(669 days)
Not Found
No
The summary describes a mechanical fixation device made of titanium alloy with no mention of software, algorithms, or any technology related to AI or ML. The performance studies are based on mechanical testing, not data analysis or image processing.
No
The device is described as a system for fixation of cranioplasty plates and cranial fractures, which are structural and mechanical functions rather than therapeutic.
No
The device description and intended use clearly state that the Speedy Flap System is for fixation of plates and fractures, which is a therapeutic or surgical function, not a diagnostic one.
No
The device description explicitly states it is made of Titanium Alloy and is composed of three physical parts (upper plate, lower plate, and rod). The performance studies focus on physical properties like force and separation, not software performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of cranioplasty plates, and fixation of cranial fractures." This is a surgical procedure performed directly on a patient's body.
- Device Description: The device is a physical implant made of titanium alloy, designed to mechanically fix bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for structural support and fixation.
N/A
Intended Use / Indications for Use
Speedy Flap System is intended for use in the fixation of cranioplasty plates, and fixation of cranial fractures.
Product codes
GXN, GXR
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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
Non-clinical testing was performed including Dimension Test, Movement Force Test, Separation Force Test, Separation Force testing before and after rod cutting, Climatic conditioning, Package performance, Visual inspections, Gross leak detection(bubble) and seal strength(peel) testing, Chemical Analysis Qualitative analysis of organic residual, Shelf Life Test, and Sterilization Validation Test.
Key results:
- Dimension Test: within ±5%
- Movement Force Test: Speedy Flap System - SF-12F: 141N, SF-20F: 98N. CranioFix System - CranioFix 2 (11mm): 94N, CranioFix 2 (20mm): 96N.
- Separation Force Test: Speedy Flap System - SF-12F: 323N, SF-20F: 198N. CranioFix System - CranioFix 2 (11mm): 312N, CranioFix 2 (20mm): 147N.
- Separation Force testing before and after rod cutting: No significant change. The test results support that the upper disk will not be loosened after the rod cutting.
- Climatic conditioning, Package performance, Visual inspections, Gross leak detection(bubble) and seal strength(peel) testing: There were no anomalies throughout the conduct of the test and the test results of all the test samples support the suitability of the package configuration for the Speedy Flap System.
- Chemical Analysis Qualitative analysis of organic residual: There was no other elements on the surface of the subject device other than the elements of the raw material (titanium alloy). The residual detected.
- Shelf Life Test: The product met all acceptance criteria.
- Sterilization Validation Test: The sterilization method for the Speedy Flap System has been validated as effective through the study.
The test results of the movement force test and the separation force test of the subject device were higher than the predicate device; therefore, it was concluded that the subject device performs as well as or better than the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5330 Preformed nonalterable cranioplasty plate.
(a)
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.(b)
Classification. Class II (performance standards).
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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
1
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 (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 Industry and Consumer Education 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,
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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 |
| 811, Guro-Dong, Guro-Gu | |
| Seoul, Republic of Korea 152-050 | |
| Phone | +82 2 850-3524 |
| Fax | +82 2 850-3525 |
| Contact | Jieun Kim |
3. Submission Contact Person
Priscilla Chung LK Consulting Group USA, Inc. US Agent for Jeil Medical Corporation Tel: 714-202-5789 Fax: 714-409-3357 E-mail: juhee.c@lkconsultinggroup.com
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
2 Titanium Clamp
System |
|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K130447 | K040864
K122353 |
| Manufacturer | Jeil Medical Coporation | Aesculap, Inc. |
| Intended use | The Speedy Flap System
is intended for use in
fixation of cranioplasty
plates, covering burr
holes, and fixation of
cranial fractures. | The CranioFix System is
intended for use in fixation
of cranioplasty plates,
covering burr holes, and
fixation of cranial
fractures. |
| Device Design | Clamp Outer Diameter
SF-12F - 12mm
SF-16F - 16mm | Clamp Outer Diameter
FF490T - 11mm
FF491T - 16mm |
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| SF-20F - 20mm | FF492T - 20mm | |
|---|---|---|
| Clamp Length | ||
| SF-12F - 42.1mm, | ||
| SF-16F - 43.3mm, | ||
| SF-20F - 43.3mm | Clamp Length | |
| FF490T - 51.0mm, | ||
| FF491T - 51.0mm, | ||
| FF492T - 51.0mm | ||
| Movement force between | ||
| the Plate and the Rod: | ||
| Technical Specification | SF-12F: 141N | |
| SF-20F: 98N | Cranio Fix2(11mm): 94N | |
| Cranio Fix2(20mm): 96N | ||
| Separation force between | ||
| the Plate and the Rod: | ||
| SF-12F: 323N | ||
| SF-20F: 198N | Cranio Fix2(11mm): 312N | |
| Cranio Fix2(20mm): 147N | ||
| Biocompatibility | Acceptable | Acceptable |
| Composition | ||
| of Material | Titanium Alloy Ti6Al4V | |
| ELI | ||
| conforming to ASTM | ||
| F136-11 | Titanium Alloy Ti6Al4V ELI | |
| conforming to ASTM | ||
| 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 | |
| the test sample by Vernia- | ||
| Calipus. The tolerance of | ||
| the error range of the | ||
| dimension shall be within | ||
| ±5%. | within ±5% | |
| Movement Force Test | Compress the axial load at | |
| the lower plate at a rate of | ||
| 1mm/min. Measure the | ||
| maximum load that the | ||
| lower plate fixes. | Speedy Flap Syste |
- SF-12F: 141N
- SF-20F: 98N
CranioFix System: - CranioFix 2 (11mm):
94N - CranioFix 2 (20mm):
96N |
| Separation Force Test | Grip the rod of the system
and apply compressive
axial load at a rate of
1mm/min until the rod is
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
testing before and
after rod cutting | Same test method as
above.
Compare test results
between the sample with
the rod and the sample
with the rod cut | No significant change. The
test results support that the
upper disk will not be
loosened after the rod
cutting. |
| Climatic conditioning,
Package
performance, Visual
inspections, Gross
leak
detection(bubble) and
seal strength(peel)
testing | The purpose of testing was
to validate the ability of the
package systems to
protect the Speedy Flap
System from hazards
typically associated with
the shipping and
distribution environment.
The testing was performed
in accordance with the
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
throughout the conduct of
the test and the test results
of all the test samples
support the suitability of
the package configuration
for the Speedy Flap
System. |
| Chemical Analysis
Qualitative analysis of
organic residual | SEM(Scanning
Electron Microscopy)
Gas chromatograph
Mass spectrometer | There was no other
elements on the surface
of the subject device
other than the elements
of the raw
material(titanium alloy). The residual detected. |
| Shelf Life Test | Accelerated and real time
shelf life testing were | The product met all
acceptance criteria |
| | conducted to establish 3
year shelf life of the
Speedy Flap System.
Sterility, visual inspection,
package integrity and the
performance of the subject
device were evaluated
after aging. | |
| Sterilization
Validation Test | Sterilization validation test
was performed to validate | The sterilization method for
the Speedy Flap System |
| | the sterilization method for
the Speedy Flap System. | has been validated as
effective through the study. |
| | The testing was conducted | |
| | in accordance with the | |
| | following standards.
ISO 11137-1
트 | |
| | ISO 11137-2
■ | |
| | ISO 11137-3
■ | |
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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.