(28 days)
Not Found
No
The device description and performance studies section do not mention any AI or ML components or capabilities. The device is described as a manual surgical instrument.
Yes
The device is described as harvesting cancellous bone and marrow, and debriding and capturing infected, necrotic, or diseased cancellous bone, which are therapeutic actions aimed at treating a medical condition.
No
Explanation: The device is described as a surgical instrument for harvesting bone and debriding diseased bone. Its function is to collect tissue, not to analyze or diagnose conditions.
No
The device description explicitly details physical components such as a metal cutting tip, shaft, plastic handle, filter, collection chamber, and threaded plastic cap, indicating it is a hardware 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 bone and marrow, and to debride and capture diseased bone. This is a surgical procedure performed on the patient's body.
- Device Description: The device is described as a "manual surgical instrument" that physically cuts, scrapes, and collects material from the bone.
- Lack of In Vitro Activity: IVD devices are used to examine specimens outside of the body (in vitro) to provide information for diagnosis, monitoring, or screening. This device's function is entirely within the body during a surgical procedure.
The device is a surgical tool used for collecting tissue from the body, not for analyzing that tissue in a laboratory setting.
N/A
Intended Use / Indications for Use
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).
Product codes (comma separated list FDA assigned to the subject device)
KNW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Boney region that contains a cancellous reservoir or infected, necrotic or diseased cancellous bone
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 was not conducted in association with this submission. No clinical studies were conducted in association with this submission.
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.
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 SERVICES
| Food and Drug Administration | |
|---|---|
| Form Approved: OMB No. 0910-012 | |
| Expiration 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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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
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.
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.
to
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.
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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, and
Review Panel | Class II, Product Code KNW,
Classified at 21 CFR 876.1075,
Gastroenterology-urology biopsy
instrument review panel | Class II, Product Code KNW,
Classified at 21 CFR 876.1075,
Gastroenterology-urology biopsy
instrument review panel | The classification regulation,
product code and review panel
for the proposed and predicate
devices are identical. There are
no differences. |
| Indications for Use | The Avitus® Bone Harvester is
intended to harvest cancellous
bone and marrow; to debride and
capture infected, necrotic or dis-
eased cancellous bone (e.g.
OS-
teomyelitis, cancellous bone tu-
mors). | The Avitus® Bone Harvester is
intended to harvest cancellous
bone and marrow. | The indications for use are identi-
cal in relation to harvesting can-
cellous bone and marrow. They
differ in that the proposed indi-
cation for use adds debridement
and capture of infected, necrotic
or diseased cancellous bone (e.g.
osteomyelitis, cancellous bone tu-
mors). |
| Diameters | 5,6,8mm | 5,6,8mm | The diameters are
identical.
There are no differences. |
| Collection Reservoir | Located inside handle proximal
to the suction canister | Located inside handle proximal
to the suction canister | The location of the collection
reservoir is identical. There are
no differences. |
| Cutting Tip | Metal round cutting tip located
at the distal most end of the de-
vice with a cannulation for bone
material to enter | Metal round cutting tip located
at the distal most end of the de-
vice with a cannulation for bone
material to enter | The cutting tips are identical.
There are no differences. |
| Cutting Mechanism | Manual hand driven actuation of
cutting tip to cut, scrape and
carve cancellous bone | Manual hand driven actuation of
cutting tip to cut, scrape and
carve 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 Similarities
and Differences |
| Sterilization | EtO with SAL of 10-6 | EtO with SAL of 10-6 | The sterilization methods and
SALs are identical. There are no
differences. |
| Packaging | Tyvek covered tray with insert | Tyvek covered tray with insert | The packaging design and config-
urations are identical. There are
no 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 are
no differences. |
| Material - Hollow Shaft | Stainless Steel | Stainless Steel | The hollow shaft materials of con-
struction are identical. There are
no differences. |
| Material - Plastic Com-
ponents | Rigid, translucent thermoplastic
polymer | Rigid, translucent thermoplastic
polymer | 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
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E
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K210631
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| 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 from
materials that have been evalu-
ated for biocompatibility for their
intended patient contact profile
according to ISO 10993-1 | The device is manufactured from
materials that have been evalu-
ated for biocompatibility for their
intended patient contact profile
according to ISO 10993-1 | The materials of construction are
identical. There are no differ-
ences, therefore, that will impact
biocompatibility. |
| Operating
Range | Suction 150mmHg - 300mmHg | 150mmHg - 300mmHg | The operating suction ranges are
identical. 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.