act (Act) that do not require approvation of the peneral controls of the Act. The Act. The Act. The Act. The Act. The Act. The You may, therefore, market the ucvice, subject to the groupen mishrandon, listing of
general controls provisions of the Act include requirements for and general controls provisions of the needing, and prohibitions against misbranding and
devices, good manufacturing practice, and prohibitions agated to contract hiability devices, good manufacturing placiic, naoching, and programon related to contract liability.
adulteration. Please note: CDRH does not evaluate information related to adulteration. Please note: CDKFI does not evaluate internations of truthful and not misleading.
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Page 2 -Mr. Skramsted
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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 vours 1
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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STERILMED, INC.
Medical Device Reprocessing
Small Equipment & Instrument Repair
510(K) PREMARKET NOTIFICATION SUBMISSION 13 APRIL 2012 For Reprocessed EP Diagnostic Catheters
Indications for Use
510(k) Number (if known): K 121158
Device Name: Reprocessed Electrophysiology Diagnostic Catheters
Indications for Use: The reprocessed EP diagnostic catheters are intended for temporary use during electrophysiology studies for intracardiac sensing, recording, and pacing 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)
sion Slan-Off Division of Cardiovascula
510(k) Number K121158
§ 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).