(105 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 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 bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
BioSphere Putty Bioactive Bone Graft (BioSphere Putty) is an osteoconductive, bioactive bone void filler that, like its predicate device, is composed of 45S5 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. In the posterolateral spine, BioSphere Putty can be combined with autograft as a bone graft extender.
Here's a breakdown of the acceptance criteria and the study details for the BioSphere® Putty Bioactive Bone Graft, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The submission doesn't explicitly list quantitative "acceptance criteria" in the format of a target value. Instead, the primary performance measure for the expanded indication (bone graft extender in posterolateral spine) was to demonstrate substantial equivalence to autograft. This was assessed through various methods, with a focus on radiographic fusion rate and biomechanical similarity.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Radiographic Fusion at 12 Weeks: Substantially equivalent to autograft in a rabbit posterolateral fusion model. | "The radiographic fusion rate for each group was determined from the 12-week x-rays and microCT images... The results showed that the device was similar to autograft at both time points." (indicating similar fusion rates) |
| Biomechanical Properties at 12 Weeks: Similar range of motion and tensile peak load to autograft in the rabbit model. | "Additionally at 12 weeks, spines were biomechanically tested in range of motion and tensile peak load. The results showed that the device was similar to autograft at both time points." (indicating similar biomechanical performance in both aspects) |
| Histological and Histomorphometric Evaluation at 6 & 12 Weeks: Demonstrate osteoconductivity and bone formation comparable to autograft. | "In the study, spines were evaluated at 6 and 12 weeks using x-ray, microCT, histology, and histomorphometry. ... The results showed that the device was similar to autograft at both time points." (While not explicitly stating quantitative similarity, the overall conclusion of "similar" implies meeting expectations for bone formation.) |
| Resorption and Replacement with Bone: Expected behavior for a bone void filler. | "The product provides a bone void filler that resorbs and is replaced with bone during the healing process." (This is part of the intended mechanism of action, reinforced by the "similar to autograft" findings.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Five (5) animals were evaluated at each time point (6 weeks and 12 weeks) for each group (BioSphere Putty + autograft and autograft only). This implies a total of 20 animals in the test set (5 animals/group * 2 groups * 2 time points).
- Data Provenance: The study was conducted using a rabbit posterolateral fusion model, which is an animal model. The text doesn't specify the country of origin for the data or whether it was retrospective or prospective, but animal studies are typically prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: The text states that a "blinded, bilateral radiographic fusion assessment" was conducted to determine the radiographic fusion rate. However, it does not specify the number of experts who performed this assessment.
- Qualifications of Experts: The text does not specify the qualifications of the experts who performed the assessment.
4. Adjudication Method for the Test Set
- The text describes a "blinded, bilateral radiographic fusion assessment." This implies that the assessors were blinded to the treatment group (BioSphere Putty + autograft vs. autograft). However, the specific adjudication method (e.g., 2+1, 3+1, none) is not mentioned. It's unclear if multiple readers independently assessed and then reached consensus, or if a single reader performed the assessment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study described is an animal model study comparing the device to autograft. There is no mention of human readers assessing cases with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
- No, a standalone (algorithm only) performance study was not done. The device is a physical bone graft, not an algorithm. The study assessed the in-vivo performance of the physical product.
7. Type of Ground Truth Used
The ground truth for the animal study was established through a combination of:
- Radiographic Assessment: X-ray and microCT images.
- Histology and Histomorphometry: Microscopic examination of tissue for bone formation and integration.
- Biomechanical Testing: Direct measurement of range of motion and tensile peak load.
This represents a comprehensive approach to defining "fusion" and material performance in an animal model.
8. Sample Size for the Training Set
- The concept of a "training set" is not applicable here as the submission describes a physical medical device (bone graft), not a machine learning algorithm. Therefore, there is no training set in this context.
9. How the Ground Truth for the Training Set Was Established
- As there is no training set for an algorithm, this question is not applicable.
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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
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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.
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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
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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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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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§ 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.