(213 days)
BioSphere Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. BioSphere Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities and pelvis). These defects may be surgically created osseous 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.
BioSphere Putty is an osteoconductive, bioactive bone void filler that, like its predicate device (NovaBone), is composed of 4555 bioactive glass particles. In BioSphere Putty, the bioactive 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 bioactive glass particles provide an osteoconductive surface for bone formation. The bioactive 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.
The provided document is a 510(k) summary for the BioSphere™ Bioactive Bone Graft (BioSphere Putty) and its FDA clearance letter. It describes the device, its intended use, and performance data used to demonstrate substantial equivalence to predicate devices. However, the document does NOT contain information about acceptance criteria and the results of a study that directly proves the device meets those specific quantitative acceptance criteria.
The performance data section describes several tests performed, but it lacks specific quantitative acceptance criteria and detailed results to compare against them. Instead, it concludes with a statement that "Performance data demonstrate that BioSphere Putty is as safe and effective as the predicates."
Therefore, I cannot populate the table or answer all the questions as requested because the specific, quantitative acceptance criteria and the detailed study results directly comparing the device's performance against these criteria are not present in the provided text.
Here is what I CAN extract and infer from the document:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in quantitative terms. The primary acceptance criterion appears to be "substantial equivalence" to predicate devices, meaning it is "as safe and effective" and "raises no new issues of safety or effectiveness."
- Reported Device Performance:
| Test | Performance |
|---|---|
| Material Compliance | Primary component (45S5 bioactive glass) complies with ASTM F-1538. |
| Biocompatibility | Testing in accordance with ISO 10993 demonstrated materials are biocompatible. |
| Compositional/Physical Comparison | XRF, particle size analysis, and ion dissolution showed the bioactive glass component was identical to the predicate device (NovaBone). |
| In vitro Bioactivity | The bioactive glass particles were capable of forming a calcium phosphate layer when incubated in simulated body fluid. |
| In vivo Performance (Animal Model) | Performance in a clinically relevant animal model showed bone formation similar to the predicate device. (Note: Results have not been correlated to clinical performance.) |
| Overall Conclusion (Substantial Equivalence) | BioSphere Putty is as safe and effective as the predicate devices. It has the same intended uses and similar indications, technological characteristics, and principles of operation. The minor technological differences (spherical particles, inert carrier) raise no new issues of safety or effectiveness. Performance data demonstrate BioSphere Putty is as safe and effective as the predicates. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Animal Model): Not specified.
- Data Provenance: Not specified for the animal model or in vitro testing. The submission is from Synergy Biomedical, LLC, located in Phoenixville, PA, USA, implying the company is US-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This device is a bone void filler, not an AI/imaging device that requires expert review for ground truth. Therefore, this information is not applicable and not present in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as this is not an expert-adjudicated test set in the context of AI/imaging.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is a medical device (bone void filler), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable as this is a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For in vitro tests: Chemical analysis (XRF, particle size, ion dissolution), observation of calcium phosphate layer formation in SBF.
- For in vivo tests (animal model): Observation and assessment of "bone formation similar to the predicate device." The method of assessing bone formation (e.g., histology, imaging) and the ground truth standard for "similar" are not detailed.
8. The sample size for the training set
- Not applicable as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable as this is not an AI/machine learning device.
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K122868 Response #1
Synergy Biomedical
510(k) Summary BioSphere™ Bioactive Bone Graft
APR 1 9 2013
1. Submitter Information:
Synergy Biomedical, LLC 400 Franklin Ave Suite 207 Phoenixville, PA 19460
Date Prepared: September 17th, 2012
Contact Information: 2.
Jonathan Kahan Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, DC 20004
Device Name and Classification: 3.
Product Name: Common Name Classification Name: Proposed Classification: Classification Panel: Product Code: Device Class:
BioSphere Bioactive Bone Graft Putty Bone Void Filler Resorbable Calcium Salt Bone Void Filler Device 21 CFR 888.3045 Orthopedic MQV Class II
Predicate Device(s) 4.
Novabone Putty – Bioactive Synthetic Graft (K060728) Intergro DBM (K031399)
Device Description 5.
BioSphere Putty is an osteoconductive, bioactive bone void filler that, like its predicate device (NovaBone), is composed of 4555 bioactive glass particles. In BioSphere Putty, the bioactive 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 bioactive glass particles provide an osteoconductive surface for bone formation. The bioactive 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.
6. Intended Use
BioSphere Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. BioSphere Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities and pelvis). These defects may be surgically created osseous defects or osseous
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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.
Performance Data 7.
The primary component of BioSphere Putty is medical grade 4555 bioactive glass which complies with the requirements of ASTM F-1538. Testing of the device in accordance with ISO 10993 Biological Evaluation of Medical Device demonstrated that the materials are biocompatible. Comparative testing using XRF, particle size analysis, and ion dissolution showed that the bioactive glass component was identical to the predicate device. In vitro bioactivity testing of the Putty showed that the bioactive glass particles were capable of forming a calcium phosphate layer when incubated in simulated body fluid. Additionally, performance of the device in a clinically relevant animal model showed bone formation similar to the predicate device. These results have not been correlated to clinical performance.
Substantial Equivalence 8.
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 device. The minor technological difference between BioSphere Putty and its predicate devices, the use of a spherical particles and the inclusion of an inert, moldable carrier, raises no new issues of safety or effectiveness. Performance data demonstrate that BioSphere Putty is as safe and effective as the predicates. Thus, BioSphere Putty is substantially equivalent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol resembles a bird in flight, composed of three curved lines that converge to form the body and wings. The overall design is simple and conveys a sense of movement and progress.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: April 19, 2013
Synergy Biomedical, LLC % Hogan Lovells US LLP Mr. Jonathan S. Kahan 555 Thirteenth Street, Northwest Washington, District of Columbia 20004
Re: K122868
Trade/Device Name: BioSphere Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler Regulatory Class: Class II Product Code: MQV Dated: February 27, 2013 Received: February 27, 2013
· Dear Mr. Kahan:
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 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 – Mr. Jonathan S. Kahan
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Small Manufacturers, International and Consumer Assistance 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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Indications for Use Statement
510(k) Number (if known):
Device Name: BioSphere Putty
Indications for Use:
BioSphere Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. BioSphere Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous 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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Laurence D. Coyne -A
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K122868
Page ___ of
§ 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.