Micrus Design Technology Peripheral Guiding Sheaths are intended for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.

Device Description

The Micrus Design Technology Peripheral Guiding Sheaths are single lumen catheters, incorporating a Pebax body reinforced with a stainless steel wire coil. The intermediate segment is also Pebax with a stainless steel coil to reduce kinking and to promote improved torque response. They are available in 5 Fr, 6Fr, 7Fr, and 8 Fr and 45 cm, 55 cm and 90 cm in length, and in a variety of shapes. The technological characteristics are equivalent to the predicate device.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the "Micrus Design Technology Peripheral Guiding Sheath." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a full clinical trial with acceptance criteria defined by performance metrics like sensitivity or specificity.

Therefore, many of the typical study elements for AI/ML device evaluations (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, and training set details) are not applicable to this type of traditional medical device submission.

Here's an analysis based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Material Biocompatibility: Compliance with established safety standards.	Biocompatibility testing performed to assure compliance.
Mechanical Performance: Compliance with specifications (e.g., strength, durability, kink resistance, torque response).	Mechanical laboratory testing performed to assure compliance to specifications.
Technological Characteristics: Equivalence to predicate devices.	Technological characteristics are equivalent to the predicate device (Terumo Pinnacle Destination, Cook Shuttle/Flexor).
Safety and Effectiveness: Demonstration of safe and effective use for intended purpose, equivalent to predicate devices.	Non-clinical tests demonstrate that, like the predicate devices, the device is safe and effective for its intended use.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This was a non-clinical, laboratory-based testing submission for a traditional hardware medical device, not a data-driven AI/ML device requiring test datasets of patient information. The testing involved mechanical and material evaluations, not diagnostic performance on patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Ground truth, in the context of AI/ML evaluation, refers to the definitive determination of a condition based on expert review or other definitive diagnosis. For this device, "ground truth" would relate to engineering standards and material science, likely verified by internal engineers and external testing labs, rather than medical experts interpreting cases.

4. Adjudication Method (2+1, 3+1, none) for the Test Set

Not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations of clinical data, which is not the nature of this device's testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. MRMC studies are designed for diagnostic devices to assess the impact of AI on human reader performance. This device is a catheter introducer, a tool for facilitating other procedures, not a diagnostic imaging or AI system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device does not have an algorithm component.

7. The Type of Ground Truth Used

The "ground truth" for this medical device's evaluation would be based on:

Engineering Specifications: Defined parameters for mechanical strength, flexibility, torque response, etc.
Biocompatibility Standards: Established international and national standards for material safety in contact with biological tissue.
Predicate Device Characteristics: The performance and properties of the legally marketed predicate devices served as a benchmark for equivalence.

8. The Sample Size for the Training Set

Not applicable. This type of submission does not involve training data as it is not an AI/ML device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. (See answer to #8).

Summary

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Kono816 P. Loff

Section 5: 510(k) Summary

SEP 1 9 2007

Submitter'sInformation	Micrus Design Technology9344 NW 13 StreetMiami, Florida 33172 USATelephone: 1-305-477-2406Contact: Marianne Grunwaldt, MS, CQE
Preparation Date	19 March 2007
Name of Device	Common/Classification Name: Catheter IntroducerTrade Name: Micrus Design Technology Peripheral Guiding Sheath
Predicate Devices	Terumo Pinnacle DestinationCook Shuttle/Flexor
Intended Use	Micrus Design Technology Peripheral Guiding Sheaths are intended foruse in arterial and venous procedures requiring percutaneous introductionof intravascular devices.
Device Descriptionand Summary ofTechnologicalCharacteristics	The Micrus Design Technology Peripheral Guiding Sheaths are singlelumen catheters, incorporating a Pebax® body reinforced with a stainlesssteel wire coil. The intermediate segment is also Pebax® with a stainlesssteel coil to reduce kinking and to promote improved torque response.They are available in 5 Fr, 6Fr, 7Fr, and 8 Fr and 45 cm, 55 cm and 90cm in length, and in a variety of shapes. The technological characteristicsare equivalent to the predicate device.
Testing Summary	Mechanical laboratory testing has been performed on the Micrus DesignTechnology Peripheral Guiding Sheaths to assure compliance to thespecifications. In addition, testing has been performed on the materials toassure biocompatibility.
Conclusions	The non-clinical tests as discussed above demonstrate that, like thepredicate devices, the Micrus Design Technology Peripheral GuidingSheath is safe and effective for its intended use.

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Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 9 2007

Micrus Design Technology, Inc. c/o Ms. Marianne Grunwaldt, MS, CQE Product Assurance Engineer 9344 NW 13 Street Miami, FL 33172

Re: K070816

Trade/Device Name: Peripheral Guiding Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: July 25, 2007 Received: July 27, 2007

Dear Ms. Grunwaldt:

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 devire can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, TDA max publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Marianne Grunwaldt

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Dana R. Rohner

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): Ko 40816

Device Name: Micrus Design Technology Peripheral Guiding Sheath

Indications for Use:

Micrus Design Technology Peripheral Guiding Sheaths are indicated for arterial and venous procedures requiring percutaneous introduction of intravascular devices.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Varliner

(Division Si Off) Division In Cardiovascular Devices

510(k) Number Ko 70816

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Regulation Number and Section

§ 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).