(71 days)
Not Found
No
The document describes a reprocessed physical medical device (a catheter) and its intended use and testing. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML.
No.
The device is described as a diagnostic catheter used for electrophysiology studies, sensing, recording, stimulation, and mapping, which are diagnostic rather than therapeutic actions.
Yes
The device is intended for "intracardiac sensing, recording, and stimulation," and for "electrophysiology mapping of cardiac structures" for the "evaluation of cardiac arrhythmias," all of which are diagnostic functions.
No
The device description explicitly states it is a reprocessed catheter with a physical shaft, handle, electrodes, and cables, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "intracardiac sensing, recording, and stimulation," "temporary pacing," and "electrophysiology mapping of cardiac structures." These are all procedures performed within the body (in vivo) to diagnose and evaluate cardiac conditions.
- Device Description: The description details a catheter designed to be inserted into the heart.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens outside of the body, such as blood, urine, or tissue samples, which is the defining characteristic of an IVD.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This device is a therapeutic and diagnostic tool used directly on the patient's heart.
N/A
Intended Use / Indications for Use
The SterilMed Reprocessed Electrophysiology Diagnostic Catheters are intended for temporary use during electrophysiology studies for intracardiac sensing, recording, and stimulation. They also provide temporary pacing for the evaluation of cardiac arrhythmias, and are used for electrophysiology mapping of cardiac structures during these evaluations.
Product codes
NLH
Device Description
The device consists of a reprocessed catheter that has a high-torque shaft with a handle at the proximal end, and is steerable. These catheters have an outer diameter of 5F to 7F, a length ranging from 80 to 115 cm, with 4-10 platinum, radiopaque electrodes along the tip shaft and a variety of inter-electrode spacings and curve styles at the tip. The tip is deflectable. Specific cables, as recommended by the original manufacturer, connect to the handle and interface between the catheter and an external stimulator and/or an electrophysiologic recorder. It should be noted that this submission pertains to the catheter only. It does not include any other components in a system such as connector cables, external stimulators, or electrophysiologic recorders.
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)
Representative samples of reprocessed deflectable electrophysiology diagnostic catheters underwent design testing to demonstrate appropriate functional characteristics, and biocompatibility testing to demonstrate compatibility of the device materials. Process validation testing was done to validate the cleaning and sterilization procedures as well as the device's packaging. In addition, the manufacturing process includes visual and functional testing of all products produced.
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).
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MAR 1 - 2005
043513
Page 1 of 2
SECTION 2. SUMMARY AND CERTIFICATION
2.A. 510(K) SUMMARY
| Submitter: | SterilMed, Inc. |
|---|---|
| Contact Person: | Dr. Bruce R. Lester |
| SterilMed, Inc. | |
| 11400 73rd Avenue North | |
| Minneapolis, MN 55369 | |
| Ph: 763-488-3400 | |
| Fax: 763-488-3350 | |
| Date Prepared: | December 17, 2004 |
| Trade Name: | SterilMed Reprocessed Deflectable Electrophysiology |
| Diagnostic Catheter | |
| Classification Name: | |
| and Number: | Electrode Recording Catheter |
| Class II, 21 CFR 870.1220 | |
| Product Code: | NLH |
| Predicate Device(s): | The SterilMed reprocessed deflectable electrophysiology |
| diagnostic catheter is substantially equivalent to: the A20 | |
| (K953768), manufactured by Biosense Webster (formerly | |
| known as Cordis Webster); the Bard Dynamic Tip Catheter | |
| (K912213), manufactured by C.R. Bard Inc.; and their | |
| counterparts from the original manufacturers. | |
| Device Description: | The device consists of a reprocessed catheter that has a high- |
| torque shaft with a handle at the proximal end, and is steerable. | |
| These catheters have an outer diameter of 5F to 7F, a length | |
| ranging from 80 to 115 cm, with 4-10 platinum, radiopaque | |
| electrodes along the tip shaft and a variety of inter-electrode | |
| spacings and curve styles at the tip. The tip is deflectable. | |
| Specific cables, as recommended by the original manufacturer, | |
| connect to the handle and interface between the catheter and an | |
| external stimulator and/or an electrophysiologic recorder. It | |
| should be noted that this submission pertains to the catheter | |
| only. It does not include any other components in a system | |
| such as connector cables, external stimulators, or | |
| electrophysiologic recorders. |
1
72-55?
page 2 of 2
| Intended Use: | The SterilMed Reprocessed Electrophysiology Diagnostic Catheters are intended for temporary use during electrophysiology studies for intracardiac sensing, recording, and stimulation. They also provide temporary pacing for the evaluation of cardiac arrhythmias, and are used for electrophysiology mapping of cardiac structures during these evaluations. |
|---|---|
| Functional and | |
| Safety Testing: | Representative samples of reprocessed deflectable electrophysiology diagnostic catheters underwent design testing to demonstrate appropriate functional characteristics, and biocompatibility testing to demonstrate compatibility of the device materials. Process validation testing was done to validate the cleaning and sterilization procedures as well as the device's packaging. In addition, the manufacturing process includes visual and functional testing of all products produced. |
| Conclusion: | The deflectable electrophysiology diagnostic catheters reprocessed by SterilMed are substantially equivalent to the A20 (K953768) manufactured by Biosense Webster (formerly known as Cordis Webster) and the Bard Dynamic Tip Catheter (K912213) manufactured by C.R. Bard Inc., and their counterparts from the original manufacturers. This conclusion is based upon the fact that these devices are identical to the predicate devices in terms of their design, materials, indications for use, and construction. |
:
2
Public Health Service
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird with three wing-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 - 2005
SterilMed, Inc. Bruce Lester, Ph.D. Vice President Research and Development 11400 73rd Avenue North Minneapolis, MN 55369
Re: K043513
R043313
Trade Name: Sterilmed Reprocessed Deflectable Electrophysiology Diagnostic Catheters (See Enclosed List) Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: NLH Dated: December 17, 2004 Received: December 20, 2004
Dear Dr. Lester:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becaren b r (x) pe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the encreased of 76, the enactment date of the Medical Device Amendments, or to commerce proct to may 20, 1773, in accordance with the provisions of the Federal Food, Drug, de nec.s mat have been room do require approval of a premarket approval application (PMA). and Costietle Act (110.) that the device, subject to the general controls provisions of the Act. The r ou may, mererore, mains 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 may oc subject to back as a sateral Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 -- Bruce Lester, Ph.D.
Please be advised that FDA's issuance of a substantial equivalence determination and mean Please be advised that FDA s issuance of a cevice complies with other requirements of the Act
that FDA has made a determination that your device complies with other may that FDA has made a decemmanen and Jointistered by other Federal agencies. You must or any Federal Statules and regulations adminities. by registration and listing (21 comply with an the Act 31equirements, newally, good manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (becares over device as described in your Section 510(k) I mis letter will anow you to begin manteang your antial equivalence of your device to a legally premarket notification. The PDA mixing of basification 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 If you desire specific at not its you (240) 276-0120 Also, please note the regulation entitled, Comact the Office of Complance at (210) = 10 = 10 = 10 = 10 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = = = Misoranuing by telefono to promazion ibilities under the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-2041 or Manufacturers, micriational and Soless http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours,
Blairimmar for
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 – K043513
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1
List of Model numbers
| No. | BiosenseWebster (47 Models) | Bard (18 Models) |
|---|---|---|
| 1 | D5-08D-P10-FS | 200131 |
| 2 | D5-08D-P10-RT | 200344 |
| 3 | D5-DL-005-PS | 200345 |
| 4 | D5S-06AL-252-FS | 200443 |
| 5 | D5S-270L-B02-PS | 201101 |
| 6 | D5S-AL-252-PS | 201102 |
| 7 | D6-06DR-002-FS | 201103 |
| 8 | D6-08DR-002-FS | 201104 |
| 9 | D6-08DR-002-RT | 201105 |
| 10 | D6-08DR-252-RT | 201106 |
| 11 | D6-10DR-282-RT | 201107 |
| 12 | D6-10DR-P10-FS | 201108 |
| 13 | D6-10DR-P10-RS | 201109 |
| 14 | D6-10DR-P10-RT | 201110 |
| 15 | D6-DR-005-PS | 201112 |
| 16 | D6-DR-010-PS | 201113 |
| 17 | D6-DR-231-PS | 201114 |
| 18 | D6-DR-252-PS | 201115 |
| 19 | D6-QA-005-PS | - |
| 20 | D6-QD-010-PS | - |
| 21 | D6-QF-005-PS | - |
| 22 | D6S-08DR-PRY-FS | - |
| 23 | D6S-270L-252-PS | - |
| 24 | D7-06DL-002-FS | - |
| 25 | D7-08DL-002-FS | - |
| 26 | D7-08DR-002-FS | - |
| 27 | D7-08DR-002-RT | - |
| 28 | D7-08DR-005-FS | - |
| 29 | D7-08DR-252-RT | - |
| 30 | D7-08R-HIS-FS | - |
| 31 | D7-08R-HIS-RT | - |
| 32 | D7-10DR-282-RT | - |
| 33 | D7-10DR-P10-FS | - |
| 34 | D7-10DR-P10-RS | - |
| 35 | D7-10DR-P10-RT | - |
| 36 | D7-10FR-252-RT | - |
| 37 | D7-270RG-252-PS | - |
| 38 | D7-270RL-252-PS | - |
| 39 | D7-DL-005-PS | - |
| 40 | D7-DL-010-PS | - |
| 41 | D7-DL-252-RT | - |
| 42 | D7-DR-005-PS | - |
| 43 | D7-DR-010-PS | - |
| 44 | D7-DR-252-PS | - |
| 45 | D7-PSL-252-PS | - |
| 46 | OD7-3X4D-010-FS | - |
| 47 | OD7-8X2D-005-FS | - |
.
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Page 4 – K043513
:
6
Indications for Use
510(k) Number (if known): K043513
Reprocessed Deflectable Electrophysiology Diagnostic Catheters Device Name:
Indications For Use:
The SterilMed Reprocessed Electrophysiological Diagnostic Catheters are intended for The Dierminou resproosescophysiology studies for intracardiac sensing, recording, and stimulation. They also provide temporary pacing for the evaluation of cardiac armulation. - They are used for electrophysiology mapping of cardiac structures during these evaluations.
Prescription Use X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
Blumme
(Division Sign-Off)
Division of Cardiovascular Devices 510(k) Number
Page 1 of 1
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