The Avitus® Bone Harvester is intended to harvest cancellous bone and marrow; to debride and capture infected, necrotic or diseased cancellous bone (e.g. osteomyelitis, cancellous bone tumors).

Device Description

The proposed device is a minimally invasive manual non-powered cancellous bone and marrow graft harvester that can also be used for the removal of infected, necrotic, and diseased cancellous bone. The proposed changes described in this submission add to the types of materials to be collected to include infected, necrotic, or diseased cancellous bone. The Avitus® Bone Harvester consists of a metal cutting tip and shaft with transparent plastic handle, filter, collection chamber, and a threaded plastic cap.

The principles of action for the proposed device with revised indications for use are identical to the predicate device. The Avitus® Bone Harvester is a manual surgical instrument that harvests cancellous bone and marrow, and debrides infected, necrotic, or diseased cancellous bone by manual actuation of the cutting tip. The Cap contains a barbed nozzle that connects to standard sized suction tubing to connect to a vacuum source. With the device connected to a vacuum source, when actuated in bone the cutting tip carves, scrapes, cuts, and collects the material into the reservoir filter insert 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 to keep bone particulate in the handle.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the Avitus® Bone Harvester. It's an application to the FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than a clinical trial report proving efficacy or safety from scratch.

Therefore, the information you're asking for, which is typical for studies proving device performance against acceptance criteria for AI/ML-based devices or complex diagnostic tools, is not present in this document.

Here's why and what's missing:

This is not a software/AI device: The Avitus® Bone Harvester is a manual surgical instrument. It harvests bone and marrow and debrides diseased bone. There's no mention of AI, algorithms, or any software component.
This is not a diagnostic device: It's a surgical tool for material collection and debridement, not for diagnosing conditions or generating images that require expert interpretation.
Nature of the submission: This K210631 submission is primarily about expanding the Indications for Use of an already cleared device (K170539). The core argument for substantial equivalence relies on the fact that the device's technological characteristics (design, materials, operating principles) have not changed. The modifications are only to the intended use.
"Non-Clinical Testing" and "Clinical Testing" sections explicitly state:
- "Non-clinical testing was not conducted in association with this submission." (Section 5.10)
- "No clinical studies were conducted in association with this submission." (Section 5.12)
- Biocompatibility was conducted in prior submissions because no new materials were introduced.

To directly answer your questions based on the provided text, the answer to almost all of them is "Not applicable" or "No information provided," as this kind of study was not performed for this submission.

Here's a breakdown based on the provided document:

A table of acceptance criteria and the reported device performance:
- Not applicable / No information provided. This document does not describe performance acceptance criteria or results from a study designed to meet them. The core of this submission is a comparison of technological characteristics and indications for use to a predicate device, as shown in Table 5.1. The "performance" being evaluated is whether the device, with its unchanged design, can perform the expanded intended use (debriding diseased bone) safely and effectively, which is inferred to be true because its mechanism is identical to its previous, cleared indication for harvesting healthy bone.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable / No test set used. No new testing (clinical or non-clinical) was conducted for this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No test set or ground truth establishment was conducted for this submission.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set or expert adjudication was conducted for this submission.
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:
- No. This is not an AI-assisted device. No MRMC study was conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No new ground truth was established as no new studies were conducted. The "ground truth" for this submission is the established safety and effectiveness of the predicate device (K170539) and the argument that the identical technological characteristics allow for the expanded indications.
The sample size for the training set:
- Not applicable. This device does not use a training set.
How the ground truth for the training set was established:
- Not applicable. This device does not use a training set.

In summary, this document is a regulatory filing for a physical medical device (bone harvester) and specifically states that no new non-clinical or clinical testing was conducted for this submission, as it relies on substantial equivalence to a previously cleared predicate device for an expanded indication.

Summary

{0}------------------------------------------------

March 31, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

Avitus Orthopaedics, Inc. % William G. McLain President and Principal Consultant Keystone Regulatory Services, LLC 342 E. Main Street Leola, Pennsylvania 17540

Re: K210631

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: March 1, 2021 Received: March 3, 2021

Dear William G. McLain:

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

{1}------------------------------------------------

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 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 (OS) 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 mediation-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, Ph.D. 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}------------------------------------------------

SECTION 4. INDICATIONS FOR USE STATEMENT

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration
Form Approved: OMB No. 0910-012Expiration Date: 06/30/2020
Indications for Use
See PRA Statement below.
510(k) Number (if known)
K210631
Device Name
Avitus® Bone Harvester
Indications for Use (Describe)

The Avitus® Bone Harvester is intended to harvest cancellous bone and marrow; to debride and capture infected, necrotic or diseased cancellous bone (e.g. osteomyelitis, cancellous bone tumors).

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)	☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
☑ 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."

FORM FDA 3881 (7/17)

{3}------------------------------------------------

Submission Number: K210631 Date Received: 03/03/2021

Section 5 510(k) Summary

5.1 Submission Owner and Correspondent

Submission Owner

Avitus Orthopaedics, Inc. Mr. Maxim Budyansky and Mr. Neil Shah Co-Presidents, Co-Founders 6 Armstrong Rd. 2nd Floor Shelton, CT 06484

Submission Correspondent

Additionally, the following individual is identified as a submission correspondent.

Keystone Regulatory Services, LLC 342 E. Main Street, Suite 207 Leola, PA 17540 Contact: William McLain Phone: 717-656-9656 E-Mail: bill.mclain@keystoneregulatory.com

5.2 Date Summary Prepared

March 1, 2021

Device Trade Name 5.3

Avitus® Bone Harvester

5.4 Device Common Name

Bone Harvester

{4}------------------------------------------------

5.5 Device Classification Name

Instrument, Biopsy Classified as Class 2, product code KNW at 21 CFR 876.1075

5.6 Legally Marketed Device To Which The Device Is Substantially Equivalent

The Avitus® Bone Harvester is substantially equivalent to the Avitus® Bone Harvester cleared under K170539.

5.7 Description of the Device

Indications for Use 5.8

The Avitus® Bone Harvester is intended to harvest cancellous bone and marrow; to debride and capture infected, necrotic or diseased cancellous bone (e.g. osteomyelitis, cancellous bone tumors).

5.9 Technological Characteristics

The proposed modifications described in this submission have not resulted in any changes to technological characteristics. The overall design, materials of construction and sterilization methods remain the Same The only change is to modify the indications for use from:

The Avitus® Bone Harvester is intended to harvest cancellous bone and marrow.

The Avitus® Bone Harvester is intended to harvest cancellous bone and marrow; to debride and capture infected, necrotic or diseased cancellous bone (e.g. osteomyelitis, cancellous bone tumors).

{5}------------------------------------------------

SECTION 5. 510(K) SUMMARY

To account for differences in the indication for use, the Instructions for Use have been modified by:

· stating the revised indications for use,
adjusting the contraindications, and
· providing procedural steps for removal of infected, necrotic, or diseased bone.

Table 5.1 provides additional detail regarding similarities and differences related to Technological Characteristics.

{6}------------------------------------------------

K210631 Page 4 of 8

Feature	Proposed Device - Avitus®Bone Harvester	Predicate Device - Avitus®Bone Harvester (K170539)	Comments on Similarities and Differences
Classification Regulation, Product Code, andReview Panel	Class II, Product Code KNW,Classified at 21 CFR 876.1075,Gastroenterology-urology biopsyinstrument review panel	Class II, Product Code KNW,Classified at 21 CFR 876.1075,Gastroenterology-urology biopsyinstrument review panel	The classification regulation,product code and review panelfor the proposed and predicatedevices are identical. There areno differences.
Indications for Use	The Avitus® Bone Harvester isintended to harvest cancellousbone and marrow; to debride andcapture infected, necrotic or dis-eased cancellous bone (e.g.OS-teomyelitis, cancellous bone tu-mors).	The Avitus® Bone Harvester isintended to harvest cancellousbone and marrow.	The indications for use are identi-cal in relation to harvesting can-cellous bone and marrow. Theydiffer in that the proposed indi-cation for use adds debridementand capture of infected, necroticor diseased cancellous bone (e.g.osteomyelitis, cancellous bone tu-mors).
Diameters	5,6,8mm	5,6,8mm	The diameters areidentical.There are no differences.
Collection Reservoir	Located inside handle proximalto the suction canister	Located inside handle proximalto the suction canister	The location of the collectionreservoir is identical. There areno differences.
Cutting Tip	Metal round cutting tip locatedat the distal most end of the de-vice with a cannulation for bonematerial to enter	Metal round cutting tip locatedat the distal most end of the de-vice with a cannulation for bonematerial to enter	The cutting tips are identical.There are no differences.
Cutting Mechanism	Manual hand driven actuation ofcutting tip to cut, scrape andcarve cancellous bone	Manual hand driven actuation ofcutting tip to cut, scrape andcarve cancellous bone	The cutting mechanisms are iden-tical. There are no differences.
Table 5.1: continued
Feature	Proposed Device - Avitus® Bone Harvester	Predicate Device - Avitus® Bone Harvester (K170539)	Comments on Similarities and Differences
Hollow Connection Between Handle and Cutting Tip	Yes - Rigid	Yes - Rigid	The connections between the handle and cutting tip are identical. There are no differences.
Power Source	None	None	The power sources are identical in that there are none. There are no differences.
Collection Mechanism	Active suction aspirates and pulls the bone graft into the bone graft reservoir	Active suction aspirates and pulls the bone graft into the bone graft reservoir	The collection mechanisms are identical. There are no differences.
Filter	Filter in lid prevents collected material from going into the suction system.	Filter in lid prevents collected material from going into the suction system	The locations and purposes of the filter are identical. There are no differences.
Filter Insert	Filter Insert is included	Filter Insert is included	The filter inserts are identical. There are no differences.
Material Retrieval	Material can be removed from reservoir by unscrewing the cap and tapping out the material or scooping out with an osteotome or other tool	Material can be removed from reservoir by unscrewing the cap and tapping out the material or scooping out with an osteotome or other tool	The material retrieval methods are identical. There are no differences.
Material Retrieval Using the Filter Insert	The removable Filter Insert can be used to pull out the collected material from inside the bone graft reservoir.	The removable Filter Insert can be used to pull out the collected material from inside the bone graft reservoir.	The methods of retrieving material using the filter insert are identical. There are no differences.
Anatomical Site	Boney region that contains a cancellous reservoir or infected, necrotic or diseased cancellous bone	Boney region that contains a cancellous reservoir	The anatomical sites are identical. The differences are related to the proposed indication for use.
Table 5.1: continued
Feature	Proposed Device - Avitus®Bone Harvester	Predicate Device - Avitus®Bone Harvester (K170539)	Comments on Similaritiesand Differences
Sterilization	EtO with SAL of 10-6	EtO with SAL of 10-6	The sterilization methods andSALs are identical. There are nodifferences.
Packaging	Tyvek covered tray with insert	Tyvek covered tray with insert	The packaging design and config-urations are identical. There areno differences.
Radiopaque	Yes	Yes	Because the materials of con-struction are identical, the ra-diopaque characteristics are iden-tical. There are no differences.
Material - Cutting Tip	Stainless Steel	Stainless Steel	The cutting tip materials of con-struction are identical. There areno differences.
Material - Hollow Shaft	Stainless Steel	Stainless Steel	The hollow shaft materials of con-struction are identical. There areno differences.
Material - Plastic Com-ponents	Rigid, translucent thermoplasticpolymer	Rigid, translucent thermoplasticpolymer	The plastic components materi-als of construction are identical.There are no differences.
Reusable/Disposable	Disposable	Disposable	The devices are disposable.There are no differences.
Depth Markings	Yes	Yes	The depth markings are identical.There are no differences.

Table 5.1: Technological Characteristics Table

{7}------------------------------------------------

K210631 Page 5 of 8

{8}------------------------------------------------

K210631

Page 6 of 8

{9}------------------------------------------------

K210631

Page 7 of 8

Table 5.1: continued
----------------------	--

Feature	Proposed Device - Avitus®Bone Harvester	Predicate Device - Avitus®Bone Harvester (K170539)	Comments on Similarities and Differences
Biocompatibility	The device is manufactured frommaterials that have been evalu-ated for biocompatibility for theirintended patient contact profileaccording to ISO 10993-1	The device is manufactured frommaterials that have been evalu-ated for biocompatibility for theirintended patient contact profileaccording to ISO 10993-1	The materials of construction areidentical. There are no differ-ences, therefore, that will impactbiocompatibility.
OperatingRange	Suction 150mmHg - 300mmHg	150mmHg - 300mmHg	The operating suction ranges areidentical. There are no differ-ences.

{10}------------------------------------------------

5.10 Non-Clinical Testing

Non-clinical testing was not conducted in association with this submission.

5.11 Biocompatibility

The proposed Avitus® Bone Harvester (Avitus Orthopaedics, Inc.) was not subject to new biocompatibility testing because there are no new materials associated with this submission. Biocompatibility was conducted in association with prior submissions.

5.12 Clinical Testing

No clinical studies were conducted in association with this submission.

5.13 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 device.

Regulation Number and Section

§ 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.