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).

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.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "InterV Kyphoplasty Catheter." As such, it focuses on demonstrating substantial equivalence to existing devices rather than proving performance against specific acceptance criteria through a clinical study for a novel device. The information provided is for a modified/new size device, not an AI/ML powered medical device, therefore many of the standard questions about acceptance criteria for AI/ML devices do not apply.

Here's an analysis based on the provided text, addressing the points where applicable and noting where the information is not relevant to this type of submission:

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

The document does not provide a table of acceptance criteria and reported device performance in the context of an AI/ML device. Instead, it describes "predetermined acceptance criteria were met" for non-clinical tests without detailing the specific criteria or exact results for each.

The summary of non-clinical tests states:
"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."

It also mentions:
"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."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable. The device is a physical medical device (kyphoplasty catheter), not an AI/ML algorithm that processes data. The testing mentioned refers to mechanical, functional, and sterility tests performed on physical samples of the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. Ground truth and expert consensus are concepts relevant to AI/ML model validation, not to the verification of mechanical and functional performance of a physical medical device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as it pertains to establishing ground truth for AI/ML models.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human interpretation, which is not applicable to a physical medical device like a kyphoplasty catheter.

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

This information is not applicable as there is no AI algorithm involved in this device submission.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not applicable. For a physical device, testing verifies that the device meets its design specifications and functional requirements (e.g., burst pressure, inflation volume, material compatibility, sterility), rather than comparing its output to a "ground truth" derived from patient data.

8. The sample size for the training set

This information is not applicable as there is no AI/ML algorithm with a training set.

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

This information is not applicable as there is no AI/ML algorithm with a training set.

Summary of Device and Study Type:

This document is for a Special 510(k) submission for modifications (new sizes) to an existing InterV Kyphoplasty Catheter. The core of a 510(k) is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.

Acceptance Criteria and Proof of Meeting Them (as described in the document):

Overall Goal: To confirm the subject device functions as intended and does not raise any new issues of safety or effectiveness compared to the predicate devices.
Method: "Verification activities including mechanical and functional testing as required by the risk analysis for the line extension were performed."
Acceptance Criteria for Non-Clinical Tests: "predetermined acceptance criteria were met." (Specific criteria and quantitative results are not detailed in this summary, but would be present in the full submission).
Specific Example of Acceptance Criteria and Performance:
- Test: Bacterial Endotoxin Test (BET)/ Limulus Amebocyte Lysate (LAL) test.
- Acceptance Criteria: Pyrogen limit specification of 20 EU/device.
- Reported Performance: "confirmed that the device met the pyrogen limit specification of 20 EU/device."

Clinical Studies:

"N/A - No clinical tests were conducted for this submission." This is common for 510(k) submissions, especially for modifications or line extensions where substantial equivalence can be demonstrated through non-clinical testing.

Conclusion of the Submission:

The conclusion states that based on the same indications for use, similar materials (with a minor stylet change noted and justified as not affecting safety/effectiveness), same operating principle, same shelf life, and same packaging/sterilization, along with the results from risk analysis and associated verification testing, the new devices are substantially equivalent to the currently marketed predicate devices.

Summary

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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

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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

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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:

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)

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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 CementArthroscope
Classification Panel:	Orthopedic Devices
Classification Regulation:	21 CFR 888.302721 CFR 888.1100
Product Code(s):	NDNHRX
Identification of the predicatelegally 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 aredesigned for use in balloon kyphoplasty; they come as a single-usedouble lumen catheter with a low profile balloon mounted on the distaltip. The balloon is designed to compress cancellous bone and/or movecortical bone as it inflates. The key components are the balloon, shaft,Y-connector and two radiopaque marker bands positioned on the innertubing/lumen at the proximal and distal ends of the inflatablecomponent.

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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)

TECHNOLOGICALCHARACTERISTICS	PREDICATE DEVICES:8G INTERV KYPHOPLASTYCATHETER AND 11G INTERVKYPHOPLASTY CATHETER(MINI) CLEARED UNDERK132620 & K150322;INTV-10, INTV-15 AND INTV-20; INTVMN-10, INTVMN-15AND INTVMN-20	SUBJECT DEVICE (LINEEXTENSION):13G INTERV KYPHOPLASTYCATHETER (MICRO);INTVMC-10, INTVMC-15 &INTVMC-20	SUBJECT DEVICE (LINEEXTENSION):11G INTERVKYPHOPLASTYCATHETER (FLEX);INTVMN-20-FL
Balloon Length(Deflated)	10, 15 and 20 mm	10, 15 and 20 mm	20 mm
MaximumRecommendedInflation Volume	10 mm balloon: 4 ml15 mm balloon:4 ml20 mm balloon: 6 ml	10 mm balloon: 4 ml15 mm balloon:4 ml20 mm balloon: 6 ml	6 ml
MaximumRecommendedInflation 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 CannulaSize	8G and 11G	13G	11G
Overall Length of theCatheter	30 cm	30 cm	30 cm
Effective Length of theCatheter	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 InflationMedium	60% Contrast	60% Contrast	60% Contrast
Sterility	Delivered sterile (EtO)	Delivered sterile (EtO)	Delivered sterile (EtO)
Shelf Life	3 years from the date ofSterilization	3 years from the date ofSterilization	3 years from the date ofSterilization

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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).

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.”