(407 days)
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Not Found
No
The document describes a demineralized bone matrix product and does not mention any AI or ML components.
Yes.
The device is used for "treatment of surgically created osseous defects or osseous defects created from traumatic injury", which is a therapeutic purpose.
No
The device description clearly states its purpose as a bone void filler and for treatment of osseous defects, which are therapeutic functions, not diagnostic.
No
The device description clearly states that DBX® is composed of processed human bone and sodium hyaluronate, which are physical materials, not software.
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 DBX® is a "bone void filler" for surgical and traumatic osseous defects. This describes a device used in vivo (within the body) for treatment, not a device used in vitro (outside the body) to diagnose a condition.
- Device Description: The description details the composition of the product (processed human bone, sodium hyaluronate) and its forms (Paste, Putty, Mix), all of which are consistent with a surgical implant or filler.
- Lack of Diagnostic Language: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance study mentioned is an in vivo assay for osteoinductive potential, which is relevant to bone growth and healing within the body, not in vitro diagnostic testing.
In summary, DBX® is a therapeutic device used during surgery to fill bone voids, not a diagnostic device used to test samples outside the body.
N/A
Intended Use / Indications for Use
DBX® Demineralized Bone Matrix is intended for use as bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. DBX® Putty can be used to fill bone voids in the extremities, posterolateral spine, pelvis and cranium. DBX® Paste and Mix can be used to fill bone voids in the extremities and pelvis. It is indicated for use in the treatment of surgically-created osseous defects or osseous defects created from traumatic injury.
DBX® is intended for use as a Demineralized Bone Matrix for voids or gaps that may be and and sectors. It can be used in the:
Paste and Mix
extremities
pelvis
Putty
extremities
posterolateral spine
pelvis
It is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury.
DBX® is for single patient use only.
Product codes (comma separated list FDA assigned to the subject device)
MQV, GXP
Device Description
DBX® is intended for single patient use only. DBX® Demineralized Bone Matrix is available in three forms: Paste, Putty and Mix. DBX® products are completely resorbable. DBX® Paste and Putty are composed of processed human cortical bone; the DBX® Mix is composed of processed human corticocancellous bone. The bone granules are mixed with sodium hyaluronate ("NaHA") in varying combinations to form the DBX® Putty, Paste and Mix. All versions of DBX® are available in five sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
extremities, posterolateral spine, pelvis, cranium
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
DBX® is assayed in vivo for its osteoinductive potential. Standard testing DDA = 15 assayed m etco 101 15 - 800 - 15 - 800 - 15
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Kosolo Call
MAR 1 7 2005
AR 17 2005
510(k) SUMMARY OF SAFETY & EFFECTIVENESS XI.
| PROPRIETARY NAME: | DBX® Demineralized Bone Matrix Putty
DBX® Demineralized Bone Matrix Paste
DBX® Demineralized Bone Matrix Mix |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------|
| 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: | MQV |
| PANEL CODE: | 87 - Orthopedic Devices |
| SPONSOR: | Musculoskeletal Transplant Foundation
125 May Street
Edison, NJ 08837
732-661-0202 |
INDICATIONS FOR USE:
DBX® Demineralized Bone Matrix is intended for use as bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. DBX® Putty can be used to fill bone voids in the extremities, posterolateral spine, pelvis and cranium. DBX® Paste and Mix can be used to fill bone voids in the extremities and pelvis. It is indicated for use in the treatment of surgically-created osseous defects or osseous defects created from traumatic injury.
DEVICE DESCRIPTION:
DBX® is intended for single patient use only. DBX® Demineralized Bone Matrix is available in three forms: Paste, Putty and Mix. DBX® products are completely resorbable. DBX® Paste and Putty are composed of processed human cortical bone; the DBX® Mix is composed of processed human corticocancellous bone. The bone granules are mixed with sodium hyaluronate ("NaHA") in varying combinations to form the DBX® Putty, Paste and Mix. All versions of DBX® are available in five sizes.
1
OSTEOINDUCTIVE POTENTIAL:
DBX® is assayed in vivo for its osteoinductive potential. Standard testing DDA = 15 assayed m etco 101 15 - 800 - 15 - 800 - 15
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized lines representing its wings or feathers.
MAR 1 7 2005
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kathleen M. Laffan, RAC Regulatory Submission Specialist Musculoskeletal Tissue Foundation 125 mav Street Edison, NJ 08837
Re: K040262
DBX® Demineralized Bone Matrix Putty, Paste, and Mix Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler devices Regulatory Class: Class II Product Code: MQV, GXP Dated: December 22, 2004 Received: December 23, 2004
Dear Ms. Laffan:
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 applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 -- Kathleen M. Laffan, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manetally your device of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your dove premarket notification. The PDA miding of basification 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 If you desire specific advice ion your ac not the complexe note the regulation entitled, Contact the Office of Complance at (210) = 16 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 ( = 0 = 0 ( = 0 = 0 ( = 0 = 0 ( = 0 " Misoranumy by reference to premaixed notilities under the Act from the Division of Small other gelleral Information on your responser Assistance at its toll-free number (800) 638-204 or Manufacturers, International and Consailters http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
K. Malle A. Melleman
Miriam C. Provost, Ph.D. 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
K040262 510(k) Number (if known):
DBX Demineralized Bone Matrix Putty, Paste and Mix Device Name:
Indications for Use:
DBX® is intended for use as a Demineralized Bone Matrix for voids or gaps that
and the may be and and sectors. It can be used in the: DBX is intended for use as a Deinment and and work. It can be used in the:
| Paste and Mix | Putty |
|---|---|
| extremities | extremities |
| pelvis | posterolateral spine |
| pelvis | |
It is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury.
DBX® is for single patient use only.
Prescription Use __X (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED.)
510(k) Num
Concurrence of ODRH, Office of Device Evaluation (ODE)
f
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices