(249 days)
Reprocessed Electrophysiology (EP) Catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures.
Reprocessed electrophysiology catheter cables are indicated for use with the appropriate electrode catheter during electrophysiology studies.
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.
The provided text details the FDA clearance for Alliance Medical Corporation's Reprocessed Electrophysiology (EP) Catheters. However, it does not contain a specific "acceptance criteria" table with numerical performance metrics or a detailed study description with sample sizes, ground truth establishment, or expert qualifications as requested.
The document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a standalone study with quantitative performance data against predefined acceptance criteria.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not explicitly present in the provided document. The document states: "Performance testing demonstrates that Reprocessed Electrophysiology (EP) Catheters perform as originally intended." and "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." This implies that the reprocessed devices met certain performance expectations, but the specific, quantifiable acceptance criteria and the numerical results against them are not provided.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | "Performs as originally intended" (General statement) |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not specified in the document. The document mentions "Each individual electrophysiology catheter is tested for appropriate function of its components prior to packaging and labeling operations," but it does not provide the sample size of catheters used for the performance testing cited in the submission.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It refers to "Bench and laboratory testing."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable or not specified. The document describes "Bench and laboratory testing" and "Function test(s)." This suggests instrumental testing rather than expert-derived ground truth based on clinical interpretation (e.g., radiologists interpreting images). If "ground truth" refers to the original device specifications or functionality, it was likely established by the manufacturer's engineering and quality control departments.
4. Adjudication Method for the Test Set:
Not applicable or not specified. The nature of the testing (bench and laboratory) does not suggest a need for an adjudication method in the way one would for clinical imaging studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
Not applicable. The device described is a reprocessed medical catheter, not an AI-powered diagnostic tool, and therefore, an MRMC study comparing human reader performance with or without AI assistance is not relevant or mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a physical medical instrument (catheter), not a standalone algorithm. Its performance is inherent in its physical and electrical characteristics.
7. The Type of Ground Truth Used:
The "ground truth" for this type of device would typically be the original manufacturer's specifications for new, equivalent devices, and possibly established performance benchmarks for functionality, electrical integrity, and material properties. The document states: "Performance testing demonstrates that Reprocessed Electrophysiology (EP) Catheters perform as originally intended" and implies they are "substantially equivalent to the predicate devices." This suggests the ground truth for their "performance" is derived from the expected function and specifications of the original, new devices.
8. The Sample Size for the Training Set:
Not applicable. This is a reprocessed physical device, not a machine learning model, so there is no training set in the AI sense.
9. How the Ground Truth for the Training Set Was Established:
Not applicable for the same reason as above.
Summary of what is present:
- Device: Reprocessed Electrophysiology (EP) Catheters.
- Indication for Use: "temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures."
- Performance Data: "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Electrophysiology (EP) Catheters. Biocompatibility Validation of reprocessing Sterilization Validation Function test(s)."
- Conclusion: The reprocessed device "is safe, effective and substantially equivalent to the predicate devices."
- Key tests performed: Biocompatibility, reprocessing validation, sterilization validation, function tests.
In conclusion, while the document confirms that performance testing was done and the devices were deemed "safe, effective and substantially equivalent," it lacks the detailed quantitative acceptance criteria and study particulars (like sample sizes, ground truth establishment methods, and expert involvement) commonly found in submissions for AI/ML-based medical devices or diagnostic tools.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or a stylized human figure.
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
1 2004 NoW
K030279 - Supplemental Validation Submission Re: Trade Name: See Enclosed List Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter and Patient Transducer and Electrode Cable (including connector) Regulatory Class: Class II (two) Product Code: NLH & DSA Dated: January 24, 2003 Received: January 27, 2003
Dear Ms. Barton:
The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on October 3, 2003. 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 - K030279
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.
Blymmmon for
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 3 – K030279
Enclosure – List of Devices
| K030279 Models |
|---|
| [OEM, (n)] |
| (n=6) |
| Medtronic (6) |
| 043302M |
| 043325M |
| 043328M |
| 04401SM |
| 04402SM |
| 072322M |
.
.
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Indications for Use Statement 11.
KO30279 510(k) Number (if known):
Device Name: Alliance Medical Corporation Reprocessed Electrophysiology (EP) Catheters
Indications for Use: Reprocessed Electrophysiology (EP) Catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures.
Indications for Use: Reprocessed electrophysiology catheter cables are indicated for use with the appropriate electrode catheter during electrophysiology studies.
Concurrence of CDRH, Office of Device Evaluation (ODE)
N. De Cert
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K030279
Prescription Use
(per 21 CFR 801.109)
or
Over-the-Counter Use __
nce Medical Corporatio montvslology ( fitional 510/k
13
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OCT 03 2003
PART B: 510(k) SUMMARY
Image /page/4/Picture/2 description: The image shows the logo for Alliance Medical Corporation. Above the logo is the text "KO30279 p 1/2". The logo itself is a stylized image of three curved lines above the company name, which is written in a serif font.
MEDICAL CORPORATION
TEL 480.763.5300
FAX 480.763.5310
Free 888.888.888.3433
Free 888.888.888.3433
alliance-medical.com
| Submitter: | Alliance Medical Corporation 10232 South 51 st Street Phoenix, Arizona 85044 | TEL 480.763.5300 FAX 480.763.5302 Toll Free 888.888.3424 www.alliance-medical.com |
|---|---|---|
| Contact: | Moira Barton Senior Regulatory Affairs Specialist (480) 763-5300 (o) (480) 763-5310 (f) | |
| Date of preparation: | 6/13/2002 | |
| Name of device: | Trade/Proprietary Name: Reprocessed Electrophysiology Catheter Common or Usual Name: Electrophysiology Catheter or Electrode Recording Catheter Classification Name: Electrode Recording Catheter | |
| Predicate device(s): | Legally marketed Electrophysiology Catheter devices under various 510(k) premarket notifications. | |
| K931794 Marinr Series EP Diagnostic Catheters K951347 Marinr Series EP Diagnostic Catheters K981642 Stablemapr Steerable Intracardiac Catheters | ||
| Device description: | 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. | |
| Intended use: | Reprocessed Electrophysiology Catheters are intended for temporary intracardiac sensing, recording, stimulation, and electrophysiological mapping of cardiac structures. | |
| Indications statement: | Reprocessed diagnostic EP catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures.Reprocessed electrophysiology catheter cables are indicated for use with the appropriate electrode catheter during electrophysiology studies. |
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The design, materials, and intended use of Reprocessed Technological Electrophysiology (EP) Catheters are identical to the predicate characteristics: 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. Performance data: Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Electrophysiology (EP) Catheters. Biocompatibility ● Validation of reprocessing . Sterilization Validation ● . Function test(s) Performance testing demonstrates that Reprocessed Electrophysiology (EP) Catheters perform as originally intended. Conclusion: 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.
030279
p 212
§ 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).