C0-AXIAL INTRODUCER NEEDLE by INRAD

The design of the Inrad Co-axial Introducer Needle as well as the predicate device, Manan Medical Products is referenced in the Comparison Information Section. The products are identically manufactured using the same manufacturing systems, design and materials. Both needles are manufactured by Manan Medical Products, Inc. The primary differences are packaging and sterilization which will be performed by Inrad.

AI/ML Overview

This document is a 510(k) summary for a medical device called the "Inrad Co-axial Introducer Needle." It's a submission to the FDA to demonstrate substantial equivalence to a previously approved device, not a study describing acceptance criteria and performance data. Therefore, most of the requested information regarding acceptance criteria, study data, sample sizes, and expert adjudication is not present in this document.

However, I can extract the following relevant information:

1. A table of acceptance criteria and the reported device performance:

This document does not contain explicit acceptance criteria or reported device performance data in the manner typically found in a study report for an AI/algorithm-based device. Instead, the "acceptance criteria" here implicitly refer to demonstrating substantial equivalence to a predicate device.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Same Indications for Use as predicate device	Met (stated to be the same)
Similar Design to predicate device	Met (stated to be identical)
Same Materials as predicate device	Met (stated to be identical)
Safe and Effective as predicate device	Met (no differences in safety and effectiveness asserted based on predicate's history)
Differences only in packaging and sterilization (not impacting core functionality)	Met (only differences cited are packaging and sterilization)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Not applicable. This document is for a physical medical device (co-axial introducer needle), not an AI or software device that would typically involve a test set with data. The proof of safety and effectiveness relies on the substantial equivalence to a legally marketed predicate device and the fact that they are "identically manufactured."

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. See point 2.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. See point 2.

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 device is a physical medical instrument, not an AI or imaging diagnostic tool.

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

Not applicable. This device is a physical medical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable in the context of an algorithm's ground truth. For this device, the "ground truth" for its safety and effectiveness is the historical performance and regulatory approval of the predicate device (Manan Medical Products, Inc. Co-axial Introducer Needle, K940024) and the assertion that the new device is "identically manufactured" and "proven to be safe and effective" by the predicate's market history.

8. The sample size for the training set:

Not applicable. This document is not describing an AI model or algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. See point 8.

In summary: This 510(k) submission is for a physical medical device. The "study" described is a demonstration of substantial equivalence to an existing predicate device rather than a performance study with acceptance criteria and statistical data as would be performed for a novel or AI-powered diagnostic device. The basis for safety and effectiveness is largely the claim of identical manufacturing (design, materials, systems) to a device already on the market since 1994, with the only differences being packaging and sterilization by the new applicant.

Summary

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92(c))

1. INDICATIONS: The indications or intended use for the Inrad Co-axial Introducer Needle as well as the predicate device, Manan Medical Products, Inc. Co-axial Introducer Needle (K 940024) are the same. Both have the same indications, which is to guide biopsy needles to the target lesion for obtaining multiple biopsy samples.
1. DESIGN: The design of the Inrad Co-axial Introducer Needle as well as the predicate device, Manan Medical Products is referenced in the Comparison Information Section. The products are identically manufactured using the same manufacturing systems, design and materials. Both needles are manufactured by Manan Medical Products, Inc. The primary differences are packaging and sterilization which will be performed by Inrad.
1. MATERIALS: The device is manufactured from plastic and-stainless steel. The plastic hubs have no direct patient contact. The stainless steel is the only part of the device that has patient contact. Both products are identically manufactured by Manan Medical Products Inc. using the same manufacturing systems, design and materials
1. SAFETY AND EFFECTIVENESS: Manan Medical Products Inc. has sold the identical device in the market place since 1994 and has proven it to be safe and effective. The products are identically manufactured using the same manufacturing systems, design and materials and there are no differences in safety and effectiveness.
1. DIFFERENCES: There are no differences between the Inrad Inc. Coaxial Introducer Needle and the Manan Medical Products Inc. Co-axial Introducer Needle other than the source of packaging and sterilization. Inrad will be purchasing the identical product marketed by Manan, bulk and non-sterile, and then packaging and sterilizing the product using Inrad traditional systems.

Anne Armstrong

Anne Armstrong Director Quality Assurance/Regulatory Affairs

Inrad Incorporated 3956 44th St. SE Kentwood,MI 49512

Phone:(616) 554-7750 Ext. 102 (616) 554-7751 Fax:

K981721

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 28 1998

Ms. Anne Armstrong · Director, Quality Assurance/Regulatory Affairs INRAD. Inc. 3956 44th Street, S.E Kentwood, Michigan 49512

Re: K981721 Trade Name: Co-Axial Introducer Needle Regulatory Class: II Product Code: KNW Dated: May 14, 1998 Received: May15, 1998

Dear Ms. Armstrong:

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 regulations 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 Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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 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.

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.

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Page 2 - Ms. Anne Armstrong

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) 594-4595. 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 regulation 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,

Celia M. Witten, Ph.D., M.D.

M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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12981721 510 (k) Number (IF Known):

Device Name:

Indications for Use:

Co-axial Introducer Needle Catalog Codes: 611410, 611416, 611810, 611816

The device is used to guide a biopsy needle to the target lesion for obtaining multiple biopsy samples.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
X
(Per 21 CFR 801.109)
OR
Over-The-Counter-Use
(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number L981721

Regulation Number and Section

§ 876.1075 Gastroenterology-urology biopsy instrument.

(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.