(84 days)
Not Found
No
The summary describes a physical implant made of resorbable material with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is described as a cement restrictor used during surgery to prevent the flow of cement in long bones, and it does not actively treat or cure a disease or condition.
No.
The device is described as a resorbable implant used as a cement restrictor in bones during surgery, not for diagnosing a condition.
No
The device description clearly states it is a resorbable implant manufactured from poly lactic acid (PLA) and describes its physical characteristics and intended use as a cement restrictor, indicating it is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The MacroPore IB Resorbable Plug is an implantable device used within the body during surgery to restrict the flow of cement in bones. It is a physical barrier, not a diagnostic tool that analyzes biological samples.
- Lack of Diagnostic Function: The description focuses on the material properties, shape, and surgical application of the plug. There is no mention of analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies described are related to the material properties and the effect of heating, which are relevant to an implantable device, not an IVD.
Therefore, based on the provided information, the MacroPore IB Resorbable Plug is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MacroPore IB Resorbable Plug is indicated for use as a cement restrictor in the femur, tibia and humerus.
Product codes
JDK, JDI
Device Description
MacroPore IB Resorbable Plug is a resorbable implant manufactured from poly lactic acid (PLA). The MacroPore IB Resorbable Plug is designed to wedge into the inter medullary region of long bones to restrict the flow of cement. The MacroPore IB Resorbable Plug is fully malleable when heated to approximately 55℃ (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation. Resorbable Plug is provided in various shapes such as rectangles, ovals, and MacroPore IB cylinders and will be provided in other similar shapes and sizes as needed for particular surgical procedures. The wall thickness of the MacroPore IB Resorbable Plug ranges from 0.5 mm to 4.0 mm according to the region to be treated. The major outer diameter of the MacroPore IB Resorbable Plug ranges from 4mm to 30mm according to the region to be treated. A minimum of two sides of the MacroPore IB Resorbable Plug contain fenestrated edges to assure fit within the inter medullary region and to prevent dislodging. These fenestrated edges also allow for a secure fit between segmental defects.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur, tibia and humerus
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
In Vitro Testing: Because the MacroPore IB Resorbable Plug is intended to be heated in the surgical suite to temperatures above the material's glass transition temperature to facilitate shaping to anatomic structures, testing was performed to determine the effect of prolonged heating in saline at 60°C on inherent viscosity. The testing demonstrates that viscosity stayed within an appropriate range over 120 minutes. Therefore, the relatively brief exposure anticipated during the surgical preparation of MacroPore IB Resorbable Plug is not expected to have a significant effect on its mechanical properties. Crystallinity was tested for by DSC (differential scanning calorimetery). This test measures the amount of heat energy that is absorbed by a material. A crystalline material will require more energy once it reaches it's melting point. This release of heat energy can be seen on a graph as a sharp spike and is referred to as a "melting endotherm". The tests ran on the sterile and non-sterile samples revealed no endothermic spikes, confirming the amorphous (non-crystalline) nature of the implants.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
AUG 2 7 2001
Koll715-
510K Summary
MacroPoreIB Resorbable Plug
Page 1 of 2
ADMINISTRATIVE INFORMATION
Manufacturer Name:
Official Contact:
MacroPore, Inc. 6740 Top Gun Street San Diego, CA 92121
Kenneth K. Kleinhenz Director of Regulatory Affairs
DEVICE NAME
Classification Name:
Trade/Proprietary Name:
Hip Joint Cemented Prosthesis
MacroPore IB Resorbable Plug
ESTABLISHMENT REGISTRATION NUMBER 2031733
DEVICE CLASSIFICATION AND PRODUCT CODE
As shown in 21CFR 888.3350 Hip Joint Cemented Prosthesis are intended for use in orthopedic cementing procedures and are classified as Class II. Hip Joint Cemented Prosthesis have been assigned Product Code JDK.
INTENDED USE
MacroPore IB Resorbable Plug is indicated for use as a cement restrictor in the femur, tibia and humerus.
DEVICE DESCRIPTION
Design Characteristics
MacroPore IB Resorbable Plug is a resorbable implant manufactured from poly lactic acid (PLA). The MacroPore IB Resorbable Plug is designed to wedge into the inter medullary region of long bones to restrict the flow of cement. The MacroPore IB Resorbable Plug is fully malleable when heated to approximately 55℃ (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation.
Resorbable Plug is provided in various shapes such as rectangles, ovals, and MacroPore IB cylinders and will be provided in other similar shapes and sizes as needed for particular surgical procedures. The wall thickness of the MacroPore IB Resorbable Plug ranges from 0.5 mm to 4.0 mm according to the region to be treated. The major outer diameter of the MacroPore IB Resorbable Plug ranges from 4mm to 30mm according to the region to be treated. A minimum of two sides of the MacroPore IB Resorbable Plug contain fenestrated edges to assure fit within the inter medullary region and to prevent dislodging. These fenestrated edges also allow for a secure fit between segmental defects.
1
Material Composition
The MacroPore IB Resorbable Plug is fabricated from polylactic acid (PLA).
In Vitro Testing
Because the MacroPore IB Resorbable Plug is intended to be heated in the surgical suite to temperatures above the material's glass transition temperature to facilitate shaping to anatomic structures, testing was performed to determine the effect of prolonged heating in saline at 60°C on inherent viscosity. The testing demonstrates that viscosity stayed within an appropriate range over 120 minutes. Therefore, the relatively brief exposure anticipated during the surgical preparation of MacroPore IB Resorbable Plug is not expected to have a significant effect on its mechanical properties.
Crystallinity was tested for by DSC (differential scanning calorimetery). This test measures the amount of heat energy that is absorbed by a material. A crystalline material will require more energy once it reaches it's melting point. This release of heat energy can be seen on a graph as a sharp spike and is referred to as a "melting endotherm". The tests ran on the sterile and non-sterile samples revealed no endothermic spikes, confirming the amorphous (non-crystalline) nature of the implants.
EQUIVALENCE TO MARKETED PRODUCT
MacroPore IB Resorbable Plug shares indications and design principles with the following predicate device, which has been determined by FDA to be substantially equivalent to the following pre- amendment devices: Medtonic Sofamor Danek Cement Restrictor, Medtronic Sofamor Danek Titanium Cement Restrictor, and the MacroPore OS Protective Sheet, Class II medical device that were cleared for marketing in the United States under K010529, K003718 and K994158 respectively.
Indications For Use
The MacroPore IB Resorbable Plug and the predicate device share substantially equivalent indications for use as they both are indicated for cement restriction. Specifically, the MacroPore IB Resorbable Plug is intended for use as a cement restrictor in the femur, tibia and humerus.
Design and Materials
The MacroPore IB Resorbable Plug and the predicate device share substantially couivalent design features, principles of operation, and materials.
2
Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's emblem, which consists of a stylized caduceus-like symbol with three wavy lines representing the human form. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 4 2001
Mr. Kenneth K. Kleinhenz Director of Regulatory Affairs MacroPore, Inc. 6740 Top Gun Street San Diego, California 92121
Re: K011715
Trade Name: MacroPore IB Resorbable Plug Regulation Number: 888.3350 Regulatory Class: II Product Code: JDI Dated: June 1, 2001 Received: June 4, 2001
Dear Mr. Kleinhenz:
This letter corrects our substantially equivalent letter of August 27, 2001.
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use above and we nave acterificated predicate devices marketed in interstate commerce stated in the cherobard, to cenactment 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). You may, therefore, market the device, subject to the general controls Cosmotions of the Act and the limitations described below. The general controls provisions of the provisions of the Act the miral registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this The Office of Dovice Drailation has associdentified in the proposed labeling and that such use device with be abour ror an accordance with Section 513(i)(1)(E) of the Act, the following vourd canso na appear in the Warnings section of the device's package insert and also as a Warning on the product label:
WARNING: THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS. THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations ( Femanet I repression) in the Code of Federal Regulations, Title 21, Parts 800 to 895.
3
Page 2 - Mr. Kenneth K. Kleinhenz
A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to inspections, and Drig regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification if the limitation statement above is added to your labeling, as described.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. I herefore, a new 510(k) is required before these limitations are modificd in any way or removed from the device's labeling.
If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR production the regulation on your responsibilities under the Act may be obtained from 001:37): Other Echeral Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) the DIVibion of Billan The address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours.
Bert Estlat
Bernard E. Statland, M.D., Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Device Name: _MacroPore IB_Resorbable Plug
Indications for Use:
MacroPore IB Resorbable Plug is indicated for use as a cement restrictor in the femur, tibia and humerus.
Koll715
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NECESSARY) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use yes Over-The-Counter Use No
for Mark n OR Mulker
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
K011715
510(k) Number