(105 days)
Reprocessed Electrophysiology (EP) Catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures.
Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Diagnostic EP catheters incorporate a handpiece, a flexible shaft and a distal tip section containing diagnostic electrodes. The distal tips of deflectable catheters can be deflected into a curve by manipulating the handpiece; fixed curve catheters have an established distal tip shape. Reprocessed Electrophysiology Catheters are intended for temporary intracardiac sensing, recording, stimulation, and electrophysiological mapping of cardiac structures.
This document describes the Reprocessed Electrophysiology (EP) Catheters by Alliance Medical Corporation.
Here's a breakdown of the requested information:
Acceptance Criteria and Device Performance
The provided document does not specify quantitative acceptance criteria with numerical targets (e.g., "sensitivity > 90%"). Instead, the acceptance criteria are implicitly defined by the demonstration that the reprocessed catheters perform "as originally intended" and are "safe, effective and substantially equivalent to the predicate devices."
The reported device performance is a categorical assertion of meeting these implied criteria through various tests.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Technological Characteristics | The design, materials, intended use, mechanism of action, mechanical design, materials, sizes, claims, clinical applications, patient population, performance specifications, and method of operation are identical to the predicate devices. |
| Reprocessing Validation | Reprocessing includes successful removal of adherent visible soil and decontamination. Each individual catheter is tested for appropriate function of its components prior to packaging and labeling. This indicates the reprocessing procedure itself was validated to ensure cleanliness and functionality. |
| Biocompatibility | Bench and laboratory testing demonstrated biocompatibility. |
| Sterilization Validation | Bench and laboratory testing demonstrated sterilization validation. |
| Function Test(s) | Bench and laboratory testing demonstrated appropriate function of the components post-reprocessing. |
| Packaging Validation | Bench and laboratory testing demonstrated packaging validation. |
| Overall Conclusion | Performance testing demonstrates that Reprocessed EP Catheters perform as originally intended. The device is concluded to be safe, effective, and substantially equivalent to the predicate devices in accordance with the Federal Food, Drug and Cosmetic Act 21 CFR Part 807. |
Study Details
The provided information pertains to a 510(k) premarket notification for a reprocessed medical device. This type of submission relies heavily on demonstrating substantial equivalence to a predicate device rather than conducting large-scale clinical trials measuring performance against specific endpoints in a patient population.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document does not specify a numerical sample size for the "test set" in the traditional sense of a clinical study. The performance data is based on "Bench and laboratory testing." This would typically involve a sample of reprocessed catheters undergoing the listed tests. The exact number of catheters tested is not provided, which is common for 510(k) submissions focusing on substantial equivalence through engineering and laboratory testing rather than clinical performance data.
- Data Provenance: The testing was conducted by Alliance Medical Corporation, located in Phoenix, Arizona, USA. The data is retrospective in the sense that it evaluates the performance of the reprocessed devices under controlled lab conditions.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in this context. The "ground truth" for this type of submission is not established by human experts interpreting clinical data. Instead, the "ground truth" is adherence to engineering specifications, validated reprocessing procedures, and performance metrics (e.g., electrical conductivity, mechanical integrity, sterility) derived from the original device's specifications and regulatory requirements for reprocessed devices. The expertise involved would be in engineering, microbiology, and quality assurance, rather than clinical specialists establishing a "diagnosis."
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials where multiple human readers interpret medical images or patient data to establish a consensus ground truth. This submission relies on objective, measurable laboratory and bench tests, where the results are typically quantitative or pass/fail based on predefined criteria, not subjective interpretation requiring adjudication.
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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:
- No. This is a submission for a reprocessed medical device (electrophysiology catheters), not an AI diagnostic or assistance tool. Therefore, an MRMC study and effects on human reader performance are not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device, not a software algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission is based on objective engineering specifications, validated reprocessing parameters, and standardized laboratory tests (e.g., sterility tests, mechanical integrity tests, electrical function tests). It is essentially conformance to established benchmarks for the original device and regulatory standards for reprocessed devices.
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The sample size for the training set:
- Not applicable in the typical sense of machine learning. This is a reprocessed physical device. There isn't a "training set" to develop an algorithm. However, the development of the reprocessing procedures themselves would involve extensive internal testing and refinement, which could be seen as an iterative "training" process for the reprocessing protocol, but not a data set in the AI context.
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How the ground truth for the training set was established:
- Not applicable. As noted above, there isn't a "training set" for an algorithm. The "ground truth" for developing the reprocessing procedure would be successful validation that the reprocessed device consistently meets the performance and safety characteristics of a new equivalent device. This involves engineering design, material science, and regulatory compliance expertise.
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K04239?
Image /page/0/Picture/1 description: The image shows a logo for Alliance Medical Corporation. The logo consists of three curved lines above the word "ALLIANCE" in a sans-serif font. Below the word "ALLIANCE" is the phrase "MEDICAL CORPORATION" in a smaller font.
MEDICAL CORPORATION
10232 South 51st Street Phoenix, Arizona 85044
TEL 480.763 5300 FAX 480.763.5310 oll Free 888.888.3433 iance-medical.com
| MAR 25 2003 |
|---|
| ------------- |
SECTION B: 510(k) SUMMARY
| 10232 South 51st StreetPhoenix, Arizona 85044 | ||
|---|---|---|
| Contact: | Moira BartonRegulatory Affairs Manager(480) 763-5350 (o)(480) 763-5310 (f)mbarton@alliance-medical.com | |
| Date of preparation: | December 6, 2004 | |
| Name of device: | Trade/Proprietary Name: Reprocessed ElectrophysiologyCathetersCommon or Usual Name: Electrophysiology Catheter orElectrode Recording CatheterClassification Name: Electrode Recording Catheter |
Alliance Medical Corporation
Predicate device:
Submitter:
| K Number | Device Description |
|---|---|
| K894500 | Daig Electrophysiology Catheter |
| K942379 | Daig Diagnostic Electrophysiology Catheter |
| K012708 | Reprocessed Electrophysiology Catheters |
Diagnostic electrophysiology (EP) catheters are specially Device description: designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Diagnostic EP catheters incorporate a handpiece, a flexible shaft and a distal tip section containing diagnostic electrodes. The distal tips of deflectable catheters can be deflected into a curve by manipulating the handpiece; fixed curve catheters have an established distal tip shape. Reprocessed Electrophysiology Catheters are intended for Intended use: temporary intracardiac sensing, recording, stimulation, and electrophysiological mapping of cardiac structures. Reprocessed diagnostic EP catheters are indicated for Indications
10
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| Technological characteristics: | The design, materials, and intended use of Reprocessed Electrophysiology (EP) Catheters are identical to the predicate devices. The mechanism of action of Reprocessed Electrophysiology (EP) Catheters is identical to the predicate devices in that the same standard mechanical design, materials and sizes are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation. |
|---|---|
| Alliance Medical Corporation's reprocessing of electrophysiology catheters includes removal of adherent visible soil and decontamination. Each individual electrophysiology catheter is tested for appropriate function of its components prior to packaging and labeling operations. | |
| Alliance Medical Corporation's reprocessing of EP Catheters includes removal of adherent visible soil and decontamination. Each individual EP Catheter is tested for appropriate function of its components prior to packaging and labeling operations. | |
| Performance data: | Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed EP Catheter. |
| BiocompatibilityValidation of reprocessingSterilization ValidationFunction test(s)Packaging Validation | |
| Performance testing demonstrates that Reprocessed EP Catheters perform as originally intended. | |
| Conclusion: | In accordance with the Federal Food, Drug and Cosmetic Act 21 CFR Part 807 and based on the information provided in this premarket notification, Alliance Medical Corporation concludes that the modified device (the Reprocessed Electrophysiology (EP) Catheter) is safe, effective and substantially equivalent to the predicate devices as described herein. |
:
the predicate devices as described herein.
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Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
MAR 2 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Alliance Medical Corporation c/o Ms. Moira Barton Regulatory Affairs Manager 10232 South 51st Street Phoenix, AZ 85044
Re: K043392
K043392
Trade Name: Reprocessed Electrophysiology Catheters (See Enclosed List)
Trade Name: Reprocessed Electrophysiology Catheters (See Enclosed List) Regulation Number: 21 CFR 870.1220 Regulation Number: 21 CFN 870.1220
Regulation Name: Electrode Recording Catheter or Electrode Recording Probe
Seconding Name: Electrode Recording Catheter or Electrode Rec Regulatory Class: Class II Product Code: NLH Dated: January 19, 2005 Reccived: January 21, 2005
Dear Ms. Barton:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premained in substantially equivalent (for the indications
referenced above and have determined the device is substantial in interstate referenced above and nave decemblic the arrest received ate devices marketed in interstate for use stated in the encrosule) to regally manced promotion Device Americans, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the chance with the provisions of the Federal Food. Drug, devices that have been reciassified in accordance while toper of a provide approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of and Cosmetic Act (Act) that do not require approval of the general controls provisions of the Act. The You may, therefore, market the device, successfor for annual registration, listing of
general controls provisions of the Act include requirements michaeading and general controls provisions of the rict merides requests of the summer misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classified (sec above) mis exist case regulations affecting your device can
may be subject to such additional controls. Existing major regulations EDA may may be subject to such additional controlls. Existing major segment of addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 may be found in the Code of Peachar Regaring your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA 3 issumted on a bacevice complies with other requirements of the Act
that FDA has made a determination that your device complies with other require that FDA has made a decemmanon that your are received by other Federal agencies. You must
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Page 2 – Ms. Moira Barton
comply with all the Act's requirements, including, but not limited to: registration and listing (21 l comply with all the Act s requirements, nieras manufacturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements CFR Part 807); labeling (21 CFR Part 800); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 100); and if applicable, the electronic forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 100-1050.
product radiation control provisions (Sections 531-542 of the Action Section 2 product radiation control provisions (occuolis 95 = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = This letter will allow you to begin marketing your antial equivalence of your device to a legally premarket notification. The PDA mailing of subscribed on 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
s and the many of the many of any 1100 - All and case the regulation entitl If you desire specific advice for your ac no no no the more the regulation entitled, and the regulation entitled, a contact the Office of Complance at (210) 270 - 17 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 " Misbranding by reletence to premarket issuffication - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - other general information on your responsionnes and its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistent (demonsin html Manufacturers, International and Consulter Piessenser Piessens of Carb/dsmamain.html
Sincerely yours,
B Sommer 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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| St. Jude Daig LiveWire TM Steerable Diagnostic Catheter - 33- | ||||
|---|---|---|---|---|
| Models | ||||
| 401939 | 401933 | 401578 | 401580 | 401932 |
| 401940 | 401934 | 401586 | 401581 | - |
| 401938 | 401575 | 401587 | 401582 | - |
| 401941 | 401915 | 401588 | 401904 | - |
| 401600 | 401923 | 401583 | 401905 | - |
| 401603 | 401926 | 401584 | 401914 | - |
| 401572 | 401576 | 401585 | 401908 | - |
| 401606 | 401577 | 401579 | 401918 | - |
1000 Children
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: : :
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Indications for Use Statement 2.
510(k) Number (if known)
510(k) Number (if known): /K043392
Device Name: Alliance Medical Corporation Reprocessed Electrophysiology Catheters
Indications for Use: Reprocessed Electrophysiology (EP) Catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures.
Prescription Use
(per 21 CFR 801.109)
or
Over-the-Counter Use _ . .__
Concurrence of CDRH, Office of Device Evaluation (ODE)
B. Simmon
Division Sign-Off ular Devices Division of Cardlov 510(k) Number
Alliance Medical Corporation Reprocessed EP Catheters Traditional 510(k)
§ 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).