OsteoProbe

K221195 · Active Life Scientific, Inc. · QGQ · Jun 28, 2022 · Orthopedic

Device Facts

• Record ID: K221195
• Device Name: OsteoProbe
• Applicant: Active Life Scientific, Inc.
• Product Code: QGQ · Orthopedic
• Decision Date: Jun 28, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.1600
• Device Class: Class 2

Intended Use

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.

Device Story

OsteoProbe is a bone microindentation measurement tool; used to measure bone tissue resistance on the tibia in adults. Device consists of reusable components and a single-use, sterile disposable component with a sterile cover. Reusable components require cleaning and intermediate-level disinfection between uses. Device is prescription-only. Output provides a measurement of bone tissue resistance; clinical significance of this measurement is unknown. Device is not intended for diagnosis or treatment of any clinical condition.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including sterilization validation, distribution testing, shelf-life testing, and biocompatibility (cytotoxicity, sensitization, irritation, acute systemic toxicity, and rabbit pyrogen testing).

Technological Characteristics

Bone indentation device. Includes reusable components and single-use sterile disposable component. Sterilization per AAMI TIR28, ISO 10993-7, ISO 11135. Biocompatibility per ISO 10993-5, -10, -11. Distribution/Shelf-life per ASTM D4169, D4332-1, F1980, F2096, F88.

Indications for Use

Indicated for measuring bone tissue resistance to microindentation on the tibia in adults. No specific disease state or contraindications listed.

Regulatory Classification

Identification

A bone indentation device is a device that measures resistance to indentation in bone.

Special Controls

In combination with the general controls of the FD&C Act, the bone indentation device is subject to the following special controls: - (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. - The patient-contacting components of the device must be demonstrated to be (4) biocompatible. - (ર) Performance testing must demonstrate: - The sterility of the patient-contacting components of the device; and (i) - (ii) Validation of reprocessing instructions for any reusable components of the device. - Performance data must support the shelf life of the device by demonstrating continued (6) sterility and device functionality over the identified shelf life. - Software verification, validation, and hazard analysis must be performed. (7) - (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 - A detailed summary of the accuracy and precision of the device. (v)

*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.

Predicate Devices

• OsteoProbe (DEN210013)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

| <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------------------------------|
| <span style="font-size:16px">☐</span> 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: [phone] x109 |
| | Email: [e-mail] |
| 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 tissue<br>resistance to microindentation on the tibia in adults. The clinical significance of<br>resistance to microindentation is unknown. The device is not intended to diagnose or<br>treat any clinical condition. |
| Device Description: | OsteoProbe® is a bone microindentation measurement tool. It is a prescription device<br>per 21 CFR Part 801.109. The device includes a single-use disposable component and<br>reusable components. The single-use disposable component has a Spaulding<br>classification of critical and is provided sterile. The reusable components have a<br>Spaulding classification of non-critical and must be reprocessed (cleaning and<br>intermediate-level disinfection) between each use. The device has one accessory: a<br>single-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.