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510(k) Data Aggregation
(167 days)
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.
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.
This document describes a 510(k) premarket notification for the "PrecisionPoint Biopsy Needle Guide." A 510(k) submission typically demonstrates substantial equivalence to a predicate device, rather than proving that a device meets specific clinical performance acceptance criteria through the kind of study described in the prompt. Therefore, many of the requested elements for a study proving device acceptance criteria are not applicable in this context.
Here's a breakdown of the information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
This document describes performance testing against standards for sterilization, biological evaluation, and packaging, rather than clinical performance criteria with numerical targets. The acceptance criteria are implicit in meeting these recognized standards.
| Acceptance Criteria (Standard Met) | Reported Device Performance |
|---|---|
| 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 | The PrecisionPoint Biopsy Needle Guide was "tested against" this standard, implying that it meets the requirements for ethylene oxide sterilization. |
| ISO 10993-1 - Biological Evaluation of Medical Devices | The PrecisionPoint Biopsy Needle Guide was "tested against" this standard, implying that it meets the requirements for biological compatibility. |
| ANSI/AAMI/ISO 11607-1 Packaging for Terminally Sterilized Medical Devices Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging | The PrecisionPoint Biopsy Needle Guide was "tested against" this standard, implying that its packaging meets the requirements for 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 | The PrecisionPoint Biopsy Needle Guide was "tested against" this standard, implying that its packaging manufacturing processes meet the validation requirements. |
| Functional Equivalence to Predicate Device (Sonosite iLook 25 Needle Guide Attachment and Bracket Assembly - K030064) | The PrecisionPoint Biopsy Needle Guide is presented as substantially equivalent in: (1) Indications for Use: Both are for minimally invasive procedures involving soft tissue biopsies and share similar language. (2) Design and Materials: Both are sterile, single-use, non-invasive, medical-grade polymeric devices that attach to an ultrasound transducer and hold a biopsy needle. (3) Design Principles: Both accept a biopsy needle guide, attach to an ultrasound transducer, and are non-invasive devices placed on the patient's skin to guide biopsy procedures. |
Regarding clinical performance acceptance criteria and a study to prove them:
The document describes performance testing related to basic medical device standards (sterilization, biocompatibility, packaging). It does not present a clinical study with an acceptance criterion for device effectiveness or accuracy (e.g., biopsy success rate, targeting accuracy). The primary "proof" for this 510(k) submission is showing substantial equivalence to a legally marketed predicate device.
Given that this is a 510(k) submission for a needle guide and relies on substantial equivalence to a predicate, the following requested information is not provided in this document:
2. Sample size used for the test set and the data provenance: Not applicable for this type of submission. There is no clinical "test set" described for performance evaluation of the needle guide's clinical efficacy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set or ground truth establishment by experts is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 needle guide, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. There is no clinical "ground truth" described for the device's performance. The "ground truth" in this submission relates to adherence to manufacturing and safety standards, and demonstrating design and intended use equivalence to the predicate.
8. The sample size for the training set: Not applicable. There is no "training set" in the context of this device and submission type.
9. How the ground truth for the training set was established: Not applicable.
Summary of what the document does indicate:
The device is a PrecisionPoint Biopsy Needle Guide, intended to facilitate proper needle placement during ultrasound-guided biopsies when used with a BK ProFocus 2202 ultrasound system. Its acceptance by the FDA (via 510(k) clearance) is based on:
- Meeting recognized standards for sterilization (ISO 11135-1), biological evaluation (ISO 10993-1), and packaging (ANSI/AAMI/ISO 11607-1, ANSI/AAMI/ISO 11607-2).
- Demonstrating substantial equivalence in indications for use, design, and materials to a predicate device: the Sonosite iLook 25 Needle Guide Attachment and Bracket Assembly (K030064). The document explicitly states the substantial equivalence in these areas.
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