(367 days)
The Kyphoplasty Balloon System (KYBS) is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during 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.
The Kyphoplasty Balloon System (KYBS) is designed to reduce spinal compression fracture and restore sagittal alignment. The device creates a space in the vertebral body to facilitate the insertion of bone cement and using cement dispensing plunger. The KYBS components are balloon catheter, cement dispenser and balloon dilator.
The main components of the balloon catheter are the shaft, hub and the inflatable balloon located at the distal tip and inflatable balloon is covered 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.
This document describes a medical device submission (K221142) for a Kyphoplasty Balloon System. The FDA has determined the device to be substantially equivalent to a legally marketed predicate device.
However, the provided text does not contain any information regarding acceptance criteria, reported device performance in terms of clinical accuracy or effectiveness, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details beyond non-clinical testing.
The document focuses on:
- Regulatory clearance: Confirmation of substantial equivalence.
- Device description: Components (balloon catheter, cement dispenser, balloon dilator), materials, and mechanisms.
- Intended Use/Indications for Use: Reduction and fixation of fractures, creation of a void in cancellous bone in the spine, and use with PMMA bone cements.
- Non-clinical performance tests: Biocompatibility, bacterial endotoxin, packaging stability, and device characterization (referencing ISO and ASTM standards). These are primarily safety and engineering performance criteria, not clinical performance for detection or diagnostic accuracy.
- Comparison to predicate device: Similarities in balloon size, material, production method, and use, with a noted difference in the twisting capability of the balloon part for easier insertion.
Therefore, based solely on the provided text, it is not possible to answer the detailed questions regarding acceptance criteria and the study proving the device meets them in the context of clinical performance or AI diagnostic accuracy. The device described is a medical instrument (Kyphoplasty Balloon System), not an AI/ML-driven diagnostic or image analysis tool.
If the request was based on a misunderstanding of the device type, and if this were an AI/ML device, the information would typically be found in a performance study section or clinical validation report, which is absent here.
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April 21, 2023
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OK MediNet Korea Co., Ltd. % Yang Ho Dong Manager Onbix Corporation 821 Samil Plaza, 14, Dogok-ro 1-gil Gangnam-gu Seoul, South Korea 06253
Re: K221142
Trade/Device Name: Kyphoplasty Balloon System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: April 18, 2023 Received: April 18, 2023
Dear Yang Ho Dong:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 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,
Sara S. Thompson -S
Sara S. Thompson, D.V.M. Acting 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) K221142
Device Name Kyphoplasty Balloon System
Indications for Use (Describe)
The Kyphoplasty Balloon System (KYBS) is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during 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.
| 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 K221142
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.
| Submitter Information: | OK Medinet Korea Co., Ltd.#418, Namsung Plaza, 130, Digital-ro, Geumcheon-gu(08589) Seoul, KoreaT 82-2-833-4489 F 82-2-833-4432 |
|---|---|
| Contact Person: | Ho Dong, YangOnbix Corporation#821 Samil Plaza, 14, Dogok-ro 1-gil, Gangnam-guSeoul, Korea (06253)Tel: *82-2-566-3360 / Fax: *82-2-6280-3360Email: onbix@naver.com |
| Date Summary Prepared: | April 20, 2023 |
Device Information:
| Trade Name(s): | Kyphoplasty Balloon System |
|---|---|
| Classification Name: | Arthroscope |
| Product code & regulation: | HRX & 888.1100 |
Predicate Device Information:
K202027 Balex Bone Expander System, TAEYEON Medical Co.
Device Description:
The Kyphoplasty Balloon System (KYBS) is designed to reduce spinal compression fracture and restore sagittal alignment. The device creates a space in the vertebral body to facilitate the insertion of bone cement and using cement dispensing plunger. The KYBS components are balloon catheter, cement dispenser and balloon dilator.
The main components of the balloon catheter are the shaft, hub and the inflatable balloon located at the distal tip and inflatable balloon is covered 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.
Intended Use/ Indications for Use:
The Kyphoplasty Balloon System (KYBS) is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during 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.
Performance properties
The device was conducted in compliance with the following Standards:
- Biocompatibility tests in accordance with ISO 10993-4, ISO 10993-4, ISO 10993-.
10 for Cytotoxicity, Skin sensitization, Intracutaneous reactivity, Acute systemic toxicity,
Material-mediated Pyrogen testing, and Hemolysis
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- Bacterial Endotoxin Test - the device met the limit specifications of ANSI/AMMI ST72:2019
- . Packaging stability tests in accordance with ISO 11607
- . Device characterization and performance tests in accordance with ISO 10555-1, ISO 10555-4, ASTM F1874 and ASTM F2132
Summary of the technological characteristics compared to the predicate device
Similarity: The standard size of the balloon component is the same at 10mm. 15mm. and 20mm. the raw material used is the same as thermoplastic polyurethane (TPU), and the appearance is similar. In addition, the high-frequency welding method of the balloon part and the connection part is the same during production, the purpose of use for instability due to spinal compression fractures, and method of use, such as the method of perforating diseased parts, are similar. In addition, contrast medium, use of cannula tube for balloon insertion, balloon removal, and use of bone cement are similar between devices.
Difference: Our product balloon part is able to twist for easier insertion into the affected part of the spine compared to the predicate device.
Non-Clinical (Animal) Study performance
Not applicable
Conclusion
Kyphoplasty Balloon System is substantially equivalent to the predicate device in its intended use and technological characteristics
§ 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.