(53 days)
Not Found
No
The device description details a manual surgical instrument with mechanical components for bone harvesting, and there is no mention of AI or ML in the provided text.
No
The device is described as a surgical instrument for harvesting bone and marrow, which is a procedure rather than a therapeutic treatment.
No
The device is described as a "manual surgical instrument that cuts cancellous bone" and "collects the bone graft inside the handle." Its intended use is to "harvest cancellous bone and marrow." This functionality is for obtaining tissue, not for diagnosing a condition or disease.
No
The device description clearly states it is a manual surgical instrument with physical components like a cutting tip, cap, barbed nozzle, and filter, indicating it is a hardware device, not software-only.
Based on the provided information, the Avitus(TM) Bone Harvester is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "harvest cancellous bone and marrow." This is a surgical procedure performed on a living patient to collect tissue for grafting or other medical purposes.
- Device Description: The description details a manual surgical instrument used to cut and collect bone and marrow from the body. It describes a physical process of harvesting tissue.
- Lack of IVD Characteristics: IVD devices are used to examine specimens outside of the body (in vitro) to provide information for diagnosis, monitoring, or screening. The description does not mention any analysis, testing, or diagnostic function performed on the collected bone and marrow.
The device is a surgical tool for tissue collection, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Avitus(TM) Bone Harvester is intended to harvest cancellous bone and marrow.
Product codes
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 (tube with an ID of 6-10 mm) to connect to a vacuum source, wherein the vacuum source has a static maximum pressure between 150 mmHg. 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 marrow from the cutting tip and into the bone reservoir inside the handle. The cap contains a filter that prevents material from escaping the handle into the suction system by utilizing a physical sieve to keep bone particulate in the handle. After harvesting, the bone graft can be retrieved from the handle.
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
Non-Clinical Testing: Tests were performed to demonstrate substantial equivalence in the following areas:
- Clinical Load Evaluation
- Worst Case Failure Of Cutting Tip Breakage
These tests concluded that the proposed device will perform in a manner that exceeds anticipated clinical loads and are therefore, substantialy equivalent to the predicate MarrowMiner K071732 device.
Biocompatibility: Materials were tested for cytotoxicity, sensitization, intracutaneous reactivity, and systemic toxicity. The materials were confirmed to be biocompatible.
Clinical Testing: No clinical testing was performed in association with this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines extending from their faces. The profiles are arranged in a way that suggests unity and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Avitus Orthopaedics Incorporated Mr. Maxim Budyansky Copresident, Cofounder 400 Farmington Avenue, Suite R1717 Farmington, Connecticut 06032
October 23, 2015
Re: K152474
Trade/Device Name: Avitus™ Bone Harvester Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology-biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: August 28, 2015 Received: August 31, 2015
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 [SELECT ONE: Part 801 [or, for IVDs only] Parts 801 and 809]); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS)
1
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 vours.
Joshua
Binita S. Ashar, M.D., M.B.A., F.A.C.S. For Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 4. INDICATIONS FOR USE STATEMENT
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
Avitus(TM) Bone Harvester
Indications for Use (Describe) The Avitus(TM) 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)
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."
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Section 5
510(k) Summary
Submission Correspondent 5.1
Mr. Maxim Budyansky Co president, Co founder Avitus Orthopaedics Inc. 400 Farmington CT RM R1717 Farmington CT 06032 Phone: 860 679 6078 Cell: 860 372 7213 Email: maxim@avitusortho.com
Submission Owners 5.2
Mr. Maxim Budyansky and Mr. Neil Shah Co presidents, Co founders Avitus Orthopaedics Inc. 400 Farmington CT RM R1717 Farmington CT 06032
5.3 Date Summary Prepared
August 28, 2015
Device Trade Name 5.4
Avitus™ Bone Harvester
5.5 Device Common Name
Bone harvester
Device Classification Name 5.6
Class II, Instrument, Biopsy, KNW at 21 CFR 876.1075.
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5.7 Legally Marketed Device To Which The Device Is Substantially Equivalent
The Avitus™ Bone Harvester is substantially equivalent to the MarrowMiner cleared under K071732.
5.8 Description Of The 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 (tube with an ID of 6-10 mm) to connect to a vacuum source, wherein the vacuum source has a static maximum pressure between 150 mmHg. 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 marrow from the cutting tip and into the bone reservoir inside the handle. The cap contains a filter that prevents material from escaping the handle into the suction system by utilizing a physical sieve to keep bone particulate in the handle. After harvesting, the bone graft can be retrieved from the handle.
Intended Use 5.9
The Avitus™ Bone Harvester is intended to harvest cancellous bone and bone marrow.
Technological Characteristics 5.10
The proposed device has the same technological characteristics as the predicate device(s). Specifi-cally, both the proposed and predicate devices use a cutting edge and suction to harvest bone and/or bone marrow.
While there is a difference in the indication for use between proposed and predicated device, there is no impact on substantial equivalence. Specifically, the proposed Avitus™ Bone Harvester is intended to harvest both cancellous bone and bone marrow. The predicate MarrowMiner K071732 device is only cleared for collection of bone marrow. Both devices allow for the collection of these materials utilizing a cutting and suction action with no further direction given to the user regarding the use of the collected material. Therefore, there is no negative impact on safety and effectiveness regarding the indication for use.
5.11 Non-Clinical Testing
Tests were performed to demonstrate substantial equivalence in the following areas:
- · Clinical Load Evaluation
- · Worst Case Failure Of Cutting Tip Breakage
These tests concluded that the proposed device will perform in a manner that exceeds anticipated clinical loads and are therefore, substantialy equivalent to the predicate MarrowMiner K071732 device.
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SECTION 5. 510(K) SUMMARY
Biocompatibilty 5.12
Materials were tested for cytotoxicity, sensitization, intracutaneous reactivity, and systemic toxicity. The materials were confirmed to be biocompatible.
5.13 Clinical Testing
No clinical testing was performed in association with this submission.
5.14 Conclusions
The results of the comparison of design, materials, intended use and technological characteristics demonstrate that the device is as safe and effective as the legally marketed predicate devices.