Who is the manufacturer of Universal CMF System?

Stryker Leibinger GmbH & Co KG filed the 510(k) submission for Universal CMF System (K221855).

What is the FDA product code for Universal CMF System?

JEY. It is classified under 21 CFR 872.4760 as a Class 2 device in the Dental panel.

What is the regulatory pathway for Universal CMF System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Universal CMF System?

Universal CMF System (K022185); Stryker NewGen/Universal Mandibular System (K014263).

Who can help prepare an FDA 510(k) submission like Universal CMF System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Universal CMF System

K221855 · Stryker Leibinger GmbH & Co KG · JEY · Nov 9, 2022 · Dental

Device Facts

Record ID	K221855
Device Name	Universal CMF System
Applicant	Stryker Leibinger GmbH & Co KG
Product Code	JEY · Dental
Decision Date	Nov 9, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.4760
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Craniomaxillofacial Implants: The Universal CMF System is a Craniomaxillofacial (CMF) plate and screw system intended for osteotomy, stabilization and rigid fixation of CMF fractures and reconstruction. Mandible Implants: The Universal CMF System (mandible modules) is a mandibular plate and screw system intended for stabilization and rigid fixation of mandibular fractures and mandibular reconstruction.

Device Story

Universal CMF System is a plate and screw fixation system for craniomaxillofacial and mandibular fractures and reconstruction. System comprises various modules including straight, angled, curved, pre-bent, and hemi/full mandible bridging plates; screws include 1.2-2.7mm self-tapping, self-drilling, and locking types. Device is used by surgeons in clinical settings to provide rigid stabilization of bone segments during surgical procedures. System is provided non-sterile and requires end-user steam sterilization. Output is physical stabilization of bone, aiding in healing and structural reconstruction. No changes to design, materials, or operating principle from predicates; submission covers labeling changes and harmonization of sterilization parameters.

Clinical Evidence

No clinical data required. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993-1), insertion/removal/failure torque (ASTM F543), and failure strength (ASTM F382) conducted under prior clearances, plus new sterilization validation (DIN EN ISO 14937, DIN EN ISO 17665-1).

Technological Characteristics

Materials: Commercially pure titanium (ASTM F 67-95) and titanium alloy (ASTM F136-98). Fixation: Plate and screw system. Sterilization: Moist heat (steam) per harmonized IFU parameters. Dimensions: Plates 9.35-168.36mm length; screws 0.8-1.9mm diameter, 3-42mm length. No software or electronic components.

Indications for Use

Indicated for osteotomy, stabilization, and rigid fixation of craniomaxillofacial and mandibular fractures and reconstruction in patients requiring bone fixation.

Regulatory Classification

Identification

A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.

Predicate Devices

Universal CMF System (K022185)
Stryker NewGen/Universal Mandibular System (K014263)

Reference Devices

Universal Neuro System (K031659)

Related Devices

K022185 — UNIVERSAL CMF SYSTEM · Stryker Instruments · Dec 17, 2002
K172572 — Stryker Upper-Face AXS screws and Mid-Face AXS screws · Stryker · Oct 31, 2017
K071612 — MODUS TRILOCK 2.0/2.3/2.5 · Medartis AG · Sep 11, 2007
K171364 — MP LeFort I Plates · Stryker · Jul 24, 2017
K030806 — BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY · Bioplate, Inc. · Apr 8, 2003

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure, while the right side features the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. 11/9/2022 Stryker Leibinger GmbH & Co. KG Amelia Kesti Staff Regulatory Affairs Specialist Boetzinger Strasse 41 Freiburg, Freiburg D-79111 GERMANY Re: K221855 Trade/Device Name: Universal CMF System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY Dated: October 5, 2022 Received: October 7, 2022 Dear Amelia Kesti: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 II (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. {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Sherrill Lathrop Blitzer for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. Submission Number (if known) K221855 Device Name Universal CMF System Indications for Use (Describe) Craniomaxillofacial Implants: The Universal CMF System is a Craniomaxillofacial (CMF) plate and screw system intended for osteotomy, stabilization and rigid fixation of CMF fractures and reconstruction. Mandible Implants: The Universal CMF System (mandible modules) is a mandibular plate and screw system intended for stabilization and rigid fixation of mandibular fractures and mandibular reconstruction. 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary This section provides a summary of 510(k) information in accordance with the requirements of 21 CFR 807.92. #### I. SUBMITTER [§807.92(a)(1)] | 510(k) Owner: | Stryker Leibinger GmbH & Co. KG Boetzinger Strasse 41 D-79111 Freiburg, Germany | |-------------------|---------------------------------------------------------------------------------------| | Submitter/Contact | | Person: Amelia Kesti Staff Regulatory Affairs Specialist Stryker Craniomaxillofacial (CMF) 1941 Stryker Way Portage, MI 49002 Phone: 269-330-5919 Date prepared: 11/09/2022 - II. DEVICE [§807.92(a)(2)] | Trade Name: | Universal CMF System | |--------------------------------------------------|-------------------------------------------------| | Abbreviated Name: | Universal CMF System | | Common or Usual Name: | Bone Plates, Bone Fixation Fasteners | | Device: | Universal CMF System | | Classification Name & Regulation Description: | Plate, Bone; per 21 CFR §872.4760 | | | Regulation Medical Specialty & Review Panel: | | Product Code: | | | Subsequent Prod. Codes: | | | Regulatory Device Class: | Class II | {4}------------------------------------------------ #### III. PREDICATE DEVICE [§807.92(a)(3)] - A. Predicate Devices: The predicate devices for this bundled, traditional 510(k) are: - 1. Universal CMF System K022185 - i. Submission Branch of Predicate Device- Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices; Office of Device Evaluation, Center for Devices and Radiological Health - 2. Stryker NewGen/Universal Mandibular System K014263 - i. Submission Branch of Predicate Device- Division of Dental, Infection Control, and General Hospital Devices; Office of Device Evaluation, Center for Devices and Radiological Health - IV. DEVICE DESCRIPTION [§807.92(a)(4)] - A. Submission Branch of Subject Device: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, Office of Product Evaluation and Quality (OHT1) / Division of Dental Devices (DHT1B) - B. Subject Device: Universal CMF System - V. The subject device (combination of Universal CMF System (K022185) and NewGen/Universal Mandibular System (K014263)) consists of multiple modules including fracture and reconstruction modules. The modules consist of straight, angled, hemi/full mandible bridging, curved, and pre-bent plates. The screws in the modules include 1.2-2.7mm self-tapping, self-drilling, and locking screws that vary from 3mm-42mm in length. The plates and screws are made of commercially pure titanium (ASTM F 67-95) and titanium alloy (ASTM F136-98). See Table 1 below for a summary of dimensions for the subject device and predicates. There is no change to the subject device as part of this submission, only labeling changes. | Table 1: Comparison of Size Ranges Between the Predicate And Subject Devices | | | | |------------------------------------------------------------------------------|--------------------------------------------|------------------------------|---------------------------------| | Dimension range or attribute | Predicate Devices – K022185 and K014263 | Subject Device | Explanation of differences | | Plate Length (straight and 3D plates only) | Min 9.35 mm Max 168.36 mm | Min 9.35 mm Max 168.36 mm | No differences in comparison | | Screw Length | Min 2.7 mm Max 42 mm | Min 2.7 mm Max 42 mm | No differences in comparison | | Screw | Min 0.8 mm | Min 0.8 mm | No differences | {5}------------------------------------------------ | Diameter | Max 1.9 mm | Max 1.9 mm | in comparison | |--------------------------------------------------------------------------------------|---------------------------|---------------------------|---------------------------------| | Plate Profile | Min 0.3 mm | Min 0.3 mm | No differences | | Height | Max 2.85 mm | Max 2.85 mm | in comparison | | Plate Main bar width (not applicable for plates with double strip) | Min 0.65 mm Max 5.5 mm | Min 0.65 mm Max 5.5 mm | No differences in comparison | | Plate Outer diameter at screw hole | Min 3 mm Max 9 mm | Min 3 mm Max 9 mm | No differences in comparison | {6}------------------------------------------------ #### VI. INDICATIONS FOR USE [§807.92(a)(5)] | Table 2: Comparison of Indications for Use | | | | | |--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Subject Device | Predicate Device – K022185 | Predicate Device – K014263 | Equivalence Assessment | | Indications for Use | Craniomaxillofacial Implants: The Universal CMF System is a Craniomaxillofacial* (CMF) plate and screw system intended for osteotomy, stabilization and rigid fixation of CMF fractures and reconstruction. Mandible Implants: The Universal CMF System (mandible modules) is a mandibular plate and screw system intended for stabilization and rigid fixation of mandibular fractures and mandibular reconstruction. | The Stryker Leibinger Universal CMF System is a Cranio- maxillofacial (CMF) plate and screw system intended for osteotomy, stabilization and rigid fixation of CMF fractures and reconstruction. | The Stryker Leibinger New Generation System is a mandibular plate and screw system intended for stabilization and rigid fixation of mandibular fractures and mandibular reconstruction. | Similar The K022185 and K014263 indications are kept the same in the new submission. The indications listed in the new submission are the same as the predicates, but are labeled as "Craniomaxillofacial Implants" and "Mandible Implants" for K022185 and K014263 respectively. | *The use of the term "craniomaxillofacial" in the subject device's intended use and indication for use is to maintain alignment with the name of the System. Additionally, the term "craniomaxillofacial" is not intended for cramial use, but rather to address fractures where there is some overlap between the cranial and facial bones. For clinical conditions involving the cranium. Universal Neuro System (K031659) is utilized. This is a separate 510(k) cleared device specifically intended for the cranium and is not part of this K221855 submission. # VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE [§807.92(a)(6)] The subject device is compared to its predicate device for substantial equivalence of technological characteristics based on the following criteria: - A. Principles of Operation - B. Technological Characteristics This submission is intended to demonstrate substantial equivalence for the following proposed changes: changing device name to Universal CMF System, merging indications for use, harmonization to add new sterilization parameters across the subject devices from previous clearances, and labeling changes. # A. Principles of Operation / Operating Principle The operational principle of the subject device is a plate and screw system intended for stabilization and rigid fixation of the craniomaxillofacial (CMF) skeleton. The method of site preparation, implant preparation, and fixation remains the same as the predicate devices as there is no change to the device. {7}------------------------------------------------ ## B. Technological Characteristics The technological characteristics of the subject device remain the same as the predicates. See table 3 below for a comparison of technological characteristics between the predicate and subject devices: - Similar Intended Use and Indication for Use: The K022185 and K014263 indications are kept the same. The indications listed in the subject device are the same as the predicates but are labeled as "Craniomaxillofacial Implants" and "Mandible Implants" for K022185 and K014263 respectively. - -Same Mode of Fixation: There is no change to the mode of fixation of subject device as part of this submission, only labeling changes. {8}------------------------------------------------ - Same Materials of Construction: There is no change to the materials of construction to the subject device as part of this submission, only labeling changes. - -Same Design: There is no change to the design of the subject device as part of this submission. This 510(k) is submitted to demonstrate substantial equivalence for the following proposed changes: changing device name to Universal CMF System, merging indications for use, harmonization to add new sterilization parameters across the subject devices from previous clearances, and labeling changes. | Table 3: Comparison of Technological Characteristics Between the Predicate And Subject Devices | | Predicate Device – K014263 | Subject Device | Explanation of differences | |------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Predicate Device – K022185 | | | | | Mode of fixation | Fixated to bone | Fixated to bone | Fixated to bone | No differences in comparison | | Operating Principle | The operating principle of the Universal CMF System is to stabilize or rigidly fixate bone during osteotomy for fractures and reconstruction using plates and screws. | The operating principle of the Universal CMF System is to stabilize or rigidly fixate mandibular fractures during mandibular reconstruction using plates and screws. | The operating principle of the Universal CMF System to stabilize or rigidly fixate craniomaxillofacial (CMF) skeleton for fractures and reconstructive surgeries using plates and screws. | This is only a labeling change, there is no change to the product design or use. The two prior 510(k)s are being combined under one brand- Universal CMF System. | | Device materials | Commercially pure titanium (ASTM F 67-95) and titanium alloy (ASTM F136-98) | Commercially pure titanium (ASTM F 67- 95) and titanium alloy (ASTM F136-98) | Commercially pure titanium (ASTM F 67-95) and titanium alloy (ASTM F136-98) | No differences in comparison | | Device design | The Universal CMF System (K022185) is a comprehensive craniomaxillofacial titanium plating system and includes a wide selection of implants for bone fixation of craniomaxillofacial fractures and reconstruction. The system consists of multiple modules including: 1.2mm Upperface Plating, 1.7mm Midface Plating, Orthognathic Fixation, and 2.0mm Mini Plating Modules. The modules consist of straight, angled, curved, | The NewGen/Universal Mandibular System (K014263) is a mandibular plate and screw system intended for stabilization and rigid fixation of mandibular fractures and mandibular reconstruction. The system consists of modules including: 2.0mm and 2.3mm Fracture and Reconstruction Modules. The 2.0 and 2.3mm Fracture/Reconstruction Modules consist of straight, angled, curved plates, and pre-bent plates for fractures and hemi/full mandible bridging plates for reconstruction. The screws in the modules include 2.0mm | The subject device (combination of Universal CMF System (K022185) and NewGen/Universal Mandibular System (K014263)) consists of multiple modules including fracture and reconstruction modules. The modules consist of straight, angled, hemi/full mandible bridging, curved, and pre-bent plates. The screws in the modules include 1.2-2.7mm self-tapping, self- drilling, and locking screws that vary from 3mm- 42mm in | The subject device is a combination of the two predicate devices (Universal CMF System (K022185) and NewGen/Universal Mandibular System (K014263). | | | plates. The screws in the modules include 1.2-2.7mm diameter self- tapping, self- drilling, and locking screws that vary from 3mm- 20mm in length. The plates and screws are made of commercially pure titanium (ASTM F 67-95) and titanium alloy (ASTM F136-98). | lag, and locking screws that vary from 4mm- 42mm in length. The plates and screws are made of commercially pure titanium (ASTM F 67-95) and titanium alloy (ASTM F136-98). | and screws are made of commercially pure titanium (ASTM F 67-95) and titanium alloy (ASTM F136-98). | | | Size ranges | Screws from 0.8mm to 1.9mm in diameter and 2.7mm to 42mm in length. Plates from 9.35mm to 168.36mm in length. | Screws from 0.8mm to 1.9mm in diameter and 2.7mm to 42mm in length. Plates from 9.35mm to 168.36mm in length. | Screws from 0.8mm to 1.9mm in diameter and 2.7mm to 42mm in length. Plates from 9.35mm to 168.36mm in length. | No differences in comparison | | Method of sterilization | Provided non-sterile. Sterilized by end user using moist heat (steam) per IFU parameters. | Provided non-sterile. Sterilized by end user using moist heat (steam) per IFU parameters. | Provided non-sterile. Sterilized by end user using moist heat (steam) per IFU parameters. | The sterilization parameters were harmonized for the subject device. The method of sterilization remains the same. | {9}------------------------------------------------ ## VIII. PERFORMANCE DATA [§807.92(b)(7)] There are no modifications to the subject device as part of this submission, only labeling changes. The labeling change included a harmonization of the sterilization parameters, testing for this update is outlined below. Table 4 summarizes the sterilization testing performed on the subject device, Table 5 outlines testing conducted under prior clearances (K022185 and K014263) to demonstrate substantial equivalence. ## Sterilization and Biocompatibility Testing The subject device includes single-use medical implants provided non-sterile to the user. Although there were no modifications to the subject device as part of this submission, the sterilization parameters within the IFU (instructions for use) were harmonized. Compared to the predicate devices, the sterilization testing conducted for the subject device has the same sterilization type, source, and validation standards as the predicate devices. Although there is a change in the sterilization parameters listed in the updated IFU for some components of the subject device, the change does not affect the Sterility Assurance Level (SAL) and there is no change to the way the device is provided (device is still provided non-sterile). The change does not affect performance or biocompatibility of the device. The harmonized sterilization parameters for the subject device do not impact sterility of the final end-product, as the harmonization encompasses the previously valid sterilization parameters that were used for the components under prior clearances (K022185 and K014263). A summary of the sterilization testing for the subject device can be found in Table 4 below. {10}------------------------------------------------ | Table 4: Sterilization Testing | | |------------------------------------------------------------------------------------------------------------|-------------| | Test | Conclusions | | Sterilization Validation (Pre-Vacuum) (DIN EN ISO 14937, DIN EN ISO 17665-1 and ISO/TS 17665- 2.) | Pass | | Sterilization Validation (Flash Gravity) (DIN EN ISO 14937, DIN EN ISO 17665-1 and ISO/TS 17665- 2.) | Pass | ### Performance Bench Testing The following testing listed in Table 5 was conducted under the prior clearances (K022185, K014263) to demonstrate substantial equivalence. | Product | Test | Result | |----------------------------------|-----------------------------------------------|--------| | Universal CMF Plates | Biocompatibility (ISO 10993-1) | Pass | | Universal CMF Screws | Biocompatibility (ISO 10993-1) | Pass | | Universal CMF Screws | Insertion Torque (ASTM F543) | Pass | | Universal Mandible and MP System | Removal Torque (ASTM F543) | Pass | | Universal CMF Screws | Failure Torque (shaft shear test) (ASTM F543) | Pass | | Universal CMF Mid-Face Plates | Failure Strength (ASTM F382) | Pass | ### Animal Testing Animal testing was not required as a basis for substantial equivalence. ## Clinical Testing [§807.92(b)(2)] Clinical testing was not required as a basis for substantial equivalence. #### IX. CONCLUSIONS [§807.92(b)(3)] In summary, the subject device is substantially equivalent to its predicate device. The subject device's fundamental scientific technology, technological characteristics, and materials of construction are the same as the predicate devices. The subject device's intended use and indications for use have the same scope, content and meaning as the predicate devices. According to the comparison based on the requirements of 21 CFR 807.87 and the information provided herein, it is concluded that the information included in this submission supports substantial equivalence to the predicate device.