(64 days)
The OsteoProbe is indicated for use as a measure bone tissue resistance to microindentation on the tibia in adults. The clinical significance of resistance to microindentation is unknown. The device is not intended to diagnose or treat any clinical condition.
OsteoProbe® is a bone microindentation measurement tool. It is a prescription device per 21 CFR Part 801.109. The device includes a single-use disposable component and reusable components. The single-use disposable component has a Spaulding classification of critical and is provided sterile. The reusable components have a Spaulding classification of non-critical and must be reprocessed (cleaning and intermediate-level disinfection) between each use. The device has one accessory: a single-use, disposable sterile cover.
This document is a 510(k) premarket notification for the OsteoProbe device. This type of submission is for establishing substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness. Therefore, based on the provided document, the device did not undergo a study to prove it meets specific acceptance criteria related to its clinical performance or diagnostic capability.
The document explicitly states: "Clinical testing was not necessary to support equivalence."
The "acceptance criteria" and "device performance" described in the document relate to the physical and material characteristics of the device, primarily to demonstrate substantial equivalence to a predicate device.
Here's an analysis based on the provided text, addressing your questions where possible:
1. Table of acceptance criteria and the reported device performance
Based on the provided document, the "acceptance criteria" and "reported device performance" are primarily related to general device characteristics and safety/manufacturing standards, rather than direct measurements of the device's intended clinical function (measuring bone tissue resistance to microindentation). The document does not provide quantitative performance metrics for the microindentation measurement itself, as clinical testing was not deemed necessary for this 510(k) submission.
| Acceptance Criteria Category/Test | Reported Device Performance Summary |
|---|---|
Sterilization Validation (AAMI TIR28, ISO 10993-7, & ISO 11135) | Validated to ensure the single-use disposable component is sterile. No specific performance metrics (e.g., SAL) are provided, but validation implies meeting relevant standard requirements. |
Distribution Testing (ASTM D4169, ASTM D4332-1) | Validated to ensure the device maintains integrity and performance during shipping and handling. No specific performance metrics (e.g., damage rate) are provided. |
Shelf Life (ASTM F1980, ASTM F2096, ASTM F88) | Validated to ensure the device remains safe and effective for its intended shelf life. No specific duration or performance metrics (e.g., degradation rate) are provided. |
Biocompatibility (ISO 10993-5, -10, -11) | Includes validation for: - Cytotoxicity - Sensitization - Irritation/Intracutaneous Reactivity - Acute Systemic Toxicity - Rabbit Pyrogen-Material Mediated These tests were conducted to ensure the device materials are safe for patient contact. No specific pass/fail criteria or quantitative results are provided, but completion indicates meeting standard requirements. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
No clinical test set was used for clinical performance evaluation as part of this submission. The tests performed (sterilization, distribution, shelf life, biocompatibility) are typically laboratory-based validations. Therefore, this information is not applicable to the provided document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No clinical test set or ground truth established by experts for clinical performance was used in this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring adjudication was used in this 510(k) submission.
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. The OsteoProbe is described as a "bone microindentation measurement tool" and is not an AI-assisted diagnostic or imaging interpretation device that would typically involve human readers. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The OsteoProbe is a physical device measuring bone tissue resistance, not an algorithm. Clinical performance studies were not performed for this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No ground truth for clinical performance was established, as clinical testing was not performed for this 510(k) submission. The "ground truth" for the non-clinical tests (e.g., sterility, biocompatibility) would be defined by the specific standards and their acceptance criteria (e.g., acceptable levels of extractables for biocompatibility, absence of microbial growth for sterility).
8. The sample size for the training set
Not applicable. The OsteoProbe is a physical measurement device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, no training set was used.
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June 28, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right, there is a blue square with the letters "FDA" in white. Next to the square, the words "U.S. FOOD & DRUG" are written in blue, followed by the word "ADMINISTRATION" in a smaller font size.
Active Life Scientific, Inc. Alexander Proctor Chief Technology Officer 1027 Garden Street Santa Barbara, California 93101
Re: K221195
Trade/Device Name: OsteoProbe Regulation Number: 21 CFR 888.1600 Regulation Name: Bone Indentation Device Regulatory Class: Class II Product Code: QGQ Dated: June 6, 2022 Received: June 7, 2022
Dear Alexander Proctor:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laura C. Rose, PhD Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221195
Device Name OsteoProbe
Indications for Use (Describe)
The OsteoProbe is indicated for use as a measure bone tissue resistance to microindentation on the tibia in adults. The clinical significance of resistance to microindentation is unknown. The device is not intended to diagnose or treat any clinical condition.
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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510(k) Summary
| Device Trade Name: | OsteoProbe |
|---|---|
| Manufacturer: | Active Life Scientific, Inc. |
| 1027 Garden Street, Santa Barbara, CA 93101 | |
| Contact: | Alexander Proctor |
| Chief Technology Officer | |
| Phone: 805-770-2600 x109 | |
| Email: alex@activelifescientific.com | |
| Date Prepared: | 6/23/2022 |
| Classification: | 21 CFR §888.1600, Bone indentation device |
| Class: | II |
| Product Code: | QGQ |
| Predicate Devices: | OsteoProbe - DEN210013 |
| Indications for Use: | The OsteoProbe is indicated for use as a measurement tool to measure bone tissueresistance to microindentation on the tibia in adults. The clinical significance ofresistance to microindentation is unknown. The device is not intended to diagnose ortreat any clinical condition. |
| Device Description: | OsteoProbe® is a bone microindentation measurement tool. It is a prescription deviceper 21 CFR Part 801.109. The device includes a single-use disposable component andreusable components. The single-use disposable component has a Spauldingclassification of critical and is provided sterile. The reusable components have aSpaulding classification of non-critical and must be reprocessed (cleaning andintermediate-level disinfection) between each use. The device has one accessory: asingle-use, disposable sterile cover. |
Substantial Equivalence:
The subject OsteoProbe device is substantially equivalent to the predicate device with respect to indications, function, and performance. The sterilization, distribution, shelf-life, and biocompatibility of the single-use disposable of the subject device are substantially equivalent to the predicate device and do not raise different questions of safety and effectiveness.
Preclinical Testing:
The following validations and testing were performed on the OsteoProbe device:
- . Sterilization validation testing (AAMI TIR28, ISO 10993-7, & ISO 11135)
- . Distribution Testing (ASTM D4169, ASTM D4332-1)
- Shelf Life (ASTM F1980, ASTM F2096, ASTM F88)
- Biocompatibility
- o Cytotoxicity (ISO 10993-5)
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- O Sensitization (ISO 10993-10)
- Irritation/Intracutaneous Reactivity (ISO 10993-10) O
- o Acute Systemic Toxicity (ISO 10993-11)
- Rabbit Pyrogen-Material Mediated (ISO 10993-11) O
Clinical Testing:
Clinical testing was not necessary to support equivalence.
Conclusion:
The subject OsteoProbe device is substantially equivalent for its intended use to the previously-cleared, predicate device.
N/A