(119 days)
Reprocessed Electrophysiology Catheters are intended for temporary intracardiac sensing, recording, stimulation, and electrophysiological mapping of cardiac structures.
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.
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.
The provided document describes the premarket notification (510(k)) for Alliance Medical Corporation's reprocessed Electrophysiology (EP) Catheters and Cables. The FDA has determined the device is substantially equivalent to legally marketed predicate devices. The document highlights the indications for use, technological characteristics, and performance data used to support this determination.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state numerical "acceptance criteria" for performance metrics in a table. Instead, it relies on demonstrating that the reprocessed devices perform as originally intended and are substantially equivalent to predicate devices. The performance attributes evaluated are listed as types of testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Biocompatibility | Biocompatibility testing conducted |
| Effectiveness: Proper Reprocessing | Validation of reprocessing conducted |
| Safety: Sterility | Sterilization Validation conducted |
| Effectiveness: Appropriate Function of Components (mechanical, electrical) | Function test(s) conducted for each individual catheter prior to packaging |
| Overall Performance: As originally intended | Performance testing demonstrates that Reprocessed Electrophysiology (EP) Catheters perform as originally intended. |
| Overall Equivalence: Substantially equivalent to predicate devices | 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. |
2. Sample Size Used for the Test Set and Data Provenance:
The document broadly mentions "Bench and laboratory testing was conducted," but it does not specify the sample size for the test set used for performance validation.
The data provenance is implicitly from Alliance Medical Corporation's internal testing ("Bench and laboratory testing was conducted"). The document does not specify the country of origin, but given the company's address in Phoenix, Arizona, and the FDA submission, it can be inferred that the testing was likely conducted in the USA or supervised under US regulatory standards. It's a retrospective evaluation of the reprocessed devices against established performance criteria, rather than a prospective clinical study with human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the device's performance. The "ground truth" here seems to be inherent in the established performance specifications for new EP catheters and the successful completion of the described laboratory tests.
4. Adjudication Method for the Test Set:
The document does not specify an adjudication method. For laboratory and bench testing, adjudication as seen in clinical studies (e.g., 2+1 physician review) is typically not applicable. The results of the tests (e.g., sterilization efficacy, biocompatibility, functional integrity) are generally objective measurements directly compared against predefined specifications.
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:
An MRMC comparative effectiveness study is not applicable to this device. This document concerns the reprocessing of an electrophysiology catheter, which is a physical medical device, not an AI-driven diagnostic tool that assists human readers. Therefore, there is no discussion of radiologists, AI, or human reader improvement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This question is also not applicable as the device is not an algorithm or an AI system. It is a reprocessed physical medical device.
7. The Type of Ground Truth Used:
The ground truth used for assessing the reprocessed catheters is based on engineering specifications and established performance standards for new, legally marketed electrophysiology catheters. This includes:
- Biocompatibility standards: Ensuring the reprocessed device is safe for contact with human tissue.
- Reprocessing validation criteria: Demonstrating that the reprocessing procedures effectively clean and prepare the device for reuse.
- Sterilization validation criteria: Confirming the device is sterile after reprocessing.
- Functional performance specifications: Verifying that the electrical and mechanical functions of the reprocessed catheter meet the original design specifications of new devices.
8. The Sample Size for the Training Set:
The concept of a "training set" is not applicable here. This device is a reprocessed physical medical device, not an AI algorithm that undergoes machine learning training.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable as there is no training set for this type of device.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 6 2004
Alliance Medical Corporation c/o Ms. Moira Barton Senior Regulatory Affairs Specialist 10232 South 51st Street Phoenix, Arizona 85044
Re: K030026
Trade Name: Reprocessed Electrophysiology (EP) Catheters & Cables 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: April 7, 2003
Dear Ms. Barton:
Received: April 7, 2003
This letter corrects our substantially equivalent letter of May 02, 2003 regarding one of the product codes for your devices. The code was erroneously written as NHL when it should have been NLH.
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 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 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.
{1}------------------------------------------------
Page 2 - Ms. Moira Barton
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 (301) 594-4646. 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,
Blyumman for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
II. Indications for Use Statement
K030026 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)
(Division Sign-Off)
Division of Cardiovascular Devices
| 510(k) Number | K050026 |
|---|---|
| --------------- | --------- |
| Prescription Use (per 21 CFR 801.109) | or | Over-the-Counter Use | __________ | |
|---|---|---|---|---|
| --------------------------------------- | ---------------------------------------------------------- | ---- | ---------------------- | ------------ |
CONFIDENTIAL
Alliance Medical Corporation
Reprocessed Electrophysiology Catheters
Traditional 510(k)
13
{3}------------------------------------------------
Image /page/3/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 a stylized symbol featuring three horizontal lines that curve and converge, resembling a human figure in profile.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 2004 NOV
Alliance Medical Corporation c/o Ms. Moira Barton Regulatory Affairs Manager 10232 South 51st Street Phoenix, AZ 85044
Re: K030026 - Supplemental Validation Submission 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 2, 2003 Received: January 3, 2003
Dear Ms. Barton:
The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on May 2, 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.
{4}------------------------------------------------
Page 2 - K030026
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
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
{5}------------------------------------------------
Page 3 – K030026
.
Enclosure – List of Devices
and the comments of the comments of the comments of the contribution of the contribution of the contribution of the contribution of the contribution of the contribution of th
| K030026 |
|---|
| Models OEM (n)) |
| (total=37) |
| Daig (37) |
| 401206 |
| 401210 |
| 401211 |
| 401222 |
| 401223 |
| 401225 |
| 401226 |
| 401227 |
| 401228 |
| 401260 |
| 401261 |
| 401262 |
| 401275 |
| 401276 |
| 401281 |
| 401287 |
| 401305 |
| 401306 |
| 401309 |
| 401311 |
| 401328 |
| 401353 |
| 401356 |
| 401357 |
| 401362 |
| 401379 |
| 401380 |
| 401381 |
| 401382 |
| 401383 |
| 401386 |
| 401389 |
| 401392 |
| 401393 |
| 401399 |
| 401400 |
.
{6}------------------------------------------------
Page 4 - K030026
1
Image /page/6/Figure/1 description: The image shows a label with the text "K030026" at the top, followed by "M.4.1.1.5 OEM1" in the middle, and "L-370" below that. At the bottom of the label, there is a box with the number "401401" inside. The text is in black and the background is a light gray color.
100 Career States
: 上一篇:
- Participant
: 2017-02-20 1
{7}------------------------------------------------
AY - 2 2003
Image /page/7/Picture/1 description: The image shows the text "K030026" on the top line and "Q1/2" on the bottom line. The text is written in a handwritten style, with thick, dark strokes. The numbers and letters are clearly legible, although the handwriting is not perfectly neat.
Image /page/7/Picture/2 description: The image shows the word "ALLIANCE" in a serif font, with a stylized graphic above it. The graphic consists of three curved lines that are thick and black. The lines are arranged in a parallel fashion, with the top line being the shortest and the bottom line being the longest, creating a sense of depth and movement.
RATION
PART B: 510(k) SUMMARY
| TEL | 480.763.5300 |
|---|---|
| FAX | 480.763.5310 |
| Toll Free | 888.888.3433 |
| www.alliance-medical.com |
| Submitter: | Alliance Medical Corporation10232 South 51st StreetPhoenix, Arizona 85044 | TEL 480.763.53FAX 480.763.53Toll Free 888.888.34www.alliance-medical. |
|---|---|---|
| Contact: | Moira BartonSenior Regulatory Affairs Specialist(480) 763-5300 (o)(480) 763-5310 (f) | |
| Date of preparation: | 12/30/2002 | |
| Name of device: | Trade/Proprietary Name: Reprocessed ElectrophysiologyCatheterCommon or Usual Name: Electrophysiology Catheter orElectrode Recording CatheterClassification Name: Electrode Recording Catheter | |
| Predicate device(s): | Daig Response™ legally marketed Electrophysiology Catheterdevices under various 510(k) premarket notifications. | |
| K894500 Daig Electrophysiology CatheterK913940 Response™ Steerable CatheterK942379 Daig Diagnostic Electrophysiology CatheterK002976 Daig Electrophysiology Catheter - Response™ and Supreme™K012708 Reprocessed Electrophysiology Catheters | ||
| 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.Reprocessed electrophysiology catheter cables are indicated foruse with the appropriate electrode catheter duringelectrophysiology studies. |
{8}------------------------------------------------
K030026
p.2/2
| Technological characteristics: | The design, materials, and intended use of Reprocessed Electrophysiology (EP) Catheters and Electrophysiology Catheter Cables are identical to the predicate devices. The mechanism of action 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. |
| BiocompatibilityValidation of reprocessingSterilization ValidationFunction 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).