(76 days)
Not Found
No
The summary describes a reprocessed ultrasound imaging catheter and its intended use, device description, and performance testing. There is no mention of AI, ML, or any related technologies in the provided text.
No
The device is used for imaging and visualization of anatomy and other devices, not for treating a condition.
Yes
The device is intended for "intravascular or intracardiac ultrasound imaging in order to provide visualization of vascular anatomy, cardiac and great vessel anatomy and physiology, or other devices in the heart." This visualization is used to understand the patient's condition, which is a diagnostic purpose. The predicate device also explicitly includes "Diagnostic" in its name.
No
The device description clearly states it is a physical catheter with a transducer, which is hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "intravascular or intracardiac ultrasound imaging in order to provide visualization of vascular anatomy, cardiac and great vessel anatomy and physiology, or other devices in the heart." This describes a device used in vivo (within the body) for imaging and visualization.
- Device Description: The description details a catheter with an ultrasonic transducer for imaging, which is consistent with an in vivo imaging device.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health status. There is no mention of analyzing biological samples or performing tests on specimens in the provided text.
Therefore, the SterilMed Reprocessed Imaging Catheter is an in vivo imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The SterilMed Reprocessed Imaging Catheter is intended for intravascular or intracardiac ultrasound imaging in order to provide visualization of vascular anatomy, cardiac and great vessel anatomy and physiology, or other devices in the heart. This device is intended for use in the right-heart only.
Product codes (comma separated list FDA assigned to the subject device)
NLI
Device Description
The SterilMed Reprocessed Imaging Catheter is intended to be used with a compatible ultrasound imaging system. It is steerable, has a useable length of 90 cm and a diameter of 10 French. The distal end of the catheter contains an ultrasonic phased array imaging transducer. The transducer offers imaging modes at frequencies between 4.0 and 10.0 MHz.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
intravascular or intracardiac (right-heart only), vascular anatomy, cardiac and great vessel anatomy
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 imaging catheters underwent design testing to demonstrate appropriate functional characteristics. 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. Finally, testing to support the required Special 510(k) Report was successfully performed and provided to the Agency.
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
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
K043453
Page 1 of 2
MAR 1 - 2065
SUMMARY AND CERTIFICATION SECTION 2.
2.A. 510(K) SUMMARY
f
| Submitter: | SterilMed, Inc. |
|---|---|
| Contact Person: | Dr. Bruce R. Lester |
| SterilMed, Inc. | |
| 11400 73rd Avenue North | |
| Minneapolis, MN 55369 | |
| Ph: 763-488-3409 | |
| Fax: 763-488-3350 | |
| Date Prepared: | December 13, 2004 |
| Trade Name: | SterilMed Reprocessed IVUS Imaging Catheter |
| Classification Name: | |
| and Number: | Angiography Catheter |
| Class II, 21 CFR 870.1200 | |
| Product Code: | NLI |
| Predicate Device(s): | The SterilMed Reprocessed Imaging Catheter is |
| substantially equivalent to the AcuNav™ Diagnostic | |
| Ultrasound Catheter Manufactured by Acuson Corp. | |
| (K992631). | |
| Device Description: | The SterilMed Reprocessed Imaging Catheter is intended to |
| be used with a compatible ultrasound imaging system. It is | |
| steerable, has a useable length of 90 cm and a diameter of | |
| 10 French. The distal end of the catheter contains an | |
| ultrasonic phased array imaging transducer. The transducer | |
| offers imaging modes at frequencies between 4.0 and 10.0 | |
| MHz. | |
| Intended Use: | The SterilMed Reprocessed Imaging Catheter is intended |
| for intravascular or intracardiac ultrasound imaging in | |
| order to provide visualization of vascular anatomy, cardiac | |
| and great vessel anatomy and physiology, or other devices | |
| in the heart. This device is intended for use in the right | |
| heart only. | |
| Functional and | |
| Safety Testing: | Representative samples of reprocessed imaging catheters |
| underwent design testing to demonstrate appropriate |
1
1 6 4 34 1. 3
page 2 of 2
functional characteristics. 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. Finally, testing to support the required Special 510(k) Report was successfully performed and provided to the Agency.
The imaging catheters reprocessed by SterilMed are Conclusion: substantially equivalent to the AcuNav™ Diagnostic Ultrasound Catheter Manufactured by Acuson Corp. (K992631). This conclusion is based upon the fact that this device is identical to the predicate device in terms of its design, materials, indications for usc, and construction.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight.
MAR 1 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SterilMed, Inc. c/o Bruce Lester, Ph.D. Vice President Research and Development 11400 73rd Avenue North Minneapolis, MN 55369
Re: K043453
1949139
Trade Name: Sterilmed Reprocessed IVUS Imaging Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: NLI Dated: December 13, 2004 Received: December 15, 2004
Dear Dr. Lester:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have teviewed your bocurer. 310(s) fee device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regars actment date of the Medical Device Amendments, or to conninered provision to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices mat have been recuire approval of a premarket approval application (PMA). and Cosment Act (Act) that to not requent of the general controls provisions of the Act. The 1 ou may, therefore, market the act include requirements for annual registration, listing of general controls profitive proctice, 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 If your device is crassimod (soc ac refrols. Existing major regulations affecting your device can may be subject to saen adonations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Coursements 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 does not mean Please be advised that I DA 3 issualites of a cases of the other requirements of the Act that I DA has made a dolorimiation administered by other Federal agencies. You must or any rederal statutes and regulations and limited to: registration and listing (21 Comply with an the Act 3 requirements, morealing, and manufacturing practice requirements as set CFK Part 807), adomig (21 CFRT art 820), good if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro risions (oveting your device as described in your Section 5 lo(k) This letter will anow you to begin maxicoling of substantial equivalence of your device to a legally premarket notheation. The PDA muding of backandar 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 titsire specific at 700-10-10-10-10-20 Also, please note the regulation entitled, Collider the Orifice of Councilication" (21CFR Part 807.97). You may obtain of Small other general information on your response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours,
Bhiminor for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 3 -- Bruce Lester, Ph.D.
Enclosure - List of Devices Substantially Equivalent
:
| Orig Models found to be SE |
|---|
| Acuson (1) |
| 55790 |
5
Indications for Use
510(k) Number (if known):
Device Name:
Reprocessed Imaging Catheters
Indications For Use:
The SterilMed Reprocessed Imaging Catheter is intended for intravascular or intracardiac ultrasound imaging in order to provide visualization of vascular anatomy, cardiac and great vessel anatomy and physiology, or other devices in the heart. This device is intended for use in the right-heart only.
Prescription Use
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)
Blamminion
ision Sign-Off Division of Cardiovas 510(k) Number
Page I of 1