(67 days)
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.
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.
The provided text describes a medical device, the "Steerable Stylet," and its submission for FDA approval (K040001). However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through quantitative metrics.
Instead, the document focuses on the regulatory submission process, stating that the device is "substantially equivalent" to a legally marketed predicate device (The Locator Steerable Stylet, Model 4036, K972814). This substantial equivalence is based on "similar performance, technological characteristics, and indication for use." The "Testing" section broadly mentions that "Test results are included in submission" without detailing those results or the defined acceptance criteria.
Therefore, I cannot populate the requested table or answer most of the specific questions as the necessary information is not present in the provided text.
Here's what can be inferred and what is missing:
- Acceptance Criteria and Reported Device Performance: This information is not provided. The document primarily focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting specific quantitative acceptance criteria and the device's performance against them.
- Study Details (Sample Size, Data Provenance, Ground Truth, Training Set): No details are provided regarding any specific studies conducted to establish performance metrics. The submission relies on demonstrating equivalence to a predicate device.
- Adjudication Method: Not applicable as no specific study with ground truth establishment is described.
- MRMC Comparative Effectiveness Study: Not mentioned or implied.
- Standalone Performance Study: Not explicitly described with quantitative results. The "substantial equivalence" claim suggests performance is in line with the predicate, but specific standalone metrics are absent.
- Type of Ground Truth Used: Not applicable, as no study with ground truth established is detailed.
- Sample Size for Training Set: Not applicable, as this is not an AI/algorithm-based device in the sense that would require a training set.
- How Ground Truth for Training Set was Established: Not applicable.
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| 3.0 SUMMARY OF SAFETY AND EFFECTIVENESS | |
|---|---|
| Submitted by | Synovis Interventional Solutions, Inc.475 Apollo DriveLino Lakes, MN 55014Tel: 651-603-5229Fax: 651-603-5211 |
| Contact Person | James JenkinsSynovis Surgical Innovations2575 University Avenue W.St. Paul, Minn. 55114-1024Tel. 651-603-5229 or 651-796-7368Fax 651-603-5211 |
| Device Trade Name: | To be determined |
| Common Name | Catheter Stylet |
| Classification Name | Catheter Stylet870.1380 |
| Predicate device | The Locator Steerable Stylet, Model 4036K972814St. Jude Medical |
| Device Description | The Steerable Stylet is a sterile, single-use, disposableimplantation tool which assists defining and varying thecurvature of the distal portion of the pacemaker lead duringimplantation. |
| Statement ofIntended use | The Steerable Stylet is intended to aid in the placement ofpacemaker leads. |
| TechnologicalComparisons | The Steerable Stylet is substantially equivalent to thepredicate device, having similar performance, technologicalcharacteristics, and indication for use. |
| Testing | The Steerable Stylet is substantially equivalent to thepredicate device in terms of performance testing.Testresults are included in submission. |
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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.
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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
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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
< Number _ KO4000 |
§ 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).