REPROCESSED ELECTROPHYSIOLOGY CATHETERS

K082023 · Ascent Healthcare Solutions · NLH · Sep 16, 2008 · Cardiovascular

Device Facts

• Record ID: K082023
• Device Name: REPROCESSED ELECTROPHYSIOLOGY CATHETERS
• Applicant: Ascent Healthcare Solutions
• Product Code: NLH · Cardiovascular
• Decision Date: Sep 16, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended 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.

Device Story

Reprocessed Electrophysiology (EP) catheters are diagnostic devices used for temporary intracardiac sensing, recording, stimulation, and mapping of cardiac structures. The device consists of a hand piece, a flexible shaft, and a distal tip containing diagnostic electrodes; deflectable models allow for curve adjustment via the hand piece. Used by physicians in clinical settings, the device transmits electrical impulses to and from the heart. Reprocessing involves cleaning, decontamination, and functional testing of previously used catheters to ensure they meet original performance specifications. The output is electrical signal data used by clinicians to map cardiac activity and guide clinical decision-making during electrophysiology procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included biocompatibility, validation of the reprocessing process, sterilization validation, functional testing of components, and packaging validation to demonstrate safety and effectiveness.

Technological Characteristics

Standard mechanical design; flexible shaft with distal diagnostic electrodes; hand-actuated deflection mechanism. Materials and dimensions are identical to predicate devices. Sterilization is performed as part of the validated reprocessing cycle. No software or electronic processing components integral to the catheter itself.

Indications for Use

Indicated for patients requiring temporary intracardiac sensing, recording, stimulation, and electrophysiological mapping of cardiac structures, including atrial mapping.

Regulatory Classification

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.

Predicate Devices

• Lasso™ 2515 Variable Circular Mapping Catheter (K031161)
• Lasso™ Deflectable Circular Mapping Catheter (K002333)

Submission Summary (Full Text)

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082023

:

## SECTION 5: 510(k) SUMMARY

| Submitter: | Ascent Healthcare Solutions<br>10232 South 51st Street<br>Phoenix, Arizona 85044 | |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Contact: | Amanda Babcock<br>Regulatory Affairs Specialist<br>[phone] (o)<br>[phone] (f)<br>[e-mail] | |
| Date of preparation: | July 15, 2008 | |
| Name of device: | Trade/Proprietary Name: Reprocessed Electrophysiology<br>Catheters<br>Classification Name: Electrode recording catheter or electrode<br>recording probe | |
| Predicate Device | 510(k) Title | Manufacturer |
| K031161 | Lasso™ 2515 Variable Circular<br>Mapping Catheter | Biosense Webster, Inc. |
| K002333 | Lasso™ Deflectable Circular<br>Mapping Catheter | Biosense Webster, Inc. |
| Device description: | Diagnostic Electrophysiology (EP) Catheters are specially<br>designed electrode catheters that transmit electrical impulses<br>and can be positioned for endocardial recording or stimulation.<br>Diagnostic EP catheters incorporate a hand piece, a flexible<br>shaft and a distal tip section containing diagnostic electrodes.<br>The distal tip of deflectable catheters can be deflected into a<br>curve by manipulating the hand piece. | |
| Indications for Use: | Reprocessed Electrophysiology Catheters are indicated for<br>temporary intracardiac sensing, recording, stimulation, and<br>electrophysiology mapping of cardiac structures. In addition, the<br>Lasso® 2515 Variable Circular Mapping Catheter is designed<br>for electrophysiological mapping of the atria of the heart. | |
| Technological<br>characteristics: | The design, materials, and intended use of Reprocessed<br>Electrophysiology Catheters are identical to the predicate<br>devices. The mechanism of action of Reprocessed<br>Electrophysiology Catheters is identical to the predicate devices<br>in that the same standard mechanical design, materials, and<br>sizes are utilized. There are no changes to the claims, intended<br>use, clinical applications, patient population, performance<br>specifications, or method of operation. In addition, Ascent<br>Healthcare Solutions' reprocessing of Electrophysiology<br>Catheters 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 [phone]. 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 [phone] or [phone] 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 | French<br>Size | Electrode<br>Spacing | Lasso<br>Diameter | Insertion<br>Length | Curve<br>Type |
|--------------------|--------------------------------------------|------------|----------------|----------------------|-------------------|---------------------|---------------|
| D7-L10-2515-<br>RT | Lasso 2515<br>Variable Mapping<br>Catheter | 10 | 7Fr | 8mm | 25-15 mm | 115 cm | Lasso |
| D7-L20-2515-<br>RT | Lasso 2515<br>Variable Mapping<br>Catheter | 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)

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