(61 days)
Not Found
No
The 510(k) summary describes a mechanical device (catheter with a balloon) used in a surgical procedure. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on mechanical and functional testing.
Yes
The device is intended to be used for reduction and fixation of fractures and creation of a void in cancellous bone in the spine during balloon kyphoplasty, which are therapeutic interventions.
No
Explanation: The device is intended for reduction and fixation of fractures and/or creation of a void in cancellous bone, which are therapeutic interventions, not diagnostic ones.
No
The device description clearly outlines physical components like a catheter, balloon, shaft, Y-connector, and marker bands, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical procedure (balloon kyphoplasty) to treat bone fractures in the spine. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a catheter with a balloon designed to be inserted into the bone. This is a medical device used for a physical procedure.
- 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 compatibility testing.
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 treatment.
N/A
Intended Use / Indications for Use
8G InterV Kyphoplasty Catheter, 11G InterV Kyphoplasty Catheter (Mini), 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Flex) are 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
NDN, HRX
Device Description
Both the predicate and the subject InterV Kyphoplasty Catheters are designed for use in balloon kyphoplasty; they come 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 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
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)
Verification activities including mechanical and functional testing as required by the risk analysis for the line extension were performed to confirm that the subject device functions as intended and does not raise any new issues of safety or effectiveness. The results from the testing demonstrated that the predetermined acceptance criteria were met and the device does not raise any new issues of safety or effectiveness.
Bacterial Endotoxin Test (BET)/ Limulus Amebocyte Lysate (LAL) test conducted on the subject device confirmed that the device met the pyrogen limit specification of 20 EU/device.
N/A- No clinical tests were conducted for this submission
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.”
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a design that resembles a bird in flight above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 1, 2016
Pan Medical Ltd. Ms. Jennie Budding Director of Research and Development/Production Barnett Way, Barnwood Gloucester Gloucestershire, GL4 3RT United Kingdom
Re: K162453
Trade/Device Name: 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex) Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN, HRX Dated: October 11, 2016 Received: October 12, 2016
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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
1
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 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/ResourcesforYou/Industry/default.htm. 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
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/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
InterV Kyphoplasty Catheter Modification Special 510(k) Submission
Indications for Use
K162453 510(k) Number (if known):
Device Name: 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)
Indications for Use:
8G InterV Kyphoplasty Catheter, 11G InterV Kyphoplasty Catheter (Mini), 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Flex) are 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)
3
Image /page/3/Picture/1 description: The image shows the logo for Pan Medical. The logo consists of a dark blue circle with a white crescent shape cut out of the bottom left corner. The words "pan medical" are written in white, sans-serif font to the right of the circle, with "pan" on the top line and "medical" on the bottom line.
Special [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: | 17-August-2016 |
DEVICE INFORMATION
| Trade Name: | 13G InterV Kyphoplasty Catheter (Micro)
11G InterV Kyphoplasty Catheter (Flex) |
|-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 |
| Identification of the predicate
legally marketed device: | InterV Kyphoplasty Catheter and InterV Kyphoplasty Catheter (Mini)
cleared under 510(k) Numbers K132620 and K150322 |
| Device Description: | Both the predicate and the subject InterV Kyphoplasty Catheters are
designed for use in balloon kyphoplasty; they come 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 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. |
4
Both the predicate and the subject InterV Kyphoplasty Catheters are Intended use: 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 COMPARISON OF TECHNICAL ATTRIBUTES OF THE NEW SIZE KYPHOPLASTY CATHETER TO TO ITS LEGALLY MARKETED INTERV PREDICATES (K132620 & K150322)
| TECHNOLOGICAL
CHARACTERISTICS | PREDICATE DEVICES:
8G INTERV KYPHOPLASTY
CATHETER AND 11G INTERV
KYPHOPLASTY CATHETER
(MINI) CLEARED UNDER
K132620 & K150322;
INTV-10, INTV-15 AND INTV-
20; INTVMN-10, INTVMN-15
AND INTVMN-20 | SUBJECT DEVICE (LINE
EXTENSION):
13G INTERV KYPHOPLASTY
CATHETER (MICRO);
INTVMC-10, INTVMC-15 &
INTVMC-20 | SUBJECT DEVICE (LINE
EXTENSION):
11G INTERV
KYPHOPLASTY
CATHETER (FLEX);
INTVMN-20-FL |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Balloon Length
(Deflated) | 10, 15 and 20 mm | 10, 15 and 20 mm | 20 mm |
| Maximum
Recommended
Inflation Volume | 10 mm balloon: 4 ml
15 mm balloon:4 ml
20 mm balloon: 6 ml | 10 mm balloon: 4 ml
15 mm balloon:4 ml
20 mm balloon: 6 ml | 6 ml |
| Maximum
Recommended
Inflation Pressure | 50 ATM (750 psi) | 50 ATM (750 psi) | 50 ATM (750 psi) |
| Shaft Diameter | 8 Fr and 6 Fr | 5 Fr | 6 Fr |
| Compatible Cannula
Size | 8G and 11G | 13G | 11G |
| Overall Length of the
Catheter | 30 cm | 30 cm | 30 cm |
| Effective Length of the
Catheter | 22 cm | 22 cm | 22 cm |
| Balloon Shape | Cylindrical | Cylindrical | Cylindrical |
| Balloon Material | Polyurethane | Polyurethane | Polyurethane |
| Guide wire (Stylet)
Material | Stainless Steel | Stainless Steel | Nitinol |
| Balloon Inflation
Medium | 60% Contrast | 60% Contrast | 60% Contrast |
| Sterility | Delivered sterile (EtO) | Delivered sterile (EtO) | Delivered sterile (EtO) |
| Shelf Life | 3 years from the date of
Sterilization | 3 years from the date of
Sterilization | 3 years from the date of
Sterilization |
5
ACCESSORIES KIT
Bone access tools (Bone access trocar, Kirschner wire, Bone access drill, Curette, Bone access cannula); Cement delivery tools (Cement delivery cannula, Cement dispenser) and Inflation device
SUMMARY OF NON-CLINICAL TESTS
Verification activities including mechanical and functional testing as required by the risk analysis for the line extension were performed to confirm that the subject device functions as intended and does not raise any new issues of safety or effectiveness. The results from the testing demonstrated that the predetermined acceptance criteria were met and the device does not raise any new issues of safety or effectiveness.
Bacterial Endotoxin Test (BET)/ Limulus Amebocyte Lysate (LAL) test conducted on the subject device confirmed that the device met the pyrogen limit specification of 20 EU/device.
SUMMARY OF CLINICAL TESTS
N/A- No clinical tests were conducted for this submission
CONCLUSION
As the current sizes and the proposed new size InterV Kyphoplasty Catheter
- have the same indications for use,
- Incorporate the same materials except for the Stylet which is Nitinol in the case of the ● 11G Interv Kyphoplasty Catheter (Flex). However this does not affect the intended use of the device or its safety and effectiveness as evidenced by the verification testing results and as the stylet does not come into contact with the patient at any point.
- use the same operating principle, ●
- . have the same shelf life and
- are packaged and sterilised using the same materials and processes
And based on the results from risk analysis associated verification testing, we believe that the subject devices, the 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Flex) are substantially equivalent to the currently marketed 8G InterV Kyphoplasty Catheter and 11G InterV Kyphoplasty Catheter (Mini).