(188 days)
Not Found
No
The summary describes a bone void filler composed of biological materials and does not mention any computational or algorithmic components.
Yes
The device is indicated as a bone void filler for treatment of surgically created osseous voids or gaps, which is a therapeutic purpose.
No
The device is a bone void filler intended for treatment of osseous voids or gaps, not for diagnosing conditions.
No
The device description clearly states it is composed of physical materials (demineralized bone matrix, sodium hyaluronate, etc.) and is a physical "strip" for surgical implantation. There is no mention of software components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "bone void filler for treatment of surgically created osseous voids or gaps". This describes a device used in vivo (within the body) for a therapeutic purpose (filling bone voids).
- Device Description: The description details the composition of the device (human demineralized bone matrix, etc.) and its physical form (flat, malleable strip). This aligns with a surgical implant or filler, not a diagnostic test performed in vitro (outside the body).
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition. The device's function is to physically fill a void.
- Performance Studies: The performance studies focus on biocompatibility, sterility, osteoconductivity, and viral inactivation, which are relevant to an implantable device, not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
Product codes
MBP, MQV
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvis, extremities, and the posterolateral spine
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)
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 .
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
FEB - 5 2007
X. 510(k) SUMMARY OF SAFTEY & EFFECTIVENESS
| PROPREIETARY NAME: | DBX® Strip |
|---|---|
| COMMON NAME: | Bone Void Filler Containing Human Demineralized |
| Bone Matrix (DBM) | |
| PROPOSED REGULATORY | |
| CLASS: | Class II |
| CLASSIFICATION | |
| IDENTIFICATION: | 21 C.F.R. §888.3045 Resorbable calcium salt bone |
| void filler device | |
| PRODUCT CODE: | 87-Orthopedic Devices |
| SPONSOR: | Musculoskeletal Transplant Foundation |
| 125 May Street | |
| Edison, NJ 08837 | |
| 732-661-0202 |
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.
1
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 .
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.
2
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