(134 days)
Not Not Found
No
The summary describes a mechanical device for bone distraction and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended to correct congenital or post-traumatic defects in the mandible, which is a therapeutic intervention.
No
The device is a Pediactric Mandible Distractor intended for bone stabilization and lengthening, not for diagnosing medical conditions.
No
The device description clearly outlines physical components like a distractor with integrated footplates, an activation rod, and an activation key, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "bone stabilization and lengthening of the mandibular body and ramus" to correct defects. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a mechanical system designed to physically distract bone segments. It consists of components like a distractor, footplates, and activation rods.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. This device does not interact with biological specimens for diagnostic purposes.
The device is a surgical implant used for bone distraction, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Stryker Pediatric Mandible Distractor is intended to be used for bone stabilization and lengthening of the mandibular body and ramus. The Stryker Pediatric Mandible Distractor is indicated to correct congenital or post traumatic defects in the body and ramus of the mandible of neonates and children up to 4 years old.
Product codes
MQN
Device Description
The Pediatric Mandible Distractor (PMD) System is a distraction system consisting of the following major components: distractor with integrated footplates, a removable activation rod and an activation key. The distractor initially stabilizes and then gradually distracts the bone segments separated by osteotomy. The removable activation rod is connected to the distractor and provides the point of attachment for the external activation key used to initiate the distraction of the bone segments.
The Pediatric Mandible Distractor (Subject Device) includes the distractor body. integrated footblates, a sliding footblate, and the activation ioint (to attach the activation rod). It is available in eight variants with two different distraction lengths (20 and 30 mm), right or left footplate configuration with footplate sizes having either a 2X2 or 3X3 hole pattern.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibular body and ramus
Indicated Patient Age Range
neonates and children up to 4 years old
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Testing:
No clinical testing was performed to support this submission.
Non-Clinical Testing:
Verification and Validation (V&V) evaluation has been performed on the Subject Device in the following categories: biocompatibility, corrosion, cleaning validation, sterilization validation, simulated aging, residual moisture after sterilization, bench testing (static and dynamic four-point bending test, compression force, distraction force tests), and handling of system (end use test). The Subject Device fulfilled all set acceptance criteria for each category in accordance with either ISO or ASTM specifications, or internally predetermined acceptance criteria if no standards are applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4760 Bone plate.
(a)
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.(b)
Classification. Class II.
0
Stryker Pediatric Mandible Distractor
MAR 2 0 2014
stryker
510(k) Summary
| Date prepared: | November 05, 2013 |
|---|---|
| Submitter: | Stryker Leibinger GmbH & Co. KG |
| Bötzinger Straße 41 | |
| 79111 Freiburg | |
| Germany | |
| Contact: | Jamshed Badarpura |
| Stryker Craniomaxillofacial | |
| 750 Trade Centre Way, Suite 200 | |
| Portage, MI 49002, USA | |
| Phone: (269) 389-4260 | |
| Fax: (877) 648-7114 | |
| jamshed.badarpura@stryker.com | |
| Proprietary Name: | Stryker Pediatric Mandible Distractor |
| Common Name: | Bone plate system |
| Proposed Regulatory Class: | Class II |
| Product Codes: | MQN - Bone Plate |
| Predicate Devices: | 1. OsteoMed Pediatric Intraoral Mandibular Distraction System, Extended - K062851 |
- KLS Micro Zurich Distractor (aka: Zurich Distraction System) - K010139
- Leibinger Advance Internal Midface Distraction System - K092743 |
Intended Use:
The Stryker Pediatric Mandible Distractor is intended to be used for bone stabilization and lengthening of the mandibular body and ramus.
Indication for Use:
The Stryker Pediatric Mandible Distractor is intended to be used for bone stabilization and lengthening of the mandibular body and ramus. The Stryker Pediatric Mandible Distractor is indicated to correct congenital or post traumatic defects in the body and ramus of the mandible of neonates and children up to 4 years old.
Traditional 510(k)
1
Stryker Pediatric Mandible Distractor : 上一篇: 上一篇:
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Image /page/1/Picture/17 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase except for the "s", which is uppercase. There is a small superscript symbol to the right of the "r".
Device Description:
The Pediatric Mandible Distractor (PMD) System is a distraction system consisting of the following major components: distractor with integrated footplates, a removable activation rod and an activation key. The distractor initially stabilizes and then gradually distracts the bone segments separated by osteotomy. The removable activation rod is connected to the distractor and provides the point of attachment for the external activation key used to initiate the distraction of the bone segments.
The Pediatric Mandible Distractor (Subject Device) includes the distractor body. integrated footblates, a sliding footblate, and the activation ioint (to attach the activation rod). It is available in eight variants with two different distraction lengths (20 and 30 mm), right or left footplate configuration with footplate sizes having either a 2X2 or 3X3 hole pattern.
Technological and Operational Characteristics:
The Stryker Pediatric Mandible Distractor is similar to its predicate devices having the following technological and operational characteristics:
- Both the subject device and the predicate devices Material: are made of biocompatible titanium:
- . The subject device is made of commercially pure titanium (CP Ti) and stainless steel.
- The Predicate Device Nº 1 is made of titanium . and nickel titanium.
- The Predicate Device Nº 2 is made of titanium . allov.
- . The Predicate Device Nº 3 is made of titanium, titanium alloy, and stainless steel.
- Design:
The design of the subject device is similar to the predicate devices. They all have the same components: body, footplates, activation joint (for activation rod connection), In addition, the subject device uses the same components and interfaces (e.q. activation rod) for distraction activation as the predicate devices. The subject device and its predicate devices offer various options of
2
distraction lengths and footplate sizes. The footplates of the subject device are fully integrated (i.e. non-welded) compared to the predicate device Nº1 (assembled), Nº 2 (welded footplates), and the predicate device Nº 3 (screwed footplates).
The basic operational principle of the subject Principal of device as well as the predicate devices is for bone Operation: stabilization and lengthening. The method of site preparation and fixation is the same for both subject and predicate devices. The subject device and predicate devices are temporary implants.
The subject device and all predicate devices are Packaging: . dispensed non-sterile.
Clinical Testing:
.
No clinical testing was performed to support this submission.
Non-Clinical Testing:
Verification and Validation (V&V) evaluation has been performed on the Subject Device in the following categories: biocompatibility, corrosion, cleaning validation, sterilization validation, simulated aging, residual moisture after sterilization, bench testing (static and dynamic four-point bending test, compression force, distraction force tests), and handling of system (end use test). The Subject Device fulfilled all set acceptance criteria for each category in accordance with either ISO or ASTM specifications, or internally predetermined acceptance criteria if no standards were applicable. All applied ISO standards are listed below:
3
stryker®
| Reference | Title |
|---|---|
| Biocompatibility | |
| DIN EN ISO 10993 ff as | |
| valid 2013 | Biological evaluation of medical devices. Part 1: |
| Evaluation and testing within a risk management | |
| system | |
| Bench Testing | |
| ASTM F 382 | Standard Specification and Test Method for Metallic |
| Bone Plates | |
| ASTM STP 731 | Tables for Estimating Median Fatigue Limits |
| Sterility/Reprocessing | |
| ISO 11138-1:2006 | Sterilization of health care products - Biological |
| indicators - Part 1: General requirements | |
| DIN EN ISO 11737-1:2009 | Sterilization of medical devices - Microbiological |
| methods - Part 1: Determination of a population of | |
| microorganisms on products | |
| DIN EN ISO 11737-2:2009 | Sterilization of medical devices - Microbiological |
| methods - Part 2: Tests of sterility performed in the | |
| validation of a sterilization process | |
| DIN EN ISO 14161:2011 | Sterilization of health care products - Biological |
| indicators - Guidance for the selection, use and | |
| interpretation of results | |
| DIN EN ISO 14937:2009 | Sterilization of health care products - general criteria |
| for characterization of a sterilizing agent and | |
| development, validation and routine control of a | |
| sterilization process | |
| EN ISO 15883-1:2009 | Washer-disinfectors: General requirements, terms |
| and definitions and tests | |
| DIN EN ISO 17664:2004 | Sterilization of medical devices - Information to be |
| Reference | Title |
| provided by the manufacturer for the processing of | |
| resterilizable medical devices | |
| DIN EN ISO 17665-1:2006 | Sterilization of health care products – Moist heat – |
| Part 1: Requirements for the development, validation | |
| and routine control of a sterilization process for | |
| medical devices | |
| DIN ISO/TS 17665-2:2009 | Sterilization of health care products – Moist heat - |
| Part 2: Guidance on the application of ISO 17665-1 |
4
stryker
Substantial Equivalence Conclusion:
The Stryker Pediatric Mandible Distractor is substantially equivalent to its predicate devices with respect to its intended use, design, materials and operational principle. Further, the performance testing confirms that the Stryker Pediatric Mandible Distractor is safe and effective for its intended use, and performs as well as the predicate devices.
Traditional 510(k)
5
Image /page/5/Picture/0 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the edge. In the center of the seal is a stylized image of an eagle with its wings spread. The eagle is facing to the right. The image is black and white.
Public Health Service
Food and Drue Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 20, 2014
Stryker Leibinger GmbH & Co. KG C/O Mr. Jamshed Badarpura Senior Regulatory Compliance Analyst Stryker Craniomaxillofacial 750 Trade Center Way, Suite 200 Portage. MI 49002
Re: K133398
Trade/Device Name: Stryker Pediatric Mandible Distractor Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate System Regulatory Class: II Product Code: MQN Dated: February 10, 2014 Received: February 14, 2014
Dear Mr. Badarpura:
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. Ilisting 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 cither 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.
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Page 2 - Mr. Badarpura
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 (OS) 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/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/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Clinical Deputy Director
DAGRID
FOR
Erin 1. 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
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Indications for Use
| 510(k) Number (if known): | K133398 |
|---|---|
| --------------------------- | --------- |
Device Name: Stryker Pediatric Mandible Distractor
Indications For Use: The Stryker Pediatric Mandible Distractor is intended to be used for bone stabilization and lengthening of the mandibular body and ramus. The Stryker Pediatric Mandible Distractor is indicated to correct congenital or post traumatic defects in the body and ramus of the mandible of neonates and children up to 4 years old.
x
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mary S. Runner -S
Susan Runner DDS, MS 2014.03.19
09:42:59 -04'00'
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