(103 days)
Reprocessed diagnostic EP catheters are indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology 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.
The provided text describes the reprocessing of Electrophysiology (EP) Catheters by Alliance Medical Corporation and their substantial equivalence to predicate devices, rather than a device with AI components. Therefore, many of the requested criteria, such as "effect size of how much human readers improve with AI vs without AI assistance" or "sample size for the training set," are not applicable to this submission.
However, I can extract information related to the performance data and the conclusion of substantial equivalence.
Here's the summary of the acceptance criteria and study findings based on the provided text:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness (Implied for substantial equivalence) | Demonstrated through bench and laboratory testing. |
| Biocompatibility | Tested and demonstrated. |
| Validation of reprocessing | Tested and demonstrated. |
| Sterilization Validation | Tested and demonstrated. |
| Function Test(s) | Tested and demonstrated for appropriate function of components. |
| Packaging Validation | Tested and demonstrated. |
| Performance as originally intended (i.e., identical to predicate devices) | Demonstrated that Reprocessed EP Catheters perform as originally intended. |
| Design, materials, and intended use are identical to predicate devices | Stated as identical. |
| Mechanism of action is identical to predicate devices | Stated as identical. |
| No changes to claims, intended use, clinical applications, patient population, performance specifications, or method of operation | Stated as no changes. |
2. Sample sized used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document globally refers to "bench and laboratory testing" and "each individual electrophysiology catheter is tested," but does not provide specific numbers for the test set.
- Data Provenance: Not specified. It's laboratory testing, implying controlled environments, but the geographical origin of the data is not mentioned. It is prospective testing of reprocessed devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is not an AI/diagnostic imaging device that would typically involve expert ground truth for image interpretation. The "ground truth" for this device would be its physical and functional performance meeting specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study requiring adjudication of diagnostic interpretations. The performance testing involves objective measures (e.g., sterilization validation, function tests).
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:
- Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm-based device. The performance testing is for the physical medical device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance validation is adherence to established engineering specifications and performance benchmarks, demonstrating that the reprocessed catheters function identically to their original, predicate counterparts (e.g., biocompatibility standards, functional electrical properties, sterility).
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/machine learning device.
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K043393
1 of 2
SECTION B: 510(k) SUMMARY
10232 South 5 Ist Street Phoenix, Arizona 85044
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 |
|---|---|
| Contact: | Jenn Selvey |
Research and Development Specialist (480) 763-2950 (o) (480) 763-5310 (f) iselvey@alliance-medical.com
November 16, 2004 Date of preparation:
Trade/Proprietary Name: Reprocessed EP Technologies Name of device: Electrophysiology Catheters Common or Usual Name: Electrophysiology Catheter or Electrode Recording Catheter Classification Name: Electrode Recording Catheter
MAR 2 3 2005
Predicate device:
| K924109 | Steerocath Dx |
|---|---|
| K924163 | Polaris LE |
| K003452 | Polaris X |
| K954651 | Electrode Recording 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 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.
- Reprocessed Electrophysiology Catheters are intended for Intended use: temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.
- Reprocessed diagnostic EP catheters are indicated for Indications temporary intracardiac sensing, recording, stimulation, and statement: electrophysiology mapping of cardiac structures.
The design, materials, and intended use of Reprocessed Technological Electrophysiology Catheters are identical to the predicate characteristics: devices. The mechanism of action of Reprocessed
Alliance Medical Corporation Reprocessed EP Technologies EP Catheters Traditional 510(k)
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Image /page/1/Picture/0 description: The image shows handwritten text. The first line reads "K043393". The second line reads "2 of 2". The handwriting is somewhat rough, but the characters are still legible.
Electrophysiology Catheters is identical to the predicate devices in that the same standard mechanical design, marerials 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 EP Technologies 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.
Bench and laboratory testing was conducted to demonstrate Performance data: performance (safety and effectiveness) of the Reprocessed Electrophysiology (EP) Catheters.
- Biocompatibility
- Validation of reprocessing .
- Sterilization Validation .
- . Function test(s)
- Packaging Validation .
Performance testing demonstrates that Reprocessed Electrophysiology (EP) Catheters perform as originally intended.
Alliance Medical Corporation concludes that the modified device Conclusion: (the Reprocessed Electrophysiology Catheter) is safe, effective and substantially equivalent to the predicate devices as described herein.
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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of an eagle with three lines forming its body and wings, conveying a sense of motion and progress.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 3 2005
Alliance Medical Corporation c/o Ms. Jenn Selvey Research and Development Specialist 10232 South 51st Street Phoenix, AZ 85044
Re: K043393
K043393
Trade Name: Reprocessed EP Technologies Electrophysiology Catheters (See Enclosed List)
Trade Name: Reprocessed EP Technologies Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: NLH Dated: January 19, 2005 Received: January 21, 2005
Dear Ms. Selvey:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 910(x) press.) presidentially equivalent (for the indications for use stated in the enclosure) the aveced predicate devices marketed in interstate for use stated in the encrosure) to regally manative in commerce prior to May 20, 1770, the enascance with the provisions of the Federal Food, Drug, devices that have bech recalismed in asserval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval applicati and Cosment Act (Act) that do not require subject to the general controls provisions of the Act. The Act. The You may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the fiel labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it If your device is classified (500 abs. 19) ins. Existing major regulations affecting your device can hiay be subject to such additional controller. Entroller of the 21, Parts 800 to 898. In addition, FDA may the found in the Gods acements concerning your device in the Federal Register.
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Page 2 - Ms. Jenn Selvey
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a budenice complies with other requirements of the Act that I DA has made a determination administered by other Federal agencies. You must of ally reachardes and regularents aincluding, but not limited to: registration and listing (21 Comply with an the Hot 810 CFR Part 801); good manufacturing practice requirements as set CTN Fart 807), rabeing (21 OFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro horoms (seting your device as described in your Section 510(k) This icher wifi anow you to oegin maining of substantial equivalence of your device to a legally premarket notification: "The PDA mailing of basification 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 If you desire specific acrisoliation of (240) 276-0120 Also, please note the regulation entitled, Connect the Office of Comparket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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,
B. Limmer 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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Page 3 – Ms. Jenn Selvey
Г
..
| Orig models found to be SE |
|---|
| EPT-Dx (5) |
| 1101 |
| 1102 |
| 1103 |
| 1300 |
| 1301 |
| Valve Mapper SteeroCath-Dx (7) |
| 2200 |
| 2250 |
| 2270 |
| 2250K2 |
| 2270K2 |
| 2270L |
| 2270N4 |
| Polaris-Dx (15) |
| 5571 |
| 5572 |
| 5574 |
| 5570S |
| 5571S |
| 5572S |
| 5573S |
| 5574S |
| 5577 |
| 5579 |
| 5427S |
| 9663S |
| 5575 |
| 5576 |
| 5578 |
| Polaris LE Mapping (2) |
| 5593 |
| 5595 |
.
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Indications for Use Statement 2.
510(k) Number (if known):
510(k) Number (if known):
Device Name: Alliance Medical Corporation Reprocessed EP Technologies Electrophysiology (EP) Catheters
Indications for Use: Reprocessed diagnostic EP catheters are indicated for Indications for ooking, recording, stimulation, and electrophysiology 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. Hummer
Division Sign-Of Division of Cardlovascular Devices 510(k) Number
§ 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).