ORIGEN DBM WITH BIOACTIVE GLASS, NANOFUSE DBM by NANOTHERAPEUTICS, INC.

Origen DBM® with Bioactive Glass (NanoFUSE® DBM) is indicated to be gently placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. It is indicated to be placed into bony voids or gaps of the skeletal structure (e.g., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created by traumatic injury to the bone. The product provides a bone graft substitute that remodels into the recipient's skeletal system.

Device Description

Origen DBM® with Bioactive Glass (also registered with the FDA as NanoFUSE® DBM) is a malleable, putty-like, bone-void filler for use in general orthopedic applications. The product is comprised of human demineralized bone matrix (DBM) and synthetic calcium phosphor-silicate particulate material particles (45s5 bioactive glass), both coated with gelatin derived from porcine skin. These coated particles are packaged dry in a single use, polypropylene syringe (20 cc or 3 cc), double-wrapped in peel-back pouches, and final packaged in a dust cover paperboard carton. The 20 cc syringe will be filled with either of two different fill quantities of dry powder. identified as 10 cc or 5 cc final product volume. The 3 cc syringe will be filled with dry powder, identified as 2 cc final product volume. Origen DBM® with Bioactive Glass (NanoFUSE® DBM) is intended for single patient use only. At point of use, the surgeon will reconstitute the product with an appropriate sterile solution of his/her choice (sterile saline, water for injection). The coated particles rehydrate in less than 30 seconds and do not require mixing to form a uniform paste or putty. The material is then gently extruded by the surgeon into the appropriate bone voids. Origen DBM® with Bioactive Glass (NanoFUSE® DBM) is progressively resorbed and replaced by host bone during the osteo-remodeling process.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Origen DBM® with Bioactive Glass / NanoFUSE® DBM). It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include detailed information about specific acceptance criteria and a study demonstrating the device meets those criteria, as typically found in clinical study reports or more detailed verification and validation documents.

The document primarily focuses on demonstrating that the modified manufacturing process for the applicant device does not affect its safety or effectiveness compared to the predicate device. It states, "The minor change in manufacturing process does not alter the fundamental scientific technology of the device and has been shown to have no effect on the safety or effectiveness of the device."

Therefore, based solely on the provided text, I cannot complete many of the requested sections as the specific "study that proves the device meets the acceptance criteria" in the way one might expect for a diagnostic or AI-driven device is not present. The document focuses on showing equivalence rather than a new standalone performance study with detailed metrics.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in terms of quantitative metrics for performance. The overall acceptance criterion is "substantial equivalence" to the predicate device, implying that its safety and effectiveness are comparable.
Reported Device Performance: The document only states that the modification "has been shown to have no effect on the safety or effectiveness of the device." No specific performance metrics (e.g., strength, resorption rate, osteoinductivity quantification) or their values are reported in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable/Not mentioned. The document describes a manufacturing process change and asserts equivalence. It does not refer to a test set of data in the context of a performance study with a specific sample size.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not mentioned. Ground truth establishment is not relevant to this type of 510(k) submission focused on a manufacturing change for a bone void filler.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not mentioned.

5. 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

Not applicable. This device is a bone void filler, not a diagnostic imaging device involving human readers or AI.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/Not mentioned.

8. The sample size for the training set

Not applicable/Not mentioned. This is not a machine learning model.

9. How the ground truth for the training set was established

Not applicable/Not mentioned.

Summary regarding the "Study that proves the device meets the acceptance criteria":

The core of this 510(k) submission is to demonstrate Substantial Equivalence to a legally marketed predicate device, specifically after a minor manufacturing process modification. The "study" (or rather, the justification) provided is that this manufacturing change results in a thicker paste-like form at initial extrusion but does not fundamentally alter the scientific technology or affect the safety or effectiveness of the device.

The document states:

"The subject of this Special 510(k), the applicant version of Origen DBM® with Bioactive Glass (NanoFUSE® DBM), is produced under a modified manufacturing process to the legally marketed Origen DBM® with Bioactive Glass."
"Origen DBM® with Bioactive Glass (NanoFUSE® DBM) has the same intended uses and indications and similar technological characteristics as the currently cleared version of Origen DBM® with Bioactive Glass."
"The minor change in manufacturing process does not alter the fundamental scientific technology of the device and has been shown to have no effect on the safety or effectiveness of the device."
It also notes that "Each lot of DBM used in manufacturing the applicant version of Origen DBM® with Bioactive Glass (NanoFUSE® DBM) will be screened for osteoinductivity in an in vitro assay," which implies an ongoing quality control measure, not a specific performance study for the 510(k) itself to demonstrate new acceptance criteria.

In essence, the "study" for this Special 510(k) is the demonstration that the manufacturing change does not negatively impact the previously established safety and effectiveness of the predicate device, thereby maintaining substantial equivalence. Specific quantitative performance data comparing the new and predicate devices is not detailed in this summary.

Summary

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K110976

SPECIAL 510(K) SUMMARY

Origen DBM® with Bioactive Glass (NanoFUSE® DBM)

MAY - 3 2011

Date:	April 6, 2011
Submitted by:	Nanotherapeutics, Inc.13859 Progress Blvd., Suite 300Alachua, FL 32615
Representative:	Dennis Tomisaka, MS, MBASenior Vice President of OperationsPhone: (386) 462-9663FAX: (386) 462-2087
Proprietary Name:	Origen DBM® with Bioactive Glass (NanoFUSE® DBM)
Common Name:	Bone Void Filler, Bone Graft Substitute
Classification Name:	Filler, Calcium Sulfate Preformed Pellets, Section 888.3045
Classification Codes:	MQV, MBP - Class II

Predicate Devices:

Trade/Proprietary Name	Manufacturer	510(k) Number
Origen™ DBM with Bioactive Glass	Nanotherapeutics	K062459

Description:

At point of use, the surgeon will reconstitute the product with an appropriate sterile solution of his/her choice (sterile saline, water for injection). The coated particles rehydrate in less than 30 seconds and do not require mixing to form a uniform paste or putty. The material is then gently extruded by the surgeon into the appropriate bone voids. Origen DBM® with Bioactive Glass (NanoFUSE® DBM) is progressively resorbed and replaced by host bone during the osteo-remodeling process.

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Indications for Use:

Technological Characteristics: Origen DBM® with Bioactive Glass (NanoFUSE® DBM) is indicated to be gently placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. It is indicated to be placed into bony voids or gaps of the skeletal structure (e.g., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created by traumatic injury to the bone. The product provides a bone graft substitute that remodels into the recipient's skeletal system.

The applicant version of Origen DBM® with Bioactive Glass (NanoFUSE® DBM) is essentially identical to the currently legally marketed medical device Origen DBM® with Bioactive Glass, also manufactured by Nanotherapeutics, Inc. with respect to materials, design, and intended use. The applicant version is comprised of human demineralized bone matrix (DBM) and synthetic calcium phosphor-silicate particulate material particles (45s5 bioactive glass), both coated with gelatin derived from porcine skin. It is provided dry and is reconstituted at the point of use into a paste-like, malleable form that can be molded or manipulated into bony defects.

As currently manufactured, the predicate version of Origen DBM® with Bioactive Glass (NanoFUSE® DBM) is reconstituted by the addition of fluid and waiting 30 seconds before expelling the contents from the syringe. At 30 seconds, the product extrudes as a very fluid paste and, with time, the gelatin carrier absorbs the fluid, becomes progressively thicker, and eventually sets in a rubbery mass. The technological characteristics of the applicant device differ from the predicate product only as the manufacturing process has been modified to produce a thicker paste-like form at initial extrusion (i.e. at 30 seconds post reconstitution). The applicant device still becomes progressively thicker until it sets up as a rubbery mass. This modification does not affect the safety or effectiveness of the device.

Each lot of DBM used in manufacturing the predicate Origen DBM® with Bioactive Glass (NanoFUSE® DBM) is screened for osteoinductivity in an in vitro assay. Each lot of DBM used in manufacturing the applicant version of Origen DBM® with Bioactive Glass (NanoFUSE® DBM) will be screened for osteoinductivity in an in vitro assay.

The subject of this Special 510(k), the applicant version of Origen DBM® with Bioactive Glass (NanoFUSE® DBM), is produced under a modified manufacturing process to the legally marketed Origen DBM® with Bioactive Glass. Origen DBM® with Bioactive Glass (NanoFUSE® DBM) has the same intended uses and indications and similar technological characteristics as the currently cleared version of Origen DBM® with Bioactive Glass. The minor change in manufacturing process does not alter the fundamental scientific technology of the device and has been shown to have no effect on the safety or effectiveness of the device. Therefore, the applicant version of Origen DBM® with Bioactive Glass (NanoFUSE® DBM) is

Substantial Equivalence:

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substantially equivalent to the currently cleared version of Origen
DBM® with Bioactive Glass.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Nanotherapeutics, Inc. % Mr. Dennis Tomisaka 13859 Progress Blvd. Suite 300 Alachua, Florida 32615

MAY

3 2011

Re: K110976

Trade/Device Name: Origen™ DBM with Bioactive Glass Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV, MBP Dated: April 6, 2011 Received: April 7, 2011

Dear Mr. Tomisaka:

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

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Page 2 – Mr. Dennis Tomisaka

CFR Part 807); labeling (21 CFR Part 801); 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) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

AS vs-Rh
fen

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and . Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): K110976

Device Name: Origen DBM® with Bioactive Glass (NanoFUSE® DBM)

Indications for Use:

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

n Sign-Off) (Divis Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K110976

Regulation Number and Section

§ 888.3045 Resorbable calcium salt bone void filler device.

(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.