(238 days)
Not Found
No
The 510(k) summary describes a mechanical device (a catheter with an inflatable balloon) used in a surgical procedure. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies are non-clinical and focus on the mechanical properties of the device.
Yes
The device is intended for the "reduction and fixation of fractures" and "creation of a void in cancellous bone in the spine during balloon kyphoplasty," which are therapeutic interventions.
No
The InterV Kyphoplasty Catheter is intended for reduction and fixation of fractures and/or creation of a void in cancellous bone, which are therapeutic actions, not diagnostic ones. It is a surgical tool used in a procedure, not for identifying disease or conditions.
No
The device description clearly outlines physical components like a catheter, balloon, shaft, Y-connector, and radiopaque marker bands, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for a surgical procedure (reduction and fixation of fractures, creation of a void in bone) within the spine. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The description details a physical device (catheter with a balloon) designed for mechanical action within the body.
- 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, etc.) to provide information for diagnosis, monitoring, or screening.
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
InterV Kyphoplasty Catheter is intended to be used for 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).
Product codes (comma separated list FDA assigned to the subject device)
NDN, HRX
Device Description
InterV Kyphoplasty Catheter is designed for use in balloon kyphoplasty; it comes as a single-use double lumen catheter with a low profile balloon mounted on the distal tip. The balloon is designed to compress cancellous bone and/or move cortical bone as it inflates. The balloon is designed to withstand bone resistance leading to an a internal pressure of up to 400 psi (27 ATM). The key components are the balloon, shaft, Y-connector and two radiopaque marker bands positioned on the inner tubing/lumen at the proximal and distal ends of the inflatable component
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cancellous bone in the 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)
SUMMARY OF NON-CLINICAL TESTS
| Characteristic | Test Method | Results Summary |
|---|---|---|
| Inflation pressure | Constrained Burst Test | The balloon catheter exceeded the requirements for the minimum burst pressure in a constrained environment |
| Inflation Volume | Unconstrained Burst Test | The balloon catheter exceeded the requirements for the minimum burst volume in a constrained environment |
| Inflated Balloon Dimensions | Balloon Inflation Test | The inflated balloon dimensions were substantially equivalent to those of the predicate devices |
| Balloon Double Wall Thickness | Calibrated Measurement | The double wall thickness of the balloons was substantially equivalent to those of the predicate devices |
CONCLUSION DRAWN FROM NON-CLINICAL DATA
The results of the non-clinical tests show that the InterV Kyphoplasty Catheter meets or exceeds all performance requirements, and are substantially equivalent to the predicate devices.
SUMMARY OF CLINICAL TESTS
N/A- No clinical tests were conducted for this submission
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.
Kyphon Inflatable Bone Tamp, K981251, Kyphx® Xpander Inflatable Bone Tamps, K041454
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
§ 888.3027 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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APR 1 6 2014
K132620 - Page 1 of 3
Image /page/0/Picture/2 description: The image shows the logo for "pan medical". The word "pan" is written in white letters inside of a black circle. The word "medical" is written in black letters to the right of the circle.
InterV Kyphoplasty Catheter Premarket Notification [510(k)] Submission
Premarket Notification [510(k)] Summary
.
SUBMITTER INFORMATION
| Manufacturer's Name: | Pan Medical Ltd |
|---|---|
| Manufacturer's Address: | Barnett Way, Barnwood, Gloucester, GL4 3RT UK |
| Telephone (DDI): | +44 1452 621621 |
| Fax: | +44 1452 372140 |
| Establishment Registration: | 3005146147 |
| Contact Person: | · Jennie Budding (Director of R&D/Production) |
| Date Prepared: | 16-April-2014 |
DEVICE INFORMATION
| Trade Name: | InterV Kyphoplasty Catheter |
|---|---|
| Common Name: | Inflatable Bone Tamp |
| Device Class: | II |
| Classification Name: | Polymethylmethacrylate (PMMA) Bone Cement |
| Arthroscope | |
| Classification Panel: | Orthopedic Devices |
| Classification Regulation: | 21 CFR 888.3027 |
| 21 CFR 888.1100 | |
| Product Code(s): | NDN |
| HRX | |
| Predicate Device: | Kyphon Inflatable Bone Tamp, K981251 |
| Kyphx® Xpander Inflatable Bone Tamps, K041454 | |
| Reason for 510(k) submission: | New Device |
1
Pan Medical Ltd.
InterV Kyphoplasty Catheter Premarket Notification [510(k)] Submission
Device Description:
InterV Kyphoplasty Catheter is designed for use in balloon kyphoplasty; it comes as a single-use double lumen catheter with a low profile balloon mounted on the distal tip. The balloon is designed to compress cancellous bone and/or move cortical bone as it inflates. The balloon is designed to withstand bone resistance leading to an a internal pressure of up to 400 psi (27 ATM). The key components are the balloon, shaft, Y-connector and two radiopaque marker bands positioned on the inner tubing/lumen at the proximal and distal ends of the inflatable component
Intended use:
InterV Kyphoplasty Catheter is intended to be used for 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).
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICES
| Characteristic | New device | Predicate Device |
|---|---|---|
| Trade name | InterV Kyphoplasty | |
| catheter | Kyphon Inflatable Bone Tamp, | |
| K981251 | ||
| Kyphx® Xpander Inflatable Bone | ||
| Tamps, K041454 | ||
| Compatible Cannula Size | 8 G / 4.2 mm | 8 G / 4.2 mm |
| Balloon Inflation Medium | 60% Contrast | 60% Contrast |
| Balloon Material | Polyurethane | Polyurethane |
| Balloon Size (Deflated Length) | 10, 15 and 20 mm | 10, 15 and 20 mm |
| Guide wire (Stylet) | Stainless Steel | Stainless Steel |
| Balloon Shape | Cylindrical | Cylindrical |
| Maximum Recommended Inflation | ||
| Pressure | 400 psi (27 ATM) | 400 psi (27 ATM) |
| Maximum Recommended Inflation | ||
| Volume (10 mm and 15 mm) | 4 ml | 4 ml |
| Maximum Recommended Inflation | ||
| Volume (20 mm) | 6 ml | 6 ml |
2
InterV Kyphoplasty Catheter Premarket Notification [510(k)] Submission
| Characteristic | Test Method | Results Summary |
|---|---|---|
| Inflation | ||
| pressure | Constrained Burst | |
| Test | The balloon catheter exceeded the requirements for the | |
| minimum burst pressure in a constrained environment | ||
| Inflation | ||
| Volume | Unconstrained Burst | |
| Test | The balloon catheter exceeded the requirements for the | |
| minimum burst volume in a constrained environment | ||
| Inflated Balloon | ||
| Dimensions | Balloon Inflation | |
| Test | The inflated balloon dimensions were substantially | |
| equivalent to those of the predicate devices | ||
| Balloon Double | ||
| Wall Thickness | Calibrated | |
| Measurement | The double wall thickness of the balloons was substantially | |
| equivalent to those of the predicate devices |
SUMMARY OF NON-CLINICAL TESTS
SUMMARY OF CLINICAL TESTS
N/A- No clinical tests were conducted for this submission
CONCLUSION DRAWN FROM NON-CLINICAL DATA
The results of the non-clinical tests show that the InterV Kyphoplasty Catheter meets or exceeds all performance requirements, and are substantially equivalent to the predicate devices.
.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 16, 2014
Pan Medical Ltd. Ms. Jennie Budding Director of R&D/Production Barnett Way, Barnwood Gloucester GL4 3RT United Kingdom
Re: K132620
Trade/Device Name: InterV Kyphoplasty Catheter Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN, HRX Dated: February 28, 2014 Received: March 4, 2014
Dear Ms. Budding:
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
4
Page 2 - Ms. Jennie Budding
(21 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Pan Medical Ltd.
InterV Kyphoplasty Catheter Premarket Notification [510(k)] Submission
Indications for Use
510(k) Number (if known): K132620
Device Name: InterV Kyphoplasty Catheter
Indications for Use:
InterV Kyphoplasty Catheter is intended to be used for 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).
Prescription Use __ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use ________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Laurence D. Coyne -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K132620
Indications For Use Statement