(188 days)
DBX® Strip is indicated as a bone void filler for treatment of surgically created osseous voids or gaps that are not intrinsic to the stability of the bony structure. It can be used in the pelvis, extremities, and the posterolateral spine for posterolateral fusion. DBX® Strip, when used for posterolateral spine fusion, may be used with autograft.
DBX® Strip is for single patient use only.
DBX® Strip is a flat, malleable device composed of human demineralized bone matrix (DBM), sodium hyaluronate (NaHy), sodium phosphate dibasic buffer and gelatin (procine origin). DBX® Strip is for single patient use only and is available in five sizes.
The provided text describes a 510(k) submission for the DBX® Strip, a bone void filler. The submission focuses on demonstrating substantial equivalence to a previously cleared device (K042829) rather than presenting a de novo study with explicit acceptance criteria and performance data. Therefore, many of the requested criteria cannot be directly extracted from this document.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance & 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 & 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the device is a bone void filler, not an AI/imaging device. The submission is not for a software-as-a-medical-device (SaMD) or an AI-powered diagnostic tool. The "acceptance criteria" discussed are related to demonstrating substantial equivalence for a medical device, primarily through biocompatibility and osteoinductivity potential, rather than performance metrics like sensitivity, specificity, accuracy, or reader improvement, which are typical for AI studies.
| Acceptance Criteria (related to Substantial Equivalence) | Reported Device Performance |
|---|---|
| Biocompatibility | Established through long history of safe and effective clinical use of materials, and further supported by laboratory testing per ISO 10993. |
| Sterility | Single-donor processed using aseptic techniques and tested for sterility per current USP <71>. |
| Osteoinductivity Potential | DBX® Strip is osteoconductive and shown to have osteoinductivity potential in an athymic mouse model. Every lot of final product will be tested to ensure osteoinductive potential. (Note: "Osteoinduction assay results in the athymic mouse model should not be interpreted to predict clinical performance in human subjects.") |
| Viral Clearance and Inactivation | Demonstrated suitable viral inactivation potential of the processing method for a wide spectrum of potential human viruses through testing a panel of model potential human viruses. This process further reduces the risk of viral contamination beyond donor testing and screening procedures. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not applicable in the context of an AI/imaging study's "test set" because the submission is for a medical device (bone void filler). The "studies" mentioned are laboratory tests (biocompatibility, sterility, osteoinductivity, viral clearance) and a reference to prior clinical use of the materials. No specific "test set" of patient data in the AI sense is described.
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):
This information is not applicable for the same reason as above. There is no "ground truth" to be established by clinical experts in the context of an AI study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as there is no "test set" requiring adjudication by multiple experts.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's safety and effectiveness is established through:
- Biocompatibility testing: Compliance with ISO 10993 standards.
- Sterility testing: Compliance with USP <71>.
- Osteoinductivity potential: Demonstrated in an athymic mouse model.
- Viral clearance: Laboratory testing with model viruses.
- Previous clinical use: The materials used in the device have a "long history of safe and effective clinical use."
These are primarily laboratory and regulatory compliance-based "ground truths" for the device's properties, not clinical "ground truths" for diagnostic accuracy.
8. The sample size for the training set:
This information is not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
This information is not applicable. Since there is no training set, there is no ground truth established for it.
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FEB - 5 2007
X. 510(k) SUMMARY OF SAFTEY & EFFECTIVENESS
| PROPREIETARY NAME: | DBX® Strip |
|---|---|
| COMMON NAME: | Bone Void Filler Containing Human DemineralizedBone Matrix (DBM) |
| PROPOSED REGULATORYCLASS: | Class II |
| CLASSIFICATIONIDENTIFICATION: | 21 C.F.R. §888.3045 Resorbable calcium salt bonevoid filler device |
| PRODUCT CODE: | 87-Orthopedic Devices |
| SPONSOR: | Musculoskeletal Transplant Foundation125 May StreetEdison, NJ 08837732-661-0202 |
INDICATIONS FOR USE:
DBX® Strip is indicated as a bone void filler for treatment of surgically created osseous voids or gaps that are not intrinsic to the stability of the bony structure. It can be used in the pelvis, extremities, and the posterolateral spine for posterolateral fusion. DBX® Strip, when used for posterolateral spine fusion, may be used with autograft.
DBX® Strip is for single patient use only.
DEVICE DESCRIPTION:
DBX® Strip is a flat, malleable device composed of human demineralized bone matrix (DBM), sodium hyaluronate (NaHy), sodium phosphate dibasic buffer and gelatin (procine origin). DBX® Strip is for single patient use only and is available in five sizes.
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SUBSTANTIAL EQUIVALENCE INFORMATION:
DBX® Strip was cleared by FDA (K042829) as a bone void filler for use in the posterolateral spine. The new DBX® Strip is substantially equivalent to DBX® Strip, FDA cleared K042829. The only modification is the expansion of the indications to include use of DBX® Strip in the pelvis and extremities.
SAFETY AND EFFECTIVENESS INFORMATION:
Biocompatibility of DBX® Strip materials has been established through their long history of safe and effective clinical use, further supported by laboratory testing conducted per ISO 10993. DBX® Strip is single-donor processed using aseptic techniques and is tested for sterility per current USP <71>.
OSTEOINDUCTIVITY POTENTIAL:
DBX® Strip is osteoconductive, and has been shown to have osteoinductivity potential in an athymic mouse. Every lot of final product will be tested to ensure the osteoinductive potential of the final product. Osteoinduction assay results in the athymic mouse model should not be interpreted to predict clinical performance in human subjects.
VIRAL CLEARANCE AND INACTIVATION:
A panel of model potential human viruses representing various virus types, sizes, shapes and genomes were evaluated. The viral inactivation testing demonstrated suitable viral inactivation potential of the processing method for a wide spectrum of potential human viruses. The DBX® Strip process further reduces the risk of viral contamination beyond donor testing and screening procedures.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
FFB - 5 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Musculoskeletal Transplant Foundation c/o Ms. Nancy Bennewitz Regulatory Affairs Submission Specialist 125 May Street Edison, NJ 08837
Re: K062205
DBX® Strip Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler devices Regulatory Class: Class II Product Code: MBP, MQV Dated: November 10, 2006 Received: November 13, 2006
Dear Ms. Bennewitz:
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.
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Page 2 - Ms. Nancy Bennewitz
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 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 substantial 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buchwald
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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IV. INDICATIONS FOR USE
510(k) Number (if known): K062205
Device Name: DBX® Strip
Indications for Use:
DBX® Strip is indicated as a bone void filler for treatment of surgically created osseous voids or gaps that are not intrinsic to the stability of the bony structure. It can be used in the pelvis, extremities, and the posterolateral spine for posterolateral fusion. DBX " Strip, when used for posterolateral spine fusion, may be used with autografi
DBX® Strip is for single patient use only.
Prescription Use _ X OR (Per 21 CFR 801 Subpart D)
Over-The-Counter Use (Per 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)
Saulare Buem
(Division Sign-C Division of General. Restorative. and Neurological Devices
510(k) Number K064 2203
§ 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.