(25 days)
Not Found
No
The device description and performance studies indicate a manual surgical instrument with mechanical components for bone harvesting. There is no mention of AI, ML, image processing, or data-driven algorithms.
No.
The device is described as a surgical instrument for harvesting cancellous bone and marrow, which is a collection process, not a therapeutic treatment of a disease or condition.
No.
The device is described as a surgical instrument for harvesting bone and marrow, not for diagnosing a condition or disease.
No
The device description clearly describes a manual surgical instrument with physical components (cutting tip, handle, cap, nozzle, filter) and mechanical actions (cutting, scraping, suction). It is not a software-only device.
Based on the provided information, the Avitus® Bone Harvester is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "harvest cancellous bone and marrow." This is a surgical procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a manual surgical instrument used to cut and collect bone and marrow during surgery. It describes the mechanical action of the device and how it collects the material.
- Lack of IVD Characteristics: The description does not mention any analysis, testing, or examination of a sample outside of the body for diagnostic purposes. IVDs are typically used to detect, measure, or identify substances or characteristics in samples like blood, urine, tissue, etc., to provide information for diagnosis, monitoring, or screening.
The Avitus® Bone Harvester is a surgical instrument used for tissue collection during a procedure, not for in vitro diagnostic testing of a sample.
N/A
Intended Use / Indications for Use
The Avitus® Bone Harvester is intended to harvest cancellous bone and marrow.
Product codes (comma separated list FDA assigned to the subject device)
KNW
Device Description
The proposed device is a manual surgical instrument that cuts cancellous bone by manual actuation of the cutting tip. The Cap contains a barbed nozzle that connects to standard sized suction tubing connect to a vacuum source. The proposed device can be connected to a waste canister that leads to standard operating room wall suction or to an external pump. With the device connected to a vacuum source, when actuated in bone the cutting tip carves, scrapes and cuts cancellous bone and collects the bone graft inside the handle. The suction pulls the bone and bone marrow from the cutting tip and into the bone reservoir inside the handle. The Cap has a filter feature that prevents material from escaping the handle into the suction system by utilizing a physical sieve. After harvesting, the bone graft can be retrieved from the handle. The proposed device includes a Filter Insert accessory that can assist the user to scoop the bone out from within the Handle after harvesting.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
- Clinical Load Evaluation
- Worst Case Failure of Cutting Tip Breakage
- Benchtop Verification Test
These tests concluded that the proposed device will perform in a manner that exceeds anticipated clinical loads and are therefore, substantially equivalent to the predicate Avitus® Bone Harvester - 8mm device (K152474).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around a central graphic. The graphic consists of three stylized human profiles facing to the right, with the profiles overlapping each other to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 20, 2017
Avitus Orthopaedics, Inc Mr. Maxim Budyansky Co-president. Co-founder 400 Farmington Ave Suite. R2826. CB889 Farmington, Connecticut 06032
Re: K170539
Trade/Device Name: Avitus® Bone Harvester with Filter Insert - 5mm Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: February 22, 2017 Received: February 23, 2017
Dear Mr. Budyansky:
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. 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 (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170539
Device Name
Avitus® Bone Harvester with Filter Insert - 5mm
Indications for Use (Describe)
The Avitus® Bone Harvester is intended to harvest cancellous bone and marrow.
| Type of Use (Select one or both, as applicable) |
|---|
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Submission Correspondent 3.1.
Mr. Maxim Budvanskv Co president. Co founder Avitus Orthopaedics Inc. 400 Farmington Ave Suite R2826, CB889 Farmington CT 06032 Phone: 860 372 7213 Email: maxim@avitusortho.com
3.2. Submission Owners
Mr. Maxim Budyansky and Mr. Neil Shah Co presidents, Co founders Avitus Orthopaedics Inc. 400 Farmington Ave, Suite R2826, CB889 Farmington CT 06032
3.3. Date Summary Prepared February 22, 2017
3.4. Device Trade Name
Avitus® Bone Harvester with Filter Insert – 5mm
3.5. Device Common Name
Bone Harvester
3.6. Device Classification Name
Class II, Instrument, Biopsy, KNW at 21 CFR 876.1075
Legally Marketed Device to Which the Device is Substantially Equivalent 3.7.
This submission proposes two modifications to the predicate device. 1) The addition of the Filter Insert accessory 2) a reduction in cutting tip size from 8mm to 5mm.
The Avitus® Bone Harvester with Filter Insert - 5mm (proposed device) is substantially equivalent to the Avitus® Bone Harvester - 8mm (predicate device) cleared under K152474
3.8. MDR Database Results of the Predicate Device
The predicate device has no records or reports in the FDA MDR Database.
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3.9. Description of The Proposed Device
The proposed device is a manual surgical instrument that cuts cancellous bone by manual actuation of the cutting tip. The Cap contains a barbed nozzle that connects to standard sized suction tubing connect to a vacuum source. The proposed device can be connected to a waste canister that leads to standard operating room wall suction or to an external pump. With the device connected to a vacuum source, when actuated in bone the cutting tip carves, scrapes and cuts cancellous bone and collects the bone graft inside the handle. The suction pulls the bone and bone marrow from the cutting tip and into the bone reservoir inside the handle. The Cap has a filter feature that prevents material from escaping the handle into the suction system by utilizing a physical sieve. After harvesting, the bone graft can be retrieved from the handle. The proposed device includes a Filter Insert accessory that can assist the user to scoop the bone out from within the Handle after harvesting.
3.10. Intended Use
The Avitus® Bone Harvester is intended to harvest cancellous bone and bone marrow.
3.11. Technological Characteristics
The proposed device has the same technological characteristics as the predicate device. The proposed device cuts and collects bone and bone marrow by manually actuating a cutting blade that is assembled in conjunction with standard operating room suction. The collected contents get aspirated into the Handle of the device. This method of operation and function is identical to the predicate device and therefore there is no difference in technological characteristics. The difference sizes between the proposed and predicate device are identical in how they function and therefore have no difference in technological characteristics. The addition of the optional Filter Insert accessory to the proposed device does not change the function of the device and therefore has no difference to the predicate device in technological characteristics.
3.12. Non-Clinical Testing
The following tests were performed to demonstrate substantial equivalence-
- -Clinical Load Evaluation
- Worst Case Failure of Cutting Tip Breakage -
- Benchtop Verification Test
These tests concluded that the proposed device will perform in a manner that exceeds anticipated clinical loads and are therefore, substantially equivalent to the predicate Avitus® Bone Harvester - 8mm device (K152474).
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3.13. Biocompatibility
Materials were tested in conjunction with the predicate device for cytotoxicity, sensitization, intracutaneous reactivity, and systemic toxicity. The materials were confirmed to be biocompatible. The materials in proposed device are identical to the materials in the predicate device and therefore had no negative impact on substantial equivalence.
Clinical Testing 3.14.
No clinical testing was performed in association with this submission
3.15. Conclusions
The results of the comparison of design, materials, intended use and technological characteristics demonstrate that the proposed device is as safe and effective as the legally marketed predicate device (K152474).