(80 days)
No
The device description and performance studies focus on the material properties and biological integration of a bone void filler, with no mention of AI or ML technologies.
Yes
The device is intended to fill bony voids or gaps and resorb, being replaced with bone during the healing process, which are therapeutic actions.
No.
The device is described as a material intended to fill bony voids or gaps in the skeletal system, which functions as a resorbable scaffold for bone regeneration, not for diagnosing medical conditions.
No
The device description clearly states it is a porous composite material consisting of ceramic granules and a collagen scaffold, which are physical components, 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 the device is "intended to fill bony voids or gaps of the skeletal system (posterolateral spine)." This describes a surgical implant used directly within the body for structural support and bone regeneration.
- Device Description: The description details a "porous composite material consisting of resorbable ß-tricalcium phosphate ceramic granules... in a porcine collagen scaffold." This is a description of a physical material intended for implantation, not a reagent or instrument used to test samples outside the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This device does not perform any such tests.
The device is a bone graft substitute intended for surgical implantation.
N/A
Intended Use / Indications for Use
Ceracell® Ortho Foam is intended to fill bony voids or gaps of the skeletal system (posterolateral spine). These osseous defects may be surgically created or from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. In the posterolateral spine Ceracell® Ortho Foam is to be mixed with autograft bone. The device resorbs and is replaced with bone during the healing process.
Product codes (comma separated list FDA assigned to the subject device)
MOV
Device Description
Ceracell® Ortho Foam is a porous composite material consisting of resorbable ß-tricalcium phosphate ceramic granules (85% by weight of the final device) in a porcine collagen scaffold (Type I and Type III, 15% by weight of the final device). The porcine collagen scaffold component of the subject device is identical to the collagen component of curasan AG's previously cleared device, Cerasorb Ortho Foam, K 160566. The ceramic component of the subject device (B-tricalcium phosphate with approximately 4% SiO2-MgO-Na2O) is identical to the ceramic component of curasan AG's previously cleared device, Curasan Ceracell® DENTAL, K103709.
Ceracell® Ortho Foam is provided as Ceracell® Ortho Flexible Foam Strip and Ceracell® Ortho Moldable Foam. Ceracell® Ortho Flexible Foam Strip is provided in various sizes from 2.5 cc to 25 cc. Ceracelle Ortho Moldable Foam is provided in various sizes from 1.2 cc to 25 cc.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Pre-clinical testing data were submitted according to the guidance documents Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device (issued June 2003) and Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile (issued January 2016). The pre-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included chemical composition, physical properties, biocompatibility, sterilization, material mediated pyrogenicity, bacterial endotoxin, sterile barrier shelf life, and product shelf life.
Animal testing performed to demonstrate substantial equivalence included determination of radiographic. histologic, and histomorphometric characteristics of the subject device and the predicate device in a rabbit posterolateral spine fusion model. Animals implanted with autograft (positive control) also were evaluated. The study time points included baseline (time 0), 6 weeks, and 12 weeks. Evaluation endpoints included manual palpation, range of motion/flexibility testing, plain and high-resolution radiography, micro-computed tomography (micro-CT) imaging, undecalcified histologic evaluation, and histomorphometric analysis. Decalcified paraffin histology sections also were graded according to AAMI/ANSI/ISO 10993-6 (Annex E).
The radiographic, histologic, and histomorphometric performance of the subject device were compared to that of the primary predicate device K140375 in a rabbit posterolateral fusion model. The results of the study demonstrated that the performance of the subject device was equivalent to that of the primary predicate device K140375.
No clinical data were included in this submission.
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.
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.
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September 17, 2018
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA) along with the Department of Health & Human Services-USA. The FDA logo is in blue and consists of the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION." To the left of the FDA logo is the Department of Health & Human Services logo, which is a stylized emblem. The overall design is clean and professional, reflecting the official nature of the organizations represented.
curasan AG % Kevin A. Thomas, Ph.D. Vice President, Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K181721
Trade/Device Name: Ceracell® Ortho Foam Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: June 28, 2018 Received: June 29, 2018
Dear Dr. Thomas:
We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laurence D. Coyne -S
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Ceracell® Ortho Foam
Indications for Use (Describe)
Ceracell® Ortho Foam is intended to fill bony voids or gaps of the skeletal system (posterolateral spine). These osseous defects may be surgically created or from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. In the posterolateral spine Ceracell® Ortho Foam is to be mixed with autograft bone. The device resorbs and is replaced with bone during the healing process.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| [X] Prescription Use (Part 21 CFR 801 Subpart D) | [ ] Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary Ceracell® Ortho Foam
curasan AG
June 28, 2018
ADMINISTRATIVE INFORMATION
| Manufacturer Name | curasan AG
Lindigstrasse 4
Kleinostheim, 63801 Germany
Telephone +49 6027-40900-0
Fax +49 6027-40900-19 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact | Dr. Gregor Thomas
Medical Director |
| Representative/Consultant | Kevin A. Thomas, PhD
Floyd G. Larson, MS, MBA
PaxMed International, LLC
12264 El Camino Real, Suite 400
San Diego, CA 92130
Telephone +1 858-792-1235
Fax +1 858-792-1236
Email kthomas@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | Ceracell® Ortho Foam |
|---|---|
| Common Name | Filler, bone void, calcium compound |
| Classification Name | Resorbable calcium salt bone void filler device |
| Classification Regulations | 21 CFR 888.3045, Class II |
| Product Code | MQV |
| Classification Panel | Orthopaedic and Rehabilitation Devices Panel |
| Reviewing Branch | Restorative and Repair Devices Branch (RRDB) |
PREDICATE DEVICE INFORMATION
The primary predicate device is K140375, MASTERGRAFT® Strip; MASTERGRAFT® Putty, Medtronic Sofamor Danek USA, Inc. The reference predicate devices are K160566, Cerasorb Ortho Foam, curasan AG, and K103709, Curasan Ceracell® DENTAL, curasan AG.
INDICATIONS FOR USE
Ceracell® Ortho Foam is intended to fill bony voids or gaps of the skeletal system (posterolateral spine). These osseous defects may be surgically created or from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. In the posterolateral spine Ceracell® Ortho Foam is to be mixed with autograft bone. The device resorbs and is replaced with bone during the healing process.
4
SUBJECT DEVICE DESCRIPTION
Ceracell® Ortho Foam is a porous composite material consisting of resorbable ß-tricalcium phosphate ceramic granules (85% by weight of the final device) in a porcine collagen scaffold (Type I and Type III, 15% by weight of the final device). The porcine collagen scaffold component of the subject device is identical to the collagen component of curasan AG's previously cleared device, Cerasorb Ortho Foam, K 160566. The ceramic component of the subject device (B-tricalcium phosphate with approximately 4% SiO2-MgO-Na2O) is identical to the ceramic component of curasan AG's previously cleared device, Curasan Ceracell® DENTAL, K103709.
Ceracell® Ortho Foam is provided as Ceracell® Ortho Flexible Foam Strip and Ceracell® Ortho Moldable Foam. Ceracell® Ortho Flexible Foam Strip is provided in various sizes from 2.5 cc to 25 cc. Ceracelle Ortho Moldable Foam is provided in various sizes from 1.2 cc to 25 cc.
PERFORMANCE DATA
Pre-clinical testing data were submitted according to the guidance documents Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device (issued June 2003) and Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile (issued January 2016). The pre-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included chemical composition, physical properties, biocompatibility, sterilization, material mediated pyrogenicity, bacterial endotoxin, sterile barrier shelf life, and product shelf life.
Animal testing performed to demonstrate substantial equivalence included determination of radiographic. histologic, and histomorphometric characteristics of the subject device and the predicate device in a rabbit posterolateral spine fusion model. Animals implanted with autograft (positive control) also were evaluated. The study time points included baseline (time 0), 6 weeks, and 12 weeks. Evaluation endpoints included manual palpation, range of motion/flexibility testing, plain and high-resolution radiography, micro-computed tomography (micro-CT) imaging, undecalcified histologic evaluation, and histomorphometric analysis. Decalcified paraffin histology sections also were graded according to AAMI/ANSI/ISO 10993-6 (Annex E).
No clinical data were included in this submission.
EQUIVALENCE TO MARKETED DEVICE
curasan AG submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the subject device is substantially equivalent in indications and design principles to the legally marketed predicate devices:
K140375, MASTERGRAFT® Strip; MASTERGRAFT® Putty, Medtronic Sofamor Danek USA, Inc .;
K160566, Cerasorb Ortho Foam, curasan AG; and
K103709, Curasan Ceracel1® DENTAL, curasan AG.
A comparison of the technological characteristics of the subject device and the primary predicate device K140375 is provided in the following table.
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| | Subject Device
Ceracell® Ortho Foam
curasan AG | | Primary Predicate Device |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison | | | K140375
MASTERGRAFT® Strip; MASTERGRAFT® Putty
Medtronic Sofamor Danek USA, Inc. |
| Indications for Use
Statement | Ceracell® Ortho Foam is intended to fill bony voids or gaps
of the skeletal system (posterolateral spine). These osseous
defects may be surgically created or from traumatic injury
to the bone and are not intrinsic to the stability of the bony
structure. In the posterolateral spine Ceracell® Ortho Foam
is to be mixed with autograft bone. The device resorbs and
is replaced with bone during the healing process. | | MASTERGRAFT® Putty combined with either autogenous
bone marrow, and/or sterile water, and/or autograft is
indicated as a bone void filler for bony voids or gaps that
are not intrinsic to the stability of the bony structure:
Additionally. MASTERGRAFT® Putty can be used with
autograft as a bone graft extender. MASTERGRAFT® Putty
is to be gently packed into bony voids or gaps of the skeletal
system (e.g., the posterolateral spine, pelvis. ilium. and/or
extremities). These defects may be surgically created
osseous defects or osseous defects created from traumatic
injury to the bone. MASTERGRAFT® Putty resorbs and is
replaced with bone during the healing process. |
| Product Code | MQV | | MQV |
| Intended Use | Bone void filler for skeletal system
(posterolateral spine) | | Bone void filler for skeletal system
(extremities, pelvis, and posterolateral spine) |
| Use in Spine | Yes | | Yes |
| Hydration
prior to use | Sterile saline (required) | | Bone marrow aspirate and/or sterile water (required) |
| Mix with bone
prior to use | Autograft bone (required) | | Autograft bone (optional) |
| Design | | | |
| Form | Granules uniformly dispersed in collagen scaffold
85 wt % granules, 15 wt % collagen | | Granules uniformly dispersed in collagen scaffold |
| Granule Size | 1000-2000 μm | | 0.5 mm - 1.6 mm in diameter |
| Porosity | Granules - up to 75%
Final device (granules in collagen scaffold) - 80% | | Granules - 80%
Final device - not stated in 510(k) Summary |
| Materials | | | |
| Calcium salts | β-tricalcium phosphate with
approximately 4% SiO2-MgO-Na2O | | β-tricalcium phosphate (85%) and
Hydroxyapatite (15%) |
| Scaffold/Binder | Type I and Type III porcine collagen
(15 wt % of total material) | | Type I bovine collagen |
| How Provided | | | |
| Sizes, shapes | Flexible Foam Strip
25 x 25 x 4 mm (2.5 cc)
25 x 50 x 4 mm (5 cc)
25 x 100 x 4 mm (10 cc)
65 x 65 x 6 mm (25 cc) | Moldable Foam
25 x 12 x 4 mm (1.2 cc)
25 x 25 x 4 mm (2.5 cc)
25 x 50 x 4 mm (5 cc)
25 x 100 x 4 mm (10 cc)
65 x 65 x 6 mm (25 cc) | MASTERGRAFT® Putty
Various volumes:
0.75 cc, 1.5 cc, 3.0 cc, 6.0 cc, and 9.0 cc packages |
| Single use | Provided sterile to end-user | | Provided sterile to end-user |
| Sterile | Gamma irradiation | | Not stated |
| Sterilization | Single patient, single use | | Single patient, single use |
The primary predicate device is K140375 for substantial equivalence in the animal model performance testing. The reference predicate devices K160566 and K103709 are for substantial equivalence in terms of the subject device material composition.
The subject device and the primary predicate device K140375 have the same intended use, the same product classification and product code (MQV), and have similar Indications for Use statements. The
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subject device and the primary predicate devices are bone void fillers that are intended for bony voids or gaps that are not intrinsic to the bony structure. The subject device and primary predicate device are indicated for use in the posterolateral spine with autograft bone (extender). Although the subject device and the primary predicate have slightly different Indications for Use language, this difference in language does not change the intended use as a bone void filler in the posterolateral spine.
The subject device and the primary predicate device K140375 each incorporate calcium phosphate materials within a collagen scaffold. The subject device scaffold is Type I and Type III porcine collagen, and the primary predicate K140375 scaffold is Type I bovine collagen. The subject device is made of the identical collagen as the reference predicate device K160566, and the subject device is made of identical calcium phosphate component as the reference predicate device K103709. The subject device and all predicate devices are provided sterile for single-patient, single-use in similar ranges of graft volumes.
The radiographic, histologic, and histomorphometric performance of the subject device were compared to that of the primary predicate device K140375 in a rabbit posterolateral fusion model. The results of the study demonstrated that the performance of the subject device was equivalent to that of the primary predicate device K140375.
CONCLUSION
The subject device and the predicate devices have the same intended use, have similar technological characteristics, and are made of similar materials. The subject and predicate devices are packaged in similar materials and are sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.