(167 days)
No
The device description focuses on the mechanical components and function of a needle guide for ultrasound-guided biopsies. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a needle guide that facilitates proper needle placement for biopsies, which is a diagnostic procedure, not a therapeutic one. It assists in accessing anatomical structures for sampling, not for treating a condition.
No
This device is a needle guide designed to facilitate proper needle placement during biopsies. It aids in accessing anatomical structures for biopsy procedures. While biopsies are often performed to diagnose conditions, the needle guide itself does not perform the diagnostic function; it is a tool used in the sampling process. The diagnosis is made by examining the tissue collected using the biopsy.
No
The device description explicitly details physical, polymeric components (carriage, rail/clamp) that are sterile, single-use, and disposable. It is a hardware device designed to hold an ultrasound probe and needle guide.
Based on the provided information, the Perineologic PrecisionPoint™ Biopsy Needle Guide is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate proper needle placement to access anatomical structures." This describes a device used during a medical procedure to guide a needle into the body for biopsy.
- Device Description: The description details a physical device that attaches to an ultrasound transducer to hold both the transducer and a needle in a fixed relative position. It's a mechanical guide.
- Lack of IVD Characteristics: IVD devices are used to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any analysis or testing of biological samples. It's a tool for obtaining the sample.
In summary, the PrecisionPoint Biopsy Needle Guide is a surgical accessory used to aid in the process of obtaining a biopsy sample, not a device that analyzes the sample itself.
N/A
Intended Use / Indications for Use
The intended use of the Perineologic PrecisionPoint™ Biopsy Needle Guide when used in conjunction with a BK ProFocus 2202 ultrasound system and attached to the ultrasound system's transducer, is to facilitate proper needle placement to access anatomical structures.
Product codes (comma separated list FDA assigned to the subject device)
ITX
Device Description
The PrecisionPoint Biopsy Needle Guide is a sterile, single use, disposable, polymeric needle guide containing 2 pieces of molded plastic (carriage and rail/clamp). The PrecisionPoint Biopsy Needle Guide is pressed / placed onto the region overlying the area to be biopsied. The PrecisionPoint Biopsy Needle Guide holds both the ultrasound probe and the needle guide in place relative to each other while the ultrasound-guided biopsy is being preformed. The PrecisionPoint Biopsy Needle Guide is an assembly of 3 unique polymeric components: carriage, rail, and clamp. The carriage component slides onto the rails to create an assembly that can hold and maintain the relative position of an ultrasound probe and a needle guide at the same time.
The clamp component is a ring shaped structure with 2 opposing rectangular handles at the bottom of the ring that contain a male flange that is designed to mate with the opposing female cavern. The male flange has ridges on the bottom of the flange while the female cavern has ridges on the top of the cavern, creating an adjustable locking mechanism in which the next row of ridges align and lock as the male flange advances. The advancement of the male flange into the opposing female cavern creates a ring with decreased and smaller circumference that imposes increased pressure on a cylindrical ultrasound probe positioned within the ring of the clamp component. The clamp component is designed to accommodate a cylindrical style transrectal ultrasound transducer (0.7' to .85" diameter BK #8658 or equivalent) associated with a BK ProFocus ultrasound system cleared under K043524.
The carriage component has 5 equal holes to accommodate a 14 gauge needle and may contain holes of equal or various diameters from 14 gauge to 20 gauge. The 5 needle holes are equally spaced approximately 5cm apart and may be spaced closer or farther apart depending on the diameter of the holes. The number of needle holes may vary from as few as 1 to as many as 8. The dimensions of the fully assembled PrecisionPoint Biopsy Needle Guide are approximately 5.5cm long, 7cm tall, and 4.5cm wide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
anatomical structures, region overlying the area to be biopsied, soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 PrecisionPoint Biopsy Needle Guide was tested against the following standards: ISO 11135-1:2007 -Sterilization of health care products - Ethylene oxide - Part 1: 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the profile graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 1, 2016
Corbin Clinical Resources, LLC % Mr. Kenneth Kleinhenz Regulatory Affairs Consultant 12234 Williams Road CUMBERLAND MD 21502
Re: K160414
Trade/Device Name: PrecisionPoint Biopsy Needle Guide Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: ITX Dated: July 1, 2016 Received: July 8, 2016
Dear Mr. Kleinhenz:
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. 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.
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); medical device reporting (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.
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If you 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Robert Odlo
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160414
Device Name PrecisionPoint Biopsy Needle Guide
Indications for Use (Describe)
The intended use of the Perineologic PrecisionPoint™ Biopsy Needle Guide when used in conjunction with a BK ProFocus 2202 ultrasound system and attached to the ultrasound system's transducer, is to facilitate proper needle placement to access anatomical structures.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------------------- | ----------------------------------------------- |
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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 |
| DEVICE NAME
Classification Name: | Diagnostic Ultrasonic Transducer
Accessory |
| Trade/Proprietary Name: | PrecisionPoint Biopsy Needle Guide |
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 892.1570. Accessories to Diagnostic Ultrasonic Transducers are devices intended for use in/with diagnostic ultrasonic medical devices and may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container. These devices are classified as Class II. Diagnostic Ultrasonic Transducers have been assigned Product Code ITX.
INTENDED USE
The intended use of the Perineologic PrecisionPoint™ Biopsy Needle Guide when used in conjunction with a BK ProFocus 2202 ultrasound system and attached to the ultrasound system's transmucer, is to facilitate proper needle placement to access anatomical structures.
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DEVICE DESCRIPTION
Design Characteristics
The PrecisionPoint Biopsy Needle Guide is a sterile, single use, disposable, polymeric needle guide containing 2 pieces of molded plastic (carriage and rail/clamp). The PrecisionPoint Biopsy Needle Guide is pressed / placed onto the region overlying the area to be biopsied. The PrecisionPoint Biopsy Needle Guide holds both the ultrasound probe and the needle guide in place relative to each other while the ultrasound-guided biopsy is being preformed. The PrecisionPoint Biopsy Needle Guide is an assembly of 3 unique polymeric components: carriage, rail, and clamp. The carriage component slides onto the rails to create an assembly that can hold and maintain the relative position of an ultrasound probe and a needle guide at the same time.
The clamp component is a ring shaped structure with 2 opposing rectangular handles at the bottom of the ring that contain a male flange that is designed to mate with the opposing female cavern. The male flange has ridges on the bottom of the flange while the female cavern has ridges on the top of the cavern, creating an adjustable locking mechanism in which the next row of ridges align and lock as the male flange advances. The advancement of the male flange into the opposing female cavern creates a ring with decreased and smaller circumference that imposes increased pressure on a cylindrical ultrasound probe positioned within the ring of the clamp component. The clamp component is designed to accommodate a cylindrical style transrectal ultrasound transducer (0.7' to .85" diameter BK #8658 or equivalent) associated with a BK ProFocus ultrasound system cleared under K043524.
The carriage component has 5 equal holes to accommodate a 14 gauge needle and may contain holes of equal or various diameters from 14 gauge to 20 gauge. The 5 needle holes are equally spaced approximately 5cm apart and may be spaced closer or farther apart depending on the diameter of the holes. The number of needle holes may vary from as few as 1 to as many as 8. The dimensions of the fully assembled PrecisionPoint Biopsy Needle Guide are approximately 5.5cm long, 7cm tall, and 4.5cm wide.
PERFORMANCE TESTING
The PrecisionPoint Biopsy Needle Guide was tested against the following standards: ISO 11135-1:2007 -Sterilization of health care products - Ethylene oxide - Part 1: 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 PrecisionPoint Biopsy Needle Guide shares indications and design principles with the following predicate devices which have been determined by FDA to be substantially equivalent to pre-amendment devices: Sonosite iLook 25 Needle Guide Attachment and Bracket Assembly; Class II medical devices that were cleared for marketing in the United States under K030064.
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Indications For Use
The PrecisionPoint Biopsy Needle Guide shares indications for use principles with the Sonosite iLook 25 Needle Guide Attachment and Bracket Assembly predicate devices (K030064) as both devices are indicated for use in the same minimally invasive procedures involving soft tissue biopsies. Moreover, the PrecisionPoint Biopsy Needle Guide shares indications for use language with the Sonosite iLook 25 Needle Guide Attachment and Bracket Assembly (K030064) predicate devices.
Design and Materials
The material and design principles of the PrecisionPoint Biopsy Needle Guide and the Sonosite iLook 25 Needle Guide Attachment and Bracket Assembly predicate device (K030064) are substantially equivalent, consisting of sterile, single-use, non-invasive devices fabricated from a medical grade polymeric material. All devices also share the common design principles of attaching to an ultrasound transducer and holding a biopsy needle.
The PrecisionPoint Biopsy Needle Guide and the Sonosite iLook 25 Needle Guide Attachment and Bracket Assembly predicate device (K030064) are substantially equivalent as the devices are fabricated from substantially equivalent, medical-grade, polymeric materials.
The PrecisionPoint Biopsy Needle Guide and the Sonosite iLook 25 Needle Guide Attachment and Bracket Assembly predicate device (K030064) are substantially equivalent as they share substantially equivalent design principles of accepting a biopsy needle guide and attaching to an ultrasound transducer.
The PrecisionPoint Biopsy Needle Guide and the Sonosite iLook 25 Needle Guide Attachment and Bracket Assembly predicate device (K030064) are substantially equivalent as they share substantially equivalent design principles of being non-invasive devices that are placed onto the patient's skin in preparation for guiding a biopsy procedure involving a biopsy needle.