(187 days)
Origen™ DBM with Bioactive Glass is indicated for bony voids or gaps 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 system (e.g., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone graft substitute that remodels into the recipient's skeletal system.
Origen™ DBM with Bioactive Glass is a malleable, putty-like bonevoid filler. The product is comprised of human demineralized bone matrix (DBM) and synthetic calcium phosphor-silicate particulate material particles, both coated with gelatin derived from porcine skin. These coated particles are packaged dry in a single use, polypropylene syringe (20 cc or 5 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 5 cc syringe will be filled with two additional fill quantities of dry powder, identified as 2.5 cc or 1 cc final product volume. Origen™ DBM with Bioactive Glass 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 (WFI, sterile normal saline). 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 is progressively resorbed and replaced by host bone during the osteo-remodeling process.
The provided text (K062459) is a 510(k) Summary for a medical device called "Origen™ DBM with Bioactive Glass." This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing specific acceptance criteria and proving performance through a standalone clinical study with defined endpoints and statistical significance.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, particularly in the context of clinical performance metrics like sensitivity, specificity, accuracy, or human reader improvement, is not present in this document.
Here is what the document does describe in relation to non-clinical performance and substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not present a table of acceptance criteria for a specific performance metric (e.g., accuracy, sensitivity) and then report the device's performance against it. Instead, it asserts substantial equivalence based on material composition, intended use, and comparative non-clinical studies.
| Acceptance Criterion (Not explicitly stated as such, but inferred from the equivalence argument) | Reported Device Performance (as presented for equivalence) |
|---|---|
| Osteoinductivity: DBM component must exhibit osteoinductive potential. | Each lot of DBM is screened for osteoinductivity in an in vitro assay, which has been correlated to the athymic rat model. |
| Bone Formation & Healing: Performance comparable to autogenous bone graft and predicate devices in promoting bone formation and healing. | GLP compliant study comparing bone formation and subsequent healing with Origen™ to autogenous bone graft and predicate devices (Novabone K021336 and Osteofil Paste K043420). The study "indicates that Origen™ DBM with Bioactive Glass is substantially equivalent to the predicate devices." |
| Viral Reduction: Demineralization process effectively eliminates or reduces viruses. | A viral reduction study demonstrated the demineralization process effectively eliminates or reduces viruses tested (BVDV, HAV, HIV-1, PPV, PrV). |
| Biocompatibility: Human demineralized bone used in the product must be biocompatible. | Stated that "Human demineralized bone used in Origen™ DBM with Bioactive Glass is single-donor processed and biocompatible." |
2. Sample Size Used for the Test Set and Data Provenance:
- For the "bone formation and healing" study: The document does not specify the sample size used in this GLP compliant study.
- Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective for the "bone formation and healing" study, beyond it being a "GLP compliant study."
- For the "viral reduction study": The "test set" would be the viral models used. The document lists five specific viruses: bovine diarrhea virus (BVDV); hepatitis A virus (HAV); human immunodeficiency virus type 1 (HIV-1), porcine parvovirus (PPV); and pseudorabies virus (PrV).
- Data Provenance (Viral Reduction): Conducted by a CLIA certified testing laboratory (location not specified).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- This information is not provided in the document. The studies referenced are non-clinical (animal model, in vitro assay, viral reduction). Clinical ground truth established by experts is not described.
4. Adjudication Method for the Test Set:
- This information is not provided as the studies are not clinical trials requiring adjudication of endpoints by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done as this is a bone void filler device, not an imaging or diagnostic AI device that would involve human readers interpreting cases.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- This concept is not directly applicable. Origen™ DBM with Bioactive Glass is a physical medical device (bone void filler) used by a surgeon, not an algorithm. The "performance" is its biological effect (bone formation/healing), not an algorithmic output. The studies mentioned (osteoinuctivity assay, bone formation/healing study, viral reduction) are "standalone" in the sense they evaluate the biological/physical properties of the product itself.
7. Type of Ground Truth Used:
- For osteoinductivity: In vitro assay correlated to the athymic rat model.
- For bone formation and healing: Comparison to autogenous bone graft and predicate devices, implying assessment of osseous tissue formation or healing outcomes in a relevant animal model (though the specific outcome measures are not detailed).
- For viral reduction: Direct measurement of viral load reduction/elimination following the demineralization process.
8. Sample Size for the Training Set:
- This concept is not applicable as Origen™ DBM with Bioactive Glass is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- This concept is not applicable for the reasons stated above.
In summary: The provided 510(k) summary focuses on demonstrating "substantial equivalence" of the Origen™ DBM with Bioactive Glass to existing legally marketed predicate devices based on material composition, intended use, and non-clinical studies. It does not present detailed acceptance criteria for clinical performance or a standalone clinical study to prove those criteria are met in the way one would for a diagnostic AI device.
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510(k) Summary
FEB 2 6 2007
Origen™ DBM with Bioactive Glass
| Date: | February 16, 2007 |
|---|---|
| Submitted by: | Nanotherapeutics, Inc.12085 Research DriveAlachua, FL 32615 |
| Representative: | Dennis Tomisaka, M.S., MBAVP Operations and Product DevelopmentPhone: (386) 462-9663FAX: (386) 462-2087 |
| Proprietary Name: | Origen™ DBM with Bioactive Glass |
| Common Name: | Bone Void Filler, Bone Graft Substitute |
| Classification Name: | Filler, Calcium Sulfate Preformed Pellets, Section 88.3045. |
| Classification Code: | MBP, MQV, Class II |
Predicate Devices:
| Trade/Proprietary Name | Manufacturer | 510(k) Number |
|---|---|---|
| Novabone | NovaBone Products, Inc. | K021336 |
| Osteofil Paste DBM with InertCarrier Porcine Collagen | Regeneration Technologies, Inc. | K043420 |
Description:
Origen™ DBM with Bioactive Glass is a malleable, putty-like bonevoid filler. The product is comprised of human demineralized bone matrix (DBM) and synthetic calcium phosphor-silicate particulate material particles, both coated with gelatin derived from porcine skin. These coated particles are packaged dry in a single use, polypropylene syringe (20 cc or 5 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 5 cc syringe will be filled with two additional fill quantities of dry powder, identified as 2.5 cc or 1 cc final product volume. Origen™ DBM with Bioactive Glass 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 (WFI, sterile normal saline). 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 is progressively resorbed and replaced by host bone during the osteo-remodeling process.
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Origen™ DBM with Bioactive Glass is indicated for bony voids or Indications for Use: gaps that are not intrinsic to the stability of the bony structure. It is indicated to be gently 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. Technological Origen™ DBM with Bioactive Glass is substantially equivalent to the Characteristics: two identified predicate devices, Novabone (K021336) and Osteofil Paste (DBM) with Inert Carrier Porcine Collagen (K043420), with respect to materials and intended use in that it consists of human demineralized bone matrix (DBM) and non-tissue additives. 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. Origen™ DBM with Bioactive Glass is composed of approximately equal parts, by mass, of DMB, BioActive Glass, and porcine gel. Novabone (K021336) and Osteofil Paste (DBM) with Inert Carrier Porcine Collagen (K043420) were chosen as Predicate devices due to their Substantial Equivalence to Origen™ DBM with Bioactive Glass in their declared Indications for Use, Design, and Materials. NovaBone is a one-component resorbable bone void filler compound of synthetic calcium phosphor-silicate (45S5 Bioglass) particulate. This material is chemically and physically analogous to the glass material used in the OrigenTM device. The Intended Use of both Origen™ and NovaBone is for bony void or gaps that are not intrinsic to the stability of the bony structure. Osteofil Paste DMB is comprised of Demineralized Bone Matrix (DBM) in a porcine collagen carrier. Both the RTI and the Nanotherapeutics DBM are sourced from donated human tissue and both bone void products are coated with gelatin derived from porcine skin. Each lot the demineralized bone matrix in Origen™ DBM with Bioactive Glass is screened for osteoinductivity in an in vitro assay, which has been correlated to the athymic rat model. Non-Clinical Performance Tests: Nanotherapeutics has conducted a GLP compliant study comparing bone formation and subsequent healing with Origen compared to autogenous bone graft and Predicate Devices: Novabone (K021336); and, Osteofil Paste DBM with Inert Carrier Porcine Collagen (K043420). The results of this study indicate that Origen™ DBM with Bioactive Conclusion: Glass is substantially equivalent to the predicate devices. Safety Information: Human demineralized bone used in Origen™ DBM with Bioactive Glass is single-donor processed and biocompatible.
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A viral reduction study was conducted by a CLIA certified testing laboratory using four virus models representing RNA, DNA, envelope, and non-envelope virus. The test viruses included: 1. bovine diarrhea virus (BVDV); hepatitis A virus (HAV); human immunodeficiency virus type 1 (HIV-1), porcine (arvovirus (PPV); and pseudorabies virus (PrV). This study demonstrates the demineralization process used on donor bone contained in Nanotherapeutics' Origen™ DBM with Bioactive Glass effectively eliminates or reduces the virus responsible for potential infectious disease, which include HIV and Hepatitis.
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Public Health Service
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nanotherapeutics, Inc. c/o Ms. Paula Wilkerson RAC, CRA Actualized Science, LLC 12337 NW 9th Lane Newberry, FL 32615
FEB 2, 6 2007
Re: K062459
Trade 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: MBP, MQV Dated: December 4, 2006 Received: December 5, 2006
Dear Ms. Wilkerson:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if
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Page 2 - Ms. Paula Wilkerson RAC, CRA
applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantal equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark A Milliken
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 4
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Origen™ DBM with Bioactive Glass
Indications For Use:
Origen™ DBM with Bioactive Glass is indicated for bony voids or gaps 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 system (e.g., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone graft substitute that remodels into the recipient's skeletal system.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mah n Mill
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K062459
§ 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.