(105 days)
Not Found
No
The device description focuses on the material composition and physical properties of a bone graft material. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for bony voids or gaps and acts as a bone graft extender, promoting bone healing and replacement, which classifies it as a therapeutic device.
No
This device is a bone graft material and extender used to fill bony voids or gaps, which is a therapeutic function, not a diagnostic one. It is used to aid in the healing process of bone defects, not to identify or assess medical conditions.
No
The device description clearly states it is made from physical materials (collagen and biphasic calcium phosphate ceramic) and is a porous implant, indicating 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:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The description of MASTERGRAFT® Contain clearly states it is a bone graft material intended to be implanted directly into bony voids or gaps in the skeletal system. It is used to facilitate bone healing and is resorbed by the body.
- Lack of Specimen Examination: The device does not involve the collection, preparation, or examination of any specimens taken from the human body. It is a material implanted into the body.
Therefore, MASTERGRAFT® Contain falls under the category of an implantable medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
MASTERGRAFT® Contain is to be combined with autogenous bone marrow and is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure and can be used as a bone graft extender.
The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., 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. The device resorbs and is replaced with bone during the healing process. When used in the pelvis, ilium, or extremities, the device is to be used with bone marrow aspirate. When used in the posterolateral spine, the device must be mixed with bone marrow aspirate and autograft bone and used as a bone graft extender.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
MASTERGRAFT® Contain is made from a combination of medical grade purified collagen of bovine origin and biphasic calcium phosphate ceramic. In the MASTERGRAFT® Contain device, the collagen is a highly purified (>95%) Type I bioresorbable lyophilized collagen. The biphasic ceramic portion of the device is provided in a 15 percent hydroxyapatite and 85 percent ß- tricalcium phosphate formulation. The device is supplied sterile in a premixed form for single patient use. The device is a biocompatible, osteoconductive, porous implant that allows for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing. The device readily absorbs bone marrow aspirate and has been shown to heal bone defects. The device is designed with a cavity (ies) to contain and deliver autologous bone to the surgical site when used as a bone graft extender.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e., the posterolateral spine, pelvis, ilium, and/or extremities)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Non-clinical testing was performed in support of substantial equivalence for the cited predicate K082166 [S.E. 06/02/2009] in accordance with FDA Recognized Consensus Standards and FDA Guidelines, where applicable. No new non-clinical testing was performed or submitted in support of this 510(k).
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.
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medtronic Sofamor Danek USA, Incorporated Mr. Gregory Maschek Senior Regulatory Affairs Manager 1800 Pyramid Place Memphis, Tennessee 38132
August 14, 2015
Re: K151172
Trade/Device Name: Mastergraft® Contain Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: July 8, 2015 Received: July 9, 2015
Dear Mr. Mascheck:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the
1
Page 2 - Mr. Gregory Maschek
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" (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 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
2
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) K151172
Device Name MASTERGRAFT® Contain
Indications for Use (Describe)
MASTERGRAFT® Contain is to be combined with autogenous bone marrow and is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure and can be used as a bone graft extender.
The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., 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. The device resorbs and is replaced with bone during the healing process. When used in the pelvis, illium, or extremittes, the device is to be used with bone marrow aspirate. When used in the posterolateral spine, the device must be mixed with bone marrow aspirate and autograft bone and used as a bone graft extender.
| Type of Use (Select one or both, as applicable) | Authorization to Use EPA SET-2021 Interim Strategy Other | Authorization to Use EPA SET-2021 Interim Strategy | Other |
|---|---|---|---|
| Authorization to Use EPA SET-2021 Interim Strategy | |||
| Other |
|X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
| I. SUBMITTER NAME & ADDRESSS: | Medtronic Sofamor Danek USA, Inc |
|---|---|
| 1800 Pyramid Place | |
| Memphis, Tennessee 38132 | |
| Telephone: (901) 396-3133 | |
| Fax: (901) 346-9738 | |
| Establishment Registration: 1030489 | |
| CONTACT PERSON: | Gregory Maschek |
| Sr. Regulatory Affairs Specialist | |
| DATE PREPARED: | July 7, 2015 |
II. PROPOSED PROPRIETARY TRADE NAME: MASTERGRAFT® Contain
| DEVICE CLASSIFICATION NAME: | Resorbable Calcium Salt Bone Void Filler |
|---|---|
| REGULATION NUMBER: | 21 CFR 888.3045 |
| CLASSIFICATION PRODUCT CODE: | MQV |
| CLASS: | II |
III. IDENTIFICATION OF LEGALLY MARKETED DEVICES:
| Table 1. Legally Marketed Devices | ||
|---|---|---|
| Device name | 510(k) number | Substantial Equivalence date |
| MASTERGRAFT® Strip | K082166 | 06/02/2009 |
| MASTERGRAFT® MATRIX | ||
| EXT | K130335 | 04/19/2013 |
4
IV. DEVICE DESCRIPTION:
MASTERGRAFT® Contain is made from a combination of medical grade purified collagen of bovine origin and biphasic calcium phosphate ceramic. In the MASTERGRAFT® Contain device, the collagen is a highly purified (>95%) Type I bioresorbable lyophilized collagen. The biphasic ceramic portion of the device is provided in a 15 percent hydroxyapatite and 85 percent ß- tricalcium phosphate formulation. The device is supplied sterile in a premixed form for single patient use. The device is a biocompatible, osteoconductive, porous implant that allows for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing. The device readily absorbs bone marrow aspirate and has been shown to heal bone defects. The device is designed with a cavity (ies) to contain and deliver autologous bone to the surgical site when used as a bone graft extender.
The purpose of this Traditional 510(k) application is to add MASTERGRAFT® Contain to the MASTERGRAFT® product family. The material composition of MASTERGRAFT® Contain is identical to that of predicate devices MASTERGRAFT® Strip and MASTERGRAFT® Matrix EXT. The intended use (i.e., bone void filler and posterolateral spine bone graft extender) of MASTERGRAFT® Contain are similar to that of predicate devices MASTERGRAFT® Strip and MASTERGRAFT® Matrix EXT. The overall dimensions of the MASTERGRAFT® Contain devices are similar to MASTERGRAFT® Strip and MASTERGRAFT® Matrix EXT, with the addition of a cavity to contain and deliver autogenous bone to the implant site when used as bone graft extender. Compared to the predicate devices, the inclusion of the cavity in the design of MASTERGRAFT® Contain does not present a new worst case for safety or effectiveness of the device for its intended use.
V. INDICATIONS FOR USE:
MASTERGRAFT® Contain is to be combined with autogenous bone marrow and is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure and can be used as a bone graft extender.
5
The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., 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. The device resorbs and is replaced with bone during the healing process. When used in the pelvis, ilium, or extremities, the device is to be used with bone marrow aspirate. When used in the posterolateral spine, the device must be mixed with bone marrow aspirate and autograft bone and used as a bone graft extender.
| Table 2. Summary of the technological Characteristics | |||
|---|---|---|---|
| Comparison Feature | Subject | ||
| MASTERGRAFT | |||
| ® Contain | Predicate | ||
| MASTERGRAFT® Strip | |||
| K082166 | |||
| S.E. 06/02/2009 | Predicate | ||
| MASTERGRAFT® | |||
| Matrix EXT | |||
| K130335 S.E. | |||
| 04/19/2013 | |||
| Indication for Use | Similar | S.E. 06/02/2009 | S.E. 04/19/2013 |
| Fundamental Scientific | |||
| Technology | |||
| • Operating Principle | |||
| • Mechanism of Action | Identical | S.E. 06/02/2009 | S.E. 04/19/2013 |
| Sizes | Similar | S.E. 06/02/2009 | S.E. 04/19/2013 |
| Performance | Identical | S.E. 06/02/2009 | S.E. 04/19/2013 |
| Sterilization | Identical | S.E. 06/02/2009 | S.E. 04/19/2013 |
| Manufacturing principles | Identical | S.E. 06/02/2009 | S.E. 04/19/2013 |
| Shelf-Life | Identical | S.E. 06/02/2009 | S.E. 04/19/2013 |
| Packaging | Identical | S.E. 06/02/2009 | S.E. 04/19/2013 |
| Material Composition | |||
| • Collagen | |||
| • Granules | Identical | S.E. 06/02/2009 | S.E. 04/19/2013 |
| Use of rigid fixation | Identical | S.E. 06/02/2009 | S.E. 04/19/2013 |
| Safety and Effectiveness | |||
| profile | Identical | S.E. 06/02/2009 | S.E. 04/19/2013 |
| Geometry | Similar | S.E. 06/02/2009 | S.E. 04/19/2013 |
VI. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS:
6
VII. DISCUSSION OF NON-CLINICAL TESTING:
Non-clinical testing was performed in support of substantial equivalence for the cited predicate K082166 [S.E. 06/02/2009] in accordance with FDA Recognized Consensus Standards and FDA Guidelines, where applicable. No new non-clinical testing was performed or submitted in support of this 510(k).
Previously submitted non-clinical testing was performed in accordance with the following standards:
- · ASTM F1185-03: 2009 Specification for Composition of Ceramic Hydroxyapatite for Surgical Implants
- ASTM F1088-04a: 2010, Specification for ß-tricalcium Phosphate for Surgical . Implantation
- ISO 22442-1: 2007 Animal Tissues and Their Derivatives Utilized in the . Manufacture of Medical Devices -- Part 1 Analysis and Risk Management
- . ISO 22442-2: 2007 Animal Tissues and Their Derivatives Utilized in the Manufacture of Medical Devices -- Part 2 Controls on Sourcing, Collection, and Handling
- ISO 22442-3: 2007 Animal Tissues and Their Derivatives Utilized in the . Manufacture of Medical Devices -- Part 3 Validation of the Elimination and/or Inactivation of Virus and Transmissible Agents
- ISO 10993-3: 2003/(R) 2009, Biological evaluation of medical devices -- Part 3 . Tests for genotoxicity, carcinogenicity, and reproductive toxicity. (Biocompatibility)
- ISO10993-4: 2009, Biological evaluation of medical devices -- Part 4: Selection . of tests for interactions with blood
- ISO 10993-5: 2009, Biological evaluation of medical devices -- Part 5: Tests for 0 In Vitro cytotoxicity. (Biocompatibility)
- ISO 10993-6: 2009, Biological evaluation of medical devices -- Part 6: Tests for ● local effects after implantation. (Biocompatibility)
7
- ISO 10993-10: 2009, Biological evaluation of medical devices -- Part 10: Tests for ● irritation and skin sensitization. (Biocompatibility)
- ISO 10993-11: 2009, Biological evaluation of medical devices -- Part 11: Tests for ● systemic toxicity. (Biocompatibility)
- ISO 10993-12: 2009, Biological evaluation of medical devices -- Part 12: Sample . preparation and reference materials. (Biocompatibility)
VIII. CONCLUSION:
Documentation provided in this submission demonstrates that the subject device is substantially equivalent to the previously cleared bone void filler MASTERGRAFT® Strip [K082166 S.E. 06/02/2009] and MASTERGRAFT® Matrix EXT [K130335 S.E. 04/19/2013.]
The subject device is substantially equivalent to predicates MASTERGRAFT® Strip and MASTERGRAFT® Matrix EXT in several categories including: indication, material composition (including biphasic calcium phosphate granules and collagen), sterility, shelf-life, biocompatibility and the ability to resorb during the healing process.