(272 days)
Not Found
No
The summary describes a mechanical system for kyphoplasty and does not mention any AI or ML components or functions.
Yes
The device is used to reduce and fix fractures and create a void in bone, which are therapeutic interventions.
No
Explanation: The device description states its purpose is for "reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine," indicating a therapeutic or surgical intervention rather than a diagnostic one. It is used during percutaneous vertebral augmentation with bone cements.
No
The device description explicitly lists multiple hardware components (Balloon Catheter, Tool Kit, Puncture Needle, Balloon Catheter Syringe Pump, Kyphoplasty Multifunctional Tool) and describes a physical procedure (reduction and fixation of fractures, creation of a void in cancellous bone).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical procedure performed on the patient's body (reduction and fixation of fractures, creation of a void in bone). IVDs are used to examine specimens from the body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The components listed are instruments used in a surgical procedure (catheters, needles, pumps, tools). These are not reagents, analyzers, or other equipment typically associated with laboratory testing of specimens.
- Anatomical Site: The device is used on the "spine," which is an anatomical site within the body, not a specimen taken from the body.
Therefore, the KMC Kyphoplasty System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The KMC Kyphoplasty System 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.
Product codes
HRX, NDN
Device Description
KMC Kyphoplasty System consists of five components:
- Balloon Catheter .
- Tool Kit
- . Puncture Needle
- Balloon Catheter Syringe Pump .
- Kyphoplasty Multifunctional Tool .
The Kyphoplasty Multifunctional Tool can be substituted for the Puncture Needle and Kyphoplasty Tool Kit.
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
The KMC Kyphoplasty system was evaluated in a multicenter study. A total of 25 patients were treated at two sites. The conclusions from the study show the system performed per specification when used according to the instructions for use.
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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K113742:
PAGE 1 OF 3
SEP 1 7 2012
510(k) Summary
General Information
Classification
Regulation Number
21CFR 888.1100 21CFR 888.3027
Arthroscope
Class II
Regulation Name
Product Code
HRX NDN
Trade Name
Submitter
Submitted by
KMC Kyphoplasty System
Cement/Bone Vertebroplasty
Shanghai Kinetic Medical Co., Ltd
Regulatory Strategies, Inc. 3924 Cascade Beach Road Lutsen, MN 55612
Tel: (218) 387-1559
Gregory Mathison
Contact
Date Prepared
April 20, 2011
President
Indications for Use
The KMC Kyphoplasty System 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.
Predicate Devices
| K061222 | Kyphx Inflatable Bone Tamp | Kyphon Inc. |
|---|---|---|
| K103231 | Kyphon Inflation Syringe | Kyphon Inc |
1
Device Description
KMC Kyphoplasty System consists of five components:
- Balloon Catheter .
- Tool Kit
- . Puncture Needle
- Balloon Catheter Syringe Pump .
- Kyphoplasty Multifunctional Tool .
The Kyphoplasty Multifunctional Tool can be substituted for the Puncture Needle and Kyphoplasty Tool Kit.
Sterilization
The system is provided sterile and is for single use only. The ETO gas sterilization process is validated with a resulting sterility assurance level (SAL) of 10°.
K13742
AGE 2 OF 3
ETO residual testing was also performed and the products met specification.
Packaging
The components are placed in a thermoformed PETG/PET tray with a heat sealed Tyvek lid. The sealed tray is placed in a Tyvek flexible peel pouch and heat sealed. The heat sealed pouches are placed in white shelf cartons and then packaged in a corrugated shipper box. Expiration dating testing was conducted using the industry standard ASTM method for accelerated aging and real-time aging was also performed.
Materials
All materials used in the manufacture of the KMC Kyphoplasty System are suitable for this use and have been used in s previously cleared products.
Testing
Product testing was performed on final sterilized devices. Testing was completed, including: dimensional, inflation/deflation, balloon size and system compatibility. All testing met the acceptance criteria.
Biocompatibility testing was performed per ISO10993 as required for a temporary bone/tissue contacting device. All materials were found to be biocompatible and suitable for this use.
Clinical Evaluation
The KMC Kyphoplasty system was evaluated in a multicenter study. A total of 25 patients were treated at two sites. The conclusions from the study show the system performed per specification when used according to the instructions for use.
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K113742
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. ·
Summary of Substantial Equivalence
The KMC Kyphoplasty System is equivalent to the features of the predicate products. The indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 17 2012
Shanghai Kinetic Medical Company, Limited % Regulatory Strategies, Incorporated Mr. Gregory Mathison President 3924 Cascade Beach Road Lutsen, Minnesota 55612
Re: K113742
Trade/Device Name: KMC Kyphoplasty System Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN, HRX Dated: August 20, 2012 Received: August 29, 2012
Dear Mr. Mathison:
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. 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
4
Page 2 – Mr. Gregory Mathison
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
For
Deb Lin Din
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Indications for Use
510(k) Number (if known):
Device Name:
KMC Kyphoplasty System
Indications for Use:
The KMC Kyphoplasty System 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.
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
thumor M. Taylor
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113742
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