(259 days)
No
The summary describes a mechanical system for kyphoplasty and does not mention any AI or ML components or functionalities.
Yes.
The device is intended for the reduction of fractures and/or creation of a void in cancellous bone in the spine, tibia, radius, and calcaneus, which are medical treatments.
No
Explanation: The device is intended for fracture reduction and void creation in bone, which are therapeutic procedures. There is no indication that it is used to diagnose a condition.
No
The device description explicitly lists multiple hardware components, including a Balloon Catheter, Bone Expander Syringe, Needle Pipe, Needle Pin, Wire Pin, Cannula, Expander, Spacer, Cement Pusher, Cement Filler, and Guide Wire.
Based on the provided information, the MEDINAUT Kyphoplasty System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the reduction of fractures and/or creation of a void in cancellous bone in specific anatomical sites (spine, tibia, radius, and calcaneus) and for percutaneous vertebral augmentation. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device components are instruments used for a surgical procedure (balloon catheter, bone expander syringe, needles, cannulas, etc.).
- Lack of In Vitro Activity: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. The MEDINAUT Kyphoplasty System does not perform any such analysis on biological specimens.
- Input Imaging Modality: Fluoroscopic visualization is used during the procedure to guide the placement of the device within the patient's body, not to analyze a specimen.
Therefore, the MEDINAUT Kyphoplasty System is a surgical device used for a therapeutic procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MEDINAUT Kyphoplasty System is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine, tibia, radius, and calcaneus. This includes percutaneous vertebral augmentation. The system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.
Product codes (comma separated list FDA assigned to the subject device)
NDN, HRX
Device Description
The MEDINAUT Kyphoplasty System is designed to reduce compression fracture and create a void in cancellous bone in the spine, tibia, radius, and calcaneus. Bone cement insertion using cement dispensing plunger is applied for spinal use only.
The MEDINAUT Kyphoplasty System consists of the MEDINAUT-X (Inflatable Bone Expander System) and MEDINAUT-I (Cement Dispenser System).
The MEDINAUT-X is comprised of a Balloon Catheter and a Bone Expander Syringe. The Balloon Catheter's main components are the shaft, Y-hub and the inflatable balloon located at the distal tip. The inflatable balloon is covered with a maximum 0.03g of silicone fluid to enhance lubricity when the balloon catheter is inserted in the cannula. Radiopaque markers located at the distal and proximal end of deflated working surface allow fluoroscopic visualization of the deflated balloon catheter during positioning. The Balloon Catheter and Bone Expander Syringe are supplied sterile and are disposable.
The MEDINAUT-I is a cement dispenser system consisting of a Needle Pipe, Needle Pin, Wire Pin, Cannula, Expander, Spacer, Cannula Expander, Cement Pusher, Cement Filler, and Guide Wire. They are supplied sterile and are disposable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spine, tibia, radius, and calcaneus
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
- Sterilization validating testing has been performed in accordance with ISO 11137-1, 2, 3 and ISO 11737-1, 2, 3, and the test results met the pre-set criteria.
- The tests to validate the shelf life of the device were conducted and the test results validated 1 year shelf life.
- Biocompatibility tests were performed in accordance with ISO 10993-4, 5, 10, 11, and the test results supported that the subject devices are biocompatible.
- Various bench tests including balloon deflation time, burst pressure constrained, burst pressure unconstrained, fatigue strength, balloon dimension before and after inflation, insertion and withdrawal force and tensile bond strength were performed to evaluate the performance and the safety of the subject devices and the test results met the preset criteria.
Key Results:
The test results supported that the subject device is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol depicts three overlapping human profiles facing to the right, suggesting a sense of community and care.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 29, 2016
IMEDICOM Company, Limited % Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Incorporated 2651 East Chapman Avenue, Suite 110 Fullerton, California 92831
Re: K153296
Trade/Device Name: MEDINAUT Kyphoplasty System Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN, HRX Dated: July 1, 2016 Received: July 5, 2016
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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,
Vincent J. Devlin -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K153296
Device Name
MEDINAUT Kyphoplasty System
Indications for Use (Describe)
The MEDINAUT Kyphoplasty System is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine, tibia, radius, and calcaneus. This includes percutaneous vertebral augmentation. The system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.
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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
510(k) Summary
(K153296)
This summary of 510(K) - safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: July 1, 2016
1. Applicant / Submitter
IMEDICOM Co., Ltd. #612, 172, LS-ro, Gunpo-si, Gyeonggi-do, 435-824 Republic of Korea Tel:+82-31-479-1156 Fax:+82-31-479-1157
2. Submission Correspondent
LK Consulting Group USA, Inc. 2651 E Chapman Ave. Ste 110, Fullerton CA 92831 Priscilla Chung Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
3. Device
- י Trade Name: MEDINAUT Kyphoplasty System
- Common Name: Inflatable Bone Tamp '
- י Classification Name: Arthroscope
- Cement, Bone, Vertebroplasty
- י Product Code: NDN, HRX
- Classification regulation: Class II, 21 CFR 888.3027 / 21 CFR 888.1100 י
4. Predicate Device:
- . MEDINAUT Kyphoplasty System by IMEDICOM Co., Ltd. (K133669)
- . KyphX Inflatable Bone Tamp by Kyphon Inc. (K010246, K041454, K981251)
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5. Description:
The MEDINAUT Kyphoplasty System is designed to reduce compression fracture and create a void in cancellous bone in the spine, tibia, radius, and calcaneus. Bone cement insertion using cement dispensing plunger is applied for spinal use only.
The MEDINAUT Kyphoplasty System consists of the MEDINAUT-X (Inflatable Bone Expander System) and MEDINAUT-I (Cement Dispenser System).
The MEDINAUT-X is comprised of a Balloon Catheter and a Bone Expander Syringe. The Balloon Catheter's main components are the shaft, Y-hub and the inflatable balloon located at the distal tip. The inflatable balloon is covered with a maximum 0.03g of silicone fluid to enhance lubricity when the balloon catheter is inserted in the cannula. Radiopaque markers located at the distal and proximal end of deflated working surface allow fluoroscopic visualization of the deflated balloon catheter during positioning. The Balloon Catheter and Bone Expander Syringe are supplied sterile and are disposable.
The MEDINAUT-I is a cement dispenser system consisting of a Needle Pipe, Needle Pin, Wire Pin, Cannula, Expander, Spacer, Cannula Expander, Cement Pusher, Cement Filler, and Guide Wire. They are supplied sterile and are disposable.
6. Indication for use:
The MEDINAUT Kyphoplasty System is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine, tibia, radius, and calcaneus. This includes percutaneous vertebral augmentation. The system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.
7. Basis for Substantial Equivalence
The MEDINAUT Kyphoplasty System is identical to the device made by our company cleared under K133669. There are no modifications occurred since 510k clearance including raw materials, design, and manufacturing processes. The purpose of this 510k is to add more anatomic sites(adding the claims of use in tibia, radius and calcaneus) to the indications for use statement and we are presenting a reference predicate device, Kyph X Inflatable Bone Tamp by Kyphon Inc. (K010246, K041454, and K981251),which have the same anatomic site use claims.
As stated above, the subject device itself is exactly identical to the primary predicate device (K133669). When comparing to the KyphX Inflatable Bone Tamp by Kyphon Inc. (K010246, K041454, and K981251), the subject device has the same indications for use and the technology used. The subject device also has similar designs and configurations as well as physical specifications to the KyphX Inflatable Bone Tamp. The devices are used in the same manner, perform the same functions, are of similar size and shape, and constructed from the similar material, and physical specifications.
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| Subject Device | Primary Predicate Device | Reference Predicate Device | |
|---|---|---|---|
| Device Name | MEDINAUT Kyphoplasty | ||
| System | MEDINAUT Kyphoplasty | ||
| System | KyphX Inflatable Bone Tamp | ||
| 510k Number | K153296 | K133669 | K010246, K041454, K981251 |
| Manufacturer | IMEDICOM Co., Ltd. | IMEDICOM Co., Ltd. | Kyphon Inc. |
| Product Code | HRX, NDN | HRX, NDN | HRX |
| Common Name | Inflatable Bone Tamp | Inflatable Bone Tamp | Inflatable Bone Tamp |
| Indication for use | The MEDINAUT | ||
| Kyphoplasty System is | |||
| intended to be used for the | |||
| reduction of fractures | |||
| and/or creation of a void in | |||
| cancellous bone in the | |||
| spine, tibia, radius, and | |||
| calcaneus. This includes | |||
| percutaneous vertebral | |||
| augmentation. The system | |||
| is to be used with cleared | |||
| spinal | |||
| polymethylmethacrylate | |||
| (PMMA) bone cements | |||
| indicated for use during | |||
| percutaneous vertebral | |||
| augmentation, such as | |||
| kyphoplasty. | The MEDINAUT Kyphoplasty | ||
| System is intended to be used | |||
| for the reduction of fracture | |||
| and/or creation of a void in | |||
| cancellous bone in the spine. | |||
| This includes use during | |||
| percutaneous vertebral | |||
| augmentation. This system is to | |||
| be used with cleared spinal | |||
| Polymethylmethacrylate | |||
| (PMMA) bone cements | |||
| indicated for use during | |||
| percutaneous vertebral | |||
| augmentation procedures, such | |||
| as kyphoplasty | KyphX® Inflatable Bone | ||
| Tamps are intended to be used | |||
| as conventional bone tamps for | |||
| the reduction of fractures | |||
| and/or creation of a void in | |||
| cancellous bone in the spine | |||
| (including use during balloon | |||
| kyphoplasty with KyphX® | |||
| MHV-RTM Bone Cement), | |||
| hand, tibia, radius and | |||
| calcaneus. | |||
| Components | Same as Primary Predicate | ||
| Device(K133669) | • Bone Catheter | ||
| • Expander Syringe | |||
| • Kit (Needle Pipe, Needle | |||
| Pin, Expander, Cannula, | |||
| Spacer, Guide Wire, Wire | |||
| Pin, Cement Pusher, Cement | |||
| Filler, and Guide wire) | • Bone Catheter | ||
| • Expander Syringe | |||
| • Kit (Bone Access Needle, | |||
| Introducer System, Precision | |||
| Drill, Cannula, Expander, | |||
| Spacer, Cement Pusher, | |||
| Cement Filler and Guide | |||
| Wire) | |||
| Balloon Size | Same as Primary Predicate | ||
| Device(K133669) | 10mm, 15mm, 20mm | 10mm, 15mm, 20mm | |
| Bone Tamp | |||
| Max. Inflation | |||
| Pressure | Same as Primary Predicate | ||
| Device(K133669) | 350 PSI | 400 PSI | |
| Composition of | |||
| Material | |||
| Balloon tip | |||
| Radiopaque Marker | |||
| Expander body | |||
| Accessory kit | Same as Primary Predicate | ||
| Device(K133669) | Thermoplastic Polyurethane | ||
| Platinum | |||
| Polycarbonate & ABS | |||
| Stainless Steel & ABS | Thermoplastic Polyurethane | ||
| Platinum | |||
| Polycarbonate & ABS | |||
| Stainless Steel & ABS | |||
| Packaging | Same as Primary Predicate | ||
| Device(K133669) | Pouch, Tyvek Blister Tray, | ||
| Cardboard Box | Pouch, Tyvek Blister Tray, | ||
| Cardboard Box | |||
| Sterilization | Same as Primary Predicate | ||
| Device(K133669) | Gamma Sterilization | Gamma Sterilization | |
| Biocompatibility | Same as Primary Predicate | ||
| Device(K133669) | Meets ISO 10993 | Meets ISO 10993 |
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8. Non-Clinical Testing
- · Sterilization validating testing has been performed in accordance with ISO 11137-1, 2, 3 and ISO 11737-1, 2, 3, and the test results met the pre-set criteria.
- · The tests to validate the shelf life of the device were conducted and the test results validated 1 year shelf life.
- · Biocompatibility tests were performed in accordance with ISO 10993-4, 5, 10, 11, and the test results supported that the subject devices are biocompatible.
- . Various bench tests including balloon deflation time, burst pressure constrained, burst pressure unconstrained, fatigue strength, balloon dimension before and after inflation, insertion and withdrawal force and tensile bond strength were performed to evaluate the performance and the safety of the subject devices and the test results met the preset criteria.
The test results supported that the subject device is substantially equivalent to the predicate devices.
9. Conclusion
Based on the similarities, we conclude that the MEDINAUT Kyphoplasty System is substantially equivalent to the predicate devices.