MEDINAUT Plus

• K Number: K182287
• Device Name: MEDINAUT Plus
• Manufacturer: Imedicom Co., Ltd.
• Date Cleared: 2019-04-06 ( 226 days)
• Product Code: HRX HXG NDN
• Regulation Number: 888.1100

Intended Use

MEDINAUT Plus Kyphoplasty System is intended to be used as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during balloon kyphoplasty with a PMMA-based bone cement that is cleared for use in kyphoplasty procedures), hand, tibia, radius, and calcaneus.

Device Description

The MEDINAUT Plus Kyphoplasty System is designed to reduce compression fracture and create a void in cancellous bone in the spine. By creating a space in the operating point, the major benefits of MEDINAUT Plus Kyphoplasty System are the reduction in pain and the increase of patient s functional abilities, which allow for the patient's return to the previous level of activity. The MEDINAUT Plus Kyphoplasty System consists of the Balloon Expander, Balloon Catheter, Cement Dispenser System, Cement Mixer System and Syringe. The Balloon Catheter consists of an inner-outer tube, Y-port and an inflatable balloon located at the distal tip. The radiopaque markers located at the distal and proximal end allow fluoroscopic visualization of the deflated balloon catheter during positioning. The Balloon Expander consists of a gauge, housing, a half nut, a plunger, a piston, a hose, a luer connector and a 3 way valve. The Balloon Expander is used for inflating the balloon by rotating the plunger clockwise. The lock mechanism maintains pressure. The Cement Dispenser System consists of Cannula, Needle (3 types: Bevel, Diamond, Trocar), Spacer, Biopsy, Biopsy Cap. Cement Filler, Cement Pusher and Cement Side Filler. The Cement Mixer System consists of Cement Mixer, Tube, Cap, Funnel and Pusher. The user can mix cement inside the cylinder by moving the mixer up and down repeatedly and apply the cement into a patient by rotating the pusher handle. The Syringe is an optional device. If there is air found in the Catheter Balloon before surgery, the user can remove the air with this syringe. All the components including Balloon Expander, Balloon Catheter, Cement Dispenser System. Cement Mixer System and Syringe are supplied sterile and are disposable.

Predicate Devices

K123771

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.

Therapeutic

Yes.

The device is intended to be used as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone, with the major benefits being the reduction in pain and the increase of patient's functional abilities. These directly describe a therapeutic purpose.

Diagnostic

No

The device is described as a kyphoplasty system intended for the reduction of fractures and/or creation of a void in cancellous bone, which are therapeutic and surgical interventions, not diagnostic procedures.

SaMD (Software as a Medical Device)

No

The device description explicitly lists multiple hardware components (Balloon Expander, Balloon Catheter, Cement Dispenser System, Cement Mixer System, Syringe) and describes their physical functions.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states the device is used for physical procedures like reducing fractures and creating voids in bone. This is a surgical/interventional procedure, not a diagnostic test performed on samples outside the body.
• Device Description: The description details components used for mechanical manipulation within the body (balloon, cement delivery system, etc.). These are tools for treatment, not for analyzing biological samples.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on in vitro analysis.

IVD devices are designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The MEDINAUT Plus Kyphoplasty System is a surgical device used for treatment.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

MEDINAUT Plus Kyphoplasty System is intended to be used as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during balloon kyphoplasty with a PMMA-based bone cement that is cleared for use in kyphoplasty procedures), hand, tibia, radius, and calcaneus.

Product codes

HRX, HXG, NDN

Device Description

The MEDINAUT Plus Kyphoplasty System is designed to reduce compression fracture and create a void in cancellous bone in the spine. By creating a space in the operating point, the major benefits of MEDINAUT Plus Kyphoplasty System are the reduction in pain and the increase of patients functional abilities, which allow for the patient's return to the previous level of activity.

The MEDINAUT Plus Kyphoplasty System consists of the Balloon Expander, Balloon Catheter, Cement Dispenser System, Cement Mixer System and Syringe.

The Balloon Catheter consists of an inner-outer tube, Y-port and an inflatable balloon located at the distal tip. The radiopaque markers located at the distal and proximal end allow fluoroscopic visualization of the deflated balloon catheter during positioning.

The Balloon Expander consists of a gauge, housing, a half nut, a plunger, a piston, a hose, a luer connector and a 3 way valve. The Balloon Expander is used for inflating the balloon by rotating the plunger clockwise. The lock mechanism maintains pressure.

The Cement Dispenser System consists of Cannula, Needle (3 types: Bevel, Diamond, Trocar), Spacer, Biopsy, Biopsy Cap. Cement Filler, Cement Pusher and Cement Side Filler.

The Cement Mixer System consists of Cement Mixer, Tube, Cap, Funnel and Pusher. The user can mix cement inside the cylinder by moving the mixer up and down repeatedly and apply the cement into a patient by rotating the pusher handle.

The Syringe is an optional device. If there is air found in the Catheter Balloon before surgery, the user can remove the air with this syringe.

All the components including Balloon Expander, Balloon Catheter, Cement Dispenser System. Cement Mixer System and Syringe 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, hand, 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 was performed.

• 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 3 year shelf life. Both the accelerated aging method in accordance to ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices and the real time test were performed.
• Biocompatibility tests were performed in accordance with ISO 10993-4, 5, 7, 10, 11, and the test results supported that the subject devices are biocompatible.
• Various bench tests including Visual Inspection. Size Measurement, Liquid leakage under pressure, Tensile force, Burst strength, Balloon fatigue, Inflated balloon size, Balloon deflation, EO Gas residue, Sterility Test, Balloon rated burst pressure (RBP) in constrained condition, Balloon rated burst pressure (RBP) in unconstrained condition. Balloon Fatigue. Freedom from leakage and damage on inflation. Balloon diameter to inflation pressure. Insertion force and withdrawal force.
  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)

Kyphon Express II by Medtronic Sofamor Danek (K123771)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 888.1100 Arthroscope.

(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.

Summary

0

510(k) Summary (K182287)

This summary of 510(K) is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: April 2, 2019

1. Applicant / Submitter

IMEDICOM Co., Ltd. #612, 172, LS-ro, Gunpo-si, Gyeonggi-do, 435824 Republic of Korea Tel:[phone] Fax:[phone]

2. Submission Correspondent

LK Consulting Group USA, Inc. 690 Roosevelt, Irvine CA 92620 Priscilla Chung Phone: [phone] Fax: [phone] Email: [e-mail]

3. Device

• י Trade Name: MEDINAUT Plus
• י Common Name: Inflatable Bone Tamp
• י Classification Name: Arthroscope

Tamp

Polymethylmethacrylate (PMMA) bone cement

• . Product Code: HRX, HXG, NDN
• י Classification regulation: Class II, 21 CFR 888.1100/ 888.4540/ 888.3027

4. Predicate Device:

• ' Kyphon Express II by Medtronic Sofamor Danek (K123771)

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5. Description:

The MEDINAUT Plus Kyphoplasty System is designed to reduce compression fracture and create a void in cancellous bone in the spine. By creating a space in the operating point, the major benefits of MEDINAUT Plus Kyphoplasty System are the reduction in pain and the increase of patient s functional abilities, which allow for the patient's return to the previous level of activity.

The MEDINAUT Plus Kyphoplasty System consists of the Balloon Expander, Balloon Catheter, Cement Dispenser System, Cement Mixer System and Syringe.

The Balloon Catheter consists of an inner-outer tube, Y-port and an inflatable balloon located at the distal tip. The radiopaque markers located at the distal and proximal end allow fluoroscopic visualization of the deflated balloon catheter during positioning.

The Balloon Expander consists of a gauge, housing, a half nut, a plunger, a piston, a hose, a luer connector and a 3 way valve. The Balloon Expander is used for inflating the balloon by rotating the plunger clockwise. The lock mechanism maintains pressure.

The Cement Dispenser System consists of Cannula, Needle (3 types: Bevel, Diamond, Trocar), Spacer, Biopsy, Biopsy Cap. Cement Filler, Cement Pusher and Cement Side Filler.

The Cement Mixer System consists of Cement Mixer, Tube, Cap, Funnel and Pusher. The user can mix cement inside the cylinder by moving the mixer up and down repeatedly and apply the cement into a patient by rotating the pusher handle.

The Syringe is an optional device. If there is air found in the Catheter Balloon before surgery, the user can remove the air with this syringe.

All the components including Balloon Expander, Balloon Catheter, Cement Dispenser System. Cement Mixer System and Syringe are supplied sterile and are disposable.

6. Indication for use:

MEDINAUT Plus Kyphoplasty System is intended to be used as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during balloon kyphoplasty with a PMMA-based bone cement that is cleared for use in kyphoplasty procedures), hand, tibia, radius, and calcaneus.

7. Basis for Substantial Equivalence

MEDINAUT Plus is substantially equivalent to the Kyphon Express II (K123771) made by Medtronic Sofamor Danek. There are no significant differences between the subject devices and the predicate device. The subject devices have the same intended use as the identified predicate device and they are similar in fundamental scientific technology, design, and size.

The materials used in the subject devices might be different from the predicate device; however, the biocompatibility testing results of the subject device support that the subject

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		Subject Device	Predicate Device
Device Name		MEDINAUT Plus	Kyphon Express II
510(k) Number		K182287	K123771
Product Code		HRX, HXG, NDN	HRX, HXG, NDN
Common Name		Inflatable Bone Tamp	Inflatable Bone Tamp
Manufacturer		IMEDICOM Co., Ltd.	Medtronic Sofamor Danek
Indications for Use		MEDINAUT Plus Kyphoplasty
System is intended to be used as a
conventional bone tamp for the
reduction of fractures and/or
creation of a void in cancellous
bone in the spine (including use
during balloon kyphoplasty with a
PMMA-based bone cement that is
cleared for use in kyphoplasty
procedures), hand, tibia, radius,
and calcaneus.	The KYPHON Xpander II
Inflatable Bone Tamps and Kyphon
Express II Inflatable Bone Tamps
are intended to be used as a
conventional bone tamp for the
reduction of fractures and/or
creation of a void in cancellous
bone in the spine (including use
during balloon kyphoplasty with a
PMMA-based bone cement that is
cleared for use in kyphoplasty
procedures), hand, tibia, radius, and
calcaneus.
Balloon Size		10, 15, 20mm			10, 15, 20mm
Balloon
Specification	Model #	PIBE-10	PIBE-15	PIBE-20	KE102	KE152	KE202
	Length of
Balloon	10.0mm	15.0mm	20.0mm	10.0mm	15.0mm	20.0mm
	Max. inflation
volume	3cc	4cc	5cc	3cc	4cc	5cc
	Max. inflated
dimension	15.0mm	15.3mm	16.0mm	15.0mm	15.3mm	16.0mm
	Max. inflated
length	18.7mm	24.4mm	28.5mm	18.7mm	24.4mm	28.5mm
Bone Tamp Max.
Inflation pressure		700 psi			700 psi
Packaging		Pouch, Tyvek Blister Tray,
Cardboard Box			Pouch, Tyvek Blister Tray,
Cardboard Box
Biocompatibility		Meets ISO 10993			Meets ISO 10993

devices are biocompatible and the performance testing results show that the subject device would perform as well as the predicate device.

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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 3 year shelf life. Both the accelerated aging method in accordance to ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices and the real time test were performed.
• · Biocompatibility tests were performed in accordance with ISO 10993-4, 5, 7, 10, 11, and the test results supported that the subject devices are biocompatible.
• . Various bench tests including Visual Inspection. Size Measurement, Liquid leakage under pressure, Tensile force, Burst strength, Balloon fatigue, Inflated balloon size, Balloon deflation, EO Gas residue, Sterility Test, Balloon rated burst pressure (RBP) in constrained condition, Balloon rated burst pressure (RBP) in unconstrained condition. Balloon Fatigue. Freedom from leakage and damage on inflation. Balloon diameter to inflation pressure. Insertion force and withdrawal force

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 Plus Kyphoplasty System is substantially equivalent to the predicate devices.

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IMEDICOM Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 690 Roosevelt Irvine, California 92620

Re: K182287

Trade/Device Name: MEDINAUT Plus Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX, HXG, NDN Dated: March 4, 2019 Received: March 6, 2019

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm_identifies_combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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

510(k) Number (if known)

K182287

Device Name MEDINAUT Plus

Indications for Use (Describe)

MEDINAUT Plus Kyphoplasty System is intended to be used as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during balloon kyphoplasty with a PMMA-based bone cement that is cleared for use in kyphoplasty procedures), hand, tibia, radius, and calcaneus.

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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