(139 days)
Reprocessed Electrophysiology 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 hand piece, a flexible shaft and a distal tip section containing diagnostic electrodes. The distal tip of deflectable catheters can be deflected into a curve by manipulating the hand piece.
Here's a breakdown of the acceptance criteria and study information for Alliance Medical Corporation's Reprocessed Electrophysiology Catheters (K061045) based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests Conducted | Reported Device Performance (Conclusion) |
|---|---|---|
| Safety & Effectiveness | Biocompatibility | N/A (Tests listed, but specific numerical results or criteria aren't detailed in this summary. The general conclusion is that the device performs as intended.) |
| Validation of reprocessing | N/A | |
| Sterilization Validation | N/A | |
| Function test(s) | N/A | |
| Packaging Validation | N/A | |
| Overall | (Implied comparison to predicate device) | "Performance testing demonstrates that Reprocessed Electrophysiology Catheters perform as originally intended.""Alliance Medical Corporation concludes that the modified devices (Reprocessed Electrophysiology Catheters) are safe, effective, and substantially equivalent to the predicate devices as described herein." |
Important Note: The provided 510(k) summary is a high-level overview. It lists the types of tests conducted but does not provide specific acceptance values or detailed results for each test. The conclusion section broadly states that the device passes.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in the provided text. The document mentions "Bench and laboratory testing" but doesn't quantify the number of reprocessed catheters or tests performed during the performance evaluation.
- Data Provenance: The studies were retrospective in the sense that they were conducted on already reprocessed devices, comparing their performance to the "originally intended" performance of the new predicate devices. The country of origin for the data is implicitly the United States, where Alliance Medical Corporation is based and where the testing would have been overseen for FDA submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. The studies described are bench and laboratory tests, not clinical studies involving human observers forming a ground truth for diagnostic accuracy.
4. Adjudication Method for the Test Set
- Adjudication methods (e.g., 2+1) are relevant for studies where multiple human readers interpret data to establish a ground truth. Since the studies described are bench and laboratory tests, an adjudication method for a test set is not applicable or mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not conducted or mentioned. This type of study typically involves human readers using a device (often an AI) to evaluate cases. The studies here are bench tests on the reprocessed physical device.
6. Standalone (Algorithm Only) Performance Study
- Not applicable. This device is a reprocessed physical medical device (catheter), not an algorithm or software. Therefore, there is no "standalone" algorithm performance to evaluate. The performance noted is that of the reprocessed physical product.
7. Type of Ground Truth Used
- The ground truth for the bench and laboratory tests would have been established by engineering and performance specifications of the original, new predicate devices. For example, a function test for electrical conductivity would compare the reprocessed catheter's performance against the expected conductivity of a new catheter. The "ground truth" is adherence to established engineering parameters and predicate device performance.
8. Sample Size for the Training Set
- Not applicable. This device is a reprocessed physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, there is no training set for this device.
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K061045
p 1/2
AUG 3 1 2006
PART B: 510(k) SUMMARY
| Submitter: | Alliance Medical Corporation10232 South 51st StreetPhoenix, Arizona 85044 |
|---|---|
| Contact: | Elizabeth RenkenRegulatory Affairs Specialist(480) 763-5394 (o)(480) 763-6089 (f)erenken@alliance-medical.com |
| Date of preparation: | April 5, 2006 |
| Name of device: | Trade/Proprietary Name: Reprocessed ElectrophysiologyCathetersClassification Name: Reprocessed Electrode RecordingCatheter |
| Predicate Device | 510(k) Title | Manufacturer |
|---|---|---|
| K915563 | CardioRhythm's Torqr Catheters | CardioRhythm/Medtronic |
| Device description: | Diagnostic Electrophysiology (EP) Catheters are speciallydesigned electrode catheters that transmit electrical impulsesand can be positioned for endocardial recording or stimulation.Diagnostic EP catheters incorporate a hand piece, a flexibleshaft and a distal tip section containing diagnostic electrodes.The distal tip of deflectable catheters can be deflected into acurve by manipulating the hand piece. | |
| Intended use: | Reprocessed Electrophysiology Catheters are intended fortemporary intracardiac sensing, recording, stimulation, andelectrophysiology mapping of cardiac structures. | |
| Indicationsstatement: | Reprocessed Electrophysiology Catheters are indicated fortemporary intracardiac sensing, recording, stimulation andelectrophysiological mapping of cardiac structures. | |
| Technologicalcharacteristics: | The design, materials, and intended use of ReprocessedElectrophysiology Catheters are identical to the predicatedevices. The mechanism of action of ReprocessedElectrophysiology Catheters is identical to the predicate devicesin that the same standard mechanical design, materials, andsizes are utilized. There are no changes to the claims, intendeduse, clinical applications, patient population, performancespecifications, or method of operation. In addition, AllianceMedical Corporation's reprocessing of EndoscopicElectrophysiology Catheters includes removal of adherentvisible soil and decontamination. Each individualElectrophysiology Catheters is tested for appropriate function of |
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its components prior to packaging and labeling operations.
Performance data: Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Electrophysiology Catheters. This included the following tests:
- . Biocompatibility
- Validation of reprocessing .
- . Sterilization Validation
- . Function test(s)
- . Packaging Validation
Performance testing demonstrates that Reprocessed Electrophysiology Catheters perform as originally intended.
Conclusion: Alliance Medical Corporation concludes that the modified devices (Reprocessed Electrophysiology Catheters) are safe, effective, and substantially equivalent to the predicate devices as described herein.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 1 2006
Ascent Healthcare Solutions c/o Ms. Elizabeth Renken Regulatory Affairs Specialist 10232 South 51st Street Phoenix, Arizona 85044
Re: K061045
Trade Name: Reprocessed Electrophysiology Catheters (See Attached List) Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: II (two) Product Code: NLH Dated: August 4, 2006 Received: August 8, 2006
Dear Ms. Renken:
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 for and in 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 - Ms. Elizabeth Renken
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 yours,
Brimmerfor
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures (2)
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Page 3 - Ms. Elizabeth Renken ,
:
Device Models Found SE:
-
- -:
| Medtronic ==================================================================================================================================================================== |
|---|
| Torqr® CS Fixed Curve |
| Decapolar Coronary Sinus |
| Catheter |
| 041265CS |
| 041290CS |
| 041565CS |
| 041865CS |
| 041590CS |
| 041890CS |
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2. Indications for Use Statement
510(k) Number (if known):
Device Name: Reprocessed Electrophysiology Catheters
Reprocessed Electrophysiology (EP) Catheters are Indications for Use: indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures.
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bikmuma
(Divisish Sign-Off) Division of Cardlovascular Deyloes 510(k) Number Knli/045
Alliance Medical Corporation Reprocessed Electrophysiology 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).