The Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters are 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. This system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements for use during percutaneous vertebral augmentation, such as kyphoplasty.

Device Description

The inflation of the balloon serves to create a cavity in the vertebral body, compressing the cancellous bone and/or move cortical bone, thereby reducing the fracture and preventing cement leakage, while still allowing for cement interdigitation.

Modified Winch Kypholplasy (15 and 20 mm) 11 Gauge balloon catheters fit through a 10 Gauge cannula allowing a minimally invasive kyhoplasty procedure. The low pre-inflation profile (low wrapping profile of folded balloon) enables their insertion into these small working cannulas.

The stiff distal end of the balloon catheter provides rigidity for smooth insertion while the flexible proximal catheter allows for easy maneuverability. The inflating component, laserbonded to the shaft, is a low-pressure elastomeric balloon of tubular shape (which is inflated by volume, not pressure). The inflation can expand the balloon several times its original size, it can be inflated to precise dimensions and retain well defined shapes and high pressures and when the pressure is released, it recovers close to its original size and shape, re-folding back to similar original profiles.

AI/ML Overview

This document, a 510(k) Pre-Market Notification for the "Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters," does not contain information about an AI/ML-based medical device. Instead, it describes a conventional medical device (balloon catheters used in kyphoplasty) and its modification.

Therefore, many of the requested details regarding acceptance criteria and study design for an AI/ML device (e.g., sample size for test/training sets, ground truth establishment by experts, MRMC studies, standalone algorithm performance, effect size of human improvement with AI) are not applicable to the content provided.

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K152557) based on design verification and validation testing of the modified physical device, rather than performance of an AI algorithm against a medical condition.

Here's a breakdown of what can be extracted from the provided text, and what cannot be answered given the nature of the document:

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

The document states:
"Using design FMECA, G21 identified the necessary verification and validation testing to assure the new balloon met the catheters original performance specifications. All testing demonstrated that the modified catheters continues to meet all performance specifications."

While the general statement is made that "all performance specifications" were met, the document does not provide a specific table of quantitative acceptance criteria or the numerical reported device performance results for the physical properties of the balloon catheters (e.g., burst pressure, inflation/deflation times, material strength, dimensions). It refers to the use of Design FMECA (Failure Mode and Effects Criticality Analysis) to identify necessary testing.

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

Not applicable / Not provided. This device is a physical medical instrument, not an AI algorithm evaluated on patient data. The "test set" would refer to the physical units undergoing engineering and performance testing. The document does not specify the number of catheters tested or the origin of any "data" in the sense of patient data.

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)

Not applicable. "Ground truth" in this context would typically relate to clinical outcomes or definitive diagnoses for AI models. For a physical device, testing is against engineering specifications and performance metrics. There's no mention of experts establishing a clinical "ground truth" for the device's function or performance in the human body within this document, beyond standard medical device development and regulatory review processes.

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

Not applicable. This method is used for resolving discrepancies in expert labeling for AI/ML ground truth. It is not relevant to the engineering and performance testing of a physical device.

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

Not applicable. This type of study is specific to evaluating the clinical impact of AI-assisted diagnostic or decision-making tools. The device is a surgical instrument.

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

Not applicable. The device is a physical instrument, not an algorithm.

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

Not applicable. The "ground truth" for this device would be its adherence to pre-defined engineering design specifications and performance characteristics, verified through physical and mechanical testing, not clinical diagnostic accuracy.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable. There is no "training set" or corresponding ground truth establishment in the context of AI/ML.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

G-21 S.R.L. % Mr. Paul Speidel Senior Regulatory/Quality Consultant ROMIS. Inc. 110 Haverhill Road Suite 526 Amesbury, Massachusetts 01913

August 23, 2017

Re: K172214

Trade/Device Name: Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN, HRX Dated: July 21, 2017 Received: July 24, 2017

Dear Mr. Speidel:

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

Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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INDICATIONS FOR USE

510(k) Number (if known): K172214

Device Name: Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters

Indications for Use:

Prescription Use X____________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use ________ (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) SUMMARY

G-21 S.R.L.'s Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters

Submitter	G-21 S.R.L.Maurizio ForoniVia S. Pertini, 8San Possidonio, Italy 41039Phone: +39 0535 30312
Contact Person:	Barry SandsRQMIS, Inc.110 Haverhill Road, Suite 526Amesbury, MA 01913Phone: 978-358-7307
Date Prepared:	July 21, 2017
Name of Device	Modified Winch Kyphoplasty(15 and 20 mm) 11 GaugeBalloon Catheters
Name/Address of Sponsor:	G-21Maurizio ForoniVia S. Pertini, 8San Possidonio, Italy 41039

Common or Usual Name

Kyphoplasty Balloon Catheter

Classification Name

Cement, Bone, Vertebroplasty, Class II (21 CFR 888.3027) Arthroscope, Class II (21 CFR, Sec. 888.1100)

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Product Codes

HRX and NDN

Predicate Device

K152557, Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters

Intended Use / Indications for Use

Indications for Use:

Technological Characteristics

The Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters are primarily composed of polyurethane, polycarbonate, and polyether/polyamide materials. A Silicone lubricant is provided to facilitate insertion of the catheters. This premarket submission represents a change to the balloon material to a different type of polyurethane.

Device Description

Image /page/4/Picture/12 description: The image shows a medical device, possibly a catheter or similar instrument, laid out horizontally. It features a connector at one end, a long, slender tube, and a tip at the opposite end, which is encircled and labeled 'A'. The device appears to be designed for insertion into the body, with the connector facilitating attachment to other medical equipment.

Figure 1: Modified Winch Kyphoplasty 11 Gauge Balloon Catheter

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Image /page/5/Picture/0 description: This image is a figure that shows an isometric view of the modified winch kyphoplasty 11 gauge balloon catheter. The catheter is long and thin, with a balloon at the end. The catheter is used to treat vertebral compression fractures. The figure is labeled as Figure 2.

Performance Data

Using design FMECA, G21 identified the necessary verification and validation testing to assure the new balloon met the catheters original performance specifications. All testing demonstrated that the modified catheters continues to meet all performance specifications.

Substantial Equivalence

G-21 used dFMECA to determine substantial equivalence. The Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters and the K152557 predicate device have the same intended use/indications for use, equivalent technical characteristics, and identical principles of operation.

G-21 submits the information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters is substantially equivalent in indications, design principles, and performance standards to the predicate device.

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.”