(142 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and performance studies focus on mechanical measurement and variability testing, not AI/ML algorithms.
No
The device is described as a "measurement tool" and explicitly states it is "not intended to diagnose or treat any clinical condition."
No
Explanation: The "Intended Use / Indications for Use" section explicitly states, "This device is not intended to diagnose or treat any clinical condition." It is described as a "measurement tool to measure bone tissue resistance to microindentation."
No
The device description explicitly lists multiple hardware components: Stylus, Electronics Adapter, Reference Block Holder, single-use Reference Block, single-use disposable Tip Assembly, and Operator Interface.
Based on the provided information, the OsteoProbe is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use explicitly states that the device is a "measurement tool to measure bone tissue resistance to microindentation on the tibia in adults." It also clearly states, "This device is not intended to diagnose or treat any clinical condition." IVD devices are specifically intended for use in vitro (outside the body) to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- Device Description: The description details a system that interacts directly with the bone tissue in vivo (within the body) through microindentation. This is a physical measurement performed on the living subject, not an analysis of a biological sample in a laboratory setting.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), using reagents, or performing tests in a laboratory setting, which are hallmarks of IVD devices.
The OsteoProbe is a device that performs a physical measurement on bone tissue in vivo. While the measurement might eventually be used in conjunction with other clinical information, the device itself is not performing an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The OsteoProbe is indicated for use as a measurement tool to measure bone tissue resistance to microindentation on the tibia in adults. The clinical significance of resistance to microindentation is unknown. This device is not intended to diagnose or treat any clinical condition.
Product codes
QGQ
Device Description
The OsteoProbe is a cortical bone microindentation measurement tool based on reference point indenter technology. System hardware consists of a Stylus (1), an Electronics Adapter (2), a Reference Block Holder and single-use Reference Block (3), a single-use disposable Tip Assembly (4), and an Operator Interface (5).
The single-use Tip Assembly consists of a polycarbonate Guide and stainless steel Tip, which are both steam sterilized by the user. The 28-guage solid Tip is made of AISI 440C stainless steel with a 90° conical tip and
§ 888.1600 Bone indentation device.
(a)
Identification. A bone indentation device is a device that measures resistance to indentation in bone.(b)
Classification. Class II (special controls). The special controls for this device are:(1) In vivo performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must evaluate the risk of bone fracture, soft tissue damage, pain, discomfort, bruising, or bleeding.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including an evaluation of the accuracy and precision of the device with respect to resistance to bone indentation.
(3) Human factors testing must demonstrate that the intended user(s) can correctly use the device, based on the instructions for use.
(4) The patient-contacting components of the device must be demonstrated to be biocompatible.
(5) Performance testing must demonstrate:
(i) The sterility of the patient-contacting components of the device; and
(ii) Validation of reprocessing instructions for any reusable components of the device.
(6) Performance data must support the shelf life of the device by demonstrating continued sterility and device functionality over the identified shelf life.
(7) Software verification, validation, and hazard analysis must be performed.
(8) Performance data must be provided to demonstrate the electromagnetic compatibility (EMC) and electrical safety of the device.
(9) Labeling must include:
(i) Instructions for use;
(ii) Validated methods and instructions for reprocessing of any reusable components;
(iii) A shelf life for any sterile components;
(iv) Information regarding limitations of the clinical significance of the device output; and
(v) A detailed summary of the accuracy and precision of the device.
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DE NOVO CLASSIFICATION REQUEST FOR OSTEOPROBE
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Bone indentation device. A bone indentation device is a device that measures resistance to indentation in bone.
NEW REGULATION NUMBER: 21 CFR 888.1600
CLASSIFICATION: Class II
PRODUCT CODE: QGQ
BACKGROUND
DEVICE NAME: OsteoProbe
SUBMISSION NUMBER: DEN210013
DATE DE NOVO RECEIVED: March 31, 2021
SPONSOR INFORMATION:
Active Life Scientific, Inc. 1027 Garden Street Santa Barbara, California 93101
INDICATIONS FOR USE
The OsteoProbe is indicated for use as a measurement tool to measure bone tissue resistance to microindentation on the tibia in adults. The clinical significance of resistance to microindentation is unknown. This device is not intended to diagnose or treat any clinical condition.
LIMITATIONS
The sale, distribution, and use of the OsteoProbe are restricted to prescription use in accordance with 21 CFR 801.109.
PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
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DEVICE DESCRIPTION
The OsteoProbe is a cortical bone microindentation measurement tool based on reference point indenter technology. System hardware consists of a Stylus (1), an Electronics Adapter (2), a Reference Block Holder and single-use Reference Block (3), a single-use disposable Tip Assembly (4), and an Operator Interface (5).
Image /page/1/Picture/2 description: The image shows an OsteoProbe device connected to a laptop. The OsteoProbe is a medical device used to measure bone density. The device consists of a probe (1, 4), a control unit (2), and a computer (5) with software. The probe is connected to the control unit, which is connected to the computer. There is also a calibration device (3) connected to the computer.
The single-use Tip Assembly (image below) consists of a polycarbonate Guide and stainless steel Tip, which are both steam sterilized by the user. The 28-guage solid Tip is made of AISI 440C stainless steel with a 90° conical tip and logs for (b) (4) a log reduction of > (b) (4) ogs for (b) (4)
Shelf Life
Accelerated aging testing was performed on the OsteoProbe reusable components per ASTM F1980-16. Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. The service life of two years was verified by accuracy testing after accelerated aging.
ELECTROMAGNETIC COMPATIBILITY AND ELECTRICAL SAFETY
Electrical safety and electromagnetic compatibility testing has been performed per IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 (or IEC 60601-1:2012 reprint) CAN/CSA-C22.2 No. 60601-1:14IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for basic safety and essential performance and IEC 60601-1-2:2014. Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - Requirements and tests. The test results support electrical safety and electromagnetic compatibility.
SOFTWARE
The OsteoProbe software documentation was reviewed according to the FDA Guidance document, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued May 11, 2005. The software was found to have a Moderate Level of Concern, because a failure of the device may result in a minor injury to a patient
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prior to risk mitigation. The software documentation included management of cybersecurity and:
- Software Description 1.
- Device Hazard Analysis 2.
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- Software Requirements Specification
- Architecture Design Chart 4.
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- Software Design Specification
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- Traceability Analysis
- Software Development Environment Description 7.
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- Verification and Validation Documentation
- Revision Level History 9.
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- Unresolved Anomalies
The software documentation provided in support of the OsteoProbe was found to be acceptable.
PERFORMANCE TESTING
Strain gage sensor testing was performed with comparison to a calibrated micrometer. (b) (4)strain gages were subjected to (b) (4) measurements each at (b) (4) (b) (4) , representing the physiological range of indentation depths. This testing resulted in sensor linearity of (b) (4) resulted in sensor linearity of (b) (4) = = = = = average accuracy = (b) (4) = , and
precision = (b) (4) average deviation (SD=(b) (4) = ). These results indicated that the linear equation used for calculating BMSi is appropriate.
Accuracy and precision tests were performed to characterize the (1) (1) sources of variability: device, operator, bone, and clinical use environment. The sponsor performed one-way random effects analysis of variation (ANOVA) to obtain point estimates of variability for each source.
Device Variability Testing
An automated actuator was used to conduct variability testing on " " "Hevices, using Noryl reference blocks only, to eliminate variable effects of the operator, indented material, and clinical use environment.
Five measurements each were made, for a total of (4) (4) data points. Difference from the target value of (b) (4)BMSi was evaluated. Results (mean difference from the target value) showed device accuracy (b) (4) BMSi units, SD=b)(4). The sponsor performed one-way random effects ANOVA to obtain the point estimate of Device Variability [b) (4BMSi units (b) (4)
Operator Variability Testing
Operator variability testing was performed per ISO 5725 Accuracy (trueness and precision) of measurement methods and results, across " different laboratories with a
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different operator/device used at each lab. Labs with difference experience levels were included, from least experienced to most experienced. Testing was conducted using b reference polymer materials, to cover the range of expected patient measurements (range was (b) (4) BMSi from 905 patients in prior clinical research): (b) (4)
. Each lab measured the (b) (4) materials (b) (4)times, in randomly assigned order, different order across the labs, and all testing performed within (b) (4)hour at each lab.
Results showed operator accuracy (bias) was