(246 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.
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.
This document is a 510(k) summary for the Alliance Medical Corporation's Reprocessed Electrophysiology (EP) Catheters. As such, it describes the device and its intended use, but it does not detail specific acceptance criteria or a dedicated study that proves the device meets particular performance metrics beyond what is stated in the "Performance data" section.
However, based on the provided text, we can infer some information relating to acceptance criteria and the "study" (validation activities) performed.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results. Instead, it broadly states that "Performance data: Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Electrophysiology (EP) Catheters."
The reported areas of performance validation are:
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Biocompatibility | Validation performed (implies meeting biocompatibility standards) |
| Reprocessing Effectiveness | Validation performed (implies effective removal of soil & decontamination) |
| Sterilization Effectiveness | Validation performed (implies effective sterilization) |
| Functionality | Each individual reprocessed catheter is tested for appropriate function of its components (implies meeting functional requirements) |
| Overall safety and effectiveness | "Performance testing demonstrates that Reprocessed Electrophysiology (EP) Catheters perform as originally intended." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states, "Each individual electrophysiology catheter is tested for appropriate function of its components prior to packaging and labeling operations." This implies that every reprocessed device undergoes functional testing as part of the quality control process.
For biocompatibility, reprocessing validation, and sterilization validation, the document does not specify the sample size or data provenance. These types of validations are typically prospective studies conducted in a controlled laboratory environment. The country of origin of the data is not specified, but given the company (Alliance Medical Corporation) is based in Phoenix, Arizona, USA, it's highly probable the testing was conducted in the US or by a contracted lab.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The validation activities mentioned (biocompatibility, reprocessing, sterilization, function tests) are primarily objective technical validations and would not typically involve expert "ground truth" establishment in the way it's used for AI/clinical diagnostic studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not applicable to the types of technical validations described in the document. Adjudication methods are typically used in clinical studies where subjective interpretation or classification is involved.
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
No, an MRMC comparative effectiveness study was not done. This document describes the reprocessing of medical devices, not an AI software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This document pertains to physical reprocessed medical devices, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mentioned "Function test(s)," the ground truth is against the original intended function of the new (unreprocessed) device. For biocompatibility, reprocessing, and sterilization, the "ground truth" is established by regulatory standards and industry-accepted test methods that define what constitutes a "biocompatible," "effectively reprocessed," or "sterile" device.
8. The sample size for the training set
This concept is not applicable to this document. "Training set" refers to data used to train an AI algorithm, which is not the subject of this 510(k) summary.
9. How the ground truth for the training set was established
This concept is not applicable to this document.
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Image /page/0/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 2004
Alliance Medical Corporation c/o Ms. Moira Barton Regulatory Affairs Manager 10232 South 51st Street Phoenix. AZ 85044
Re: K030187 - Supplemental Validation Submission Trade Name: See Enclosed List Regulation Number: 21 CFR 870.1220 & 870.2900 Regulation Name: Electrode Recording Catheter and Patient Transducer and Electrode Cable (including connector) Regulatory Class: Class II (two) Product Code: NLH & DSA Dated: January 17, 2003 Received: January 21, 2003
Dear Ms. Barton:
The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on September 24, 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 - K030187
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 littp://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Bfimmuman 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 4 – K030187
Enclosure – List of Devices
:
| Bard (24) |
|---|
| 200131 |
| 200344 |
| 200526 |
| 200740 |
| 200769 |
| 200770 |
| 200794 |
| 200795 |
| 200796 |
| 200797 |
| 200798 |
| 201101 |
| 201102 |
| 201103 |
| 201104 |
| 201105 |
| 201106 |
| 201107 |
| 201109 |
| 201114 |
| 320001 |
| 320002 |
| 7FAM00004 |
| 7FAM00007 |
:
: 上一篇:
.
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Indications for Use Statement ll.
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. Q. Cetter
diovascular Devices
510(k) Number K030187
Prescription Use
(per 21 CFR 801.109)
ОГ
Over-the-Counter Use
Alliance Medical Corporation Reprocessed Electrophysiology Catheters Traditional 510(k)
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Image /page/4/Picture/1 description: The image shows the text "p. 1/2" in the upper left corner. Below the text are three curved lines stacked on top of each other. The lines are thick and black, and they curve upwards.
A L L I A N C E
MEDICAL CORPORATION
PART B: 510(k) SUMMARY
SEP 2 4 2003
8.5100
8.5310
8.12.2018 12.00 10.000
2.1.2018
1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.000 1.
| Submitter: | Alliance Medical Corporation10232 South 51st StreetPhoenix, Arizona 85044 | TEL 480.763FAX 480.763Toll Free 888.888www.alliance-medic |
|---|---|---|
| Contact: | Moira BartonSenior Regulatory Affairs Specialist(480) 763-5300 (o)(480) 763-5310 (f) | |
| Date of preparation: | 6/13/2002 | |
| Name of device: | Trade/Proprietary Name: Reprocessed ElectrophysiologyCatheterCommon or Usual Name: Electrophysiology Catheter orElectrode Recording CatheterClassification Name: Electrode Recording Catheter | |
| Predicate device(s): | ||
| K891908 Bard Tip Deflecting Electrode CatheterK874208 Bard Octapolar Electrode CatheterK881966 Electrophysiology Electrode Catheter with Silver/SilverK992373 Orbiter ST Diagnostic Electrode Catheter | ||
| 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 handpiece, a flexibleshaft and a distal tip section containing diagnostic electrodes.The distal tips of deflectable catheters can be deflected into acurve by manipulating the handpiece; fixed curve catheters havean established distal tip shape. | |
| Intended use: | Reprocessed Electrophysiology Catheters are intended fortemporary intracardiac sensing, recording, stimulation, andelectrophysiological mapping of cardiac structures. | |
| Indicationsstatement: | Reprocessed diagnostic EP catheters are indicated fortemporary intracardiac sensing, recording, stimulation andelectrophysiological mapping of cardiac structures. | |
| Technologicalcharacteristics: | The design, materials, and intended use of ReprocessedElectrophysiology (EP) Catheters are identical to the predicatedevices. The mechanism of action of ReprocessedElectrophysiology (EP) Catheters is identical to the predicate |
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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.
§ 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).