(196 days)
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.
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.
The provided text describes a medical device called "Sygnal™ DBM," a bone void filler. However, it does not include information about acceptance criteria or a study proving the device meets those criteria, as typically found in submissions for Artificial Intelligence/Machine Learning (AI/ML) devices.
Instead, the document is a 510(k) summary for a Class II medical device, which focuses on demonstrating substantial equivalence to a predicate device. This type of submission generally relies on established safety and performance characteristics of the predicate and the materials used in the new device, rather than detailed performance studies with acceptance criteria for an AI algorithm.
Therefore, I cannot provide the requested information because it is not present in the provided input. The document describes:
- Device Description: Sygnal DBM is a resorbable bone void filler composed of donated cortical bone mixed with sodium hyaluronate and carboxymethylcellulose.
- Indications for Use: Treatment of surgically-created osseous defects or osseous defects from traumatic injury, alone or as an extender in the posterolateral spine with bone marrow.
- Safety and Effectiveness Information:
- Biocompatibility: Established through long clinical use of components and laboratory testing per ISO 10993.
- Sterility: Tested per current USP <71>.
- Osteoinductive Potential: Demonstrated in an athymic mouse model, with every lot assayed in vivo for positive osteoinductive potential for lot release. Crucially, it states: "Osteoinduction assay results in the athymic mouse model should not be interpreted to predict clinical performance in human subjects."
- Viral Clearance and Inactivation: Evaluated for its potential to inactivate a panel of model human viruses.
The document is an FDA letter acknowledging substantial equivalence (K080405) to a legally marketed predicate device, allowing the sponsor to market Sygnal™ DBM.
In summary, none of the requested information regarding acceptance criteria or a study proving the device meets those specific acceptance criteria (as would be relevant for an AI/ML device) is available in the provided text.
{0}------------------------------------------------
Koroyos
510(k) SUMMARY OF SAFETY & EFFECTIVENESS
AUG 2 8 2008
| PROPRIETARY NAME: | Sygnal™ DBM |
|---|---|
| COMMON NAME: | Bone Void Filler Containing Human DemineralizedBone Matrix (DBM) |
| REGULATORY CLASS: | Class II |
| CLASSIFICATIONIDENTIFICATION: | 21 C.F.R. §888.3045 Resorbable calcium salt bonevoid filler device |
| PRODUCT CODE: | MBP, MQV |
| PANEL CODE: | 87—Orthopedic Devices |
| SPONSOR: | Musculoskeletal Transplant Foundation125 May StreetEdison, NJ 08837732-661-0202723-661-2189 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 <71>.
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.
{2}------------------------------------------------
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.
{3}------------------------------------------------
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
{4}------------------------------------------------
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
§ 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.