(30 days)
Not Found
No
The description focuses on software manipulation of images and additive manufacturing, with no mention of AI or ML algorithms. The process relies on trained employees and physician input, not automated learning.
No
The device is a software system and associated manufacturing equipment used for pre-operative planning and creation of patient-specific outputs (physical and digital models, surgical guides, etc.) for maxillofacial surgery. It does not directly treat a disease or condition; rather, it aids the surgeon in treatment.
No
The VSP® System is described as a "software system and image segmentation system for the transfer of imaging information from a medical scanner" and a "pre-operative software tool for simulating surgical treatment options." Its primary function is to process imaging data for surgical planning and produce physical and digital outputs (models, guides, splints) for use in surgery. While it processes medical images, its role is for planning and manufacturing aids rather than making a diagnosis.
No
The device description explicitly states that the system is a "collection of software and associated additive manufacturing (rapid prototyping) equipment" and produces "physical outputs including anatomical models and surgical guides." This indicates the system includes hardware components beyond just software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the system is for processing imaging information, simulating surgical treatment options, and producing physical outputs like anatomical models and surgical guides for use in maxillofacial surgery. This is focused on surgical planning and execution, not on diagnosing a condition based on in vitro examination of specimens.
- Device Description: The description reinforces that the system uses medical images to manipulate patient anatomy for planning and executing surgery and produces outputs like models, guides, and splints. This is a tool for surgical preparation and execution, not for diagnostic testing of biological samples.
- Lack of IVD Characteristics: The text does not mention any of the key characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.).
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on in vitro testing.
- Reagents, calibrators, or controls typically associated with IVD tests.
The system is a surgical planning and manufacturing tool that utilizes medical imaging data, which is distinct from the in vitro analysis of biological samples that defines an IVD.
N/A
Intended Use / Indications for Use
The Medical Modeling VSP® System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as CT based system. The is processed by the VSP® System and the result is an output data file that may then be provided as digital models or used as ingut to a rapid prototyping portion of the system that produces physical outputs including and surgical guides for use in maxillofacial surgery. The VSP® System is also intended as a pre-operative software tool for simulating surgical reatment options.
Product codes (comma separated list FDA assigned to the subject device)
DZJ, LLZ
Device Description
The Medical Modeling VSP® System is a collection of software and associated additive manufacturing (rapid prototyping) equipment intended to provide a variety of outputs to support orthognathic or reconstructive surgery. The system uses electronic medical images of the patient's anatomy with input from the physician, to manipulate original patient images for planning and executing surgery. The system manipulate enginal patient specific outputs including, anatomical models (physical and digital), surgical templates / guides, splints, and patient specific case reports.
Following the Medical Modeling Quality System and specific Work Instructions, trained employees utilize a combination of Commercial Off-The-Shelf (COTS) and trantom software to manipulate 3D medical scan images which can include Computed Tomography (CT), Cone Beam CT (CBCT), 3D scan images from patient physical models (stone models of the patient's teeth), and / or standard (non-bent) or priyered model implant files to create patient-specific physical and digital outputs. The process requires clinical input and review from the physician during planning and process telivery of the final outputs. While the process and data-flow can vary and phor to activery of the particular requirements of a given patient and physician, the following description outlines the functions of key sub-components of the system, following doben pour can be the defined system outputs. It should be noted that the system is operated only by trained Medical Modeling employees, and the the oyotan to open area the information. The physician only provides input for priysioian doos not anothy mactive feedback through viewing of digital models of model mempulation are modified by the engineer during the planning session.
The VSP® System is made up of 14 individual pieces of software and additional manufacturing equipment integrated to provide a range of anatomical models (physical and digital), surgical templates / guides and patient-specific case reports for (priyalour and digital), bargham, burgical region. Surgical guides for graft bone harvesting from patient bone such as, but not limited to, the fibula and hip, are also produced by the system.
The VSP® System requires an input 3D image file from medical imaging systems (i.e. CT) and / or a standard or patient contoured implant file. This input is then used, (i.e. ST) and from the prescribing physician to provide the following categories of with ourport reconstructive surgery. Each system output is designed with outpute to oupper roosiewed by the physician prior to finalization and distribution. priysician input, and foviotity direct physician involvement to reduce the criticality of the outputs.
- System Outputs:
- Anatomical Models
- Surgical Positioning Templates / Guides
- Osteotomy Templates / Guides
- Plate Bending Templates / Guides
- Patient Specific Case Reports
The VSP® System also contains Stainless Steel Cutting and Drill Inserts (VSP® System Accessories) which are intended to be used by the physician to guide cutting and drilling activities during the surgical procedure. The inserts fit into a standard slot / hole in the cutting / drill guides, and can be used across all VSP® System quides and templates.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
medical image sogments a CT based system.
3D medical scan images which can include Computed Tomography (CT), Cone Beam CT (CBCT), 3D scan images from patient physical models (stone models of the patient's teeth), and / or standard (non-bent) or priyered model implant files.
3D image file from medical imaging systems (i.e. CT) and / or a standard or patient contoured implant file.
Images from medical scanners (i.e. CT) or standard implant files ( STL format).
Anatomical Site
maxillofacial surgery
orthognathic or reconstructive surgery
graft bone harvesting from patient bone such as, but not limited to, the fibula and hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained Medical Modeling employees
physician
non-medical manufacturing or office environment
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)
Verification and validation testing was performed on the modified VSP® System as a control program. The intention of these tests was to provide objective evidence that the modified VSP® System conforms to specifications, is fit for its intended use, and that its performance is substantially equivalent to the unmodified VSP® System.
Because the modified VSP® System is the combination of a manufacturing process and the patient-specific outputs of the manufacturing process (models, guides and templates), the performance testing for the device typically includes methods of process validation (IQ, OQ, PQ). Due to the specific nature of the device production that was subjected to system validation, it was determined that modified that frue fras calidation would comprise the following challenge: 1) use as input a worst-case patient contoured implant file, 2) process the worst-case as input a wored implant file using currently validated software versions, and 3) output digital files for templates and guides that meet requirements.
The final output .STL files the cases designed using a patient contoured implant .STL ifile as input demonstrated clinical and / or dimensional equivalency to .STL files mo as inpusing a standard implant .STL file as input. The equivalency was produced using a standard implant of increative surgeon, and / or demonstratou inrough ourgooy of parts for comparison analysis. The reconstructive surgeon approved both design, which indicated that there is no clinically significant sufference between the implant template .STL file created from a patient contoured implant .STL file and a standard implant .STL file.
Additional Verification and Validation Testing:
Medical Modeling has also implemented minor modifications to the device since the original clearance in K120956, which required additional verification and validation testing.
- Software Updates: Four (4) software components were upgraded to match the vendor's current version of the software component. The following tests were executed for each software version upgrade:
- Software installation qualification
- Software validation
- Additional Stereolithography Apparatus (SLA): An additional SLA model and associated wash tanks have been added to the manufacturing process of the VSP® System, in order to manage a larger capacity of outputs. The operational software for the additional SLAs have been incorporated into the VSP® as a result. The following verification and validation was performed for these modifications:
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Software Validation
All Design, Process, and other Verification and Validation testing which were based on hazard analyses and design impact assessments, showed conformity to pre-established specifications and acceptance criteria. The conformity to pre octablished in order to demonstrate device performance and substantial equivalence of the system to the unmodified version of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
VSP® System, Medical Modeling Inc. (K120956)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.
0
Medical Modeling Inc. - Special 510(k) for Modified VSP® System Section 7: 510(k) Summary
JAN 222 2014
SECTION 7: 510(K) SUMMARY
INTRODUCTION 1
- This document contains the 510(k) summary for the VSP® System. The content of 1.1 this summary is based on the requirements of 21 CFR 807.92.
APPLICANT NAME AND ADDRESS 2
| Name: | Medical Modeling Inc. |
|---|---|
| Address: | 17301 West Colfax Avenue |
| Suite 300 | |
| Golden, CO 80401, USA | |
| Phone: (303) 273-5344 | |
| Fax: (303) 273-6463 |
Andrew Christensen Official Contact: President
Summary December 23, 2013 Preparation Date:
DEVICE NAME AND CLASSIFICATION 3
| Trade Name: | VSP® System |
|---|---|
| Common Name: | System for the creation of patient specific anatomical |
| models, templates, guides, and surgical plans | |
| Classification | |
| Name: | Bone Cutting Instrument and Accessories |
| Classification: | Class II, 21 CFR 872.4120 |
| Product Code: | DZJ. LLZ |
PREDICATE DEVICES 4
1
- The modified VSP® System is claimed to be substantially equivalent to the following 4.1 legally marketed predicate device:
VSP® System, Medical Modeling Inc. (K120956) 4.1.1
PERFORMANCE STANDARDS ട്
- There are no performance standards for this device type. 5.1
1
Medical Modeling Inc. – Special 510(k) for Modified VSP® System Section 7: 510(k) Summary
INDICATIONS FOR USE 6
- The Medical Modeling VSP® System is intended for use as a software system and 6.1 ime Mediodi Modeling vor the transfer of imaging information from a medical image sogments a CT based system. The input data file is processed by the VSP® System and the result is an output data file that may then be provided as digital oyotels or used as input to a rapid prototyping portion of the system that produces nhysical outputs including anatomical models, templates, and surgical guides for use in maxillofacial surgery. The VSP® System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.
DESCRIPTION OF THE DEVICE 7
- The Medical Modeling VSP® System is a collection of software and associated 7.1 additive manufacturing (rapid prototyping) equipment intended to provide a variety of outputs to support orthognathic or reconstructive surgery. The system uses electronic medical images of the patient's anatomy with input from the physician, to manipulate original patient images for planning and executing surgery. The system manipulate enginal patient specific outputs including, anatomical models (physical and digital), surgical templates / guides, splints, and patient specific case reports.
- Following the Medical Modeling Quality System and specific Work Instructions, 7.2 trained employees utilize a combination of Commercial Off-The-Shelf (COTS) and trantom software to manipulate 3D medical scan images which can include Computed Tomography (CT), Cone Beam CT (CBCT), 3D scan images from patient physical models (stone models of the patient's teeth), and / or standard (non-bent) or priyered model implant files to create patient-specific physical and digital outputs. The process requires clinical input and review from the physician during planning and process telivery of the final outputs. While the process and data-flow can vary and phor to activery of the particular requirements of a given patient and physician, the following description outlines the functions of key sub-components of the system, following doben pour can be the defined system outputs. It should be noted that the system is operated only by trained Medical Modeling employees, and the the oyotan to open area the information. The physician only provides input for priysioian doos not anothy mactive feedback through viewing of digital models of model mempulation are modified by the engineer during the planning session.
- The VSP® System is made up of 14 individual pieces of software and additional 7.3 manufacturing equipment integrated to provide a range of anatomical models (physical and digital), surgical templates / guides and patient-specific case reports for (priyalour and digital), bargham, burgical region. Surgical guides for graft bone harvesting from patient bone such as, but not limited to, the fibula and hip, are also produced by the system.
- The VSP® System requires an input 3D image file from medical imaging systems 7.4 (i.e. CT) and / or a standard or patient contoured implant file. This input is then used, (i.e. ST) and from the prescribing physician to provide the following categories of with ourport reconstructive surgery. Each system output is designed with outpute to oupper roosiewed by the physician prior to finalization and distribution. priysician input, and foviotity direct physician involvement to reduce the criticality of the outputs.
2
Medical Modeling Inc. - Special 510(k) for Modified VSP® System Section 7: 510(k) Summary
- System Outputs: 7.5
- Anatomical Models 7.5.1
- Surgical Positioning Templates / Guides 7.5.2
- 7.5.3 . Osteotomy Templates / Guides
- Plate Bending Templates / Guides 7.5.4
- Patient Specific Case Reports 7.5.5
- The VSP® System also contains Stainless Steel Cutting and Drill Inserts (VSP® 7.6 System Accessories) which are intended to be used by the physician to guide cutting and drilling activities during the surgical procedure. The inserts fit into a standard slot / hole in the cutting / drill guides, and can be used across all VSP® System quides and templates.
COMPARISON OF INTENDED USE AND TECHNOLOGICAL CHARACTERISTICS 8
- The intended use and technological characteristics of the subject device (modified 8.1 VSP® System) are either identical or substantially equivalent to the predicate device (unmodified VSP® System). The potential impact on substantial equivalence of each technological difference was addressed by extensive risk analysis and verification and validation testing.
- The modified VSP® System employs similar fundamental technologies as 8.1.1 the unmodified version of the device:
- Software for image transfer, manipulation, and surgical planning; 8.1.1.1
- Hardware for rapid manufacturing of patient-specific anatomical 8.1.1.2 models, quides and templates
- The principles of operation and technological characteristics are all either 8.1.2 identical or substantially equivalent between the modified and unmodified VSP® System.
- The modified VSP® has the following identical technological characteristics: 8.1.3
- System Inputs: Images from medical scanners (i.e. CT) or 8.1.3.1 standard implant files ( STL format)
- System Outputs: Physical and digital outputs such as patient-8.1.3.2 specific anatomical models, cutting and drill guides, templates and splints
- Materials: Biocompatible polymers and surgical instrument grade 8.1.3.3 stainless steel
- Sterility Assurance Level: 1 x 10 € 8.1.3.4
- The modification that prompted the submission of this Special 510(k) is the 8.1.4 THE mountieution the nontoured implant files from the implant vendor to the list ation of patiem inputs. The unmodified VSP® System was cleared to use or cloured oyotom the implant files from the implant vendor for manipulation into patient-specific digital and / or physical implant templates. Both the into patient open in contoured implant files are in .STL format, are used Standard and the patient-specific digital and / or physical implant
- The modified VSP® System employs similar fundamental technologies as 8.1.1 the unmodified version of the device:
3
templates, and have pre-determined fixation holes to assist the surgeon in implant fixation.
- See subsection 9 below for a description of the performance 8.1.4.1 testing and the results that support a determination of substantial equivalence.
- The intended use of the modified VSP® System has not been modified in 8.1.5 any way since the clearance of the unmodified VSP® System:
- Both devices are intended to provide tools and accessories 8.1.5.1 (software for image manipulation, anatomical models, guides and templates) for use in reconstructive or orthognathic surgery.
- The modified VSP® System and its predicate device are both 8.1.5.2 intended to be used by trained personnel, in a non-medical manufacturing or office environment, with active support from the surgeon.
- The modified and unmodified VSP® Systems are both intended i 8.1.5.3 for use on surgical candidates undergoing complex reconstructive or orthognathic surgery.
- The modified and unmodified VSP® System Accessories are manufactured 8.1.6 to ASTM F899-11 and are sterilized by the healthcare facility with the same cycle as the other cleared system outputs. The addition of the 2.0mm drill guide to the modified VSP® System Accessories does not change the intended use of the system or of the VSP® System Accessories; therefore, a determination of substantial equivalence between the modified VSP® System and the unmodified VSP® System can be made.
SUMMARY OF PERFORMANCE TESTING 9
- Verification and validation testing was performed on the modified VSP® System as a 9.1 vernication and validation tooting the Control Program. The intention of these tests was to provide objective evidence that the modified VSP® System conforms to specifications, is fit for its intended use, and that its performance is substantially equivalent to the unmodified VSP® System.
- Because the modified VSP® System is the combination of a manufacturing process 9.2 and the patient-specific outputs of the manufacturing process (models, guides and and the performance testing for the device typically includes methods of process validation (IQ, OQ, PQ). Due to the specific nature of the device production that was subjected to system validation, it was determined that modified that frue fras calidation would comprise the following challenge: 1) use as input a worst-case patient contoured implant file, 2) process the worst-case as input a wored implant file using currently validated software versions, and 3) output digital files for templates and guides that meet requirements.
- The final output .STL files the cases designed using a patient contoured implant .STL 9.3 ifile as input demonstrated clinical and / or dimensional equivalency to .STL files mo as inpusing a standard implant .STL file as input. The equivalency was produced using a standard implant of increative surgeon, and / or demonstratou inrough ourgooy of parts for comparison analysis. The reconstructive
4
surgeon approved both design, which indicated that there is no clinically significant sufference between the implant template .STL file created from a patient contoured implant .STL file and a standard implant .STL file.
Additional Verification and Validation Testing 9.4
- Medical Modeling has also implemented minor modifications to the device 9.4.1 since the original clearance in K120956, which required additional verification and validation testing. A summary of these modifications and their associated verification and validation is provided below.
- Software Updates: Four (4) software components were upgraded 9.4.1.1 to match the vendor's current version of the software component. The following tests were executed for each software version upgrade:
- Software installation qualification 9.4.1.1.1
- 9.4.1.1.2 Software validation
- Additional Stereolithography Apparatus (SLA): An additional SLA 9.4.1.2 model and associated wash tanks have been added to the manufacturing process of the VSP® System, in order to manage a larger capacity of outputs. The operational software for the additional SLAs have been incorporated into the VSP® as a result. The following verification and validation was performed for these modifications:
- Installation Qualification (IQ) 9.4.1.2.1
- Operational Qualification (OQ) 9.4.1.2.2
- Performance Qualification (PQ) 9.4.1.2.3
- Software Validation 9.4.1.2.4
- Software Updates: Four (4) software components were upgraded 9.4.1.1 to match the vendor's current version of the software component. The following tests were executed for each software version upgrade:
- All Design, Process, and other Verification and Validation testing which were 9.5 All Design, I 100000, and oth analyses and design impact assessments, showed conformity to pre-established specifications and acceptance criteria. The conformity to pre octablished in order to demonstrate device performance and substantial equivalence of the system to the unmodified version of the device.
10 SUBSTANTIAL EQUIVALENCE
- Based on a comparison of the intended use and technological characteristics, the 10.1 Based on a companison of the interially equivalent to the identified predicate device. Minor differences in technological characteristics were demonstrated by performance Minor differences in toonnological of equivalence and validation data supports that they system performs in accordance with its intended use and is substantially equivalent to the following predicate device:
- 10.1.1 VSP® System, Medical Modeling Inc., (K120956)
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three legs, 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 pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 22, 2014
Medical Modeling Incorporated C/O Mr. Jonathan Kahan Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, DC 20004
Re: K133907
Trade/Device Name: VSP® System Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: II Product Code: DZJ, LLZ Dated: December 23, 2013 Received: December 23, 2013
Dear Mr. Kahan:
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 I he general controls proctice, 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 may be subject to additions, 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 r lease of advised that I Dr 3 issuance or or device complies with other requirements of the Act
6
Page 2 – Mr. Kahan
.............................................................................................................................................................................. 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); 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/Resourcesfor You/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for
Image /page/6/Picture/9 description: The image shows the name "Kwame O. Ulmer" in bold, black font at the top. Below the name is the acronym "FDA" in a textured, dotted pattern. To the left of the acronym is the letter "-S" in a similar font style to the name.
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K133907
Device Name VSP(R) System
Indications for Use (Describe)
The Medical Modeling VSP(R) System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as CT based system. The is processed by the VSP(R) System and the result is an output data file that may then be provided as digital models or used as ingut to a rapid prototyping portion of the system that produces physical outputs including and surgical guides for use in maxillofacial surgery. The VSP(R) System is also intended as a pre-operative software tool for simulating surgical reatment options.
Type of Use (Select one or both, as applicable)
网 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY ... . . . . . . , . Concurrence of Center for Devices and Radiclogical Health (CDRH) (Signature)
Mary S. Runner -S
D06.m 2014.01.17 14:07:03 -05:00
FORM FDA 3881 (1/14)
ca don 443 674