The Balex Bone Expander 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 Balex Bone Expander 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 the Balex Bone Expander 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 Balex Bone Expander System consists of the Balloon Expander and Balloon Catheter. They are used with Cement Dispenser System, Cement Mixer System and Syringe which are Class I, 510k exempt devices.

The Balloon Catheter consists of an inner-outer tube, inflatable balloon located at the balloon tip. The radiopaque markers located at the balloon tip end allow fluoroscopic visualization of the deflated balloon catheter during positioning. The Balloon Expander consists of a pressure gauge, compression cylinder, a connect Line and a 3 way valve. The Balloon Expander is used for inflating the balloon by rotating the plunger clockwise. The lock mechanism maintains pressure. All the components are supplied sterile and are disposable.

AI/ML Overview

The provided document is a 510(k) summary for the Balex Bone Expander System. It describes the device, its intended use, and a comparison to predicate devices, but it does not contain the detailed acceptance criteria and a study proving the device meets those criteria in the format requested.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and performance tests for safety and biocompatibility. It lists several non-clinical performance tests conducted, but it does not provide specific acceptance criteria values for these tests or detailed results demonstrating compliance.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance: While a list of performance tests is provided, specific quantitative acceptance criteria and corresponding reported device performance values are not included.
Sample size used for the test set and the data provenance: The document mentions "non-clinical tests" but does not specify sample sizes or data provenance for these tests.
Number of experts used to establish the ground truth... and their qualifications: This is not applicable as the document describes a non-clinical evaluation, not a study involving human or image-based ground truth established by experts.
Adjudication method for the test set: Not applicable for non-clinical performance and safety tests.
Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned or implied. The evaluation is for a physical medical device (bone expander), not an AI algorithm.
Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an algorithm.
Type of ground truth used: Not applicable in the traditional sense. The "ground truth" for the non-clinical tests would be defined by the standards and specifications against which the device is tested (e.g., burst pressure limits, material strength requirements).
Sample size for the training set: Not applicable as this is a physical medical device, not an AI model.
How the ground truth for the training set was established: Not applicable.

Summary of available information (related to your questions, but not directly answering them due to content limitations):

The document lists the following performance tests and standards, implying that these are the areas where the device's performance was evaluated to ensure safety and effectiveness:

Sterilization Validation Tests in accordance with ISO 10993-7
Shelf Life Tests in accordance with ASTM F1980, ASTM F88, ISO11737-2
Biocompatibility Tests in accordance with ISO 10993 (Cytotoxicity, Maximization sensitization, Material-mediated pyrogenicity, Acute Systemic toxicity, Intracutaneous reactivity)
Extraction Test (Non-volatile Residue, Residue on Ignition, Heavy Metals, Buffering Capacity)
EO Gas Sterilization Residual
Appearance for Balloon
Balloon Dimensions
Burst Pressure (constrained and unconstrained)
Balloon leakage
Pressure gauge precision
Inflation and deflation time
Insertion force and withdrawal force
Tensile and tensile bond strength
Balloon fatigue test

The document concludes that "The test results of non-clinical tests performed on the subject device supported that it is substantially equivalent to the predicate devices despite the differences." This indicates that the device met the internal specifications and regulatory requirements based on these tests, but the specific numerical acceptance criteria and performance data are not disclosed in this summary.

Summary

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February 3, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Taeyeon Medical Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 1150 Roosevelt. STE 200 Irvine, California 92620

Re: K202027/S001

Trade/Device Name: Balex Bone Expander System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX, HXG, NDN Dated: December 23, 2020 Received: December 30, 2020

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, 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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality 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)

K202027

Device Name

Balex Bone Expander 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)
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510(k) Summary

(K202027)

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

Date: Feb 2, 2021

1. 510K Applicant / Submitter:

TAEYEON MEDICAL Co., Ltd. 132-1 Donghwagongdan-Ro, Munmak-eup Wonju-Si, Gangwon-do, 26365, Republic of Korea

Tel:+82-33-742-7555 Fax:+82-33-742-2227

2. Submission Contact Person

LK Consulting Group USA, Inc. 1150 Roosevelt, STE 200, Irvine CA 92620 Priscilla Juhee Chung Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com

3. Device

Proprietary Name: Balex Bone Expander System .
Common Name: Inflatable Bone Tamp ●
Classification: Class II (21 CFR 888.1100/ 888.4540/ 888.3027)
Product Code: HRX, HXG, NDN .

4. Predicate Device

Kyphon Inflatable Bone Tamps (K041454) by Kyphon Inc. Medinaut Kyphoplasty System (K133669) by Imedicom Co., Ltd.

5. Description:

The Balex Bone Expander System consists of the Balloon Expander and Balloon Catheter.

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They are used with Cement Dispenser System, Cement Mixer System and Syringe which are Class I, 510k exempt devices.

8. Indications for Use

9. Substantial Equivalence Discussion:

9.1. Comparison Chart

	Subject Device	Predicate Device	Reference Device
Device Name	Balex Bone Expander System	KYPHX XPANDERINFLATABLE BONETAMPSMODEL#KO8A,KO9A,K13A	MEDINAUT KyphonplastySystem
510(k) Number	K202027	K041454	K133669
Product Code	HRX, HXG, NDN	HRX	HRX, NDN
Common Name	Inflatable Bone Tamp	Inflatable Bone Tamp	Inflatable Bone Tamp
Manufacturer	TAEYEON MEDICAL Co., Ltd.	Medtronic Sofamor Danek	Imedicom Co., Ltd.
Indications for Use	The Balex Bone ExpanderSystem is intended to be used asa conventional bone tamp for thereduction of fractures and/orcreation of a void in cancellousbone in the spine (including useduring balloon kyphoplasty witha PMMA-based bone cementthat is cleared for use inkyphoplasty procedures), hand,tibia, radius, and calcaneus.	The Kyphx® Inflatable BoneTamp is intended to be used asa conventional bone tamp forthe reduction of fracturesand/or creation of a void incancellous bone in the spine(including use during balloonkyphoplasty with a PMMA-based bone cement that iscleared for use in kyphoplastyprocedures), hand, tibia, radius,and calcaneus.	The MEDINAUTKyphonplasty System isintended to be used for thereduction and fixation offractures and/or creation of avoid in cancellous bone inthe spine. This includes useduring percutaneousvertebral angmentation. Thissystem is to be used clearedspinalpolymethylmethacrylate(PMMA) bone cementsindicated for use duringpercutaneous vertebralaugmentation, such askyphoplasty.

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Balloon Size		10, 15, 20mm			10, 15, 20mm			10, 15, 20mm
	Model #	TYP0510	TYP0515	TYP0520	K13A	K09A	K08A	IBE-10	IBE-15	IBE-20
	Length ofBalloon	10.0mm	15.0mm	20.0mm	10.0mm	15.0mm	20.0mm	10.0mm	15.0mm	20.0mm
BalloonSpecification	Max.InflationVolume	3cc	5cc	7cc	3cc	4cc	5cc	3cc	5cc	7cc
	Max.InflatedDimension	15.05mm	18.15mm	19.49mm	15.0mm	5.3mm	16.0mm	14.1mm	17.1mm	19.3mm
	Max.InflatedLength	18.25mm	23.70mm	31.83mm	18.7mm	24.4mm	28.5mm	16.3mm	22.2mm	29.4mm
	Bone Tamp Max.Inflation pressure		350 psi			700 psi			350psi
	Composition of Material		ABS, TPU, Polycarbonate			ABS, TPU, STS304, Rubber			ABS, TPU, Platinum
Packaging		Tyvek, Cardboard Box			Pouch, Tyvek Blister Tray,Cardboard Box			Pouch, Tyvek Blister Tray,Cardboard Box
Biocompatibility		Meets ISO 10993			Meets ISO 10993			Meets ISO 10993
Sterilization		Ethylene Oxide Gas Sterilization			Gamma irradiation sterilization/Ethylene Oxide GasSterilization			Gamma irradiationsterilization

9.2. Substantial Equivalence Discussion

There are no significant differences between the subject devices and the predicate devices. The subject device has the same intended use as the identified predicate devices and they are similar in fundamental scientific technology, design, and size.

The materials used in the subject device might be different from the predicate devices; however, the biocompatibility testing results of the subject device support that the subject device is biocompatible and the performance testing results show that the subject device would perform as well as the predicate devices.

10. Performance Tests (Non-clinical)

Sterilization Validation Tests in accordance with ISO 10993-7
Shelf Life Tests in accordance with ASTM F1980, ASTM F88, ISO11737-2
Biocompatibility Tests in accordance with ISO 10993

No.	Items	ReferencedStandard
1	Cytotoxicity Test	ISO 10993-5
2	Maximization sensitization test	ISO-10993-10

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3	Material-mediated pyrogenicity test	ISO10993-11
4	Acute Systemic toxicity	ISO10993-11
5	Intracutaneous(intadermal) Reactivity Test	ISO10993-10

Performance Tests including the following test items. ●

No.	Test Items
1	Extraction Test- Non-volatile Residue, Residue on Ignition,Heavy Metals, Buffering Capacity
2	EO Gas Sterilization Residual
3	Appearance for Balloon
4	Balloon Dimensions
5	Burst Pressure (constrained and unconstrained)
6	Balloon leakage
7	Pressure gauge precision
8	Inflation and deflation time
9	Insertion force and withdrawal force
10	Tensile and tensile bond strength
11	Balloon fatigue test

The test results of non-clinical tests performed on the subject device supported that it is substantially equivalent to the predicate devices despite the differences.

11. Conclusions:

Based on the information provided in this premarket notification, TAEYEON MEDICAL Co., Ltd. concludes that the BALEX Bone Expander System is substantially equivalent to the predicate devices as described herein in.

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.