(196 days)
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No
The description focuses on the material composition and biological properties of the bone void filler, with no mention of AI or ML for analysis, prediction, or decision-making.
Yes
The device is described as a "bone void filler" used in the "treatment of surgically-created osseous defects or osseous defects created from traumatic injury," indicating its direct role in healing and repairing damaged bone tissue.
No
The device is a bone void filler intended for treatment of osseous defects, not for diagnosing conditions.
No
The device description clearly states it is composed of donated cortical bone mixed with sodium hyaluronate and carboxymethylcellulose, indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Sygnal DBM is a "bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure." It is used in the treatment of surgically-created or traumatic osseous defects. This describes a device used in vivo (within the body) for structural support and bone regeneration.
- Device Description: The description details the composition of the device (donated bone granules, sodium hyaluronate, carboxymethylcellulose) and its form (resorbable material). This is consistent with a surgical implant or filler.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, analyze a sample from the body (like blood, urine, or tissue), or provide information about a patient's health status. IVDs are specifically designed for these purposes.
- Performance Studies: The performance studies focus on biocompatibility, sterility, osteoinductivity potential in an animal model, and viral inactivation potential of the processing method. These are relevant to the safety and efficacy of an implantable device, not a diagnostic test.
In summary, Sygnal DBM is a therapeutic device used to fill bone voids, not a diagnostic device used to analyze samples or provide diagnostic information.
N/A
Intended Use / Indications for Use
Sygnal DBM is a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Sygnal DBM can be used alone or as an extender in the posterolateral spine with bone marrow. It is indicated for use in the treatment of surgically-created osseous defects or osseous defects created from traumatic injury.
Sygnal DBM is for single patient use only.
Product codes
MBP, MQV
Device Description
Sygnal DBM is completely resorbable and is composed of donated cortical bone. The bone granules are mixed with sodium hyaluronate (Hy) and carboxymethylcellulose (CMC). Sygnal DBM is available in sizes of 0.5 cc, 1.0 cc, 2.5 cc, 5.0 cc, and 10.0 cc.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
posterolateral spine
Indicated Patient Age Range
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Intended User / Care Setting
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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
Biocompatibility of Sygnal DBM components has been established through their long history of safe and effective clinical use, further supported by laboratory testing conducted per ISO 10993. Sygnal DBM is single-donor processed using aseptic techniques and is tested for sterility per current USP .
Sygnal DBM is osteoconductive, and has been shown to have osteoinductivity potential in an athymic mouse model. Every lot of final product is assayed in vivo for its osteoinductive potential. Standard testing performed in an athymic mouse model must prove positive for lot release. Osteoinduction assay results in the athymic mouse model should not be interpreted to predict clinical performance in human subjects.
The method for processing the demineralized bone matrix contained in Sygnal DBM was evaluated for its viral inactivation potential. A panel of model potential human viruses representing various virus types, sizes, shapes and genomes were evaluated. The DBM processing methods were determined to provide significant viral inactivation potential for a wide range of potential viruses.
Key Metrics
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Predicate Device(s)
Not Found
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
Koroyos
510(k) SUMMARY OF SAFETY & EFFECTIVENESS
AUG 2 8 2008
| PROPRIETARY NAME: | Sygnal™ DBM |
|---|---|
| COMMON NAME: | Bone Void Filler Containing Human Demineralized |
| Bone Matrix (DBM) | |
| REGULATORY CLASS: | Class II |
| CLASSIFICATION | |
| IDENTIFICATION: | 21 C.F.R. §888.3045 Resorbable calcium salt bone |
| void filler device | |
| PRODUCT CODE: | MBP, MQV |
| PANEL CODE: | 87—Orthopedic Devices |
| SPONSOR: | Musculoskeletal Transplant Foundation |
| 125 May Street | |
| Edison, NJ 08837 | |
| 732-661-0202 | |
| 723-661-2189 fax |
INDICATIONS FOR USE:
Sygnal DBM is a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Sygnal DBM can be used alone or as an extender in the posterolateral spine with bone marrow. It is indicated for use in the treatment of surgically-created osseous defects or osseous defects created from traumatic injury.
Sygnal DBM is for single patient use only.
DEVICE DESCRIPTION:
Sygnal DBM is completely resorbable and is composed of donated cortical bone. The bone granules are mixed with sodium hyaluronate (Hy) and carboxymethylcellulose (CMC). Sygnal DBM is available in sizes of 0.5 cc, 1.0 cc, 2.5 cc, 5.0 cc, and 10.0 cc.
1
SAFETY AND EFFECTIVENESS INFORMATION:
Biocompatibility of Sygnal DBM components has been established through their long history of safe and effective clinical use, further supported by laboratory testing conducted per ISO 10993. Sygnal DBM is single-donor processed using aseptic techniques and is tested for sterility per current USP .
OSTEOINDUCTIVE POTENTIAL:
Sygnal DBM is osteoconductive, and has been shown to have osteoinductivity potential in an athymic mouse model. Every lot of final product is assayed in vivo for its osteoinductive potential. Standard testing performed in an athymic mouse model must prove positive for lot release. Osteoinduction assay results in the athymic mouse model should not be interpreted to predict clinical performance in human subjects.
VIRAL CLEARANCE AND INACTIVATION:
The method for processing the demineralized bone matrix contained in Sygnal DBM was evaluated for its viral inactivation potential. A panel of model potential human viruses representing various virus types, sizes, shapes and genomes were evaluated. The DBM processing methods were determined to provide significant viral inactivation potential for a wide range of potential viruses.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES. USA
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Musculoskeletal Transplant Foundation % Ms. Nancy Bennewitz Regulatory Affairs Submission Specialist Edison Corporate Center 123 May Street, Suite 300 Edison, New Jersey 08837
AUG 2 8 2008
Re: K080405
Trade Name: Sygnal DBM Regulation Number: 21 CFR § 888.3045 Regulation Name: Resorbable Bone Substitute Regulatory Class: Class II Product Code: MBP Dated: August 22, 2008 Received: August 25, 2008
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. 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.
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Page 2 – Ms. Nancy Bennewitz
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 premated 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 vours.
Mark M Wilkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Indications for Use
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INDICATIONS FOR USE
510(k) Number (if known): K080405
Device Name: Sygnal™ DBM
Indications for Use:
Sygnal DBM is a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Sygnal DBM can be used alone or as an extender in the posterolateral spine with bone marrow. It is indicated for use in the treatment of surgically-created osseous defects or osseous defects created from traumatic injury.
Sygnal DBM 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)
Chorbara Muchup
Division of General, Restorativ and Neurological Devices
510(k) Number K080405