(101 days)
RD837
No
The document describes a physical bone void filler made of synthetic material with different shapes and sizes. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended to fill bony voids or gaps and promote bone ingrowth, which is a therapeutic function.
No
This device is a bone void filler intended to fill bony voids or gaps; it is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a "macroporous implant made of synthetic beta tri Calcium Phosphate (βΤCP)" and comes in various physical shapes and forms (stick, granule, cube, block, wedges). This indicates a physical medical device, not a software-only one.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "resorbable calcium salt bone void filler intended to fill bony voids or gaps of the skeletal system... caused by trauma or surgery". This describes a device used in vivo (within the body) for structural support and bone regeneration.
- Device Description: The description details a "macroporous implant made of synthetic beta tri Calcium Phosphate (βΤCP)" that is "slowly resorbs during the remodeling and bone defect repair process". This further confirms its use as an implant within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze biological samples. This device is used inside the body to fill bone voids.
N/A
Intended Use / Indications for Use
BIOSORB Resorbable Bone Void Filler is a resorbable calcium salt bone void filler intended to fill bony voids or gaps of the skeletal system (i.e. the extremities, posterolateral spine and pelvis,) caused by trauma or surgery, that are not intrinsic to the stability of the bony structure. BIOSORB Resorbable BoneVoid Filler does not possess sufficient mechanical strength to support reduction of a defect prior to soft and hard tissue ingrowth. Rigid fixation techniques are recommended as needed to assure stabilization of the defect in all plans.
In addition, when used with appropriate opening osteotomy system devices, plates and screws, BIOSORB Resorbable Bone Void Filler Is Intended to be used as a bone void filler in tiblal osteotomies.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
BIOSORB bone void filler (K021963 and K071155) is an osseo-conductive macroporous implant made of synthetic beta tri Calcium Phosphate (βΤCP) indicated for Bone Void Filling.
BIOSORB bone void filler presents a multidirectional interconnected porosity structure, similar to that of the human cancellous bone. BIOSORB bone void filler implant slowly resorbs during the remodeling and bone defect repair process and is progressively replaced with bone and soft tissues.
To better fit the surgeon's needs and surgical preferences and patient's anatomy the full range of BIOSORB RESORBABLE BONE VOID FILLER will comprise:
- 9 shapes: stick, granule, cube, block (6 shapes) o
- 3 material specifications: BIOSORB 30, BIOSORB 45 and BIOSORB 70 o
- 3 packaging: box, vial, syringe 0
The design modifications of the new NEOTIS set of wedges with respect to OTIS set of wedges include a sharper anterior area and a wider posterior area more fitting the natural tibia anatomy. 3 letters are printed to help the surgeon with the wedge orientation: A stands for Anterior, M stands for Medial and P for Posterior.
There are 50 NEOTIS parts instead of 10 OTIS parts, so that the range is increased.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e. the extremities, posterolateral spine and pelvis), Tibial Osteotomies
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The new implant design offers an enhanced anatomical fitting for HTO opening filling as verified by surgeons through cadaveric labs (RD837 - enclosed in Appendix 1).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
RD837
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K130953 - Page 1/3
510 (k) Special Biosorb Bone Void
Filler
:
2017-12
510(K) SUMMARY
JUL 1 5 2013
1. GENERAL INFORMATION
.
| Trade Name | BIOSORB RESORBABLE BONE VOID FILLER |
|---|---|
| Common Name | Bone void filler |
| Classification Name | Resorbable Calcium Salt Bone Void Filler device |
| Class | II |
| Product Code | MQV |
| CFR section | 888.3045 |
| Device panel | Orthopedic |
| Legally marketed predicate devices | BIOSORB RESORBABLE BONE VOID FILLER (K021963 and K071155) |
| Reason for special 510k | Extension of the range of products |
| Submitter | SCIENCE FOR BIOMATERIALS |
| Sciences et Bio Matériaux | |
| ZI du Monge | |
| F 65100 LOURDES - FRANCE | |
| Owner operation Number : 9063735 | |
| Contact | Denis CLEMENT, General Manager |
| Tel : +33 (0)5 62 42 21 01 | |
| Fax : +33 (0)5 62 42 21 00 | |
| e-mail : denis.clement@sbm-fr.com | |
| Regulatory contact: anne.cospin@sbm-fr.com |
1
K130953 - Page 2/3
510 (k) Special Biosorb Bone Void Filler
2. DEVICE DESCRIPTION
BIOSORB bone void filler (K021963 and K071155) is an osseo-conductive macroporous implant made of synthetic beta tri Calcium Phosphate (βΤCP) indicated for Bone Void Filling.
BIOSORB bone void filler presents a multidirectional interconnected porosity structure, similar to that of the human cancellous bone. BIOSORB bone void filler implant slowly resorbs during the remodeling and bone defect repair process and is progressively replaced with bone and soft tissues.
To better fit the surgeon's needs and surgical preferences and patient's anatomy the full range of BIOSORB RESORBABLE BONE VOID FILLER will comprise:
- 9 shapes: stick, granule, cube, block (6 shapes) o
- 3 material specifications: BIOSORB 30, BIOSORB 45 and BIOSORB 70 o
- 3 packaging: box, vial, syringe 0
The design modifications of the new NEOTIS set of wedges with respect to OTIS set of wedges include a sharper anterior area and a wider posterior area more fitting the natural tibia anatomy. 3 letters are printed to help the surgeon with the wedge orientation: A stands for Anterior, M stands for Medial and P for Posterior.
There are 50 NEOTIS parts instead of 10 OTIS parts, so that the range is increased.
3. INTENDED USE
BIOSORB Resorbable Bone Void Filler is a resorbable calcium salt bone void filler intended to fill bony voids or gaps of the skeletal system (i.e. the extremities, posterolateral spine and pelvis,) caused by trauma or surgery, that are not intrinsic to the stability of the bony structure. BIOSORB Resorbable Bone Void Filler does not possess sufficient mechanical strength to support reduction of a defect prior to soft and hard tissue ingrowth. Rigid fixation techniques are recommended as needed to assure stabilization of the defect in all plans.
In addition, when used with appropriate opening osteotomy system devices, plates and screws, BIOSORB Resorbable Bone Void Filler is intended to be used as a Bone void filler in Tibial Osteotomies.
2
4. PERFORMANCE DATA
BIOSORB bone void filler medical devices conform to Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA" established for Resorbable calcium salt bone void filler (21 CFR 888.3045).
30953
313
Page
The new implant design offers an enhanced anatomical fitting for HTO opening filling as verified by surgeons through cadaveric labs (RD837 - enclosed in Appendix 1).
5. SUBSTANTIAL EQUIVALENCE
The additional BIOSORB RESORBABLE BONE VOID FILLER products have the same fundamental scientific technology, operating principle and intended use as previously cleared BIOSORB RESORBABLE BONE VOID FILLER K021963 and K071155.
The design modification reduces the risk of inadequate filling of the HTO opening with concern to former wedges, and does not generate new risks. The device is as safe, as effective and performs as well as or better than the predicate BIOSORB RESORBABLE BONE VOID FILLER.
Summary preparation date: July 1, 2013
3
Image /page/3/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 with three legs and a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 15, 2013
Science for Biomaterials Sciences et Bio Matériaux % Mr. Denis Clement CEO ZI du Monge F 65100 LOURDES FRANCE
Re: K130953
Trade/Device Name: BIOSORB Resorbable Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: June 11, 2013 Received: June 17, 2013
Dear Mr. Clement:
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
4
Page 2 - Mr. Denis Clement
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 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/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/ReportalProblem/dcfault.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.
Erin I. Keith
. For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: BIOSORB Resorbable Bone Void Filler
Indications for Use:
BIOSORB Resorbable Bone Void Filler is a resorbable calclum salt bone void filler intended to fill bony voids or gaps of the skeletal system (i.e. the extremities, posterolateral spine and pelvis,) caused by trauma or surgery, that are not intrinsic to the stability of the bony structure. BIOSORB Resorbable BoneVoid Filler does not possess sufficient mechanical strength to support reduction of a defect prior to soft and hard tissue ingrowth. Rigid fixation techniques are recommended as needed to assure stabilization of the defect in all plans.
In addition, when used with appropriate opening osteotomy system devices, plates and screws, BIOSORB Resorbable Bone Void Filler Is Intended to be used as a bone void filler in tiblal osteotomies.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Laurence D. Coyne -A
(Division Sign-Off) Division of Orthopedic Devices 510{k) Number: K130953