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).

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

AI/ML Overview

The provided text describes the InterV Kyphoplasty Catheter and its premarket notification [510(k)] submission. It outlines the device's technical characteristics and the non-clinical tests conducted to demonstrate its substantial equivalence to predicate devices.

1. A table of acceptance criteria and the reported device performance

Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Inflation Pressure	Exceed minimum burst pressure in a constrained environment	The balloon catheter exceeded the requirements for the minimum burst pressure in a constrained environment.
Inflation Volume	Exceed minimum burst volume in a constrained environment	The balloon catheter exceeded the requirements for the minimum burst volume in a constrained environment.
Inflated Balloon Dimensions	Substantially equivalent to predicate devices	The inflated balloon dimensions were substantially equivalent to those of the predicate devices.
Balloon Double Wall Thickness	Substantially equivalent to predicate devices	The double wall thickness of the balloons was substantially equivalent to those of the predicate devices.

Note: The document does not explicitly state "acceptance criteria" values but rather reports that the device "exceeded the requirements" or was "substantially equivalent" to predicate devices, implying these as the criteria.

2. Sample size used for the test set and the data provenance

The document does not provide details on the specific sample sizes for the non-clinical tests (e.g., number of catheters tested for each characteristic). It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for these non-clinical tests. As these were non-clinical tests, the concept of "data provenance" in the context of human subjects is not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable. The study involved non-clinical, in-vitro testing of device characteristics, not an evaluation requiring human expert interpretation of data or images.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human readers, which this submission explicitly states were not conducted ("N/A- No clinical tests were conducted for this submission"). The tests described are engineering performance tests.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. The document explicitly states: "N/A- No clinical tests were conducted for this submission." This product is a physical medical device (catheter), not an AI diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

A standalone performance evaluation was done in the sense that the device's physical characteristics were tested independently. However, this is not an "algorithm only" or "AI without human-in-the-loop" study as the device is not an AI algorithm. The performance evaluation was focused on the mechanical and physical properties of the catheter itself.

7. The type of ground truth used

The ground truth for the non-clinical tests was established by direct measurement and observation against predefined engineering specifications and criteria, or by comparison to the performance of legally marketed predicate devices. For example:

Inflation Pressure: Measured burst pressure.
Inflation Volume: Measured burst volume.
Inflated Balloon Dimensions: Measured dimensions compared against predicate devices.
Balloon Double Wall Thickness: Calibrated measurement.

8. The sample size for the training set

This information is not applicable. This submission describes a physical medical device, not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable as there was no training set for an AI algorithm.

Summary

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APR 1 6 2014

K132620 - Page 1 of 3

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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 CementArthroscope
Classification Panel:	Orthopedic Devices
Classification Regulation:	21 CFR 888.302721 CFR 888.1100
Product Code(s):	NDNHRX
Predicate Device:	Kyphon Inflatable Bone Tamp, K981251Kyphx® Xpander Inflatable Bone Tamps, K041454
Reason for 510(k) submission:	New Device

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Pan Medical Ltd.

InterV Kyphoplasty Catheter Premarket Notification [510(k)] Submission

Device Description:

Intended use:

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICES

Characteristic	New device	Predicate Device
Trade name	InterV Kyphoplastycatheter	Kyphon Inflatable Bone Tamp,K981251Kyphx® Xpander Inflatable BoneTamps, 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 InflationPressure	400 psi (27 ATM)	400 psi (27 ATM)
Maximum Recommended InflationVolume (10 mm and 15 mm)	4 ml	4 ml
Maximum Recommended InflationVolume (20 mm)	6 ml	6 ml

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InterV Kyphoplasty Catheter Premarket Notification [510(k)] Submission

Characteristic	Test Method	Results Summary
Inflationpressure	Constrained BurstTest	The balloon catheter exceeded the requirements for theminimum burst pressure in a constrained environment
InflationVolume	Unconstrained BurstTest	The balloon catheter exceeded the requirements for theminimum burst volume in a constrained environment
Inflated BalloonDimensions	Balloon InflationTest	The inflated balloon dimensions were substantiallyequivalent to those of the predicate devices
Balloon DoubleWall Thickness	CalibratedMeasurement	The double wall thickness of the balloons was substantiallyequivalent 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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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

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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

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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:

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

Regulation Number and Section

§ 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.”