(168 days)
Not Found
No
The description focuses on mechanical inflation and restoration of vertebral height, with no mention of AI/ML for analysis, decision-making, or image processing.
Yes
The device is intended to be used for the reduction of fractures and creation of a void in cancellous bone in the spine, specifically to treat vertebral compression fractures. These actions are therapeutic in nature, aimed at alleviating a medical condition and restoring function.
No
The device is described as a "Balloon Inflation System" used for "reduction of fractures and/or creation of a void in cancellous bone in the spine" and "to treat vertebral compression fractures." This description explicitly details a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines physical components like puncture needles, dilators, balloon catheters, and an inflation device, indicating it is a hardware-based system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the mechanical reduction of fractures and creation of a void in bone, specifically in the spine, and for use with bone cement. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device description details a system used to physically manipulate bone tissue and deliver bone cement. This is a therapeutic and surgical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for a surgical procedure.
N/A
Intended Use / Indications for Use
The Balloon Inflation System is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes 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.
Product codes
NDN, HRX
Device Description
Balloon Inflation System is mainly used to treat vertebral compression fractures caused by osteoporosis. Puncture needles or dilators are used to establish working channels, then balloon catheters are placed along the working channels and inflation device connect to balloon catheter and control it expansion to lift the upper and lower endplates of the vertebral body, restore the height of the vertebral body, and form bone cement filling cavities.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spine
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
Non-clinical tests of the device-the Balloon Inflation System have been performed under Good Laboratory Practices requlations (FDA, 21 CFR Part 58-Good Laboratory Practice for Noncinical Laboratory Studies) and in accordance to standard operating procedures and a standard protocol.
Sterilization validating testing has been performed in accordance with ISO 11138-2, 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.
Biocompatibility tests were performed in accordance with ISO 1099-5, 10, 11, 23, and the test results supported that the subject devices are biocompatible
Various bench tests including product size, tensile bond strength, burst pressure constrained, fatique strength, maximum inflalted volume, balloon deflation time, burst straint, balloon dimension after inflation, insertion and withdrawal force, range, volume, accuracy, tensile bond strength, and leakproofness were performed to evaluate the party of the subject devices and the test results met the preset criteria.
These tests demonstrate that the device is as safe, as effective, and perform as well as the legally marketed device the MEDNAUT Kyphoplasty System.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”
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February 29, 2024
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Ningbo HicRen Biotechnology Co., Ltd. % Raymond Wu Project Engineer PureID Medical Technology Co., Ltd. Guangzhou International Biology Island Luoxuan Blvd Guanzhou Life Science Innovation Cntr, Bd.A 3301-3310 & 3316-3318 Guangzhou, China
Re: K232842
Trade/Device Name: Balloon Inflation System Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: NDN Dated: September 14, 2023 Received: September 14, 2023
Dear Raymond Wu:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
Image /page/2/Figure/3 description: The image shows a digital signature of Jesse Muir. The signature includes the name "Jesse Muir" followed by "-S". The text "Digitally signed by Jesse Muir -S" is present above the date and time stamp. The date and time stamp indicates the signature was created on February 29, 2024, at 13:16:15, with a time zone offset of -05'00'.
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
Submission Number (if known)
Device Name
Balloon Inflation System
Indications for Use (Describe)
The Balloon Inflation System is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes 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) #: K232842
510(k) Summary
Prepared on: 2024-02-27
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | Ningbo HicRen Biotechnology Co., Ltd | |
|---|---|---|
| Applicant Address | Building 1 Block B No.777 Binhai 4th Road Hangzhou Bay New District, | |
| Ningbo, China Ningbo Zhejiang 315336 China | ||
| Applicant Contact Telephone | (86-574)-637297 | |
| Applicant Contact | Ms. Qian Jia | |
| Applicant Contact Email | qianjia@hicren.com | |
| Correspondent Name | PureID Medical Technology Co., Ltd. | |
| Correspondent Address | Guangzhou International Biology Island Luoxuan Blvd Guanzhou Life | |
| Science Innovation Center, Bd.A 3301-3310 & 3316-3318 | ||
| Guangzhou China | ||
| Correspondent Contact Telephone | (86-400)-093330 | |
| Correspondent Contact | Mr. Da-guang Sun | |
| Correspondent Contact Email | raq@pureglobal.cn | |
| Device Name | ||
| 21 CFR 807.92(a)(2) | ||
| Device Trade Name | Balloon Inflation System | |
| Common Name | Polymethylmethacrylate (PMMA) bone cement | |
| Classification Name | Cement, Bone, Vertebroplasty | |
| Regulation Number | 888.3027 | |
| Product Code(s) | NDN, HRX | |
| Legally Marketed Predicate Devices | ||
| 21 CFR 807.92(a)(3) | ||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K153296 | MEDINAUT Kyphoplasty System | NDN |
| Device Description Summary | ||
| 21 CFR 807.92(a)(4) | ||
| Balloon Inflation System is mainly used to treat vertebral compression fractures caused by osteoporosis. Puncture needles or dilators are | ||
| used to establish working channels, then balloon catheters are placed along the working channels and inflation device connect to | ||
| balloon catheter and control it expansion to lift the upper and lower endplates of the vertebral body, restore the height of the vertebral | ||
| body, and form bone cement filling cavities. | ||
| Intended Use/Indications for Use | 21 CFR 807.92(a)(5) |
The Balloon Inflation System is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the
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spine. This includes percutaneous vertebral augmentation. The system is to be used with cleared spinal polymethy memate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.
Indications for Use Comparison
The indication of use of the device is "The Balloon Inflation System is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes 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,", which is similar to the indication of use of the MEDNAUT Kyphoplasty System is intended to be used for the reduction of fractures and/or creation of a void incancellous bone in the spine, tibia, radius, This includes percutaneous vertebral augmentation. The systemist o be used spinal polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneousvertebral augmentation, such as kyphoplasty."
Technological Comparison
21 CFR 807.92(a)(6)
There are no significant differences between the predicate devices. The subject devices. The subject device has the similar indication for use with minor differences that does not afficacy of the product compared with the predicate devices. The subject device has the same balloon max inflation predicate devices and they are similar in fundamental components, balloon size, composition of materials and packaging. The subject device might be different from the predicate device, however, the sterility test report of balloon catheter and balloon inflation system examination record of EO residue show that the subject device would perform as well as the predicate device.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Non-clinical tests of the device-the Balloon Inflation System have been performed under Good Laboratory Practices requlations (FDA, 21 CFR Part 58-Good Laboratory Practice for Noncinical Laboratory Studies) and in accordance to standard operating procedures and a standard protocol.
@Sterilization validating testing has been performed in accordance with ISO 11138-2, 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.
® Biocompatibility tests were performed in accordance with ISO 1099-5, 10, 11, 23, and the test results supported that the subject devices are biocompatible
@Various bench tests including product size, tensile bond strength, burst pressure constrained, fatique strength, maximum inflalted volume, balloon deflation time, burst straint, balloon dimension after inflation, insertion and withdrawal force, range, volume, accuracy, tensile bond strength, and leakproofness were performed to evaluate the party of the subject devices and the test results met the preset criteria.
These tests demonstrate that the device is as safe, as effective, and perform as well as the legally marketed device the MEDNAUT Kyphoplasty System.