(85 days)
The InnerDyne, Inc., Radially Expanding Vascular Access System is intended to provide percutaneous access to the vasculature. The Radially Expanding Vascular Access System is indicated for the following usages: Percutaneous vascular access.
The Radially Expanding Vascular Access System 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 vessel over a previously placed guidewire. (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 sleve which expands radially to accommodate the dilator/sheath. This process in turn, radially expands the surrounding tissue. Following 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 lumen of the sleeve while leaving the sleve 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 provided text describes a 510(k) premarket notification for a medical device, the InnerDyne Radially Expanding Vascular Access System, and its substantial equivalence to a predicate device. However, it does not include detailed information regarding specific acceptance criteria, performance studies with reported metrics, sample sizes, expert involvement, or any of the other specific study design elements requested in the prompt.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is what can be inferred or stated based on the document:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated. The device is determined to be "substantially equivalent" to a predicate device (K931489). This implies that its performance is expected to be comparable to the predicate device, but specific quantitative criteria are not listed.
- Reported Device Performance: Not provided in quantitative terms. The document concludes that the device is "as safe and effective as currently marketed devices for the stated indications." This is a qualitative statement of equivalence, not a report of specific performance metrics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No information on test set sample size or data provenance is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This type of study (e.g., clinical trial, diagnostic accuracy study) is not described. The submission is based on substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or ground truth establishment process is described.
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
- No MRMC or AI-related study is mentioned. This is a 1997 submission for a mechanical medical device, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. Ground truth for a clinical study is not described. The "ground truth" for this regulatory submission is the established safety and effectiveness of the predicate device.
8. The sample size for the training set
- Not applicable. This is not a machine learning device, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable.
Summary of Substantial Equivalence Basis:
The core of the submission (K972684) relies on demonstrating substantial equivalence to a previously cleared predicate device: the InnerDyne, Inc., Radially Expanding Dilating Introducer device (K931489).
The key arguments for substantial equivalence are:
- Similarities in Design Principles: "basic design principles... are similar, and remain essentially unchanged."
- Similarities in Configuration, Composition, Materials: "product configuration, composition, and utilized materials are similar."
- Similar Principles of Operation: "each of these products employs a similar insertion technique, indications for use, contraindications for use, warnings and precautions."
- Minor Differences: The subject device differs only in "changes to the materials used in the construction of the expanding sleeve portion and the presentation style of the product. Alternative locations and methods of sterilization are being included."
- Validation of New Materials/Sterilization: The new material and alternative sterilization methods are stated to be "similar to those used in the InnerDyne Step™ family of products" which likely have their own history of FDA clearance (K943253, K940232, K950632, and K950658). This implies these components/processes have been previously deemed safe and effective in similar contexts.
In essence, the "study" proving the device meets acceptance criteria is the argument that the new device is fundamentally the same as a device already on the market and cleared by the FDA, with only minor changes that do not alter its safety or effectiveness profile. This is typical for a 510(k) submission where a device is not entirely novel but rather a modification or evolution of an existing product.
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OCT 10 1997
SUMMARY OF SAFETY & EFFECTIVENESS INFORMATION
-
InnerDyne, Inc. Submitter: 5060 Amelia Earhart Dr Salt Lake City, Utah (801)-350-3600
Date Prepared: 11 July 1997 -
Rick Gaykowski Contact: Corporate Vice President, Regulatory Affairs and Quality Assurance
Classification Name: Percutaneous Introducer Common/Usual Name: Percutaneous Introducer With Sheath Trade/Proprietary Name: InnerDyne Radially Expanding Vascular Access System
The Radially Expanding Vascular Access System 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 vessel over a previously placed guidewire. (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 sleve which expands radially to accommodate the dilator/sheath. This process in turn, radially expands the surrounding tissue. Following 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 lumen of the sleeve while leaving the sleve 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 device is substantially equivalent to the predicate InnerDyne, Inc., Radially Expanding Dilating Introducer device (K931489). The subject Radially Expanding Vascular Access System device is similar to the referenced predicate in size, function, product dimensions and indications for use.
The Radially Expanding Vascular Access System is intended for use during minimally invasive surgery for temporary dilation access to the vasculature for passage of instruments into the vasculature. The
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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 device and the predicate Radially Expanding Dilating Introducer device (K931489) 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 device, and the predicate Radially Expanding Dilating Introducer device (K931489) 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 Dilating Introducer predicate (931489) only with changes to the materials used in the construction of the expanding sleve portion and the presentation style of the product. Alternative locations and methods of sterilization are being included. The new material used in the construction of the expandable sleeve as well as the alternative sterilization locations and methods are similar to those used in the InnerDrne Step™ family of products ( K943253, K940232, K950632, and K950658).
From the foregoing, we conclude that the Radially Expanding Vascular Access System device is as safe and effective as currently marketed devices for the stated indications.
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OCT 1 0 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Rick Gaykowski InnerDyne, Inc. 5060 Amelia Earhart Drive Salt Lake City, Utah 84116
Re: K972684 InnerDyne Radially Expanding Vascular Access System Regulatory Class: II (two) Product Code: 74 DYB Dated: July 11, 1997 Received: July 17, 1997
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 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this 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 regulations.
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Page 2 - Mr. Rick Gaykowski
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 leqally 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) 594-4639. 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" (21 CFR 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/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
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 I of I
510(k) Number (if known): K972684
Device Name: InnerDyne, Inc., Radially Expanding Vascular Access System
The InnerDyne, Inc., Radially Expanding Vascular Access System is intended Indications for Use: to provide percutaneous access to the vasculature. The Radially Expanding Vascular Access System 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) | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K972684 |
| 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).