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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Medical Modeling Inc. VSP® System:

This document describes a "Special 510(k) for Modified VSP® System," which focuses on verifying that a modified version of an already cleared device (the predicate device) is substantially equivalent to the original. Therefore, the study details are primarily about demonstrating equivalence rather than establishing entirely new performance criteria or efficacy for a novel device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of specific, quantitative "acceptance criteria" for the VSP® System's performance in the way one might expect for diagnostic accuracy (e.g., sensitivity, specificity thresholds). Instead, the acceptance criteria are framed around demonstrating equivalence to the predicate device and conformity to specifications for the modifications introduced.

Acceptance Criteria Category	Reported Device Performance / Assessment Method
Substantial Equivalence	"The modified VSP® System conforms to specifications... and that its performance is substantially equivalent to the unmodified VSP® System." (Section 9.1) "All Design, Process, and other Verification and Validation testing... showed conformity to pre-established specifications and acceptance criteria. The tests were performed in order to demonstrate device performance and substantial equivalence of the system to the unmodified version of the device." (Section 9.5) "Based on a comparison of the intended use and technological characteristics, the modified VSP® System is substantially equivalent to the identified predicate device." (Section 10.1)
Patient Contoured Implant Files	"The final output .STL files the cases designed using a patient contoured implant .STL file as input demonstrated clinical and / or dimensional equivalency to .STL files created using a standard implant .STL file as input." (Section 9.3)
Clinical Equivalence (for Implant Files)	"The reconstructive surgeon approved both design, which indicated that there is no clinically significant difference between the implant template .STL file created from a patient contoured implant .STL file and a standard implant .STL file." (Section 9.3)
Conformity to Specifications (Software Updates)	"Software installation qualification" and "Software validation" tests were executed for each software version upgrade. (Section 9.4.1.1.1, 9.4.1.1.2)
Conformity to Specifications (Additional SLA Hardware)	"Installation Qualification (IQ)", "Operational Qualification (OQ)", "Performance Qualification (PQ)", and "Software Validation" were performed for the additional Stereolithography Apparatus (SLA) model and associated wash tanks. (Section 9.4.1.2.1-9.4.1.2.4)
ASTM Standards (Accessories)	"The modified and unmodified VSP® System Accessories are manufactured to ASTM F899-11". (Section 8.1.6)

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" with a quantifiable sample size in terms of number of patients or cases. Instead, the testing appears to be focused on specific modifications and their impact.

For Patient Contoured Implant Files: "The final output .STL files the cases designed using a patient contoured implant .STL file as input..." (Section 9.3). The text refers to "cases" (plural) but does not provide a specific number.
For Software Updates: "Four (4) software components were upgraded". Tests were executed "for each software version upgrade." (Section 9.4.1.1). The direct sample size of test cases for these software validations is not detailed.
For Additional SLA: "An additional SLA model and associated wash tanks have been added..." (Section 9.4.1.2). The testing here (IQ, OQ, PQ, Software Validation) is for the hardware and its integration, not a patient-case-based test set.

Data Provenance: Not explicitly stated, though the context implies internal testing by Medical Modeling Inc. The document does not mention external data, country of origin of data, or if it was retrospective or prospective in the sense of a clinical trial. It describes a "process validation" (Section 9.2) focused on a "worst-case patient contoured implant file" and subsequent digital file outputs that met requirements.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

For Patient Contoured Implant Files: "The reconstructive surgeon approved both design..." (Section 9.3). This indicates one expert, identified as "the reconstructive surgeon." The specific qualifications (e.g., years of experience) are not provided beyond the title "reconstructive surgeon."

4. Adjudication Method for the Test Set

For Patient Contoured Implant Files: The document states, "The reconstructive surgeon approved both design." This suggests a single expert's approval was sufficient, implying no formal adjudication method (e.g., 2+1 or 3+1 consensus) among multiple experts was necessary for this specific part of the testing. The "clinical input and review from the physician during planning and processing" (Section 7.2) and "reviewed by the physician prior to finalization and distribution" (Section 7.4) of system outputs also points to individual physician review.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This submission is for a special 510(k) for a modified Virtual Surgical Planning (VSP) system, where the modifications primarily relate to input file types (patient contoured implant files) and internal manufacturing/software processes. The device itself is a software system for surgical planning and creating physical guides/models, not a diagnostic AI system meant to assist human readers in interpretation. The goal was substantial equivalence, not improved human reader performance with AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The VSP® System is itself a software component, so in a sense, its underlying algorithms operate in a "standalone" fashion to process inputs and generate outputs. However, the system is explicitly designed with "human-in-the-loop" aspects:

"The process requires clinical input and review from the physician during planning and delivery of the final outputs." (Section 7.2)
"The system is operated only by trained Medical Modeling employees, and the physician only provides input for interactive feedback through viewing of digital models... models are modified by the engineer during the planning session." (Section 7.2)
"Each system output is designed with physician input, and direct physician involvement to reduce the criticality of the outputs." (Section 7.4)

So, while the software performs its functions without direct human intervention at every step of its internal computations, the overall device workflow is inherently human-("clinician and trained employee")-in-the-loop, with outputs subject to expert review and approval. The testing described (e.g., "clinical and/or dimensional equivalency," "reconstructive surgeon approved") assesses the output of the system in the context of its intended use, which includes human oversight.

7. The Type of Ground Truth Used

The ground truth for the "patient contoured implant file" modification was based on:

Expert Consensus/Approval: "The reconstructive surgeon approved both design, which indicated that there is no clinically significant difference..." (Section 9.3). This relies on the expert judgment of a reconstructive surgeon.
Dimensional Equivalency: The comparison also sought "dimensional equivalency" (Section 9.3), implying quantitative measurements were involved, compared against established specifications or direct comparison of the designs.

For other internal modifications (software, hardware), the ground truth was conformity to "pre-established specifications and acceptance criteria" (Section 9.5) as demonstrated through standard qualification processes (IQ, OQ, PQ, software validation).

8. The Sample Size for the Training Set

The document does not specify a training set sample size. The VSP® System is not described as a machine learning or AI system that undergoes "training" in the conventional sense (i.e., learning from large datasets to develop an algorithm). It's a system that utilizes a combination of Commercial Off-The-Shelf (COTS) and custom software to manipulate 3D medical scan images based on predefined algorithms and engineering principles (Section 7.2). The modifications described are related to inputs, software updates, and manufacturing hardware, not algorithm retraining.

9. How the Ground Truth for the Training Set Was Established

As no training set is described (see point 8), the concept of establishing ground truth for a training set is not applicable to this submission.

Summary

{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 AvenueSuite 300Golden, 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 anatomicalmodels, templates, guides, and surgical plans
ClassificationName:	Bone Cutting Instrument and Accessories
Classification:	Class II, 21 CFR 872.4120
Product Code:	DZJ. LLZ

PREDICATE DEVICES 4

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

{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
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

Regulation Number and Section

§ 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.