(306 days)
MASTERGRAFT® Strip is to be combined with autogenous bone marrow and is indicated for bony voids or qaps 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.
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 (s95%) Type I bioresorbable lyophilized collagen. The biphasic ceramic portion of all devices is provided in a 15% hydroxyapatite and 85% b-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.
This document is a 510(k) Summary for the Medtronic Sofamor Danek MASTERGRAFT® Strip, a resorbable calcium salt bone void filler device. It focuses on establishing substantial equivalence to previously cleared predicate devices rather than presenting a study with specific acceptance criteria and performance data in the way you've outlined for AI/diagnostic devices.
Therefore, the requested information categories are largely not applicable to this type of regulatory submission. The document explicitly states: "Documentation is provided that demonstrates MASTERGRAFT® Strip to be substantially equivalent to the previously cleared..."
Here's a breakdown of why many of your categories cannot be filled from this text:
- Acceptance Criteria & Device Performance: This document does not describe specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy) or quantitative performance metrics for the MASTERGRAFT® Strip. Its purpose is to demonstrate equivalence based on material composition, intended use, and general safety/effectiveness features.
- Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone): There is no mention of a clinical study designed to test the device's performance against specific acceptance criteria. This implies that the substantial equivalence was likely demonstrated through non-clinical testing (e.g., biocompatibility, material characterization, mechanical properties) and comparison to predicate devices, rather than a prospective clinical trial with human subjects for performance evaluation in the context of imaging or diagnostic tasks.
- Ground Truth: Since there's no clinical performance study described, there's no "ground truth" established in the way it would be for a diagnostic tool (e.g., confirming disease presence). The "ground truth" for a bone void filler is ultimately successful bone healing and integration, which would be assessed in clinical use, but not typically as part of a 510(k) summary for substantial equivalence.
- Training Set: As no AI or algorithm is involved, there is no training set.
Summary of available information based on the provided text:
-
Table of Acceptance Criteria and Reported Device Performance: This information is not provided. The document's purpose is to demonstrate substantial equivalence to predicate devices, not to present performance against specific numerical acceptance criteria.
-
Sample Size Used for the Test Set and Data Provenance: Not applicable. No clinical "test set" in the context of performance metrics (like for a diagnostic device) is described. Substantial equivalence is based on comparison to predicate devices and material characteristics.
-
Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable. Ground truth as typically defined for diagnostic or AI studies is not relevant here.
-
Adjudication Method: Not applicable.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is not an AI or diagnostic device that would typically undergo such a study.
-
Standalone Performance Study: Not applicable. This is not an algorithm, so "standalone performance" for an algorithm is not relevant. The device itself is "standalone" in its physical form.
-
Type of Ground Truth Used: Not applicable in the traditional sense of a diagnostic study. The "ground truth" for a bone void filler is successful bone healing and integration, which is assessed clinically but not detailed as a "ground truth" method for this 510(k) summary.
-
Sample Size for the Training Set: Not applicable. This is not an AI/ML device.
-
How the Ground Truth for the Training Set was Established: Not applicable.
Key information from the provided text:
- Device Name: MASTERGRAFT® Strip
- Product Description: Made from a combination of medical grade purified collagen and biphasic calcium phosphate ceramic (15% hydroxyapatite, 85% b-tricalcium phosphate). It is biocompatible, osteoconductive, porous, absorbs bone marrow aspirate, and resorbs while being replaced with bone.
- Intended Use/Indications: To be combined with autogenous bone marrow for bony voids or gaps not intrinsic to bony structure stability, and as a bone graft extender. Packed into bony voids/gaps of the skeletal system (posterolateral spine, pelvis, ilium, extremities), which can be surgically created or due to traumatic injury.
- Regulatory Pathway: 510(k) Premarket Notification, seeking substantial equivalence.
- Predicate Devices:
- Conclusion of the 510(k) Summary: The documentation demonstrates MASTERGRAFT® Strip to be substantially equivalent to the listed predicate devices.
{0}------------------------------------------------
Medtronic Sofamor Danek MASTERGRAFT® Strip 510(K) Summary July 2008
JUN - 2 2009
- Company: Medtronic Sofamor Danek USA 1800 Pyramid Place Memphis, TN 38132 Telephone: (901) 396-3133 Fax: (901) 346-9738
Contact: Michelle Obenauer Regulatory Affairs Manager
- II. Proposed Proprietary Trade Name: MASTERGRAFT® Strip Classification Name: filler device
Product Code: Regulation No .: Resorbable calcium salt bone void MQV 888.3045
lll. Product Description/Purpose of Application
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 (s95%) Type I bioresorbable lyophilized collagen. The biphasic ceramic portion of all devices is provided in a 15% hydroxyapatite and 85% b-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.
The purpose of this 510(k) application is to add MASTERGRAFT® Strip to the MASTERGRAFT® family of products. Like the previously cleared
pg 1 o 2
{1}------------------------------------------------
predicates, MASTERGRAFT® Matrix (K023553, SE 04/22/2003, bone void filler) and MASTERGRAFT® Putty (K071813, SE 11/09/07, autograft extender ), the subject system is intended to be combined with autogenous bone marrow as a bone void filler for bony voids or qaps that are not intrinsic to the stability of the bony structure. In addition, MASTERGRAFT® Strip can be mixed with autogenous bone and used as a bone graft extender.
IV. Indications
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, illium, 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.
Substantial Equivalence V.
Documentation is provided that demonstrates MASTERGRAFT® Strip to be substantially equivalent to the previously cleared MASTERGRAFT® Matrix (K023553), MASTERGRAFT® Putty (K071813), OssiMend Bone Graft Material (K052812), Collagraft Strip Bone Graft Material (K000122) and Integra MOZAIK™ Osteoconductive Scaffold - Strip (K063124).
pg 2 of 2
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medtronic Sofamor Danek % Ms. Michelle Obenauer Regulatory Affairs Manager 1800 Pyramid Place Memphis, Tennessee 38132
JUN - 2 2009
Re: K082166
Trade/Device Name: MASTERGRAFT® Strip Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: II Product Code: MOV Dated: May 21, 2009 Received: May 22, 2009
Dear Ms. Obenauer:
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.
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 forth in the quality systems (QS) regulation (21 CFR Part 820);
{3}------------------------------------------------
Page 2-Ms. Michelle Obenauer
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
510(k) Number (if known): KO82)66
Device Name: MASTERGRAFT® Strip
Indications for Use:
MASTERGRAFT® Strip is to be combined with autogenous bone marrow and is indicated for bony voids or qaps 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 પ્ર Per 21 CFR 801.109
OR
Over-The-Counter Use
Signature
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K082166
pg lof)
§ 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.