(78 days)
The Strada™ Carotid Guiding Sheath is indicated for the introduction of diagnostic and therapeutic devices into the human vasculature including, but not limited to, the carotid artery.
The Strada™ Carotid Guiding Sheath is designed to perform as an introducer and a guiding sheath. The device is a single-use system that consists of a delivery sheath with hemostatic valve and dilator. Upon removal of the dilator, the delivery sheath provides a pathway for diagnostic and interventional devices into the vasculature. The Strada™ Carotid Guiding Sheath is available in 80 and 90cm lengths. The sheath has an 8F outer diameter and 6F inner diameter. The distal end is straight, has a hydrophilic coating (20cm) and has a radiopaque marker approximately 2.5 mm from the tip. The device is provided sterile and non-pyrogenic.
The provided text describes a 510(k) submission for the Strada™ Carotid Guiding Sheath, focusing on demonstrating substantial equivalence to a predicate device. This type of submission relies heavily on non-clinical testing and comparison to an already cleared device, rather than extensive clinical studies with specific performance metrics for the new device.
Therefore, many of the requested elements pertaining to acceptance criteria and clinical study details (like sample sizes, expert qualifications, adjudication methods, MRMC studies, and ground truth for clinical test sets) are not applicable to this 510(k) submission, as it does not present independent clinical performance data for the Strada™ device in the same way a de novo or PMA submission might.
However, I can extract the information that is present and explain why other details are missing based on the nature of a 510(k) submission for this device.
Acceptance Criteria and Device Performance (Based on 510(k) principles):
For a 510(k) submission of this nature, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device through non-clinical testing that confirms the new device meets its own product specifications and intended uses, without raising new questions of safety or effectiveness. The performance is gauged by comparison to the established predicate.
| Acceptance Criteria (Implicit for 510(k) Equivalence) | Reported Device Performance (Strada™ Carotid Guiding Sheath) |
|---|---|
| Intended Use: Identical to predicate device | Met: "The intended use is identical to the predicate device." "The Strada™ Carotid Guiding Sheath is indicated for the introduction of diagnostic and therapeutic devices into the human vasculature including, but not limited to, the carotid artery," mirroring the predicate. |
| Technological Characteristics: Substantially equivalent to predicate device (design, material types, technology) | Met: "The device design and material types are key features that determine performance of the device. The components and material characteristics of the device are substantially equivalent to the predicate device." "The intended use, design, material types, technology, and performance of the Strada™ Sheath is identical to the predicate device." |
| Safety and Effectiveness: No new questions raised compared to predicate device | Met: "There are no differences between devices which would raise issues of safety or effectiveness." |
| Product Specifications: Meets internal product specifications | Met: "Results of the testing demonstrate that the Strada™ Sheath design meets product specifications and intended uses." (Based on non-clinical testing) |
| Non-clinical Performance: Equivalent to predicate in bench, animal, biocompatibility, shelf-life, package testing, sterilization. | Met: "Non-clinical testing of the Strada™ Carotid Guiding Sheath includes in vitro bench testing, animal evaluation, biocompatibility testing, shelf-life and package testing and sterilization validation." (Implied successful completion and equivalence.) |
Detailed Study Information (Where applicable/deduced):
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a single "test set" for performance evaluation in a clinical study. The device underwent "in vitro bench testing," "animal evaluation," "biocompatibility testing," "shelf-life and package testing," and "sterilization validation." The sample sizes for these individual non-clinical tests are not provided in the summary.
- Data Provenance: The studies are non-clinical (bench, animal, lab-based tests). There is no mention of human clinical data, and thus no country of origin or retrospective/prospective designation for human data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable: This was a 510(k) submission based on non-clinical testing and substantial equivalence to a predicate device. There was no clinical trial data presented that would require expert adjudication to establish ground truth for a test set.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable: No clinical test set requiring expert adjudication was presented in this summary.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable: This is a physical medical device (catheter introducer), not an AI-powered diagnostic or therapeutic device. Therefore, no MRMC study or AI-related effectiveness analysis was performed or is relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable: See point 4. This is not an algorithm or AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Non-Clinical Standards: The "ground truth" for the non-clinical tests would have been established by engineering specifications, validated test methodologies, and established safety standards (e.g., ISO standards for biocompatibility, sterility, material properties, mechanical performance). For animal studies, the "ground truth" would be observed physiological responses and outcomes in animal models.
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The sample size for the training set:
- Not Applicable: This is a physical medical device. There is no concept of a "training set" in the context of machine learning for this device. The device design and manufacturing processes are "trained" through iterative R&D and testing, but these are not quantified as a "training set" in the common understanding of AI/ML.
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How the ground truth for the training set was established:
- Not Applicable: See point 7.
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SJM ST. JUDE MEDICAL
510(K) SUMMARY
1. ADMINISTRATIVE INFORMATION
| Name: | St. Jude Medical | APR - 6 2007 |
|---|---|---|
| Address: | 6550 Wedgwood Road North, Suite 150Maple Grove, MN 55311 | |
| Phone: | 763-463-5713 | |
| Fax: | 763-488-9780 | |
| Contact Person: | Jeff SturmSenior Regulatory Affairs Specialist | |
| Date: | January 17, 2007 |
2. DEVICE INFORMATION
| Name of Device: | Strada™ Carotid Guiding Sheath |
|---|---|
| Common Name: | Access Sheath, Introducer |
| Classification Name: | Catheter Introducer |
| Product Code: | DYB |
3. PREDICATE DEVICE INFORMATION
The predicate device is the Destination® Carotid Guiding Sheath manufactured by Terumo and cleared by premarket notification in 2005 (K052185).
- DEVICE DESCRIPTION
The Strada™ Carotid Guiding Sheath is designed to perform as an introducer and a guiding sheath. The device is a single-use system that consists of a delivery sheath with hemostatic valve and dilator. Upon removal of the dilator, the delivery sheath provides a pathway for diagnostic and interventional devices into the vasculature.
The Strada™ Carotid Guiding Sheath is available in 80 and 90cm lengths. The sheath has an 8F outer diameter and 6F inner diameter. The distal end is straight, has a hydrophilic coating (20cm) and has a radiopaque marker approximately 2.5 mm from the tip. The device is provided sterile and non-pyrogenic.
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Image /page/1/Picture/0 description: The image shows the logo for St. Jude Medical. The logo consists of the letters "SJM" inside of an octagon on the left, followed by the words "ST. JUDE MEDICAL" in all caps. The text is in a bold, sans-serif font.
INTENDED USE 5.
The Strada™ Carotid Guiding Sheath is indicated for the introduction of diagnostic and therapeutic devices into the human vasculature including, but not limited to, the carotid artery.
The intended use is identical to the predicate device.
6. TECHNOLOGICAL CHARACTERISTICS
The device design and material types are key features that determine performance of the device. The components and material characteristics of the device are substantially equivalent to the predicate device. Both devices are used manually by the user.
SUMMARY OF NON-CLINICAL TESTING 7.
Non-clinical testing of the Strada™ Carotid Guiding Sheath includes in vitro bench testing, animal evaluation, biocompatibility testing, shelf-life and package testing and sterilization validation. Results of the testing demonstrate that the Strada™ Sheath design meets product specifications and intended uses.
8. SUBSTANTIAL EQUIVALENCE CONCLUSION
The Strada™ Carotid Guiding Sheath in this 510(k) is substantially equivalent to the Terumo Destination® Carotid Guiding Sheath (K052185). The intended use, design, material types, technology, and performance of the Strada™ Sheath is identical to the predicate device. There are no differences between devices which would raise issues of safety or effectiveness.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
St. Jude Medical c/o Mr. Jeff Sturm Senior Regulatory Affairs Specialist 6550 Wedgwood Road North, Suite 150 Maple Grove, MN 55311
Re: K070166
Strada™ Carotid Guiding Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: March 30, 2007 Received: April 2, 2007
Dear Mr. Sturm:
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.
APR - 6 2007
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Page 2 - Mr. Jeff Sturm
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Brent D. Zanke, M.D.
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):
Device Name: Strada™ Carotid Guiding Sheath
Indications for Use:
The Strada™ Carotid Guiding Sheath is indicated for the introduction of diagnostic and therapeutic devices into the human vasculature including, but not limited to the carotid artery.
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 IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K070/66
Page 1 of 1
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).