(112 days)
Not Found
No
The summary describes a physical medical device (a catheter) and its mechanical features. There is no mention of software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies focus on the physical and functional characteristics of the reprocessed device.
No
The device is used for diagnosis and evaluation of cardiac conditions, not for treating them.
Yes
The "Intended Use / Indications for Use" section explicitly states that the catheters are intended for "intracardiac sensing, recording, and pacing for the electrophysiological mapping and evaluation of cardiac structures and arrhythmias," which describes a diagnostic purpose.
No
The device description clearly details a physical, steerable catheter with electrodes, a hand piece, and a shaft, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Function: The description clearly states the device is an "EP diagnostic catheter" used for "intracardiac sensing, recording, and pacing for the electrophysiological mapping and evaluation of cardiac structures and arrhythmias." This involves inserting the device into the body (intracardiac) to interact directly with the heart's electrical activity.
- Lack of Sample Testing: There is no mention of the device being used to test samples taken from the body. Its function is to directly interact with and measure electrical signals within the heart.
Therefore, based on the provided information, this device is an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The reprocessed EP diagnostic catheters are intended for temporary use during electrophysiology studies for intracardiac sensing, recording, and pacing for the electrophysiological mapping and evaluation of cardiac structures and arrhythmias.
Product codes
NLH
Device Description
The EP diagnostic catheters are steerable, multi-electrode catheters with a deflectable tip designed to facilitate electrophysiological mapping of the heart. The catheters have a high-torque shaft with a braided bi-directional deflectable tip section containing an array of ten platinum electrodes that includes a 2 mm tip dome, which can be used for stimulation and recording. The catheters are 7 french with a usable length of 115 cm. The rocker lever located on the hand piece is used to deflect the tip section. A friction control knob is located on the opposite side of the rocker lever and can be rotated clockwise to lock both the tip curve and rocker lever in place. The high-torque shaft allows the plane of the curved tip to rotate, enabling accurate positioning of the catheter tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart (cardiac structures)
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 EP diagnostic 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.
Specific non-clinical tests performed included: cleaning validation, sterilization (ISO 11135, USP ), biocompatibility testing (ISO 10993-1), ethylene oxide residual testing (ISO 10993-7), packaging validation (ASTM D 4169, 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 EP diagnostic catheters to perform as originally intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K12 1158
Image /page/0/Picture/1 description: The image shows the logo for SterilMed, INC. The logo is in black and white and features the company name in a bold, sans-serif font. Below the company name, there is smaller text that reads "Medical Device Reprocessing" and "Small Equipment & Instrument Repair."
II. SUMMARY AND CERTIFICATION
- 510(k) Summary A.
| Submitter: | Sterilmed, Inc. | AUG 6 20 |
|---|---|---|
| Contact Person: | Jason Skramsted | |
| 11400 73rd Avenue North | ||
| Maple Grove, MN 55369 | ||
| Phone: 763-488-3483 | ||
| Fax: 763-488-4491 | ||
| Date Prepared: | 13 April 2012 | |
| Trade Name: | Reprocessed Electrophysiology Diagnostic Catheters | |
| Classification Name: | Electrode Recording Catheter or Electrode Recording Probe | |
| Classification Number: | Class II, 21 CFR 870.1220 | |
| Product Code: | NLH |
| Predicate
Devices: | The reprocessed EP diagnostic catheters are substantially equivalent to the Biosense Webster Coronary Sinus
Catheters with EZ Steer Technology (K101345). |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Description: | The EP diagnostic catheters are steerable, multi-electrode catheters with a deflectable tip designed to facilitate
electrophysiological mapping of the heart. The catheters have a high-torque shaft with a braided bi-
directional deflectable tip section containing an array of ten platinum electrodes that includes a 2 mm tip
dome, which can be used for stimulation and recording. The catheters are 7 french with a usable length of
115 cm. The rocker lever located on the hand piece is used to deflect the tip section. A friction control knob
is located on the opposite side of the rocker lever and can be rotated clockwise to lock both the tip curve and
rocker lever in place. The high-torque shaft allows the plane of the curved tip to rotate, enabling accurate
positioning of the catheter tip. |
| Intended Use: | The reprocessed EP diagnostic catheters are intended for temporary use during electrophysiology studies for
intracardiac sensing, recording, and pacing for the electrophysiological mapping and evaluation of cardiac
structures and arrhythmias. |
| Technological
Characteristics: | The reprocessed EP diagnostic 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. |
| Functional and
Safety Testing: | Representative samples of reprocessed EP diagnostic 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. |
| Summary of
Non-clinical
Tests
Conducted: | Specific non-clinical tests performed included: cleaning validation, sterilization (ISO 11135, USP
), biocompatibility testing (ISO 10993-1), ethylene oxide residual testing (ISO 10993-7), packaging
validation (ASTM D 4169, 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 EP diagnostic
catheters to perform as originally intended. |
| Conclusion: | Sterilmed concludes that the reprocessed EP diagnostic catheters are safe, effective, and substantially
equivalent to the predicate devices, Biosense Webster Coronary Sinus Catheters with EZ Steer Technology
(K101345), as described in this premarket notification submission. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized design featuring three curved shapes that resemble abstract human figures or flowing ribbons. The overall design is simple and conveys a sense of unity and service.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 6 2012
Sterilmed, Inc. c/o Mr. Jason Skramsted 11400 73rd Avenue North Maple Grove, MN 55369
Re: K121158
Trade Name:
Reprocessed Electrophysiology Diagnostic Catheters (4 models manufactured by Biosense - Webster: (4 "models" BD710FJ282CT, BD710DF282CT, BD710DF282CT)
BD710FJ282RTS,
Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode recording catheter or electrode recording probe Regulatory Class: Class II (two)
Product Codes: NLH Dated: July 18, 2012 Received: July 19, 2012
Dear Mr. Skramsted:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(x) premation is substantially equivalent (for the indications
referenced above and have determined the devices marketed in interstate referenced above and have determined the arrested predicate devices marketed in interstate for use stated in the enclosure) to tegally manated provice Americal Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the encordance with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance what as proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosmetic Act (Act) that do not require approvation of the peneral controls of the Act. The Act. The Act. The Act. The Act. The Act. The You may, therefore, market the ucvice, subject to the groupen mishrandon, listing of
general controls provisions of the Act include requirements for and general controls provisions of the needing, and prohibitions against misbranding and
devices, good manufacturing practice, and prohibitions agated to contract hiability devices, good manufacturing placiic, naoching, and programon related to contract liability.
adulteration. Please note: CDRH does not evaluate information related to adulteration. Please note: CDKFI does not evaluate internations of truthful and not misleading.
2
Page 2 -Mr. Skramsted
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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 vours 1
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
STERILMED, INC.
Medical Device Reprocessing
Small Equipment & Instrument Repair
510(K) PREMARKET NOTIFICATION SUBMISSION 13 APRIL 2012 For Reprocessed EP Diagnostic Catheters
Indications for Use
510(k) Number (if known): K 121158
Device Name: Reprocessed Electrophysiology Diagnostic Catheters
Indications for Use: The reprocessed EP diagnostic catheters are intended for temporary use during electrophysiology studies for intracardiac sensing, recording, and pacing for the electrophysiological mapping and evaluation of cardiac structures and arrhythmias.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
sion Slan-Off Division of Cardiovascula
510(k) Number K121158