(105 days)
No
The summary describes a bone void filler composed of bioactive glass and a carrier. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as a bone void filler and bone graft extender used in the healing process of bony defects, fitting the definition of a therapeutic device.
No
Explanation: The device is described as a "bone void filler" and "bone graft extender" which resorbs and is replaced with bone. Its purpose is to fill bony voids or gaps and aid in bone formation and regeneration, not to diagnose a condition.
No
The device description clearly states it is a physical material (putty) composed of bioactive glass particles and a carrier, intended for surgical implantation. It is a physical medical device, 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 BioSphere Putty is a bone void filler and bone graft extender used in vivo (within the body) to fill bony voids and gaps in the skeletal system.
- Device Description: The description details a material that is implanted into the body to aid in bone regeneration.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples in vitro (outside the body), such as blood, urine, or tissue, to diagnose a condition or provide information about a patient's health status.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or compatibility purposes. BioSphere Putty is a therapeutic device used to facilitate bone healing within the body.
N/A
Intended Use / Indications for Use
BioSphere Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. BioSohere Putty is indicated to be gently packed into bony voids or gaps of the skeletal system as a bone void filler in the extremities and pelvis, and as a bone graft extender in the posterolateral spine. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the product provides a bone void filler that resorbs and is replaced with bone during the healing process.
Product codes
MQV
Device Description
BioSphere Putty Bloactive Bone Graft (BroSphere Putty) is an osteoconductive, bloactive bone void filler that, like its predicate device, is composed of 45S5 bioactive glass particles In BioSphere Putty, the bloactive glass is mixed with an inert, moldable carrier that aids in placement of the product into bony voids. Upon implantation, the carrier is absorbed by the site and the remaining bloactive glass particles provide an osteoconductive surface for bone formation The broactive glass particles are provided in a spherical form, and the natural packing of the spheres creates 3-dimensional, interconnected porosity that allows for bone regeneration throughout the defect site. In the posterolateral spine, BioSphere Putty can be combined with autograft as a bone graft extender.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray, microCT
Anatomical Site
skeletal system (extremities, pelvis, 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
The primary component of BioSphere Putty is medical grade 45S5 bioactive glass which complies with the requirements of ASTM F-1538. The composition and formula used in BioSphere Putty is identical the BioSphere Putty predicate. Expansion of the device indications, to include use as a bone graft extender for posterolateral fusion, is supported by performance testing of the device in a clinically relevant spinal animal model. Using a rabbit posterolateral fusion model, the device (BioSphere Putty + autograft) was compared to autograft in order to demonstrate substantial equivalence to the predicate. In the study, spines were evaluated at 6 and 12 weeks using x-ray, microCT, histology, and histomorphometry. Additionally at 12 weeks, spines were biomechanically tested in range of motion and tensile peak load. The radiographic fusion rate for each group was determined from the 12 week x-rays and microCT images by conducting a blinded, bilateral radiographic fusion assessment. Five (5) animals were evaluated at each time point for each group. The results showed that the device was similar to autograft at both time points.
Key Metrics
Not Found
Predicate Device(s)
BioSphere Putty (K122868), Novabone Putty - Broactive Synthetic Graft (K080009), InterGro DBM (K082793)
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.
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JUL 16 2014
510(k) Summary BioSphere® Putty Bioactive Bone Graft
1. Submitter Information:
Synergy Bromedical, LLC 100 Springhouse Dr Suite 108 Collegeville, PA 19426
Date Prepared. April 1, 2014
2. Contact Information:
Randy Prebula Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, DC 20004
3. Device Name and Classification:
Product Name. Common Name Classification Name Proposed Classification Classification Panel Product Code Device Class.
BioSphere Putty Broactive Bone Graft Bone Vold Filler Resorbable Calcıum Salt Bone Voıd Filler Device 21 CFR 888 3045 Orthopedic MQV Class II
4. Predicate Device(s)
BioSphere Putty (K122868) Novabone Putty - Broactive Synthetic Graft (K080009) InterGro DBM (K082793)
5. Device Description
BroSphere Putty Bloactive Bone Graft (BroSphere Putty) is an osteoconductive, bloactive bone void filler that, like its predicate device, is composed of 45S5 bioactive glass particles In BioSphere Putty, the bloactive glass is mixed with an inert, moldable carrier that aids in placement of the product into bony voids. Upon implantation, the carrier is absorbed by the site and the remaining bloactive glass particles provide an osteoconductive surface for bone formation The broactive glass particles are provided in a spherical form, and the natural packing of the spheres creates 3-dimensional, interconnected porosity that allows for bone regeneration throughout the defect site. In the posterolateral spine, BioSphere Putty can be combined with autograft as a bone graft extender.
6. Intended Use
BroSphere Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure BroSphere Putty is indicated to be gently packed into bony voids or gaps of the skeletal system as a bone void filler in the extremities and pelws, and as a bone graft extender in the posterolateral spine These defects may be surgically created osseous
1
defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
7. Performance Data
The primary component of BioSphere Putty is medical grade 45S5 bioactive glass which complies with the requirements of ASTM F-1538. The composition and formula used in BioSphere Putty is identical the BioSphere Putty predicate. Expansion of the device indications, to include use as a bone graft extender for posterolateral fusion, is supported by performance testing of the device in a clinically relevant spinal animal model. Using a rabbit posterolateral fusion model, the device (BioSphere Putty + autograft) was compared to autograft in order to demonstrate substantial equivalence to the predicate. In the study, spines were evaluated at 6 and 12 weeks using x-ray, microCT, histology, and histomorphometry. Additionally at 12 weeks, spines were biomechanically tested in range of motion and tensile peak load. The radiographic fusion rate for each group was determined from the 12 week x-rays and microCT images by conducting a blinded, bilateral radiographic fusion assessment. Five (5) animals were evaluated at each time point for each group. The results showed that the device was similar to autograft at both time points.
8. Substantial Equivalence
BioSphere Putty is as safe and effective as the predicate devices. BioSphere Putty has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. In vivo performance data demonstrated that BioSphere Putty is as safe and effective as autograft. Thus, BioSphere Putty is substantially equivalent to the predicates.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
July 16, 2014
Synergy Biomedical, LLC % Mr. Randy Prebula Partner Hogan Lovells US LLP 555 Thirteenth Street, Northwest Washington. District of Columbia 20004
Re: K140844
Trade/Device Name: BioSphere Putty Bioactive Bone Graft (BioSphere Putty) Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: April 17, 2014 Received: April 17, 2014
Dear Mr. Prebula:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Randy Prebula
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K 140844
Device Name
BioSphere Putty Bioactive Bone Graft (BioSphere Putty)
Indications for Use (Describe)
BioSphere Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. BioSohere Putty is indicated to be gently packed into bony voids or gaps of the skeletal system as a bone void filler in the extremities and pelvis, and as a bone graft extender in the posterolateral spine. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the product provides a bone void filler that resorbs and is replaced with bone during the healing process.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Laurence D. Coyne -A
(Division Sign-Off) Division of Orthopedic Devices SIO(k) Number: K140844
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