(206 days)
The InnerDyne, Inc., Radially Expanding Vascular Access System (Heparin Coated) is intended to provide percutaneous access to the vasculature. The Radially Expanding Vascular Access System (Heparin Coated) is indicated for the following usages: Percutaneous vascular access.
The Radially Expanding Vascular Access System (Heparin Coated) consists of an expandable sleeve assembly. The tubular member of the expandable is configured so as to be radially compressed to reduce the outside diameter of the device prior to insertion. Upon use, the expandable sleeve assembly is inserted through the skin and surrounding tissue into the selected ver a previously placed guidewire according to the techniques of Seldinger. (An alternative placement method would have the needle placed within the lumen of the expandable sleeve, and the combined needle and sleeve inserted into the target vessel. The guidewire would be placed and the needle removed.) The dilator/sheath assembly, which consists of a tapered dilator and sheath with integral hemostasis valve, is inserted over the guidewire through the lumen of the expandable sleeve which expands radially to accommodate the dilator/sheath. This process in turn, radially expands the surrounding tissue. Following dilation the dilator is removed, leaving the expandable sleeve and sheath with integral hemostasis valve in place to provide a sealed port for passage of instruments. This system configuration allows the user to initially place a small diameter sheath for passage of small instruments. The sheath can then be removed from the sleeve while leaving the sleeve inserted in the vessel. A larger diameter dilator/sheath can then be inserted through the sleeve to create a larger port for passage of the larger instruments. The device is assembled from medical grade materials under GMP and ISO conditions. Components are molded and machined by qualified suppliers. The components are assembled and secured by adhesives, welds, and mechanical interlocks.
This document is a 510(k) premarket notification for the InnerDyne Radially Expanding Vascular Access System (Heparin Coated). The FDA's review of 510(k) submissions primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials or performance studies with specific acceptance criteria that would typically be associated with novel, high-risk devices.
Therefore, many of the typical elements requested in your prompt regarding acceptance criteria and detailed study information are not present or not applicable in this type of submission. The key finding is "substantial equivalence" based on design, function, materials, and indications for use being similar to a predicate device, with an added heparin coating and an expanded sheath diameter range noted as the primary differences.
Here's an attempt to address your points based on the provided text, highlighting where information is absent or not relevant to a 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the 510(k) summary. For a 510(k) submission, the "acceptance criteria" are generally met by demonstrating that the device is substantially equivalent to a predicate device in terms of safety and effectiveness, based on similar technological characteristics and intended use. Performance data in the context of specific quantitative measures with defined thresholds is typically not required for 510(k) clearance unless there are new technological features posing different risks.
The document states: "From the foregoing, we conclude that the Radially Expanding Vascular Access System (Heparin Coated) device is as safe and effective as currently marketed devices for the stated indications." This is the broad "performance" claim, achieved by comparison to the predicate.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. The submission relies on a comparison to a predicate device, not on new clinical performance data from a specific test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable/provided. No "test set" in the sense of patient data requiring expert ground truth assessment is described as part of this 510(k) submission.
4. Adjudication Method for the Test Set
This information is not applicable/provided.
5. 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
This information is not applicable. This device is a physical medical device (vascular access system), not an AI algorithm or imaging device that would typically involve human readers or MRMC studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable.
7. The Type of Ground Truth Used
This information is not applicable/provided. The basis for clearance is substantial equivalence to an existing legally marketed device (the predicate). The "truth" in this context is that the new device is as safe and effective as the predicate.
8. The Sample Size for the Training Set
This information is not applicable/provided. There is no mention of a "training set" as this is not an AI or machine learning device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided.
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SUMMARY OF SAFETY & EFFECTIVENESS INFORMATION
InnerDyne, Inc. Submitter: 5060 Amelia Earhart Dr Salt Lake City, Utah (801)-350-3600
Date Prepared: February 13, 1998
Rick Gaykowski Contact: Corporate Vice President, Regulatory Affairs and Ouality Assurance
Classification Name: Percutaneous Introducer Common/Usual Name: Percutaneous Introducer With Sheath Trade/Proprietary Name: InnerDyne Radially Expanding Vascular Access System (Heparin Coated)
The Radially Expanding Vascular Access System (Heparin Coated) consists of an expandable sleeve assembly. The tubular member of the expandable is configured so as to be radially compressed to reduce the outside diameter of the device prior to insertion. Upon use, the expandable sleeve assembly is inserted through the skin and surrounding tissue into the selected ver a previously placed guidewire according to the techniques of Seldinger. (An alternative placement method would have the needle placed within the lumen of the expandable sleeve, and the combined needle and sleeve inserted into the target vessel. The guidewire would be placed and the needle removed.) The dilator/sheath assembly, which consists of a tapered dilator and sheath with integral hemostasis valve, is inserted over the guidewire through the lumen of the expandable sleeve which expands radially to accommodate the dilator/sheath. This process in turn, radially expands the surrounding tissue. Following dilation the dilator is removed, leaving the expandable sleeve and sheath with integral hemostasis valve in place to provide a sealed port for passage of instruments.
This system configuration allows the user to initially place a small diameter sheath for passage of small instruments. The sheath can then be removed from the sleeve while leaving the sleeve inserted in the vessel. A larger diameter dilator/sheath can then be inserted through the sleeve to create a larger port for passage of the larger instruments.
The device is assembled from medical grade materials under GMP and ISO conditions. Components are molded and machined by qualified suppliers. The components are assembled and secured by adhesives, welds, and mechanical interlocks.
The subject InnerDyne, Inc., Radially Expanding Vascular Access System (Heparin Coated) device is substantially equivalent to the predicate InnerDyne, Inc., Radially Expanding Vascular Access System device (K972684). The subject Radially Expanding Vascular Access System (Heparin Coated) device is similar to the referenced predicate in size, function, product dimensions and indications for use.
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The Radially Expanding Vascular Access System (Heparin Coated) is intended for use during minimally invasive surgery for temporary percutaneous vascular access for passage of instruments into the vasculature. The device is configured to be used for arterial or venous access.
The basic design principles for the subject InnerDyne, Inc., Radially Expanding Vascular Access System (Heparin Coated) device and the predicate Radially Expanding Vascular Access System device (K972684) are similar, and remain essentially unchanged from information previously provided to the Agency. The product configuration, composition, and utilized materials are similar in each of the products. The principles of operation for the InnerDyne, Inc., Radially Expanding Vascular Access System (Heparin Coated) device, and the predicate Radially Expanding Vascular Access System device (K972684) are similar. That is, each of these products employs a similar insertion technique, indications for use, contraindications for use, warnings and precautions. The subject device differs from the referenced Radially Expanding Vascular Access System predicate (K972684) with the addition of a heparin coating to the surface of the expandable sleeve portion of the device, and an expansion of the sheath working diameter range from (6 - 12F). The inclusion of a heparin coating on an offered product is a common industry practice in distributed devices which come in contact with circulating blood. An example of a substantially equivalent heparin coated device is the Research Medical Pediatric Femoral Arterial Cannula, which contains the DuraFlow II Heparin Coating cleared for marketing under K861641.
From the foregoing, we conclude that the Radially Expanding Vascular Access System (Heparin Coated) device is as safe and effective as currently marketed devices for the stated indications.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a silhouette effect. Encircling the image is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 1 1998
Mr. Rick Gaykowski Corporate Vice President, RA/QA InnerDyne, Inc. 5060 West Amelia Earhart Dr Salt Lake City, UT 84116
Re: K980578 Trade Name: InnerDyne Radially Expanding Vascular Access System (Heparin Coated) Requlatory Class: II Product Code: DYB Dated: June 12, 1998 Received: June 15, 1998
Dear Mr. Gaykowski:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this
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Page 2 - Mr. Rick Gaykowski
response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Judith Lanierison
802 Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known):
Device Name: InnerDyne, Inc., Radially Expanding Vascular Access System
.
Indications for Use: The InnerDyne, Inc., Radially Expanding Vascular Access System (Heparin Coated) is intended to provide percutaneous access to the vasculature. The Radially Expanding Vascular Access System (Heparin Coated) is indicated for the following usages:
Percutaneous vascular access.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Judith Aanebsox for Boyle Gantt
(Division Sign-Off) Acting Brunch Chief ICOC
Division of Cardiovascular, Respiratory,
and Neurological Devices K980578
510(k) Number
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use
(Optional Format 1-2-96)
§ 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).