(365 days)
The Reprocessed Sealed Electrophysiology Diagnostic Catheters, are intended for temporary use during electrophysiology studies for intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias; and for electrophysiologic 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 may or may not be steerable. These catheters have an outer diameter of 4F to 7F, a length ranging from 65 to 120 cm, with 2-20 platinum, radiopaque electrodes along the tip shaft and a variety of inter-electrode spacings and curve styles at the tip. The tip generally 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 document is a 510(k) clearance letter from the FDA for a reprocessed medical device, specifically "Reprocessed Sealed Electrophysiology Diagnostic Catheters." It indicates that supplemental validation data was reviewed and the devices were found substantially equivalent to legally marketed predicate devices.
However, the document does not contain details about specific acceptance criteria or the study that proves the device meets those criteria, in the format usually provided for AI/algorithm performance claims. The document is a regulatory approval for reprocessing, focusing on demonstrating substantial equivalence to existing devices through functional and safety testing related to the reprocessing procedure (cleaning, sterilization, packaging) and ensuring that the reprocessed devices maintain appropriate functional characteristics.
Therefore, I cannot directly answer your detailed questions about acceptance criteria for AI algorithms, sample sizes for test sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance, as this information is not present in the provided text. The document is concerned with the safety and effectiveness of a reprocessing procedure for existing hardware, not with the performance metrics of a new diagnostic algorithm.
Here's what I can extract from the document relevant to the reprocessing validation, which is the closest equivalent to a "study" described herein:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied from validation types) | Reported Device Performance (Implied) |
|---|---|
| Maintain appropriate functional characteristics post-reprocessing | Functional characteristics were found appropriate |
| Effective cleaning procedures | Cleaning procedures were validated |
| Effective sterilization procedures | Sterilization procedures were validated |
| Effective packaging procedures | Packaging procedures were validated |
| Visual and functional integrity post-reprocessing for all products | Visual and functional testing included in manufacturing process for all products |
2. Sample sized used for the test set and the data provenance:
- The document states "Functional and Representative samples of reprocessed sealed electrophysiology diagnostic catheters underwent design testing". It does not specify the exact number of samples used for this testing.
- The data provenance is implied to be from SterilMed, Inc.'s internal validation processes and manufacturing, likely conducted in the USA (Minneapolis, MN). The text does not specify if the testing was retrospective or prospective, but validation generally involves prospective testing of reprocessed samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The "ground truth" here would relate to the functional integrity and safety of the reprocessed catheters, which would be assessed through standard engineering and microbiological testing, not typically by clinical experts establishing a ground truth in the same way for diagnostic AI.
4. Adjudication method for the test set:
- Not applicable/Not mentioned. The validation involves testing against defined specifications, not expert adjudication in the context of diagnostic interpretation.
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 a study of an AI or diagnostic algorithm, but rather a validation of a reprocessing method for a physical medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm.
7. The type of ground truth used:
- The "ground truth" in this context refers to the defined specifications and performance characteristics of the original new device, which the reprocessed device must meet. This would be established through industry standards, regulatory requirements, and the original manufacturer's specifications.
8. The sample size for the training set:
- Not applicable. This is not an AI algorithm that requires a training set. The "training" here would refer to the development and optimization of the reprocessing procedures.
9. How the ground truth for the training set was established:
- Not applicable. See #8.
In summary, the provided text concerns the regulatory clearance of reprocessed single-use medical devices based on physical and functional equivalence and safety after reprocessing, not the performance of a diagnostic AI algorithm. Therefore, many of your questions are not directly addressable by this specific document.
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Image /page/0/Picture/1 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 an abstract symbol that resembles an eagle or a stylized human figure, composed of three overlapping profiles.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 2004
SterilMed, Inc. c/o Dr. Bruce Lester Vice President Research and Development 11400 7310 Avenue North Minneapolis, MN 55369
Re: K012678 - Supplemental Validation Submission Trade Name: See Enclosed List Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Regulatory Class: Class II (two) Product Code: NLH Dated: August 13, 2001 Received: August 14, 2001
Dear Dr. Lester:
The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on August 14, 2002 . We have received your supplemental validation data as required for reprocessed single-use devices by the Medical Device User Fee and Modernization Act of 2002. After reviewing your supplemental validation data, we have determined the devices listed in the enclosure accompanying this letter are 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 these devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA) they 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 devices in the Federal Register.
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Page 2 - K012678
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your devices comply 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 applicable 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in classification for your devices and thus, permits you to legally market the devices. This letter will allow you to continue marketing the devices listed in the enclosure accompanying this letter.
If you desire specific advice for your devices 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,
Bhimmer for
Roy D. Zuckerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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Page 4 – K012678
Enclosure – List of Devices
| Orig models found to be | SE |
|---|---|
| Daig (132) | |
| 401206 | |
| 401207 | |
| 401209 | |
| 401210 | |
| 401211 | |
| 401212 | |
| 401221 | |
| 401222 | |
| 401223 | |
| 401224 | |
| 401225 | |
| 401226 | |
| 401227 | |
| 401228 | |
| 401259 | |
| 401260 | |
| 401261 | |
| 401262 | |
| 401271 | |
| 401272 | |
| 401273 | |
| 401274 | |
| 401275 | |
| 401276 | |
| 401277 | |
| 401278 | |
| 401279 | |
| 401281 | |
| 401282 | |
| 401283 | |
| 401284 | |
| 401285 | |
| 401287 | |
| 401288 | |
| 401290 | |
| 401291 | |
| 401293 | |
| 401294 | |
| Orig models found to be | SE |
| 401296 | |
| 401297 | |
| 401298 | |
| 401299 | |
| 401300 | |
| 401301 | |
| 401305 | |
| 401306 | |
| 401307 | |
| 401308 | |
| 401309 | |
| 401310 | |
| 401311 | |
| 401312 | |
| 401313 | |
| 401317 | |
| 401318 | |
| 401325 | |
| 401328 | |
| 401329 | |
| 401353 | |
| 401354 | |
| 401355 | |
| 401356 | |
| 401357 | |
| 401359 | |
| 401360 | |
| 401362 | |
| 401366 | |
| 401374 | |
| 401375 | |
| 401376 | |
| 401379 | |
| 401380 | |
| 401381 | |
| 401382 | |
| 401383 | |
| 401384 | |
| 401385 | |
| 401386 | |
| 401387 | |
| Orig models found to be | SE |
| 401388 | |
| 401389 | |
| 401390 | |
| 401392 | |
| 401393 | |
| 401397 | |
| 401399 | |
| 401400 | |
| 401401 | |
| 401430 | |
| 401433 | |
| 401434 | |
| 401435 | |
| 401436 | |
| 401438 | |
| 401440 | |
| 401441 | |
| 401442 | |
| 401443 | |
| 401444 | |
| 401445 | |
| 401448 | |
| 401449 | |
| 401450 | |
| 401451 | |
| 401453 | |
| 401466 | |
| 401468 | |
| 401474 | |
| 401475 | |
| 401527 | |
| 401528 | |
| 401530 | |
| 401531 | |
| 401532 | |
| 401534 | |
| 401688 | |
| 401859 | |
| 401860 | |
| 401863 | |
| 401864 | |
| Orig models found to be | SE |
| 401865 | |
| 401871 | |
| 401872 | |
| 401873 | |
| 401874 | |
| 401876 | |
| 401877 | |
| 401878 | |
| 401890 | |
| 401891 | |
| 401893 | |
| 401894 |
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and the comments of the comments of the comments of
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Indications for Use Page
Device Name: Reprocessed Sealed Electrophysiology Diagnostic Catheters
Indications for Use:
The Reprocessed Sealed Electrophysiology Diagnostic Catheters, are intended for temporary use during electrophysiology studies for intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias; and for electrophysiologic mapping of cardiac structures during these evaluations.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thos. A. for Bran Zucher
(Division Sign-Off)
Division of Cardiovascular
and Respiratory Devices
510(k) Number K012628
Prescription Use
(Per 21 CFR 801.109)
SterilMed, Inc. Reprocessed Sealed EP Diagnostic Catheters Confidential
Premarket Notification
Page I
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AUG 1 4 2002
SECTION 2. SUMMARY AND CERTIFICATION
510(K) SUMMARY A.
・
| Submitter: | SterilMed, Inc. |
|---|---|
| Contact Person: | Patrick Fleischhacker11400 73rd Avenue NorthMinneapolis MN, 55369Ph: 888-856-4870Fax: 763-488-3350 |
| Date Prepared: | August 13, 2001 |
| Trade Name: | SterilMed Reprocessed Sealed ElectrophysiologyDiagnostic Catheters |
| Classification Name:and Number: | Class II, 21 CFR 870.1220 |
| Product Code: | DRF |
| Predicate Device(s): | The SterilMed reprocessed sealed electrophysiologydiagnostic catheter is substantially equivalent to: the A20(K953768), manufactured by Biosense Webster (formerlyknown as Cordis Webster), the Bard Dynamic Tip Catheter(K912213), and the Bard Intracardiac Electrode Cathetermanufactured by C.R. Bard Inc., the Stablemapr EPDiagnostic Catheter (K981642), manufactured byMedtronic Inc., and the original manufacturer's devices. |
| Device Description: | The device consists of a reprocessed catheter that has ahigh-torque shaft with a handle at the proximal end, andmay or may not be steerable. These catheters have an outerdiameter of 4F to 7F, a length ranging from 65 to 120 cm,with 2-20 platinum, radiopaque electrodes along the tipshaft and a variety of inter-electrode spacings and curvestyles at the tip. The tip generally is deflectable. Specificcables, as recommended by the original manufacturer,connect to the handle and interface between the catheterand an external stimulator and/or an electrophysiologicrecorder. It should be noted that this submission pertains tothe catheter only. It does not include any other componentsin a system such as, connector cables, external stimulators,or electrophysiologic recorders. |
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The reprocessed sealed electrophysiology diagnostic Intended Use: catheters, are intended for temporary use during electrophysiology studies for intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias; and for electrophysiologic mapping of cardiac structures during these evaluations. Functional and Representative samples of reprocessed sealed Safety Testing: electrophysiology diagnostic catheters underwent design testing to demonstrate appropriate functional characteristics. 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. The electrophysiology diagnostic catheters sealed and Conclusion: reprocessed by SterilMed are substantially equivalent to the A20 (K953768), manufactured by Biosense Webster (formerly known as Cordis Webster), the Bard Dynamic Tip Catheter (K912213), and the Bard Intracardiac Electrode Catheter manufactured by C.R. Bard Inc., the Stablemapr EP Diagnostic Catheter (K981642), manufactured by Medtronic Inc., and the reprocessed devices' counterparts from the original manufacturer. This conclusion is based upon the fact that these devices' are essentially identical to the predicate devices in terms of functional design, materials, indications for use, and construction.
§ 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).