(199 days)
Not Found
No
The device description and intended use describe a purely mechanical biopsy needle. There is no mention of software, algorithms, or any components that would suggest AI/ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is used for obtaining biopsy samples, which is a diagnostic procedure, not a therapeutic intervention.
No
Explanation: The device is a guiding needle used to obtain core biopsy samples. Biopsy samples are collected to be analyzed, but the needle itself does not perform the diagnostic analysis.
No
The device description clearly details a physical, sterile, single-use needle made of stainless steel and polymeric materials. There is no mention of software as a component or the primary function of the device.
Based on the provided information, the Perineologic Access Needle is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to obtain core biopsy samples from soft tissue and tumors of various organs. This is a procedure performed on the patient's body to collect a sample.
- Device Description: The device is a needle designed for physical access and sample collection from within the body.
- Lack of In Vitro Activity: There is no mention of the device being used to examine or test samples outside of the body (in vitro). IVD devices are typically used to analyze biological samples (like blood, urine, tissue) in a laboratory setting to diagnose or monitor conditions.
The Perineologic Access Needle is a medical device used for a biopsy procedure, which is an in vivo (within the living body) process of sample collection. The subsequent analysis of the collected biopsy sample would likely involve IVD devices and procedures, but the needle itself is not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
FCG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue and tumors of such organs as liver, kidney, spleen, lymph nodes, prostate, lung and various soft tissue lesions.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem depicts a stylized human figure with three faces in profile, representing the department's focus on health and human well-being. The logo is simple and recognizable, conveying the department's mission and purpose.
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.
1
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)
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.
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, LLC
12234 Williams Road
Cumberland, MD 21502
Tel: 301-724-0132
Fax: 301-759-5874 |
|--------------------|-------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Kenneth K. Kleinhenz
Regulatory Affairs Consultant
Telephone (858) 458-0900
Fax (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
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.
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DEVICE DESCRIPTION
Design Characteristics
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.
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.