(247 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon catheter, with no mention of AI or ML technologies.
Yes
The device is used to reduce and fix fractures and create a void in bone, which are therapeutic actions aimed at treating a medical condition.
No
Explanation: The device is a balloon catheter used for fracture reduction and void creation in bone, which is a therapeutic rather than diagnostic function.
No
The device description explicitly details physical components like an outer tube, core tube/rod, inflatable balloon, and radiopaque markers, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that this is a physical device (a balloon catheter) used within the body during a surgical procedure (kyphoplasty) to treat bone fractures. It does not involve the analysis of bodily specimens.
The device is an implantable medical device used in a surgical procedure.
N/A
Intended Use / Indications for Use
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).
Product codes (comma separated list FDA assigned to the subject device)
HRX, HXG
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench test:
The following tests were performed in support of the substantial equivalence determination.
- Balloon Burst Pressure: Acceptance Criteria: Balloon Burst Pressure (Constrained) ≥ 400psi
- Balloon Burst Volume: Acceptance Criteria: Balloon Burst Volume (Constrained) ≥ 6ml
- Balloon Inflation Behavior (Unconstrained Balloon Compliance): Acceptance Criteria: 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.
- Tensile Force: Acceptance Criteria: Tensile force ≥ 15N.
- Balloon Repeated Inflation: Acceptance Criteria: The balloon should withstand 20 inflation/deflation cycles at rated filling volume without rupture or leak.
- Balloon Deflation Time: Acceptance Criteria: 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
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:
- EO and ECH residuals: ISO 10993-7:2008 Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals
- Bacteria Endotoxin Limit: USP 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
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
Indications for Use
510(k) Number (if known) K223709
Device Name Kyphoplasty Balloon Catheter
Indications for Use (Describe)
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).
| 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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3
510(k) summary
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
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.
4
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 Balloon
Catheter | Joline® Kyphoplasty
System 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 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). | The Joline® Kyphoplasty
System Allevo 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
polymethylmethacrylate
(PMMA) bone cements). | same |
| Balloon Size | 10.0mm, 15.0mm,
20.0mm | 10.0mm, 16.0mm, 22.0mm | Different¹ |
| Balloon Brust
Pressure | 400 psi | 400 psi | same |
| Balloon
Burst
Volume | ≥ 6 ml | ≥ 6 ml | same |
| Balloon
Inflation
Behavior | Balloon Diameter:
$18.3\pm3.0$ mm.
Balloon working length:
$28.0\pm3.0$ | Balloon Diameter $\leq$ 19 mm
Balloon working length $\leq$ 24mm | Different¹ |
| Tensile
Force
Balloon | $\geq$ 15 N | $\geq$ 15 N | same |
| Balloon | The balloon must not | The balloon must not burst | Different² |
| Repeated
Inflation | rupture or leak within 20
inflation/deflation cycles | within 3 inflation/deflation
cycles | |
| Balloon
Deflation Time | $\leq$ 3 s | $\leq$ 3 s | same |
| Shapes | Peanut, cylindrical | Cylindrical | Different3 |
| Inflation
medium | Contrast medium | Contrast medium | Same |
| Single/double
use of catheter | Single | Single and double | Different4 |
| Sterility | Yes | Yes | same |
| Biocompatibility | Confirm to the
requirements of ISO
10993 series standards | Confirm to the
requirements of ISO 10993
series standards | Same |
Table 1 General Comparison of Kyphoplasty Balloon Catheter
5
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) ≥ |
6
| 400psi | |
|---|---|
| Balloon Burst Volume | Balloon Burst Volume (Constrained) ≥ 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. | |
| Tensile Force | Tensile force ≥ 15N. |
| Balloon Repeated | |
| Inflation | The balloon should withstand 20 |
| inflation/deflation cycles at rated filling | |
| volume 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 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 |
7
- 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.