(179 days)
The Hansen Medical Transseptal Needle and dilator are intended to create the primary puncture in the interatrial septum for passing an introducer and/or catheter through the septum from the right side of the heart to the left side.
The Hansen Medical Transseptal Needle consists of an outer needle cannula and includes in its proximal end a female luer. The distal section is comprised of flexible thin walled tubing and contains a marker for visibility during fluoroscopy while the distal tip of the needle is ground into a beveled shape. The Hansen Medical Dilator is made of a flexible tube with a fapered end on the distal outer diameter. Attached to its proximal end is a Tuohy Borst® adapter to prevent fluid egress. The adapter includes a side port with a 1-way stopcock to provide flushing capability. The dilator also has imbedded markers at two positions on the distal end to provide visual feedback under fluoroscopy.
The provided document is a 510(k) Summary for the Hansen Medical Transseptal Needle and Dilator. This type of regulatory submission establishes substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a study. Therefore, the document does not contain the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.
The document indicates that the device is "substantially equivalent in intended use and method of operation to" predicate devices:
- Daig Corp., BRK Transseptal Needle (pre-amendment)
- Thomas Medical Products, Inc., Transseptal Needle/Trocar, K011727
- Thomas Medical Products, Inc., Catheter Introducer Set, K020090 Vessel Dilator (part of the set)
The basis for calling it "substantially equivalent" is stated as: "Based upon the indication for use, the technological characteristics and the design and engineering data provided in this pre-market notification, the Hansen Medical Transseptal Needle and Dilator have been shown to be substantially equivalent to other legally marketed predicate devices."
Therefore, I cannot extract the information required for your questions from this document, as the document focuses on regulatory equivalence rather than detailed performance study results against acceptance criteria.
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SECTION 6
0C7 1 3 2006
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: K o 6/0070
Applicant Information:
| Owner Name: | Hansen Medical, Inc. |
|---|---|
| Address: | 380 N. Bernardo Ave.Mountain View, CA. 94043Office: 650-404-5800 |
| Contact Person: | Nina Peled, PhD |
| Phone Number: | 650 404 5834 |
| Facsimile Number: | 650 404 5901 |
| Date Prepared: | April 14, 2006 |
Device Information:
| Classification: | Class II |
|---|---|
| Trade Name: | Hansen Medical Transseptal Needle and Dilator |
| Common name: | Transseptal needle and dilator |
| Classification name: | Trocar (21 CFR 870.1390, Product Code DRC) |
| Vessel Dilator (21 CFR 870.1310, Product Code DRF) |
Predicate Devices:
The Hansen Medical Transseptal Needle and Dilator are substantially equivalent in intended use and method of operation to:
-
- Daig Corp., BRK Transseptal Needle, pre-amendment.
-
- Thomas Medical Products, Inc., Transseptal Needle/Trocar, K011727.
- Thomas Medical Products, Inc., Catheter Introducer Set, K020090 Vessel Dilator 3. part of the set.
Device Description:
The Hansen Medical Transseptal Needle consists of an outer needle cannula and includes in its proximal end a female luer. The distal section is comprised of flexible thin walled tubing and contains a marker for visibility during fluoroscopy while the distal tip of the needle is ground into a beveled shape.
| Hansen Medical | 510(k) Submission | Section 6, Page 1 of |
|---|---|---|
| Transseptal Needle and Dilator | 510(k) Summary |
380 North Bernardo Avenue · Mountain View, CA 94043 · T 650.404.5800 www.hansenmedical.com
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The Hansen Medical Dilator is made of a flexible tube with a fapered end on the distal outer diameter. Attached to its proximal end is a Tuohy Borst® adapter to prevent fluid egress. The adapter includes a side port with a 1-way stopcock to provide flushing capability. The dilator also has imbedded markers at two positions on the distal end to provide visual feedback under fluoroscopy.
Intended Use:
The Hansen Medical Transseptal Needle and dilator are intended to create the primary puncture in the interatrial septum for passing an introducer and/or catheter through the septum from the right side of the heart to the left side.
Comparison to Predicate Device(s):
The Hansen Medical Transseptal Needle and Dilator have the same general intended use and similar technological characteristics as the predicate devices.
Substantial equivalence:
Based upon the indication for use, the technological characteristics and the design and engineering data provided in this pre-market notification, the Hansen Medical Transseptal Needle and Dilator have been shown to be substantially equivalent to other legally marketed predicate devices.
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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 features a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 3 2006
Hansen Medical c/o Nina Peled, Ph.D., MBA Vice President, Quality and Regulatory Affairs 380 North Bernardo Ave. Mountain View, CA 94043
Re: K061070
Hansen Medical Transseptal Needle and Dilator Regulation Number: 21 CFR 870.1390 Regulation Name: Trocar Regulatory Class: Class II (two) Product Code: DRC Dated: September 1, 2006 Received: September 6, 2006
Dear Dr. Peled:
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.
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Page 2 - Nina Peled, Ph.D., MBA
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
R. Varlmer
( ) 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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SECTION 5
Indications for Use
510(k) Number (if known): _ K 0 6 / 0 7 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0
Device Name: Hansen Medical Transseptal Needle and Dilator
Indications for Use:
The Hansen Medical Transseptal Needle and dilator are intended to create the primary puncture in the interatrial septum for passing an introducer and/or catheter through the 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)
Hansen Medical Transseptal Needle and Dilator 510(k) Submission R. V. J. July Segtion 5, Page 1 of 1 (Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number_K061070
§ 870.1390 Trocar.
(a)
Identification. A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.(b)
Classification. Class II (special controls). Except for trocars that are reprocessed for multiple use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.