(220 days)
GRAFTON® DBM is intended for use as a bone graft extender, bone graft substitute, and bone void filler in bony voids or gaps of the skeletal system (i.e., spine, pelvis and extremities); surgically created defects or defects created by trauma. The voids or gaps may be large or small and may be unicortical or bicortical. GRAFTON® DBM is resorbed/remodeled and is replaced by host bone during the healing process.
GRAFTON®DBM is a human bone allograft product containing human demineralized bone matrix (DBM) and an inert additive for intraoperative use in filling bony voids or gaps of the skeletal system needing structural support. It is intended to be used in bony voids or gaps that are not intrinsic to the stability of the bony structure. GRAFTON® DBM is provided ready-to-use in various physical forms and in various package sizes by volume or dimension. GRAFTON® DBM is a demineralized bone product that is osteoconductive as well as osteoinductive in an athymic rat assay. It is prepared via a proprietary process of Osteotech, Inc. that has been validated to consistently produce DBM that is osteoinductive in an athymic rat assay. Product and process consistency are confirmed via ongoing testing of GRAFTON® DBM product for osteoinductivity in this validated athymic rat assay utilizing a five point linear scale to score bone formation at 28 days.
The provided text describes a 510(k) premarket notification for the GRAFTON® DBM device. This submission process focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy through a controlled clinical trial with acceptance criteria for device performance. Therefore, many of the requested categories for a study proving device acceptance criteria are not directly applicable or explicitly stated in this type of submission.
Here's an analysis of the provided information in the context of your request:
Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" as used in studies proving device performance (e.g., sensitivity, specificity, accuracy) is not explicitly detailed in a 510(k) summary for a demineralized bone matrix allograft. Instead, the submission focuses on demonstrating substantial equivalence to legally marketed predicate devices. The "performance data" section in a 510(k) typically refers to evidence supporting the device's functional characteristics and safety compared to predicates, rather than quantifiable metrics against predefined targets.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Osteoconductivity | GRAFTON® DBM is reported as osteoconductive. |
| Osteoinductivity (in athymic rat assay) | GRAFTON® DBM is reported as osteoinductive in an athymic rat assay, validated to consistently produce DBM with osteoinductivity. – A "five point linear bone formation histological scoring system (0-5)" is used for assessment at 28 days. |
| Viral Inactivation | The proprietary production process for DBM in GRAFTON® DBM has been validated to inactivate viruses (HIV-1, hepatitis B virus, hepatitis C virus, CMV, Polio). |
| Substantial Equivalence (overall) | GRAFTON® DBM is claimed to be substantially equivalent to predicate devices for similar indications for use, with respect to materials, readiness for use, and performance. |
Study Details (as inferable from the 510(k) summary)
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Sample size used for the test set and the data provenance:
- Osteoinductivity: An "athymic rat assay" was used. The sample size for this assay is not specified in the provided text.
- "Studies in animals and humans": The text mentions "The results of studies in animals and humans showed that GRAFTON® DBM performs as well as, if not better than, predicate devices and/or performs at least as well at load." However, no specific sample sizes or details of these studies are provided.
- Data Provenance: The athymic rat assay is an animal model. No specific country of origin or whether the animal/human studies were retrospective or prospective is mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the 510(k) summary. For the athymic rat assay, the scoring system ("five point linear bone formation histological scoring system") is referenced, but the experts involved in applying this scoring or their qualifications are not detailed.
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Adjudication method for the test set:
- This information is not provided.
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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 MRMC or AI-assisted study was performed. GRAFTON® DBM is a bone graft product, not an AI-powered diagnostic or assistive device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is not an AI algorithm.
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The type of ground truth used:
- Osteoinductivity: Histological scoring (0-5 scale) of bone formation in an athymic rat model at 28 days. This is a surrogate biological measure.
- Viral Inactivation: Validation of the proprietary production process to inactivate specific viruses. This involves laboratory testing methods (e.g., spiking studies).
- Overall Performance: Comparison to "predicate devices and/or performs at least as well at load." The exact ground truth for these comparisons is not specified but would likely involve clinical outcomes or functional assessments used for the predicate devices.
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The sample size for the training set:
- Not applicable in the context of this 510(k) submission for a non-AI bone graft. The "proprietary production process" for DBM is mentioned as having been "validated to consistently produce DBM that is osteoinductive," implying a developmental and validation phase, but specific training set sizes are not relevant here.
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How the ground truth for the training set was established:
- Not applicable in the context of this 510(k) submission for a non-AI bone graft. The consistency and osteoinductivity of the product are "confirmed via ongoing testing... utilizing a validated athymic rat assay." The "validation" of the production process implies a ground truth was used to establish its effectiveness in achieving osteoinductivity, likely based on the histological scoring in the athymic rat model.
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DEC 1 6 2005
XII. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
December 15, 2005
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- Submission Applicant & Correspondent:
| Name: | Osteotech, Inc. |
|---|---|
| Address: | 51 James WayEatontown, NJ 07724 |
| Phone No.: | (732) 542-2800 |
| Contact Person: | Chris Talbot |
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- Name of Product:
| Trade/Proprietary/Model Name: | GRAFTON® DBM (Gel, Flex, Putty, MatrixCrunch, Orthoblend) |
|---|---|
| Common or Usual Name: | Demineralized Bone Matrix Allograft |
| Classification Name: | Resorbable Bone Void Filler |
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- Devices to Which New Product is Substantially Equivalent:
GRAFTON® DBM is substantially equivalent, for the purpose of this 510(k), to other devices that have received 510(k) clearance for similar indications for use.
- Devices to Which New Product is Substantially Equivalent:
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- Device Description:
GRAFTON®DBM is a human bone allograft product containing human demineralized bone matrix (DBM) and an inert additive for intraoperative deminerallizon bone matinr use in filling bony voids or gaps of the skeletal system nanding. It is internativility of the bony structure. GRAFTON® DBM is provided ready-to-use in various physical forms and in various package sizes by volume or dimension.
- Device Description:
GRAFTON® DBM is a demineralized bone product that is osteoconductive as well as osteoinductive in an athymic rat assay. It is prepared via a proprietary woll as betterfuler of Osteotech, Inc. that has been validated to consistently produce DBM that is osteoinductive in an athymic rat assay. Product and process consistency are confirmed via ongoing testing of GRAFTON® DBM product for osteoinductivity in this validated athymic rat assay utilizing a missica product for occomise , a to score bone formation at 28 days*. This bone five point linear boals (0) 7/2/07/27TON® DBM in this athymic rat surrogate assay should not be interpreted as a predictor of clinical performance.
*Edwards, J.T., PhD, Diegmann, M.H., MS, Scarborough, N.L., PhD.: Osteoinduction of Human Edwards, a. F., F.B., Diogramm, Rating in a Rat Model. Clinical Orthopaedics, December, 1998, Volume 357.
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- Intended Use/Indications
GRAFTON® DBM is intended for use as a bone graft extender, bone graft GRAFTON - DDM is interiaculation as a sor gaps of the skeletal system (i.e., substitute, and bone vold micr in bony volto the stability of the bony structure. spine, peris and Oxtromitios); created defects or defects or defects created by The volus of gaps may be bargiously on the bone. In and is resorbed/remodeled and is treplaced by host bone during the healing process
- Intended Use/Indications
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- Technical Comparison
GRAFTON® DBM is substantially equivalent to one or more of the predicate devices with respect to materials in that it contains human demineralized bone devices with respect to matemals in the enditive or carrier. It is provided readymatin (DDM) in a roonbable non of that can be molded, manipulated or cut to-use in various malicablomoxible room or sizes. It is implanted in this malleable/flexible state.
- Technical Comparison
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- Performance Data
The results of studies in animals and humans showed that GRAFTON® DBM THE TESGIRS of Station ell as, if not better than, predicate devices and/or performs at load. as not animal and clinical data exist that support the successful performance of GRAFTON® DBM.
- Performance Data
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- Viral Inactivation
The DBM in GRAFTON® DBM is produced by a proprietary production process that has been validated to inactivate viruses including: HIV-1; hepatitis B virus (duck hepatitis virus as model); hepatitis C virus (bovine diarrhea virus as (adok hopatitio virus as mous , This process is used to further reduce the risk of model), OMY, and Pollo the use of this product beyond the protection provided by donor testing and screening procedures.
- Viral Inactivation
The process used to produce the non-demineralized cancellous bone chips in Grafton® DBM Orthoblend does not afford the same degree of viral inactivation as the process used to produce the DBM. However, the risk of disease as the prooooo used to proac component remains low due to multiple safeguards that are rigorously employed, including donor screening, laboratory testing and material processing.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The logo also includes the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged in a circular fashion around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 6 2005
Mr. Christopher Talbot Director, Regulatory Affairs Osteotech, Inc. 51 James Way Eatontown, NJ 07724
Re: K051195
GRAFTON ® DBM Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler devices Regulatory Class: Class II Product Code: MBP, MQV Dated: September 16, 2005 Received: September 19, 2005
Dear Mr. Talbot:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becater on edited is substantially equivalent (for the itelered above and have acteriminoure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Amendinens, or to dovroes that in i e Act (Act) that do not require approval of a premarket the rederal I ood, Drag, and Commonsy, therefore, market the device, subject to the general approvin uppheation (The Act. The general controls provisions of the Act include controls provideons of the sixtration, 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 17 your device to such additional controls. Existing major regulations affecting (1 Nr.), it may of subject to tack adde of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Cours nouncements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not I least be advised that 1 DT of issualise on that your device complies with other requirements mean that I Dr I has made statutes and regulations administered by other Federal agencies.
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Page 2 – Mr. Christopher Talbot
You must comply with all the Act's requirements, including, but not limited to: registration You must comply with an the Act s requirements int 801); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing (21 CFR Par and listing (21 CFR Part 807), labeling (21 CFR Part 807), Books (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Parts A requirements as set form in the quality systems (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 This letter will anow you to ocgin marketing your es substantial equivalence of your device and thus ว I 0(K) premarket notification: The 1 DA minute of our 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 Patt 801), If you desire specific advice for your device on our labor, also, please note the regulation please contact the Office of Comphance at (210) = 10 = 10 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Division of Sman Manaka (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark N. Melkerson. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use – Statement 111.
510(k) Number (if known): K051195
Device Name: GRAFTON ®DBM
Indications for Use:
GRAFTON® DBM is intended for use as a bone graft extender, bone graft GRAFTON "DDM is intended for acc access of the skeletal system.
substitute, and bone void filler in bony voids or gaps of the first hany Substitute, and bone vold mior in bony volume to the stability of the bony (I.E., Spine, perios and Oxtronikas) he surgically created defects or defects Structure. The volue of gapo the bone. GRAFTON® DBM is created by tradmationing to the bel by host bone during the healing process.
Prescription Use__X (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Title: Sign Off
ral. Restorative, Division of Get and Neurological Devices
510(k) Number K051195
§ 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.