(63 days)
No
The device description focuses on the material composition and physical properties of a bone graft substitute. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The purpose of the 510(k) is also stated as adding a contraindication, not introducing new technology.
Yes
The device is described as a 'bone void filler' and 'bone graft extender' that is used to heal bone defects by allowing bony ingrowth and resorption, indicating it is intended to treat a medical condition.
No
This device is a bone void filler and bone graft extender, used for therapeutic purposes (to help heal bone defects), not for diagnosing conditions.
No
The device description clearly states that the device is made from physical materials (collagen and biphasic calcium phosphate ceramic) and is supplied as a physical strip or putty. It is a physical implant for bone voids.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description and intended use of the MASTERGRAFT® devices clearly indicate they are implants used to fill bony voids or gaps within the skeletal system. They are surgically placed within the body and resorb over time, being replaced by bone.
- No Mention of Testing Samples: There is no mention of the device being used to test samples taken from the body. Its function is structural and regenerative within the body itself.
Therefore, the MASTERGRAFT® Strip and Putty devices are considered medical devices but not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
MASTERGRAFT® Strip
MASTERGRAFT® Strip 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; MASTERGRAFT® Strip can also be used with autograft 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.
MASTERGRAFT® PUTTY
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 codes
MQV
Device Description
IV. DEVICE DESCRIPTION: MASTERGRAFT® STRIP
MASTERGRAFT® Strip is made from a combination of medical grade purified collagen and biphasic calcium phosphate ceramic. In the MASTERGRAFT® Strip device, the collagen is a highly purified (>95%) Type I bioresorbable Iyophilized collagen. The biphasic ceramic portion of all devices is provided in a 15% hydroxyapatite and 85% ß-tricalcium phosphate formulation. MASTERGRAFT® Strip is supplied sterile in a premixed strip form for single patient use.
MASTERGRAFT® Strip 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.
MASTERGRAFT® Putty
MASTERGRAFT® Putty is made from a combination of medical grade purified collagen of bovine origin and biphasic calcium phosphate ceramic. The collagen component in the MASTERGRAFT® Putty device is Type I bovine collagen. The biphasic ceramic portion of MASTERGRAFT® Putty is provided in a 15 percent hydroxyapatite and 85 percent ß-tricalcium phosphate formulation. MASTERGRAFT® Putty is supplied as a sterile, dry, solid, construct hydrated for single patient use and is a moldable form of bone void filler. MASTERGRAFT® Putty is a osteoconductive, porous implant that allows for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing. MASTERGRAFT® Putty is biocompatible. MASTERGRAFT® Putty readily absorbs bone marrow aspirate and has been shown to heal bone defects.
The purpose of this Change Being Effected 510(k) is the addition of a new contraindication to the Instructions for Use (IFU) for the MASTERGRAFT® Strip and MASTERGRAFT® Putty devices.
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
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)
VII. DISCUSSION OF NON-CLINICAL TESTING:
Non-clinical testing was performed in support of substantial equivalence for the cited predicates K082166 and K071813 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).
| Table 4. Non-clinical testing | |||
|---|---|---|---|
| Cleared Device | Animal Model | Study Purpose | Substantial Equivalence |
| MASTERGRAFT® Strip | Ovine Femoral Defect Model | In-vivo performance comparison | MASTERGRAFT® Matrix (K023553 S.E. 04/22/2003) |
| Rabbit Lumbar Intertransverse Process Fusion Model | Fusion results MASTERGRAFT® Strip + autograft as bone graft extender compared to autograft fusion results | Equivalent to autograft fusion results | |
| MASTERGRAFT® Putty | Ovine Cortico- cancellous Defect Model | In-vivo performance comparison | HEALOS® Bone Graft Material (K012751 S.E. 11/14/2001) |
| Rabbit Lumbar Intertransverse Process Fusion Model | Fusion results MASTERGRAFT® Putty + autograft as bone graft extender compared to autograft fusion results | Equivalent to autograft fusion results |
VIII. CONCLUSION:
Documentation provided in this submission demonstrates that the subject devices are substantially equivalent to the previously cleared MASTERGRAFT® Strip (K082166 S.E. 06/02/2009) and MASTERGRAFT® Putty (K071813 S.E. 11/09/2007) devices. The subject devices are substantially equivalent to predicates in several categories including: indication, material components, sterility, shelf-life, and 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
.
APR 1 8 2014
510(K) Summary
·
| 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: | Kelly Anglin
Senior Regulatory Affairs Specialist |
| DATE PREPARED: | April 02, 2014 |
| II. PROPOSED PROPRIETARY TRADE NAME: | MASTERGRAFT® Strip
MASTERGRAFT® Putty |
| 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® Putty | K071813 | 11/09/2007 |
1
IV. DEVICE DESCRIPTION: MASTERGRAFT® STRIP
MASTERGRAFT® Strip is made from a combination of medical grade purified collagen and biphasic calcium phosphate ceramic. In the MASTERGRAFT® Strip device, the collagen is a highly purified (>95%) Type I bioresorbable Iyophilized collagen. The biphasic ceramic portion of all devices is provided in a 15% hydroxyapatite and 85% ß-tricalcium phosphate formulation. MASTERGRAFT® Strip is supplied sterile in a premixed strip form for single patient use.
MASTERGRAFT® Strip 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.
MASTERGRAFT® Putty
MASTERGRAFT® Putty is made from a combination of medical grade purified collagen of bovine origin and biphasic calcium phosphate ceramic. The collagen component in the MASTERGRAFT® Putty device is Type I bovine collagen. The biphasic ceramic portion of MASTERGRAFT® Putty is provided in a 15 percent hydroxyapatite and 85 percent ß-tricalcium phosphate formulation. MASTERGRAFT® Putty is supplied as a sterile, dry, solid, construct hydrated for single patient use and is a moldable form of bone void filler. MASTERGRAFT® Putty is a osteoconductive, porous implant that allows for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing. MASTERGRAFT® Putty is biocompatible. MASTERGRAFT® Putty readily absorbs bone marrow aspirate and has been shown to heal bone defects.
The purpose of this Change Being Effected 510(k) is the addition of a new contraindication to the Instructions for Use (IFU) for the MASTERGRAFT® Strip and MASTERGRAFT® Putty devices.
2
V. INDICATIONS FOR USE:
MASTERGRAFT® Strip
MASTERGRAFT® Strip 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; MASTERGRAFT® Strip can also be used with autograft 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.
MASTERGRAFT® PUTTY
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.
3
| Table 2. Summary of the technological Characteristics | ||
|---|---|---|
| Comparison Feature | Subject | |
| MASTERGRAFT® Strip | ||
| K082166 S.E. 06/02/2009 | 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 |
| 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 |
| Use of rigid fixation | Identical | K082166 S.E. 06/02/2009 |
| Safety and | ||
| Effectiveness profile | Identical | K082166 S.E. 06/02/2009 |
VI. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS:
and the same of the same
:
| Table 3. Summary of the technological Characteristics | ||
|---|---|---|
| Comparison Feature | Subject | |
| MASTERGRAFT® Putty | ||
| K071813 S.E. 11/09/2007 | Predicate MASTERGRAFT® | |
| Putty | ||
| Indication for Use | Identical | K071813 S.E. 11/09/2007 |
| Fundamental | ||
| Scientific Technology | ||
| • Operating | ||
| Principle | ||
| • Mechanism of | ||
| Action | Identical | K071813 S.E. 11/09/2007 |
| Basic Design | Identical | K071813 S.E. 11/09/2007 |
| Performance | Identical | K071813 S.E. 11/09/2007 |
| Sterilization | Identical | K071813 S.E. 11/09/2007 |
| Shelf-Life | Identical | K071813 S.E. 11/09/2007 |
| Packaging | Identical | K071813 S.E. 11/09/2007 |
| Use of rigid fixation | Identical | K071813 S.E. 11/09/2007 |
| Safety and | ||
| Effectiveness profile | Identical | K071813 S.E. 11/09/2007 |
4
VII. DISCUSSION OF NON-CLINICAL TESTING:
Non-clinical testing was performed in support of substantial equivalence for the cited predicates K082166 and K071813 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).
| Table 4. Non-clinical testing | |||
|---|---|---|---|
| Cleared Device | Animal Model | Study Purpose | Substantial |
| Equivalence | |||
| MASTERGRAFT® | |||
| Strip | Ovine Femoral | ||
| Defect Model | In-vivo performance | ||
| comparison | MASTERGRAFT® | ||
| Matrix (K023553 S.E. | |||
| 04/22/2003) | |||
| Rabbit Lumbar | |||
| Intertransverse | |||
| Process Fusion | |||
| Model | Fusion results | ||
| MASTERGRAFT® | |||
| Strip + autograft as | |||
| bone graft extender | |||
| compared to | |||
| autograft fusion | |||
| results | Equivalent to autograft | ||
| fusion results | |||
| MASTERGRAFT® | |||
| Putty | Ovine Cortico- | ||
| cancellous Defect | |||
| Model | In-vivo performance | ||
| comparison | HEALOS® Bone | ||
| Graft Material | |||
| (K012751 S.E. | |||
| 11/14/2001) | |||
| Rabbit Lumbar | |||
| Intertransverse | |||
| Process Fusion | |||
| Model | Fusion results | ||
| MASTERGRAFT® | |||
| Putty + autograft as | |||
| bone graft extender | |||
| compared to | |||
| autograft fusion | |||
| results | Equivalent to autograft | ||
| fusion results |
VIII. CONCLUSION:
Documentation provided in this submission demonstrates that the subject devices are substantially equivalent to the previously cleared MASTERGRAFT® Strip (K082166 S.E. 06/02/2009) and MASTERGRAFT® Putty (K071813 S.E. 11/09/2007) devices. The
5
subject devices are substantially equivalent to predicates in several categories including: indication, material components, sterility, shelf-life, and biocompatibility.
.
、
.
6
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 18, 2014
Medtronic Sofamor Danek USA, Inc. Ms. Kelly Anglin Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
Re: K140375
Trade/Device Name: MASTERGRAFT® Strip; MASTERGRAFT® Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: February 13, 2014 Received: February 14, 2014
Dear Ms. Anglin:
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
7
Page 2 -- Ms. Kelly Anglin
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.
Lori A. Wiggins
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
510(k) Number (if known): K140375
Device Name: MASTERGRAFT® Strip
INDICATIONS FOR USE:
MASTERGRAFT® Strip 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.
| Prescription Use _____________________________________________________________________________________________________________________________________________________________ | AND/OR | Over-The-Counter Use |
|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Laurence D. Coyne -S
: 上
Page 1 of 2
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K140375
9
510(k) Number (if known): K140375
Device Name: MASTERGRAFT® Putty
INDICATIONS FOR USE:
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, ilium, and/or extremities). These defects may be surgically created osseous defects or usseous defects created from traumatic injury to the bone. MASTERGRAFT® Putty resorbs and is replaced with bone during the healing process.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) | |
| AND/OR | |
| Over-The-Counter Use | |
| (21 CFR Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Laurence D. Coyne -S
Page 2 of 2
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K140375