(67 days)
Not Found
No
The summary describes a mechanical tool for shaping a pacemaker lead and contains no mention of AI, ML, or related concepts.
No
The device is described as an "implantation tool" that "assists defining and varying the curvature of the distal portion of the pacemaker lead during implantation." It does not directly treat a disease or condition; rather, it facilitates the implantation of another device (pacemaker lead) which is therapeutic.
No
The device is described as an "implantation tool" that helps physicians vary the curvature of a pacemaker lead during implantation. Its purpose is to facilitate the physical act of implantation, not to diagnose a medical condition or provide diagnostic information.
No
The device description explicitly states it is a "sterile, single-use, disposable implantation tool," indicating it is a physical hardware 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 examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states the Steerable Stylet is an "implantation tool" used to "define and vary the curvature of the distal end of a compatible pacemaker lead" during "lead implantation for cardiac pacing." This is a tool used during a surgical procedure on the patient's body, not for testing specimens outside the body.
The information provided focuses on the device's function as a surgical tool for lead placement, which is not the purpose of an IVD.
N/A
Intended Use / Indications for Use
The Steerable Stylet is intended to allow the physician to define and vary the curvature of the distal end of a compatible pacemaker lead in patients requiring lead implantation for cardiac pacing.
Product codes (comma separated list FDA assigned to the subject device)
DRB
Device Description
The Steerable Stylet is a sterile, single-use, disposable implantation tool which assists defining and varying the curvature of the distal portion of the pacemaker lead during implantation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
The Steerable Stylet is substantially equivalent to the predicate device in terms of performance testing. Test results are included in submission.
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
§ 870.1380 Catheter stylet.
(a)
Identification. A catheter stylet is a wire that is run through a catheter or cannula to render it stiff.(b)
Classification. Class II (performance standards).
0
| 3.0 SUMMARY OF SAFETY AND EFFECTIVENESS | |
|---|---|
| Submitted by | Synovis Interventional Solutions, Inc. |
| 475 Apollo Drive | |
| Lino Lakes, MN 55014 | |
| Tel: 651-603-5229 | |
| Fax: 651-603-5211 | |
| Contact Person | James Jenkins |
| Synovis Surgical Innovations | |
| 2575 University Avenue W. | |
| St. Paul, Minn. 55114-1024 | |
| Tel. 651-603-5229 or 651-796-7368 | |
| Fax 651-603-5211 | |
| Device Trade Name: | To be determined |
| Common Name | Catheter Stylet |
| Classification Name | Catheter Stylet |
| 870.1380 | |
| Predicate device | The Locator Steerable Stylet, Model 4036 |
| K972814 | |
| St. Jude Medical | |
| Device Description | The Steerable Stylet is a sterile, single-use, disposable |
| implantation tool which assists defining and varying the | |
| curvature of the distal portion of the pacemaker lead during | |
| implantation. | |
| Statement of | |
| Intended use | The Steerable Stylet is intended to aid in the placement of |
| pacemaker leads. | |
| Technological | |
| Comparisons | The Steerable Stylet is substantially equivalent to the |
| predicate device, having similar performance, technological | |
| characteristics, and indication for use. | |
| Testing | The Steerable Stylet is substantially equivalent to the |
| predicate device in terms of performance testing. | |
| Test | |
| results are included in submission. |
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1
Image /page/1/Picture/1 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 symbol of three horizontal lines that resemble a human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 9 2004
Synovis Interventional Solutions, Inc. c/o Mr. James Jenkins Regulatory Affairs Specialist 2575 University Avenue St. Paul, MN 55114-1024
Re: K040001
Trade Name: Steerable Stylet Regulation Number: 21 CFR 870.1380 Regulation Name: Catheter Stylet Regulatory Class: Class II (two) Product Code: DRB Dated: December 31, 2003 Received: January 2, 2004
Dear Mr. Jenkins:
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. James Jenkins
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 (301) 594-4646. 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/dsma/dsmamain.html
Sincerely yours.
Dona R. Kirchner
A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K040001
Device Name: Steerable Stylet
Indications For Use:
The Steerable Stylet is intended to allow the physician to define and vary the curvature of the distal end of a compatible pacemaker lead in patients requiring lead implantation for cardiac pacing.
Prescription Use (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)
Dung R. bochner
Sion Sign-Off) on of Cardiovascular Devices