(62 days)
Reprocessed Electrophysiology (EP) Catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures. In addition, the Lasso® 2515 Variable Circular Mapping Catheter is designed for electrophysiological mapping of the atria of the heart.
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 an analysis of the provided text regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text, a 510(k) summary for Reprocessed Electrophysiology Catheters, does not explicitly define quantitative acceptance criteria for device performance in a table format. Instead, it broadly states that "Performance testing demonstrates that Reprocessed Electrophysiology Catheters perform as originally intended."
The closest approximations to "acceptance criteria" are the types of tests performed. Since specific numerical targets for these tests are not provided, I will present the tests as the criteria implied to demonstrate safety and effectiveness.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Bench and laboratory testing demonstrated satisfactory performance. |
| Validation of reprocessing | Bench and laboratory testing demonstrated satisfactory performance. |
| Sterilization Validation | Bench and laboratory testing demonstrated satisfactory performance. |
| Function test(s) (of components prior to packaging and labeling) | Each individual catheter tested for appropriate function. |
| Packaging Validation | Bench and laboratory testing demonstrated satisfactory performance. |
| Equivalent to predicate devices in design, materials, intended use, mechanism of action, clinical applications, patient population, performance specifications, or method of operation. | "The design, materials, and intended use of Reprocessed Electrophysiology Catheters are identical to the predicate devices." No changes to claims, intended use, clinical applications, patient population, performance specifications, or method of operation. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific sample sizes for the test sets used in biocompatibility, reprocessing validation, sterilization validation, function tests, or packaging validation. It only states that "Bench and laboratory testing was conducted." The data provenance is also not specified beyond being "bench and laboratory testing," implying it was conducted by Ascent Healthcare Solutions, likely in a controlled, prospective manner to demonstrate equivalence. There is no mention of country of origin of the data.
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 study described is a series of bench and laboratory tests to demonstrate device performance and equivalence to predicate devices, not a clinical study involving diagnosis or interpretation by human experts to establish ground truth.
4. Adjudication Method for the Test Set
This information is not applicable as the described study is focused on bench and laboratory testing of the reprocessed device itself, not on human interpretation or diagnostic accuracy where adjudication would be relevant.
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
An MRMC comparative effectiveness study was not conducted. The device is a reprocessed medical catheter, not an AI-assisted diagnostic or interpretative system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical instrument, not an algorithm, so the concept of "standalone performance" in the context of AI does not apply.
7. The Type of Ground Truth Used
For the performance testing (biocompatibility, reprocessing, sterilization, function, packaging), the ground truth was established through validated laboratory methods and engineering specifications designed to ensure the reprocessed device meets the original design requirements and safety standards of the new predicate devices. For demonstrating equivalence, the ground truth was the specifications and performance characteristics of the predicate devices.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable here. This document describes the re-processing of medical devices, not the development or training of an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set mentioned or implied in the context of this device.
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082023
:
SECTION 5: 510(k) SUMMARY
| Submitter: | Ascent Healthcare Solutions10232 South 51st StreetPhoenix, Arizona 85044 | |
|---|---|---|
| Contact: | Amanda BabcockRegulatory Affairs Specialist(480) 763-5376 (o)(480) 763-6089 (f)ababcock@ascenths.com | |
| Date of preparation: | July 15, 2008 | |
| Name of device: | Trade/Proprietary Name: Reprocessed ElectrophysiologyCathetersClassification Name: Electrode recording catheter or electroderecording probe | |
| Predicate Device | 510(k) Title | Manufacturer |
| K031161 | Lasso™ 2515 Variable CircularMapping Catheter | Biosense Webster, Inc. |
| K002333 | Lasso™ Deflectable CircularMapping Catheter | Biosense Webster, Inc. |
| 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. | |
| Indications for Use: | Reprocessed Electrophysiology Catheters are indicated fortemporary intracardiac sensing, recording, stimulation, andelectrophysiology mapping of cardiac structures. In addition, theLasso® 2515 Variable Circular Mapping Catheter is designedfor electrophysiological mapping of the atria of the heart. | |
| 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, AscentHealthcare Solutions' reprocessing of ElectrophysiologyCatheters includes removal of adherent visible soil and |
Reprocessed Electrophysiology Catheters
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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 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.
Ascent Healthcare Solutions concludes that the modified Conclusion: 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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
SEP 1 6 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ascent Healthcare Solutions c/o Ms. Amanda Babcock Regulatory Affairs Specialist, 10232 South 51st Street Phoenix, AZ 85044
Re: K082023
Reprocessed Electrophysiology Catheters (See Enclosed List) Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II (two) Product Code: NLH Dated: July 15, 2008 Received: July 16, 2008
Dear Ms. Babcock:
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. Ilisting 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. Amanda Babcock
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,
e. Attebery
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. Amanda Babcock
List of Models Found SE:
.
.
| Item No. | Description | Electrodes | FrenchSize | ElectrodeSpacing | LassoDiameter | InsertionLength | CurveType |
|---|---|---|---|---|---|---|---|
| D7-L10-2515-RT | Lasso 2515Variable MappingCatheter | 10 | 7Fr | 8mm | 25-15 mm | 115 cm | Lasso |
| D7-L20-2515-RT | Lasso 2515Variable MappingCatheter | 20 | 7Fr | 2-6-2 mm | 25-15mm | 115 cm | Lasso |
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SECTION 4: INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
082023
Device Name: Reprocessed Electrophysiology Catheters
Indications For Use: Reprocessed Electrophysiology (EP) Catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures. In addition, the Lasso® 2515 Variable Circular Mapping Catheter is designed for electrophysiological mapping of the atria of the heart.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
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)
for Buckerman
vision Sianvision of Cardiovascular Devices
K082023 510(k) Number
Ascent Healthcare Solutions Reprocessed Electrophysiology Catheters Traditional 510(k)
Page 12
§ 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).