SELECTIVA SB GUIDEWIRE by NEO METRICS, INC.

The Selectiva SB Guidewires are constructed of a nickel-titanium alloy with a PTFE polymer jacket. Devices are available in a diameter of 0.035 inches and in lengths ranging from 40 to 300 cm.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "Selectiva SB Guidewire." This is a regulatory filing for a medical device, and as such, it focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed clinical study demonstrating device performance against specific acceptance criteria for an AI or software-based device.

Therefore, the information requested about acceptance criteria, detailed study design, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies, is largely not applicable or present in this document. This document describes a physical medical device (a guidewire), not an AI or software-based medical device.

However, I can extract the relevant information regarding the "study" that proves the device meets the (implied) acceptance criteria of substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a physical guidewire and not an AI/software device, there aren't quantitative "acceptance criteria" in the same way one would have for an AI's performance metrics (e.g., sensitivity, specificity). Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices. The performance is assessed through bench testing comparing the functional and performance characteristics to the predicate.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (Summary)
Similarity in design	Constructed of nickel-titanium alloy with PTFE polymer jacket; available in 0.035 inches diameter and 40 to 300 cm lengths (similar to predicate).
Similarity in principles of operation	Intended to facilitate placement of devices for diagnostic and interventional procedures (same as predicate, excluding PTCA).
Similarity in materials	Nickel-titanium alloy and PTFE polymer jacket.
Similarity in performance characteristics	Representative samples underwent bench testing to demonstrate appropriate functional and performance characteristics compared to the predicate device(s).
Safety	Implied through similarity to legally marketed predicate devices and bench testing.

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

Sample Size for Test Set: Not explicitly stated. The document refers to "Representative samples of the device" used for bench testing. This typically implies a statistically relevant but undisclosed number of devices were tested to characterize their mechanical and performance properties.
Data Provenance: The data is generated from bench testing conducted by the manufacturer (NeoMetrics, Inc.). This is a prospective data generation process from newly manufactured devices. The concept of "country of origin of the data" is not applicable as it's not clinical data.

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

This is not applicable. The "ground truth" for a physical guidewire's performance in bench testing would be defined by engineering specifications and objective measurements (e.g., force required to buckle, torque response, lubricity measurements). It would not involve expert consensus in the way clinical image interpretation or diagnosis would.
The comparison is to existing predicate devices, which were previously cleared based on their own performance data and established safety and effectiveness.

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study involving human interpretation of data where adjudication would be necessary. Bench testing results are typically objective measurements against predefined engineering specifications.

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

Not applicable. This is a physical medical device submission, not an AI or software device. Therefore, no MRMC study, human readers, or AI assistance is involved.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context refers to established engineering specifications, performance standards, and the known performance characteristics of the predicate devices. It is based on objective physical measurements and comparisons rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI/ML model that requires a training set. The design and manufacturing process are informed by engineering principles and experience, but there isn't a "training set" in the computational sense.

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

Not applicable, as there is no "training set." The design and development of the device would be based on engineering principles, materials science, and knowledge gained from predicate devices, rather than a data-driven "ground truth" for training.

In summary, the provided document is a 510(k) premarket notification for a physical medical device. Its "study" consists of bench testing to demonstrate substantial equivalence to predicate devices, not clinical trials or AI performance evaluations.

Summary

{0}------------------------------------------------

NOV - 5 2003

Section 9 510(k) Summary

のお気になる。

Submitter:	NeoMetrics, Inc.14800 28th Avenue South, Suite 150Plymouth, MN 55447Telephone: 763-559-4440Fax: 763-559-7676
ContactPerson:	Mark PedersonProduct Development EngineerTelephone: 763-559-4440Fax: 763-559-7676pedersonm@qwest.net
DatePrepared:	October 14, 2003
Trade Name:	Selectiva SB Guidewire
ClassificationName andNumber:	Wire, Guide, Catheter870.1330
Product Code:	DQX
PredicateDevice(s):	NeoMetrics Selectiva™ Guidewire (K013024)FlexMedics FlexFinder Guidewire (K943390)
DeviceDescription:	The Selectiva SB Guidewires are constructed of a nickel-titaniumalloy with a PTFE polymer jacket. Devices are available in adiameter of 0.035 inches and in lengths ranging from 40 to 300 cm.
Intended Use:	The NeoMetrics Selectiva SB Guidewire is intended to facilitatethe placement of devices for diagnostic and interventionalprocedures.NOTE: These guidewires are not intended for PTCA use.
Functional andSafety Testing:	Representative samples of the device underwent bench testing todemonstrate appropriate functional and performance characteristicscompared to the predicate device(s).
Conclusion:	The NeoMetrics Selectiva SB Guidewire modified as proposed in thissubmission, is substantially equivalent to the predicate devices.This conclusion is based upon the similarity in design, principles ofoperation, materials, and performance of the modified devicecompared to the originally, cleared device.

{1}------------------------------------------------

Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is a symbol of medicine and health. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV = 5 2003

NeoMetrics, Inc. c/o Mr. Mark Pederson Product Development Engineer 14800 28th Avenue South, Suite 150 Plymouth, MN 55447

Re: K033321 Selectiva SB Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: October 14, 2003 Received: October 21, 2003

Dear Mr. Pederson:

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.

{2}------------------------------------------------

Page 2 - Mr. Mark Pederson

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 (301) 594-4648. 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 (301) 443-6597 or at its Internet address

http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Elsie D. Harvey Jr

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Section 3 Indications for Use

The NeoMetrics Selectiva SB Guidewire is intended to facilitate the placement of devices for diagnostic and interventional procedures.

NOTE: These guidewires are not intended for PTCA use.

Prescription Use
(Per 21 CFR 801.109)

Elyn Ots
Bran Zadema
11/4/03

Division of Cardiovascular & Respiratory Devices
510(k) Number K033321

Shaugh BD

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.