(67 days)
The MIIG™ paste is intended to be injected into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremittes, spine, and pelvis) and to cure in-situ. These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The MIIGM paste provides a bone void filler that resorbs and is replaced with bone during the healing process.
The MIIG™ paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g., K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.
The MIIG™M II is provided sterile for single use only.
The MIIGTM II paste consists of pre-measured surgical grade calcium sulfate, premeasured mixing solution, and the tools necessary to the components into a paste and inject the material into the defect site. These products are provided sterile for single patient use. When mixed and injected according to directions. MIIG™ II paste will harden in situ and provide temporary intra-operative support to a site prior to the fixation of final hardware. The MIIGTM II product has been developed to address the identical indications as the MIIGTM product.
This document is a 510(k) Pre-market Notification for the MIIG™ II bone void filler. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting new clinical studies with acceptance criteria in the traditional sense. Therefore, many of the requested categories are not applicable to this document.
Here's an analysis based on the provided text:
1. Table of acceptance criteria and the reported device performance:
This document does not present a table of acceptance criteria and reported device performance in the manner typically seen for clinical studies demonstrating efficacy or safety with quantifiable metrics. The submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, the original MIIG™.
The core "performance" demonstrated is that the MIIG™ II is substantially equivalent to the MIIG™ regarding its intended use, material composition, and design features.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use: Identical to predicate device. | The MIIG™ II has identical indications for use as the MIIG™. |
| Material Composition: Substantially equivalent to predicate. | Materials used for MIIG™ II are substantially equivalent to MIIG™ (Surgical Grade Calcium Sulfate Hemihydrate Accelerator and Sterile Water for Irrigation). |
| Design Features: Substantially equivalent to predicate. | Design features of MIIG™ II are substantially equivalent to MIIG™. |
| Safety and Effectiveness: Adequately supported by substantial equivalence information, materials data, and testing results. | The safety and effectiveness of the MIIG™ II is adequately supported by the provided information establishing substantial equivalence. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This is not a study involving a test set of data from patients in the typical sense for evaluating algorithm performance. It's a regulatory submission demonstrating substantial equivalence based on material composition, intended use, and design features compared to a predicate device. The "data" refers to material science data and comparisons, not patient data in a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. See point 2. No ground truth in the context of expert consensus on patient data was established for an AI/algorithm test set.
4. Adjudication method for the test set:
- Not Applicable. See point 2.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This document pertains to a medical device (bone void filler), not an AI algorithm for image analysis or diagnosis. Therefore, no MRMC study with human readers and AI assistance was conducted or discussed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This document pertains to a medical device (bone void filler), not an algorithm.
7. The type of ground truth used:
- Not Applicable. In the context of a 510(k) for a bone void filler, the "ground truth" is established through documented material specifications, chemical analysis, product design, and intended use as compared to the predicate device. It's about demonstrating equivalency to a known, cleared product, rather than establishing a new clinical outcome or diagnostic truth.
8. The sample size for the training set:
- Not Applicable. This document pertains to a medical device (bone void filler), not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
- Not Applicable. This document pertains to a medical device (bone void filler), not a machine learning model requiring ground truth for a training set.
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Image /page/0/Picture/1 description: The image shows the logo for Wright Medical Technology. The logo consists of a stylized "W" formed by three black triangles, followed by the words "WRIGHT MEDICAL TECHNOLOGY" stacked on top of each other. A registered trademark symbol is located at the bottom left of the "W" symbol. A horizontal line is located underneath the text.
MAR 0 4 2003
A Wright Medical Group Company
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the MIIG™ II.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | February 22, 2001 |
| Contact Person: | Ehab M. EsmailManager, Regulatory AffairsPhone: 901-867-4732 Fax: 901-867 4630 |
| Proprietary Name: | MIIG TM II |
| Common Name: | Bone Void Filler |
| Classification Name and Reference: | Unclassified |
| Device Product Code and Panel Code: | Orthopedics/87/MOV |
DEVICE INFORMATION
INTENDED USES/ INDICATIONS A.
The MIIG™ paste is intended to be injected into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremittes, spine, and pelvis) and to cure in-situ. These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The MIIGM paste provides a bone void filler that resorbs and is replaced with bone during the healing process.
The MIIG™ paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g., K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.
The MIIG™M II is provided sterile for single use only.
Image /page/0/Picture/12 description: The image shows the logo for Wright Medical Technology. The logo consists of a stylized "W" on the left, followed by the words "WRIGHT MEDICAL TECHNOLOGY" stacked on top of each other. Below the logo is the text "A Wright Medical Group Company".
Image /page/0/Picture/13 description: The image shows the text '510(K) SUMMARY.doc'. The text is in a serif font and is black. The image appears to be a document or file name.
Image /page/0/Picture/14 description: The image shows a black and white drawing of a globe. The globe is partially shaded, with the darker areas likely representing landmasses or geographical features. A curved line is visible above the globe, possibly indicating an atmospheric layer or a celestial arc. The bottom of the globe is cut off by the edge of the image.
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B. DEVICE DESCRIPTION
The MIIGTM II paste consists of pre-measured surgical grade calcium sulfate, premeasured mixing solution, and the tools necessary to the components into a paste and inject the material into the defect site. These products are provided sterile for single patient use. When mixed and injected according to directions. MIIG™ II paste will harden in situ and provide temporary intra-operative support to a site prior to the fixation of final hardware. The MIIGTM II product has been developed to address the identical indications as the MIIGTM product.
C. MATERIALS
The materials used for the MIIG™ II are substantially equivalent to the previously submitted and cleared MIIGTM.
| MIIGTM | MIIGTM II | |
|---|---|---|
| POWDER | MIIGTM Powder | MIIGTM II Powder |
| Surgical Grade Calcium Sulfate Hemihydrate Accelerator Setting Additive | Surgical Grade Calcium Sulfate Hemihydrate Accelerator | |
| LIQUID | Diluent | Diluent |
| Saline Irrigation | Sterile Water for Irrigation |
SUBSTANTIAL EQUIVALENCE INFORMATION D.
The intended use, material composition, and design features of the MIIGTM II are substantially equivalent to the intended use, material composition, and design features of the previously submitted and cleared MIIG.
The safety and effectiveness of the MIIGTM II is adequately supported by the substantial equivalence information, materials data, and testing results provided within this Premarket Notification.
Image /page/1/Picture/9 description: The image is a logo for Wright Medical Technology. The logo features a stylized "W" on the left, followed by the words "WRIGHT MEDICAL TECHNOLOGY" stacked on top of each other. Below a horizontal line, the text "A Wright Medical Group Company" is present.
Image /page/1/Picture/10 description: The image shows a black and white photograph of what appears to be a cell or a planet. The object is circular with a dark upper right portion and a lighter, textured area in the lower left. There is a small, dark object near the center of the lighter area, and a small, dark line at the bottom of the image.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 0 4 2003
Mr. Ehab M. Esmail Manager, Regulatory Affairs Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002
Re: K024336
Trade/Device Name: MIIG™ II Regulatory Class: Unclassified Product Code: MQV Dated: February 11, 2003 Received: February 12, 2003
Dear Mr. Esmail:
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 such 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); good manufacturing practice requirements as set 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.
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Page 2 - Mr. Ehab M. Esmail
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N Milken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo for Wright Medical Technology. The logo consists of a stylized "W" on the left, followed by the words "WRIGHT MEDICAL" stacked on top of "TECHNOLOGY" on the right. The "W" is made up of three thick, black, angled lines, and the text is in a simple, sans-serif font.
A Wright Medical Group Company
MIIGTM II
INDICATIONS STATEMENT
The MIIG™ paste is intended to be injected into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities, spine, and pelvis) and to cure in-situ. These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The MIIG™ paste provides a bone void filler that resorbs and is replaced with bone during the healing process.
The MIIGM paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g., K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.
The MIIGTM is provided sterile for single use only.
R. Mark McMillenn
Division Sign-Off
Sign-Off Division of Gene I, Restorative and Nearological Devices
510(k) Number K024336
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General Restorative Devices 510(k) Number
Prescription Use V (Per21 CFR 801.109) OR
Over-The Counter Use (Optional Format 1-2-96)
Image /page/4/Picture/16 description: The image shows the logo for Wright Medical Technology. The logo consists of a large, stylized "W" on the left, followed by the words "WRIGHT MEDICAL TECHNOLOGY" stacked on top of each other. Below the logo is the text "A Wright Medical Group Company."
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INDICATIONS STATEMENT.doc
§ 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.