(872 days)
"intended for percutaneous dilation of tissue surrounding indwelling catheters or foreign objects."
The Flexible Dilating Sheath is intended for percutaneous dilation of tissue surrounding indwelling catheters or foreign objects. The device is supplied sterile and is intended for one-time use. Reasonable assurance of biocompatibility of the materials comprising the Flexible Dilating Sheath is provided by their established history of use in medical product manufacturing. Results of toxicity testing also provide reasonable assurance of biocompatibility, with the results showing the material to meet the test requirements
The provided text describes a 510(k) summary for a medical device called the "Flexible Dilating Sheath." This summary, dated November 11, 1994, is a regulatory submission for premarket notification and not a study proving device performance against acceptance criteria.
Therefore, the input document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria.
Specifically, the document focuses on:
- Device Identification: Trade name, common name, classification.
- Predicate Device: Comparison to existing Cook Pacemaker Corporation dilating sheaths.
- Device Description: Intended use (percutaneous dilation of tissue), sterility, single-use, biocompatibility (established history of use and toxicity testing).
- Substantial Equivalence: Manufacturing process, quality assurance, packaging, sterilization, indications for use, materials, and physical construction compared to predicate devices.
There is no mention of:
- A table of acceptance criteria or reported device performance.
- Sample sizes, data provenance, or test sets.
- Number or qualifications of experts.
- Adjudication methods.
- Multi-reader multi-case (MRMC) studies.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for a training set.
- How ground truth for a training set was established.
This document serves as a regulatory notification demonstrating substantial equivalence to a legally marketed predicate device, not as a clinical performance study.
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K<45586
510 (K) SUMMARY I.
Submitted By:
Neal E. Fearnot President MED Institute, Incorporated P.O. Box 2402 West Lafayette, IN 47906 (317) 463-7537 November 11, 1994
Device:
Trade Name: Common/Usual Name:
Proposed Classification:
Flexible Dilating Sheath Vessel Dilator, Catheter Dilator Vessel Dilator for Percutaneous Catheterization 21 CFR Part 870.1310 (74DRE)
Predicate Devices:
The Flexible Dilating Sheath is similar to predicate dilating sheaths manufactured by Cook Pacemaker Corporation.
Device Description:
The Flexible Dilating Sheath is intended for percutaneous dilation of tissue surrounding indwelling catheters or foreign objects. The device is supplied sterile and is intended for one-time use. Reasonable assurance of biocompatibility of the materials comprising the Flexible Dilating Sheath is provided by their established history of use in medical product manufacturing. Results of toxicity testing also provide reasonable assurance of biocompatibility, with the results showing the material to meet the test requirements
Substantial Equivalence:
The device will be manufactured according to specified process controls and a Quality Assurance Program, undergoing packaging and sterilization procedures similar to devices currently marketed and distributed by Cook Pacemaker Corporation. This device is similar with respect to indications for use, materials and physical construction to predicate devices in terms of section 510(k) substantial equivalency.
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).