(23 days)
Not Found
No
The summary describes a mechanical dilator and explicitly states "Not Found" for mentions of AI, DNN, or ML, and lacks any description of training or test sets typically associated with AI/ML development.
No.
The device is a dilator used to introduce a catheter; it facilitates a procedure but does not directly treat a disease or condition itself.
No
Explanation: The "Intended Use" states that the device is intended to introduce a catheter into the heart, which is a procedural function, not a diagnostic one.
No
The device description clearly describes a physical, flexible tube with a tapered end, a hemostasis valve, and a stopcock. This indicates a hardware device, not a software-only device.
Based on the provided information, 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, or tissue) to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a "Dilator for Artisan™ Control Catheter" and its intended use is to "introduce the Artisan Control Catheter into the atria and through the intraatrial septum". This is a device used within the body for a procedural purpose (facilitating catheter insertion), not for testing samples outside the body.
- Lack of IVD Characteristics: The description does not mention any testing, analysis of biological samples, reagents, or any other components typically associated with IVD devices.
Therefore, this device is a surgical or interventional medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Dilator for Artisan™ Control Catheter is intended to introduce the Artisan Control Catheter into the atria and through the intraatrial septum from the right side of the heart to the left side.
Product codes (comma separated list FDA assigned to the subject device)
DRE
Device Description
The Dilator for Artisan Control Catheter is made of a flexible tube with a tapered end on the distal outer diameter. A hemostasis valve and stopcock are attached on the proximal end. The Dilator has a through lumen for introduction over a guide wire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
atria, intraatrial septum, heart
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)
Not Found
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
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).
0
K082075 p 1/2
SECTION 7
AUG 1 5 2008
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number:
Applicant Information:
| Owner Name: | Hansen Medical, Inc. |
|---|---|
| Address: | 800 East Middlefield Rd. |
| Mountain View, CA. 94043 | |
| Office: | 650-404-5800 |
| Contact Person: | Kate Whitin |
| Phone Number: | 650 404 5800 |
| Facsimile Number: | 650 404 5901 |
Date Prepared: 7/21/08
Device Information:
Classification: Class II Trade Name; Hansen Medical Dilator for Artisan™ Control Catheter Dilator for Artisan Control Catheter Common name: Classification name: Vessel Dilator (21 CFR 870.1310, Product Code DRE)
Predicate Devices:
Hansen Medical Transseptal Needle and Dilator (K061070).
Device Description:
The Dilator for Artisan Control Catheter is made of a flexible tube with a tapered end on the distal outer diameter. A hemostasis valve and stopcock are attached on the proximal end. The Dilator has a through lumen for introduction over a guide wire.
Hansen Medical 510(k) Summary Special 510(k) Submission Section 7, Page 1 of 2
COMPANY CONFIDENTIAL DO NOT COPY
1
Intended Use:
The Dilator for Artisan Control Catheter is intended to introduce the Artisan Control Catheter into the atria and through the intraatrial septum from the right side of the heart to the left side.
Comparison to Predicate Device(s):
The Dilator for Artisan Control Catheter has the same general intended use and similar technological characteristics as the predicate device. The indications for use is confined to the role of the dilator without the needle.
Substantial equivalence:
The Dilator has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the Dilator and its predicate device raise no new issues of safety or effectiveness. Based upon this pre-market notification, the Dilator is substantially equivalent.
Hansen Medical 510(k) Summary
Special 510(k) Submission
Section 7, Page 2 of 2
COMPANY CONFIDENTIAL DO NOT COPY
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 5 2008
Hansen Medical, Inc. c/o Ms. Kate Whitin Director, Regulatory Affairs 800 Middlefield Road Mountain View, CA 94043
Re: K082075
Trade/Device Name: Hanson Medical Dilator for Artisan™ Control Catheter Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel Dilator Regulatory Class: Class II Product Code: DRE Dated: July 22, 2008 Received: July 23, 2008
Dear Ms. Whitin:
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.
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
3
Page 2 -- Ms. Kate Whitin
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 yours.
Qomall
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 6
Indications for Use
510(k) Number (if known):
Device Name: Hansen Medical Dilator for Artisan™ Control Catheter
Indications for Use:
The Dilator for Artisan™ Control Catheter is intended to introduce the Artisan Control Catheter into the atria and through the intraatrial septum from the right side of the heart to the left side.
| Prescription Use | x
(Part 21 CFR 801 Subpart D) |
| ------------------ | ---------------------------------- |
|---|
AND/OR
| Over-The-Counter Use | (21 CFR 801 Subpart C) |
|---|---|
| ---------------------- | ------------------------ |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
| Hansen Medical
Indication for Use | Special 510(k) Submission
510(k) Number K082075
Section 6, Page 1 of 1 |
|--------------------------------------|------------------------------------------------------------------------------|
| | COMPANY CONFIDENTIAL DO NOT COPY |