(64 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the device description focuses on mechanical measurement.
No
The "Intended Use / Indications for Use" explicitly states, "The device is not intended to diagnose or treat any clinical condition." This indicates it is not a therapeutic device.
No
The "Intended Use / Indications for Use" section explicitly states, "The device is not intended to diagnose or treat any clinical condition."
No
The device description explicitly states that the device includes both single-use disposable and reusable hardware components, in addition to a disposable sterile cover accessory.
Based on the provided information, the OsteoProbe is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device "is indicated for use as a measure bone tissue resistance to microindentation on the tibia in adults." It also explicitly says, "The device is not intended to diagnose or treat any clinical condition." IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease. The OsteoProbe is measuring a physical property of bone in vivo (on the living body), not analyzing a sample in vitro (outside the body).
- Device Description: The description focuses on a "bone microindentation measurement tool" that interacts directly with the tibia. This is consistent with an in vivo measurement device, not an in vitro diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or laboratory procedures typically associated with IVD devices.
Therefore, the OsteoProbe is a device that measures a physical property of bone in vivo, not an IVD device that analyzes biological samples in vitro.
N/A
Intended Use / Indications for 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.
Product codes
QGQ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tibia
Indicated Patient Age Range
adults
Intended User / Care Setting
Prescription Use
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
Clinical testing was not necessary to support equivalence.
Key Metrics
Not Found
Predicate Device(s)
OsteoProbe - DEN210013
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 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 Description: | 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. |
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)
4
- 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.