MEDINAUT Plus

K182287 · Imedicom Co., Ltd. · HRX · Apr 6, 2019 · Orthopedic

Device Facts

• Record ID: K182287
• Device Name: MEDINAUT Plus
• Applicant: Imedicom Co., Ltd.
• Product Code: HRX · Orthopedic
• Decision Date: Apr 6, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

The MEDINAUT Plus Kyphoplasty System is a manual surgical instrument set used to reduce compression fractures and create voids in cancellous bone. The system includes a balloon catheter, balloon expander, cement dispenser, and cement mixer. During a procedure, the surgeon inserts the balloon catheter into the bone; the balloon is inflated using the manual balloon expander (plunger-driven) to create a void. Radiopaque markers on the catheter allow for fluoroscopic visualization. Once the void is created, the surgeon uses the manual cement mixer and dispenser to deliver PMMA bone cement into the site. The device is used in a clinical/surgical setting by a physician. The system aims to reduce pain and restore functional ability by stabilizing fractures. All components are sterile and disposable.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included sterilization validation (ISO 11137), shelf-life validation (ASTM F1980), biocompatibility (ISO 10993), and mechanical bench testing (visual inspection, size measurement, liquid leakage, tensile force, burst strength, balloon fatigue, inflation/deflation performance, and insertion/withdrawal forces).

Technological Characteristics

Manual inflatable bone tamp system. Components: balloon catheter, expander, cement dispenser, cement mixer. Materials: biocompatible per ISO 10993. Energy source: manual (mechanical). Connectivity: none. Sterilization: sterile, disposable. Dimensions: balloon sizes 10, 15, 20mm; max inflation pressure 700 psi.

Indications for Use

Indicated for patients requiring reduction of fractures or creation of a void in cancellous bone in the spine, hand, tibia, radius, and calcaneus, including use during balloon kyphoplasty with cleared PMMA-based bone cement.

Regulatory Classification

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.

Predicate Devices

• Kyphon Express II (K123771)

Submission Summary (Full Text)

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# 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<br>System is intended to be used as a<br>conventional bone tamp for the<br>reduction of fractures and/or<br>creation of a void in cancellous<br>bone in the spine (including use<br>during balloon kyphoplasty with a<br>PMMA-based bone cement that is<br>cleared for use in kyphoplasty<br>procedures), hand, tibia, radius,<br>and calcaneus. | The KYPHON Xpander II<br>Inflatable Bone Tamps and Kyphon<br>Express II Inflatable Bone Tamps<br>are intended to be used as a<br>conventional bone tamp for the<br>reduction of fractures and/or<br>creation of a void in cancellous<br>bone in the spine (including use<br>during balloon kyphoplasty with a<br>PMMA-based bone cement that is<br>cleared for use in kyphoplasty<br>procedures), hand, tibia, radius, and<br>calcaneus. | | | | |
| Balloon Size | | 10, 15, 20mm | | | 10, 15, 20mm | | |
| Balloon<br>Specification | Model # | PIBE-10 | PIBE-15 | PIBE-20 | KE102 | KE152 | KE202 |
| | Length of<br>Balloon | 10.0mm | 15.0mm | 20.0mm | 10.0mm | 15.0mm | 20.0mm |
| | Max. inflation<br>volume | 3cc | 4cc | 5cc | 3cc | 4cc | 5cc |
| | Max. inflated<br>dimension | 15.0mm | 15.3mm | 16.0mm | 15.0mm | 15.3mm | 16.0mm |
| | Max. inflated<br>length | 18.7mm | 24.4mm | 28.5mm | 18.7mm | 24.4mm | 28.5mm |
| Bone Tamp Max.<br>Inflation pressure | | 700 psi | | | 700 psi | | |
| Packaging | | Pouch, Tyvek Blister Tray,<br>Cardboard Box | | | Pouch, Tyvek Blister Tray,<br>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) | |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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