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.

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.

AI/ML Overview

This document is a 510(k) summary for the MEDINAUT Kyphoplasty System. It is an FDA submission seeking approval to market a medical device, asserting its substantial equivalence to previously cleared devices. It primarily details physical and functional attributes and does not contain detailed "acceptance criteria" or "study that proves the device meets the acceptance criteria" in the way one might expect for a diagnostic AI device.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices. This means that the device is shown to be as safe and effective as a legally marketed device (the predicate device) that does not require premarket approval.

Here's an analysis based on the provided text, addressing your points where possible, and noting where the information is not applicable or unavailable in this type of submission:

1. A table of acceptance criteria and the reported device performance

This information is not present in the document as it would be for a diagnostic AI device. For a device like the MEDINAUT Kyphoplasty System, "acceptance criteria" are related to mechanical performance, biocompatibility, and sterilization standards, and "reported device performance" refers to the results of non-clinical bench tests comparing these attributes to pre-set criteria or predicate devices.

The closest equivalent is the "Non-Clinical Testing" section and the comparison table.

Non-Clinical Testing Summary:

Test Type	Acceptance Criteria (Implied)	Reported Device Performance
Sterilization Validation	In accordance with ISO 11137-1, 2, 3 and ISO 11737-1, 2, 3	Test results met pre-set criteria.
Shelf Life	Validated shelf life	Test results validated 1-year shelf life.
Biocompatibility	In accordance with ISO 10993-4, 5, 10, 11 (Meets ISO 10993)	Test results supported that devices are biocompatible.
Bench Tests (Mechanical/Performance)	Met pre-set criteria for:	Test results met pre-set criteria for all listed tests.
- Balloon deflation time
- Burst pressure constrained
- Burst pressure unconstrained
- Fatigue strength
- Balloon dimension (before/after)
- Insertion and withdrawal force
- Tensile bond strength

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable/provided in this context. This document describes a medical device (kyphoplasty system), not an AI/software device that processes data. The "test set" here refers to physical samples of the device undergoing mechanical, chemical, and biological testing, not a dataset of patient information. No patient data or provenance are mentioned because it's a non-clinical submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/provided. The "ground truth" for this type of device is established through engineering and laboratory standards (e.g., ISO standards for sterilization, biocompatibility, and mechanical properties). There are no "experts" in the sense of clinicians establishing a diagnostic ground truth for patient data. The "experts" involved would be engineers and laboratory technicians performing standardized tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are used in clinical studies or evaluations of diagnostic performance where human interpretation of medical data (e.g., images) is involved. For non-clinical bench testing of a physical medical device, test results are typically validated against established quantitative standards and protocols, not through expert adjudication of uncertain cases.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable/provided. MRMC studies are specific to evaluating diagnostic systems, especially AI in medical imaging, and its impact on human reader performance. This document concerns a physical surgical device for bone fracture reduction, not a diagnostic system. There is no AI component mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable/provided. As stated, this is a physical medical device (kyphoplasty system), not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's safety and effectiveness is established through adherence to international standards (e.g., ISO 11137, ISO 11737, ISO 10993) and engineering specifications. For example:

Sterilization: Demonstrated bacterial inactivation based on ISO standards.
Biocompatibility: Demonstrated material safety based on ISO 10993.
Mechanical Performance: Quantitative measurements (e.g., burst pressure, tensile strength) meeting design specifications and being comparable to predicate devices.

8. The sample size for the training set

This information is not applicable/provided. This device is not an AI model that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable/provided. As above, no training set for an AI model is involved.

Summary of Device and Equivalence Claim:

The document states that the MEDINAUT Kyphoplasty System (K153296) is substantially equivalent to its primary predicate device (MEDINAUT Kyphoplasty System, K133669) because it is identical in raw materials, design, and manufacturing processes. The purpose of the current 510(k) is to add more anatomical sites (tibia, radius, and calcaneus) to the indications for use. This expanded indication is supported by referencing an additional predicate device, the KyphX Inflatable Bone Tamp (K010246, K041454, K981251), which already has these broader claims and shares similar design, function, size, shape, materials, and physical specifications.

The "study that proves the device meets the acceptance criteria" (in this context, substantial equivalence to predicates for the expanded indications) is the non-clinical testing enumerated in section 8, which includes sterilization, shelf life, biocompatibility, and various bench tests. These tests confirmed that the device performs as intended and is safe when compared to established standards and the characteristics of the predicate devices.

Summary

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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

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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

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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)

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."

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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 consists of the MEDINAUT-X (Inflatable Bone Expander System) and MEDINAUT-I (Cement Dispenser System).

6. Indication for use:

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 KyphoplastySystem	MEDINAUT KyphoplastySystem	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 MEDINAUTKyphoplasty System isintended to be used for thereduction of fracturesand/or creation of a void incancellous bone in thespine, tibia, radius, andcalcaneus. This includespercutaneous vertebralaugmentation. The systemis to be used with clearedspinalpolymethylmethacrylate(PMMA) bone cementsindicated for use duringpercutaneous vertebralaugmentation, such askyphoplasty.	The MEDINAUT KyphoplastySystem is intended to be usedfor the reduction of fractureand/or creation of a void incancellous bone in the spine.This includes use duringpercutaneous vertebralaugmentation. This system is tobe used with cleared spinalPolymethylmethacrylate(PMMA) bone cementsindicated for use duringpercutaneous vertebralaugmentation procedures, suchas kyphoplasty	KyphX® Inflatable BoneTamps are intended to be usedas conventional bone tamps forthe reduction of fracturesand/or creation of a void incancellous bone in the spine(including use during balloonkyphoplasty with KyphX®MHV-RTM Bone Cement),hand, tibia, radius andcalcaneus.
Components	Same as Primary PredicateDevice(K133669)	• Bone Catheter• Expander Syringe• Kit (Needle Pipe, NeedlePin, Expander, Cannula,Spacer, Guide Wire, WirePin, Cement Pusher, CementFiller, and Guide wire)	• Bone Catheter• Expander Syringe• Kit (Bone Access Needle,Introducer System, PrecisionDrill, Cannula, Expander,Spacer, Cement Pusher,Cement Filler and GuideWire)
Balloon Size	Same as Primary PredicateDevice(K133669)	10mm, 15mm, 20mm	10mm, 15mm, 20mm
Bone TampMax. InflationPressure	Same as Primary PredicateDevice(K133669)	350 PSI	400 PSI
Composition ofMaterialBalloon tipRadiopaque MarkerExpander bodyAccessory kit	Same as Primary PredicateDevice(K133669)	Thermoplastic PolyurethanePlatinumPolycarbonate & ABSStainless Steel & ABS	Thermoplastic PolyurethanePlatinumPolycarbonate & ABSStainless Steel & ABS
Packaging	Same as Primary PredicateDevice(K133669)	Pouch, Tyvek Blister Tray,Cardboard Box	Pouch, Tyvek Blister Tray,Cardboard Box
Sterilization	Same as Primary PredicateDevice(K133669)	Gamma Sterilization	Gamma Sterilization
Biocompatibility	Same as Primary PredicateDevice(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.

Regulation Number and Section

§ 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.”