(253 days)
Not Found
No
The summary describes a reprocessed electrophysiology catheter used for mapping the heart. It mentions compatibility with a navigation system but does not describe any AI/ML capabilities for data analysis, interpretation, or decision support. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is indicated for electrophysiological mapping, stimulation, and recording, which are diagnostic procedures, not therapeutic interventions.
Yes
Explanation: The device is indicated for "electrophysiological mapping of the cardiac structures of the heart" and obtaining "electrograms in the atrial regions of the heart," which are diagnostic activities.
No
The device description clearly states it is a physical catheter with electrodes and navigation capabilities, not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The description clearly states that this device is a catheter used for electrophysiological mapping of the cardiac structures of the heart. It is inserted into the body to stimulate and record electrical signals directly from the heart tissue.
- Lack of Specimen Analysis: There is no mention of analyzing any specimens taken from the body. The device interacts directly with the internal anatomy.
Therefore, based on the provided information, this device falls under the category of an invasive medical device used for diagnosis and potentially treatment (though the description focuses on mapping).
N/A
Intended Use / Indications for Use
The Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters are indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. stimulation and recording only. The catheters are designed to obtain electrograms in the atrial regions of the heart.
The Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters with navigation (Nav) capabilities provide location information when used with compatible Carto® 3 EP Navigation Systems. (These catheters are not compatible with Carto® 3 EP Navigation Systems prior to version 2.3.)
Product codes (comma separated list FDA assigned to the subject device)
NLH
Device Description
The Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters are designed to facilitate electrophysiological mapping of the atria of the heart. They are deployed in the right or left atrium through an 8F guiding sheath. These deflectable catheters consist of a circular spine on the distal tip with platinum/iridium electrodes that can be used for stimulation and recording.
Models designated as NAV are compatible with the Carto® 3 EP Navigation System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac structures of the heart, atrial regions of the heart, right or left atrium
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Representative samples of Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters were tested to demonstrate appropriate functional characteristics. Process validation testing was performed to validate the cleaning and sterilization procedures as well as device packaging. In addition, the manufacturing process includes visual and validated functional testing of 100% of products reprocessed. The Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters are reprocessed no more than one (1) time. Each device is marked and tracked through each reprocessing cycle. After the device has reached the maximum number of reprocessing cycles (1), the device is rejected from further reprocessing. Reprocessing is performed only by the manufacturer Sterilmed.
Specific non-clinical tests performed included: cleaning validation, sterilization validation (ISO 11135, USP ), biocompatibility testing (ISO 10993-1), ethylene oxide residual testing (ISO 10993-7), packaging validation (ASTM D 4169, ASTM F 88, ASTM F 2096), and shelf life validation (ASTM F 1980). In addition, validation of functional performance (bench testing) was performed through simulated use, visual inspection, fatigue testing, and function testing. Performance testing shows the Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters to perform as originally intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 23, 2016
Sterilmed. Inc. Patricia Kaufman Regulatory Affairs Specialist 5010 Cheshire Parkway, Suite 2 Plymouth, Minnesota 55446
Re: K153006
Trade/Device Name: Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Catheter Electrophysiology (EP) Catheters (See attached list of models) Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: NLH Dated: May 23, 2016 Received: May 24, 2016
Dear Patricia Kaufman:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mitchell Stein
for Bram D. Zuckerman, M.D Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| Catheter | Model | Poles | Loop | | Curve | Electrode
Spacing (mm) | Shaft | |
|--------------------------------------|---------|-------|---------------|-------------|-------|---------------------------|-------------|-------------|
| | | | Diameter (mm) | Profile (F) | | | Profile (F) | Length (cm) |
| LASSO 2515 NAV eco Variable Catheter | | | | | | | | |
| 1 | D134301 | 20 | 25 - 15 | 4 | D | 2-6-2 | 7 | 115 |
| 2 | D134302 | 10 | 25 - 15 | 4 | D | 8 | 7 | 115 |
| LASSO NAV eco Catheter | | | | | | | | |
| 3 | D134901 | 10 | 15 | 4.5 | D | 4.5 | 7 | 115 |
| 4 | D134902 | 20 | 15 | 4.5 | D | 4.5 pairs | 7 | 115 |
| 5 | D134903 | 10 | 20 | 4.5 | D | 6.0 | 7 | 115 |
| 6 | D134904 | 20 | 20 | 4.5 | D | 6.0 pairs | 7 | 115 |
| 7 | D134905 | 10 | 25 | 4.5 | D | 8.0 | 7 | 115 |
| 8 | D134906 | 20 | 25 | 4.5 | D | 8.0 pairs | 7 | 115 |
| 9 | D134909 | 10 | 20 | 4.5 | D | 6.0 | 7 | 115 |
K153006 MODELS INTENDED FOR REPROCESSING
3
Indications for Use
510(k) Number (if known) K153006
Device Name
Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters
Indications for Use (Describe)
The Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters are indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. stimulation and recording only. The catheters are designed to obtain electrograms in the atrial regions of the heart.
The Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters with navigation (Nav) capabilities provide location information when used with compatible Carto® 3 EP Navigation Systems. (These catheters are not compatible with Carto® 3 EP Navigation Systems prior to version 2.3.)
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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2. 510(K) SUMMARY
This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| APPLICANT | Sterilmed, Inc.
5010 Cheshire Pkwy N, Suite 2
Plymouth, MN 55446
www.sterilmed.com
Tel: (888) 541-0078 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| OFFICIAL
CORRESPONDENT | Patricia F. Kaufman
Sterilmed, Inc.
5010 Cheshire Pkwy N, Suite 2
Plymouth, MN 55446
pkaufman@sterilmed.com
Tel: (763) 488-3211
Fax: (763) 488-3350 |
| DATE PREPARED | 12 October 2015 |
| TRADE NAME | Reprocessed LASSO NAV eco and Reprocessed LASSO
2515 NAV eco Variable Electrophysiology (EP) Catheters |
| COMMON NAME | Electrophysiology Diagnostic Catheters |
| 510(K) NUMBER | K153006 |
| DEVICE CLASSIFICATION | Name: Catheter, Recording, Electrode, Reprocessed
Regulation No: §870.1220
Product Code: NLH
Class: II
Panel: Cardiovascular |
| PREDICATE DEVICE | Lasso 2515 NAV eco Variable Catheter, Lasso NAV eco
Catheter - K113213 |
SUBSTANTIALLY EQUIVALENT TO:
The Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters are substantially equivalent to the single use Biosense Webster Lasso 2515 NAV eco Variable Catheter and Lasso NAV eco Catheter in intended use and technological features.
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
5
The Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters are designed to facilitate electrophysiological mapping of the atria of the heart. They are deployed in the right or left atrium through an 8F guiding sheath. These deflectable catheters consist of a circular spine on the distal tip with platinum/iridium electrodes that can be used for stimulation and recording.
Models designated as NAV are compatible with the Carto® 3 EP Navigation System.
| | Catheter
Model | Poles | Loop | | Curve | Electrode
Spacing (mm) | Shaft | |
|---------------------------------------|-------------------|-------|---------------|-------------|-------|---------------------------|-------------|-------------|
| | | | Diameter (mm) | Profile (F) | | | Profile (F) | Length (cm) |
| LASSO® 2515 NAV eco Variable Catheter | | | | | | | | |
| 1 | D134301 | 20 | 25 - 15 | 4 | D | 2 - 6 - 2 | 7 | 115 |
| 2 | D134302 | 10 | 25 - 15 | 4 | D | 8 | 7 | 115 |
| LASSO® NAV eco Catheter | | | | | | | | |
| 3 | D134901 | 10 | 15 | 4.5 | D | 4.5 | 7 | 115 |
| 4 | D134902 | 20 | 15 | 4.5 | D | 4.5 pairs | 7 | 115 |
| 5 | D134903 | 10 | 20 | 4.5 | D | 6.0 | 7 | 115 |
| 6 | D134904 | 20 | 20 | 4.5 | D | 6.0 pairs | 7 | 115 |
| 7 | D134905 | 10 | 25 | 4.5 | D | 8.0 | 7 | 115 |
| 8 | D134906 | 20 | 25 | 4.5 | D | 8.0 pairs | 7 | 115 |
| 9 | D134909 | 10 | 20 | 4.5 | D | 6.0 | 7 | 115 |
The following models are the subject of this submission:
INDICATIONS FOR USE:
The Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters are indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. stimulation and recording only. The catheter is designed to obtain electrograms in the atrial regions of the heart.
The Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters with navigation (NAV) capabilities provide location information when used with compatible Carto® 3 EP Navigation Systems. (These catheters are not compatible with Carto® 3 EP Navigation Systems prior to version 2.3.)
TECHNICAL CHARACTERISTICS:
The Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters are identical to the predicate devices in design, materials of construction, and intended use. There are no changes to the clinical applications, patient population, performance specifications, or method of operation.
6
PERFORMANCE STANDARDS:
No applicable performance standards have been issued under 514 of the Food, Drug and Cosmetic Act for a Catheter, Recording, Electrode, Reprocessed §870.1220.
FUNCTIONAL AND SAFETY TESTING:
Representative samples of Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters were tested to demonstrate appropriate functional characteristics. Process validation testing was performed to validate the cleaning and sterilization procedures as well as device packaging. In addition, the manufacturing process includes visual and validated functional testing of 100% of products reprocessed. The Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters are reprocessed no more than one (1) time. Each device is marked and tracked through each reprocessing cycle. After the device has reached the maximum number of reprocessing cycles (1), the device is rejected from further reprocessing. Reprocessing is performed only by the manufacturer Sterilmed.
SUMMARY OF NONCLINICAL TESTING:
Specific non-clinical tests performed included: cleaning validation, sterilization validation (ISO 11135, USP ), biocompatibility testing (ISO 10993-1), ethylene oxide residual testing (ISO 10993-7), packaging validation (ASTM D 4169, ASTM F 88, ASTM F 2096), and shelf life validation (ASTM F 1980). In addition, validation of functional performance (bench testing) was performed through simulated use, visual inspection, fatigue testing, and function testing. Performance testing shows the Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters to perform as originally intended.
BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
Sterilmed concludes that the Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters are safe, effective, and substantially equivalent to the predicate devices, Biosense Webster Lasso Catheters (K113213), as described in this premarket notification submission. The Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters are substantially equivalent to the listed predicate devices with respect to their indications for use (intended use) and technical characteristics. The information and data provided in this 510(k) submission identifies no new safety or effectiveness issues.