(182 days)
Not Found
No
The description focuses on the physical characteristics and intended use of a reprocessed catheter, with no mention of AI or ML capabilities.
No
The device is described as an "electrophysiology diagnostic catheter" used for sensing, stimulation, mapping, and evaluation of cardiac structures and arrhythmias. Its purpose is diagnostic, not therapeutic.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is indicated for "electrophysiological mapping and evaluation of cardiac structures and arrhythmias," which are diagnostic activities.
No
The device description clearly states it is a physical catheter with a shaft, handle, electrodes, and cables, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "intracardiac sensing, cardiac stimulation, and for the electrophysiological mapping and evaluation of cardiac structures and arrhythmias." This involves direct interaction with the patient's body for diagnostic purposes related to the heart's electrical activity.
- Device Description: The description details a catheter that is inserted into the body (intracardiac) and connects to external equipment for sensing and stimulation.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not operate on samples taken from the body; it operates within the body.
Therefore, this device falls under the category of a medical device used for in-vivo (within the living body) diagnostic procedures, not in-vitro diagnostics.
N/A
Intended Use / Indications for Use
The reprocessed EP diagnostic catheters are intended for temporary use during electrophysiology studies for intracardiac sensing, recording, cardiac stimulation, and for the electrophysiological mapping and evaluation of cardiac structures and arrhythmias.
The reprocessed electrophysiology diagnostic catheters are indicated for temporary use during electrophysiology studies for intracardiac sensing, cardiac stimulation, and for the electrophysiological mapping and evaluation of cardiac structures and arrhythmias.
Product codes
NLH
Device Description
SterilMed Reprocessed Reflexion EP diagnostic catheters consist of a shaft with a handle at the proximal end, and are considered to be steerable. These catheters have an outer diameter of either 6 or 7F and are either 99 or 105cm in length, with 2 - 20 platinum, radiopaque tip electrodes and a variety of inter-electrode spacing's and curve styles at the distal tip. The distal tip is steerable and cables connect to the handle and interface between the catheter and an external stimulator and/or an electrophysiological recorder.
Note: Only the catheter is the subject of this submission, the external stimulator and/or electrophysiological recorder and any other related equipment are not included in the scope of this submission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
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 all products produced.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
The reprocessed EP diagnostic catheters are substantially equivalent to St. Jude Medical Reflexion™ catheters.
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
Image /page/0/Picture/0 description: The image shows the logo for SterilMed INC. The text "SterilMed INC." is in a bold, sans-serif font. Below the logo, in a smaller font, is the text "Medical Device Reprocessing" and "Small Equipment & Instrument Repair."
II. SUMMARY AND CERTIFICATION
- A. 510(k) Summary
JAN 1 4 2010
| Submitter: | SterilMed, Inc. |
|---|---|
| Contact Person: | Dennis Toussaint |
| 11400 73rd Avenue North | |
| Maple Grove, MN 55369 | |
| Ph: 763-488-3410 | |
| Fax: 763-488-2051 |
| Date Prepared: | July 14, 2009 |
|---|---|
| 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 St. Jude Medical
Reflexion™ catheters. |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Description: | SterilMed Reprocessed Reflexion EP diagnostic catheters consist of a shaft with a handle at the
proximal end, and are considered to be steerable. These catheters have an outer diameter of
either 6 or 7F and are either 99 or 105cm in length, with 2 - 20 platinum, radiopaque tip
electrodes and a variety of inter-electrode spacing's and curve styles at the distal tip. The distal
tip is steerable and cables connect to the handle and interface between the catheter and an
external stimulator and/or an electrophysiological recorder. |
| | Note: Only the catheter is the subject of this submission, the external stimulator and/or
electrophysiological recorder and any other related equipment are not included in the scope of
this submission. |
| Intended Use: | The reprocessed EP diagnostic catheters are intended for temporary use during
electrophysiology studies for intracardiac sensing, recording, cardiac stimulation, and for the
electrophysiological mapping and evaluation of cardiac structures and arrhythmias. |
| 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 all products produced. |
| Conclusion: | The reprocessed EP diagnostic catheters are substantially equivalent to the St. Jude Medical
Reflexion™ electrophysiology diagnostic catheters. |
| | This conclusion is based upon the devices' similarities in functional design (principle of
operation), materials, indications for use and methods of construction. |
PAGE 1 OF 1
CONFIDENTIAL CEROPRIETARY INFORMATION OF STEBILMED, INC.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it, representing medicine and health. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
SterilMed, Inc c/o Mr. Garrett Ahlborg Regulatory Affairs Manager, 1400 73td Avenue North, Suite 100 Maple Grove, MN 55369
JAN 1 4 2010
Re: K092158
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: December 22, 2009 Received: December 23, 2009
Dear Mr. Ahlborg:
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.
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.
2
Page 2 - Mr. Garrett Ahlborg
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 vours.
Dina R. Vahuner
A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
3
Image /page/3/Picture/0 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". The logo is simple and professional, and it conveys the company's focus on medical device reprocessing and repair.
Indications for Use
K092/58.
510(k) Number (if known):
Device Name: Reprocessed Electrophysiology Diagnostic Catheters
Indications for Use:
The reprocessed electrophysiology diagnostic catheters are indicated for temporary use during electrophysiology studies for intracardiac sensing, cardiac stimulation, and 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)
wnad. vclmes
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number_ko-92158
Page 1 of 1
CONFIDENTIAL & PROPRIETARY INFORMATION OF STERILMED, INC.