(67 days)
No
The 510(k) summary describes a bone graft material composed of collagen and ceramic, with no mention of software, algorithms, or any technology related to AI or ML. The focus is on the material properties and physical form of the device.
Yes
The device is indicated for bony voids or gaps and acts as a bone graft extender, which directly contributes to the healing process of the skeletal system.
No
The device is described as a bone graft extender used to fill bony voids or gaps, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it consists of physical components (purified collagen and biphasic calcium phosphate ceramic) supplied in a sterile, premixed strip form, indicating it is a physical medical device, not software-only.
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 for filling bony voids or gaps in the skeletal system and is combined with autogenous bone marrow. This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The description details the composition of the device (collagen and ceramic) and its function as a porous implant for bony ingrowth and resorption. This aligns with a medical device used for treatment or repair, not for testing samples from the body to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or to provide information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
MASTERGRAFT® Strip and MASTERGRAFT® UltraMatrix are 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.
Product codes
MQV
Device Description
MASTERGRAFT® Strip and MASTERGRAFT® UltraMatrix consist of a combination of medical grade purified collagen of bovine origin and biphasic calcium phosphate ceramic. In the MASTERGRAFT® Strip and MASTERGRAFT® UltraMatrix devices, the collagen is a highly purified (>95%) Type I bioresorbable Iyophilized collagen. The biphasic ceramic portion of MASTERGRAFT® Strip and MASTERGRAFT® UltraMatrix is provided in a 15 percent hydroxyapatite and 85 percent B-tricalcium phosphate formulation.
MASTERGRAFT® Strip and MASTERGRAFT® UltraMatrix are supplied sterile in a premixed strip form for single patient use.
MASTERGRAFT® Strip and MASTERGRAFT® UltraMatrix devices are biocompatible, osteoconductive, porous implants that allow for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing. The devices readily absorbs bone marrow aspirate and had been shown to heal bone defects.
The purpose of this Special 510(k) application is to add additional sizes (known as MASTERGRAFT® UltraMatrix 5cc, 10cc, and 20cc) to the previously cleared MASTERGRAFT® Strip product family. The sizes proposed in this Special 510(k) were part of the original product design for MASTERGRAFT® Strip device, and were included in the design verification and validation activities reported in K082166.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterolateral spine, pelvis, ilium, and/or extremities
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)
Non-clinical testing was performed in accordance with FDA Recognized Consensus Standards and FDA Guidelines wherever they are applicable. Data to support these rationales are provided to demonstrate that the subject devices are substantially equivalent to the predicate device. 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 B-tricalcium Phosphate for Surgical Implantation; ISO 22442-1: Animal Tissues and Their Derivatives Utilized in the Manufacture of Medical Devices -- Part 1 Analysis and Risk Management; ISO 22442-2: Animal Tissues and Their Derivatives Utilized in the Manufacture. of Medical Devices -- Part 2 Controls on Sourcing, Collection, and Handling; ISO 22442-3: 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 In Vitro cytotoxicity. (Biocompatibility); ISO 10993-6: 2007, Biological evaluation of medical devices -- Part 6: Tests for. local effects after implantation. (Biocompatibility); ISO 10993-10: 2010, Biological evaluation of medical devices -- Part 10: Tests for. irritation and skin sensitization. (Biocompatibility); ISO 10993-11: 2006, Biological evaluation of medical devices -- Part 11: Tests for. systemic toxicity. (Biocompatibility); ISO 10993-12: 2008, Biological evaluation of medical devices -- Part 12: Sample. preparation and reference materials. (Biocompatibility).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
30335 SE I OF 5
APR 1 9 2013
510(K) Summary
| I. SUBMITTER NAME & ADDRESSS: | Medtronic Sofamor Danek
1800 Pyramid Place
Memphis, Tennessee |
| ------------------------------- | --------------------------------------------------------------------- |
|---|
CONTACT PERSON:
DATE PREPARED:
mor Danek USA, Inc lace Memphis, Tennessee 38132 Telephone: (901) 396-3133 -Fax: (901) 346-9738 Establishment Registration: 1030489 Ryan Massey · Principal Regulatory Affairs Specialist February 8, 2013
II. PROPOSED PROPRIETARY TRADE NAME: MASTERGRAFT® Strip MASTERGRAFT® UltraMatrix
DEVICE CLASSIFICATION NAME: Resorbable Calcium Salt Bone Void Filler REGULATION NUMBER: 21 CFR 888.3045 CLASSIFICATION PRODUCT CODE: MQV CLASS: I I
III. IDENTIFICATION OF LEGALLY MARKETED DEVICES: MASTERGRAFT® Strip K082166 (S.E. 06/02/2009)
IV. DEVICE DESCRIPTION:
MASTERGRAFT® Strip and MASTERGRAFT® UltraMatrix consist of a combination of medical grade purified collagen of bovine origin and biphasic calcium phosphate ceramic. In the MASTERGRAFT® Strip and MASTERGRAFT® UltraMatrix devices, the collagen is a highly purified (>95%) Type I bioresorbable Iyophilized collagen. The
1
biphasic ceramic portion of MASTERGRAFT® Strip and MASTERGRAFT® UltraMatrix is provided in a 15 percent hydroxyapatite and 85 percent B-tricalcium phosphate formulation.
MASTERGRAFT® Strip and MASTERGRAFT® UltraMatrix are supplied sterile in a premixed strip form for single patient use.
MASTERGRAFT® Strip and MASTERGRAFT® UltraMatrix devices are biocompatible, osteoconductive, porous implants that allow for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing. The devices readily absorbs bone marrow aspirate and had been shown to heal bone defects.
The purpose of this Special 510(k) application is to add additional sizes (known as MASTERGRAFT® UltraMatrix 5cc, 10cc, and 20cc) to the previously cleared MASTERGRAFT® Strip product family. The sizes proposed in this Special 510(k) were part of the original product design for MASTERGRAFT® Strip device, and were included in the design verification and validation activities reported in K082166.
V. INDICATIONS FOR USE:
MASTERGRAFT® Strip and MASTERGRAFT® UltraMatrix are 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.
2
VI. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS:
| Comparison Feature | Subject
MASTERGRAFT®
UltraMatrix | Predicate
MASTERGRAFT® Strip |
|----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Indication for Use | Identical | K082166 (S.E. 06/02/2009) |
| Fundamental Scientific
Technology
• Operating Principle
• Mechanism of Action | Identical | K082166 (S.E. 06/02/2009) |
| Basic Design | Identical | K082166 (S.E. 06/02/2009) |
| Performance | Identical | K082166 (S.E. 06/02/2009) |
| Manufacturing principles | Identical | K082166 (S.E. 06/02/2009) |
| Sterilization | Identical | K082166 (S.E. 06/02/2009) |
| Shelf-Life | Identical | K082166 (S.E. 06/02/2009) |
| Packaging | Identical | K082166 (S.E. 06/02/2009) |
| Material Composition
• Collagen
• Granules | Identical | K082166 (S.E. 06/02/2009) |
| Use of rigid fixation | Identical | K082166 (S.E. 06/02/2009) |
| Safety and Effectiveness
profile | Identical | K082166 (S.E. 06/02/2009) |
| Size | 5cc Product
Length: 4.7 cm ± 0.5 cm
Width: 1.0 cm ±0.3 cm
Thickness: 1.1 cm ±0.3
cm | 12cc Product
Length: 10.0cm +/- 0.5cm
Width: 2.0cm +/- 0.3cm
Thickness: 0.6cm +/-
0.2cm |
| | 10cc Product (2 x 5cc)
Length: 4.7 cm ± 0.5 cm
Width: 1.0 cm ± 0.3 cm
Thickness: 1.1 cm ± 0.3
cm | |
| | 20cc Product
Length: 4.7 cm ± 0.5 cm
Width: 1.9 cm ± 0.4 cm
Thickness: 1.1 cm ±
0.3 cm | 43cc Product
Length: 36.0cm +/- 1.0cm
Width: 2.0cm +/- 0.3cm
Thickness: 0.6cm +/-
0.2cm |
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K 20335 AGE 4 OF 5
VII. DISCUSSION OF NON-CLINICAL TESTING:
-
Non-clinical testing was performed in accordance with FDA Recognized Consensus Standards and FDA Guidelines wherever they are applicable. Data to support these rationales are provided to demonstrate that the subject devices are substantially equivalent to the predicate device.
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: Animal Tissues and Their Derivatives Utilized in the Manufacture of Medical Devices -- Part 1 Analysis and Risk Management
-
ISO 22442-2: Animal Tissues and Their Derivatives Utilized in the Manufacture . of Medical Devices -- Part 2 Controls on Sourcing, Collection, and Handling
-
. ISO 22442-3: 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 In Vitro cytotoxicity. (Biocompatibility)
-
ISO 10993-6: 2007, Biological evaluation of medical devices -- Part 6: Tests for . local effects after implantation. (Biocompatibility)
4
- ISO 10993-10: 2010, Biological evaluation of medical devices -- Part 10: Tests for . irritation and skin sensitization. (Biocompatibility)
- ISO 10993-11: 2006, Biological evaluation of medical devices -- Part 11: Tests for . systemic toxicity. (Biocompatibility)
- ISO 10993-12: 2008, 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, SE 06/02/2009).
The subject device is substantially equivalent to predicate MASTERGRAFT® Strip in several categories including: indication, material composition (including biphasic calcium phosphate granules and collagen), biodegradability, shelf-life, need for rigid fixation, biocompatibility and the ability to resorb during the healing process.
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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle symbol.
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
Medtronic Sofamor Danek USA, Incorporated % Mr. Ryan Massey Principal Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
Letter dated: April 19, 2013
Re: K130335
Trade/Device Name: MASTERGRAFT® Strip and MASTERGRAFT® UltraMatrix Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: March 20, 2013 Received: March 22, 2013
Dear Mr. Massey:
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
6
Page 2 - Mr. Ryan Massev
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/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 Nighterson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
510(k) Number (if known):
Device Name: MASTERGRAFT® Strip and MASTERGRAFT® UltraMatrix
Indications for Use:
MASTERGRAFT® Strip and MASTERGRAFT® UltraMatrix are to be combined with autogenous bone marrow and are 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use
(21 CFR 807 Subpart C)
Laurence D. Coyne -A
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K130335