The Perineologic Access Needle is intended for use as a guiding needle in obtaining core biopsy samples from soft tissue and tumors of such organs as liver, kidney, spleen, lymph nodes, prostate, lung and various soft tissue lesions.

Device Description

The Perineologic Access Needle is a sterile, single use, disposable, hollowed/tubular, stainless steel needle that is sharpened at one end and blunt on the opposing end while containing a polymeric hub with a female luer-lock style fitting to accept a male luer lock syringe. The polymeric hub contains a female luer fitting on the proximal end, a protruding, elongated rectangle for gripping, and a distal circumferential tubular lip that protrudes approximately 1 cm along the axis of the stainless steel needle. The protruding rectangle in the middle of the polymeric hub has 2 opposing and equal sides in the shape of a tapered rectangle containing ribs for gripping. The remaining 2 sides of the tapered rectangle are hollowed.

The Perineologic Access Needle is provided in various lengths and diameters as required for particular biopsy procedures. The Perineologic Access Needle is provided in lengths ranging from 7cm to 20cm and inner diameters ranging from 14 gauge to 20 gauge.

AI/ML Overview

This document describes a 510(k) premarket notification for the Perineologic Access Needle, a device intended for use as a guiding needle in obtaining core biopsy samples.

Unfortunately, the provided text does not contain information about acceptance criteria or a specific study that proves the device meets those criteria in terms of clinical performance. The document focuses on demonstrating substantial equivalence to existing predicate devices based on design characteristics, materials, and intended use, rather than presenting novel performance data against pre-defined clinical acceptance criteria.

The "Performance Testing" section (page 4) lists general standards related to sterilization, biological evaluation, and packaging, which are crucial for device safety and regulatory compliance but are not, strictly speaking, clinical performance acceptance criteria.

Therefore, I cannot provide a detailed answer to your request as the information is not present in the provided text. To answer your questions, I would need a section describing clinical performance studies with specific statistical outcomes and acceptance criteria.

However, based on the provided text, I can infer some general information about the device and its regulatory submission:

Device Name: Perineologic Access Needle
Intended Use: Guiding needle in obtaining core biopsy samples from soft tissue and tumors of organs like liver, kidney, spleen, lymph nodes, prostate, lung, and various soft tissue lesions.
Regulatory Pathway: 510(k) premarket notification, demonstrating substantial equivalence.
Predicate Devices:
- Bard TrueGuide™ Coaxial Biopsy Needle Guide (K936194)
- PFM Medical Biopsy Needle System (K140137)

Missing Information (based on your request):

Table of Acceptance Criteria and Reported Device Performance: Not available. The document does not define specific clinical acceptance criteria (e.g., success rate, accuracy) for the device's function as a guiding needle, nor does it report performance against such criteria.
Sample Size and Data Provenance for Test Set: Not available. No clinical test set data is provided.
Number and Qualifications of Experts for Ground Truth: Not applicable, as no clinical performance data requiring expert-established ground truth is presented.
Adjudication Method: Not applicable.
MRMC Comparative Effectiveness Study: Not mentioned or conducted. The submission is for a medical device (a needle), not an AI algorithm.
Standalone Performance Study: Not clearly detailed in terms of clinical performance. The focus is on equivalence.
Type of Ground Truth Used: Not applicable, as no clinical performance data is presented.
Sample Size for Training Set: Not applicable, as this is not an AI/algorithm-based device requiring a training set.
How Ground Truth for Training Set was Established: Not applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 22, 2016

Corbin Clinical Resources, LLC Kenneth K. Kleinhenz Regulatory Affairs Consultant 12234 Williams Road Cumberland, MD 21502

Re: K160423

Trade/Device Name: Perineologic Access Needle Regulation Number: 21 CFR§ 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: II Product Code: FCG Dated: August 15, 2016 Received: August 17, 2016

Dear Kenneth K. Kleinhenz:

This letter corrects our substantially equivalent letter of September 2, 2016.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially (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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

For Division

Douglas Silverstein -S 2016.09.22 11:06:41 -04'00'

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K160423

Device Name Perineologic Access Needle

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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DATE OF PREPARATION

02 SEPTEMBER 2016

ADMINISTRATIVE INFORMATION

Manufacturer Name:	Corbin Clinical Resources, LLC12234 Williams RoadCumberland, MD 21502Tel: 301-724-0132Fax: 301-759-5874
Official Contact:	Kenneth K. KleinhenzRegulatory Affairs ConsultantTelephone (858) 458-0900Fax (858) 458-0994

Classification Name:

Trade/Proprietary Name:

Biopsy Needle Kit

Perineologic Access Needle

ESTABLISHMENT REGISTRATION NUMBER

This is the first Corbin Clinical Resources, LLC device applications to FDA. Corbin Clinical Resources, LLC will register and pay the fee within 30 days of FDA's clearance of this device.

DEVICE CLASSIFICATION AND PRODUCT CODE

As shown in 21CFR 876.1075, Gastroenterology-urology biopsy instruments are devices used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. These devices are classified as Class II. Gastroenterology-urology biopsy instruments have been assigned product code FCG.

INDICATIONS FOR USE

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DEVICE DESCRIPTION

Design Characteristics

PERFORMANCE TESTING

The Perineologic Access Needle was tested against the following standards: ANSI/AAMI/ISO 11135:2014 - Sterilization of Health Care Products - Ethylene Oxide - Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices, ISO 10993-1 - Biological Evaluation of Medical Devices, and ANSI/AAMI/ISO 11607-1 Packaging for Terminally Sterilized Medical Devices Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging, ANSI/AAMI/ISO 11607-2 Packaging for Terminally Sterilized Medical Devices Part 2: Validation Requirements for Forming, Sealing and Assembly Process.

EQUIVALENCE TO MARKETED PRODUCT

Corbin Clinical Resources, LLC Perineologic Access Needle shares indications and design principles with the following predicate devices which have been determined by FDA to be substantially equivalent to the following devices: Bard TrueGuide™ Coaxial Biopsy Needle Guide (K936194) and the PFM Medical Biopsy Needle System (K140137); Class II medical devices that were cleared for marketing in the United States under K936194 and K140137 respectively.

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Design and Materials

The material and design principles of the Perineologic Access Needle and the predicate devices [Bard TrueGuide ™ Coaxial Biopsy Needle Guide (K936194) and the PFM Medical Biopsy Needle System (K140137)] are substantially equivalent, consisting of sterile, single-use fabricated from a medical grade polymeric material and stainless steel. All devices also share the common design principles of being composed of materials that are intended for transient use with soft tissues.

The Perineologic Access Needle and the predicate devices [Bard TrueGuide™ Coaxial Biopsy Needle Guide (K936194) and the PFM Medical Biopsy Needle System (K140137)] are substantially equivalent as the needles are all fabricated from substantially equivalent, medical-grade, stainless steel and the opposite end of the needle is fabricated from substantially equivalent, medical-grade, polymeric material to a polymeric syringe.

The Perineologic Access Needle and the predicate devices [Bard TrueGuide™ Coaxial Biopsy Needle Guide (K936194) and the PFM Medical Biopsy Needle System (K140137)] are substantially equivalent as they all share the same design of a polymeric female luer lock hub that is designed to attach to a luer style syringe.

The Perineologic Access Needle and the predicate devices [Bard TrueGuide]10 Coaxial Biopsy Needle Guide (K936194) and the PFM Medical Biopsy Needle System (K140137)] are substantially equivalent as they all share the same design of a hollowed, stainless steel tube sharpened at one end and blunt at the other end with a polymeric hub attached to the blunt end.

The Perineologic Access Needle and the predicate devices [Bard TrueGuide™ Coaxial Biopsy Needle Guide (K936194) and the PFM Medical Biopsy Needle System (K140137)] are substantially equivalent as they all share the same design principals of puncturing tissue to guide the position of a biopsy needle and to create a passage for another needle of smaller diameter to pass through and obtain a biopsy sample.

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.