(161 days)
Not Found
No
The summary describes standard image processing, 3D reconstruction, and templating functionalities common in pre-operative planning software. There is no mention of AI, ML, or related concepts like deep learning, neural networks, or training/inference processes.
No
The device is described as a software package intended for pre-operative planning, assisting medical professionals with 3D templating, measurements, and visualizations. It does not directly treat or diagnose a patient's condition.
No
The device is used for pre-operative planning and surgical assistance, not for diagnosing medical conditions. It assists medical professionals in templating implants and calculating surgical parameters based on existing 2D image data.
Yes
The device is described as a "software package" and its functions are entirely software-based (importing, storing, templating, measuring, visualizing, communicating with PACS). There is no mention of accompanying hardware that is part of the medical device itself.
Based on the provided information, 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.
- ZedView's Function: ZedView is a software package used for pre-operative planning for surgical procedures related to the hip and knee. It uses medical imaging data (CT scans, X-rays) to assist medical professionals in planning surgeries, templating implants, and performing measurements.
- No Sample Analysis: The description clearly states that ZedView works with image data. It does not involve the analysis of biological samples from the patient.
Therefore, ZedView falls under the category of medical imaging software or surgical planning software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
ZedView is intended to be used to assist qualified medical professionals to perform fast and effective pre-operative planning for various surgical procedures related to hip and knee by using 2D image data. The software is basically intended to be standalone, however some part of the software provides features for communicating with PACS servers to acquire the CT data of various patients or to upload planned projects, images or reports to the servers.
ZedView is indicated for pre-operative planning for various surgical procedures related to hip and knee, such as artificial joint replacement (3D templating of implants) and osteotomy.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
ZedView is a software package that provides computer-assisted 3D planning and evaluations using 2D image data in DICOM or other formats, for various pre-operative hip and knee surgical procedures. The software is composed of various modules as shown in Figure 1, below.
ZedView is intended to be used to assist qualified medical professionals to perform fast and effective pre-operative planning for various surgical procedures related to hip and knee by using 2D image data. The software is basically intended to be standalone, however some part of the software provides features for communicating with PACS servers to acquire the CT data of various patients or to upload planned projects, images or reports to the servers.
The software primarily provides import and storage of CT images of various patients in DICOM or other formats. Also, it provides a means of 3D templating of implants and positioning of fixation devices by calculating surgical parameters in simulated environments and performing 3D measurements on each pre-operative patient data, using 2D image viewing and manipulations, 3D visualizations and various MPR (Multi-Planar Reconstruction) functions.
The software also provides separate modules that support pre-operative planning of hip and knee arthroplasty for 2D digital X-rav images obtained with the EOS imaging system by providing quasi-3D templating, 3D measurement, etc. Besides the functional modules for artificial joint replacement surgeries, the software also provides a module that incorporates planning and evaluations for osteotomy (Curved Periacetabular Osteotomy etc.).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
2D image data in DICOM or other formats, CT images, 2D digital X-ray images obtained with the EOS imaging system.
Anatomical Site
Hip and Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified medical professionals. The software is basically intended to be standalone.
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
The Lexi ZedView Software was fully tested, verified and validated by Lexi as part of its own internal design control requirements using the test image data or real-life patient data.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Data: (Non-clinical Testing)
The Lexi ZedView Software was fully tested, verified and validated by Lexi as part of its own internal design control requirements using the test image data or real-life patient data. Verification and validation results confirm that the ZedView Software meets its requirements for intended use and its performance requirements.
Conclusions of non-clinical tests
The results of the non-clinical tests confirm that ZedView is as safe, as effective, and performs as well as or better than the predicates.
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.
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
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/1 description: The image shows the word LEXI in bold, black letters. To the left of the word is a blue square design with several squares inside of each other. There is a blue line on either side of the word and design.
''510(k) SUMMARY'' AS REQUIRED BY SECTION 807.92(c)
510(k) Owner's Name, Address, Telephone Number, Fax Number, Contact Person and Date Prepared.
Lexi Co., Ltd. Kyodo-Keikaku Bldg. 9F 3-36-6 Sugamo, Toshima-ku, Tokyo 170-0002, JAPAN Phone: +81 (0)3 5394 4833 Fax: + 81 (0)3 5394 4834 E-mail: admin@lexi.co.jp Website: http://www.lexi.co.jp/
Contact Person:
Edward A. Kroll President, Spectre Solutions, Inc. and Representative Consultant for Lexi Co., Ltd. 5905 Fawn Lane Cleveland, Ohio 44141 Phone: (440) 546-9801 Fax: (440) 546-9124
Date Prepared: September 8, 2013
Name of Device
- Trade Name: ZedView ●
- Common Name: Image Management Software
- Classification Name: Medical Image Management System, Product Code LLZ
Predicate Device
ZedView is substantially equivalent to the Meridian Technique Ltd. Orthoview™ (510(k) Accession Numbers: K032401 and K063327).
| Volume Number |
|---|
| 8 |
1
Image /page/1/Picture/1 description: The image contains the word "LEXI" in bold, black letters. To the left of the word is a blue square design with multiple squares nested inside each other. There are also short blue lines on either side of the word "LEXI".
Device Description:
ZedView is a software package that provides computer-assisted 3D planning and evaluations using 2D image data in DICOM or other formats, for various pre-operative hip and knee surgical procedures. The software is composed of various modules as shown in Figure 1, below.
Image /page/1/Figure/4 description: The image is a flowchart that shows the architecture of the ZedView software. The top-level component is ZedView, which is composed of ZedViewDB, ZedView3D, and ZedReport. ZedViewDB is responsible for 2D slice image data management, ZedView3D is responsible for 3D visualization, measurement, and simulations, and ZedReport is responsible for screenshot report generation, editing, and transmission. The ZedViewDB and ZedReport components are connected to ZedEdit, ZedHip, ZedKnee/JIGEN, ZedHip-EOS, ZedKnee-EOS, and ZedOsteotomy.
Image /page/1/Figure/5 description: The image shows the text "FIGURE 1" in a bold, sans-serif font. The text is underlined. The words are stacked on a single line.
ZedView is intended to be used to assist qualified medical professionals to perform fast and effective pre-operative planning for various surgical procedures related to hip and knee by using 2D image data. The software is basically intended to be standalone, however some part of the software provides features for communicating with PACS servers to acquire the CT data of various patients or to upload planned projects, images or reports to the servers.
The software primarily provides import and storage of CT images of various patients in DICOM or other formats. Also, it provides a means of 3D templating of implants and positioning of fixation devices by calculating surgical parameters in simulated environments and performing 3D measurements on each pre-operative patient data, using 2D image viewing and manipulations, 3D visualizations and various MPR (Multi-Planar Reconstruction) functions.
The software also provides separate modules that support pre-operative planning of hip and knee arthroplasty for 2D digital X-rav images obtained with the EOS imaging system by providing quasi-3D templating, 3D measurement, etc. Besides the functional modules for artificial joint replacement surgeries, the software also provides a module that incorporates planning and evaluations for osteotomy (Curved Periacetabular Osteotomy etc.).
2
Image /page/2/Picture/0 description: The image contains the word "LEXI" in bold, black letters. To the left of the word is a blue square design with a series of squares inside of each other. There is a blue line on either side of the word and the square design. The word is the main focus of the image.
Intended Use
ZedView is intended to be used to assist qualified medical professionals to perform fast and effective pre-operative planning for various surgical procedures related to hip and knee by using 2D image data. The software is basically intended to be standalone, however some part of the software provides features for communicating with PACS servers to acquire the CT data of various patients or to upload planned projects, images or reports to the servers.
Predicate Device Comparison
The ZedView software is substantially equivalent to the Meridian Technique Ltd. Orthoview™ Software (K032401 and K063327). (See Page 11-1 for the comparative analysis).
Performance Data: (Non-clinical Testing)
The Lexi ZedView Software was fully tested, verified and validated by Lexi as part of its own internal design control requirements using the test image data or real-life patient data. Verification and validation results confirm that the ZedView Software meets its requirements for intended use and its performance requirements.
Conclusions of non-clinical tests
The results of the non-clinical tests confirm that ZedView is as safe, as effective, and performs as well as or better than the predicates.
3
Image /page/3/Picture/0 description: The image contains the word "LEXI" in bold, black letters. To the left of the word is a blue square design with several squares nested inside of each other. There is a short blue line on either side of the word and the square design.
ZedView/OrthoView Comparative Analysis
| Characteristic | Meridian Technique
OrthoView (K032401) | Meridian Technique
OrthoView (K063327) | Lexi ZedView |
|------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|-------------------------------------|
| Computer | PC Workstation | Personal computer or
Workstation/Server | Personal computer or
Workstation |
| Operating
System | Windows | Windows | Same |
| Availability of
Device | Can be configured to be
launched from within a
workstation environment or
as a standalone PC
application for planning
orthopedic procedures. | Same | Same |
| Source of
images | Receive digital images
from various sources
(including PACS system) | Same | Same |
| Processing of
data | Scaling of image facility | Same | Same |
| Superimposing
digital
Prosthetic
Templates | Permits overlay of
templates | Same | Same |
| Interactive
positioning of
template | Yes | Same | Same |
| Interactive
sizing of
template | Yes | Same | Same |
| Permits template
rotation | Yes | Same | Same |
| Provides
templating
support from
prosthetic
manufacturers. | Yes | Same | Same |
| Permits
automatic
scaling | Yes | Same | Semi-automatic
measurements |
| Pre-operative
planning | Allowed | Same | Same |
| Osteotomy
module | No | Yes | Yes |
| Patient contact | None | Same | Same |
| Control of life-
sustaining
devices | None | Same | Same |
| Human
intervention for
interpretation of | Required | Same | Same |
Volume Number
Page Number
4
Image /page/4/Picture/0 description: The image shows the word "LEXI" in bold, black letters. To the left of the word is a blue square design with a series of squares inside of each other. There is a blue dash on either side of the word and the square design.
| Characteristic | Meridian Technique
OrthoView (K032401) | Meridian Technique
OrthoView (K063327) | Lexi ZedView |
|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| images | | | |
| Ability to add
additional
modules when
available | Yes | Same | Same |
| Intended use | The OrthoviewTM system
is designed with the
intention that licensed
medical professionals can
access digitised medical X-
Ray images in DICOM or
other formats obtained
from a variety of
modalities such as PACS
systems, X-Ray digitisers
etc.
This permits the review of
such images and allows the
overlay of digitised images
of templates for prosthetic
devices thereby providing
an alternative to traditional
means of optically viewing
processed X-Ray films
overlaid with the acetate
templates of such
prostheses supplied by the
prosthetic manufacturer.
OrthoviewTM provides the
means of recording, storing
and retrieving the
templating process steps
performed by the licensed
medical professional when
assessing the
optimum prosthetic device
for a particular patient.
The OrthoviewTM system
does not have any function
such as image acquisition,
image storage etc, this is
the responsibility of the
systems alongside which
OrthoviewTM operates.
The OrthoviewTM system
does not specify the
requirements for the
prosthetic template - this is
the responsibility of the
prosthetic manufacturer. | OrthoviewTM intended use is to
enable a suitably licensed and
qualified healthcare
professional access to medical
images with the intention of
using such images, in conjunction
with templates for prosthetic and
fixation devices, for the purposes
of choosing the nature and
characteristics of the
prosthetic/fixation device to be
used when
planning a potential surgical
procedure. In addition, Trauma
and Osteotomy modules and
Trauma Templates are included
to extend the range of
functionality available to the
healthcare professional. | ZedView is intended to be
used to assist qualified
medical professionals to
perform fast and effective pre-
operative planning for various
surgical procedures related to
hip and knee by using 2D
image data. The software is
basically intended to be
standalone, however some
part of the software provides
features for communicating
with PACS servers to acquire
the CT data of various
patients or to upload planned
projects, images or reports to
the servers.
The software primarily
provides import and storage
of CT images of various
patients in DICOM or other
formats and provides a means
of 3D templating of implants
and positioning of fixation
devices by calculating
surgical parameters in
simulated environments and
performing 3D measurements
on each pre-operative patient
data using 2D image viewing
and manipulations, 3D
visualizations and various
MPR (Multi-Planar
Reconstruction) functions.
The software also provides
separate modules that support
pre-operative planning of hip
and knee arthroplasty for 2D
digital X-ray images obtained
with the EOS imaging system
by providing quasi-3D
templating, 3D measurement,
etc.
Besides the functional
modules for artificial joint
replacement surgeries, the
software also provides a |
5
Image /page/5/Picture/0 description: The image shows the word "LEXI" in black, bold letters. To the left of the word is a blue square design with several squares nested inside each other. There is a short blue line on either side of the word and square design.
| Characteristic | Meridian Technique
OrthoView (K032401) | Meridian Technique
OrthoView (K063327) | Lexi ZedView |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | module that incorporates
planning and evaluations for
osteotomy (Curved
Periacetabular Osteotomy
etc.). |
| Indications for
use | OrthoviewTM is indicated
for use when a suitably
licensed and qualified
healthcare professional
requires access to medical
images with the intention
of using such images, in
conjunction with templates
for prosthetic devices, for
the purposes of choosing
the nature and
characteristics of the
prosthetic device to be used
when planning a potential
surgical procedure. | OrthoviewTM is indicated for use
when a suitably licensed and
qualified healthcare professional
requires access to medical images
with the intention of using such
images, in conjunction with
templates for prosthetic and
fixation devices, for the purposes
of choosing the nature and
characteristics of the
prosthetic/fixation device to be
used when planning a potential
surgical procedure. In addition,
Trauma and Osteotomy modules
and Trauma Templates are
provided to extend the range of
functionality available to
healthcare professionals. | Pre-operative planning for
various surgical procedures
related to hip and knee like
artificial joint replacement
(3D templating of implants),
osteotomy. |
6
Image /page/6/Picture/0 description: The image shows the word "ZedView" in a serif font. The text is black and the background is white. The word is written in a slightly italicized style.
Image /page/6/Picture/1 description: The image shows the word "LEXI" in bold, black letters. To the left of the word is a blue square with a series of smaller squares inside, creating a tunnel-like effect. A short blue line is on either side of the word, connecting it to the square.
Discussion of Differences
Important Differences
1. Image format
OrthoView uses digital X-ray image data, ZedView provides pre-operative planning from CT sliced image data.
Discussion:
The CT image data provides more relevant information than the X-ray images, thus offers a better and precise pre-operative planning, while the intended use and the indications for use remain the same. Besides, ZedView also contains separate operational modules (ZedHip-EOS, ZedKnee-EOS) for providing pre-operative planning for hip and knee using the digital X-ray (DX modality) images from the EOS imaging systems.
2. Templating system
In contrast to the conventional 2D templating of OrthoView. ZedView provides CTbased 3D templating system. In addition to the template overlays in 2D cross-sectional images, the software allows user to place and register the 3D imported models of implants or fixation devices over the 3D reconstructed bone models and also provides 3D movement (translation, rotation) of the implants. In addition. ZedView offers visualization of bone models in various simulated post-operative positions and calculation of surgical parameters with respect to various coordinate systems.
Discussion:
The 3D templating system provides flexibility and extension of functionality by providing additional information (surgical parameters, range of motion analysis, etc.) for pre-operative planning than the 2D templating systems. Moreover, the 3D visualizations of bone and implant models help visualize elements that cannot be visualized in 2D, thus allowing for intuitive, effective and more accurate and precise planning.
3. Osteotomy operational module
In addition to the joint replacement modules, the Osteotomy module in ZedView also offers simulations, measurements, surgical parameters calculations, etc. in 3D.
Discussion:
Similar to the discussion in section 2 above, the extra information and the 3D visualization of simulated bone models allow for intuitive, effective and more accurate and precise planning.
Conclusion
While there are some differences between ZedView and its predicates, these differences are minor and do not affect device substantial equivalence. It has the same basic operational principles and technical characteristics as its predicates and it functions in the same manner. Additionally, it has the indications for use and intended function and
| Volume Number | Page Number |
|---|---|
| 8 | 8-7 |
7
Image /page/7/Picture/0 description: The image contains the word "LEXI" in bold, black letters. To the left of the word is a blue square design with a series of squares inside of each other. There is a short blue line on either side of the word and design.
use and performs as well as or better than its predicates. Therefore, Lexi believes that ZedView is substantially equivalent to the predicate devices cited within this submission.
| Volume Number | Page Number |
|---|---|
| 8 | 8-8 |
8
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
March 6, 2014
LEXI Co., Ltd. % Mr. Edward Kroll President Spectre Solutions, Inc. 5905 Fawn Lane CLEVELAND OH 44141
Re: K133022
Trade/Device Name: ZedView Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 20, 2014 Received: February 21, 2014
Dear Mr. Kroll:
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 11 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
9
Page 2-Mr. Kroll
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/ReportalProblem/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,
Smh.7)
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
10
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133022
Device Name
ZedView
Indications for Use (Describe)
ZedView is indicated for pre-operative planning for various surgical procedures related to hip and knee, such as artificial joint replacement (3D templating of implants) and osteotomy.
Type of Use (Select one or both, as applicable)
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 Radiological Health (CDRH) (Signature)
Sm.h.7)
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