Kyphoplasty Balloon Catheter is intended to be used for the reduction of fixation of fractures and/or creation of a void in cancellous bone in the spine during balloon kyphoplasty (for use with cleared spinal polymethymethacrylate (PMMA) bone cements).

Device Description

Kyphoplasty Balloon Catheter is an inflatable balloon catheter used in percutaneous kyphoplasty (PKP). The Balloon Catheter consists of an outer tube and core tube/rod, inflatable balloon located at the distal tip. The radiopaque markers located at the balloon tip to reflect the balloon position during positioning. The balloon catheter is supplied sterilized, single-use.

AI/ML Overview

The provided text describes the 510(k) summary for the Kyphoplasty Balloon Catheter, focusing on its non-clinical testing to demonstrate substantial equivalence to a predicate device. It explicitly states that no clinical study was performed or included in the submission. Therefore, I cannot provide information on acceptance criteria and study proving device meets acceptance criteria related to a clinical study, human reader performance, or multi-reader multi-case studies, as there were none reported.

The information below is derived from the non-clinical (bench) testing section, which serves as the primary evidence for this device's acceptance.

Here's the breakdown based on the provided text for the non-clinical testing:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Bench Testing)

The document primarily lists acceptance criteria for various bench tests. It states that "The test results show pass the requirements" for the performance tests, implying the device met these criteria, but specific reported values are not provided, except for the "Balloon Inflation Behavior" which includes a target range.

Test Performed	Acceptance Criteria	Reported Device Performance (Implied, as "passed requirements")
Balloon Burst Pressure	Balloon Burst Pressure (Constrained) ≥ 400psi	Met acceptance criterion (implicitly ≥ 400psi)
Balloon Burst Volume	Balloon Burst Volume (Constrained) ≥ 6ml	Met acceptance criterion (implicitly ≥ 6ml)
Balloon Inflation Behavior (Unconstrained Balloon Compliance)	Inflated with 6 ml, the balloon diameter should be 18.3±3.0 mm, and the balloon working length should be 28.0±3.0 mm.	Met acceptance criterion (within specified diameter and length range)
Tensile Force	Tensile force ≥ 15N.	Met acceptance criterion (implicitly ≥ 15N)
Balloon Repeated Inflation	The balloon should withstand 20 inflation/deflation cycles at rated filling volume without rupture or leak.	Met acceptance criterion (implicitly withstands 20 cycles)
Balloon Deflation Time	Deflation time ≤ 3s.	Met acceptance criterion (implicitly ≤ 3s)

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify the sample size (number of devices) used for each bench test. The studies were non-clinical (bench tests) meaning they were conducted in a lab environment using the physical device. Data provenance refers to the origin of the data. For bench testing, this would typically be from the manufacturer's internal testing facilities (Jiangsu Changmei Medtech Co., Ltd.). The data is prospective in the sense that the testing was performed specifically for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. For non-clinical bench testing, "ground truth" is established by engineering specifications, validated test methods, and measurement against international standards (ISO, ASTM, USP). Experts involved would be engineers and quality control personnel, not medical practitioners.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, typically for resolving disagreements among human readers or expert reviewers of clinical data. This document describes bench testing where measurements are objective and quantitative.

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

No, an MRMC study was not done. The document explicitly states: "No clinical study is included in this submission." This device is a physical medical device (balloon catheter), not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

For non-clinical bench tests, the "ground truth" is based on:

Pre-defined engineering specifications and acceptance criteria.
Measurements against established physical properties and performance metrics.
Compliance with recognized international standards (e.g., ISO 10993 for biocompatibility, ISO 11135 for sterilization, ASTM F1980 for shelf-life, ISTA-2A for shipping).

8. The Sample Size for the Training Set

Not applicable. "Training set" refers to data used to train machine learning algorithms. This document describes a physical medical device and its non-clinical testing.

9. How the Ground Truth for the Training Set was Established

Not applicable for the same reason as above.

Summary

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August 16, 2023

Image /page/0/Picture/1 description: The image contains 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.

Jiangsu Changmei Medtech Co., Ltd. % Amber Pang Landlink Healthcare Technology (Shanghai) Co., Ltd. Room 1308, Baohua International Plaza 555 West Guangzhong Road Shanghai. 200072 China

Re: K223709

Trade/Device Name: Kyphoplasty Balloon Catheter Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX, HXG Dated: July 31, 2023 Received: July 31, 2023

Dear Ms. Pang:

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/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,

Jesse Muir -S

Jesse Muir, 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

510(k) Number (if known) K223709

Device Name Kyphoplasty Balloon Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) summary

K223709

l Submitter

Jiangsu Changmei Medtech Co., Ltd. No.27, Xinke West Road, Luoyang Town, Wujin District, Changzhou, Jiangsu, CN 213104.

Establishment Registration Number: 3016789487

Contact person: Yang Lifan Position: Regulation Manager Tel.: +86-18651969542 E-mail: ylf@czmed.com

Preparation date: Aug 8, 2023

II Proposed Device

Trade Name of Device:	Kyphoplasty Balloon Catheter
Common name:	Inflatable Bone Tamp
Regulation Number:	21 CFR 888.1100
Regulatory Class:	Class II
Product code:	HRX, HXG
Review Panel:	Orthopedic

III Predicate Devices

510(k) Number:	K192449
Trade name:	Joline® Kyphoplasty System Allevo
Common name:	Vertebroplasty System; Inflatable Bone Tamp
Classification:	Class II
Product Code:	HRX, NDN
Manufacturer	Joline GmbH & Co. KG

IV Device description

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V Indication for use

Kyphoplasty Balloon Catheter is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine during balloon kyphoplasty (for use with cleared spinal polymethymethacrylate (PMMA) bone cements).

VI Comparison of technological characteristics with the predicate devices

The comparison and discussion between the subject device and the predicate device is listed in Table 1 below:

Item	Proposed device	Predicate device(K192449)	Discussion
Product name	Kyphoplasty BalloonCatheter	Joline® KyphoplastySystem Allevo	same
Product Code	HRX, HXG	HRX, NDN	same
Regulation No.	21 CFR 888.1100	21 CFR 888.1100	same
Class	Class II	Class II	same
Indication foruse	Kyphoplasty BalloonCatheter is intended tobe used for thereduction and fixation offractures and/or creationof a void in cancellousbone in the spine duringballoon kyphoplasty (foruse with cleared spinalpolymethymethacrylate(PMMA) bone cements).	The Joline® KyphoplastySystem Allevo is intendedto be used for the reductionand fixation of fracturesand/or creation of a void incancellous bone in thespine during balloonkyphoplasty (for use withcleared spinalpolymethylmethacrylate(PMMA) bone cements).	same
Balloon Size	10.0mm, 15.0mm,20.0mm	10.0mm, 16.0mm, 22.0mm	Different¹
Balloon BrustPressure	400 psi	400 psi	same
BalloonBurstVolume	≥ 6 ml	≥ 6 ml	same
BalloonInflationBehavior	Balloon Diameter:$18.3\pm3.0$ mm.Balloon working length:$28.0\pm3.0$	Balloon Diameter $\leq$ 19 mmBalloon working length $\leq$ 24mm	Different¹
TensileForceBalloon	$\geq$ 15 N	$\geq$ 15 N	same
Balloon	The balloon must not	The balloon must not burst	Different²
RepeatedInflation	rupture or leak within 20inflation/deflation cycles	within 3 inflation/deflationcycles
BalloonDeflation Time	$\leq$ 3 s	$\leq$ 3 s	same
Shapes	Peanut, cylindrical	Cylindrical	Different3
Inflationmedium	Contrast medium	Contrast medium	Same
Single/doubleuse of catheter	Single	Single and double	Different4
Sterility	Yes	Yes	same
Biocompatibility	Confirm to therequirements of ISO10993 series standards	Confirm to therequirements of ISO 10993series standards	Same

Table 1 General Comparison of Kyphoplasty Balloon Catheter

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1 The difference in the size does not raise additional questions for safety and effectiveness of the device. The performance test of the subject devices has been performed on the final finished device. The test results show pass the requirements.

2 The Balloon repeated inflation in the subject device might be different from the predicate devices. The requirement of balloon with subject device must not rupture or leak within 20 inflation/deflation cycles, and predicate device is 3 cycles. Therefore, the differences on balloon repeated inflation do not raise new questions about safety and effectiveness.

3 The shape of proposed device has peanut type, and predicate device haven't. The peanut shape Balloon Catheter have no different in shape with the cylindrical type under rated filling volume state. Therefore, the differences on balloon shape do not raise new questions about safety and effectiveness.

4 The predicate device has single use and double use of catheter, and proposed device have single use of catheter only. The predicated device can cover proposed device. Therefore, the differences on use of catheter do not raise new questions about safety and effectiveness.

VII Non-Clinical Testing

Bench test: A

The following tests were performed in support of the substantial equivalence determination.

Test Performed	Acceptance Criteria
Balloon Burst Pressure	Balloon Burst Pressure (Constrained) ≥

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	400psi
Balloon Burst Volume	Balloon Burst Volume (Constrained) ≥ 6ml
BalloonInflationBehavior(Unconstrained BalloonCompliance)	Inflated with 6 ml, the balloon diametershould be 18.3±3.0 mm, and the balloonworking length should be 28.0±3.0 mm.
Tensile Force	Tensile force ≥ 15N.
Balloon RepeatedInflation	The balloon should withstand 20inflation/deflation cycles at rated fillingvolume without rupture or leak.
Balloon Deflation Time	Deflation time ≤ 3s.

> Biocompatibility Testing:

In accordance with ISO 10993-1, the Kyphoplasty Balloon Catheter is classified as: Externally Communicating Device, Intact bone/tissue, Limited Contact (≤ 24hours). The following biocompatibility endpoints were addressed:

Cytotoxicity ●
. Sensitization
Intracutaneous Reactivity .
Acute Systemic Toxicity .
Material-Mediated Pyrogenicity .

A Sterility, Shipping and Shelf Life:

The sterilization method has been validated per ISO 11135: 2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices. The shelf life of the Kyphoplasty Balloon Catheter is 3 years, determined based on stability studies which includes accelerated aging and simulated shipping.

Sterilization shelf-life studies were conducted in compliance with the following standards:

Item	Standard
EO and ECH residuals	ISO 10993-7:2008 Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals
Bacteria Endotoxin Limit	USP <85> Bacterial Endotoxins
Shelf-Life Evaluation	Shelf life of 3 years is validated using the FDA recognized standard ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

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Package integrity testing, after accelerated aging, environmental conditioning and simulated transportation in accordance with ISTA-2A:2011 68kg or less partial simulation performance test procedure for individual packaged-products, was conducted on the final, packaged, and sterile devices. All packaging deemed acceptable for protection of product and sterility maintenance.
Sterile Barrier Packaging Testing performed on the proposed device:
- Visual Inspection in accordance with ASTM F1886 / F1886M-16
- Seal Strength in accordance with ASTM F88/F88M-15
- Dye Penetration in accordance with ASTM F1929-15

VIII Clinical Testing

No clinical study is included in this submission.

IX Conclusion

The proposed device has the same indication for use and has similar design features and technological characteristic as the predicate device. Performance testing data demonstrates that the proposed device is safety and effectiveness as the predicated device. Accordingly, the proposed device is substantially equivalent to the predicate device.

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.