SPEEDY FLAP SYSTEM

K130447 · Jeil Medical Corporation · GXN · Dec 22, 2014 · Neurology

Device Facts

• Record ID: K130447
• Device Name: SPEEDY FLAP SYSTEM
• Applicant: Jeil Medical Corporation
• Product Code: GXN · Neurology
• Decision Date: Dec 22, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5330
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Speedy Flap System is intended for use in the fixation of cranioplasty plates, and fixation of cranial fractures.

Device Story

Speedy Flap System is a sterile, single-use cranial fixation device consisting of an upper plate, lower plate, and rod. It is used by surgeons in clinical settings to secure cranioplasty plates and fix cranial fractures. The device is made of titanium alloy (ASTM F136). During surgery, the device is applied to the cranial bone/plate interface to provide mechanical fixation. The surgeon manually operates the system to clamp the components together. The device provides stable fixation of bone segments or plates, which aids in the healing process and structural integrity of the cranium post-surgery or trauma. It is a mechanical fastener system; no electronic or software components are involved.

Clinical Evidence

Bench testing only. Testing included dimension verification, movement force testing, separation force testing (before and after rod cutting), climatic conditioning, package performance, visual inspection, leak detection, seal strength, chemical analysis (SEM/GC-MS), shelf-life testing (accelerated and real-time), and sterilization validation (ISO 11137). Results confirmed the device meets all acceptance criteria and performs equal to or better than the predicate.

Technological Characteristics

Materials: Titanium Alloy Ti6Al4V ELI (ASTM F136-11). Components: Upper plate, lower plate, rod. Sterilization: Radiation. Mechanical principle: Clamp-based fixation. Dimensions: 12mm, 16mm, 20mm diameters. No software or electronic components.

Indications for Use

Indicated for fixation of cranioplasty plates, covering burr holes, and fixation of cranial fractures in patients requiring cranial stabilization.

Regulatory Classification

Identification

A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.

Predicate Devices

• CranioFix (K040864)
• CranioFix 2 Titanium Clamp System (K122353)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and connection.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 22, 2014

Jeil Medical Corporation % Ms. Priscilla Chung Official Correspondent LK Consulting Group USA, Inc. 2651 E Chapman Avenue, Suite 110 Fullerton, CA 92831

Re: K130447

> Trade/Device Name: Speedy Flap System Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed Non-Alterable Cranioplasty Plate Regulatory Class: Class II Product Code: GXN, GXR Dated: November 21, 2014 Received: November 24, 2014

Dear Ms. Chung:

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 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.

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

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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 Industry and Consumer Education at its toll-free number [phone] or [phone] 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carlos L. Pena -S FD/A

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K130447

Device Name Speedy Flap System

### Indications for Use (Describe)

Speedy Flap System is intended for use in the fixation of cranioplasty plates, and fixation of cranial fractures.

Type of Use (*Select one or both, as applicable*)

| <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> |
|--------------------------------------------------------------------------------------------------------|
| <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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# 510(k) Summarv

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92(c).

#### 1. Date

December 17, 2014

#### 2. Applicant

| | Company |
|---------|-----------------------------------------------------------------------------------------------|
| Name | Jeil Medical Corporation |
| Address | #702, Kolon science valley 2nd<br>811, Guro-Dong, Guro-Gu<br>Seoul, Republic of Korea 152-050 |
| Phone | [phone] |
| Fax | [phone] |
| Contact | Jieun Kim |

#### 3. Submission Contact Person

Priscilla Chung LK Consulting Group USA, Inc. US Agent for Jeil Medical Corporation Tel: [phone] Fax: [phone] E-mail: [e-mail]

#### 4. Device Identification

- Proprietary Name Speedy Flap System
- · Common Name Cranioplasty Plate Fastener
- · Classification Name Plate, Cranioplasty

#### 5. Device Classification

- י Classification: Class II
- י Product Code: GXN, GXR
- Regulation Number: 21CFR882.5330, 21 CFR 882.5250 트

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- . Review Panel: Neurology
#### Predicate Devices 6.

- 510(k) Number: K040864 and K122353 I
- Product Name: CranioFix and CranioFix 2 Titanium Clamp System '
- Manufacturer's Name: Aesculap, Inc. I

#### Device Description 7.

The Speedy Flap is designed for the fixation of cranioplasty plates, covering burr holes, and fixation of cranial fractures. This device is made of the Titanium Alloy (ASTM F136). The Speedy Flap is composed of three parts: upper plate, lower plate and rod. This device supplied sterile and single use only.

#### 8. Indication for Use

The Speedy Flap is intended for use in the fixation of cranioplasty plates, covering burr holes, and fixation of cranial fractures.

#### Substantial Equivalence Discussion 9.

The Speedy Flap System has the same device characteristics, intended use, materials, design and use concept, sterilization, etc. as the predicate device, the CranioFix System. Only the dimensional specifications - shape, diameter and length - are slightly different. There are no technological differences that affect the safety or effectiveness of the device.

The table below compares the Speedy Flap System attributes with those of the predicate device.

| Attribute | Speedy Flap System | CranioFix and CranioFix<br>2 Titanium Clamp<br>System |
|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K130447 | K040864<br>K122353 |
| Manufacturer | Jeil Medical Coporation | Aesculap, Inc. |
| Intended use | The Speedy Flap System<br>is intended for use in<br>fixation of cranioplasty<br>plates, covering burr<br>holes, and fixation of<br>cranial fractures. | The CranioFix System is<br>intended for use in fixation<br>of cranioplasty plates,<br>covering burr holes, and<br>fixation of cranial<br>fractures. |
| Device Design | Clamp Outer Diameter<br>SF-12F - 12mm<br>SF-16F - 16mm | Clamp Outer Diameter<br>FF490T - 11mm<br>FF491T - 16mm |

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| | SF-20F - 20mm | FF492T - 20mm |
|----------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|
| | Clamp Length<br>SF-12F - 42.1mm,<br>SF-16F - 43.3mm,<br>SF-20F - 43.3mm | Clamp Length<br>FF490T - 51.0mm,<br>FF491T - 51.0mm,<br>FF492T - 51.0mm |
| | Movement force between<br>the Plate and the Rod: | |
| Technical Specification | SF-12F: 141N<br>SF-20F: 98N | Cranio Fix2(11mm): 94N<br>Cranio Fix2(20mm): 96N |
| | Separation force between<br>the Plate and the Rod: | |
| | SF-12F: 323N<br>SF-20F: 198N | Cranio Fix2(11mm): 312N<br>Cranio Fix2(20mm): 147N |
| Biocompatibility | Acceptable | Acceptable |
| Composition<br>of Material | Titanium Alloy Ti6Al4V<br>ELI<br>conforming to ASTM<br>F136-11 | Titanium Alloy Ti6Al4V ELI<br>conforming to ASTM<br>F136-11 |
| Usage | Not Reusable | Not Reusable |
| Sterilization | Radiation Sterilization | Radiation Sterilization |

The cranial plates and rods of the Speedy Flap System are substantially equivalent to the cranial plates and rods of its predicate Device, CranioFix System. There are no technological differences that affect the safety or effectiveness of the device.

# 10. Non-clinical testing

| Test | Test Method | Results |
|---------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dimension Test | Measure the dimension of<br>the test sample by Vernia-<br>Calipus. The tolerance of<br>the error range of the<br>dimension shall be within<br>±5%. | within ±5% |
| Movement Force Test | Compress the axial load at<br>the lower plate at a rate of<br>1mm/min. Measure the<br>maximum load that the<br>lower plate fixes. | Speedy Flap Syste<br>- SF-12F: 141N<br>- SF-20F: 98N<br>CranioFix System:<br>- CranioFix 2 (11mm):<br>94N<br>- CranioFix 2 (20mm):<br>96N |
| Separation Force Test | Grip the rod of the system<br>and apply compressive<br>axial load at a rate of<br>1mm/min until the rod is<br>separated from the plate. | Speedy Flap Syste SF-12F: 323N SF-20F: 198N CranioFix System: CranioFix 2 (11mm): 312N CranioFix 2 (20mm): 147N |
| Separation Force<br>testing before and<br>after rod cutting | Same test method as<br>above.<br>Compare test results<br>between the sample with<br>the rod and the sample<br>with the rod cut | No significant change. The<br>test results support that the<br>upper disk will not be<br>loosened after the rod<br>cutting. |
| Climatic conditioning,<br>Package<br>performance, Visual<br>inspections, Gross<br>leak<br>detection(bubble) and<br>seal strength(peel)<br>testing | The purpose of testing was<br>to validate the ability of the<br>package systems to<br>protect the Speedy Flap<br>System from hazards<br>typically associated with<br>the shipping and<br>distribution environment.<br>The testing was performed<br>in accordance with the<br>following standards. ASTM D4332-13 ASTM D5276-98 ASTM D642-00 ASTM D999-08 ASTM D4728-06 ASTM D6344-04 ASTM D5276-98 ASTM F1886/F1886M-09 ASTM F2096-11 ASTM F88/F88M-09 | There were no anomalies<br>throughout the conduct of<br>the test and the test results<br>of all the test samples<br>support the suitability of<br>the package configuration<br>for the Speedy Flap<br>System. |
| Chemical Analysis<br>Qualitative analysis of<br>organic residual | SEM(Scanning<br>Electron Microscopy)<br>Gas chromatograph<br>Mass spectrometer | There was no other<br>elements on the surface<br>of the subject device<br>other than the elements<br>of the raw<br>material(titanium alloy). The residual detected. |
| Shelf Life Test | Accelerated and real time<br>shelf life testing were | The product met all<br>acceptance criteria |
| | conducted to establish 3<br>year shelf life of the<br>Speedy Flap System.<br>Sterility, visual inspection,<br>package integrity and the<br>performance of the subject<br>device were evaluated<br>after aging. | |
| Sterilization<br>Validation Test | Sterilization validation test<br>was performed to validate | The sterilization method for<br>the Speedy Flap System |
| | the sterilization method for<br>the Speedy Flap System. | has been validated as<br>effective through the study. |
| | The testing was conducted | |
| | in accordance with the | |
| | following standards.<br>ISO 11137-1<br>트 | |
| | ISO 11137-2<br>■ | |
| | ISO 11137-3<br>■ | |

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The test results of the movement force test and the seperation force test of the subject device were higher than the predicate devie; therefore, we conclude that the subject device performs as well as or better than the predicate device. Other testing results support that the subject device has a safety profile that is similar to the predicate devices.

## 11. Conclusions

Based on the information provided in this premarket notification, Jeil Medical Corporation concludes that Speedy Flap System has a safety and effectiveness profile that is similar to the legally marketed predicate devices.